Headgear and method for forming headgear

Abstract

To provide a closed-loop headgear having a connection mechanism with a mask assembly that ensures that the patient interface seal remains centered on the user's face when donning or doffing the headgear. [Solution] Headgear 9102 for use in combination with a respiratory device includes a unitary plastic core within a textile casing, where the plastic core material penetrates or breaks through the textile casing of the straps. Some configurations include a junction housing with an overmolded section, alignment posts, T-joints, and injection openings. A variety of connectors connect the headgear assembly to a mask assembly, where the headgear, mask, and connector form a closed loop and the connector is detachable from the mask assembly.

Description

Technical Field

[0001] Incorporation by reference to any priority applications This application claims priority to and is related to U.S. Provisional Patent Application Nos. 62 / 309,400, 62 / 323,459, 62 / 364,767, 62 / 401,462, 62 / 468,915, 62 / 323,489, and 62 / 327,942, the entireties of which are hereby incorporated by reference and made a part of this disclosure.

[0002] The present disclosure generally relates to headgear used in combination with a breathing apparatus. More particularly, the present disclosure relates to the formation of three-dimensional headgear, parts of three-dimensional headgear, and processes for molding such headgear. Further applications of the molding process are also disclosed. The present disclosure also generally relates to a full-face sub-nasal patient interface having various components of a closed-loop headgear and a patient interface.

Background Art

[0003] A patient interface is used to provide respiratory therapy to the airway of a person suffering from any of a number of respiratory diseases or conditions. Such therapies can include, but are not limited to, continuous positive airway pressure (CPAP) therapy and non-invasive ventilation (NIV) therapy.

[0004] CPAP therapy can be used to treat obstructive sleep apnea (OSA), which is a condition in which a patient's airway intermittently collapses during sleep, preventing the patient from breathing for a period of time. The cessation of breathing, i.e., apnea, causes the patient to wake up. Due to frequent repeated apneas, the patient may rarely achieve a full and restorative night's sleep.

[0005] CPAP therapy involves delivering a continuous positive pressure (CPAP) supply to the patient's airway via a patient interface. The continuous positive pressure acts as a splint within the patient's airway, holding it open so that the patient's breathing and sleep are not interrupted.

[0006] A patient interface typically comprises a mask assembly and a headgear assembly, the mask assembly being configured to deliver a supply of continuous positive airway pressure to the patient's airway via a seal or cushion that forms a substantial airtight seal in or around the patient's nose and / or mouth. Mask assemblies are available in a wide range of styles, including full-face masks, nasal masks, direct-nasal masks, and mouth masks, which create a substantial airtight seal with the nose and / or mouth. The seal or cushion is held in place on the patient's face by the headgear assembly. To maintain a substantial airtight seal, the headgear assembly should provide support to the mask assembly so that it is held in a stable position relative to the patient's face during use. Such patient interfaces can also be used to deliver NIV and other therapies.

[0007] The patient interface creates a substantial “seal” over or around the user’s nose and / or mouth, while the cannula, although not providing a seal, provides a delivery route for supplemental respiratory gas delivery. The combination of this “seal” and the sealed area of ​​the respiratory device and its internal pressure generates a force that tends to push the respiratory device away from the face. To counteract this force, a headgear is typically used, featuring a continuous strap that passes around the back and / or top of the user’s head. [Overview of the project] [Problems that the invention aims to solve]

[0008] A common problem with adjustable headgear, specifically subnasal masks and headgear requiring the formation of left and right connection points, is that the user may overtighten one side of the headgear, causing the mask to be pulled off-center. In other cases, the user may simply pull the mask off-center as a result of connecting one side of the mask first. While over-nasal masks are centered by the apex of the mask seal, subnasal masks may be more prone to being pulled off-center than masks that pass over the nasal bridge because the nasal portion may be compressed. Therefore, it is desirable to form a closed-loop headgear design with a connection mechanism to the mask assembly that ensures the patient interface seal remains centered on the user's face when the headgear is put on or taken off. [Means for solving the problem]

[0009] The systems, methods, and apparatus described herein have innovative aspects, and none of them are essential, nor do any of them individually possess desirable attributes. Some of the advantageous features are outlined here without limiting the scope of the claims.

[0010] According to at least one of the embodiments disclosed herein, a headgear is provided. The headgear includes a top strap and a bottom strap, the bottom strap being connected to the top strap at a position between the ends of the bottom strap. A single plastic core material is integrally formed within the textile casing of both the top strap and the bottom strap.

[0011] In a further embodiment, a single plastic core material extends through at least one of the textile casings of the top strap and the bottom strap.

[0012] In a further embodiment, the textile casing has a seamless tubular shape.

[0013] In a further embodiment, the textile casing is knitted, woven, braided, or crocheted.

[0014] In a further embodiment, the end of the textile casing of the top strap is in contact with the textile casing of the bottom strap.

[0015] In a further embodiment, the textile casing of the top strap extends radially outward along the length of the top in the direction toward the end of the top strap.

[0016] In a further embodiment, the end of the textile casing of the top strap has a sealing portion, which is formed by cutting with a hot knife.

[0017] In a further embodiment, the headgear further includes a filament core bonded to a single plastic core material within a bottom strap.

[0018] In a further embodiment, the headgear further includes a strap connector disposed on the outer surface of at least one of the top strap and the bottom strap, the strap connector being formed from a single plastic core material.

[0019] According to at least one of the embodiments disclosed herein, a method for forming a headgear in a mold is provided. The method includes the steps of: positioning a first tubular textile casing and a second tubular textile casing in the cavity of a mold; introducing molten plastic material into the mold and into the first tubular textile casing; pushing the molten plastic material through the first tubular textile casing into the second tubular textile casing; and allowing the molten plastic material to solidify within the first and second textile casings to form an integrated plastic core.

[0020] In a further embodiment, the step of pushing molten plastic material into the second tubular textile casing through the first tubular textile casing further includes displacing the threads of the first tubular textile casing to form a gap in the first tubular textile casing into which the molten plastic material flows into the second tubular textile casing.

[0021] In a further embodiment, the step of pushing molten plastic material into the second tubular textile casing through the first tubular textile casing further includes tearing the threads of the first tubular textile casing to form holes in the first tubular textile casing into which the molten plastic material flows.

[0022] In a further embodiment, the step of arranging a first tubular textile casing and a second tubular textile casing within the cavity of a molding die further includes positioning the first tubular textile casing so as to be in contact with the second tubular textile casing.

[0023] In a further embodiment, the open end of the first tubular textile casing abuts against the second tubular textile casing at a position between the ends of the second tubular textile casing.

[0024] In a further embodiment, the first tubular textile casing and the second tubular textile casing are in contact with each other at a position between their ends.

[0025] In a further embodiment, the outer edge of the cavity narrows relative to the central portion of the cavity, thereby tightening the outer edges of the first tubular textile casing and the second tubular textile casing to prevent molten plastic material from flowing between the outer edges of the first and second tubular textile casings.

[0026] According to a further aspect, the central portion of the cavity includes a protrusion that presses down on at least one surface of the first tubular textile casing and the second tubular textile casing, whereby a recess is integrally formed in at least one surface of the first tubular textile casing and the second tubular textile casing.

[0027] According to at least one of the embodiments disclosed herein, a method of forming a headgear within a mold is provided. The method includes placing a first tubular textile casing within a cavity of a first mold, positioning a portion of the first tubular textile casing to contact an adjacent cavity having the shape of a connector portion, introducing a molten plastic material into the mold and within the first tubular textile casing, pushing the molten plastic material through the first tubular textile casing into the adjacent cavity, and solidifying the molten plastic material within the first tubular textile casing to form a first strap portion having an internal core formed from a single plastic core and a connector portion.

[0028] According to a further aspect, the method further includes placing the first strap portion within a second mold, positioning an end of a second tubular textile casing over the connector portion and to contact the first tubular textile casing of the first strap portion, introducing a molten plastic material into the second mold and within the second tubular textile casing, and solidifying the molten plastic material within the second textile casing to form a second strap portion having an internal core formed from a single plastic material connected to the connector portion of the first strap portion.

[0029] According to at least one of the embodiments disclosed herein, a headgear assembly is provided. The headgear assembly comprises a top strap, upper side straps connected to the top strap, and lower side straps connected to the upper side straps. The upper and lower side straps are formed as a single, integrated structure.

[0030] In a further embodiment, the upper side strap and the lower side strap are formed as a closed-loop structure.

[0031] In a further embodiment, the top strap, upper side strap, and lower side strap are formed as a single, integrated structure.

[0032] In a further embodiment, the top strap, upper side strap, and lower side strap are formed as a closed-loop structure.

[0033] In a further embodiment, the upper and lower side straps are joined by an intra-moulded web.

[0034] In a further embodiment, the headgear assembly further includes a neck panel attached to at least one of a top strap and a lower side strap.

[0035] In a further embodiment, at least one of the top strap and the neck panel includes a breathable, moisture-absorbing material.

[0036] In a further embodiment, the top strap includes a quilted textile material.

[0037] In a further embodiment, a single plastic core material is integrally formed within the upper side strap and the lower side strap.

[0038] In a further embodiment, a single plastic core material is integrally formed within the top strap, upper side strap, and lower side strap.

[0039] According to at least one of the embodiments disclosed herein, a tubular connector is provided for attaching the end of a first strap to the side wall of a second strap. The connector includes a first end having a shape corresponding to the shape of the end of the first strap and in contact with the end of the first strap; a second end located on the opposite side of the first end and having a shape corresponding to the side wall of the second strap and in contact with the side wall of the second strap; a cavity located between the first and second ends; and a plastic core material located within the cavity, the plastic core material unit joining the first and second straps together to form an integral structure.

[0040] In a further embodiment, the first end overlaps with the end of the first strap.

[0041] In a further embodiment, the end of the first strap is in contact with the second strap.

[0042] In a further embodiment, the second end overlaps with the side wall of the second strap.

[0043] According to at least one of the embodiments disclosed herein, a method is provided for joining the end of a first strap to the side wall of a second strap within a molding die. The method includes the steps of: positioning the end of a first tubular textile casing within the cavity of a tubular connector, and positioning a portion of the side wall of a second tubular textile casing adjacent to or within the cavity of a tubular connector; arranging the first tubular textile casing, the second tubular textile casing, and the tubular connector within the cavity of a molded tubular mold; introducing molten plastic material into the molded tubular mold and into the first tubular textile casing; injecting the molten plastic material into the second tubular textile casing through the first tubular textile casing and the tubular connector; and solidifying the molten plastic material within the first tubular textile casing, the second tubular textile casing, and the tubular connector to form a single internal core from the plastic material within the first tubular textile casing, the second tubular textile casing, and the tubular connector.

[0044] In a further embodiment, the positioning step includes bringing the end of the first tubular textile casing into contact with the second tubular textile casing.

[0045] According to at least one of the embodiments disclosed herein, a strap connector assembly is disclosed for connecting a first strap and a second strap, each of which has a single plastic core in a textile casing, the assembly comprising: a first connector portion located at the end of the first strap; and a second connector portion located between the ends of the second strap, having a projection of the single plastic core protruding through the textile casing of the second strap, and configured to align with the first connector portion to facilitate connection of the first and second straps. In a further embodiment, the thickness of the first connector portion is equal to the thickness of the second connector portion. In a further embodiment, the first and second connector portions are configured to have a gap between them when aligned to facilitate connection of the first and second straps. In a further embodiment, the strap connector assembly further comprises an alignment recess located in the first connector portion, which is configured to engage with a projection located on the inner surface of a mold to maintain the position of the first connector portion relative to the mold. In a further embodiment, the strap connector assembly further comprises an overmolded fitting that is overmolded over the first and second connector portions. In a further embodiment, the thickness of the overmolded fitting is equal to the thickness of the first and second connector portions. In a further embodiment, the overmolded fitting is in contact with the textile casing of the first and second straps. In a further embodiment, the first and second connector portions are shaped to interlock with each other. In a further embodiment, the first connector portion comprises an extension of a single plastic core that extends beyond the textile casing. In a further embodiment, the first connector portion extends beyond the end of the textile casing. In a further embodiment, the first and second connector portions are male and female connector portions, respectively. In a further embodiment, each of the first and / or second connector portions comprises a tab.In a further embodiment, the first connector portion and / or the second connector portion have a width equal to the width of the individual plastic core of the first strap and the second strap, respectively.

[0046] According to at least one of the embodiments disclosed herein, a strap connector assembly is disclosed for connecting a first strap portion and a second strap portion, each of which comprises a single plastic core within a textile casing, the assembly comprising: a joining tab comprising a portion of one of the single plastic cores of the strap and configured to connect the first strap portion and the second strap portion; an alignment post protruding from the surface of the joining tab; and an overmolded fitting overmolded on the joining tab. In a further embodiment, the thickness of the alignment post is greater than the thickness of the joining tab. In a further embodiment, the thickness of the alignment post is equal to the thickness of the overmolded fitting. In a further embodiment, the overmolded fitting is formed from an elastomer material. In a further embodiment, the strap connector assembly further comprises a label formed within the surface of the overmolded fitting.

[0047] According to at least one of the embodiments disclosed herein, a strap connector is disclosed for connecting a first strap portion and a second strap portion, the strap portion comprising a single plastic core within a textile casing, comprising: a housing having an external cavity located at the end of the housing and configured to receive the ends of the first strap portion and the second strap portion; an internal cavity located between the external cavity; and an injection opening extending between the internal cavity and the external cavity, through which the single plastic core of the strap portion extends. According to a further embodiment, the height of the external cavity is greater than the height of the internal cavity. According to a further embodiment, the height of the internal cavity is equal to the thickness of the single plastic core within the textile casing.

[0048] According to at least one of the embodiments disclosed herein, a strap assembly for headgear is disclosed, comprising a textile casing having an outer surface facing away from the user, an inner surface facing towards the user, and a cavity disposed between the outer surface and the inner surface, and a plastic core material disposed within the cavity of the textile casing, wherein the outer surface of the textile casing is convex. According to a further embodiment, the inner surface of the textile casing is substantially planar. According to a further embodiment, the inner surface of the textile casing is concave.

[0049] According to at least one of the embodiments disclosed herein, a strap assembly for headgear is disclosed, comprising a textile casing including an ear arch region configured to be positioned above the ears of the user, and a plastic core disposed within a cavity of the textile tubular casing, wherein the distance between the plastic core and the edge of the textile casing in the ear arch region is greater than the distance in the rest of the strap assembly.

[0050] According to at least one of the embodiments disclosed herein, a headgear assembly is disclosed comprising a headgear loop strap configured to receive the top and rear of a user's head, the headgear loop strap comprising a single plastic core integrally formed with a textile casing, and a connector tab portion formed from the single plastic core and projecting through the textile casing between the ends of the headgear loop strap; a front strap; and a connector positioned on the connector tab portion of the headgear loop strap and the end of the front strap. In a further embodiment, the connector is overmolded on the ends of the headgear loop strap and the front strap. In a further embodiment, the thickness of the connector is equal to the thickness of the connector tab portion. In a further embodiment, the thickness of the connector is equal to the thickness of the headgear loop strap. In a further embodiment, the headgear loop strap further comprises an alignment tab extending from the end of the headgear loop strap, the alignment tab comprising a portion of the single plastic core of the headgear loop strap, and an alignment post projecting from the surface of the joining tab.

[0051] According to at least one of the embodiments disclosed herein, a strap connector assembly is disclosed for connecting a first strap portion and a second strap portion, each of which comprises a single plastic core within a textile casing, the assembly comprising: a first connector portion located at the end of the first strap; a second connector portion located between the ends of the second strap and projecting through the textile casing of the second strap; and an overmolded fitting overmolded on the first and second connector portions. In a further embodiment, at least one of the first and second connector portions further comprises an alignment post projecting from the surface of the first strap, and the overmolded fitting surrounds the alignment post. In a further embodiment, at least one of the first and second connector portions further comprises a recessed region formed in a concave shape within the surface of the first strap, the recessed region receiving the overmolded material of the overmolded fitting. In a further embodiment, the strap connector assembly further comprises a recessed alignment recess formed in a concave shape within the surface of at least one of the first strap and the second strap, the alignment recess being configured to engage with a projection located on the inner surface of the molding die to maintain the position of at least one of the first strap and the second strap relative to the molding die.

[0052] According to at least one of the embodiments disclosed herein, a strap connector assembly is provided for connecting a first strap and a second strap in a mold. The straps are formed from a single plastic core injected into a tubular textile casing. The strap connector assembly includes a male connector portion located at the end of the first strap and a female connector portion located between the ends of the second strap, the female connector portion protruding through the textile casing of the second strap. The female connector portion is configured to engage with the male connector portion so that the first strap and the second strap are connected. The male connector portion and the female connector portion are formed from a molten single plastic core material. According to a further embodiment, the thickness of the male connector portion is equal to the thickness of the female connector portion. According to a further embodiment, the strap connector assembly includes a further gap between the male connector portion and the female connector portion. According to a further embodiment, the strap connector assembly further includes an alignment recess located in the male connector portion, which is configured to engage with a projection located on the inner surface of the mold to maintain the position of the male connector portion relative to the mold. In a further embodiment, the strap connector assembly further includes an overmolded fitting that is overmolded over the male connector portion and the female connector portion. In a further embodiment, the thickness of the overmolded fitting is equal to the thickness of the male connector portion and the thickness of the female connector portion. In a further embodiment, the overmolded fitting is in contact with the textile casings of the first strap and the second strap.

[0053] According to at least one of the embodiments disclosed herein, a strap connector assembly is provided for connecting a first strap portion and a second strap portion within a mold. The strap portion is formed from a single plastic core injected into a textile casing. The strap connector assembly includes a joining tab formed from the single plastic core material and configured to connect the ends of the first strap portion and the second strap portion, an alignment post protruding from the surface of the joining tab, and an overmolded fitting overmolded on the joining tab. According to a further embodiment, the thickness of the alignment post is greater than the thickness of the joining tab.

[0054] In a further embodiment, the thickness of the alignment post is equal to the thickness of the overmolded joint.

[0055] In a further embodiment, the overmolded joint is formed from an elastomer material.

[0056] In a further embodiment, the strap connector assembly further includes a label formed within the surface of the overmolded fitting.

[0057] According to at least one of the embodiments disclosed herein, a strap connector is provided for connecting a first strap portion and a second strap portion within a mold. The strap portion is formed from a single plastic core injected into a textile casing. The strap connector includes an external cavity located at the end of the housing and configured to receive the ends of the first strap portion and the second strap portion; an internal cavity located between the external cavities; and an injection opening configured to fluidly communicate with the internal cavity and the external cavity and to receive the single plastic core material.

[0058] In a further embodiment, the height of the external cavity is greater than the height of the internal cavity.

[0059] In a further embodiment, the height of the internal cavity is equal to the thickness of the single plastic core material within the tubular textile casing.

[0060] According to at least one of the embodiments disclosed herein, a strap assembly for headgear is provided. The strap assembly includes a textile tubular casing having an outer surface facing away from the user and an inner surface facing towards the user, and a plastic core material disposed within a cavity of the textile tubular casing. The outer surface of the textile tubular casing has a convex shape.

[0061] In a further embodiment, the inner surface of the textile casing has a substantially planar shape.

[0062] In a further embodiment, the inner surface of the textile casing has a concave shape.

[0063] According to at least one of the embodiments disclosed herein, a headgear assembly is provided. The headgear assembly includes a headgear loop strap configured to receive the top and rear of the user's head. The headgear loop strap includes a single plastic core material formed integrally with a textile casing, and connector tab portions formed from the single plastic core and protruding through the tubular textile casing of the headgear loop strap between the ends of the headgear loop strap. The headgear assembly further includes a front strap and a connector positioned above the connector tab portions of the headgear loop strap and the ends of the front strap.

[0064] In a further embodiment, the connector is overmolded onto the ends of the headgear loop strap and the front strap.

[0065] In a further embodiment, the thickness of the connector is equal to the thickness of the connector tab portion.

[0066] In a further embodiment, the thickness of the connector is equal to the thickness of the headgear loop strap.

[0067] In a further embodiment, the headgear loop strap further includes an alignment tab extending from the end of the headgear loop strap, the alignment tab comprising a portion of the single plastic core of the headgear loop strap, an alignment post protruding from the surface of the joining tab, and an overmolded fitting overmolded on the alignment tab and configured to connect the end of the headgear loop strap.

[0068] According to at least one of the embodiments disclosed herein, a strap connector assembly is provided for connecting a first strap portion and a second strap portion within a mold. The strap portion is formed from a single plastic core material injected into a tubular textile casing. The strap connector assembly includes a first connector portion located at the end of the first strap, a second connector portion located between the ends of the second strap and protruding through the tubular textile casing of the second strap, and an overmolded fitting overmolded on the first and second connector portions.

[0069] In a further embodiment, at least one of the first connector portion and the second connector portion further comprises an alignment post protruding from the surface of the first strap, and the overmolded joint surrounds the alignment post.

[0070] In a further embodiment, at least one of the first connector portion and the second connector portion further comprises a recessed region formed in a concave shape within the surface of the first strap, the recessed region receiving the overmolding material of the overmolded joint.

[0071] In a further embodiment, the strap connector assembly further includes a recessed alignment recess formed concavely within the surface of at least one of the first strap and the second strap, the alignment recess being configured to engage with a projection located on the inner surface of the molding die to maintain the position of at least one of the first strap and the second strap relative to the molding die.

[0072] In some configurations, the headgear assembly for the patient interface comprises a headpiece and at least one connector. The headpiece comprises a top strap, a front strap, and a rear strap. The connector includes a first strap and a second strap. The first strap is configured to extend from the mask assembly above and behind the user's ears. The second strap is configured to extend from the mask assembly below and behind the user's ears. The first strap joins the second strap at the rear connector portion. The connector includes at least one headpiece connection surface configured to connect to the headpiece. The headpiece includes at least one connector connection surface configured to connect to at least one headpiece connection surface of the connector.

[0073] In some configurations, one or more of the headpiece's top strap, rear strap, and front strap comprise separate left and right sections, each with a free end. The free ends of the left and right sections are adjustablely connected to one another.

[0074] In some configurations, the top strap and front strap meet at the junction.

[0075] In some configurations, the joint forms part of the ear loop.

[0076] In some configurations, the rear strap forms part of the ear loop.

[0077] In some configurations, the ear loop is designed to surround the user's ear without making contact with it.

[0078] In some configurations, at least one connector connection surface is configured to connect to at least one headpiece connection surface along a C-shaped connection area that extends from above to below the user's ear.

[0079] In some configurations, at least one connector connection surface is configured to connect to at least one headpiece connection surface along a connection wire that extends upward and downward from behind the user's ear, with the entire connection wire positioned above the lowest limit of the user's ear.

[0080] In some configurations, the patient interface comprises a mask assembly and the headgear assembly described above.

[0081] In some configurations, the headgear assembly for the patient interface comprises a headpiece and at least one connector. The headpiece comprises a top strap, a front strap, and a rear strap. The connector includes a middle strap and a lower strap. The middle strap is configured to extend from the mask assembly above and behind the user's ears. The lower strap is configured to extend from the mask assembly below and behind the user's ears. The middle strap joins the lower strap at the rear connector portion. The connector includes at least one headpiece connection surface configured to connect to the headpiece. The headpiece includes at least one connector connection surface configured to connect to at least one headpiece connection surface of the connector.

[0082] According to at least one of the embodiments disclosed herein, a patient interface is provided. The patient interface includes a headgear assembly, a mask assembly, and a connector portion that connects the headgear assembly to the mask assembly. The headgear assembly, the mask assembly, and the connector portion form a closed loop when the connector is separated from the mask assembly.

[0083] In a further embodiment, the effective length of the closed loop increases when the connector portion is separated from the mask assembly compared to the effective length of the closed loop when the connector portion is engaged with the mask assembly.

[0084] In a further embodiment, the connector portion is attached to the mask assembly by a hinge portion.

[0085] In a further embodiment, the connector portion is attached to the mask assembly by a tether.

[0086] In a further embodiment, the hinge is a living hinge.

[0087] In a further embodiment, the hinge portion is formed from silicone.

[0088] In a further embodiment, the living hinge is made of fabric.

[0089] In a further embodiment, the patient interface further includes a hook positioned on top of the mask assembly, with a post positioned on top of the connector. The hook engages with the mask assembly by receiving the post that accepts the hook.

[0090] In a further embodiment, the connector portion engages with the mask assembly via a snap fit or a press-fit.

[0091] In a further embodiment, the headgear assembly has a strap formed from a textile casing having a single plastic core material integrally formed inside.

[0092] In a further embodiment, the difference between the effective length of the closed loop when the connector portion is separated from the mask assembly and the effective length of the closed loop when the connector portion is engaged with the mask assembly is at least 40 millimeters.

[0093] Further embodiments of one or more of the present invention, which should be considered in all novel aspects, will become apparent from the following description.

[0094] Reference numerals may be reused in the drawings to illustrate the approximate correspondence between reference elements. The drawings are provided to illustrate the embodiments described herein and are not intended to limit the scope of this disclosure. [Brief explanation of the drawing]

[0095] [Figure 1A] This shows a side view of a bifurcated headgear configuration formed by the burst-through intra-mouling configuration of this disclosure. [Figure 1B] The above shows a top perspective view of the bifurcated headgear configuration of this disclosure. [Figure 2A] This shows an enlarged side view of the joint between the top strap and the bottom strap of the bifurcated headgear configuration of this disclosure. [Figure 2B] This shows an enlarged side view of the joint between the top strap and the bottom strap of the bifurcated headgear configuration of this disclosure. [Figure 3] This diagram shows a cross-sectional view of the joint between the top strap and the bottom strap of the bifurcated headgear configuration of this disclosure. [Figure 4] A perspective view of the injection mold forming the bifurcated headgear configuration of this disclosure is shown. [Figure 5] This shows a top view of the second half of the injection molding die. [Figure 6] This shows an enlarged top perspective view of the top and bottom straps positioned within the second mold half of the injection molding die. [Figure 7] This shows a bottom cross-sectional view of the fully formed bifurcated headgear section. [Figure 8A] A perspective view of the second mold half shows an alternative in-mold strap cavity configuration that forms an X-shaped joint and a T-shaped joint. [Figure 8B] A top view of a strap configuration having X-shaped and T-shaped joints is shown. [Figure 9A] The image shows a top view of an alternative in-mold strap configuration having straps joined to one another by integrally formed connecting members positioned between the straps. [Figure 9B] The image shows a top view of an alternative in-mold strap configuration having straps joined to one another by integrally formed web sections positioned between them. [Figure 10A] A top view is shown of an alternative in-mold strap configuration having a fillet-shaped joint that connects a fillet-shaped strap to an adjacent strap. [Figure 10B] This shows a top perspective view of an injection molding die that forms a fillet-shaped joint. [Figure 11A] The image shows a top view of an in-mold strap configuration having a molded square texture engraved on the strap. [Figure 11B] This shows a magnified top view of the molded square texture etched into the strap. [Figure 11C] Figure 11B shows a cross-sectional view of the molded square texture engraved on the strap along line 11C-11C. [Figure 11D] This shows a top view of an in-molded strap configuration having a molded hexagonal texture engraved on the strap. [Figure 11E] This shows a side perspective view of the molded hexagonal texture engraved on the strap. [Figure 12A] This shows a top view of the first molding die that forms the bottom strap along with the mounting member for the in-mold bifurcated headgear. [Figure 12B] An enlarged top view of the first molding die showing the bottom strap and mounting member is shown. [Figure 13A] This is a top view of the second molding die that forms the top strap on the mounting member. [Figure 13B] This shows an enlarged top view of the second molding die, illustrating the state in which the top strap is attached to the bottom strap. [Figure 13C] This shows a magnified cross-sectional view of the top strap positioned on the mounting member before the plastic core material is injected into the top strap. [Figure 13D] This shows a magnified cross-sectional view of the top strap attached to the mounting member after the plastic core material has been injected into the top strap. [Figure 14A] This shows an enlarged side view of the top strap, which has a sealed end at the connection point with the bottom strap. [Figure 14B] An enlarged side view of the top strap with a sealing end is shown. [Figure 14C] This shows an enlarged side view of the top strap having a sealing end attached to the bottom strap at the joint. [Figure 14D] This shows a cross-sectional view of the joint between the top strap and the bottom strap. [Figure 15A] This is an enlarged side cross-sectional view showing the top strap attached to the bottom strap, which has a filament core coupled to the bottom strap that engages with a deformation locking mechanism. [Figure 15B] This shows a top view of the bifurcated headgear section, which has a bottom strap to which the filament core is attached. [Figure 15C] A top view is shown illustrating the extension of the casing length for the bottom strap. [Figure 15D] A top view is shown illustrating how the width of the casing for the bottom strap narrows when stretched. [Figure 16A] A side perspective view is shown of an alternative bifurcated headgear configuration having a button and hole size adjustment system formed by the breakthrough mold internal molding configuration of this disclosure. [Figure 16B]A cross-sectional view of the top and bottom straps, which have a button and hole size adjustment system, is shown. [Figure 16C] This is a side perspective view of an injection mold that forms the buttons for a button and hole size adjustment system. [Figure 16D] The images show cross-sectional views of the first and second mold halves during the process of in-mold forming buttons for a button and hole size adjustment system. [Figure 17] This shows an adjustable strap configuration with adjustment and utility mechanisms formed by a breakthrough mold in-house molding process. [Figure 18] This shows an in-mold headgear having multiple straps and multiple perforated joints. [Figure 19] This example shows a headgear incorporating an additional comfort layer, along with in-mold and breakthrough processes. [Figure 20] This shows another exemplary headgear incorporating an additional comfort layer, along with in-mold and breakthrough processes. [Figure 21] An exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having a web section that joins the rear of the lower and middle straps. [Figure 22] Another exemplary headgear is shown, incorporating in-mold molding and breakthrough processes and featuring a continuous lower strap. [Figure 23] An exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having a web section that joins the rear of the lower and middle straps. [Figure 24] An exemplary headgear is shown, incorporating in-mold forming and breakthrough processes, and having a continuous lower strap combined with continuous middle and vertical straps. [Figure 25] An exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having lower and middle straps formed from a continuous casing in the form of a closed-loop structure. [Figure 26]Another exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having lower and middle straps formed from a continuous casing in the form of a closed-loop structure. [Figure 27] An exemplary headgear is shown, incorporating in-mold and break-through processes, and having quilted fabric or material attached to parts of the headgear to come into direct contact with the user's skin or hair. [Figure 28] Another exemplary headgear is shown, incorporating in-mold and break-through processes, and having quilted fabric or material attached to parts of the headgear to come into direct contact with the user's skin or hair. [Figure 29] This exhibits exemplary headgear incorporating in-mold and break-through processes, featuring vertical and neck straps formed from foam-Lycra laminate material. [Figure 30] This example shows a headgear incorporating in-mold and breakthrough processes, featuring breathable, moisture-absorbing material on the vertical and neck straps. [Figure 31] This exhibits an exemplary headgear incorporating in-mold and breakthrough processes, and lower and middle straps formed from a continuous casing in the form of a closed-loop structure. [Figure 32] An exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having a bottom lower strap, a middle strap, and a front vertical strap formed from a continuous casing in the form of a closed-loop structure. [Figure 33] An exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having lower and middle straps formed from a continuous casing in the form of a closed-loop structure. [Figure 34] An exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having lower and middle straps formed from a continuous casing in the form of a closed-loop structure. [Figure 35]An exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having a lower strap and a middle strap with a continuous casing. [Figure 36] An exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having lower and middle straps formed from a continuous casing in the form of a closed-loop structure. [Figure 37] An exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having lower and middle straps formed from a continuous casing. [Figure 38] Another exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having lower and middle straps formed from a continuous casing. [Figure 39] An exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having lower and middle straps formed from a continuous casing. [Figure 40] An exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having lower, middle, and vertical straps formed from a continuous casing. [Figure 41] An exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having a lower strap, as well as a middle strap and vertical strap formed from a continuous casing. [Figure 42] An exemplary headgear is shown, incorporating in-mold and breakthrough processes, and having lower and middle straps formed from a continuous casing. [Figure 43A] This is a front perspective view of an exemplary headgear that can be used with a patient interface. [Figure 43B] Figure 43A is a rear perspective view of an exemplary headgear. [Figure 44A] This is a front perspective view of an exemplary headgear that can be used with a patient interface. [Figure 44B]Figure 44A is a rear perspective view of an exemplary headgear. [Figure 45A] This is a front perspective view of an exemplary headgear that can be used with a patient interface. [Figure 45B] Figure 45A is a rear perspective view of an exemplary headgear. [Figure 46A] This is a front perspective view of an exemplary headgear that can be used with a patient interface. [Figure 46B] Figure 46A is a side view of an exemplary headgear. [Figure 46C] Figure 46A is a rear perspective view of an exemplary headgear. [Figure 47A] This is a front perspective view of an exemplary headgear that can be used with a patient interface. [Figure 47B] Figure 47A is a rear perspective view of an exemplary headgear. [Figure 48A] This is a front perspective view of an exemplary headgear that can be used with a patient interface. [Figure 48B] Figure 48A is a rear perspective view of an exemplary headgear. [Figure 49A] This is a front perspective view of an exemplary headgear that can be used with a patient interface. [Figure 49B] Figure 49A is a rear perspective view of an exemplary headgear. [Figure 50A] This is a front perspective view of an exemplary headgear that can be used with a patient interface. [Figure 50B] Figure 50A is a rear perspective view of an exemplary headgear. [Figure 51A] This is a side view of an exemplary headgear that can be used with a patient interface. [Figure 51B] Figure 51A is a cross-sectional view of the strap portion of an exemplary headgear. [Figure 52A] This is a side view of an exemplary headgear that can be used with a patient interface. [Figure 52B] Figure 52A is a cross-sectional view of the strap portion of an exemplary headgear. [Figure 52C] Figure 52A is a cross-sectional view of the strap portion of an exemplary headgear. [Figure 53A] This is a side view of an exemplary headgear that can be used with a patient interface. [Figure 53B] Figure 53A is a cross-sectional view of the strap portion of an exemplary headgear. [Figure 54A] This is a side view of an exemplary headgear that can be used with a patient interface and has a lower strap and a middle strap formed from a continuous casing. [Figure 54B] Figure 54A is a magnified view of the web portion of the example headgear shown. [Figure 54C] This is a cross-sectional view of the web portion along line 54C-54C in Figure 54B. [Figure 55A] This is a side view of an exemplary headgear that can be used with a patient interface and has continuous lower straps combined with continuous middle and vertical straps. [Figure 55B] This is a cross-sectional view of the web portion of an exemplary headgear along line 55B-55B in Figure 55A. [Figure 55C] Figure 55A is a magnified view of the web portion of the example headgear shown. [Figure 56A] This is a side view of an exemplary headgear that can be used as a patient interface, with lower and middle straps formed from a continuous casing in the form of a closed-loop structure. [Figure 56B] Figure 56A is an enlarged view of the joint of an example headgear. [Figure 57A] This is a side view of an exemplary headgear that can be used with a patient interface and has a lower strap and a middle strap formed from a continuous casing. [Figure 57B] Figure 57A is an enlarged view of the second vertical member of the exemplary headgear shown. [Figure 57C] This is a cross-sectional view of the second vertical member along line 57C-57C in Figure 57B. [Figure 58A]This is a side view of an exemplary headgear that can be used with a patient interface. [Figure 58B] Figure 58A is an enlarged view of the joint of an example headgear. [Figure 59A] This is a side view of an exemplary headgear that can be used with a patient interface and has continuous middle and vertical straps and continuous upper and rear straps. [Figure 59B] Figure 59A shows an enlarged view of the continuous middle and vertical straps, as well as the continuous upper and rear straps, of an exemplary headgear. [Figure 59C] These are cross-sectional views of the continuous middle and vertical straps, as well as the continuous upper and rear straps, along lines 59C-59C in Figures 59A and 59B. [Figure 60A] This is a side view of an exemplary headgear that can be used with a patient interface. [Figure 60B] Figure 60A is a close-up view of the rear strap of the exemplary headgear. [Figure 61A] This is a side view of an exemplary headgear that can be used with a patient interface and has continuous middle and vertical straps and continuous upper and rear straps. [Figure 61B] Figure 61A is a magnified view of the rear portion of the middle and lower straps of the example headgear. [Figure 61C] Figure 61B shows cross-sectional views of the continuous middle and vertical straps, as well as the continuous upper and rear straps, along line 61C-61C. [Figure 62A] This is a side view of an exemplary headgear that can be used with a patient interface. [Figure 62B] This is a magnified view of the deformation of the exemplary headgear shown in Figure 62A. [Figure 63A] This is a side view of an exemplary headgear, which can be used with a patient interface and has a quilted fabric or material attached to a portion of the headgear to make direct contact with the user's skin or hair. [Figure 63B]Figure 63A is a close-up view of the quilted fabric of an exemplary headgear. [Figure 63C] Figure 63A is a magnified view of an alternative web material for the exemplary headgear. [Figure 64A] This is a side view of an exemplary headgear, which can be used with a patient interface and has a fabric or textile material attached to a portion of the headgear to come into direct contact with the user's skin or hair. [Figure 64B] Figure 64A is a close-up view of the fabric or textile material of an exemplary headgear. [Figure 65] This is a magnified view of the disclosed headgear embodiment and the branded grip that can be used. [Figure 66A] This is a side view of the T-shaped joint between the end of the first strap and the center or middle part of the second strap. [Figure 66B] This is an enlarged view of the connector that forms the T-shaped joint in Figure 66A. [Figure 67] This is a perspective view of the T-shaped joint. [Figure 68A] This is a bottom view of the connector. [Figure 68B] This is a side view of the connector. [Figure 68C] This is a top view of the connector. [Figure 68D] This is a perspective view of the connector. [Figure 69] This is a side view of a T-shaped joint showing a connector positioned on the first strap such that the end of the first strap is positioned inside the connector. [Figure 70] This is a perspective view of the connector and T-shaped joint. [Figure 71] This is an enlarged side view of the filling connector and T-shaped joint. [Figure 72] This is a cross-sectional view of the filling connector and the T-shaped joint. [Figure 73] This is a side view of the filling connector and the T-shaped joint. [Figure 74A]A top view of the top strap of an exemplary headgear configuration having a male connector forming an overmolded joint is shown. [Figure 74B] A top view of the bottom strap of an exemplary headgear configuration having a female connector forming an overmolded joint is shown. [Figure 75A] This shows a magnified top view of the male connector on the top strap. [Figure 75B] This shows a magnified cross-sectional view of the male connector of the top strap. [Figure 76A] This shows a magnified top view of the female connector on the bottom strap. [Figure 76B] This shows a magnified cross-sectional view of the female connector of the bottom strap. [Figure 76C] This shows a magnified perspective view of the female connector on the bottom strap. [Figure 77A] Enlarged top views of aligned male and female connectors are shown. [Figure 77B] This shows an enlarged top view of a male connector inserted into and accepted by a female connector. [Figure 77C] This shows an enlarged cross-sectional view of a male connector inserted into and accepted by a female connector. [Figure 78A] Enlarged side views of the male and female connectors are shown, illustrating the relatively small gap between them. [Figure 78B] Enlarged side views of the male and female connectors are shown, illustrating the relatively large gap between them. [Figure 79A] An enlarged top view of the male connector is shown. [Figure 79B] This shows a perspective view of the overmolding cavity of an overmolding mold. [Figure 79C] This shows a cross-sectional view of a male connector inserted into the overmolded cavity of an overmolded mold. [Figure 80A] An enlarged top view of the overmolded joint connecting the top and bottom straps is shown. [Figure 80B] A perspective view of the overmolded joint connecting the top and bottom straps is shown. [Figure 80C] The diagram shows a bottom cross-section of the overmolded joint connecting the top and bottom straps. [Figure 81A] This shows a magnified top view of the joining tabs and alignment posts in front of the overmolding that joins the two halves of the bottom strap. [Figure 81B] Figure 81A shows an enlarged bottom view of the joining tab and alignment post. [Figure 81C] Figure 81A shows an enlarged cross-sectional view of the joining tab and alignment post. [Figure 81D] Figure 81A shows an enlarged top view of the overmolding formed on the joining tabs and alignment posts. [Figure 81E] Figure 81D shows an enlarged bottom view of the overmolding. [Figure 82A] A side view of the strap end joint housing is shown. [Figure 82B] Figure 82A shows a perspective view of the strap end joint housing. [Figure 83A] Figure 82A shows a top view of the strap end joint housing. [Figure 83B] Figure 82A shows a side view of the strap end joint housing. [Figure 83C] Figure 82A shows an end view of the strap end joint housing. [Figure 83D] Figure 83A shows a side cross-sectional view of the strap end joint housing along line 83D-83D. [Figure 83E] Figure 83B shows an end cross-section of the strap end joint housing along line 83E-83E. [Figure 84A] This shows a side cross-sectional view of a strap having a D-shaped cross-section with a flange portion formed along the edge of the strap. [Figure 84B] This shows a side cross-sectional view of a strap having a D-shaped cross-section in which no flange portion is formed along the edge of the strap. [Figure 85] The image shows a top view of a strap with a bottom strap that has a soft edge positioned above the user's ear. [Figure 86] This shows a side view of a bifurcated headgear configuration formed by a breakthrough-type internal molding process, which includes a rear headgear loop strap. [Figure 87A] Figure 86 shows a top view of the rear headgear loop strap. [Figure 87B] Figure 86 shows an enlarged top view of the break-through tab of the rear headgear loop strap. [Figure 87C] Figure 86 shows an enlarged top view of the alignment tab for the rear headgear loop strap. [Figure 88A] Figure 86 shows a top view of the alignment tab for the rear headgear loop strap. [Figure 88B] Figure 87C shows an enlarged cross-sectional view of the alignment tab of the rear headgear loop strap along line 88B-88B. [Figure 89A] This shows a top view of the overmolded joint connecting the rear headgear loop strap to the front strap. [Figure 89B] Figure 89A shows an enlarged cross-sectional view of the overmolded joint along line 89B-89B. [Figure 90A] A perspective view of the top strap with alignment posts and recesses is shown. [Figure 90B] Figure 90A shows a bottom view of the top strap. [Figure 90C] The image shows a top view of the bottom strap with alignment posts and recesses. [Figure 90D] Figure 90C shows a top view of the bottom strap, which has alignment posts, post holes, and recesses. [Figure 91A] Figure 90C shows a perspective view of the top strap in Figure 90A aligned with the bottom strap in Figure 90C. [Figure 91B] Figure 90C shows the bottom view of the top strap in Figure 90A, aligned with the bottom strap in Figure 90C. [Figure 91C]Figure 90C shows a perspective view of the top strap in Figure 90A aligned with the bottom strap in Figure 90C. [Figure 91D] Figure 90C shows a cross-sectional perspective view of the top strap in Figure 90A, aligned with the bottom strap in Figure 90C. [Figure 92A] Figure 90C shows a bottom view of the overmolded joint connecting the top strap in Figure 90A and the bottom strap in Figure 90C. [Figure 92B] Figure 92A shows a top view of the overmolded joint. [Figure 92C] Figure 92A shows a cross-sectional perspective view of the overmolded joint. [Figure 92D] A cross-sectional perspective view of an overmolded connector is shown. [Figure 93A] This is a perspective view of non-limiting exemplary embodiments of a patient interface having a headgear assembly and a mask assembly according to the present disclosure. The headgear assembly includes a headpiece and one or more connectors between the headpiece and the mask assembly. [Figure 93B] Figure 93A is a perspective view of the patient interface, where the connector is separated from the headpiece. [Figure 93C] Figure 93A is a rear perspective view of the patient interface. [Figure 94A] This is a perspective view of another non-limiting exemplary embodiment of a patient interface having a headgear assembly and a mask assembly according to the present disclosure. The headgear assembly includes a headpiece and one or more connectors between the headpiece and the mask assembly. [Figure 94B] Figure 94A is a perspective view of the patient interface, where the connector is separated from the head component. [Figure 94C] Figure 94A is a rear perspective view of the patient interface. [Figure 95] An isometric view of the patient interface of this disclosure, including the headgear, mask assembly, and connectors, is shown. [Figure 96] Figure 95 shows a rear isometric view of the patient interface. [Figure 97]An isometric view of the patient interface showing the connector separated from the mask assembly is shown. [Figure 98] Figure 97 shows an isometric view of the patient interface, illustrating the connector fully extended away from the mask assembly. [Figure 99A] An isometric view of the living hinge connector is shown. [Figure 99B] An isometric view of an alternative living hinge connector is shown. [Figure 100] This shows a top view of a living hinge connector with a reduced thickness section. [Figure 101A] An isometric view of the assembled and disassembled living hinge connector is shown. [Figure 101B] Figure 101A shows cross-sectional views of the headgear connector member and mask connector member of the living hinge connector. [Figure 102A] An isometric view of a living hinge connector having a single mask hinge and a single connector hinge is shown. [Figure 102B] Figure 102A shows an upper cross-sectional view of the headgear connector member and mask connector member of the living hinge connector. [Figure 103A] An isometric view of a patient interface with a living hinge connector equipped with a hook and post retention system is shown. [Figure 103B] Figure 103A shows a front view of the living hinge connector in the open position. [Figure 104A] An isometric view of a patient interface with a fabric living hinge connector in the closed position is shown. [Figure 104B] Figure 104A shows an isometric view of the patient interface, illustrating the fabric living hinge connector in the open position. [Figure 105A] This shows an isometric view of a patient interface with a silicon hinge connector in the closed position. [Figure 105B] Figure 105A shows an isometric view of the patient interface, illustrating the silicon hinge connector in the open position. [Figure 106A]This shows a top view of an alternative silicone hinge with the connector in the closed position. [Figure 106B] Figure 106A shows a top view of the silicone hinge with the connector in the open position. [Figure 107A] An isometric view of the patient interface with an alternative silicon hinge connector in the closed position is shown. [Figure 107B] Figure 107A shows an isometric view of the silicon hinge connector in the open position. [Figure 108A] An isometric view of the patient interface showing the headgear connection portion of this disclosure is shown. [Figure 108B] Figure 108A shows an enlarged perspective view of the lateral end of the connector at the headgear connection point. [Figure 108C] Figure 108A shows a cross-sectional view of the connector at the headgear connection point. [Figure 109A-B] Figure 109A shows an isometric view of the headgear fixing mechanism. Figure 109B shows a top view of an alternative headgear fixing mechanism. [Figure 110A] An isometric view of the push-fit headgear fixing mechanism is shown. [Figure 110B] A cross-sectional view of the push-fit headgear fixing mechanism is shown. [Figure 111A] This shows an isometric view of a patient interface with an over-center clip-design connector in the closed position. [Figure 111B] Figure 111A shows an isometric view of the patient interface, illustrating the over-center clip-design connector in the open position. [Figure 112A] This shows an isometric view of a patient interface with a retractable pivot connector in the closed position. [Figure 112B] Figure 112A shows an isometric view of the patient interface, illustrating the retractable pivot connector in the open position. [Figure 112C] Figure 112A shows an isometric view of the patient interface, illustrating the retractable pivot connector in the open and extended position. [Figure 113A] An isometric view of a patient interface with a hard-stop sliding strap connector in the closed position is shown. [Figure 113B] Figure 113A shows an isometric view of the patient interface, illustrating the hard-stop sliding strap connector in the open position. [Figure 114A] This shows an isometric view of a patient interface with a strap end hard stop connector in the closed position. [Figure 114B] Figure 114A shows an isometric view of the patient interface, illustrating the strap end hard stop connector in the open position. [Figure 115A] This shows an isometric view of a patient interface with a break-fit magnet and tether connector in the closed position. [Figure 115B] Figure 115A shows an isometric view of the patient interface, illustrating the breakfit magnet and tether connector in the open position. [Figure 116A] An isometric view of the patient interface with the BreakFit clip and tether connector in the closed position is shown. [Figure 116B] Figure 116A shows an isometric view of the patient interface, illustrating the breakfit clip and tether connector in the open position. [Figure 117A] An isometric view of the patient interface with a clip and continuous tether connector in the closed position is shown. [Figure 117B] Figure 117A shows an isometric view of the patient interface, illustrating the clip and continuous tether connector in the open position. [Figure 118A] A front view of the patient interface with dual clips and a continuous tether connector in the closed position is shown. [Figure 118B] Figure 118A shows an isometric view of the patient interface, illustrating the dual clips and continuous tether connectors in the open position. [Figure 119A] An isometric view of the patient interface with a clip and rigid tether connector in the closed position is shown. [Figure 119B] Figure 119A shows an isometric view of the patient interface, illustrating the clip and rigid tether connector in the open position. [Figure 120A] An isometric view of the patient interface with hook and post-loop connectors in the closed position is shown. [Figure 120B] Figure 120A shows an isometric view of the patient interface, illustrating the hook and post-loop connectors in the open position. [Figure 121A] An isometric view of the patient interface with alternative hook and post-loop connectors in the closed position is shown. [Figure 121B] An isometric view of the patient interface is shown, illustrating the alternative hook and post-loop connectors in the open position as shown in Figure 121A. [Modes for carrying out the invention]

[0096] Herein, embodiments of the system, components, and assembly and manufacturing methods will be described with reference to the attached figures. Throughout the drawings, similar figures refer to similar or analogous elements. While several embodiments, examples, and illustrations are disclosed below, those skilled in the art will understand that the invention described herein extends beyond the scope of the embodiments, examples, and illustrations specifically disclosed, and may include other uses of the invention and its obvious modifications and equivalents. The terminology used in the description presented herein is not intended to be construed as limiting or restricting in any way, but is simply used in connection with the detailed description of some specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, and no single feature is solely responsible for its desired attributes or essential for carrying out the invention described herein.

[0097] In the following explanation, some terms may be used merely for reference and are therefore not intended to be limiting. For example, the terms “up” and “down” refer to directions in the referenced drawings. Terms such as “front,” “back,” “left,” “right,” “rear,” and “side” describe the orientation and / or position of a component or part of an element within a consistent but arbitrary reference system, as becomes clear by referring to the text and related drawings describing the component or element under consideration. Furthermore, terms such as “first,” “second,” and “third” may be used to describe distinct components. These terms may include the terms specifically mentioned above, their derivatives, and terms with similar meanings.

[0098] As used herein, the term “substantially inelastic” refers to the ability of a headgear or material to resist stretching with respect to the loads it may be subjected to. Thus, a headgear or material may be substantially inelastic in one direction and somewhat elastic in another. In some configurations, the headgear or material is configured to be substantially inelastic in the direction to which it is loaded by the therapy in which the headgear or material is intended to be used. A substantially inelastic headgear or material may, for example, resist stretching that would impair the seal of a breathing mask in a sealing system under normal or expected conditions. In an unsealed system, a substantially inelastic headgear or material may resist stretching that would impair the proper positioning of the breathing interface depending on normal or expected conditions, such as hose tension or user movement. When the expected load force is relatively low, the load is not sufficient to cause stretching, and the headgear or material may have higher elasticity. Conversely, if the headgear and / or material is expected to be subjected to high load forces, higher inelasticity is required to resist stretching.

[0099] Throughout this specification, we refer to “breakthrough” molding, processes, techniques, and components produced by such molding, processes, and techniques. We also refer to “breakthrough in-mold molding” and “in-mold breakthrough.” It should be understood that all such references are general references to embodiments of this disclosure and are not intended to be particularly limiting.

[0100] headgear Figure 1A shows a non-limiting exemplary embodiment of the in-mold bifurcated headgear 100 of the present disclosure used in combination with a breathing apparatus 110. "In-molding" includes forming components, such as a plastic core and a textile casing, as a single unit by adding molten plastic to the textile casing. "In-molded" straps or any other components are components formed by adding molten plastic to the textile casing.

[0101] Figures 1A and 1B show that the bifurcated headgear 100 is substantially inelastic and configured to have a three-dimensional (3D) structure. The bifurcated headgear design is preferred over a single-strap design because it improves stability on the patient's head, as the headgear is supported at multiple positions on the user's head. The three-dimensional structure as used herein is a structure whose shape extends across multiple planes rather than being located in a single plane. In other words, a three-dimensional structure is not flat. The illustrated headgear 100 comprises a right side 120 and a left side 130. Both the right side 120 and the left side 130 include a top strap 140, a bottom strap 150, and a mask connector 180.

[0102] The apex strap 140 has an elongated shape and includes lateral apex strap ends 142 and apex strap center ends 144. The apex strap 140 is configured to extend upward from the lateral ends 142, generally above each of the user's ears, across the apex or frontal region of the user's head, and then terminate at the apex strap center ends 144. The apex strap center ends 144 are configured to be positioned at or near the center point or center position of the top of the user's head. The right apex strap center ends 144 120 and the left apex strap center ends 130 are configured to be joined to each other by an apex seam 190 at a position above the top of the user's head. The apex seam 190 may include sutures, welds, adhesives, overmolding or any other fastening mechanism and may be permanent or removable / detachable. In some configurations, the top joint 190 may include an adjustment mechanism (not shown), such as a hook-and-loop fastener or snap-fit ​​connector, to allow the combined length of the top strap 140 to be changed to accommodate different user head sizes. Each lateral end 142 of the top strap is configured to be integrally formed with the bottom strap 150 in the casing or strap joint 170, as will be discussed in more detail later.

[0103] The bottom strap 150 has an elongated shape and includes a rear bottom strap portion 152 and a front bottom strap portion 162. The rear bottom strap portion 152 and the front bottom strap portion 162 are separate and integrated with each other. The rear bottom strap portion 152 includes a portion of the bottom strap 150 that extends rearward from the joint 170 and around the occipital region of the user's head, and terminates at the bottom strap posterior end 154. The ear arch 160 of the bottom strap 150 curves over the top of the patient's ear when in use, thereby preventing the strap 150 from contacting the ear. The bottom strap posterior end 154 is configured to be positioned at or near the center point or center position at the rear of the user's head. The right 120 and left 130 bottom strap posterior ends 154 are configured to be joined to each other by a bottom joint 192. The bottom seam 192 may include sutures, welds, adhesives, overmolding, or any other fastening mechanism, and may be permanent or removable / detachable. In some configurations, the bottom seam 192 may include adjustment mechanisms (not shown), such as hook-and-loop fasteners or snap-fit ​​connectors, to allow the combined length of the rear bottom strap portion 152 of the bottom strap 150 to be changed to accommodate different user head sizes.

[0104] The front bottom strap portion 162 includes a portion of the bottom strap 150 that extends forward from the joint 170 across the user's temporal region toward the user's nose. In some configurations, the front bottom strap portion 162 is shorter than one or both of the top strap 140 or the bottom strap portion 152 and terminates at the bottom strap front end 164. The bottom strap front end 164 includes a mask connector 180 or is configured to be attached to at least the mask connector 180. The bottom strap front end 164 includes a female recess 166 that engages with the mask connector 180. In some configurations, the mask connector 180 can be pressed onto the bottom strap front end 164 and into the female recess 166 or overmolded. The mask connector 180 may include a clip or retaining mechanism configured to connect to the breathing apparatus 110. The mask connector 180 may include a push-fit, snap-fit ​​or other preferred connector configured to provide a detachable connection of the breathing apparatus 110 to the mask frame 112. In some embodiments, the mask connector 180 can be configured to connect to an adjustment mechanism, which provides means for automatically or manually adjusting the size of the bifurcated headgear 100. In some configurations, the mask connector 180 can be permanently connected to a mask frame or yoke to form a continuous loop between the headgear 100 and the breathing apparatus 110.

[0105] The right side 120 and left side 130 of the bifurcated headgear 100 are formed as substantially two-dimensional (2D) parts, i.e., they are formed in a flat structure. When the top strap 140 and bottom strap 150 of the right side 120 and left side 130 are joined to each other, a 3D bifurcated structure is formed (as shown in Figure 1B). In some configurations, the bifurcated headgear 100 is configured such that the 3D bifurcated structure is always maintained when at least the right side 120 and left side 130 are connected. This 3D structure can improve the ease with which the user interacts with the bifurcated headgear 100 and associated breathing apparatus 110, and can attach or put them on. Because the bifurcated headgear 100 maintains its shape, the straps are less likely to tangle, and it should be easier for the user to grasp and orient the bifurcated headgear 100. In some configurations, the bifurcated headgear 100 maintains at least partial or complete separation of both sides 120, 130. In some configurations, the bifurcated headgear 100 maintains partial or complete separation at least at the joint 170 and / or the front bottom strap portions 162 on both sides 120, 130.

[0106] The top strap 140 and bottom strap 150 are each composed of a single plastic core material 210 surrounded by and bonded to the outer casing 220. The casing 220 can be knitted, woven, braided, crocheted, etc. The single plastic core material 210 forms both the top strap 140 and the bottom strap 150. That is, the plastic core material 210 is a single unit between the top strap 140 and the bottom strap 150 and through the bifurcated headgear 100. The casing 220 of both the top strap 140 and the bottom strap 150 can be knitted, woven, braided, crocheted, etc. into a seamless, continuous, unbroken tube. That is, the casing 220 can have a seamless, homogeneous outer surface along the length of the top strap 140 and the bottom strap 150. Casing 220 can be woven from multiple reels of yarn containing wool, cotton, nylon, Lycra, spandex, or a mixture of natural and / or synthetic materials. In some configurations, casing 220 can be woven loosely so that its length can be extended without stretching or tearing of the yarn. The amount of Lycra in the yarn can be changed to alter the elasticity of the strap.

[0107] The casing 220 provides a clean and orderly edge finish to the in-mold bifurcated headgear 100. Specifically, the top strap 140 and bottom strap 150 have a seamless, uniform shape and form to provide an aesthetically pleasing appearance. Furthermore, the straps 140, 150 formed from the casing 220 are easier to manufacture. The seamless circular woven tubes eliminate the need for additional sewing or bonding steps, reducing manufacturing time and cost. Additionally, long, straight woven tubes are easy to manufacture and form, and they can then be cut to length and shaped during a breakthrough in-mold process as described herein. Moreover, the casing 220 can be easily placed and positioned within the molding die. The tubular shape and circular cross-section of the casing 220 are self-supporting and remain open within the molding die to provide an open channel for the injection material passing through the casing.

[0108] The casing 220 is flexible before the plastic core material 210 is inserted, thereby allowing it to be easily positioned by the cavity of the molding die. The casing 220 can be woven from a material having a soft feel, thereby ensuring that the top strap 140 and bottom strap 150 are comfortable when in contact with the user's skin. Similarly, the casing 220 can have thickness and layers, thereby ensuring that the top strap 140 and bottom strap 150 are comfortable when in contact with the user's skin. Furthermore, in some configurations, the casing 220 can be woven from a material having moisture-absorbing properties to improve the comfort of the bifurcated headgear 100. Furthermore, in some configurations, the casing 220 can be woven from a material having tactile properties to reduce or prevent the bifurcated headgear 100 from sliding against the user's skin or hair. In some configurations, the casing 220 may differ between the top strap 140 and the bottom strap 150. For example, the bottom strap 150 can be constructed from a material with moisture-absorbing properties, and the top strap 140 can be constructed from a material with tactile properties. Furthermore, in some configurations, the casing 220 can be constructed from different materials along the lengths of the top strap 140 and the bottom strap 150, thereby having different properties in different areas along the lengths of the straps 140 and 150. For example, the top strap 140 and the bottom strap 150 can have different colors.

[0109] The casings 220 of the top strap 140 and bottom strap 150 are filled with a single plastic core material 210. In some configurations, the plastic core material 210 includes a relatively rectangular cross-section thermoformable or thermosetting plastic material configured to give the bifurcated headgear 100 the 3D structure described above. The plastic core material 210 provides the foundation for the overall structure of the bifurcated headgear 100. The plastic composition of the plastic core material 210 provides the benefit of a resilient structure that can maintain its pre-formed shape while somewhat conforming to the individual skull shape of the user. The plastic core material 210 has a width substantially greater than its depth. The exemplary cross-sectional shape, combined with the material selection, allows the bifurcated headgear 100 to be flexible in the direction perpendicular to its width (vertical direction in Figure 1A) and relatively inflexible in the direction perpendicular to its depth (horizontal direction in Figure 1A). This flexibility in one direction allows the bifurcated headgear 100 to conform to the user's head, while in the other direction, it provides rigidity that stabilizes the breathing apparatus 110 on the user's face and minimizes its dislodgement.

[0110] The bifurcated headgear 100 can be configured to be substantially inelastic as a result of material selection, for example. One or more composite material elements can give the bifurcated headgear 100 substantially inelastic properties. In the first non-limiting exemplary embodiment of this disclosure, the plastic core material 210 is made from a substantially inelastic material such as polypropylene or nylon, for example, without limitation. In embodiments where the load force on the bifurcated headgear 100 is expected to be low, the plastic core material 210 can be made from other materials such as thermoplastic elastomer (TPE) or silicone, without limitation. In some embodiments, the plastic core material 210 may have some elasticity, and one or both of the casings 220 of the top strap 140 and the bottom strap 150 may be substantially inelastic. Including a substantially inelastic material in the bifurcated headgear 100 is advantageous because the material reduces or eliminates the possibility of the headgear being excessively stretched or pulled over the user's head. If the bifurcated headgear 100 is excessively pulled over the user's head, the respiratory device may not be effectively positioned to deliver treatment, potentially applying uncomfortable force to the user's head, which could reduce treatment compliance.

[0111] joint Figures 2A and 2B are enlarged views of the connection between the top strap 140 and the bottom strap 150 at the joint 170. As described above, the plastic core material 210 is a single unit and is located within the casings 220 of both the top strap 140 and the bottom strap 150. Figure 3 is a cross-sectional view of the top strap 140 and the bottom strap 150 along line 3-3 in Figure 2B. As shown, the bottom strap 150 is filled with the plastic core material 210, which extends through the casing 220 of the bottom strap 150 into the lateral end 142 of the top strap at the joint 170, filling the top strap 140. As a result, the casings 220 of the top strap 140 and the bottom strap 150 are joined to each other by the plastic core material 210.

[0112] As shown in Figures 2A to 3, the top strap 140 and bottom strap 150 may have a soft edge 222, which extends along a portion of the edges of the top strap 140 and bottom strap 150 in the longitudinal direction. The soft edge 222 is the portion of the casing 220 that is not filled with the plastic core material 210. As a result, the soft edge 222 provides the top strap 140 and bottom strap 150 with a soft or cushioned edge that is comfortable and aesthetically pleasing to the user's skin. As will be described in more detail later, the soft edge 222 is formed by pressing the edge of the casing 220 before injection of the plastic core material 210 so that the plastic core material 210 is prevented or obstructed from flowing into the portion of the casing 220. The edge of the casing 220 is pressed by a portion of the mold adjacent to the molding cavity of the mold. The depth of the crimping of the edges of the top strap 140 and bottom strap 150 by the molding die can vary along the lengths of the top strap 140 and bottom strap 150, so that the width of the plastic core material 210 (vertical direction in Figure 1A) can vary along the lengths of the top strap 140 and bottom strap 150. Thus, the width of the plastic core material 210 can be relatively wider in different areas of the top strap 140 and bottom strap 150, such as the joint 170 and the front end 164 of the bottom strap, reinforcing those areas and providing additional strength to them. Similarly, in some configurations, the width of the plastic core material 210 can be relatively narrower in some areas along the lengths of the top strap 140 and bottom strap 150, providing flexibility to those relatively narrow areas. Those skilled in the art will understand that the shape and geometric form of the plastic core material can be varied to provide strength and rigidity to the top strap 140 and bottom strap 150 in a desired direction.

[0113] Molding mold Figure 4 shows an opening / closing injection mold 300 configured to form either the right side 120 or the left side 130 of a bifurcated headgear 100 in a single injection molding process. In some configurations, the right side 120 and the left side 130 are identical, and both sides 120, 130 can be formed using the injection mold 300. Figure 4 shows the fully formed bifurcated headgear 100 after the completion of the injection molding process. The injection mold 300 comprises a first mold half and a second mold half 320. The first mold half 310 is aligned with and positioned on top of the second mold half 320 to close the injection mold 300. The first mold half 310 and the second mold half 320 are substantially symmetrical (i.e., mirror images), and therefore, for brevity, the following discussion will focus on the second mold half 320. As shown in Figure 5, the second mold half 320 includes a top strap cavity 322 and a bottom strap cavity 324. The top strap cavity 322 and the bottom strap cavity 324 are configured to receive the casing 220 for both the top strap 140 and the bottom strap 150. Thus, the top strap cavity 322 and the bottom strap cavity 324 are shaped to correspond to the desired left and / or right sides of the bifurcated headgear 100. In some configurations, both the right side 120 and the left side 130 of the bifurcated headgear 100 can be formed using an injection mold 300. In some configurations, the casing 220 is cut to a length that fits into the strap cavities 322, 324 before the mold 300 is closed.

[0114] A connector insert 350 is inserted into the front end 164 of the bottom strap of the casing 220. A connector insert cavity 370 is located within the second mold half 320 and has a corresponding shape similar to that of the connector insert 350. Both the connector insert 350 and the casing 220 are located within the connector insert cavity 370 and the strap cavities 322, 324, respectively. When the casing 220 is used to form the straps 140, 150 of the bifurcated headgear 100, the end of the casing 220 is formed to be open or as a hollow tube, providing a path for the plastic core material 210 to be injected into the casing 220. Thus, the connector insert 350 located within the open end of the bottom strap 150 reduces or prevents the open end of the casing 220 from narrowing or closing. The connector insert 350 comprises a prefabricated component which fits inside the open end of the casing 220, pushing the opening of the casing 220 outward toward the walls of the strap cavities 322, 324 in the first mold half 310 and the second mold half 320. The connector insert 350 has an opening (not shown) that aligns with the runner 380, through which a direct channel is provided for the plastic core material to be injected into the casing 220. The connector insert 350 is also configured to form an internal (female) connection shape within the bottom strap front end 164 (see Figure 7) that connects to the shape (not shown) of an opposing male connector on the mask frame or other mask component. The connector insert 350 can be made from plastic or metal. In the case of plastic, in some configurations the connector insert 350 can be made from the same plastic as the core, thereby allowing a chemical bond to be formed between the connector insert 350 and the plastic core material during the breakthrough in-mold molding process. Furthermore, the connector insert 350 can be formed in a shape that allows it to have additional functions as a connector (e.g., connector 180) between headgear components, between adjustment mechanisms, or between headgear and mask.

[0115] As shown in Figures 4 and 5, the runner 380 fluidly connects the sprue injection point 390, the bottom strap front end 154 and bottom strap rear end 164, and the top strap center end 144. Thus, when the plastic core material 210 is injected into the first mold half 310 and the second mold half 320, it is injected into the casing 220 through the bottom strap front end 154 and bottom strap rear end 164 and the top strap center end 144, respectively.

[0116] The top strap cavity 322 and the bottom strap cavity 324 have a soft edge clamp 360 formed along one or both of the outer edges of the cavities 322 and 324 in the longitudinal direction. The soft edge clamp 360 is a raised area that protrudes into the top strap cavity 322 and the bottom strap cavity 324 in a direction substantially parallel to the closing direction of the injection mold 300, thereby narrowing the top strap cavity 322 and the bottom strap cavity 324 along one or both of the outer edges of the cavities 322 and 324 in the longitudinal direction when the injection mold 300 is closed (i.e., the outer edges narrow with respect to the central region of the cavities 322 and 324). Thus, the soft edge clamp 360 tightens or presses the outer edge of the casing 220 against both the top strap 140 and the bottom strap 150, thereby forming the soft edge portion 222. More specifically, the soft edge clamps 360 press the edges of the casing 220 together so that they are fully compressed. As a result, the plastic core material 210 cannot flow between the compressed edges when injected into the casing 220. This results in a soft or cushioned edge finish for the in-molded bifurcated headgear 100 by preventing the in-molded plastic core material 210 from filling the casing 220. Parts of the edges of the straps 140, 150 remain open and soft to the touch to improve patient comfort. In some configurations, the edges of the casing 220 can be narrowed but not fully compressed, allowing a reduced amount of plastic core material 210 (relative to the uncompressed portion of the casing 220) to flow between the edges of the casing 220.

[0117] Figure 6 is an enlarged view of the second mold half 320 showing the positioning of the top strap 140 and bottom strap 150 relative to each other. As shown, the lateral end 142 of the top strap is positioned in contact with or abutting the casing 220 of the bottom strap 150. That is, the casing 220 of the top strap 140 is positioned within the top strap cavity 330 such that the lateral end 142 of the top strap abuts against the edge of the casing 220 of the bottom strap 150. As will be described in more detail later, the arrangement of the straps is not limited to having the open end of one strap in contact with the edge of the other strap. In some configurations, the straps may have intermediate or non-end portions that abut each other, through which the straps are joined.

[0118] Molding process The process of molding the left side 120 or the right side 130 of the bifurcated headgear 100 using an injection molding die 300 includes the following steps: inserting the casing, closing the mold, injecting the plastic, and opening the mold to demold the part. In some configurations, these steps are achieved in this order, but in other configurations, the order can be changed and / or additional steps can be included. Such additional steps can be inserted within the steps described above.

[0119] In at least some embodiments, the process for forming the left side 120 or the right side 130 of the bifurcated headgear 100 includes a "breakthrough" forming process, as described later.

[0120] One first casing 220 is inserted into the bottom strap cavity 324 of the second mold half 320 of the injection mold 300, which is configured to form the bottom strap 150. Similarly, one second casing 220 is inserted into the top strap cavity 322, which is configured to form the top strap 140. The casings 220 can be cut to a length that fits snugly into the strap cavities 322 and 324. The connector insert 350 is positioned inside the open end of the second casing 220 (i.e., the bottom strap front end 164), and the connector insert 350 is aligned with and inserted into the connector insert cavity 370.

[0121] Once the casing 220 is aligned within the second mold half 320, the injection mold 300 is closed so that the strap cavities 322, 324 are completely sealed. Then, the thermosetting or thermoformable plastic core material 210 is injected into the molded cavity strap cavities 322, 324 via the sprue 390 and runner 380. More specifically, the plastic core material 210 is injected into the injection mold 300 through the sprue 390. Generally, the plastic core material 210 follows the path of least resistance to fill the strap cavities 322, 324. The plastic core material 210 moves through the runner 380 until it reaches the open end of the casing 220. The plastic core material 210 enters the top strap center end 144, the bottom strap rear end 154 and the bottom strap front end 164 (via the connector insert 350). Referring to Figure 6, once the casing 220 in the bottom strap cavity 324 is filled with the plastic core material 210 (i.e., filled from both open ends, as opposed to the casing 220 in the top strap cavity 322, which is filled first at one end), the plastic core material 210 penetrates, through, and pushes through the wall of the casing 220 of the bottom strap 150 at the joint 170. The plastic core material 210 penetrating the wall of the bottom strap 150 enters the open end of the casing 220 of the top strap 140 (i.e., the lateral end 142 of the top strap) and joins the plastic core material 210 entering the opposite end of the casing 220 of the top strap 140 (i.e., from the central end of the top strap) until the casing 220 of the top strap 140 is filled with the plastic core material 210. Once the casing 220 of the straps 140 and 150 is filled, the plastic core material 210 is given time to cure, cool, and solidify. Once cured, the injection mold 300 is opened and the part is removed. Thus, a single plastic core material 210 can be formed within the top strap 140 and bottom strap 150, along with the seamless, uniform casing 220 of the top strap 140 and bottom strap 150.In other words, the individual plastic core material 210 for the top strap 140 and bottom strap can be formed by pushing the plastic core material 210 into the top strap 140 through the casing 220 of the bottom strap 150. In other words, when both straps have a seamless, uniform casing 220 and one strap is attached to the middle or non-end of a seamless, adjacent strap, forming individual plastic core material 210 within the top strap 140 and bottom strap is an advantageous effect of the breakthrough in-mold molding process. In other embodiments, the plastic core material 210 penetrates and breaks through the casing 220 before the casing 220 and strap cavity are filled with the plastic core material 210. This can occur, for example, when the unsupported area of ​​the casing 220 is closer to the injection point, the plastic core material 210 is low density or low viscosity, the casing 220 has a low thread density, and / or the unsupported area is large relative to the supported area.

[0122] The plastic core material 210 penetrates and breaks through the walls of the casing 220 of the bottom strap 150, following the path of least resistance to fill the strap cavity. When the casing 220 is supported by, in contact with, or pressed against the surface of the injection mold 300, the injected plastic core material 210 flows in the direction of least resistance until the cavity in the injection mold 300 is filled. Referring to Figure 5, once the bottom strap cavity 324 is full of plastic core material 210, the casing 220 of the bottom strap 150 is no longer supported by, in contact with, or pressed against the surface of the bottom strap cavity 324, so the direction of least resistance to flow is into the top strap cavity 322. When the casing 220 is not pressed against (i.e., unsupported) the surface of the injection mold 300, the injected plastic core material 210 fills the cavity by penetrating the casing 220. Penetration of the casing 220 can occur as the plastic core material 210 flows through the casing 220. That is, when under pressure (i.e., unsupported) of the injected plastic core material 220, the threads of the casing 220 are displaced or elastically deformed (i.e., due to the material of the casing 220). As a result, the plastic core material 220 flows and pushes through the gaps created between the displaced or elastically deformed threads of the casing 220. In some configurations, the pressure of the plastic core material 220 within the casing 220 may cause the threads of the casing 220 to tear or break in the unsupported portion of the casing 220. A tear or fracture of the casing 220 may create a hole within the casing 220 through which the plastic core material 210 can penetrate and break, flowing and pushing into the adjacent strap.

[0123] Whether the plastic core material 210 penetrates the casing 220 may depend on the injection molding parameters and the textile properties of the casing 220. Regarding the injection molding parameters, whether or not penetration occurs may depend on the pressure, injection speed, location of the injection point and length of the injection path, location of the unsupported area, and the relative size of the unsupported area to the supported area, as well as the material properties of the injected plastic core material 210. Regarding the textile properties of the casing 220, whether or not penetration occurs may depend on the thread count, thread size, elasticity, thread density, denier, thread strength, etc. Penetration through the casing 220 may occur at relatively high pressures. In at least some embodiments, elasticity alone may or may not affect penetration. As a non-limiting example, a highly elastic casing combined with a high thread count may deform / stretch when not supported by the molding die 300 (i.e., as opposed to enabling penetration). However, as the casing 220 stretches, gaps or spaces between the threads begin to form, providing a path for the plastic core material to penetrate the casing 220. Thus, injection molding parameters and textile properties can be modified using a breakthrough in-mold molding process according to the desired properties and manufacturability of the bifurcated headgear 100.

[0124] Alternate configuration Figure 8A shows a second mold half of the injection mold 400, which has an alternative in-mold strap cavity configuration that joins multiple straps 410, 412, and 414 in the joint configuration shown in Figure 8B. For comparison, Figure 8B shows a T-shaped joint 420 similar to the joint 170 in Figures 1A to 7. Figure 8B also shows an alternative shape of joint in the form of an X-shaped joint 422. As described above and shown in Figure 8B, the T-shaped joint 420 is formed by positioning the open end of the casing of strap 410 to contact the edge of the casing of strap 412 (i.e., by the mold providing the configuration corresponding to the strap cavity). In contrast, the X-shaped joint 422 is formed by overlapping the non-open ends of the casings of straps 410 and 414. In other words, the straps 410 and 414 are positioned in an overlapping orientation so that they abut at a position between their open ends and form an X-shaped joint 422. In an alternative embodiment, one of the straps 414 is formed from two strap portions, which are joined to the other strap 410 by joining the respective ends of each strap portion to the other strap 410 to form an X-shaped joint. In these embodiments, the injection mold 400 includes strap cavities of corresponding shapes to support the straps 410 and 414. Figures 8A and 8B show the positioning of the sprue 430, runner 432, and injection point 434, through which the plastic core material 424 is injected into the injection mold 400 to fill the straps 410, 412, and 414. The injection point 434 is effectively positioned at one open end of the strap 410 and at the opposite open end of the strap 410 (i.e., via the injection point 434 through the strap 412). In the illustrated configuration, the open end of the strap 414 is not fluidly connected to the injection point 430 except through the X-shaped joint 422. As the plastic core material 424 is injected into the injection mold 400, it enters the open end of the strap 410 and moves toward the X-shaped joint 422.In an embodiment where one of the straps 414 is formed from two strap portions joined to the other strap 410, as the strap 414 begins filling, the plastic core material 424 follows the path of least resistance, passing through the edge of the casing of the strap 410 and then through the open end of the casing of the strap 414. That is, the strap cavity of the strap 414 is empty, thereby providing the path of least resistance through which the plastic core material 424 flows. Thus, the casing of the strap 414 is filled with the plastic core material 424 entering the strap 414 through the X-shaped joint 422. Those skilled in the art will understand that the above configuration is not limited to a joint located at the open end of one of the straps when forming the X-shaped joint 422. In some configurations, the X-shaped joint 422 can be formed such that both straps have at least one injection point at their ends.

[0125] As shown in the illustration, the T-shaped joint 420 and the X-shaped joint 422 can be used in combination to form various headgear shapes and structures with multiple straps. Multiple strap joints / connections can be formed in a single injection molding step. Such strap configurations can generally be used in four-point headgear structures used with nose masks and full-face masks.

[0126] Figure 9A shows an alternative in-mold strap configuration having straps 520, which are joined to one another by integrally formed connecting members 530 positioned between the straps 520. The connecting members 530 are formed when a plastic core material 510 penetrates the casing wall of the strap 520 and enters another area of ​​the mold. That is, the injection mold (not shown) may have a cavity corresponding to the connecting member 530 that fluidly connects the strap cavities for the straps 520. Thus, when the molten plastic core material 510 is injected into the injection mold, it enters the casing of the straps 520 at the injection point 540. As the straps 520 begin to fill, the plastic core material 510 follows the path of least resistance and penetrates the casing wall (i.e., in the unsupported portion of the casing adjacent to the cavity corresponding to the connecting member 530), thereby the plastic core material enters and fills the cavity corresponding to the connecting member 530. In some configurations, the plastic core material 510 may be an elastomer so that the connecting member 530 can be stretched. Furthermore, in such embodiments, the casing can resist stretching of the plastic core material 510.

[0127] Figure 9B shows an alternative in-mold strap configuration having straps 520, which are joined to one another by integrally formed webs 532 positioned between the straps 520. Similar to the connecting member 530 in Figure 9A, the injection mold (not shown) may have a cavity corresponding to the webs 532 that fluidly connect the strap cavities for the straps 520. The cavity corresponding to the webs 532 may have a depth shallower than the depth of the strap cavities for the straps 520. Thus, when the molten plastic core material 510 is injected into the injection mold, it enters the casing of the straps 520 at the joining point 540. As the straps 520 begin to fill, the plastic core material follows the path of least resistance, penetrating the walls of the casing (i.e., in the unsupported portion of the casing adjacent to the cavity corresponding to the webs 532), thereby the plastic core material enters and fills the cavity corresponding to the webs 532. In some configurations, the plastic core material 510 may be an elastomer so that the web portion 532 can be stretched. Furthermore, in such embodiments, the casing can resist stretching of the plastic core material 510.

[0128] Figure 10A shows an alternative in-mold strap configuration having a fillet joint 620 connecting a fillet strap 622 to an adjacent strap 624 or headgear portion. The textile casing of the fillet strap 622 has a width that expands, widens, and curves radially outward toward the fillet joint 620 with the adjacent strap 624 or headgear portion, providing a smooth transition between straps 622 and 624. In other words, the width or diameter of the textile casing of the fillet strap 622 increases along the length of the fillet strap 622 toward the end in contact with the adjacent strap 624. Thus, the fillet joint 620 can provide a larger connection area with the textile casing of the adjacent strap 624, thereby providing increased strength and aesthetic appeal compared to a non-fillet joint. Figure 10B shows an injection mold 610 forming the fillet joint 620. As shown in the figure, the injection mold 610 has a filleted strap cavity 612 having a shape corresponding to the shape of the textile casing of the filleted strap 622. In the illustrated embodiment, the textile casing of the filleted strap 622 is pre-formed from two layers of microfiber, which are sewn together and turned inside out to form a tube that curves outward at the open end. The adjacent strap 624 has a casing similar to that of the embodiment described above. Furthermore, the adjacent strap 624 is positioned in contact with the open end of the filleted strap 622 within the strap cavity 614 of the corresponding shape. Thus, the plastic core material 630 is injected into the open ends of the filleted strap 622 and / or the adjacent strap 624. The plastic core material 630 penetrates the wall of the casing of the adjacent strap 624 at the filleted joint 620, thereby integrally forming the plastic core material 630 within the filleted strap 622 and the adjacent strap 624.As illustrated, the textile casing of the filleted strap 622 can abut against another in-mold strap portion (i.e., the casing of strap 624, as shown in Figure 10B) or against an uncovered plastic core material 630, as shown in Figure 10A. In some configurations, the casing of the filleted strap 622 can be fabricated as a single woven tube woven to form a shape that includes the filleted end.

[0129] Figures 11A–11E show in-mold strap configurations having a molded texture etched into the strap. Figures 11A–11C show a strap 720 having a strap 710 with a plurality of square diamond-shaped recesses 730 arranged in rows along its length. As shown in Figure 11C, a cross-section along line 11C–11C in Figure 11B, the recesses 730 are formed on both sides of the strap 720 and are positioned to form thin areas 732 within the strap 720. The thin areas 732 can provide some degree of elasticity or stretchability to the plastic core 710. Such flexibility can be beneficial in that it can improve the patient's perception of the closed-loop headgear as being pulled over the patient's head or the patient's perception of the semi-rigid headgear. Furthermore, the textured finish of the strap 720 can also improve the aesthetic appearance of the headgear and the tactile appeal of the strap 720. That is, the strap 720 may appear less rigid and more comfortable. In some embodiments not shown, the indentations 730 can form a barrier area between the layers of the casing 712 where there is no plastic core material 710. This barrier area can improve the breathability of the strap 720, thereby improving user comfort. Figures 11D and 11E show a plurality of hexagonal indentations 730 spaced along the length of the strap 720 in a honeycomb arrangement. It should be understood that the indentations 730 are not limited to diamond or hexagonal shapes and can include various shapes, sizes, positions on the strap, geometric forms, combinations of shapes, etc. In Figures 11D and 11E, the plastic core and honeycomb pattern do not extend to the edge of the casing of the strap 720. This provides a soft edge that improves user comfort.

[0130] The recess 730 is formed during the breakthrough in-mold molding process, similar to the formation of the soft edge of the strap. That is, the strap cavity for the strap 720 may include a series of protrusions in the first and second mold halves. The protrusions project into the strap cavity and have a shape corresponding to the recess 730. As the plastic core material is injected into the strap 720, the protrusions mold the shape of the recess into the plastic core material.

[0131] Figures 12A to 13D show an in-mold strap configuration for a bifurcated headgear 1100, which has an attachment member that increases the bonding strength at the joint between the coupled straps. Similar to the bifurcated headgear 100 shown in Figures 1A to 7, the bifurcated headgear 1100 of Figures 12A to 13D comprises a top strap 1140 and a bottom strap 1150. Similarly, the open end of the top strap 1140 is coupled to the non-open end of the bottom strap 1150. In contrast to the bottom strap 150 of Figures 1A to 7, the bottom strap 1150 includes an attachment member 1156 that protrudes outward from the casing wall of the bottom strap 1150. As will be described in more detail later, the top strap 1140 is overmolded over the attachment member 1156 to form a permanent connection between the top strap 1140 and the bottom strap 1150.

[0132] The bifurcated headgear 1100 is formed by a two-step in-mold molding process. Specifically, the bottom strap 1150 and mounting member 1156 are molded in-mold using a breakthrough in-mold molding process, and then the top strap 1140 is molded on the mounting member 1156 and bottom strap 1150. Figures 12A and 12B show the first step of the breakthrough in-mold molding process that forms the bifurcated headgear 1100. As shown, the bottom strap 1150 and mounting member 1156 are formed by placing the casing 1220 of the bottom strap 1150 into the bottom strap cavity 1324 of the first molding die 1320. The mounting member 1156 is formed by a plastic core material 1210 that penetrates or breaks through the wall of the casing 1220 of the bottom strap 1150, similar to the breakthrough and breakthrough techniques described above. For brevity, redundant considerations are omitted. Figures 13A and 13D show the second step of the in-mold molding process for forming the bifurcated headgear 1100. As shown, the fully formed bottom strap 1150 is positioned within the bottom strap cavity 1326 of the second molding die 1322. The casing 1220 for the top strap 1140 is positioned within the top strap cavity 1328 of the second molding die 1322. The open end of the top strap 1140 is positioned over the mounting member 1156 of the bottom strap 1150. That is, the casing 1220 for the top strap 1140 is positioned within the second molding die 1322 such that it overlaps with and / or surrounds the mounting member 1156. The open end of the casing 1220 for the top strap 1140 abuts against the soft edge 1222 of the bottom strap 1150. The casing 1220 for the top strap 1140 is filled with plastic core material 1210 which enters the second molding tool 1322 via the injection point 1390 in the second molding die 1322. During injection, the plastic core material 1210 in the casing 1220 for the top strap 1140 overmoldes onto and / or around the mounting member 1156 to form a permanent connection between the top strap 1140 and the bottom strap 1150.Furthermore, a chemical and / or mechanical connection is formed between the mounting member 1156 and the plastic core material at the joint 1170 between the top strap 1140 and the bottom strap 1150. The mounting member 1156 may include a mechanically interlocking structure that provides a partial interlocking opening 1157 (Figures 13A and 13B) or an interlocking opening 1158 (Figures 13C and 13D) through which the plastic core material 1210 in the casing 1220 for the top strap 1140 passes. The mechanical interlocking can increase the amount of surface area of ​​the bottom strap 1150 at the joint 1170 through which the top strap 1140 can be chemically or mechanically bonded. Furthermore, the plastic core material 1210 passing through the interlocking openings 1157, 1158 can provide an interlocking mechanical connection between the plastic core material 1210 of the top strap 1140 and the bottom strap 1150. In some configurations, the top strap 1140 can be formed and attached to the bottom strap 1150 using an in-mold molding process. That is, the bottom strap 1150 and the attachment member 1156 can be formed using a different strap forming technique, and then the top strap 1140 can be overmolded onto the attachment member 1156 using an in-mold molding process.

[0133] Figures 14A to 14D show alternative strap configurations for a bifurcated headgear 1400 having a strap casing with sealed ends. The bifurcated headgear 1400 has top straps 1402 and bottom straps 1404 arranged similarly to the bifurcated headgear 100, which has top straps 140 and bottom straps 150 in Figures 1A to 7. Furthermore, the top straps 1402 and bottom straps 1404 are joined at joint 1470 using a breakthrough die-in forming process, similar to the top straps 140 and bottom straps 150 at joint 170.

[0134] FIG. 14A shows a casing 1410 for a top strap 1402 having a sealed open end 1430. The sealed open end 1430 is formed by cutting the end of the casing 1410 with a hot knife. When the casing is formed from synthetic fibers, cutting the casing 1410 with a hot knife causes the edges of the casing 1410 to melt, thereby sealing or joining together the remaining ends of the individual threads / yarns that would otherwise be exposed and / or frayed after the casing 1410 is cut to a certain length. As a result, when the sealed open end 1430 is joined to the bottom strap 1404, there are no remaining or frayed individual threads / yarns at the joint 1430, improving the aesthetics of the joint 1470 and the bifurcated head gear 1400. Further, the sealed open end 1430 can reduce the extra extrusion formed outside the casing 1410 around the joint 1470 after the plastic core material 1420 penetrates the wall of the casing during the breakthrough in-mold forming process. That is, the sealed open end 1430 provides a substantially sealed edge or surface (i.e., for the frayed open end of the casing 1410) that contacts the casing 1410 of the bottom strap 1402, thereby preventing the plastic core material 1420 from leaking through the casing 1410 of the top strap 1402 at the sealed open end 1430. FIG. 14C shows a joint 1470 formed between the sealed open end 1430 of the top strap 1420 and the edge of the casing 1412 of the bottom strap 1404. FIG. 14D shows a cross-section of the top strap 1402 and the bottom strap 1404 along line 14D-14D of FIG. 14C. The top strap 1400 and the bottom strap 1402 are joined to each other using the breakthrough in-mold forming technique discussed above. In an alternative configuration, prior to injection molding, the open end of the top strap 1402 can be overmolded to seal the end of the top strap 1402.

[0135] In another embodiment, by placing a casing within the heat sealer, a sealed open end can be formed, where the outer portion of the casing seals / melts but is not cut by the heat sealer. Then, the casing is cut in the middle part of the sealing area (i.e., after the sealing area has cooled), resulting in an open end. The inner walls of the casing are neither sealed nor fused together, but the individual yarns are fused on the outside of the casing (i.e., the outer wall), thus fixing the excess yarn of the individual yarns, thereby providing a clean aesthetic and preventing or blocking the plastic core material from leaking through the casing at the sealed open end.

[0136] Figures 15A - 15D show a bifurcated headgear 1500 having a filament core 1550 with a core end 1512 anchored within a plastic core material 1510 in a bottom strap 1502. The filament core 1550 can be used with a deformation locking mechanism as disclosed in U.S. Patent Application No. 14 / 856,193, which is incorporated herein by reference. The filament core 1550 and the deformation locking mechanism provide a length adjustment mechanism for adjusting the length and tension of the bottom strap of the headgear to loosen or tighten the mask interface with respect to the user's face. For example, in some configurations, the locking mechanism can engage the filament core to adjust the effective length of the bottom strap.

[0137] The bifurcated headgear 1500 has a top strap 1502 and a bottom strap 1504, which are configured similarly to the bifurcated headgear 100 with a top strap 140 and a bottom strap 150 of FIGS. 1A - 7. Further, the top strap 1502 and the bottom strap 1504 are joined at a joint 1570 using a breakthrough in - molding process, similar to the top strap 140 and the bottom strap 150 at the joint 170.

[0138] As shown in Figure 15A, the top strap 1502 is joined to the bottom strap 1504 at the joint 1570. The top strap 1502 and the bottom strap 1504 are joined via a molded plastic core material 1510, which is integrally formed within the casing 1520 of the top strap 1502 and the bottom strap 1504 using the perforation molding technique discussed above. Similarly, the top strap 1502 and the bottom strap 1504 have soft edges 1522. As shown, the filament anchor portion 1552 of the filament core 1550 is positioned within the core end portion 1512 of the plastic core material 1510. The filament core 1550 is fixed and anchored within the core end portion 1512 at a position forward of the joint 1570 (i.e., in front of the user's ear). In some configurations, the filament core 1550 is joined to the plastic core material 1510 during the perforation molding process. The filament core 1550 is surrounded by the casing 1520 of the bottom strap 1504, but is not attached to the casing 1520. That is, between the core end 1512 and the open end 1524 of the casing 1520, the filament core 1550 is not attached to the casing 1520. Thus, the casing 1520 can move independently over the filament core 155, which is effectively non-stretchable. Furthermore, similar to the previous embodiment formed using a breakthrough mold in-molding technique, the plastic core material 1510 is coupled to the casing 1520 of the top strap 1502 and bottom strap 1504.

[0139] As illustrated in Figure 15B, the bottom strap 1504 differs from the bottom strap 150 in Figures 1A–7 in that the casing 1520 of the bottom strap 1504 is longer to cover, surround, and conceal a portion of the filament core 1550. Concealing the filament core 1550 can improve the aesthetic appearance of the headgear. As illustrated in Figures 15B and 15C, the filament core 1550 extends forward from the core end 1512 of the bottom strap 1504 and has a length greater than the stretched or extended length of the casing 1520 of the bottom strap 1504. Figure 15B shows the unstretched length of the casing 1520 of the bottom strap 1504. Figure 15C shows the casing 1520 of the bottom strap 1504 stretched to its maximum length, while a portion of the filament core 1550 still extends further beyond the maximum length of the casing 1520. Therefore, the casing 1520 of the bottom strap 1504 is configured to conceal the filament core 1550 through a wide range of positions between the filament core 1550 and the locking mechanism (not shown). The stretched and unstretched lengths of the casing 1520 can be changed according to the size of the headgear and the desired range of adjustability.

[0140] Figure 15D shows an enlarged view of the casing 1520 of the bottom strap 1504 in an extended state. In a preferred embodiment, the casing 1520 of the second strap 1504 is braided and comprises inelastic yarn with incorporated linear elastic elements. The casing 1520 can extend and retract independently of the filament core 1550. As shown in Figure 15D, when stretched, the casing 1520 of the bottom strap 1504 constricts and narrows or narrows in width when stretched, as indicated by the constricted region 1526 from the core end 1512, and the individual yarns of the casing 1520 align, thus limiting the elongation length of the braided portion. The filament core 1550 is longer than the elongation length of the braided portion. When no force is applied to the braided portion, the linear elastic elements of the casing 1520 retract the braided portion.

[0141] Figure 16A shows a bifurcated headgear 2000 having top straps 2120 on the right side 2120 and 2130 on the left side, connected by a button and hole size adjustment system 2200. The button and hole size adjustment system 2200 may be similar to the “snap-fit” button and hole adjustment systems commonly used in baseball caps, but is integrally molded as part of the bifurcated headgear 2000. The size adjustment system 2200 comprises several holes 2210 (not visible in Figure 16A) extending through the top strap 2140 on the left side 2130, and several buttons 2220 protruding from the upper surface 2222 of the top strap 2140 on the right side 2120. The positioning of the multiple holes 2210 and multiple buttons 2220 relative to the right side 2120 and left side 2130 can be reversed such that the multiple buttons 2220 extend from the top strap 2140 of the left side 2130 and the multiple holes 2210 extend through the top strap 2140 of the right side 2120.

[0142] Figure 16B is an enlarged cross-sectional view of the button and hole size adjustment system 2200. That is, Figure 16B shows the button 2220 extending through the hole 2210. With respect to features not specifically discussed, the bifurcated headgear 2000 may be the same as or similar to other headgears disclosed herein. That is, the bifurcated headgear 2000 has a top strap 2140 and a bottom strap 2150 arranged similarly to the bifurcated headgear 100 with a top strap 140 and a bottom strap 150 in Figures 1A to 7. Furthermore, the top strap 2140 and the bottom strap 2150 are joined at the joint 2170 using a breakthrough die in-molding process, similar to the top strap 140 and the bottom strap 150 at the joint 170. That is, the top strap 2140 and the bottom strap 2150 are formed from a casing 2180 filled with a single plastic core material 2190.

[0143] Figures 16C–16D show an open / close injection mold 2300 configured to form buttons 2220 for a hole size adjustment system 2200. For simplicity, Figure 16C shows portions of the first mold half 2310 and the second mold half 2320 of the injection mold 2300 that form a single button 2220. The configuration of the mold 2300 and the process of forming multiple buttons 2220 are substantially the same as the process of forming a single button 2220. Furthermore, the first mold half 2310 and the second mold half 2320 are similar to the first mold half 310 and the second mold half 320 in Figures 1A–7 and include strap cavities for in-mold molding of the plastic core material within top and bottom straps. In other words, the multiple buttons 2220 of the hole size adjustment system 2200 can be formed during a breakthrough in-mold molding process in which the plastic core material 2190 is injected into the top strap 2140 and bottom strap 2150 (i.e., in a single injection molding process).

[0144] Figure 16C shows a fully formed button 2220 protruding from the upper surface 2222 of the top strap 2140. The first mold half 2310 and the second mold half 2320 each have strap cavities 2312 and 2322, respectively, in which the casing 2180 of the top strap 2140 is received and injected with plastic core material 2190. The first mold half 2310 also includes a button cavity 2314, which is fluidly connected to the strap cavities 2312 and 2322, having a shape corresponding to the button 2220, and is cylindrical in the illustrated embodiment. The button 2220 and the corresponding button cavity 2314 are not limited to a cylindrical shape. Those skilled in the art will also understand that a technique can be used to form multiple buttons 2220 to form alternative features (e.g., raised grips, logos, connector parts, etc.) on any surface of the strap.

[0145] Figure 16D shows cross-sections of the first mold half 2310 and the second mold half 2320 along line 16D-16D in Figure 16C during the process of forming the button 2220. As illustrated in step 1, the casing 2180 is positioned within the strap cavities 2312, 2322. A portion of the casing 2180 is not supported by the first mold half 2310, where the button cavity 2314 is connected to the strap cavity 2312. As illustrated in steps 2 and 3, the casing 2180 is pushed into the button cavity 2314 by the plastic core material 2190 as the strap cavities 2312, 2322 are filled with the plastic core material 2190. As illustrated in step 4, when the casing 2180 reaches the limit to accommodate the plastic core material 2190, the plastic core material 2190 will break through the casing 2180 because there is still a cavity (i.e., the button cavity 2314) to fill. That is, when the casing 2180 is filled with the plastic core 2190 in an area where the casing 2180 is not supported (for example, by the button cavity 2314 in the illustrated embodiment), the plastic core material 2190 will penetrate and break through the casing 2180, filling the button cavity 2314. Similar to the breakthrough in-mold molding process described above, the threads of the casing 2180 may be displaced or elastically deformed when under the pressure of the injected plastic core material 2190. The displacement or elastic deformation of the threads can create gaps between the threads through which the injected plastic core material 2190 can flow into the button cavity 2314. In some configurations, the threads of the casing 2180 can be split so that a hole is formed through the casing 2180, through which the injected plastic core material 2190 can flow into the button cavity 2314.

[0146] In other embodiments, the plastic core material 2190 penetrates and breaks through the casing 2180 before the casing 2180 and the strap cavities 2312, 2322 are filled with the plastic core material 2190. This can occur, for example, if the unsupported area of ​​the casing 2180 is closer to the injection point, the plastic core material 2190 is low density or low viscosity, the casing 2180 has low fiber density and / or the unsupported portion is large relative to the supported area.

[0147] Figure 17 shows an adjustable strap configuration with an adjustment and utility mechanism formed by a breakthrough die-molding process. This configuration includes a first strap 3110 and a second strap 3120. The first strap 3110 includes a breakthrough end loop 3130 configured to receive the second strap 3120. The second strap 3120 is received and folded back within the end loop 3130 and is provided with a fastening mechanism for removably fastening the free end of the second strap 3120. The second strap 3120 includes a breakthrough end or grip tab 3140. In at least one embodiment, the second strap 3120 includes an inner surface 3122 and an outer surface 3124, each having a different visual or tactile configuration. When the second strap 3120 is folded back and fastened, the inner surface 3122 of the portion of the strap that is fed over the end loop 3130 of the second strap 3120 is exposed. This provides a visual and / or tactile indication of the adjusted length.

[0148] Figure 18 shows a non-limiting exemplary embodiment of a headgear 3200 formed according to the in-mold and / or breakthrough processes described herein. The headgear 3200 comprises a lower strap 3210, a middle strap 3220, and a vertical or top strap (hereinafter referred to as the "vertical strap") 3230. The lower strap 3210 extends from the patient interface (not shown) below the user's ear, around the back of the user's head, below the user's other ear, to the patient interface. The middle strap 3220 extends from the patient interface above the patient's ear, around the back of the headgear 3200, above the user's other ear, to the patient interface. The vertical strap 3230 extends upward from the lower strap 3210 at a point in front of the user's ear, over the top of the user's head, to the point of the lower strap 3210 in front of the user's other ear.

[0149] In the embodiment shown in Figure 18, the lower strap 3210 is a continuous strap having a continuous casing. In other words, the casing of the lower strap 3210 is uninterrupted before the in-mold and / or breakthrough process. After the in-mold breakthrough process, a breakthrough joint is formed from the lower strap 3210. It should be noted that the continuous casing or strap may include pre-formed openings that allow the injection material to be exposed.

[0150] As shown in Figure 18, the vertical strap 3230 is a continuous strap because it is formed from a continuous or uninterrupted casing. After the in-mold breakthrough process, the casing end 3232 of the vertical strap 3230 is joined to the lower strap 3210 by the breakthrough joint and in-mold.

[0151] The middle strap 3220 is a segmented strap. In other words, the middle strap 3220 is formed from multiple or segmented casings. The segmented casings are joined to other straps during the in-die breakthrough process. In the embodiment shown in Figure 18, the middle strap 3220 consists of front casings 3222, each joined to the vertical or top strap 3230 at breakthrough joints, which are positioned vertically spaced from the lower strap 3210 and above the user's ears. The middle strap 3220 further includes a rear casing 3224, the end of which is joined to the vertical or top strap 3230, also above the user's ears, during the in-die breakthrough process.

[0152] Herein, this specification focuses on the non-limiting exemplary embodiments illustrated in Figures 19 to 42. For simplicity, this description focuses on additional features introduced in each figure. Therefore, features or configurations previously described may not be included in every instance. Furthermore, the features in the following non-limiting exemplary embodiments can be combined with any of the previously described non-limiting exemplary embodiments to the extent that they can be combined.

[0153] Figure 19 shows a headgear 4100 formed using an in-mold and / or breakthrough process. The headgear 4100 includes a continuous lower strap 4110 and a continuous middle strap 4120. A vertical strap 4130 is formed by a breakthrough joint from the apex 4124 of the middle strap 4120 above the user's ear. In front of the ear is a connecting strap 4140 between the lower strap 4110 and the middle strap 4120, formed by a breakthrough joint. The rear ends 4112 of the lower strap 4110 and 4122 of the middle strap 4120 are close together. A breakthrough web 4150 connects the rear ends 4112 of the lower strap 4110 and 4122 of the middle strap 4120. In some configurations, the vertical strap 4130 and the breakthrough web 4150 may be separate and integrally formed.

[0154] Figure 20 shows another headgear 4200 formed using an in-mold and / or breakthrough process. The headgear 4200 includes a continuous lower strap 4210 and coupled continuous middle and vertical straps 4220. Ear loops 4230 are provided to surround the user's ears. The lower strap 4210 is attached to the ear loop 4230 along its lower part 4232. The continuous middle and vertical straps 4220 are attached along the upper part 4234 of the ear loop 4230. Figure 21 shows a headgear 4300 similar to the headgear 3200 shown in Figure 18, but with a web portion 4350 joining the rear part 4312 of the lower strap 4310 and the rear part 4322 of the middle strap 4320.

[0155] Figure 22 shows the headgear 4400 including a continuous lower strap 4410, which extends below the user's ears, vertically upward, behind the user's ears, and forward above the user's ears, forming part of the ear loop. A continuous vertical strap 4430 extends from the lower strap 4410 at the front of the ears, and the vertical strap 4430 forms the rest of the ear loop. A middle strap 4420 is joined to the vertical strap 4430 by a breakthrough joint. The lower rear portion 4412 of the lower strap 4410 is connected by a rear panel 4440.

[0156] Figure 23 shows a headgear 4500 that is similar to the headgear 4300 shown in Figure 21, but includes a smaller web section 4550 that connects the lower strap 4510 and the middle strap 4520.

[0157] FIG. 24 shows a headgear 4600 including a continuous lower strap 4610 and a combined continuous middle and vertical strap 4620. The headgear 4600 further includes a combined continuous upper rear strap and second vertical strap 4630. A web portion 4650 extends between the first vertical strap 4620 and the second vertical strap 4630, and also between the rear portion 4612 of the continuous lower strap 4610 and the upper rear strap 4630. The web portion 4650 also forms an ear loop surrounding the ear. That is, the web portion 4650 has holes in which the ear can be placed.

[0158] FIGS. 25 and 26 show two examples of a headgear 4700 having a lower strap 4710 and a middle strap 4720 formed from a continuous casing in the form of a closed loop structure. The lower strap 4710 and the middle strap 4720 form part of an ear loop 4770. A web portion 4740 extends between the lower strap 4710 and the middle strap 4720 to form the front portion 4772 of the ear loop 4770. The vertical strap 4730 is formed by a web portion that extends between the upper part 4766 of the right ear loop 4760 and the upper part 4776 of the left ear loop 4770. The rear portion 4780 of the headgear 4700 is formed by a rear web portion 4750 that extends between the lower rear part 4764 of the right ear loop 4760 and the lower rear part 4774 of the left ear loop 4770.

[0159] Figures 27 and 28 show two examples of headgear 4900 having a quilted fabric or material 4910 that is attached to a portion of the headgear 4900, for example, on the user's face or at the back of the user's neck, in direct contact with the user's skin or hair. Similar to a down comforter, the quilted fabric is soft to the touch and provides cushioning, thereby improving the comfort of the headgear 4900 so that the user will want to wear the headgear 4900 when sleeping. The quilted material 4910 can be sewn or welded to the in-molded strap or web portion of the headgear 4900. The disclosed configurations are not limited to, but may include, fabrics and textiles having a variety of material properties, such as soft, padded, breathable, moisture-absorbing, and non-slip / sticky to the touch.

[0160] Figure 29 shows a headgear 5100 including a vertical strap 5110 and a neck strap 5120 formed from a foam-Lycra laminate material such as Breath-o-prene. Breath-o-prene allows air to pass through the straps and wicks sweat away from the skin to improve comfort and compliance. In addition, Breath-o-prene provides padding in the straps to reduce pressure points on the user's head. The vertical strap 5110 comprises a first strap 3110 and a second strap 3120. The first strap 3110 includes a perforated end loop 3130 configured to receive the second strap 3120. The second strap 3120 is received within the end loop 3130, folded back, and equipped with a fastening mechanism to removably fasten the free end of the second strap 3120. The second strap 3120 includes a perforated end or grip tab 3140. In at least one embodiment, the second strap 3120 includes an inner surface 3122 and an outer surface 3124, each having a different visual or tactile configuration. When the second strap 3120 is folded back and fastened, the inner surface 3122 of the portion of the strap that is fed over the end loop 3130 of the second strap 3120 is exposed. This provides a visual and / or tactile indication of the adjusted length.

[0161] Figure 30 shows a headgear 5200 having a breathable, moisture-wicking material 5240 over vertical straps 5210 and a neck strap 5220. The breathable, moisture-wicking material 5240 may be a competitive and performance knit that improves the breathability of the headgear 5200 in the parts that come into contact with the user's skin or hair. The breathable, moisture-wicking material 5240 can also give the headgear 5200 an active and competitive appearance.

[0162] Figure 31 shows a headgear 5300 having a lower strap 5310 and a middle strap 5320 formed from a continuous casing in the form of a closed-loop structure. The continuous lower strap 5310 and middle strap 5320 form substantial portions of the ear loop 5370. The continuous lower strap 5310 and middle strap 5320 are joined by an ear-front breakthrough joint 5330, which forms the remainder of the ear loop 5370 in front of the ear. A vertical strap 5340 is formed at the apex 5322 of the middle strap 5320 and is formed from exposed plastic via a breakthrough injection process. Similarly, the neck strap 5350 can also be formed from exposed plastic. Alternatively, the vertical strap 5340 and neck strap 5350 can be constructed from in-mold straps with a textile outer casing. The vertical strap 5340 and neck strap 5350 may also be filleted at the joints with the lower strap 5310 and the middle strap 5320 to improve the connection strength with the lower strap 5310 and the middle strap 5320.

[0163] Figure 32 shows a headgear 5400 having a bottom lower strap 5410, a middle strap 5420, and a front vertical strap 5430, formed from a continuous casing in the form of a closed soup structure. The rear vertical strap 5440 and the top lower strap 5450 are also continuous straps and can form a closed loop structure. A web portion 5460 extends between the top lower strap 5450 and the bottom lower strap 5410, as well as between the front vertical strap 5430 and the rear vertical strap 5440. The web portion 5460 also extends between the front portion 5412 of the bottom lower strap 5410 and the middle strap 5420. The web portion 5460 also forms ear loops that surround the ears; that is, the web portion 5460 has holes into which the ears can be placed.

[0164] Figures 33 and 34 show two examples of headgear 5500 having a lower strap 5510 and a middle strap 5520 formed from a continuous casing in the form of a closed-loop structure. The upper part 5574 of the ear loop 5570 is defined by the middle strap 5520. The lower part 5572 of the ear loop 5570 is defined by the lower strap 5510. The web portion 5540 extends between the rear portions 5512, 5522 of the continuous lower strap 5510 and the middle strap 5520, defining the rear portion 5578 of the ear loop 5570. A continuous vertical strap 5530 extends from the lower strap 5510 in the front portion of the ear, forming the front portion 5576 of the ear loop 5570. The middle strap 5520 overlaps the vertical strap 5530. The middle strap 5520 is joined to the vertical strap 5530 by a breakthrough joint or arc welding. Figure 34 shows a vertical strap 5530 having an outer casing formed from a different material than the material used to form the middle strap 5520 and the lower strap 5510.

[0165] Figure 35 shows a headgear 5700 having a lower strap 5710 and a middle strap 5720 having a continuous casing. The lower strap 5710 extends below the user's ear, vertically upward, behind the user's ear, and forward above the user's ear, forming part of the ear loop 5770. A continuous vertical strap 5730 extends from the lower strap 5710 in the portion in front of the ear, forming the remaining part of the ear loop 5770. The middle strap 5720 is joined to the vertical strap 5730 by a breakthrough joint. The lower rear portion 5712 of the lower strap 5710 is joined by a rear panel 5740.

[0166] Figure 36 shows a headgear 5800 having a lower strap 5810 and a middle strap 5820 formed from a continuous casing in the form of a closed-loop structure. The continuous lower strap 5810 and middle strap 5820 extend below the user's ears, vertically upward and around the user's ears to form the bottom 5872, rear 5874 and top 5876 of the ear loop 5870, and continue forward from the front portion of the user's ears to form a portion of the middle strap 5820. A continuous vertical strap 5830 extends from the lower strap 5810 in the front portion of the ears, and the vertical strap 5830 forms the front portion 5878 of the ear loop 5870. In a portion substantially parallel to the vertical strap 5830, the middle strap 5820 overlaps the vertical strap 5830 and is joined to the vertical strap 5830 by a breakthrough joint. The lower rear portion 5812 of the lower strap 5810 is joined by the rear panel or web portion 5840.

[0167] Figures 37 and 38 show two examples of headgear 5900 having a lower strap 5910 and a middle strap 5920 formed from a continuous casing. A vertical strap 5930 extends from the lower strap 5910 in the portion in front of the ears and forms the front portion 5972 and top portion 5974 of the ear loop 5970. The vertical strap 5930 extends rearward and connects to the lower strap 5910 at a position behind the user's ears. In some configurations, the vertical strap 5930 extends around the back of the user's head. The lower strap 5910 forms the bottom portion 5976 of the ear loop 5970. The middle strap 5920 connects to the vertical strap 5930 at a position in front of the user's ears. A neck strap 5940 is attached to both the vertical strap 5930 and the lower strap 5910 and extends along a portion of the length of the vertical strap 5930 at the back of the user's head. In Figure 37, the neck strap 5940 is formed from a breathable, moisture-absorbing material and may be a knitted fabric for competition and performance. The vertical strap 5930 may be covered with a textile material or may be an exposed plastic core material.

[0168] Figure 39 shows an embodiment of headgear 6100 having a lower strap 6110 and a middle strap 6120 formed from a continuous casing. The lower strap 6110 and the middle strap 6210 meet behind the user's ears. A breakthrough joint 6140 connects the lower strap 6110 and the middle strap 6120 in front of the user's ears. A vertical strap 6130 is formed above the user's ears by a breakthrough joint from the apex 6122 of the middle strap 6120. The vertical strap 6130 may be covered with a textile material or may be made of an exposed plastic core material.

[0169] Figure 40 shows an embodiment of headgear 6200 having a lower strap 6210, a middle strap 6220, and a vertical strap 6230 formed from a continuous casing. In some non-limiting configurations, the continuous straps can be formed by weaving the continuous casing entirely or by joining layers of textile material to each other.

[0170] Figure 41 shows an embodiment of headgear 6300 having a lower strap 6310 and a middle strap 6320 and a vertical strap 6330 formed from a continuous casing. The continuous strap is connected to the rear strap 6340 at the junction with the end of the lower strap 6310 behind the user's ears and at the junction with the vertical strap 6330 above the user's ears. A web portion 6350 joins the lower strap 6310 and the middle strap 6320 in front of the user's ears. Alternatively, the continuous strap can join the lower strap 6310 and the middle strap 6320 in front of the user's ears. A neck strap 6360 is attached to both the rear strap 6340 and the lower strap 6310 and extends along a portion of the length of the rear strap 6340 behind the user's head. The neck strap 6360 is formed from a breathable, moisture-absorbing material and may be a competition and performance knit.

[0171] Figure 42 shows an embodiment of a headgear 6400 having a lower strap 6410 and a middle strap 6420 formed from a continuous casing. In some configurations, the continuous straps form a closed-loop structure. The lower strap 6410 and the middle strap 6420 intersect at a position behind the user's ears. A breathable, hygroscopic material can be placed in the opening 6450 between the lower strap 6410 and the middle strap 6420. The lower strap 6410 and the middle strap 6420 are connected by an in-molded web portion or strap 6440 at a position in front of the user's ears. A vertical strap 6430 is formed by a breakthrough joint above the user's ears from the apex 6422 of the middle strap 6420. In some configurations, the middle strap 6420 overlaps the vertical strap 6430, and the vertical strap 6430 extends toward the lower strap 6410, connecting the lower strap 6410 and the middle strap 6420.

[0172] Figures 43A and 43B show perspective views of an embodiment of a headgear 6510 that can be used with the patient interface 6500. The headgear 6510 includes a mid-strap 6512, a lower strap 6511, and a vertical member 6513. The lower strap 6511 extends from the patient interface 6500 below the user's ear, vertically upward, behind the user's ear, and forward above the user's ear to form part of the ear loop 6517. The mid-strap 6512 extends from the connector above the user's ear to form the upper part of the ear loop 6517 and joins with the lower strap 6511 at the joint. The mid-strap 6512 continues from the joint over the user's head. The vertical member 6513 extends from the joint with the lower strap 6511 in the front part of the ear to the joint with the mid-strap 6512 in the front part of the ear to form the rest of the ear loop 6517. The middle strap 6512 may include an adjustment mechanism to adjust the fit of the headgear 6510 over the user's head. The lower strap 6511 may also include an adjustment mechanism. The rear strap 6515 may also include an adjustment mechanism. The adjustment mechanism allows the length of the straps to be adjusted so that the headgear 6510 fits a wide range of head sizes.

[0173] The lower strap 6511 and the middle strap 6512 are manufactured using an in-mold molding process and include a casing that can be woven from a soft-touch material so that the middle strap 6512 and the lower strap 6511 are comfortable when in contact with the user's skin. Similarly, the casing may have thickness and layers such that the headgear 6510 is comfortable when in contact with the user's skin. The interior of the casing includes plastic material to give the headgear 6510 rigidity. The middle strap 6512 and the lower strap 6511 are integrally formed at the headgear joint 6514 using a breakthrough in-mold molding technique. The vertical member 6513 is integrally formed at the middle strap 6512 and the lower strap 6511 and their respective joints using the same breakthrough in-mold molding technique.

[0174] In the illustrated embodiment, the middle strap 6512 and the lower strap 6511 are continuous straps having a continuous casing. In other words, the strap casing is uninterrupted in the in-mold and / or before the breakthrough process. It should be noted that the continuous casing or strap may include pre-formed openings that allow the injected material to be exposed.

[0175] The rear portion 6515 of the headgear 6510 passes around the back of the user's head. The rear portion 6515 can be formed from a plastic web manufactured by a breakthrough process. Alternatively, the rear portion 6515 can be formed from an elastic material so that the headgear 6510 can be configured to fit a wide variety of user head contours. Suitable materials include breath-o-prene, spacer fabric, or other stretchable and highly compliant fabrics. The fabric can be attached to the headgear 6510 using sutures, RF welding, ultrasonic welding, adhesive bonding, or any other suitable mechanism.

[0176] For simplicity, the following description of the embodiments will focus on additional features introduced in each figure. Therefore, features or configurations previously mentioned may not be included every time.

[0177] Figures 44A and 44B show perspective views of an embodiment of a headgear 6520 that can be used with the patient interface 6500. The headgear 6520 includes a lower strap 6521, a middle strap 6522, and an upper, vertical, or apex strap 6523. The lower strap 6521 extends from the patient interface 6500, behind the user's ear, around the back of the user's head, below the user's other ear, and back to the patient interface 6500. The middle strap 6522 extends from the patient interface 6500, above the user's ear, around the back of the user's head, above the user's other ear, and back to the patient interface 6500. The vertical strap 6523 extends from a joint on the lower strap 6521 in front of the user's ear to a joint with the middle strap 6522, over the top of the user's head to another joint on the middle strap 6522, and to the lower strap 6521 in front of the user's other ear. All joints in the illustrated configuration can be formed using in-die molding.

[0178] The headgear 6520 includes a rear web portion 6525 at the rear of the user's head. The rear web portion 6525 can be formed by in-die molding. The web portion 6525 can be formed integrally with the headgear 6520. Alternatively, the web portion 6525 may be manufactured from a more flexible material (e.g., Breath-o-prene) and connected to the lower strap 6521 and the middle strap 6522 by any suitable means (suturing, RF welding, adhesive, etc.).

[0179] Figures 45A and 45B show perspective views of an embodiment of a headgear 6530 that can be used with the patient interface 6500. The headgear 6530 includes a rear web portion 6535 which contains holes or voids. These holes act to improve the flexibility and breathability of the rear portion 6535. The web portion 6535 may be an in-mold plastic formed by a breakthrough process, or it may be an elastic fabric (e.g., Breath-o-prene, spacer fabric, etc.).

[0180] Figures 46A to 46C show perspective views of an embodiment of a headgear 6540 that can be used with the patient interface 6500. The headgear 6540 includes a lower strap 6541 and a middle strap 6542 formed from a continuous casing in the form of a closed-loop structure. The lower strap 6541 and the middle strap 6542 form part of the ear loop. A vertical member 6544 extends from its junction with the lower strap 6541 in an anterior position of the ear to its junction with the apex strap 6543 in an anterior position of the ear, forming the rest of the ear loop. The apex strap 6543 spans between the upper parts of the right ear loop and the left ear loop. A rear strap 6545 spans between the rear parts of the right ear loop and the left ear loop. In at least one embodiment, at least one of the top strap 6543 and the rear strap 6545 may be manufactured from a flexible material (e.g., Breath-o-prene) and connected to the lower strap 6541 and the middle strap 6542 by any suitable means (e.g., sutures, RF welding, adhesives). In at least one embodiment, either the top strap 6543 or the rear strap 6545 may be manufactured using a breakthrough die molding process. In at least one embodiment, both the top strap 6543 and the rear strap 6545 may be manufactured using a breakthrough die molding process. The rear strap 6545 may include an adjustment mechanism.

[0181] Figures 47A and 47B show perspective views of an embodiment of a headgear 6550 that can be used with the patient interface 6500. The headgear 6550 includes a lower strap 6551 and a middle strap 6552 formed from a continuous casing in the form of a closed-loop structure. The lower strap 6551 and the middle strap 6552 form part of the ear loops. The top strap 6553 is formed by a breakthrough in-mold process and extends from the joint at the top of the right ear loop to the joint at the top of the left ear loop. The first rear strap 6555 is formed from a soft-touch quilted fabric or material. The second rear strap 6557 of the headgear 6550 is formed by a rear web portion that extends between the lower rear of the right and left ear loops. The second rear strap 6557 can be manufactured from a soft-touch quilted fabric or material, or from a plastic material using an in-mold process.

[0182] Figures 48A and 48B show perspective views of an embodiment of a headgear 6560 that can be used with the patient interface 6500. The headgear 6560 includes a first lower strap 6564 formed from a continuous casing. The first lower strap 6564 extends laterally, below the user's right ear, around the back of the user's head, and joins with a middle strap 6562 at a joint opposite the user's head. The joint where the first lower strap 6564 and the middle strap 6562 join is generally located above the user's left ear. The headgear 6560 includes a second lower strap 6566, which is a segmented strap comprising the lengths of two casings. The second lower strap 6566 extends laterally, below the user's left ear, around the back of the user's head, and intersects with the first lower strap 6564 at a rear joint. The second lower strap 6566 extends from the rear joint to a joint where it connects with the middle strap 6562, which is generally located above the user's right ear. The cores of the first lower strap 6564 and the second lower strap 6566 are integrally formed using in-beam molding.

[0183] The mid-strap 6562 extends from the patient interface 6500 over the user's right ear and joins with the second lower strap 6566 at the junction. The mid-strap 6562 continues from the junction over the user's head and joins with the first lower strap 6564 at the other junction. The mid-strap 6562 continues to the patient interface 6500.

[0184] Figures 49A and 49B show perspective views of embodiments of headgear 6570 that can be used with patient interface 6500. The middle strap 6572 extends from patient interface 6500, over the user's ear, around the back of the user's head, over the user's other ear, to the opposite side of patient interface 6500. The top strap 6573 can be formed from a through-joint with the middle strap 6572. The lower strap 6571 extends from patient interface 6500, below the user's ear, around the back of the user's head, over the user's other ear, to the opposite side of patient interface 6500.

[0185] The headgear 6570 includes ear loops 6577. The ear loops 6577 extend from the rear of the user, over the user's right ear and around its front. The ear loops 6577 extend below the user's right ear and continue around the rear of the user's head. The ear loops 6577 extend below the user's left ear and around its front, continue over the user's left ear and rearward, and merge with themselves at the rear of the user's head.

[0186] The ear loop 6577 includes a rear web portion 6575 extending between opposing lengths of the ear loop 6577 at the rear of the user's head. The rear web portion 6575 can be formed by in-cut molding. The web portion 6575 can be formed integrally with the headgear 6570. Alternatively, the web portion 6575 may be manufactured from a more flexible material (e.g., Breath-o-prene) and connected to the lower strap 6571 and the middle strap 6572 by any suitable means (suturing, RF welding, adhesive, etc.). The ear loop 6577 is joined to the middle strap 6572 and the lower strap 6571 of the headgear 6570 by using sutures, RF welding, ultrasonic welding, or adhesive bonding.

[0187] Figures 50A and 50B show perspective views of an embodiment of a headgear 6580 that can be used with a patient interface 6500. The headgear 6580 includes a lower strap 6581 that extends from the patient interface 6500 below the user's ears. A middle strap 6582 extends from the patient interface 6500 above the user's ears. The middle strap 6582 and the lower strap 6581 converge at the back of the user's head to form a rear strap 6585. The middle strap 6582 and the lower strap 6581 form a first ear loop 6587. A top strap 6583 is formed by a through-joint above the user's ears. A second ear loop 6589 is formed by a through-web. In at least one embodiment, the second ear loop portion 6589 and the top strap 6583 can be integrally formed using a breakthrough process and connected to the first ear loop portion 6587 using an appropriate method (such as suturing).

[0188] Figures 51A and 51B show non-limiting exemplary embodiments of a headgear 6590 that can be used with the patient interface 6500. The headgear 6590 includes a lower strap 6591 and a middle strap 6592 formed from a continuous casing in the form of a closed-loop structure. The lower strap 6591 and the middle strap 6592 form part of the ear loops. The top strap 6593 is formed by a breakthrough in-mold process. The top strap 6593 includes a first portion 6594 extending from a filleted joint at the top of the right ear loop toward the top of the user's head, and a second portion 6595 similarly extending from a filleted joint at the top of the left ear loop toward the top of the user's head.

[0189] The first part 6594 and the second part 6595 of the top strap 6593 cooperate to allow the user of the patient interface 6500 to adjust the length of the top strap 6593. The first part 6594 and the second part 6595 of the top strap 6593 can cooperate by including a push-fit adjustment mechanism. As shown in Figure 51B, the push-fit adjustment mechanism may include a number of projections 6599 in the second part 6595 of the top strap 6593 and a number of cooperating recesses 6598 in the first part 6594 of the top strap 6593. The projections 6599 of the second part 6595 can be pushed into or press-fitted into the recesses 6598 of the first part 6594 to fix the length of the top strap 6593 as required. The projections 6599 can be formed from a breakthrough in-mold molding process. Any other suitable adjustment mechanism can be implemented to connect the first part 6594 and the second part 6595 in order to set the length of the top strap 6593.

[0190] The rear strap 6597 is formed by a breakthrough in-mold process and extends from a fillet joint at the rear of the right ear loop to a fillet joint at the rear of the left ear loop. In the illustrated configuration, the rear strap 6597 includes a casing that encloses a plastic core along the length of the strap. In at least one configuration, the rear strap 6597 may include a plastic structure extending across the rear of the headgear 6590. In at least one embodiment, the rear strap 6597 may include a length adjustment mechanism.

[0191] Figures 52A to 52C show perspective views of an embodiment of a headgear 6610 that can be used with the patient interface 6600. The headgear 6610 includes a mid-strap 6611 and a rear-strap 6613 formed from a continuous casing 6601. A top strap 6612 is formed by a breakthrough in-mold process. The top strap 6612 extends from a joint 6617 at the top of the mid-strap 6611 and / or rear-strap 6613 and extends over the user's head to the joint 6617 at the top of the mid-strap 6611 and / or rear-strap 6613 on the opposite side of the user's head. In at least one embodiment, the top strap 6612 can be formed from a fillet joint.

[0192] The joint 6617 and the adjacent portions of the mid-strap 6611 and rear-strap 6613 include a support structure 6615. Figure 52B shows a cross-sectional view of the joint 6617 and adjacent portions along line 52B-52B, illustrating the support structure 6615. In contrast, Figure 52C shows a cross-sectional view of the rear-strap 6613 along line 52C-52C, with no support structure 6615. The support structure 6615 may be arched, following the contours of the mid-strap 6611, rear-strap 6613 and joint 6617. The support structure 6615 can extend from a first position in front of the user's ear to a second position behind the user's ear. In the illustrated configuration, the support structure 6615 is formed from a plastic or polymer material 6602. The support structure 6615 can be formed from a breakthrough in-mold process. A support structure 6615 can be overmolded onto the headgear 6610. The support structure 6615 can provide a structure that helps the headgear 6610 maintain its shape and / or contributes to the structural integrity of the headgear 6610.

[0193] Figures 53A and 53B show perspective views of an embodiment of a headgear 6620 that can be used with the patient interface 6600. The headgear 6620 includes a lower strap 6621 and a middle strap 6622 formed from a continuous casing in the form of a closed-loop structure. The lower strap 6621 and the middle strap 6622 form part of the ear loop. The headgear 6620 includes a first rear section 6624 and a second rear section 6625. The second rear section 6625, the lower strap 6621 and the middle strap 6622 are integrally formed from a breakthrough in-mold molding process. The lower strap 6621 and the middle strap 6622 include a textile outer casing 6601 together with an in-mold plastic core 6602. The second rear section 6625 includes a textile outer casing 6601 together with an in-mold plastic core 6602. The web portion 6628, formed by the breakthrough die internal molding process, extends between the lower strap 6621 and the middle strap 6622 and the second rear portion 6625.

[0194] The web portion 6628 forms the plastic core of the first rear portion 6624. As shown in Figure 53B, the first rear portion 6624 includes overmolded material 6603 on at least one of the web surfaces. In the illustrated configuration, the first rear portion 6624 includes soft-touch overmolded material 6603 on both the outer and inner surfaces of the first rear portion 6624. This overmolded material 6603 can improve the level of comfort experienced by the user of the headgear 6620. The first rear portion 6624 and the second rear portion 6625 are configured to form a top strap 6623 that spans the top of the user's head and a rear strap 6627 that spans the back of the user's head.

[0195] Figures 54A to 54C show a headgear 6630 having a lower strap 6631 and a middle strap 6632 formed from a continuous casing. The upper part of the partial ear loop is defined by the middle strap 6632. The lower part of the partial ear loop is defined by the lower strap 6631. A web portion 6637 extends between the rear portions of the continuous middle strap 6632 and lower strap 6631, defining the rear portion of the partial ear loop. Figure 54B is an enlarged view of the web portion 6637. The web portion 6637 can be formed by a breakthrough in-mold molding process. Figure 54C shows a cross-sectional view of the web portion 6637 along line 54C-54C in Figure 54B. The web portion 6637 includes an overmolding material 6603. In at least one embodiment, the overmolding material 6603 may be a soft-touch material.

[0196] The top strap 6633 is formed by a breakthrough in-mold molding process. The top strap 6633 extends from the joint at the top of the middle strap 6632 and / or rear strap 6635 and extends over the user's head to the joint at the top of the middle strap 6632 and / or rear strap 6635 on the opposite side of the user's head. In at least one embodiment, the top strap 6633 may include a fillet joint. The top strap 6633 may include a soft-touch overmolded material on at least its upper surface, lower surface, or both.

[0197] Figures 55A to 55C show a headgear 6640 including a continuous lower strap 6641 and a combined continuous middle and combined continuous middle and vertical strap 6642. The headgear 6640 further includes a combined upper and rear strap 6643. A web portion 6645 extends between the first vertical strap and the second vertical strap. A web portion 6645 extends between the first rear strap and the second rear strap. Figure 55B shows a cross-section of the web portion 6645 along line 55B-55B in Figure 55A. Figure 55C shows an enlarged view of the web portion 6645. In at least one embodiment, the web portion 6645 can be formed from a breakthrough in-mold process. In at least one embodiment, the strap may include a braided tube casing 6601.

[0198] Figures 56A and 56B show a headgear 6650 having a lower strap 6651 and a middle strap 6652 formed from a continuous casing in the form of a closed-loop structure. The continuous middle strap 6652 and lower strap 6651 form a substantial portion of the ear loop. The top strap 6653 extends from the joint 6655 at the upper right side of the partial ear loop to the joint at the upper left side of the partial ear loop. Similarly, the rear strap 6657 extends from the joint at the rear right side of the partial ear loop to the joint at the rear left side of the partial ear loop.

[0199] As shown in Figure 56B, the top strap 6653 and the rear strap 6657 may be filleted or tapered at their joints with the middle strap 6652 and the lower strap 6651 to improve the connection strength with the middle strap 6652 and the lower strap 6651. In at least one embodiment, the top strap 6653 may be formed from exposed plastic. In at least one embodiment, the top strap 6653 may be constructed from an in-molded strap having a textile outer casing. In at least one embodiment, the rear strap 6657 may be formed from exposed plastic. In at least one embodiment, the rear strap 6657 may be constructed from an in-molded strap having a textile outer casing.

[0200] Figures 57A to 57C show perspective views of an embodiment of a headgear 6660 that can be used with the patient interface 6600. The headgear 6660 has a middle strap 6662 formed from a continuous casing. The headgear 6660 has a lower strap 6661 formed from a continuous casing. The middle strap 6662 extends from the mask assembly above the user's ears and continues to the back of the user's head. The upper part of the ear loops is defined by the middle strap 6662. The lower strap 6661 extends from the mask assembly below the user's ears and continues to the back of the user's head. The lower part of the ear loops is defined by the lower strap 6661.

[0201] The headgear 6660 includes a first vertical member 6665 and a second vertical member 6666. The first vertical member 6665 forms the front portion of the ear loop, extending over the distance between the lower strap 6661 and the middle strap 6662 in front of the user's ear. The first vertical member 6665 can be formed from a breakthrough die in-molding technique. The first vertical member 6665 may be exposed plastic. As shown in Figure 57B, the second vertical member 6666 forms the rear portion of the ear loop, extending over the distance between the lower strap 6661 and the middle strap 6662 behind the user's ear. The second vertical member 6666 can be formed from a breakthrough die in-molding technique. The second vertical member 6666 may be exposed plastic 6602. Figure 57C is a cross-sectional view of the second vertical member 6666 along line 57C-57C in Figure 57B.

[0202] The top strap 6663 extends from the joint 6668 at the top of the middle strap 6662 and / or rear strap 6669, and extends over the user's head to the joint 6668 at the top of the middle strap 6662 and / or rear strap 6669 on the opposite side of the user's head. The top strap 6663 can be formed from a breakthrough in-mold process. The top strap 6663 may include exposed plastic.

[0203] Figures 58A and 58B show perspective views of an embodiment of a headgear 6670 that can be used with the patient interface 6600. The headgear 6670 has a middle strap 6672 formed from a continuous casing. The headgear 6670 has a lower strap 6671 formed from a continuous casing. The middle strap 6672 extends from the mask assembly over the user's ears and continues to the back of the user's head. The upper part of the partial ear loop is defined by the middle strap 6672. The lower strap 6671 extends from the mask assembly below the user's ears and continues to the back of the user's head. The lower part of the partial ear loop is defined by the lower strap 6671.

[0204] The web portion 6677 extends between the rear portions of the continuous mid-strap 6672 and lower strap 6671, defining the rear portion of the partial ear loop. The web portion 6677 can be formed from a breakthrough in-mold molding process.

[0205] The top strap 6673 is formed from a breakthrough in-mold process. The top strap 6673 extends from the joint at the top of the middle strap 6672 and / or rear strap 6678 and extends over the user's head to the joint at the top of the middle strap 6672 and / or rear strap 6678 on the opposite side of the user's head. In at least one embodiment, the top strap 6673 may include a fillet joint 6675. The top strap 6673 may be exposed plastic, include a fabric case, or include at least one overmolded material.

[0206] Figures 59A to 59C show a headgear 6680 including a continuous lower strap 6681 and a combined continuous middle and vertical strap 6682. The headgear 6680 further includes a combined upper and rear strap 6683. A web portion 6685 extends around the back of the user's ears. The web portion 6685 can be formed from a breakthrough in-mold process.

[0207] As shown in Figure 59B, a continuous middle and vertical strap 6682 and a continuous upper and rear strap 6683 are joined via an invisible joint. Along this joint, the plastic core of the continuous middle and vertical strap 6682 is integrally formed with the plastic core 6602 of the continuous upper and rear strap 6683. In at least one embodiment, the continuous middle and vertical strap 6682 and the continuous upper and rear strap 6683 may include a common textile casing 6601. In at least one embodiment, the continuous middle and vertical strap 6682 and the continuous upper and rear strap 6683 are formed from two separate textile casings including at least one adjacent face. Furthermore, a single upper and rear strap 6683 and a single lower strap 6681 are joined via an invisible joint.

[0208] Figures 60A and 60B show perspective views of an embodiment of a headgear 6690 that can be used with the patient interface 6600. The headgear 6690 includes a lower strap 6691 and a middle strap 6692 formed from a continuous casing in the form of a closed-loop structure. The continuous middle strap 6692 and lower strap 6691 form a substantial portion of the ear loops. A top strap 6693 extends from a joint 6695 at the top of the right partial ear loop to a joint 6696 at the top of the left partial ear loop. The top strap 6693 can be formed from a breakthrough in-mold process. In at least one embodiment, the top strap 6693 can be made from an in-mold strap having an outer casing made of textile.

[0209] The headgear 6690 includes a rear strap 6697. The rear strap 6697 extends from the joint at the rear of the right partial ear loop to the joint at the rear of the left partial ear loop. The rear strap 6697 can be formed by in-mold molding of a plastic core and a fabric or textile casing. The rear strap 6697 may have a molded texture engraved on the strap 6697 or may include a contour determined during the molding process. Figure 60A shows the strap 6697 with a number of hexagonal holes arranged in a row along the length of the strap 6697. Figure 60B is a magnified view of the hexagonal holes arranged in a row along the length of the rear strap 6697. The holes protrude through the thickness of the strap 6697. This contour can give the plastic core some degree of elasticity or stretchability. Such flexibility may be beneficial in that the headgear 6690 can be pulled over the patient's head or improve the patient's perception of the headgear 6690. Furthermore, the textured finish of strap 6697 can enhance the aesthetic appearance of headgear 6690 and the tactile appeal of strap 6697. In other words, strap 6697 may appear more rigid and more comfortable. The holes can improve ventilation through strap 6697, thereby improving user comfort.

[0210] Alternatively, the rear strap 6697 may include a plurality of hexagonal recesses arranged in a row along the length of the strap 6697. It should be understood that the holes are not limited to hexagonal shapes and may include various shapes, sizes, positions on the strap, geometric forms, combinations of shapes, etc. In at least one configuration, the honeycomb-patterned plastic core does not extend to the edge of the casing of the strap 6697. This provides a soft edge that enhances user comfort. In at least one embodiment, the rear strap 6697 may be exposed plastic.

[0211] Figures 61A to 61C show perspective views of an embodiment of a headgear 7110 that can be used with a patient interface. The headgear 7110 comprises a lower strap 7111, a middle strap 7112, and a vertical or top strap 7113. The lower strap 7111 is a continuous strap with a continuous casing. The middle strap 7112 is a continuous strap with a continuous casing. The vertical strap 7113 is a segmented strap. In other words, the vertical strap 7113 is formed from multiple or segmented casings.

[0212] In at least one embodiment, the vertical strap 7113 may be a continuous strap having a continuous casing. The vertical strap 7113 may pass directly beneath the mid-length strap 7112 as it extends over the user's head. The vertical strap 7113 may pass over the mid-length strap 7112 as it extends over the user's head. The vertical strap 7113 may be adhesively bonded to the mid-length strap 7112, connected via a suitable connection mechanism such as a hook-and-loop fastener connection system, or be independent of the mid-length strap 7112.

[0213] As shown in Figure 61B, the middle strap 7112 and the lower strap 7111 include an invisible joint extending across the rear portion of each strap. Along the invisible joint, the middle strap 7112 and the lower strap 7111 may include a common plastic core 7002. Figure 61C shows a cross-sectional view of Figure 61B along line 61C-61C. The middle strap 7112 and the lower strap 7111 may have separate textile or fabric casings 7001 configured such that the common plastic core 7002 of the straps is invisible.

[0214] Figures 62A and 62B show perspective views of an embodiment of a headgear 7120 that can be used with the patient interface 7100. The headgear 7120 has a middle strap 7122 formed from a continuous casing. The headgear 7120 has a lower strap 7121 formed from a continuous casing. The middle strap 7122 extends from the mask assembly over the user's ears and continues to the back of the user's head. The upper part of the ear loops is defined by the middle strap 7122. The lower strap 7121 extends from the mask assembly below the user's ears and continues to the back of the user's head. The lower part of the ear loops is defined by the lower strap 7121.

[0215] The top strap 7123 extends from the joint at the top of the middle strap 7122 and / or the rear strap 7128 and extends over the user's head to the joint at the top of the middle strap 7122 and / or the rear strap 7128 on the opposite side of the user's head. The top strap 7123 is formed from a breakthrough in-mold process. The top strap 7123 may include fillet joints. The top strap 7123 may be exposed plastic, include a fabric case, or include at least one overmolded material.

[0216] The headgear 7120 includes a vertical member 7125. The vertical member 7125 is located in front of the user's ears and extends over the distance between the lower strap 7121 and the middle strap 7122, forming part of the ear loop. The vertical member 7125 is made of a soft-touch material, such as fabric or foam. In the illustrated configuration, the vertical member 7125 includes multiple holes. The multiple holes can improve the elasticity and / or flexibility of the vertical member 7125 and improve the user's perceived comfort.

[0217] The web portion 7127 extends between the rear of the continuous middle strap 7122 and lower strap 7121, defining the rear of the ear loop. The web portion 7127 can be made from a soft-touch material, such as cloth or foam. In the illustrated configuration, the web portion 7127 includes multiple holes. The multiple holes can improve the elasticity and / or flexibility of the web portion 7127 and improve the comfort perceived by the user.

[0218] In at least one embodiment, the vertical member 7125 can be formed from quilted fabric. In at least one embodiment, the vertical member 7125 can be formed from a perforation-type molding process to include a plurality of holes. In at least one embodiment, the vertical member 7125 may include a plurality of indentations instead of a plurality of holes. In at least one embodiment, the web portion 7127 can be formed from quilted fabric 7129, as shown in Figure 62B. In at least one embodiment, the web portion 7127 can be formed from a perforation-type molding process to include a plurality of holes. In at least one embodiment, the web portion 7127 may include a plurality of indentations instead of a plurality of holes.

[0219] Figures 63A and 63B show embodiments of the headgear 7130 having a quilted fabric or material 7132 provided to be attached to a portion of the headgear 7130 that comes into direct contact with the user's skin or hair, for example, at the back of the user's neck. The quilted material 7132 is soft to the touch and provides cushioning, thereby improving the comfort of the headgear 7130 so that the user will want to wear the headgear 7130 when sleeping. The quilted material 7132 can be sewn or welded to the in-molded strap or web portion of the headgear 7130. The disclosed configurations are not limited to, but may include, fabrics and textiles having a variety of material properties, such as (illustrated in Figure 63B), soft, padded, breathable, moisture-absorbing, and non-slip / sticky to the touch, etc.

[0220] Figures 64A and 64B show that embodiments of the headgear 7140 have a fabric or textile material provided to be attached to the portion of the headgear 7140 that comes into direct contact with the user's skin or hair. The headgear 7140 includes a vertical member 7142 and a rear strap 7144, which are formed from a material that provides cushioning and enhances the comfort of the headgear 7140. The material may be sewn or welded to the in-molded strap of the headgear 7140. The disclosed configurations are not limited to fabric or textile materials and may include quilted materials (as shown in Figure 64B). The material may have a variety of material properties, including but not limited to being soft, padded, breathable, hygroscopic, and having a non-slip / sticky feel.

[0221] Figure 65 shows an embodiment of the disclosed headgear and an embodiment of a braided grip 3300 that can be used. The braided grip 3300 can be formed from plastic by a breakthrough in-mold molding process.

[0222] In-mold strap connector Figures 66A to 73 show various diagrams of a connector 3400 positioned above a joint between two straps in an in-mold headgear embodiment. The connector 3400 is used in joints or connections 3500 between two or more adjacent straps in an in-mold headgear. More specifically, the connector 3400 is used to join two or more straps using breakthrough in-mold molding. The connector 3400 can be used in any type of connection 3500 between two or more straps, and the connection 3500 illustrated herein is merely an example. The connector 3400 provides a more orderly and stronger connection between the straps and also improves the ease with which the straps can be aligned within the molding die.

[0223] As shown in Figures 66A and 67, the first strap 3710 is joined to the second strap 3720 at a T-shaped joint between the end of the first strap 3710 and the center or middle portion of the second strap (i.e., the portion between the ends of the second strap 3720). The connector 3400 is positioned on the first strap 3710 and the second strap 3720 at the joint 3500. That is, the joint 3500 is positioned within the connector 3400, so that the connector 3400 surrounds the joint 3500. The first strap 3710 and the second strap 3720 are joined via a breakthrough in-mold molding process in which a plastic core material 3800 is injected into the second strap 3720 at an injection point 3600 (illustrated at the end of the second strap 3720 in Figure 66A). The plastic core material 3800 fills and moves through the second strap 3720. When the plastic core material 3800 reaches the joint 3500, it penetrates the sidewall of the textile casing of the second strap 3720 and fills all or part of the cavity of the textile casing of the first strap 3710, as shown by the red arrow in the joint in Figure 66A. In some configurations, the connector 3400 has a cavity 3420, which is also filled with the plastic core material 3800 penetrating the sidewalls of the textile casing of the first strap 3710 and the second strap 3720. The plastic core material 3800 can also be bonded to the connector 3400 so that the plastic core material 3800 and the connector 3400 are formed integrally. In some configurations, the plastic core material 3800 and the connector 3400 can be formed from the same or similar material.

[0224] The connector 3400 accommodates any excess threads from the ends of the straps within itself so that the joint 3500 has an orderly and aesthetic appearance. That is, the excess ends of the first strap 3710 and / or the second strap 3720 are contained within the connector 3400, thereby further preventing fraying of the straps 3710 and 3720. Furthermore, the connector 3400 may have an opaque color to conceal any exposed excess ends so that the joint 3500 has an even more orderly and aesthetic appearance. In addition, the connector 3400 defines the finished shape of the joint 3500 and accommodates any perforated plastic protrusions from the ends of the first strap 3710 and the second strap 3720 so that the joint 3500 has an orderly and aesthetic appearance.

[0225] The connector 3400 also provides a contact edge 3417 that joins the first strap 3710 and the second strap 3720, which is wider than the width of the end of the first textile strap 3710 (i.e., the width of the joint 3500 without the connector 3400), thereby providing a wider connection area between the first strap 3710 and the second strap 3720. In other words, the connector 3400 provides a wider fillet-shaped connection 3500 between the end of the first strap 3710 and the casing of the second strap 3720, thereby providing a wider connection area and thereby increasing the strength of the joint 3500. As shown in Figure 67, the end of the first strap 3710 is filled and surrounded by plastic material rather than having plastic material inside the tube of the strap casing. Thus, the strength of the joint 3500 is increased.

[0226] Figures 68A to 68D show various diagrams of the connector 3400. As shown, the connector 3400 comprises a tubular sheath having a cavity 3420 between the strap-enveloping end 3418 and the abutment end 3416. The connector 3400 has a body 3410 consisting of a first half 3412 and a second half 3414, which are joined along their opposing edges. In the illustrated configuration, the first half 3412 and the second half 3414 are identical. In other configurations, the first half 3412 and the second half 3414 are not identical and / or asymmetrical. The open ends of the first half 3412 and the second half 3414 form the abutment end 3416 and the strap-enveloping end 3418 of the connector 3400. The strap enclosing end 3418 receives or encloses the first strap 3710, and the abutment end 3416 receives or abuts against the second strap 3720. As shown in Figure 68B, the connector 3400 has a somewhat trapezoidal profile such that one end is wider than the other. The wider end of the connector 3400 forms the abutment end 3416, and the narrower end forms the strap enclosing end 3418. In some configurations, the abutment end 3416 may have a width that is twice the width of the strap enclosing end 3418.

[0227] The strap enclosing end 3418 defines an elliptical opening configured to fit snugly onto and in contact with the outer surface of the textile strap casing of the first strap 3710. The contact end 3416, when viewed from below (as shown in Figure 68A), forms a substantially rectangular opening with rounded edges. The contact end 3416 is curved to match the shape and curvature of the second strap 3720. The edge of the contact end 3416 is configured to overhang and enclose the outer edge of the second strap 3720 (the area between the contact edge 3417 and the dashed line in Figure 68B overhangs the second strap 3720). The edge of the contact end 3416 is also configured to be positioned on the outer surface of the textile strap casing of the second strap 3720. In some configurations, the protruding edge 3419 can form a loose fit with the textile strap casing of the second strap 3720 so that the connector 3400 does not restrict the flow of the plastic core material 3800 through the second strap 3720.

[0228] When the first strap 3710 and the second strap 3720 are in-mold, the connector 3400 allows the end of the first strap 3710 to align with and abut against the edge of the second strap 3720, rather than having a gap between the first strap 3710 and the second strap 3720. That is, the tight mating with the first strap 3710 provided by the connector 3400 aligns and holds the first strap 3710 in place while it is in the mold before the injection of the plastic core material 3800. Unlike the straps 3710 and 3720, the connector 3400 is semi-rigid and retains its shape, thereby ensuring that the connector 3400 is securely positioned in the mold.

[0229] During the assembly of straps 3710, 3720 and connector 3400, connector 3400 is positioned on the tubular textile casing of the first strap 3710. That is, as shown in Figure 69, connector 3400 slides on the first strap 3710 so that the end of the first strap 3710 is positioned inside connector 3400. The abutment edge 3417 of connector 3400 then abuts against the edge of the textile casing of the second strap 3720. As shown in Figure 70, the end of the first strap 3710 is positioned adjacent to the edge of the second strap 3720 within the cavity 3420 of connector 3400. The cavity 3420 is a hollow region defined by the first half 3412, the second half 3414, the strap enclosing end 3418, and the abutment end 3416. The connector 3400 fits snugly on top of the first strap 3710 so that it remains fixed to the first strap 3710.

[0230] The assembled straps 3710, 3720 and connector 3400 are positioned and aligned within an injection-molded tubular mold. Plastic core material 3800 is injected into the injection point 3600 at the end of the second textile strap 3720, piercing the sidewall of the second strap 3720 and filling the first strap 3710 (see arrow in Figure 66A). Thus, as shown in Figures 71 and 72, the cavity 3420 of the connector 3400 is also filled with plastic core material 3800 piercing the sidewall of the second strap 3720. The plastic core material 3800 in the cavity 3420 of the straps 3710, 3720 and connector 3400 forms a single structure. In some configurations, the plastic core material 3800 is coupled to the connector 3400 so that the connector 3400, straps 3710 and 3720, and plastic core material 3800 are formed as an integrated structure.

[0231] Those skilled in the art will understand that the connector 3400 and strap configuration are not limited to a T-joint, and can connect straps 3710, 3720 having joints 3500 at various angles. Similarly, the connector 3400 can be shaped and configured to connect three or more straps together. For example, the connector 3400 may have multiple strap enclosing ends 3418 or contact ends 3416.

[0232] In the alternative configuration, the connector 3400 (substantially the same as in the embodiment described above) is integrally formed with the first strap 3710 by overmolding the end of the tubular textile strap casing, as shown in Figure 73. The abutment end 3416 of the connector 3400 extends from the end of the textile strap so that it can align with and abut the second strap 3720. The cavity 3420 of the connector 3400 remains hollow so that the plastic core material 3800 can flow through the second strap 3720 and penetrate into the first strap 3710. With this configuration, the strength of the joint between the first strap 3710 and the second strap 3720 is increased by providing a permanent bond between the strap enclosing end 3418 of the connector 3400 and the first strap 3710.

[0233] In some embodiments, at least one of the first strap 3710 and the second strap 3720 may comprise a braided textile casing. The braided textile casing comprises multiple yarns provided in at least two different colors or shades. The braiding of the different colored yarns forms a random or semi-random pattern of color patches within the textile casing, resulting in a textile casing with a mottled appearance. The mottled appearance may, in some cases, camouflage or conceal any physical features formed by the plastic core, such as the transition between the soft edge (222 in Figure 2B) and the core material, making those features (and the headgear) appear softer.

[0234] In an alternative configuration, the connector 3400 can be configured so as not to protrude over the edge of the second strap 3720. Instead, the connector 3400 is configured to abut directly against the edge of the second strap 3720, as shown in Figure 73. Thus, the connector 3400 is substantially or completely bonded to the overhanging plastic core material 3800. That is, compared to the connector configuration described above, the overhanging portion of the previous connector configuration is not bonded to the plastic core material 3800.

[0235] In-type connector Figures 74A to 78B show various diagrams of the in-mold straps, joints, and fittings that form the bifurcated headgear 100 shown in Figure 1A. The bifurcated headgear 100 comprises a top strap 140, a bottom strap 150, and a mask connector 180. In some configurations, the bifurcated headgear 100 is assembled by joining the top strap 140 to the bottom strap 150. That is, before joining the top strap 140 to the bottom strap 150, each of the top strap 140 and the bottom strap 150 is formed separately via in-mold molding. That is, in some configurations, the top strap 140 and the bottom strap 150 are placed in a molding die and joined by an overmolding. Once formed, the top strap 140 and the bottom strap 150 are joined to form the bifurcated headgear 100. However, in some configurations, the top strap 140 and bottom strap 150 may move out of position relative to each other while they are in place within the molding die and / or during the overmolding process. Figures 74A to 78B show various strap connectors that maintain the top strap 140 and bottom strap 150 connected and aligned during the manufacturing and molding processes.

[0236] Figure 74A shows the top strap 140 before assembly, and Figure 74B shows the bottom strap 150 before assembly. The top strap 140 and bottom strap 150 are formed separately by in-mold molding, injecting the plastic core material 210 into the braided or braided tubular casing 220. As shown in Figure 74A, the top strap 140 includes a substantially linear continuous strap having male connector portions 4002 formed at each end. The male connector portions 4002 are formed integrally with the plastic core material 210 and are standalone. The casing 220 is continuous throughout its length. The injection point of the top strap 140 can be located at one or both of its ends; that is, one or both male connectors can be at the injection point where the plastic core material 210 is injected into the casing 220.

[0237] The bottom strap 150 includes a plastic core material 210 injected into the first braided casing section 220A and the second braided casing section 220B. The casing sections 220A and 220B can form the left and right portions of the top strap 140 and the bottom strap 150. The casing sections 220A and 220B have a first free end 4020 and a second free end 4022. A central injection point 4010 is positioned between the first free ends 4020 so that the casing sections 220A and 220B are filled with the plastic core material 210 from the first free end 4020. The plastic core material 210 filling the casing sections 220A and 220B is integrally formed and single throughout its length. In other words, the plastic core material 210 joins the casing sections 220A and 220B together to form the bottom strap 150.

[0238] In some configurations, the casing sections 220A and 220B are partially filled with plastic core material 210. That is, the second end 4022 of the casing sections 220A and 220B may be hollow, such that the bottom strap 150 has a hollow free end 4030. The hollow free end 4030 of the bottom strap 150 can accommodate a portion of the mask connector 180 (see Figure 1). That is, a portion of the mask connector 180, such as a filament core 1550 (see Figures 15A to 15D), can be housed within the casing sections 220A and 220B of the hollow free end 4030. In some configurations, the casing sections 220A and 220B can be filled with plastic core material 210 throughout the length of the bottom strap 150. That is, the plastic core material 210 may extend between the first free end 4020 and the second free end 4022 of the casing sections 220A and 220B. In some configurations, a portion of the mask connector 180 can be formed on the second free end 4022 of the bottom strap 150.

[0239] The bottom strap 150 includes a female connector 4004 positioned between the first free end 4020 and the second free end 4022 of the casing sections 220A and 220B. The female connector 4004 is configured to interlock with a male connector 4002 so that the top strap 140 and the bottom strap 150 are connected. The female connector 4004 is formed from a plastic core material 210 that has been broken through the walls of the casing sections 220A and 220B. That is, the female connector 4004 is formed by a breakthrough in-mold molding process. The female connector 4004 is formed integrally with the plastic core 210 within the casing sections 220A and 220B and is a single unit. The female connector 4004 is positioned at the apex of the curve of the bottom strap 150, which is positioned substantially above the user's ear when in use. In some configurations, the female connector 4004 can be formed on a substantially straight portion of the bottom strap 150.

[0240] Figures 75A and 75B show the male connector 4002 of the top strap 140. As shown, the male connector 4002 extends outward and protrudes beyond the end of the casing 220. The male connector 4002 is formed from a plastic core material 210 that extends beyond the end 4024 of the casing 220. The male connector 4002 includes a projection 4040 configured to mesh with a slot 4042 of the female connector 4004. The projection 4040 has a shape corresponding to the shape of the slot 4042 so that the male connector 4002 fits and engages with the female connector 4004 like a puzzle piece.

[0241] The projection 4040 comprises a head 4050 and a leg 4052. The leg 4052 is an extension of the plastic core material 210 positioned between the head 4050 and the end 4024 of the casing 220. The head 4050 is shown having an inverted arrowhead shape that engages with the slot 4042 of the female connector 4004. The slot 4042 has a shape that corresponds to and engages with the inverted arrowhead shape of the head 4050. The head 4050 is not limited to an inverted arrowhead shape, and any engagement shape can be used.

[0242] Figure 75B is a side view of the top strap 140. As shown, the head 4050 has a thickness T1 and the leg 4052 has a thickness T2. The thickness T1 of the head 4050 is greater than the thickness T2 of the leg 4052. Due to the mismatch between T1 and T2, when the top strap 140 is joined to the bottom strap, the overmolded plastic can flow around the head 4050 of the male connector 4002. In some configurations, the head 4050 can be surrounded by the overmolded plastic material because the thickness T2 is thinner.

[0243] Figures 76A to 76C show various views of the female connector 4004 of the top strap 150. The female connector 4004 has a triangular shape that extends radially outward and protrudes beyond the surfaces of the casing portions 220A and 220B. The female connector 4004 is formed from a plastic core material 210 that breaks through the casing portions 220A and 220B during a break-through in-mold molding process. The female connector 4004 includes a tab-shaped projection 4046 that forms with a slot 4042. As shown in Figure 76C, the projection 4046 has a central region 4044 and a peripheral region 4048 that extends outward from the central region 4044. The central region 4044 has a thickness T3 that is greater than the thickness T4 of the peripheral region 4048. The greater thickness T3 of the central region increases the strength of the projection 4046, while allowing the overmolded plastic to flow around the projection 4046 when joining the top strap 140 and bottom strap 150. The thickness T3 of the central region 4044 can be equal to the thickness T1 of the head 4050 of the male connector 4002.

[0244] Slot 4042 is formed within and extends through both the central region 4044 and the peripheral region 4048. Slot 4042 has a shape that matches and interlocks with the inverted arrowhead shape of the head 4050. Slot 4042 is open away from the casing portions 220A and 220B so that the head 4050 can be inserted into and accepted by slot 4042. Slot 4042 is centrally located in the radially outermost portion of the peripheral region 4048. Slot 4042 can be formed and molded within the female connector 4004 when the female connector 4004 is formed via a breakthrough die molding process. In other configurations, for example, slot 4042 can be formed by removing the plastic core material 210 from the female connector 4004 via a cutting process.

[0245] Slot 4042 is configured to receive at least the head 4050 of the male connector 4002 so that the top strap 140 and bottom strap 150 can be joined and overmolded to form a permanent joint between them. That is, the top strap 140 and bottom strap 150 are loaded into the overmolding mold, the male connector 4002 and female connector 4004 are connected, and the head 4050 is inserted into slot 4052 so that the top strap 140 and bottom strap 150 are properly aligned. Once aligned, the overmolding mold is closed and the overmolding plastic material is injected into the overmolding mold to form a permanent overmolded joint on the male connector 4002 and female connector 4004. By connecting and aligning the straps 140 and 150 before overmolding the male connector 4002 and female connector 4004, the accuracy of strap alignment is improved, reducing the possibility of straps 140 and 150 moving during overmolding, and thus improving the efficiency of the manufacturing process.

[0246] Figure 77A shows the male connector 4002 aligned with the female connector 4004 before the head 4050 is inserted into the slot 4042. Figure 77B shows the head 4050 inserted into and accepted by the slot 4042 so that the male connector 4002 and the female connector 4004 are connected. Figure 77C shows the comparative thickness of the male connector 4002 and the female connector 4004. The increased thickness T1 of the head 4050 of the male connector 4002 and the increased thickness T3 of the central region 4044 of the female connector 4004 align to form the upper surface 4060 and the lower surface 4062, respectively. The upper surface 4060 and the lower surface 4062 are configured to abut against the opposing inner surfaces of the mold cavity of the overmolding mold. This helps to align the top strap 140 and the bottom strap 150 within the overmolding mold. The upper surface 4060 and the lower surface 4062 are shown as flat planes, but this is not limited to them. Thus, opposing surfaces of the mold have corresponding shapes that engage with the upper surface 4060 and the lower surface 4062.

[0247] In some configurations, the head 4050 and slot 4052 may be sized and shaped such that there is a certain amount of gap between them when they engage. A tight, gapless connection mating between the male and female connectors may result in no space for the overmolded plastic material to flow between the connectors. This can result in the overmolded connection having a weak zone caused by gaps or voids within the overmolded fitting, thereby reducing the durability of the headgear. Figures 78A and 78B show the gap 4064 between the head 4050 and slot 4052 when the male connector 4002 and female connector 4004 are connected. The gap 4064 in Figure 78B is larger than the gap 4064 in Figure 78A. In Figure 78A, the gap 4064 is small so that the connection between the male connector 4002 and female connector 4004 has a tight mating similar to puzzle pieces. In Figure 78B, the gap 4064 is larger, which allows for more playful mating and overall alignment of the top strap 140 and bottom strap 150 within the overmolded mold. The larger the gap 4064, the more the overmolded plastic can flow between the connectors 140 and 150, providing a robust joint. In Figure 78B, the gap 4064 is preferably about 1.0 mm. In some configurations, the gap 4064 is between 0.1 mm and 1.0 mm.

[0248] Figure 79A shows an alignment recess 4070 formed in the head 4050 of the male connector 4002, configured to receive an alignment positioning pin 4072 located on the opposing inner surfaces of the mold cavity 4076 within the overmolded mold section 4074. Figure 79B shows the overmolded mold section 4074 having a mold cavity 4076 with a positioning pin 4072 protruding from the surface of the mold cavity 4076. The positioning pin 4072 is configured to be inserted into and received by the recess 4070 so that the head 4050 of the male connector 4002 is aligned and maintained in place within the mold cavity 4076 during the positioning of the top strap 140 and bottom strap 150 and during the overmolding process. The positioning pin 4072 can restrict the movement of the head 4050 within the mold cavity 4076. The positioning pin 4072 can also prevent or stop the male connector 4002 from detaching from the female connector 4004 before or during the overmolding process. In some configurations, the positioning pin 4072 can hold the head 4050 in place so that a gap 4064 is maintained between the male connector 4002 and the female connector 4004.

[0249] In some embodiments, the recess 4070 and the positioning pin 4072 may have corresponding shapes, sizes, and geometric forms. The recess 4070 is shown as a triangular recess formed in the inner corner of the head 4050, but is not limited thereto. The positioning pin 4072 is shown as a cylindrical post shape, but is not limited thereto. The triangular recess 4070 is configured to receive the positioning pin 4072 at one of the vertices of the triangular recess, as shown by the dashed circle in Figure 79A. The positioning pin 4072 has a cylindrical side surface, which is configured to abut against the side surface of the head 4050 to align the head 4050 of the male connector 4002 within the mold cavity 4076.

[0250] Figures 80A to 80C show the top strap 140 and bottom strap 150 after the overmolding process. As shown, the overmolded joint 4006 is molded over the male connector 4002 and female connector 4004 so that the top strap 140 and bottom strap 150 are permanently joined. In some configurations, the overmolded joint 4006 can be formed from the same plastic core material 210 used to form the internal cores of the top strap 140 and bottom strap 150 as well as the male connector 4002 and female connector 4004. In other configurations, the overmolded joint 4006 can be formed from a different material, such as an elastomer.

[0251] As shown in Figures 80A and 80B, the overmolded joint 4006 has an upper edge 4056 that extends over the edge of the top strap 140 and over the surface of the top strap 140. That is, the overmolded joint 4006 overlaps with and is coupled to the casing 220 of the top strap 140. Similarly, the overmolded joint 4006 has a bottom edge 4058 that extends over the edge of the bottom strap 150 and over the surface of the bottom strap 150. That is, the overmolded joint 4006 overlaps with and is coupled to the casing 220 of the bottom strap 150. By coupling the overmolded joint 4006 to the top strap 140 and the bottom strap 150, the connection area between the overmolded joint 4006 and the top strap 140 and the bottom strap 150 is increased, thereby increasing the strength of the overmolded joint 4006. Furthermore, by extending the overmolded joint 4006 beyond the end of the casing 220 so that the end of the casing 220 is enclosed within the overmolded joint 4006, the durability and appearance of the finished headgear are improved. In other words, the excess thread end of the casing is enclosed and joined within the overmolded joint 4006.

[0252] As illustrated in Figure 80C, the overmolded fitting 4006 has a thickness T substantially equal to the thickness of the top strap 140 and bottom strap 150, and also equal to the thickness of the male connector 4002 and female connector 4004. That is, the thickness T of the overmolded fitting 4006 is equal to the thickness T1 of the head 4050 and the thickness T3 of the central region 4044. Thus, the equal thickness of the overmolded fitting 4006 and the top strap 140 and bottom strap 150 provides a continuous thickness throughout the length of the straps 140, 150, as well as connection and transition between the straps 140, 150, improving the aesthetics and comfort of the headgear.

[0253] Joining tab with alignment post Figures 81A and 81C show a bottom strap 150 formed by in-mold joining two empty textile casings 220, bottom strap halves 150A and 150B. The joining of strap halves 150A and 150B is illustrated with respect to the bottom strap 150, but it is not limited to the formation of a bottom strap and can be used to form any headgear. The bottom strap 150 is formed by in-mold joining multiple textile casings 220 using a single injection molding shot to form a single strap 150. The textile casings 220 are connected by a single plastic core material 210 formed within both casings 220. A joining tab 4008 is positioned between the free ends 4026 of the casings 220 and is formed from the plastic core material 210. The joint tab 4008 extends between the two strap halves 150A and 150B and provides a central injection point 4010 for injecting the plastic core material 210 into the strap halves. The joint tab 4008 is configured to be overmolded to provide a neat and durable joint between the strap halves 150A and 150B. Before overmolding, any excess material or sprue formed at the injection point is trimmed.

[0254] The ends of the bonding tab 4008 include a pair of alignment posts 4078 that project and extend from the upper surface 4018 and lower surface 4028 of the bonding tab 4008 in opposite directions (e.g., in the thickness direction). The alignment posts 4078 are shown as rectangular projections extending across the width of the upper surface 4018 and lower surface 4028 of the bonding tab 4008, but are not limited to that. The alignment posts 4078 are configured to abut against the inner surface of the mold cavity of the overmolding mold so that the ends 4026 of the strap halves 150A, 150B are aligned within the overmolding mold (e.g., in the thickness direction of the straps).

[0255] Figure 81C shows alignment posts 4078 extending from the upper and lower surfaces 4018 and 4028 of the joint tab 4008. The joint tab 4008 is shown to have a thickness T6. The region of the joint tab 4008 including the alignment posts 4078 has a thickness T5. The thickness T5 of the region including the alignment posts 4078 is greater than the thickness T6 of the region without the alignment posts 4078. The alignment posts 4078 can also maintain a gap between the upper and lower surfaces 4018 and 4028 of the joint tab 4008 and the inner surface of the mold cavity, thereby allowing the overmolded plastic to flow over the joint tab 4008 and provide a robust joint.

[0256] Figures 81D and 81E show the strap halves 150A and 150B after the bonding tab 4008 has been overmolded. As shown, an overmolded 4080 is formed on top of the bonding tab 4008. The overmolded 4080 may be formed from the same material as the bottom strap 150 (e.g., the plastic core material 210) or from a different material. In some embodiments, the overmolded 4080 may include an elastomer material to provide a flexible and comfortable contact between the overmolded 4080 and the patient's head. The overmolded has an outer surface 4082 configured to face away from the patient's head during use and an inner surface 4084 configured to contact the patient's head during use.

[0257] Figure 81D is a top view of the overmolding 4080, showing the top surface 4082 of the overmolding 4080 facing away from the patient's head. Figure 81E is a bottom view of the overmolding 4080, showing the bottom surface 4084 of the overmolding 4080 facing the patient's head. Confirmation marks 4088 indicating the position of the alignment post 4078 can be formed in or on surfaces 4082, 4084 of the overmolding 4080. Since the thickness of the overmolding 4080 is equal to the thickness T5 of the alignment post 4078, the confirmation marks 4088 are visible through surfaces 4082, 4084. In other configurations, the thickness of the overmolding 4080 may be greater than the thickness T5 of the alignment post 4078 so that the alignment post 4078 is not visible through surfaces 4082, 4084 of the overmolding 4080. In other words, the outer surface 4082 of the overmolding 4080 may be smooth and continuous so that the confirmation mark 4088 indicating the position of the alignment post 4078 is not visible.

[0258] A product label or logo 4086 can also be formed in or on the outer surface 4082 of the overmolding 4080. The logo 4086 is molded within the surface 4082 during the overmolding process. In some configurations, the alignment posts 4078 can be configured to form part of the logo 4086. For example, in the illustrated configuration, one alignment post 4078 may have a shape consisting of the letter "F" and the other alignment post may have a shape consisting of the letter "P". The thickness of the alignment posts 4078 and / or the overmolding 4080 can be changed so that the alignment posts 4078 are visible on the surface 4082. In other configurations, the logo 4086 can be formed by a finishing process (e.g., engraving, molding, punching, etc.).

[0259] In some embodiments, the joining tab 4008 can be trimmed between the alignment posts 4078 before overmolding. This allows the overall length of the bottom strap 150 to be adjusted by increasing or decreasing the spacing between the alignment posts 4078, and therefore the length of the overmolding. That is, in some configurations, the overall length of the bottom strap 150 can be shortened or lengthened by shortening or lengthening the distance between the alignment posts 4078 (for example, in the longitudinal direction of the bottom strap 150). Using this technique, different headgear sizes can be provided using the same bottom strap component.

[0260] Injection housing Figures 82A to 83E show a strap end joint housing 4090 into which the ends 4026 of empty bottom strap halves 150A and 150B are inserted and in-mold to form a single bottom strap 150. The joining of strap halves 150A and 150B is illustrated with respect to the bottom strap 150, but it is not limited to the formation of a bottom strap and can be used to form any headgear strap. The bottom strap 150 is formed by in-molding multiple textile casings 220 together using a single injection molding shot to form a single strap. Thus, the textile casings 220 are connected by a single plastic core material 210 formed within and extending through both casings 220.

[0261] The housing 4090 has an internal chamber 4092 configured to receive the open ends 4026 of the two textile casings 220. The housing 4090 may have a shape, size and geometric form that corresponds to the shape, size and geometric form of a region within the internal cavity of the in-mold mold, so that the housing 4090 has a secure fit within the in-mold mold. Thus, the housing 4090 can be aligned with respect to the in-mold mold, thereby allowing the ends 4026 of the textile casings 220 to be aligned by the housing 4090 when they are in the in-mold mold. The housing 4090 is not limited to a rectangular shape or geometric form.

[0262] The housing 4090 has an injection opening 4094 on at least one side of the housing 4090 that provides a gate through which the in-mold plastic material 210 can be injected and flow through. In some configurations, injection openings 4094 can be located on multiple sides of the housing 4090. Figure 83E shows injection openings 4094 located on opposing sides of the housing 4090. The plastic core material 210 can be injected into both openings 4094 simultaneously, or alternatively, one opening 4094 can be blocked while the plastic material 210 is being injected into the other opening 4094.

[0263] As shown in Figure 83D, the injection opening 4094 is fluidly connected to an internal chamber 4092 that receives the open end 4026 of the textile casing 220. The end 4026 of the textile casing 220 is open toward the injection opening 4094 so that the internal cavity of the textile casing 220 is in fluid communication with the injection opening 4094. During the in-mold molding process, plastic is injected into the textile casing 220 by in-mold molding the plastic core material 210 that is injected into the opening 4094 of the housing 4090. The in-mold molded plastic core material 210 flows from the opening 4094 into the internal chamber 4092 and from the internal chamber 4092 into the textile casing 220. The housing 4090 provides a central injection point for in-mold molding the textile casing 220. In some configurations, the housing 4090 can provide an alternative to overmolding an overmolded fitting onto the end of the textile casing 220. Thus, the excess yarn ends of the textile casing 220 are enclosed and housed within the housing 4090, thereby improving the aesthetics and durability of the headgear.

[0264] The internal chamber 4092 has an internal cavity region 4092A located in the central region of the housing 4090. The internal cavity region 4092A has one end that opens toward and leads into the injection opening 4094, and a second end that opens toward and leads into the external cavity region 4092B. That is, the internal cavity region 4092A is located between the injection opening 4094 and the external cavity region 4092B. The injection opening 4094 directs the injected plastic material 210 into the internal cavity region 4092A of the internal chamber 4092. The end of the casing 220 abuts against the inner wall of the external cavity region 4092B, thereby providing a fluid passage from the injection opening 4094 into the cavity of the casing 220 so that the injected plastic material 210 flows from the injection opening 4094 into the textile casing 220.

[0265] The internal cavity region 4092A has a height D1 that is lower than the height D2 of the external cavity region 4092B. The difference in height D1 between the internal cavity region 4092A and the external cavity region 4092B creates a stepped contour within the internal chamber 4092, thereby allowing the end 4026 of the textile casing 220 to be spaced apart when placed within the housing 4090. The height D1 of the internal cavity region 4092A can be substantially equal to the thickness of the core material 210 passing through the textile casing 220.

[0266] In some configurations, the length L of the internal cavity region 4092A (as shown in Figure 83D) can be modified so that bottom straps 150 of different lengths can be formed from the same textile casing 220. That is, by changing the length of the housing 4090, bottom straps of various lengths can be formed from a textile casing 220 having a fixed length. The length L of the internal cavity region 4092A brings the ends 4026 of the textile casing 220 closer together or further apart, thereby increasing or decreasing the finished length of the strap 150. For example, in some configurations, bottom straps 150 for medium-sized headgear and medium-to-large-sized headgear can be formed using a textile casing 220 of the same length and a housing 4090 having internal cavity regions 4092A of different lengths L. That is, the difference in length between the medium-sized and medium-to-large-sized bottom straps 150 is provided by the difference in the length L of the internal cavity region 4092A.

[0267] Strap cross-section Figures 84A and 84B show cross-sectional views of the top strap 140 and bottom strap 150 as a result of an in-mold molding process in which a textile casing 220 is filled with a plastic core material 210. Both the top strap 140 and bottom strap 150 have an inner surface 4066 and an outer surface 4068, the inner surface 4066 is configured to contact the patient's head and the outer surface 4068 is configured to face away from the patient's head. In this embodiment, the plastic core material 210 of the straps 140, 150 has a substantially D-shaped cross-section, thereby the outer surface 4068 has a convex curvature and the inner surface 4066 has a substantially flat, planar, or linear contour. In some configurations, the inner surface 4066 may have a concave curvature.

[0268] The flat contour of the inner surface 4066 is configured to have an increased contact area with the patient's head, so that any load on the headgear is distributed more evenly across the patient's head (compared to a convex contour). This improves the stability of the headgear and the comfort to the patient. The convex curve of the outer surface 4068 provides some rigidity to the strap and gives the headgear a soft or aesthetically pleasing appearance.

[0269] Soft edge of the strap Figure 84A shows top straps 140 and bottom straps 150 with a plastic core material 210, including a flange portion 4036 that fills the outer edge of the textile casing 220. The flange portion 4036 provides a rigid edge treatment to the top straps 140 and bottom straps 150. Figure 84B shows top straps 140 and bottom straps 150 with a soft edge portion 4038 formed by the absence of the plastic core material 210 inside. The soft edge portion 4038 is the portion of the casing 220 that is not filled with the plastic core material 210, so that the textile casing 220 remains flexible and bendable. As a result, the soft edge portion 2032 provides the top straps 140 and bottom straps 150 with a soft or cushioned edge that is comfortable and aesthetically pleasing to the user's skin.

[0270] In some configurations, a soft edge 4038 is formed by crimping the edge of the tubular casing 220 before injection of the plastic core material 210, thereby preventing or limiting the plastic core material 210 from flowing into the portion of the casing 220 being crimped. The edge is crimped by a portion of the mold adjacent to the mold cavity. The depth of crimping of the top strap 140 and bottom strap 150 by the mold can be varied along the length of the top strap 140 and bottom strap 150, thereby allowing the width (horizontal in Figures 84A and 84B) of the plastic core material 210 to be varied along the length of the top strap 140 and bottom strap 150. Thus, by widening the width of the plastic core material 210 in different regions of the top strap 140 and bottom strap 150, those regions can be reinforced and additional strength can be provided to those regions. Similarly, in some configurations, flexibility can be provided to relatively narrow areas by making the width of the plastic core material 210 narrower in certain regions along the length of the top strap 140 and bottom strap 150. Those skilled in the art will understand that the shape and geometric form of the plastic core material can be modified to provide strength and rigidity to the top strap 140 and bottom strap 150 in a desired direction.

[0271] Figure 85 shows the top strap 140 joined to a bottom strap 150 having a soft edge 4038 provided along its length. The bottom strap 150 has a curved shape contoured to form an ear arch 4016 that is positioned above the user's ear when in use. As shown, the soft edge 4038 in the ear arch 4016 has a width W1 that is greater than the width W2 of the soft edge 4038 in the rest of the bottom strap 150. The soft edge 4038 in the ear arch 4016 has a wider width than the rest of the bottom strap 150 to provide increased softness / cushioning and comfort when the ear arch is to come into contact with the patient's ear during use. The arched portion of the user's ear is a sensitive area, and contact can cause discomfort.

[0272] In some configurations, the headgear may have a four-point connection configuration with upper and / or lower side straps (or other configurations). In such configurations, any straps that come into close contact with the patient's ears during use may include an increased width of soft edges.

[0273] Joined top and rear straps with overmolded connection points Figure 86 shows a headgear configuration 5000 consisting of a rear strap section 150 and a top strap section 140, which are integrally formed as a single halo or rear headgear loop strap 5002. The headgear loop strap 5002 is connected to a front strap 5004 via an overmolded joint 5006. The front strap 5004 is formed separately from the headgear loop strap 5002 and then connected to the rear headgear loop 5010 by an overmolded connector. The front strap 5004 may comprise an in-mold strap section, a braided filament housing for a locking mechanism, or a combination of both. In one embodiment, the front strap 5004 of the headgear configuration 5000 may be configured to include a size adjustment mechanism with a locking mechanism and filament. This is advantageous because the braided strap housing the filament can be manufactured and tested as an individual component. This reduces the complexity of manufacturing these components and prevents the loss of the headgear or a larger part of the headgear in the event that the tolerance or operation of the locking mechanism is compromised and / or faulty. In other words, since the front strap 5004 is formed separately from the headgear loop strap 5002, there is no need to discard the entire headgear due to a defective or faulty locking mechanism.

[0274] The ends of the headgear loop straps 5002 are joined together by an overmolded fitting 5008 to form a rear headgear loop 5010 that cups or cradles (indicated by a dashed line) the back of the patient's head. The overmolded fitting 5008 is positioned at the top of the patient's head during use. Positioning the overmolded fitting 5008 at the top of the patient's head is advantageous because it prevents the top of the user's head from contacting the bed or pillow (contact would apply force to the fitting 5008, potentially causing it to dig into the patient's head). In other words, positioning the overmolded fitting 5008 at the top of the patient's head may be more comfortable for the patient.

[0275] As shown in Figure 87A, the headgear loop strap 5002 is formed from a single in-mold member that connects the top strap 140 and the rear strap 150. The headgear loop strap 5002 is formed from a single textile casing material 220 filled with a plastic core material 210. The headgear loop strap 5002 includes an alignment tab 5020 formed at the free end of the top strap portion 140 and extending therefrom. The headgear loop strap 5002 also includes a breakthrough tab 5030 positioned between the top strap portion 140 and the bottom strap portion 150.

[0276] The alignment tab 5020 is substantially similar to the joining tab 4008 in Figures 81A to 81E. The alignment tab 5020 is formed from the plastic core material 210 and is configured to align the end of the headgear loop strap 5002 within an overmolding mold that forms an overmolding joint between the top strap portions 140. The joining of the ends of the top strap portions 140 forms a closed loop of the rear headgear loop 5010.

[0277] The alignment tab 5020 includes an alignment post 5022 configured to align the end of the top strap portion 140 within the overmolding mold. As shown in Figures 88A and 88B, the alignment post 5022 also has a raised contact surface 5024 which is configured to contact, engage and / or contact the inner wall of the overmolding mold cavity and to align the alignment tab 5020 within the mold (for example, in the thickness, width and / or length direction of the headgear loop strap 5002). Similar to the joining tab 4008, once the alignment tab 5020 is aligned within the overmolding mold, the alignment tab 5020 is overmolded to join the end of the headgear loop strap 5002.

[0278] The headgear loop strap 5002 includes two breakthrough tabs 5030 configured to be overmolded with the end of the front strap 5004. The breakthrough tabs 5030 are substantially similar to the male connector 4002 of the previous embodiment. As shown in Figures 89A and 89B, the breakthrough tab 5030 includes a head 5032 that engages and bites with the features of the overmolded connector 5006 so that the headgear loop strap 5002 and the front strap 5004 are connected. The head 5032 consists of projections that form a raised contact surface 5034. The contact surface 5034 is configured to contact, engage and / or contact the inner wall of the overmolded mold cavity and to align the breakthrough tab 5030 within the mold (for example, in the thickness, width and / or length direction of the headgear loop strap 5002). The contact surface 5034 is coplanar with the outer surface 5008 of the overmolded joint 5006, resulting in a smooth transition between the headgear loop strap 5002 and the front strap 5004.

[0279] The headgear loop strap 5002 and the front strap 5004 are joined by overmolding an overmolded fitting 5006 over the break tab 5030 and the end of the front strap 5004. In some configurations, the overmolded fitting 4006 can be formed from the same plastic core material 210 used to form the internal core of the headgear loop strap 5002. In other configurations, the overmolded fitting 5006 can be formed from a different material, such as an elastomer.

[0280] As shown in Figures 89A and 89B, the head 5032 of the breakthrough tab 5030 is surrounded and held within the overmolded joint 5006. Tightening openings 5036 are formed within the overmolded joint 5006, and they are configured to tighten the front strap 5004 into place. The tightening openings 5036 are formed within the overmolded joint 5006 by projections protruding from the inner wall of the overmolded mold cavity.

[0281] In some configurations, the headgear loop strap 5002 and the front strap 5004 can be joined by a connector that is tightened over the breakthrough tab 5030 and the end of the front strap 5004. Thus, the connector can engage with the head 5032 of the breakthrough tab 5030 while tightening over the end of the front strap 5004 so that the headgear loop strap 5002 and the front strap 5004 are joined.

[0282] Alignment posts, pinholes and recesses Figures 90A to 92D show in-mold top straps 140 and bottom straps 150, each having an alignment post 5102 protruding through the textile casing 220 and an alignment recess or pinhole 5104 formed concave within the textile casing 220. The alignment post 5102, like the male connector head 4002 and alignment tab 5020, is configured to abut against the inner surface of the overmolded mold cavity. The alignment post 5102 aligns and positions the ends of the straps within the overmolded mold. The alignment post 5102 protrudes from at least one of the top surface 5112 and bottom surface 5114 of the top strap 140 and bottom strap 150. The alignment post 5102 protrudes through the textile casing 220. The alignment posts 5102 are formed within the textile casing 220 during the in-mold molding of the top strap 140 and bottom strap 150. Figures 90B and 90D show the alignment posts 5102 formed on the breakthrough tab 5120. The alignment posts 5102 on the breakthrough tab 5120 are formed from the plastic core material 210 and are substantially similar to the alignment posts 5022 on the alignment tab 5020.

[0283] The user-facing surface, i.e., the bottom surface 5114, is provided with a pinhole 5104 that is partially recessed within the thickness of the straps 140, 150. The pinhole 5104 is configured to receive, for example, a pin protruding from the surface of the internal cavity of the overmolding mold. The pin and pinhole 5140 are substantially similar to the recess 4070 and positioning pin 4072 in Figures 79A-79C. The pin engages with the pinhole 5104 to hold the straps 140, 150 in a predetermined position and alignment within the overmolding mold, preventing the in-molded straps 140, 150 from moving within the overmolding mold as the overmolding plastic is injected. The pinhole 5104 is formed on the bottom surface 5114 so that it is not visible when the user is wearing it. In some configurations, the pinhole 5104 can be formed on either or both of the top surface 5112 and the bottom surface 5114 of the top strap 140 and bottom strap 150. In some configurations, the pinhole 5104 may have a depth less than the thickness of the top strap 140 and the bottom strap 150. In some configurations, the pinhole 5104 may have a depth equal to the thickness of the top strap 140 and the bottom strap 150.

[0284] The breakthrough tab 5120 and the ends of the top strap 140 and bottom strap 150 both include recesses on their inner surface 5112 and outer surface 5114. The recess 5106 is concavely formed within the plastic core material 210 of the breakthrough tab 5120 and within the textile casing 220 at the ends of the top strap 140 and bottom strap 150. As shown in Figures 92A to 92D, the recess 5106 is configured to provide increased thickness in the recess engagement region of the overmolded joint 5130 and to provide an increased surface area to form a mechanical connection between the overmolded joint 5130 and the straps 140 and 150. The increased surface area provided by the recess 5106 increases the strength of the overmolded joint 5130.

[0285] Figures 92A to 92D show the top strap 140 and bottom strap 150 after the overmolded fitting 5130 has been overmolded over the breakthrough tab 5120 and the ends of the top strap 140 and bottom strap 150. The overmolded fitting 5130 provides a permanent overmolded connection over the top strap 140 and bottom strap 150. The overmolded fitting 5130 is formed similarly to the overmolded fitting described above. The alignment post 5102 may be made to have the same thickness as the overmolded fitting 5130, resulting in the formation of a confirmation mark on the overmolded fitting 5130. In some configurations, a logo 5150 may be formed within the overmolded fitting 5130. Figures 92C and 92D show the increased thickness of the overmolded fitting material provided by the recess 5106. The overmolded joint 5130 also overlaps the edge of the bottom strap 150 to increase the strength of the joint between the top strap 140 and the bottom strap 150.

[0286] In some configurations, an overmolded connector 5140 can be provided at the free end of either strap 140 or 150. The overmolded connector 5140 is formed similarly to the overmolded fitting 5130 and can engage with the alignment post 5102 and recess 5106 of strap 140 or 150. The connector 5140 may include a loop or clip configured to connect to another headgear or mask component.

[0287] The following disclosure relates to a headgear assembly 8000 for a patient interface 8002 configured to deliver respiratory therapy to a patient or user. Figures 93A–93C show non-limiting exemplary embodiments of the patient interface 8002, including non-limiting embodiments of the headgear assembly 8000 and a mask assembly 8004. The mask assembly 8004 may be any preferred configuration for delivering a flow of respiratory gas to the airway of a patient or user. The mask assembly 8004 may include a body and one or more sealing cushions. In some configurations, the body is more rigid than the sealing cushions. In some configurations, the body and cushions are formed integrally or separately. The sealing cushions are configured to form a seal with one or both of the nose and mouth of the patient or user. The mask assembly 8004 may be, for example, a full-face supranuvisceral mask, a full-face subnasal mask, a nasal mask, a nasal pillow, or a nasal cannula, without limitation. Accordingly, the mask assembly 8004 is represented in the figures by dashed blocks.

[0288] The headgear assembly 8000 includes a headpiece 8006 and at least one connector 8008. In the illustrated configuration, at least one connector 8008 comprises a first connector 8008 and a second connector 8008 (not shown). The headgear assembly 8000 is substantially symmetrical with respect to the sagittal plane of the user. Thus, the second connector 8008 can be a mirror image of the illustrated first connector 8008, and the description of the first connector 8008 can be equally applied to the second connector 8008. Similarly, the left side (from the patient's or user's perspective) of the headpiece 8006 can be a mirror image of the right side. The first connector 8008 and the second connector 8008 connect to the mask assembly 8004 at the front 8008a and to the headpiece 8006 at the rear 8008b, respectively. In some configurations, the first connector 8008 and the second connector 8008 can be coupled to each other, or they can be an integrated or standalone structure.

[0289] The headpiece 8006 may include one or more of the following: a top or vertical strap 8010, an anterior or frontal strap 8012, a rear or occipital strap 8014, and ear loops 8016. The anterior strap 8012 substantially spans the front of the user's head; that is, the anterior strap 8012 may be located in front of the top of the head, such as the forehead. The top strap 8010 substantially spans the top of the user's head. The top strap 8010 and the anterior strap 8012 meet at a joint 8020. The joint 8020 may connect to or form part of the ear loops 8016. The rear strap 8014 substantially passes around the back of the user's head; that is, the rear strap 8014 may be located behind the top of the head. In some configurations, the ends of the rear strap 8014 form part of the ear loops 8016. The ear loops 8016 partially or completely surround the user's ears. In the illustrated configuration, the ear loop 8016 completely surrounds the user's ear, forming a closed loop. The ear loop 8016 includes at least one connector connection surface 8022 so that the headpiece 8006 can be connected to the first connector 8008 and / or the second connector 8008.

[0290] The first connector 8008 and / or the second connector 8008 include at least one strap or other structure extending between the mask assembly 8004 and the headpiece 8006. In the illustrated configuration, one or both of the first connector 8008 and / or the second connector 8008 include a first strap 8024 and a second strap 8026. Strap 8026 is referred to herein as the lower strap 8026. Strap 8024 is referred herein as the middle strap 8024 because it is positioned perpendicularly between the lower strap 8026 and the front strap 8012 and / or the top strap 8010. When in use, the middle strap 8024 extends from the first section 8008a and the mask assembly 8004 above and behind the user's ears. When in use, the lower strap 8026 extends from the front section 8008b and the mask assembly 8004 below and behind the user's ears. The middle strap 8024 joins the lower strap 8026 at the rear 8008b. In the illustrated configuration, the middle strap 8024 and the lower strap 8026 are integrally formed.

[0291] In at least one embodiment, the first connector 8008 and / or the second connector 8008 may include an intermediate strap instead of or in addition to the straps 8024, 8026. The intermediate strap may extend from the front portion 8008a and the mask assembly 8004 above and behind the user's ears. In at least one embodiment, the intermediate strap may extend from the front portion 8008a and the mask assembly 8004 below and behind the user's ears. In at least one embodiment, the intermediate strap extends from the front portion 8008a and the mask assembly 8004 and branches to extend both above and behind the user's ears, as well as below and behind.

[0292] Figure 93B shows a perspective view of the headgear assembly 8000 with the first connector 8008 separated from the headpiece 8006. When in use, the first connector 8008 can be separated from the headpiece 8006 and extended outward around the ears to release the mask assembly 8004 from the user's face. The second connector 8008 (not shown) can be similarly separated to completely detach the mask assembly 8004. In some embodiments, the front portions 8008a of the first connector 8008 and / or the second connector 8008 can remain connected to the mask assembly 8004 after removal.

[0293] Once the mask assembly 8004 and connector 8008 are separated from the headpiece 8006, the user can independently put on the headpiece 8006 before it becomes necessary to reattach the mask assembly 8004. That is, the headpiece 8006 is preferably configured to be stably supported on the user's head without relying on the mask assembly 8004 and / or connector 8008 to remain in place, at least while the user's head is relatively upright. To reattach the mask assembly 8004, one of the first connector 8008 and / or the second connector 8008 is connected to the headpiece 8006 in the associated ear loop 8016. The mask assembly 8004 is then positioned in the desired location. The other of the first connector 8008 and / or the second connector 8008 is then connected to the headpiece 8006 in the other ear loop 8016.

[0294] Figure 93C shows a perspective view of the headgear assembly 8000, in which the first connector 8008 is connected to the headpiece 8006. The headpiece connection surface 8030 on the first connector 8008 and / or the second connector 8008 facilitates the connection of the first connector 8008 and / or the second connector 8008 to the headpiece 8006. As described above, the connector connection surface 8022 on the headpiece 8006 facilitates the connection of the headpiece 8006 to the first connector 8008 and / or the second connector 8008. The connector connection surface 8022 and the headpiece connection surface 8030 allow the first connector 8008 and / or the second connector 8008 to be removably connected to the headpiece 8006. The headpiece connection surface 8030 and the connector connection surface 8022 have cooperative or complementary shapes. In some configurations, portions of the headpiece connection surface 8030 and the connector connection surface 8022 have the same shape, or are configured to overlap each other when both the headpiece 8006 and the connector 8008 are properly positioned. Referring to Figure 93C as an example, the connector connection surface 8022 of the headpiece 8006 is curved along a portion of the ear loop 8016. The headpiece connection surface 8030 is a cooperating curved portion on the first connector 8008. The connector connection surface 8022 and the headpiece connection surface 8030 cooperate to connect the first connector 8008 and the headpiece 8006.

[0295] In some embodiments, the first connector 8008 and the second connector 8008 are connected to the headpiece 8006 by using a connection system. In at least one embodiment, this is a hook-and-loop connection system including hook-and-loop fasteners. One component of the connection system is located on the headpiece connection surface 8030, and the other is located on the connector connection surface 8022. The hook-and-loop connection system is configured to hold the headpiece connection surface 8030 in place around the user's ears when the patient interface 8002 is used. The connection system allows for easy separation of the mask assembly 8004, the first connector 8008, and / or the second connector 8008 when desired by the user. Furthermore, the mask assembly 8004, the first connector 8008, and / or the second connector 8008 can be easily reconnected to the headpiece 8006 when desired.

[0296] Other configurations of the headgear assembly 8000 include a magnetic connection system between the headpiece 8006 and the connector 8008. Some configurations include one or more magnets near or on the connector connection surface 8022. In these configurations, the headpiece connection surface 8030 may include one or more ferrous metal structures. Thus, as illustrated, the connector connection surface 8022 and the headpiece connection surface 8030 can represent components of the magnetic connection system. Therefore, the connector 8008 and the headpiece 8006 are connected by the magnetic force between the magnets on the connector connection surface 8022 and the ferrous structures on the headpiece connection surface 8030. Alternatively, the headpiece connection surface 8030 may provide one or more magnets, and the connector connection surface 8022 may provide one or more ferrous metal structures.

[0297] In the alternative configuration, the first connector 8008 and / or the second connector 8008 may include one or more magnets near or on the headpiece connection surface 8030, and the headpiece 8006 may include one or more magnets near or on the connector connection surface 8022. The one or more magnets on the connector connection surface 8022 may be oriented such that their polarity is approximately opposite to the magnetism of the magnets on the headpiece connection surface 8030. This configuration ensures that incorrect mounting will be indicated by magnetic repulsion.

[0298] The magnetic connection system primarily self-aligns. This helps the user connect the headpiece 8006 to the first connector 8008 and / or the second connector 8008 in the same place (each time it is attempted). Thus, the magnetic connection system allows for easy attachment and detachment of the mask assembly 8004 and connector 8008.

[0299] In at least one embodiment, the connector connection surface 8022 and the headpiece connection surface 8030 overlap when connected. In at least one embodiment, the connector connection surface 8022 and the headgear connection surface 8030 abut such that their surfaces are complementary. For example, the headpiece connection surface 9030 and the connector connection surface 9022 may overlap along a connection area that is C-shaped and can extend from above to below the user's ear.

[0300] In at least one embodiment, the middle strap 8024 and lower strap 8026 of the first connector 8008 and / or the second connector 8008 are adjustablely connected to the mask assembly 8004. The middle strap 8024 and lower strap 8026 pass through corresponding holes in the mask assembly 8004 and can be adjustedly secured in place by folding over themselves or each other. In at least one embodiment, the middle strap 8024 and lower strap 8026 are fixedly connected to the mask assembly 8004. In at least one embodiment, the middle strap 8024 is fixedly connected to the mask assembly 8004 and the lower strap 8026 is adjustablely connected to the mask assembly 8004. In at least one embodiment, the lower strap 8026 is fixedly connected to the mask assembly 8004 and the middle strap 8024 is adjustablely connected to the mask assembly 8004.

[0301] By separating the mask assembly 8004 from the headpiece 8006 using the first connector 8008 and / or the second connector 8008, the mask assembly 8004 can be removed without adjusting the size of the headgear assembly 8000. The mask assembly 8004 can then be reattached in place via the first connector 8008 and / or the second connector 8008 without the need for size adjustment. This simplifies the attachment and detachment process.

[0302] In some configurations of the headgear assembly 8000, the top strap 8010, the front strap 8012, the rear strap 8014, or any combination thereof, includes an adjustment mechanism 8040. The adjustment mechanism may be any preferred configuration, such as a buckle. Opposing sides of the straps 8010, 8012, and 8014 can pass through the buckle and fold over themselves. The free ends of the straps 8010, 8012, and 8014 can be secured to the rest of the straps 8010, 8012, and 8014 by a preferred fastener, such as a hook-and-loop fastener.

[0303] In at least one embodiment, the top strap 8010 and the front strap 8012 form separate portions of the ear loop 8016. The portions of the ear loop 8016 defined by the top strap 8010 and the front strap 8012 can be joined together below and / or above the user's ears.

[0304] In at least one embodiment, the headpiece 8006 includes a top strap 8010 that spans the top of the user's head and a rear strap 8014 that spans the back of the user's head.

[0305] In at least one embodiment, the first connector 8008 can be fixedly connected to the headpiece 8006. In this configuration, the second connector 8008 can be separated from the headpiece 8006 and the mask assembly 8004 can be removed.

[0306] Figures 94A to 94C show perspective views of the patient interface 9002, including the headgear assembly 9000 and the mask assembly 9004. The headgear assembly 9000 includes a headpiece 9006, a first connector 9008, and a second connector 9008 (not shown). As in the embodiments shown in Figures 93A to 93C, the headgear assembly 9000 may be symmetrical with respect to the sagittal plane of the user. Details of the headgear assembly 9000 that are not expressly disclosed may be the same as or similar to the corresponding elements of the headgear assembly 8000, or may be in a different preferred configuration. In this embodiment, the headgear assembly 9000 includes a partial ear loop 9016 (Figure 94C). The first connector 9008 and the second connector 9008 connect to the mask assembly 9004 at the front 9008a and to the headpiece 9006 at the rear 9008b, respectively.

[0307] The headpiece 9006 includes a top or vertical strap 9010, a front or forehead strap 9012, and a rear or occipital strap 9014. The front strap 9012 substantially spans the front of the user's head. The top strap 9010 substantially spans the top of the user's head. The rear strap 9014 substantially passes around the rear of the user's head. The headpiece 9006 includes a connector connection surface 9022 so that it can be connected to a first connector 9008 and / or a second connector 9008.

[0308] The first connector 9008 and / or the second connector 9008 include a mid-length strap 9024 and a lower strap 9026. The mid-length strap 9024 extends from the front portion 9008a and the mask assembly 9004 above and behind the user's ears. The lower strap 9026 extends from the front portion 9008a and the mask assembly 9004 below and behind the user's ears. The mid-length strap 9024 contacts the lower strap 9026 at the rear portion 9008b. In the illustrated configuration, the mid-length strap 9024 and the lower strap 9026 are integrally formed.

[0309] In at least one embodiment, the first connector 9008 and / or the second connector 9008 may include an intermediate strap. The intermediate strap may extend from the front portion 9008a and the mask assembly 9004 above and behind the user's ears. In at least one embodiment, the intermediate strap may extend from the front portion 9008a and the mask assembly 9004 below and behind the user's ears. In at least one embodiment, the intermediate strap extends from the front portion 9008a and the mask assembly 9004 and branches to extend both above and behind the user's ears, as well as below and behind.

[0310] Figure 94B shows a perspective view of the headgear assembly 9000 with the first connector 9008 separated from the headpiece 9006. When in use, one or both of the connectors 9008 can be separated from the headpiece 9006 and extended outward around the ears to release the mask assembly 9004 from the user's face.

[0311] The headpiece connection surface 9030 on the first connector 9008 and / or the second connector 9008 facilitates connection of the first connector 9008 and / or the second connector 9008 to the headpiece 9006. The connector connection surface 9022 on the headpiece 9006 facilitates connection of the headpiece 9006 to the first connector 9008 and / or the second connector 9008. The connector connection surface 9022 and the headpiece connection surface 9030 allow the first connector 9008 and / or the second connector 9008 to be removably connected to the headpiece 9006. The headpiece connection surface 9030 and the connector connection surface 9022 have cooperative or complementary shapes. In the embodiments illustrated in Figures 94A to 94C, both the headpiece connection surface 9030 and the connector connection surface 9022 are substantially reduced in size. The headpiece connection surface 9030 and the connector connection surface 9022 are displaced backward and vertically from the user's ear (e.g., upward) and connect along a connection line that may be, for example, straight or slightly curved. In some configurations, the entire connection between the headpiece connection surface 9030 and the connector connection surface 9022 is located above the lowest limit of the user's ear.

[0312] In at least one embodiment, the first connector 9008 can be fixedly connected to the headpiece 9006. In this configuration, the second connector 9008 can be separated from the headpiece 9006 and the mask assembly 9004 can be removed.

[0313] In at least one embodiment, the first connectors 8008, 9008 and / or the second connectors 8008, 9008 are manufactured from a continuous soft fabric cover with a plastic core. In some configurations, the plastic core can be an in-mold plastic core, where molten plastic is introduced into the space between or within the fabric portion or layers and cooled. In other embodiments, the first connectors 8008, 9008 and / or the second connectors 8008, 9008 can be manufactured using a rigid polymer material. In at least one embodiment, the first connectors 8008, 9008 and / or the second connectors 8008, 9008 can be manufactured using a soft polymer material such as silicone. In at least one embodiment, the first connectors 8008, 9008 and / or the second connectors 8008, 9008 can be manufactured using at least one rigid polymer material and at least one soft polymer material. Some embodiments may include the use of fabric material. In at least one embodiment, the first connectors 8008, 9008 and / or the second connectors 8008, 9008 may include a combination of rigid polymer materials, flexible polymer materials, ceramic materials, fabric materials, foam materials and / or metal materials. In at least one embodiment, the first connectors 8008, 9008 and / or the second connectors 8008, 9008 can be manufactured from a foam and fabric composite material.

[0314] Closed-loop headgear Figures 95 and 96 show front and rear perspective views of the patient interface 9100, including the headgear 9102, mask assembly 9104, and connector 9106. The headgear 9102 is a closed-loop headgear design with no interruption in the loop of the headgear 9102 and mask assembly 9104. As shown in the figures, the upper side strap 9108 and lower side strap 9110 are formed from a single continuous strap. Thus, the upper side strap 9108 and lower side strap 9110 result in a closed-loop or continuous connection created between the headgear 9102 and the mask assembly 9104, which does not break during the process of putting on and taking off the patient interface 9100.

[0315] The closed-loop headgear 9102 design can be formed by an in-mold (i.e., breakthrough) process in which the straps of the headgear 9102 are formed from a textile casing filled with a plastic core material. The textile casing provides a soft and comfortable contact surface for the straps, while the plastic core material provides rigidity and structure to the shape so that the headgear 9102 maintains its shape.

[0316] Connector Overview As shown in Figure 95, the upper side straps 9108 and lower side straps 9110 are connected to the mask assembly 9104 via connectors 9106 on each side of the mask assembly 9104. In some configurations, the straps 9108, 9110 can form part of the connector 9106. The connector 9106 is configured to act as a mechanism that secures the mask assembly 9104 to the user's face while maintaining a closed loop between the mask assembly 9104 and the headgear 9102.

[0317] As illustrated in Figures 97 and 98, the connector 9106 is configured to separate (i.e., be opened or detached) from the mask assembly 9104 without breaking the closed loop between the mask assembly 9104 and the headgear 9102, thereby increasing the effective length of the closed loop. Figure 97 shows a first perspective view of the connector 9106 in its initial separated state from the mask assembly 9104. Figure 98 shows a second perspective view illustrating the effective increase in headgear loop length achieved by separating the connector 9106, with the connector 9106 in Figure 97 further separated and expanded from the mask assembly 9104. Preferably, the separation and expansion of the connector 9106 increases the length of the headgear loop by at least 40 mm. This increase in the headgear loop allows the patient to easily put on and take off the headgear 9102. In some configurations, the minimum increase in length may be less than 40 mm, provided that the headgear 9102 has some degree of elasticity.

[0318] Therefore, the headgear 9102, mask assembly 9104, and connector configuration 9106 provide a closed-loop headgear design that includes a symmetrical connection mechanism to the mask assembly 9104. In other words, throughout the process of attaching and detaching the patient interface 9100, the closed loop between the mask assembly 9104 and the headgear 9102 remains unbroken, thereby improving the ease with which the user can secure the mask 9104 in place by interacting with the headgear 9102 and connector 9106 without displacing the mask 9104 when centering it on the user's face. The closed-loop headgear design requires an "over the head" method to attach the patient interface 9100, thereby reducing the likelihood of the patient becoming confused or incorrectly attaching the interface 9100. Thus, the closed-loop headgear design and connector configuration provide a comfortable, effective, and intuitively attachable patient interface headgear 9102. Furthermore, the closed-loop headgear design and connector configuration ensure that the patient interface seal remains centered on the face when the headgear 9102 is being attached or detached.

[0319] Plastic living hinge Figure 99A shows a plastic living hinge connector 9106, which includes a mask connector member 9112, a headgear connector member 9114, a first mask hinge 9116, a second mask hinge 9118, a first connector hinge 9120, and a second connector hinge 9122. The connector 9106 can be in a closed position, where the mask connector member 9112 and the headgear connector member 9114 are adjacent to the mask assembly 9104 (i.e., overlapping, crushed, etc.) or attached to the mask assembly 9104, or in an open position, where they are extended. In some configurations, the connector 9106 is fastened and fixed to the mask assembly 9104 in the closed position, thereby preventing the connector 9106 from moving or rotating. The advantages of the plastic living hinge connector 9106 are that the fastening system is self-positioning and the system is resistant to misuse.

[0320] The headgear connector member 9114 is substantially "U-shaped," with headgear connection points 9124 located at each of its lateral ends. The headgear connector member 9114 is molded as a single piece. The headgear connector member 9114 can be fabricated from a soft fabric cover 9114a together with an in-mold plastic core 9114b (see, for example, Figure 101B). Alternatively, the headgear connector member 9114 can be fabricated from a molded plastic component with a fabric layer on one side. In some configurations, the fabric layer may be on the outer surface of the headgear connector member 9114. In other configurations, the fabric layer may be on the inner surface of the member 9114.

[0321] The mask connector member 9112 is also formed from plastic. In the illustrated embodiment, there are two independent mask connector members 9112, with the first mask connector member being displaced vertically from the second mask connector member. That is, the first mask connector member 9112 can be positioned above the second mask connector member 9112 with respect to a vertical plane.

[0322] At one end, the mask connector member 9112 is connected to the mask frame 9126 of the mask assembly 9104. At the other end, the mask connector member 9112 is connected to the headgear connector member 9114. The mask connector member 9112 can be formed integrally with the headgear connector member 9114, or it can be connected using other methods such as adhesive bonding, RF welding, ultrasonic welding, overmolding, snap-fit ​​mechanism, mechanical suture, etc. The mask connector member 9112 can also be formed integrally with the frame 9126 of the mask assembly 9104. Alternatively, the mask connector member 9112 can be connected using other methods such as those described above.

[0323] In the closed position, the illustrated connector 9106 is positioned to contact the frame 9126 of the mask assembly 9104, as indicated by the arrow. A recessed channel 9128 is provided in the frame 9126, which has a shape and contour corresponding to the mask connecting member 9112 and the headgear connecting member 9114. In the closed position, the mask connecting member and the headgear connecting member 9114 fit into the recessed channel 9128. This reduces the external shape of the connector 9106 on the frame 9126 and the overall external shape of the mask assembly 9104.

[0324] When the connector 9106 is in the closed position, the mask assembly 9104 is secured to the user's face. The connector 9106 can be held in the closed position against the frame 9126 and within the recessed channel 9128 using a frictional mating between the connector 9106 and the recessed channel 9128. Alternatively, snap-fit, hook and post clip, magnet, Velcro® connection system, latch mechanism, or any other connection system may be used.

[0325] In the open position, the illustrated connector 9106 rotates in the opposite direction to the indicated arrow. While open, the connector 9106 rotates around both the mask hinge 9118 and the connector hinge 9122. That is, the connector 9106 rotates away from the frame 9126 and the concave channel 9128. In the illustrated embodiment, the mask hinge 9118 and the connector hinge 9122 are living hinges (i.e., thin, flexible hinges made from the same material as the mask connector member). As shown in Figure 99B, in some configurations, the living hinge can be fabricated as a single-piece structure.

[0326] Figure 100 shows a top view of a certain type of living hinge 9130 that can be incorporated into a mask connector member 9112. The living hinge 9130 includes a reduced-thickness portion, around which the living hinge 9130 provides rotation. Reducing the thickness of the indicated region improves local flexibility. This allows the reduced-thickness region to act as a hinge point, i.e., the “living hinge” 9130. In some configurations, the living hinge 9130 can have a constant thickness along its length while still possessing flexibility that provides rotation.

[0327] Figure 101A shows an exploded view of the assembled plastic living hinge mask connector member configuration 9106. The area of ​​the mask connector member 9112 that enables the hinge action may have a contour as shown in Figure 100, or another contour that enables a living hinge configuration. In this configuration, the mask connector member 9112 includes a projection 9132 which fits into a corresponding hole 9134 of the headgear connector member 9114 to mate the two components. As shown in Figure 101B, the projection 9132 is integrally formed with the mask connector member 9112. In some configurations, the projection 9132 may not be integrally formed with the connector member 9112. In other configurations, the headgear connector member 9114 may include a projection 9132, and the mask connector member 9112 may include a hole 9134. A similar connection mechanism may be used between the mask connector member 9112 and the mask assembly 9104, or a different connection mechanism may be used.

[0328] Figure 102A shows a living hinge connector 9106 having a single mask hinge 9116, a single connector hinge 9122, a recessed channel 9128, and a recessed surface 9136. The recessed surface 9136 is configured to receive a mask connector member 9112 when the connector 9106 is in the closed position, and the recessed channel 9128 is configured to receive a headgear connector member 9114.

[0329] Figure 102B also shows a cross-section of the core 9114b of the headgear connector member 9114 and the mask connector member 9112. In this configuration, the headgear connector member 9114 and the mask connector member 9112 are formed from a single continuous molded plastic component 9114b. The mask hinge extends along the vertical length of the mask connector member 9112, providing the mask hinge with a larger surface area adjacent to the mask assembly 9104. Furthermore, the greater length of the mask connector assembly 9112 includes the connector hinge. The increased length of the hinge improves the durability of the connector 9106.

[0330] Hook and post retention system Figures 103A and 103B show a plastic living hinge connector configuration 9106 having a hook and post retention system 9140. The connector 9106 in Figures 103A and 103B is held in the closed position by the hook and post retention system 9140. A raised post 9140a is integrally formed on the mask assembly 9104, and a corresponding hook 9140b is located on the mask connector member 9112. The hook 9140b encloses the post 9140a in the closed position and holds the connector 9106 in the closed position via a snap-fit ​​or interlocking connection, etc. In some embodiments, the raised post 9140a is integrally formed on the mask connector member 9112, and the corresponding hook 9140b is located on the mask assembly 9104.

[0331] In other embodiments, the connectors in Figures 103A and 103B can be held in the closed position by using a magnetic holding system. One or more magnets can be placed on the connector 9106, and one or more ferrous metal structures can be placed on the mask assembly 9104. The magnetic force between the magnets and the ferrous structures acts to hold the connector 9106 in the closed position.

[0332] Other configurations of the connector 9106 may include, for example, a push-fit, which includes one or more mushroom-shaped protrusions on the connector 9106 and corresponding recesses on the mask assembly 9104. The mask hinge 9116 and connector hinge 9122 in Figure 103B are enclosed by dashed boxes because they can be replaced with any of the living hinge designs described above. In other embodiments, the hook and post retainer 9140 can, alternatively, be replaced with any other suitable method for holding the connector in the closed position.

[0333] Fabric living room hinges Figures 104A and 104B show a fabric living hinge connector configuration 9142 in which the connector 9106 is originally a thick fabric, and a plastic support is included to improve rigidity. The fabric living hinge connector 9142 includes a mask connector member 9112, a headgear connector member 9114, two mask hinges 9116, and a connector hinge 9122. The mask connector member 9112 is substantially U-shaped, like the headgear connector member 9114. The mask connector member 9112 and the headgear connector member 9114 are made from the same continuous piece of fabric (i.e., the piece of fabric consists of two U-shaped sections joined at the bottom of the U).

[0334] The U-shaped mask connector member 9112 and the headgear connector member 9114 each include a plastic support to improve their rigidity, but the absence of this plastic support near the connector hinge 9122 means that the inherent flexibility of the fabric is sufficient to facilitate hinge movement. The fabric living hinge connector 9142 can be manufactured from at least one of several embodiments, two of which are described.

[0335] In the first embodiment, the fabric living hinge connector 9142 includes a single sheet of fabric incorporating the "U" shapes of the mask connector member 9112 and the headgear connector member 9114. The connector 9106 further includes a "U" shaped plastic reinforcement that further reinforces the mask connector member 9112 and another "U" shaped plastic reinforcement that further reinforces the headgear connector member 9114. A space exists between the two plastic reinforcements in the connector hinge 9122 to facilitate living hinge between the two connector members 9112 and 9114. Furthermore, the plastic reinforcement of the mask connector member 9112 stops just before the mask hinge 9116 to facilitate fabric living hinge between the mask assembly 9104 and the mask connector member 9112.

[0336] In the second embodiment, the fabric living hinge connector 9142 comprises two sheet-like pieces of fabric, each of which incorporates both the mask connector member 9112 and the headgear connector member 9114 as a single sheet. These two pieces of fabric are aligned so that two "U"-shaped plastic supports are sandwiched between the two fabric layers. The plastic supports are then sealed within the two fabric pieces. The fabric pieces can be connected using sutures, RF welding, adhesive bonding, or any other relevant connection mechanism. Similar to the first embodiment, the plastic supports provide rigidity to the "U" shape of the headgear connector member 9114 and the mask connector member 9112, while allowing the fabric to act as a living hinge in the mask hinge 9116 and the connector hinge 9122.

[0337] It should be noted that a preferred embodiment of the fabric living hinge connector 9142 includes two headgear connection points 9124. In alternative embodiments, a retaining member can be used to join the upper and lower arms of the headgear connector member 9114, allowing for a different number of headgear connection points.

[0338] Silicone hinge Figures 105A to 107B show a connector configuration 9106 having a silicone portion. The mask connector member 9112 is formed from silicone (or other soft polymers such as TPE, TPU, TPV, etc.), and the headgear connector member 9114 is formed from a rigid polymer.

[0339] Figures 105A and 105B show a silicon hinge having a first end of a mask connector member 9112 that is pivotably connected to a mask assembly 9104 via a mask hinge 9116. The second end of the mask connector member 9112 is pivotally connected to a headgear connector member 9114 via a connector hinge 9122. In the illustrated embodiment, the mask connector member 9112 rotates around a central pin connected to the mask assembly 9104 to form the mask hinge 9116. Furthermore, the mask connector 9112 rotates around a central pin on the connector hinge 9122 to which the headgear connector member 9114 is coupled. This allows for a wide range of motion relative to the connector 9106.

[0340] The illustrated configuration also includes a concave central area 9144 on the mask connector member 9112. This is a region 9144 in which the thickness of the member 9112 is reduced. This region 9144 reduces the rigidity of the mask connector member 9112, allowing it to flex to a greater extent than would be possible without the concave central area 9144.

[0341] The illustrated mask connector member 9112 is held in the closed position by the mask assembly 9104 via a projection on the mask that engages with a corresponding hole in the mask connector member 9112. In other embodiments, the mask connector member 9112 may include a projection, and the mask assembly 9104 may include a corresponding hole. Further embodiments may include any suitable retaining mechanism (magnets, Velcro®, etc.).

[0342] Figures 106A and 106B show an alternative silicon hinge configuration. Instead of using a pivot hinge as the mask hinge, the mask hinge point 9116 is fixed so that the silicon flexes and bends during the opening process. Thus, the connector 9106 has a biasing force in the direction necessary to close the connector 9106. This simplifies the process of securing the mask assembly 9104 to the user's face.

[0343] Figures 107A and 107B show a mask connector member 9112 having an alternative silicon hinge configuration. In this configuration, the mask connector member 9112 includes a first part 9112a of first thickness and a second part 9112b of second thickness. The first part 9112a has a greater thickness than the second part 9112b. The first part 9112a includes providing a mask hinge 9118 and a connector hinge 9122. The second part 9112b includes providing a connector hinge 9122. The mask hinge 9118 includes a post in the mask assembly 9104, and the mask connector member 9112 rotates around it. The connector hinge 9122 similarly rotates around the mask hinge 9118 around an axis as shown.

[0344] The first section 9112a has a greater thickness than the second section 9112b, minimizing deflection within the first section 9112a when the connector 9106 is in the open position. The frame 9126 of the mask assembly 9104 includes a hole 9148 that accommodates the increased thickness of this section 9112a.

[0345] The second part 9112b has a reduced thickness to increase the allowable deflection within the second part 9112b. By allowing deflection within the second part 9112b, the elasticity of the connector 9106 is improved when excessive force is applied to the connector 9106 during the opening process. The second part 9112b of the mask connector member 9112 includes a retaining cavity 9150 configured to mate with a retaining projection 9152 of the mask assembly 9104 when the connector 9106 is in the closed position.

[0346] The headgear connector member 9114 is manufactured from a rigid polymer. The center of the headgear connector 9114 includes a cavity 9154 sized to accommodate the mask connector member 9114 when the connector 9106 is in the closed position. This cavity 9154 ensures that the external dimensions of the connector 9106 are minimized.

[0347] The position of the connector hinge 9122 relative to the mask connector member 9112 and the headgear connector member 9114 differs from the connector configuration described above. The connector hinge 9122 is offset from both ends of the mask connector member 9112 and the headgear connector member 9114, as shown by the dashed line in Figure 107B. The advantage of offsetting the hinge 9122 is that a mechanical hard stop is generated when the connector 9106 is fully extended. This hard stop is a result of the front edge of the headgear connector member 9114 colliding with or contacting the inner surface of the mask connector member 9112. The hard stop is beneficial because it prevents the user from over-rotating the headgear connector member 9114 relative to the mask connector member 9112 at the connector hinge 9122, thereby reversing the connector 9106. Furthermore, the hard stop acts to hold the connector 9106 widely when released. This makes it easier to pass the headgear 9102 over the user's ears, thereby improving the usability of the headgear 9102 and mask assembly 9104 during attachment and removal.

[0348] In some configurations, the mask connector member 9112 can be sized such that an interlocking fit is formed between the mask connector member 9112 and the central cavity 9154 of the headgear connector member 9114 when the connector 9106 is in the closed position. This is achieved by making the mask connector member 9114 slightly larger than the cavity 9154 of the headgear connector member 9114. Because the mask connector member 9112 is made of silicone (or another soft polymer), when the connector 9106 is closed, an interlocking fit is formed when the headgear connector member 9114 is pressed onto the mask connector member 9112, compressing the mask connector member 9112. The interlocking fit helps to stabilize the headgear connector member 9114 vertically when the connector 9106 is in the closed position. In alternative embodiments, the mask connector member 9112 can be manufactured from a rigid polymer.

[0349] Headgear connection Figures 108A to 108C show a headgear connection configuration used to connect connector 9106 to headgear 9102. Each lateral end of connector 9106 includes a headgear connection portion 9124. This headgear connection portion 9124 is in the form of an annular rigid structure having holes configured to receive the straps of headgear 9102. The straps of headgear 9102 are designed to fold over themselves through the headgear connection portion 9124 and be secured in place by one of several methods disclosed later. The headgear connection portion 9124 can be formed integrally with the in-mold core 9114b of connector 9106.

[0350] Headgear fixing mechanism Figures 109A and 109B show the headgear retaining mechanism 9160 used to fix the length of straps 9108 and 9110. As shown, the headgear 9102 can be held in place at a fixed length using a hook-and-loop fastener mechanism 9160a, a push-fit mechanism 9160b, or a magnetic retaining system 9160c after it has formed a loop so that it returns to itself. In some configurations, alternative fastening mechanisms may be used.

[0351] Figures 110A and 110B show a push-fit headgear retaining mechanism 9162 used to fix the length of straps 9108 and 9110. The push-fit components (e.g., projection 9162a and opening 9162b) have a transverse profile that is longer than the longitudinal profile.

[0352] Over-center clip connector Figures 111A and 111B show an alternative connector configuration 9170 having an over-centered clip design. The illustrated configuration achieves over-centered locking using a combination of pivots, hinges, and plastic components. Connector 9106 includes a mask connector member 9112, a headgear connector member 9114, a mask hinge 9118, and a connector hinge 9122. The over-centered connector operates similarly to a silicone hinge, but the mask connector member 9112 is rigid. The rigid member allows the mask hinge 9118 to create a hard stop, as shown in Figure 17B. This hard stop acts to maximize the rotation that connector 9106 can undergo during operation. The advantage of this is that the hard stop can be positioned so that connector 9106 holds the headgear 9102 more broadly when in the operating position and allows the headgear 9102 to pass over the ears more easily when attached or detached. Headgear connector member 9114 includes two headgear connection points 9124.

[0353] Telescopic pivot connector Figures 112A, 112B, and 112C show a connector configuration 9180 including a retractable pivot clip. The illustrated configuration includes a mask connector member 9112 and a headgear connector member 9114, which are coaxially aligned and configured so that the headgear connector member 9114 can move along their common axis relative to the mask connector member 9112. The mask connector member 9112 protrudes perpendicularly to the mask hinge 9118. In the closed position, the clip holds the connector 9106 to the mask assembly 9104. To open, the user applies lateral force to the mask assembly on the clip to separate the clip. The mask connector member 9112 and the headgear connector member 9114 then rotate outward around the mask hinge 9118 (Figure 112B). When pivoted to open, the mask connector member 9112 can be pulled outward in a nesting motion away from the mask assembly 9104, thereby extending the length of the connector 9106 (Figure 112C). In addition to increasing the length of the headgear loop, this configuration helps to move the headgear 9102 away from the user's ears, simplifying the removal process.

[0354] Sliding strap hard stop connector Figures 113A and 113B show a connector configuration having a hard-stop sliding strap connector configuration 9190. In this configuration, the outer portion of the headgear 9102 contacts the user's cheek and is incorporated into the connector 9106. The connector strap interface 9192 on the mask assembly 9104 acts as a fixing point for the headgear straps 9108, 9110. In the illustrated configuration, the two headgear straps 9108, 9110 are incorporated into the connector 9106. The connection mechanism for each headgear strap 9108, 9110 at the connector strap interface 9192 is not limited; that is, the connector configuration can include various types of connection mechanisms. In the illustrated configuration, the straps 9108, 9110 loop back onto themselves through the opening in the mask assembly 9104. The straps 9108 and 9110, once looped through the mask assembly 9104, can be attached to themselves, for example by suture, or by hook-and-loop fastener connection systems.

[0355] Each strap 9108, 9110 passes through a first reversal point 9193a located on the headgear 9102. The straps 9108, 9110 extend through the first reversal point 9193a to a second reversal point 9193b, where they loop back onto themselves and are secured in place. In the illustrated configuration, the straps 9108, 9110 are secured to themselves after the second reversal point 9193b via a hook-and-loop fastener connection system. The fastening system is not limited to a hook-and-loop fastener connection system and may include other connection systems. Adjusting the strap length via the second reversal point 9193b is one way the user can adjust the tightness of the headgear 9102 in this configuration.

[0356] The second reversal point 9193b is located on the clip 9194. This clip 9194 acts as part of the retaining mechanism for the connector 9106. The retaining point 9196 is located on the mask assembly 9104 and interacts with the clip 9194 to hold the connector 9106. In the illustrated configuration, the retaining point 9196 protrudes from the mask assembly 9104, and the clip 9194 is positioned across the front of the retaining point 9196. The tension in the headgear 9102 and the connector assembly 9106 acts to pull the clip 9194 against the retaining point, as illustrated in Figure 113A. The retaining mechanism 9190, including the clip 9194 and the retaining point 9196, is not particularly limited and may include other retaining mechanisms. The retaining mechanism may be a hook and post connection mechanism or any other mechanism.

[0357] Hard stop connector at the end of the strap Figures 114A and 114B show a connector configuration with a sliding strap hard stop 9200. In this configuration, each headgear strap 9108, 9110 loops over itself through the connector strap interface 9192 and is then held in place by a retaining mechanism (e.g., hook fastener) at the headgear strap end. However, the headgear strap end 9202 has a larger contour than the hole through which each strap passes in the connector strap interface 9192. As a result, when released, the headgear strap ends 9108, 9110 can extend the headgear loop by retracting through the connector strap interface 9192, but cannot easily pass through the mask assembly 9104. This prevents the user from removing the headgear 9102 without breaking the headgear / mask assembly loop. The upper strap 9108 and lower strap 9110 can be interconnected and both adjusted at the same time.

[0358] BreakFit magnets and tether connectors Figures 115A and 115B show a connector assembly 9210 incorporating two clips 9212a and 9212b, a magnetic connector 9214, and a tether 9216. In the closed position as shown in Figure 115A, the two components of the magnetic connector 9214 are in contact with each other, and the first clip 9212a and the second clip 9212b are secured to the mask assembly 9104. The first clip 9212a and the second clip 9212b can be attached to the mask assembly 9104 using hook and post clips, a magnet assembly, or any other associated mechanism.

[0359] As illustrated in Figure 115B, the position of the magnetic connectors 9214 on the ear loops of the headgear 9102 allows the user to detach the second clip 9212b and break the magnetic connectors when they wish to remove the mask assembly 9104. A tether 9216 is included, one end of which is fixed to each point of the magnetic connectors 9214, so that when the magnetic connectors 9214 are broken, the tether 9216 acts as a bridge to prevent the lower portion of the headgear 9102 from falling completely. When the magnetic connectors 9214 are broken, the length of the headgear loops 9102 below the user's ears is increased, allowing the user to remove the headgear 9102 without having to readjust the headgear 9102 when they wish to use the mask assembly 9104 again. In some configurations, the tether 9216 between the magnetic connectors 9214 may not be included.

[0360] BreakFit clip and tether connector Figures 116A and 116B show a connector assembly 9220 incorporating a hook or clip 9222, a post 9224, and a tether 9226, as illustrated. In the closed position, the hook 9222 connects to the post 9224 on the mask assembly 9104. In the open position, the user releases the hook or clip 9222 to lengthen the headgear loop. The tether 9226 acts as a bridge between the hook or clip 9222 and the retaining member or post 9224 on the mask assembly 9104. This lengthens the headgear loop sufficiently to ensure that the closed loop of the headgear 9102 is retained while the headgear 9102 can be comfortably removed by the user.

[0361] Clip and continuous tether connector Figures 117A and 117B show a clip and continuous tether connector 9230 incorporating a hook or clip 9232, a post 9234, and a continuous tether 9236 connecting both connectors 9230 on a mask assembly 9104. In this configuration, each of the two connectors 9230 is connected by a common tether 9236. The tether 9236 passes through a tether channel 9238 located on the mask assembly 9104. The tether 9236 is preferably manufactured from an elastic material. In the closed position, the clip 9232 is secured to the post 9234 of the mask assembly 9104. When the user opens the connector 9230, they release and pull the clip 9232. The tether 9236 maintains the closed loop of the headgear 9102 while allowing the headgear loop length to increase due to its elasticity. This allows the user to effectively remove the mask assembly 9104.

[0362] Figures 118A and 118B show an alternative clip and continuous tether connector 9230 incorporating a first tether 9236a and a second tether 9236b. The first tether 9236a is displaced perpendicular to the second tether 9236b. The first tether 9236a passes through the first tether channel 9238a. The second tether 9236b passes through the second tether channel 9238b. The tethers 9236a and 9236b can move approximately parallel to each other. The clip 9232 operates similarly to the first embodiment. As a result of including the first tether 9236a and the second tether 9236b, the clip 9232 has an increased tendency to automatically align during attachment and detachment. This can be due to the improved elasticity resulting from the two tethers 9236a and 9236b.

[0363] Clip and rigid tether connector Figures 119A and 119B show a connector assembly 9230 having a clip 9232 and a pair of rigid tethers 9236, each to hold a lateral headgear strap. In this configuration, the connector 9230 includes a clip and rigid tether system. As with the previous connector 9230, the clip 9232 is used to hold the headgear 9102 to the mask assembly 9104 and may be a hook and post. However, two additional rigid tethers 9236 are integrated into the mask assembly. The lateral headgear straps 9108, 9110 are each fed through slider holes in the rigid tethers 9236 during initial headgear setting, thereby allowing the outer headgear straps 9108, 9110 to slide through the sliders 9240 of the rigid tethers 9236 once secured. When the connector 9230 is pushed into the open position, the headgear 9102 can slide through the rigid tether sliders, increasing the size of the headgear loop. However, slider 9240 limits the maximum extension of the headgear loop by acting as a hard stop when it reaches clip 9232.

[0364] Hook and post-loop connectors Figures 120A and 120B show a connector assembly 9250 having a hook and post-loop connector. The illustrated connector 9250 includes a fixing connector point 9252, a clip 9254, and a material portion 9256. The fixing connector point 9252 is located on top of the mask assembly 9104. At this point, the material portion 9256 passes through the loop, folds over itself, and is fixed in place in an adjustable manner (e.g., using hook-and-loop fasteners or magnetic connections). The material portion 9256 passes through a first hole loop 9258, where it is reoriented towards a second hole loop 9260. The end of the material or fabric portion 9256 includes a clip 9254, which allows the end of the fabric portion 9256 to be removably connected to the mask assembly 9104.

[0365] To release connector 9250, clip 9254 is separated from mask assembly 9104. In the illustrated embodiment, clip 9254 is a hook-and-post clip. Alternatively, clip 9254 may be magnetic, push-fit, or another clip configuration. By releasing clip 9254, the length of the headgear loop is increased, allowing the patient to put on and take off the headgear 9102 as shown. Clip 9254 acts as a hard stop in the second hole loop 9260, thereby limiting the maximum length to which the headgear loop can be increased. The effective length of material portion 9256 can be adjusted at both the fixed connector point 9252 and clip 9254.

[0366] Material portion 9256 can be manufactured from flexible materials such as breath-o-prene, leather or synthetic leather, fabric, any combination thereof, or any other suitable material.

[0367] Figures 121A and 121B show alternative hook and post-loop connectors 9250 similar to connectors 9250 in Figures 120A and 120B. In Figures 121A and 121B, clip 9254 is modified compared to clip 9254 in Figures 120A and 120B. In other respects, connectors 9250 in Figures 121A and 121B may be the same as or substantially the same as connectors 9250 in Figures 120A and 120B.

[0368] Unless otherwise explicitly required by the context, terms such as “comprise,” “comprising,” etc., throughout the specification and claims should be interpreted in a comprehensive sense, as opposed to an exclusive or exhaustive sense, i.e., “not limited to, but including.” In particular, conditional language used herein, such as “can,” “could,” “might,” or “may,” and “for example,” is generally intended to mean that some embodiments include some features, elements, and / or states, but other embodiments do not, unless otherwise specifically stated or understood to mean otherwise in the context in which they are used. Thus, such conditional language is generally not intended to mean that features, elements, and / or states are required in some way for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether these features, elements, and / or states are included in or should be performed in any particular embodiment, with or without input or encouragement of input by the author.

[0369] The term "multiple" refers to two or more items. Enumerations of quantities, dimensions, sizes, formulations, parameters, shapes, and other features should be interpreted as if preceded by the term "about" or "approximately." The term "about" or "approximately" means that quantities, dimensions, sizes, formulations, parameters, shapes, and other features are not required to be exact and may be approximated and / or greater or less as required, reflecting acceptable tolerances, conversion factors, rounding, measurement errors, etc., and other factors known to those skilled in the art. Enumerations of quantities, dimensions, sizes, formulations, parameters, shapes, and other features should also be interpreted as if preceded by the term "substantially." The term "substantially" means that enumerated features, parameters, or values ​​are not required to be exactly achieved and may occur in an amount that does not negate the intended effect provided by that feature, for example, tolerances, measurement errors, measurement accuracy limits, and other factors known to those skilled in the art.

[0370] Numerical data may be expressed or presented in range form as described herein. Range form is used merely for convenience and clarity, and should therefore be interpreted flexibly to include not only the numbers explicitly listed as the limits of the range, but also all individual numbers or subranges contained within that range, as if each number and subrange were explicitly listed. For example, the numerical range "1 to 5" should not be interpreted to include only the explicitly listed values ​​approximately 1 to approximately 5, but also to include the individual values ​​and subranges within the indicated range. Thus, this numerical range includes individual values ​​such as 2, 3, and 4, as well as subranges such as "1 to 3," "2 to 4," and "3 to 5." This same principle applies to ranges listing only one number (e.g., "greater than 1"), regardless of the breadth of the range or feature described.

[0371] Multiple items may be presented in a common list for convenience. However, these lists should be interpreted as if each element of the list were individually identified as a distinct and unique element. Therefore, no individual element of such a list should be interpreted as a de facto equivalent of any other element of the same list, based solely on its presentation in a common group, unless otherwise indicated. Furthermore, when the terms “and” and “or” are used with a list of items, they should be interpreted broadly, meaning that any one or more of the enumerated items can be used alone or in combination with other enumerated items. The term “alternatively” refers to a choice of two or more alternatives and is not intended to limit the choice to only those enumerated alternatives, or to only one of the enumerated alternatives at a time, unless explicitly indicated otherwise in the context.

[0372] No reference to prior art in this specification constitutes, and should not be interpreted as, an acknowledgment of, that such prior art forms part of common general knowledge in any country in the world in the field of focus.

[0373] In the above description, we refer to complete bodies or components that have known equivalents, and these complete bodies are incorporated herein as if they were individually shown.

[0374] The present invention may also be broadly said to be in any part, element, and feature (any or all combination of two or more of the aforementioned parts, elements, or features) that are referred to or shown individually or collectively in the specification of this application.

[0375] It should be noted that various modifications and alterations to the currently preferred embodiments described herein will be apparent to those skilled in the art. Such modifications and alterations can be made without departing from the spirit and scope of the invention and without diminishing its incidental benefits. For example, various components can be rearranged as needed. Thus, such modifications and alterations are intended to fall within the scope of the invention. Furthermore, not all features, embodiments, and advantages are necessarily required to carry out the invention. Thus, the scope of the invention is intended to be defined solely by the following claims.

Claims

1. A headgear used with a breathing apparatus, A first strap having a first textile casing, A second strap having a second textile casing and connected to the first strap at a position between the ends of the first strap, Equipped with, The first textile casing and the second textile casing have a seamless tubular shape. A single plastic core material is integrally formed within the first textile casing and the second textile casing. By elastically deforming, displacing, or tearing the threads of the first textile casing, gaps or holes are formed in the wall of the first textile casing, and the integral plastic core material extends into the second textile casing through these gaps or holes, thereby the integral plastic core material extends from the first textile casing of the first strap to the second textile casing of the second strap. headgear.

2. The headgear according to claim 1, wherein the integral plastic core material connects the first textile casing and the second textile casing.

3. The headgear according to claim 1, further comprising a connector that surrounds the joint between the first strap and the second strap.

4. The headgear according to claim 2, further comprising a connector that surrounds the joint between the first strap and the second strap.

5. The headgear according to claim 1, further comprising a connector surrounding the joint between the first strap and the second strap, wherein the integral plastic core material is coupled to the connector such that the connector, the first textile casing, the second textile casing, and the integral plastic core material are formed as an integrated structure.

6. The headgear according to claim 2, further comprising a connector that surrounds the joint between the first strap and the second strap, wherein the integral plastic core material is coupled to the connector such that the connector, the first textile casing, the second textile casing, and the integral plastic core material are formed as an integrated structure.

7. The headgear according to claim 1, wherein the first strap and the second strap are connected via a connecting member disposed between the first strap and the second strap, and the connecting member is formed of the integral plastic core material.

8. The headgear according to claim 7, wherein the integral plastic core material is an elastomer so that the connecting member can be stretched.

9. The headgear according to claim 1, wherein the first strap and the second strap are joined together via an integrally formed web portion, the web portion being formed from the integral plastic core material and positioned between the first strap and the second strap.

10. The headgear according to claim 9, further comprising a soft-touch material overmolded onto the outer surface of the web portion.

11. The headgear according to any one of claims 1 to 10, wherein the first textile casing and the second textile casing are knitted, woven, braided or crocheted.

12. The headgear according to any one of claims 1 to 10, wherein the end of the second textile casing of the second strap is in contact with the first textile casing of the first strap.

13. The headgear according to any one of claims 1 to 10, wherein the end of the second textile casing of the second strap abuts against the first textile casing of the first strap, and the end of the second textile casing of the second strap has a sealing portion.

14. The headgear according to any one of claims 1 to 10, wherein the end of the second textile casing of the second strap abuts against the first textile casing of the first strap, and the end of the second textile casing of the second strap has a sealing portion, the sealing portion being formed by cutting with a hot knife.

15. The headgear according to any one of claims 1 to 10, further comprising a strap connector disposed on the outer surface of at least one of the first strap and the second strap, the strap connector being formed from the integral plastic core material.

16. The headgear according to any one of claims 1 to 10, wherein at least one of the first strap and the second strap has a soft edge portion that extends along the edge of the first strap and / or the edge of the second strap in the longitudinal direction.

17. The headgear according to claim 16, wherein at least one of the first strap and the second strap has a soft edge portion that extends along the edge of the first strap and / or the second strap in the longitudinal direction, and the soft edge portion of at least one of the first strap and the second strap includes a portion of the first textile casing of the first strap and / or the second textile casing of the second strap that is not filled with the integral plastic core material.

18. A method for forming a headgear in a molding die, The steps include: placing a first tubular textile casing and a second tubular textile casing in the cavity of the molding die; The steps include introducing molten plastic material into the molding die and into the first tubular textile casing, The process involves elastically deforming, displacing, or tearing the threads of the first tubular textile casing to form gaps or holes in the wall of the first tubular textile casing, through which an integral plastic core extends into the second tubular textile casing, thereby pushing the molten plastic material through the first tubular textile casing into the second tubular textile casing, The process involves solidifying the molten plastic material within the first tubular textile casing and the second tubular textile casing to form an integrated plastic core. Includes, A method for forming a headgear, wherein the first tubular textile casing and the second tubular textile casing have a seamless tubular shape.

19. A method for forming a headgear according to claim 18, wherein the step of arranging a first tubular textile casing and a second tubular textile casing in the cavity of the molding die further includes positioning the first tubular textile casing in contact with the second tubular textile casing.

20. A method for forming a headgear according to claim 18, wherein the step of arranging a first tubular textile casing and a second tubular textile casing in the cavity of the molding die further includes positioning the first tubular textile casing so as to be in contact with the second tubular textile casing, the end of the second tubular textile casing abutting with the first tubular textile casing at a position between the ends of the first tubular textile casing.

21. A method for forming a headgear according to claim 18, wherein the step of arranging a first tubular textile casing and a second tubular textile casing in the cavity of the molding die further includes positioning the first tubular textile casing in contact with the second tubular textile casing, so that the first tubular textile casing and the second tubular textile casing are in contact with each other at a position between their ends.

22. A method for forming a headgear according to claim 18, wherein the outer edge of the cavity narrows relative to the central portion of the cavity, thereby tightening the outer edges of the first tubular textile casing and the second tubular textile casing to prevent molten plastic material from flowing between the outer edges of the first tubular textile casing and the second tubular textile casing.

23. A method for forming a headgear according to claim 18, wherein the step of pushing the molten plastic material into the second tubular textile casing through the first tubular textile casing causes the first tubular textile casing and the second tubular textile casing to be joined together.

24. A method for forming a headgear according to claim 18, further comprising the step of positioning the end of the second tubular textile casing within the cavity of the tubular connector and a portion of the side wall of the first tubular textile casing adjacent to or within the cavity of the tubular connector, so that the molten plastic material is pushed into the second tubular textile casing through the first tubular textile casing and the tubular connector.

25. A method for forming a headgear according to claim 24, further comprising the step of bringing the end of the second tubular textile casing into contact with the first tubular textile casing.

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