Strapping assembly

Abstract

Various methods of forming headgear for use in conjunction with respiratory devices are disclosed, the headgear including a unitary plastic core within a textile shell. In some configurations, the plastic core material penetrates or breaks through the textile shell of the strap. Some configurations include overmolding, alignment posts, T-junctions, and junction housings with injection ports. Various different headgear arrangements are disclosed, including a top strap, front straps, rear straps, and a pair of straps extending from the mask above and below the ears to meet behind the ears. Various connectors to connect the headgear assembly to the mask assembly are disclosed, wherein the headgear, mask, and connector form a closed loop when the connector is disengaged from the mask assembly.

Description

[0001] This application is a divisional application of application number 201780030322.2 (international application number PCT / IB2017 / 051373) filed on 9 March 2017, having the title "Tie assembly, tie connector, headgear, headgear assembly, method of forming headgear, tubular connector, patient interface, and method of joining ties", the disclosure of which is hereby incorporated by reference in its entirety.

[0002] Incorporation by reference of any priority application

[0003] This application is related to and claims priority to U.S. Provisional Patent Application No. 62 / 309,400, U.S. Provisional Patent Application No. 62 / 323,459, U.S. Provisional Patent Application No. 62 / 364,767, U.S. Provisional Patent Application No. 62 / 401,462, U.S. Provisional Patent Application No. 62 / 468,915, U.S. Provisional Patent Application No. 62 / 323,489, and U.S. Provisional Patent Application No. 62 / 327,942, the entire contents of which are hereby incorporated by reference and constitute a part of the disclosure. BACKGROUND TECHNICAL FIELD

[0004] The present disclosure relates generally to headgear for use in conjunction with respiratory equipment. More particularly, the present disclosure relates to three-dimensional headgear, formation of portions of the headgear, and methods for molding such headgear. Further applications of the molding method are also disclosed. The present disclosure also relates generally to full-face, sub-nasal patient interfaces having a closed loop headgear, and various components of the patient interface.

[0005] Related Art

[0006] Patient interfaces are used to provide respiratory therapy to the airways of a person suffering from any one of a number of respiratory diseases or conditions. Such therapy can include, but is not limited to, continuous positive airway pressure (CPAP) therapy and non-invasive ventilation (NIV) therapy.

[0007] CPAP therapy can be used to treat obstructive sleep apnea (OSA), a condition that affects a patient's airway during sleep such that the patient's airway intermittently collapses, thereby preventing the patient from breathing for a period of time. The cessation of breathing, or apnea, causes the patient to wake. Repeated and frequent apneas can cause the patient to be able to sleep for only short periods of time, and thus be able to recover from nightly sleep infrequently.

[0008] CPAP therapy involves the delivery of a supply of continuous positive air pressure to the airway of a patient via a patient interface. The continuous positive air pressure acts as a splint within the patient's airway that holds the airway in an open position such that the patient's breathing and sleep are not interrupted.

[0009] Patient interfaces typically comprise a mask assembly configured to deliver a continuous positive air pressure supply to the airways of a patient via a seal or cushion that forms a substantially airtight seal in or around the patient's nose and / or mouth, and a headgear assembly. Mask assemblies are available in a range of styles including full face masks, nasal masks, and oral-nasal masks that form a substantially 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. In order to maintain a substantially airtight seal, the headgear assembly should provide support for the mask assembly so that it remains 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.

[0010] Patient interfaces form at least a substantially "seal" over or around the nose and / or mouth of the user, whereas a cannula does not provide a seal, but rather provides a delivery path for supplemental respiratory gas delivery. As a result of forming this "seal", the enclosed region of the respiratory device in combination with its internal pressure creates a resultant force that seeks to push the respiratory device away from the face. To counteract this force, a headgear is typically used that comprises a series of straps that pass around the back and / or top of the user's head.

[0011] A problem often encountered with adjustable headgear or headgear that requires left and right side connection in the case of a nasal under-type mask is that the user can pull one side of the headgear too tight, thus pulling the mask off centre. In other cases, the user can simply pull the mask off centre by first connecting one side of the mask. Nasal under-type masks can be more prone to being pulled off centre than over-the-nose masks, as the nose can collapse, whereas over-the-nose masks are centred by the apex of the mask seal itself. It is therefore desirable to develop a closed loop headgear design with a connection mechanism to the mask assembly that ensures that the patient interface seal remains centred on the user's face when the headgear is donned and doffed. SUMMARY

[0012] The systems, methods, and devices described herein have numerous innovative aspects, no single one of which is solely responsible for the desirable attributes of the aspects. Without limiting the scope of the claims, some of the advantageous features will now be summarized.

[0013] According to at least one of the embodiments disclosed herein, a headgear is provided. The headgear includes a top strap and a bottom strap, wherein the bottom strap is connected to the top strap at a location between end portions of the bottom strap. An integral plastic core is formed within textile casings of both the top strap and the bottom strap.

[0014] According to another aspect, the unitary plastic core extends through at least one of the textile casings of both the top strap and the bottom strap.

[0015] According to another aspect, the textile casings have a seamless, tubular shape.

[0016] According to another aspect, the textile casings are knitted, woven, braided, or crocheted.

[0017] According to another aspect, one end portion of the textile casing of the top strap is in abutting contact with the textile casing of the bottom strap.

[0018] According to another aspect, the textile casing of the top strap flares radially outward in a direction toward the end portion of the top strap along a length of the top strap.

[0019] According to another aspect, one end portion of the textile casing of the top strap has a sealed portion, wherein the sealed portion is formed by cutting with a hot knife.

[0020] According to another aspect, the headband further includes a filament core incorporated into the unitary plastic core within the bottom strap.

[0021] According to another aspect, the headband further includes strap connectors positioned on an outer surface of at least one of the top strap and the bottom strap, wherein the strap connectors are formed from the unitary plastic core.

[0022] According to at least one of the embodiments disclosed herein, a method for forming a headband within a molding tool is provided. The method includes placing a first tubular textile casing and a second tubular textile casing within a cavity of a molding tool; introducing a molten plastic material into the molding tool and into the first tubular textile casing; pushing the molten plastic material through the first tubular textile casing and into the second tubular textile casing; and then allowing the molten plastic material to solidify within the first and second textile casings to form a unitary plastic core.

[0023] According to another aspect, pushing the molten plastic material through the first tubular textile casing and into the second tubular textile casing further includes displacing threads of the first tubular textile casing to form gaps in a wall of the first tubular textile casing through which the molten plastic material flows into the second tubular textile casing.

[0024] According to another aspect, pushing the molten plastic material through the first tubular textile casing and into the second tubular textile casing further includes tearing a thread of the first tubular textile casing to form a hole in a wall of the first tubular textile casing through which the molten plastic material flows into the second tubular textile casing.

[0025] According to another aspect, placing the first tubular textile shell and the second tubular textile shell within the cavity of the molding tool further comprises positioning the first tubular textile shell in contact with the second tubular textile shell.

[0026] According to another aspect, one open end portion of the first tubular textile shell is in abutting contact with the second tubular textile shell at a location between end portions of the second tubular textile shell.

[0027] According to another aspect, the first tubular textile shell and the second tubular textile shell are in contact with each other at some locations between their end portions.

[0028] According to another aspect, the outer edge of the cavity narrows relative to the central portion of the cavity such that the outer edge of the first tubular textile shell and the outer edge of the second tubular textile shell are pinched to prevent molten plastic material from flowing between the outer edge of the first tubular textile shell and the outer edge of the second tubular textile shell.

[0029] According to another aspect, the central portion of the cavity comprises protrusions that press down on a surface of at least one of the first tubular textile shell and the second tubular textile shell such that an indentation is integrally formed on the surface of the at least one of the first tubular textile shell and the second tubular textile shell.

[0030] According to at least one of the embodiments disclosed herein, a method for forming a headband within a molding tool is provided. The method comprises placing a first tubular textile shell into a cavity of a first molding tool; positioning a portion of the first tubular textile shell in contact with an adjacent cavity having a shape of a connector portion; introducing molten plastic material into the first molding tool and into the first tubular textile shell; pushing the molten plastic material through the first tubular textile shell and into the adjacent cavity; and then allowing the molten plastic material to solidify within the first tubular textile shell to form a first strap portion having an inner core formed of unitary plastic material and the connector portion.

[0031] According to another aspect, the method further comprises placing the first strap portion into a second molding tool; positioning one end portion of a second tubular textile shell over the connector portion in contact with the first tubular textile shell of the first strap portion; introducing molten plastic material into the second molding tool and into the second tubular textile shell; and then allowing the molten plastic material to solidify within the second tubular textile shell to form a second strap portion having an inner core formed of unitary plastic material connected to the connector portion of the first strap portion.

[0032] According to at least one of the embodiments disclosed herein, a headgear assembly is provided. The headgear assembly includes a top strap, an upper side strap connected to the top strap, and a lower side strap connected to the upper side strap. The upper side strap and the lower side strap are integrally formed as a unitary structure.

[0033] According to another aspect, the upper side strap and the lower side strap are formed as a closed loop structure.

[0034] According to another aspect, the top strap, the upper side strap, and the lower side strap are integrally formed as a unitary structure.

[0035] According to another aspect, the top strap, the upper side strap, and the lower side strap are formed as a closed loop structure.

[0036] According to another aspect, the upper side strap and the lower side strap are joined by an internally molded webbing.

[0037] According to another aspect, the headgear assembly further includes a neck panel attached to at least one of the top strap and the lower side strap.

[0038] According to another aspect, at least one of the top strap and the neck panel includes a breathable, moisture-wicking material.

[0039] According to another aspect, the top strap includes a quilted textile material.

[0040] According to another aspect, a unitary plastic core is integrally formed within the upper side strap and the lower side strap.

[0041] According to another aspect, a unitary plastic core is integrally formed within the top strap, the upper side strap, and the lower side strap.

[0042] According to at least one of the embodiments disclosed herein, a tubular connector is provided for abutting an end of a first strap to a sidewall of a second strap. The connector includes a first end having a shape corresponding to a shape of the end of the first strap, wherein the first end contacts or is positioned over the end of the first strap; a second end positioned opposite the first end and having a shape corresponding to the sidewall of the second strap, wherein the second end contacts or is positioned over the sidewall of the second strap; a cavity positioned between the first end and the second end; and a plastic core positioned within the cavity, wherein the plastic core integrally bonds the first strap and the second strap to form a unitary structure.

[0043] According to another aspect, the first end overlaps the end of the first strap.

[0044] According to another aspect, the end of the first strap abuts the second strap.

[0045] According to another aspect, the second end overlaps a sidewall of the second strap.

[0046] According to at least one of the embodiments disclosed herein, a method for joining one end of a first strap to a sidewall of a second strap within a molding tool is provided. The method includes positioning one end of a first tubular textile casing into a cavity of a tubular connector and positioning a portion of a sidewall of a second tubular textile casing adjacent to or into the cavity of the tubular connector; placing the first and second tubular textile casings and the tubular connector into a cavity of a molding tool; introducing a molten plastic material into the molding tool and into the first tubular textile casing; injecting the molten plastic material through the first tubular textile casing and the tubular connector into the second tubular textile casing; and then allowing the molten plastic material to solidify within the first and second tubular textile casings and the tubular connector to form an integral inner core of the plastic material within the first and second tubular textile casings and the tubular connector.

[0047] According to another aspect, the positioning includes abutting the end of the first tubular textile casing against the second tubular textile casing.

[0048] According to at least one of the embodiments disclosed herein, a strap connector assembly for connecting first and second straps, each of the straps including a unitary plastic core within a textile shell, is disclosed, the strap connector assembly comprising: a first connector portion positioned at one end portion of the first strap; a second connector portion positioned between end portions of the second strap, the second connector portion including a protrusion of the unitary plastic core protruding through the textile shell of the second strap, the second connector portion configured to align with the first connector portion to facilitate connecting the first and second straps. According to another aspect, a thickness of the first connector portion is equal to a thickness of the second connector portion. According to another aspect, the first and second connector portions are configured to have a gap disposed therebetween when the first and second connector portions are aligned to facilitate connecting the first and second straps. According to another aspect, the strap connector assembly further comprises an alignment recess disposed on the first connector portion, the alignment recess configured to engage a protrusion disposed on an inner surface of a molding tool to maintain a position of the first connector portion relative to the molding tool. According to another aspect, the strap connector assembly further comprises an overmold joint overmolded over the first and second connector portions. According to another aspect, a thickness of the overmold joint is equal to the thickness of the first connector portion and the thickness of the second connector portion. According to another aspect, the overmold joint contacts the textile shell of both the first and second straps. According to another aspect, a shape of both the first and second connector portions is determined to interfit with each other. According to another aspect, the first connector portion includes an extension of the unitary plastic core beyond the textile shell. According to another aspect, the first connector portion extends beyond one end of the textile shell. According to another aspect, the first and second connector portions are a male connector portion and a female connector portion, respectively. According to another aspect, each of the first and / or second connector portions includes a tab. According to another aspect, a width of the first connector portion and / or a width of the second connector portion is equal to a width of the unitary plastic core of both the respective first and second straps.

[0049] According to at least one of the embodiments disclosed herein, a strap connector assembly for connecting a first strap portion and a second strap portion is disclosed, each of the strap portions including a unitary plastic core positioned within a textile shell, the strap connector assembly including a webbing that forms a portion of the unitary plastic core of one of the straps and is configured to connect the first strap portion and the second strap portion, an alignment post protruding from a surface of the webbing, and an overmolded junction overmolded over the webbing. According to another aspect, a thickness of the alignment post is greater than a thickness of the webbing. According to another aspect, the thickness of the alignment post is equal to a thickness of the overmolded junction. According to another aspect, the overmolded junction is formed of an elastomeric material. According to another aspect, the strap connector assembly further includes a label formed into a surface of the overmolded junction.

[0050] According to at least one of the embodiments disclosed herein, a strap connector for connecting a first strap portion and a second strap portion is disclosed, the strap portions including a unitary plastic core positioned within a textile shell, the strap connector including a housing having a plurality of outer cavities disposed at end portions of the housing and configured to receive end portions of both the first strap portion and the second strap portion, an inner cavity positioned between the outer cavities, and an injection hole extending between the inner cavity and the outer cavities, wherein the unitary plastic cores of the strap portions extend through the injection hole. According to another aspect, a height of the outer cavities is greater than a height of the inner cavity. According to another aspect, the height of the inner cavity is equal to a thickness of the unitary plastic core within the textile shell.

[0051] According to at least one of the embodiments disclosed herein, a strap assembly for a headgear is disclosed, the strap assembly including a textile shell including an outer surface facing away from a 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 positioned within the cavity of the textile shell, wherein the outer surface of the textile shell has a convex shape. According to another aspect, the inner surface of the textile shell has a substantially flat shape. According to another aspect, the inner surface of the textile shell has a concave shape.

[0052] According to at least one of the embodiments disclosed herein, a strap assembly for a headgear is disclosed, the strap assembly including a textile shell including an ear arch region configured to be positioned over an ear of a user, and a plastic core positioned within a cavity of the tubular textile shell, wherein a distance between the plastic core and a textile shell edge is greater in the ear arch region than in a remaining portion of the strap assembly.

[0053] According to at least one of the embodiments disclosed herein, a headgear assembly is disclosed, comprising: a headgear loop configured to receive a top portion and a rear portion of a user's head, the headgear loop comprising: a unitary plastic core integrally formed with a textile shell, and a connector tab portion formed from the unitary plastic core and protruding through the textile shell between end portions of the headgear loop; a front strap; and a connector positioned over the connector tab portion of the headgear loop and one end portion of the front strap. According to another aspect, the connector is overmolded onto the end portions of both the headgear loop and the front strap. According to another aspect, a thickness of the connector is equal to a thickness of the connector tab portion. According to another aspect, the thickness of the connector is equal to a thickness of the headgear loop. According to another aspect, the headgear loop further comprises: an alignment tab extending from the end portions of the headgear loop, the alignment tab constituting a portion of the unitary plastic core of the headgear loop; and an alignment post protruding from a surface of the joining tab.

[0054] According to at least one of the embodiments disclosed herein, a headgear assembly is disclosed, comprising: a headgear loop configured to receive a top portion and a rear portion of a user's head, the headgear loop comprising: a unitary plastic core integrally formed with a textile shell, and a connector tab portion formed from the unitary plastic core and protruding through the textile shell between end portions of the headgear loop; a front strap; and a connector positioned over the connector tab portion of the headgear loop and one end portion of the front strap. According to another aspect, the connector is overmolded onto the end portions of both the headgear loop and the front strap. According to another aspect, a thickness of the connector is equal to a thickness of the connector tab portion. According to another aspect, the thickness of the connector is equal to a thickness of the headgear loop. According to another aspect, the headgear loop further comprises: an alignment tab extending from the end portions of the headgear loop, the alignment tab constituting a portion of the unitary plastic core of the headgear loop; and an alignment post protruding from a surface of the joining tab.

[0055] According to at least one of the embodiments disclosed herein, a binder connector assembly for connecting a first binder and a second binder within a molding tool is provided. The binders are formed from a unitary plastic core material injected into a tubular textile shell. The binder connector assembly includes a male connector portion positioned at one end portion of the first binder and a female connector portion positioned between end portions of the second binder and protruding through the tubular textile shell of the second binder. The female connector portion is configured to engage with the male connector portion such that the first binder and the second binder are connected. The male connector portion and the female connector portion are formed from the molten unitary plastic core material. According to another aspect, a thickness of the male connector portion is equal to a thickness of the female connector portion. According to another aspect, the binder connector assembly further includes a gap disposed between the male connector portion and the female connector portion. According to another aspect, the binder connector assembly further includes an alignment recess disposed on the male connector portion configured to engage a protrusion disposed on an inner surface of the molding tool to maintain a position of the male connector portion relative to the molding tool. According to another aspect, the binder connector assembly further includes an overmolded joint overmolded over the male connector portion and the female connector portion. According to another aspect, a thickness of the overmolded joint is equal to the thickness of the male connector portion and the thickness of the female connector portion. According to another aspect, the overmolded joint contacts the tubular textile shell of both the first binder and the second binder.

[0056] According to at least one of the embodiments disclosed herein, a binder connector assembly for connecting a first binder portion and a second binder portion within a molding tool is provided. The binder portions are formed from a unitary plastic core material injected into a tubular textile shell. The binder connector assembly includes a webbing portion formed from the unitary plastic core material and configured to connect end portions of both the first binder portion and the second binder portion, an alignment post protruding from a surface of the webbing portion, and an overmolded joint overmolded over the webbing portion. According to another aspect, a thickness of the alignment post is greater than a thickness of the webbing portion.

[0057] According to another aspect, the thickness of the alignment post is equal to a thickness of the overmolded joint.

[0058] According to another aspect, the overmolded joint is formed from an elastomeric material.

[0059] According to another aspect, the binder connector assembly further includes a label formed into a surface of the overmolded joint.

[0060] According to at least one of the embodiments disclosed herein, a strap connector for connecting a first strap portion and a second strap portion within a molding tool is provided. The strap portions are formed from a unitary plastic core material injected into a tubular textile shell. The strap connector includes outer cavities disposed at end portions of a housing and configured to receive end portions of both the first strap portion and the second strap portion, an inner cavity positioned between the outer cavities, and an injection hole in fluid communication with the inner cavity and the outer cavities and configured to receive the unitary plastic core material.

[0061] According to another aspect, a height of the outer cavities is greater than a height of the inner cavity.

[0062] According to another aspect, a height of the inner cavity is equal to a thickness of the unitary plastic core material within the tubular textile shell.

[0063] According to at least one of the embodiments disclosed herein, a strap assembly for a headgear is provided. The strap assembly includes a tubular textile shell including an outer surface facing away from a user and an inner surface facing toward the user, and a plastic core material positioned within a cavity of the tubular textile shell. The outer surface of the tubular textile shell has a convex shape.

[0064] According to another aspect, the inner surface of the textile tubular has a substantially flat shape.

[0065] According to another aspect, the inner surface of the textile tubular has a concave shape.

[0066] According to at least one of the embodiments disclosed herein, a headgear assembly is provided. The headgear assembly includes a headgear looped strap configured to receive a top portion and a back portion of a user's head. The headgear looped strap includes a unitary plastic core material integrally formed within a textile shell of the headgear looped strap, and a connector tab portion positioned to be formed from the unitary plastic core material and protruding through the tubular textile shell of the headgear looped strap between end portions of the headgear looped strap. The headgear assembly further includes a front strap and a connector positioned over the connector tab portion of the headgear looped strap and one end portion of the front strap.

[0067] According to another aspect, the connector is overmolded onto the end portions of both the headgear looped strap and the front strap.

[0068] According to another aspect, a thickness of the connector is equal to a thickness of the connector tab portion.

[0069] According to another aspect, a thickness of the connector is equal to a thickness of the headgear looped strap.

[0070] According to another aspect, the headgear looped strap further comprises an alignment tab extending from an end portion of the headgear looped strap, the alignment tab being formed from the unitary plastic core material, an alignment post protruding from a surface of the joining tab, and an overmolded junction overmolded over the alignment tab and configured to connect the end portions of the headgear looped strap.

[0071] According to at least one of the embodiments disclosed herein, a strap connector assembly for connecting first and second strap portions within a molding tool is provided. The strap portions are formed from a unitary plastic core material injected into a tubular textile shell. The strap connector assembly comprises a first connector portion positioned at one end portion of the first strap, a second connector portion positioned between end portions of the second strap and protruding through the tubular textile shell of the second strap, and an overmolded junction overmolded over the first and second connector portions.

[0072] According to another aspect, at least one of the first and second connector portions further comprises an alignment post protruding from a surface of the first strap, wherein the overmolded junction surrounds the alignment post.

[0073] According to another aspect, at least one of the first and second connector portions further comprises a countersunk region recessed within a surface of the first strap, wherein the countersunk region receives overmolded material of the overmolded junction.

[0074] According to another aspect, the strap connector assembly further comprises an alignment recess recessed into a surface of at least one of the first and second straps, wherein the alignment recess is configured to engage a protrusion disposed on an inner surface of the molding tool to maintain a position of at least one of the first and second straps relative to the molding tool.

[0075] In some configurations, a headgear assembly for a patient interface includes a headgear and at least one connector. The headgear includes 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 a mask assembly over and behind an ear of a user. The second strap is configured to extend from the mask assembly under and behind the ear of the user. The first strap meets the second strap at a rear connector portion. The connector includes at least one headgear connection surface configured to connect to the headgear. The headgear includes at least one connector connection surface configured to connect to the at least one headgear connection surface of the connector.

[0076] In some configurations, one or more of the top strap, rear strap, and front strap of the headgear includes separate left and right portions, each having a free end. The free ends of both the left and right portions are adjustably connected to each other.

[0077] In some configurations, the top strap and front strap converge at a junction.

[0078] In some configurations, the junction forms part of a periauricular loop.

[0079] In some configurations, the rear strap forms part of a periauricular loop.

[0080] In some configurations, the periauricular loop is configured to surround the user's ear, but not contact the ear.

[0081] In some configurations, the at least one connector connection surface is configured to connect to the at least one headgear connection surface along a C-shaped connection area that extends from above the user's ear to below the ear.

[0082] In some configurations, the at least one connector connection surface is configured to connect to the at least one headgear connection surface along a connection line that extends from behind the user's ear to above the ear, wherein the entire connection line is configured to be above the lowest extent of the user's ear.

[0083] In some configurations, the patient interface includes a mask assembly and a headgear assembly as described above.

[0084] In some configurations, a headgear assembly for a patient interface includes a headgear and at least one connector. The headgear includes a top strap, a front strap, and a rear strap. The connector includes a mid strap and a lower strap. The mid strap is configured to extend from the mask assembly above and behind the user's ear. The lower strap is configured to extend from the mask assembly below and behind the user's ear. The mid strap meets the lower strap at a rear connector portion. The connector includes at least one headgear connection surface configured to connect to the headgear. The headgear includes at least one connector connection surface configured to connect to the connector.

[0085] 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 connecting the headgear assembly to the mask assembly. The headgear assembly, mask assembly, and connector portion form a closed loop when the connector is disengaged from the mask assembly.

[0086] According to another aspect, the effective length of the closed loop when the connector portion is disengaged from the mask assembly is increased compared to the effective length of the closed loop when the connector portion is engaged with the mask assembly.

[0087] According to another aspect, the connector portion is attached to the mask assembly by a hinge portion.

[0088] According to another aspect, the connector portion is attached to the mask assembly by a tether.

[0089] According to another aspect, the hinge portion is a living hinge.

[0090] According to another aspect, the hinge portion is formed from silicone.

[0091] According to another aspect, the living hinge is formed from fabric.

[0092] According to another aspect, the patient interface further comprises a hook provided on the mask assembly, and a post provided on the connector portion. The post receives the hook so as to engage with the mask assembly.

[0093] According to another aspect, the connector portion engages with the mask assembly via a snap fit or an interference fit.

[0094] According to another aspect, the headgear assembly has a strap formed from a textile shell having a unitary plastic core material integrally formed therein.

[0095] According to another aspect, the difference between the effective length of the closed loop when the connector portion is disengaged 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 40mm.

[0096] Further aspects of one or more embodiments of the present application should be considered in all its novel aspects, which will become apparent in light of the following description. BRIEF DESCRIPTION OF DRAWINGS

[0097] Throughout the drawings, reference numerals can be repeated among the figures to indicate a general correspondence between components in reference elements. The drawings are provided to illustrate exemplary embodiments described herein and are not intended to limit the scope of the present disclosure.

[0098] FIG. 1A A side view of a bifurcated headgear arrangement formed from a burst-through intra-moulding arrangement of the present disclosure is shown.

[0099] FIG. 1B A top perspective view of a bifurcated headgear arrangement of the present disclosure is shown.

[0100] FIG. 2AA close-up side view of the connection between the top strap and the bottom strap of the bifurcated head strap arrangement of the present disclosure is shown.

[0101] FIG. 2B A close-up side view of the connection between the top strap and the bottom strap of the bifurcated head strap arrangement of the present disclosure is shown.

[0102] FIG. 3 A cross-sectional view of the connection between the top strap and the bottom strap of the bifurcated head strap arrangement of the present disclosure is shown.

[0103] FIG. 4 A perspective view of an injection molding tool for forming the bifurcated head strap arrangement of the present disclosure is shown.

[0104] FIG. 5 A top-down view of a second tool half of an injection molding tool is shown.

[0105] FIG. 6 A close-up top perspective view of a top strap and a bottom strap positioned within a second tool half of an injection molding tool is shown.

[0106] FIG. 7 A cross-sectional bottom view of a fully formed bifurcated head strap portion is shown.

[0107] FIG. 8A A perspective view of a second tool half of an alternative internal molded strap cavity arrangement for forming X-shaped connections and T-shaped connections is shown.

[0108] FIG. 8B A top-down view of a strap arrangement having X-shaped connections and T-shaped connections is shown.

[0109] FIG. 9A A top-down view of an alternative internal molded strap arrangement having a plurality of straps joined together by integrally formed connection members positioned between the straps is shown.

[0110] FIG. 9B A top-down view of an alternative internal molded strap arrangement having a plurality of straps joined together by integrally formed web portions positioned between the straps is shown.

[0111] FIG. 10A A top-down view of an alternative internal molded strap arrangement having a chamfered connection connecting a chamfered strap to an abutting strap is shown.

[0112] FIG. 10B A top perspective view of an injection molding tool for forming a chamfered connection is shown.

[0113] FIG. 11AA top-down view of an internal molded strap arrangement is shown, the arrangement having a molded square texture imprinted into the strap.

[0114] FIG. 11B A close-up top-down view of a molded square texture imprinted into the strap is shown.

[0115] FIG. 11C A cross-sectional view of the molded square texture imprinted into the strap along line 11C-11C in FIG. 11B is shown.

[0116] FIG. 11D A top-down view of an internal molded strap arrangement is shown, the arrangement having a molded hexagonal texture imprinted into the strap.

[0117] FIG. 11E A side perspective view of a molded hexagonal texture imprinted into the strap is shown.

[0118] FIG. 12A A top-down view of a first molding tool for forming a bottom strap of an internal molded bifurcated headband is shown, the bottom strap having an attachment member.

[0119] FIG. 12B A close-up top-down view of the first molding tool is shown, illustrating the bottom strap and the attachment member.

[0120] FIG. 13A A top-down view of a second molding tool for forming a top strap over the attachment member is shown.

[0121] FIG. 13B A close-up top-down view of the second molding tool is shown, illustrating the top strap attached to the bottom strap.

[0122] FIG. 13C A close-up cross-sectional view of the top strap positioned over the attachment member prior to injection of a plastic core material into the top strap is shown.

[0123] FIG. 13D A close-up cross-sectional view of the top strap attached to the attachment member after injection of a plastic core material into the top strap is shown.

[0124] FIG. 14A A close-up side view of the top strap is shown, the top strap having a sealed end at a junction with the bottom strap.

[0125] FIG. 14B A close-up side view of the top strap having a sealed end is shown.

[0126] FIG. 14CA close-up side view of a top strap is shown with a sealed end attached to a bottom strap at a connection.

[0127] FIG. 14D A cross-sectional view of a connection between a top strap and a bottom strap is shown.

[0128] FIG. 15A A close-up cross-sectional side view of a top strap attached to a bottom strap is shown with a filament core incorporated into the bottom strap that is engaged with a conversion lock arrangement.

[0129] FIG. 15B A top-down view of a split head strap portion is shown with a bottom strap incorporating a filament core.

[0130] FIG. 15C A top-down view is shown with a stretched length of an outer shell of a bottom strap.

[0131] FIG. 15D A top-down view is shown with an outer shell of a bottom strap narrowing as it is stretched.

[0132] FIG. 16A A side perspective view of an alternative split head strap arrangement with a button and hole size adjustment system is shown formed by a breakthrough internal molding device of the present disclosure.

[0133] FIG. 16B A cross-sectional view of a top strap and a bottom strap with a button and hole size adjustment system is shown.

[0134] FIG. 16C A side perspective view of an injection molding tool for forming a button of a button and hole size adjustment system.

[0135] FIG. 16D A cross-sectional view of a first half and a second half of a molding tool during a breakthrough internal molding process of a button of a button and hole size adjustment system is shown.

[0136] FIG. 17 An adjustable strap arrangement is shown with adjustment features and usability features formed by a breakthrough internal molding process.

[0137] FIG. 18 An internally molded head strap is shown with multiple straps and multiple breakthrough connections.

[0138] FIG. 19 An example head strap is shown incorporating an internal molding process and a breakthrough process, as well as an additional comfort layer.

[0139] FIG. 20Another exemplary headgear incorporating an internal molding process and a breakthrough process, and an additional comfort layer is shown.

[0140] FIG. 21 An exemplary headgear incorporating an internal molding process and a breakthrough process, and having a web portion joining rear portions of both the lower strap and the middle strap is shown.

[0141] FIG. 22 Another exemplary headgear incorporating an internal molding process and a breakthrough process, and having a continuous lower strap is shown.

[0142] FIG. 23 An exemplary headgear incorporating an internal molding process and a breakthrough process, and having a web portion joining rear portions of both the lower strap and the middle strap is shown.

[0143] FIG. 24 An exemplary headgear incorporating an internal molding process and a breakthrough process, and having a continuous lower strap and a combined continuous middle vertical strap is shown.

[0144] FIG. 25 An exemplary headgear incorporating an internal molding process and a breakthrough process, and having a lower strap and a middle strap in the form of a closed loop structure formed by a continuous shell is shown.

[0145] FIG. 26 Another exemplary headgear incorporating an internal molding process and a breakthrough process, and having a lower strap and a middle strap in the form of a closed loop structure formed by a continuous shell is shown.

[0146] FIG. 27 An exemplary headgear incorporating an internal molding process and a breakthrough process, and having quilted fabric or material attached to portions of the headgear and in direct contact with the skin or hair of the user is shown.

[0147] FIG. 28 Another exemplary headgear incorporating an internal molding process and a breakthrough process, and having quilted fabric or material attached to portions of the headgear and in direct contact with the skin or hair of the user is shown.

[0148] FIG. 29 An exemplary headgear incorporating an internal molding process and a breakthrough process, and having vertical straps and neck straps formed from a foam-Lycra laminate is shown.

[0149] FIG. 30 An exemplary headgear incorporating an internal molding process and a breakthrough process, and having breathable, moisture-wicking material on the vertical straps and neck straps is shown.

[0150] FIG. 31 An exemplary headgear is shown that incorporates an internal molding process and a breakthrough process and has a lower strap and a mid strap in the form of a closed loop structure formed by a continuous shell.

[0151] FIG. 32 An exemplary headgear is shown that incorporates an internal molding process and a breakthrough process and has a lower strap, a mid strap, and a front vertical strap in the form of a closed loop structure formed by a continuous shell.

[0152] FIG. 33 An exemplary headgear is shown that incorporates an internal molding process and a breakthrough process and has a lower strap and a mid strap in the form of a closed loop structure formed by a continuous shell.

[0153] FIG. 34 An exemplary headgear is shown that incorporates an internal molding process and a breakthrough process and has a lower strap and a mid strap in the form of a closed loop structure formed by a continuous shell.

[0154] FIG. 35 An exemplary headgear is shown that incorporates an internal molding process and a breakthrough process and has a lower strap and a mid strap with a continuous shell.

[0155] FIG. 36 An exemplary headgear is shown that incorporates an internal molding process and a breakthrough process and has a lower strap and a mid strap in the form of a closed loop structure formed by a continuous shell.

[0156] FIG. 37 An exemplary headgear is shown that incorporates an internal molding process and a breakthrough process and has a lower strap and a mid strap in the form of a closed loop structure formed by a continuous shell.

[0157] FIG. 38 An exemplary headgear is shown that incorporates an internal molding process and a breakthrough process and has a lower strap and a mid strap in the form of a closed loop structure formed by a continuous shell.

[0158] FIG. 39 An exemplary headgear is shown that incorporates an internal molding process and a breakthrough process and has a lower strap and a mid strap in the form of a closed loop structure formed by a continuous shell.

[0159] FIG. 40 An exemplary headgear is shown that incorporates an internal molding process and a breakthrough process and has a lower strap, a mid strap, and a vertical strap in the form of a closed loop structure formed by a continuous shell.

[0160] FIG. 41An exemplary headgear is shown that combines an internal molding process and a breakthrough process and has lower straps, middle straps, and vertical straps formed from a continuous shell.

[0161] FIG. 42 An exemplary headgear is shown that combines an internal molding process and a breakthrough process and has lower straps and middle straps formed from a continuous shell.

[0162] FIG. 43A is a front perspective view of an exemplary headgear that can be used with a patient interface.

[0163] FIG. 43B is a front perspective view of an exemplary headgear that can be used with a patient interface. FIG. 43A is a rear perspective view of the exemplary headgear in

[0164] FIG. 44A is a front perspective view of an exemplary headgear that can be used with a patient interface.

[0165] FIG. 44B is a front perspective view of an exemplary headgear that can be used with a patient interface. FIG. 44A is a rear perspective view of the exemplary headgear in

[0166] FIG. 45A is a front perspective view of an exemplary headgear that can be used with a patient interface.

[0167] FIG. 45B is a front perspective view of an exemplary headgear that can be used with a patient interface. FIG. 45A is a rear perspective view of the exemplary headgear in

[0168] FIG. 46A is a front perspective view of an exemplary headgear that can be used with a patient interface.

[0169] FIG. 46B is a front perspective view of an exemplary headgear that can be used with a patient interface. FIG. 46A is a side view of the exemplary headgear in

[0170] FIG. 46C is a rear perspective view of the exemplary headgear in FIG. 46A

[0171] is a front perspective view of an exemplary headgear that can be used with a patient interface. FIG. 47A

[0172] is a front perspective view of an exemplary headgear that can be used with a patient interface. FIG. 47B FIG. 47A is a front perspective view of an exemplary headgear that can be used with a patient interface.

[0173] FIG. 48A is a front perspective view of an exemplary headgear that can be used with a patient interface.

[0174] FIG. 48B FIG. 48A is a rear perspective view of the exemplary headgear in​​

[0175] FIG. 49A is a front perspective view of an example headgear that can be used with a patient interface.

[0176] FIG. 49B is a back perspective view of the example headgear in FIG. 49A

[0177] FIG. 50A is a front perspective view of an example headgear that can be used with a patient interface.

[0178] FIG. 50B is a back perspective view of the example headgear in FIG. 50A

[0179] FIG. 51A is a side view of an example headgear that can be used with a patient interface.

[0180] FIG. 51B is a cross-sectional view of a strap portion of the example headgear in FIG. 51A

[0181] FIG. 52A is a side view of an example headgear that can be used with a patient interface.

[0182] FIG. 52B is a cross-sectional view of a strap portion of the example headgear in FIG. 52A

[0183] FIG. 52C is a cross-sectional view of a strap portion of the example headgear in FIG. 52A

[0184] FIG. 53A is a side view of an example headgear that can be used with a patient interface.

[0185] FIG. 53B is a cross-sectional view of a strap portion of the example headgear in FIG. 53A

[0186] FIG. 54A is a side view of an example headgear that can be used with a patient interface and has a lower strap and a middle strap formed from a continuous shell.

[0187] FIG. 54B is a close-up view of a fibrous web portion of the example headgear in FIG. 54A

[0188] is a cross-sectional view of the fibrous web portion along line 54C-54C in FIG. 54C FIG. 54B

[0189] ​​​​​​​​FIG. 55A is a side view of an example headgear that can be used with a patient interface, and has a lower strap and a combined continuous mid-section vertical strap.

[0190] FIG. 55B is a cross-sectional view of the fiber web portion of the example headgear along line 55B-55B in FIG. 55A

[0191] FIG. 55C is a close-up view of the connection portion of the example headgear in FIG. 55A

[0192] FIG. 56A is a side view of an example headgear that can be used with a patient interface, and has a lower strap and a mid-section strap in the form of a closed loop structure formed by a continuous shell.

[0193] FIG. 56B is a close-up view of the connection portion of the example headgear in FIG. 56A

[0194] FIG. 57A is a side view of an example headgear that can be used with a patient interface, and has a lower strap and a mid-section strap formed by a continuous shell.

[0195] FIG. 57B is a close-up view of the second vertical member of the example headgear in FIG. 57A

[0196] FIG. 57C is a cross-sectional view of the second vertical member along line 57C-57C in FIG. 57B

[0197] FIG. 58A is a side view of an example headgear that can be used with a patient interface.

[0198] FIG. 58B is a close-up view of the connection portion of the example headgear in FIG. 58A

[0199] FIG. 59A is a side view of an example headgear that can be used with a patient interface, and has a continuous mid-section vertical strap and a continuous upper rear strap.

[0200] FIG. 59B is a close-up view of the continuous mid-section vertical strap and the continuous upper rear strap of the example headgear in FIG. 59A

[0201] FIG. 59C is a cross-sectional view of the continuous mid-section vertical strap and the continuous upper rear strap along line 55B-55B in FIG. 59A ​​​​​​​and FIG. 59B cross-sectional view along line 59C-59C in FIG. 59.

[0202] FIG. 60A is a side view of an example headgear that can be used with a patient interface.

[0203] FIG. 60B is a close-up view of a rear strap of the example headgear in FIG. 60A

[0204] FIG. 61A is a side view of an example headgear that can be used with a patient interface, and has a continuous mid vertical strap and a continuous upper rear strap.

[0205] FIG. 61B is a close-up view of a rear section of the mid strap and lower strap of the example headgear in FIG. 61A

[0206] FIG. 61C is a cross-sectional view along line 61C-61C in FIG. 61. FIG. 61B

[0207] FIG. 62A is a side view of an example headgear that can be used with a patient interface.

[0208] FIG. 62B is a close-up view of a variation of the example headgear of FIG. 62A

[0209] FIG. 63A is a side view of an example headgear that can be used with a patient interface, and has quilted fabric or material provided attached to portions of the headgear and in direct contact with the skin or hair of the user.

[0210] FIG. 63B is a close-up view of the quilted fabric of the example headgear in FIG. 63A

[0211] is a close-up view of an alternative web portion material of the example headgear in FIG. 63C FIG. 63A is a side view of an example headgear that can be used with a patient interface, and has fabric or textile material provided attached to portions of the headgear and in direct contact with the skin or hair of the user.

[0212] FIG. 64A is a close-up view of the fabric or textile material of the example headgear in

[0213] FIG. 64B FIG. 64A is a close-up view of the fabric or textile material of the example headgear in​​​​​​

[0214] FIG. 65 is a close-up view of a trademarked grip that can be used with one embodiment of the disclosed headgear.

[0215] FIG. 66A is a side view of a T-connection between an end of a first strap and a central portion (or intermediate portion) of a second strap.

[0216] FIG. 66B is a close-up view of a connector used to form the T-connection in FIG. 66A

[0217] FIG. 67 is a perspective view of the T-connection.

[0218] FIG. 68A is a bottom view of the connector.

[0219] FIG. 68B is a side view of the connector.

[0220] FIG. 68C is a top view of the connector.

[0221] FIG. 68D is a perspective view of the connector.

[0222] FIG. 69 is a side view of the T-connection showing the connector positioned over the first strap such that the end of the first strap is positioned inside the connector.

[0223] FIG. 70 is a perspective view of the connector and the T-connection.

[0224] FIG. 71 is a close-up side view of the filled connector and the T-connection.

[0225] FIG. 72 is a cross-sectional view of the filled connector and the T-connection.

[0226] FIG. 73 is a side view of the filled connector and the T-connection.

[0227] FIG. 74A shows a top view of a top strap of an example headgear arrangement having a male connector for forming an overmolded joint.

[0228] FIG. 74B shows a top view of a bottom strap of such an example headgear arrangement having a female connector for forming an overmolded joint.

[0229] FIG. 75A ​A close-up top view of the male connector of the top strap is shown.

[0230] FIG. 75B A close-up cross-sectional view of the male connector of the top strap is shown.

[0231] FIG. 76A A close-up top view of the female connector of the bottom strap is shown.

[0232] FIG. 76B A close-up cross-sectional view of the female connector of the bottom strap is shown.

[0233] FIG. 76C A close-up perspective view of the female connector of the bottom strap is shown.

[0234] FIG. 77A A close-up top view of the aligned male and female connectors is shown.

[0235] FIG. 77B A close-up top view of the male connector inserted into and received by the female connector is shown.

[0236] FIG. 77C A close-up cross-sectional view of the male connector inserted into and received by the female connector is shown.

[0237] FIG. 78A A close-up side view of the male and female connectors is shown, with a small gap between the male and female connectors shown.

[0238] FIG. 78B A close-up side view of the male and female connectors is shown, with a large gap between the male and female connectors shown.

[0239] FIG. 79A A close-up top view of the male connector is shown.

[0240] FIG. 79B A perspective view of the overmolding cavity of the overmolding tool is shown.

[0241] FIG. 79C A cross-sectional view of the male connector inserted into the overmolding cavity of the overmolding tool is shown.

[0242] FIG. 80A A close-up top view of the overmolded joint incorporating the top strap and the bottom strap is shown.

[0243] FIG. 80B A perspective view of the overmolded joint incorporating the top strap and the bottom strap is shown.

[0244] FIG. 80CA cross-sectional bottom view of an overmolded junction incorporating a top strap and a bottom strap is shown.

[0245] FIG. 81A A close-up top view of the joining tabs and alignment posts before overmolding to join the two halves of the bottom strap is shown.

[0246] FIG. 81B A close-up bottom view of the joining tabs and alignment posts in FIG. 81A is shown.

[0247] FIG. 81C A close-up cross-sectional view of the joining tabs and alignment posts in FIG. 81A is shown.

[0248] FIG. 81D A close-up top view of the overmold formed over the joining tabs and alignment posts in FIG. 81A is shown.

[0249] FIG. 81E A close-up bottom view of the overmold in FIG. 81D is shown.

[0250] FIG. 82A A side view of a strap end junction housing is shown.

[0251] FIG. 82B A perspective view of the strap end junction housing in FIG. 82A is shown.

[0252] FIG. 83A A top view of the strap end junction housing in FIG. 82A is shown.

[0253] FIG. 83B A side view of the strap end junction housing in FIG. 82A is shown.

[0254] FIG. 83C An end view of the strap end junction housing in FIG. 82A is shown.

[0255] FIG. 83D A side cross-sectional view of a strap end junction housing along line 83D-83D in FIG. 83A is shown.

[0256] FIG. 83E An end cross-sectional view of a strap end junction housing along line 83E-83E in FIG. 83B is shown.

[0257] FIG. 84A A side cross-sectional view of a strap having a D-shaped cross-section with a flange portion formed along its edge is shown.

[0258] FIG. 84B A side cross-sectional view of a strap having a D-shaped cross-section is shown, the strap not having a flange portion formed along its edge.

[0259] FIG. 85 A top view of a strap is shown, the strap having a bottom strap with a soft edge positioned over a user's ear.

[0260] FIG. 86 A side view of a bifurcated headgear arrangement with a rear headgear loop strap formed by a breakthrough internal molding device is shown.

[0261] FIG. 87A A top view of a rear headgear loop strap in FIG. 86 is shown.

[0262] FIG. 87B A close-up top view of a breakthrough tab of a rear headgear loop strap in FIG. 86 is shown.

[0263] FIG. 87C A close-up top view of an alignment tab of a rear headgear loop strap in FIG. 86 is shown.

[0264] FIG. 88A A top view of an alignment tab of a rear headgear loop strap in FIG. 86 is shown.

[0265] FIG. 88B A close-up cross-sectional view of an alignment tab of a rear headgear loop strap along line 88B-88B in FIG. 87C is shown.

[0266] FIG. 89A A top view of an overmolded junction incorporating a rear headgear loop strap to a front strap is shown.

[0267] FIG. 89B A close-up cross-sectional view of an overmolded junction along line 89B-89B in FIG. 89A is shown.

[0268] FIG. 90A A perspective view of a top strap with an alignment post and a press-in recess is shown.

[0269] FIG. 90B A bottom view of a top strap in FIG. 90A is shown.

[0270] FIG. 90C A top view of a bottom strap with an alignment post and a press-in recess is shown.

[0271] FIG. 90D A top view of the bottom strap in FIG. 90C with an alignment post, post hole, and a press-in recess.

[0272] FIG. 91A A perspective view of the top strap in FIG. 90A aligned with the bottom strap in FIG. 90C .

[0273] FIG. 91B A bottom view of the top strap in FIG. 90A aligned with the bottom strap in FIG. 90C .

[0274] FIG. 91C A perspective view of the top strap in FIG. 90A aligned with the bottom strap in FIG. 90C .

[0275] FIG. 91D A perspective cross-sectional view of the top strap in FIG. 90A aligned with the bottom strap in FIG. 90C .

[0276] FIG. 92A A bottom view of an overmolded joint that joins the top strap in FIG. 90A with the bottom strap in FIG. 90C .

[0277] FIG. 92B A top view of the overmolded joint in FIG. 92A .

[0278] FIG. 92C A perspective cross-sectional view of the overmolded joint in FIG. 92A .

[0279] FIG. 92D A perspective cross-sectional view of an overmolded connector.

[0280] FIG. 93A is a perspective view of a patient interface having a headgear assembly and a mask assembly in accordance with non-limiting example embodiments of the present disclosure. The headgear assembly includes a headpiece and one or more connectors between the headpiece and the mask assembly.

[0281] FIG. 93B is a perspective view of the patient interface of FIG. 93A with the connectors disconnected from the headpiece.

[0282] FIG. 93C is a back perspective view of the patient interface of FIG. 93A .

[0283] FIG. 94AThis is a perspective view of another non-limiting exemplary embodiment of a patient interface having a headband assembly and a face mask assembly according to this disclosure. The headband assembly includes a headpiece and one or more connectors located between the headpiece and the face mask assembly.

[0284] FIG. 94B yes FIG. 94A A perspective view of the patient interface, in which the connector is disconnected from the headgear.

[0285] FIG. 94C yes FIG. 94A The back perspective view of the patient interface.

[0286] FIG. 95 An isometric view of the patient interface disclosed herein is shown, which includes a headband, a face mask assembly, and a connector.

[0287] FIG. 96 It shows FIG. 95 The rear isometric view of the patient interface.

[0288] FIG. 97 An isometric view of the patient interface is shown, illustrating the connector disengaging from the mask assembly.

[0289] FIG. 98 It shows FIG. 97 An isometric view of the patient interface, showing the connector fully extended away from the mask assembly.

[0290] FIG. 99A An isometric view of the movable hinge connector is shown.

[0291] FIG. 99B An isometric view of an alternative active hinge connector is shown.

[0292] FIG. 100 A top view of an active hinge connector with multiple segments having reduced thickness is shown.

[0293] Figure 101A An isometric exploded view of the active hinge connector is shown.

[0294] Figure 101B It shows Figure 101A Cross-sectional view of the headband connector component and the face shield connector component of the active hinge connector.

[0295] Figure 102A An isometric view of an active hinge connector with a single mask hinge and a single connector hinge is shown.

[0296] Figure 102B It shows Figure 102A Top cross-sectional view of the headband connector component and face shield connector component of the active hinge connector.

[0297] Figure 103A An isometric view of a patient interface with a movable hinge connector having a hook and post retention system is shown.

[0298] Figure 103B It is shown in the open position. Figure 103A The front view of the movable hinge connector shown.

[0299] Figure 104A An isometric view of a patient interface with a fabric movable hinge connector in the closed position is shown.

[0300] Figure 104B It shows Figure 104A An isometric view of the patient interface, showing the fabric active hinge connector in the open position.

[0301] Figure 105A An isometric view of a patient interface with a silicon hinge connector in the closed position is shown.

[0302] Figure 105B It shows Figure 105A An isometric view of the patient interface, showing the silicon hinge connector in the open position.

[0303] Figure 106A A top-down view of an alternative silicon hinge is shown, with the connector in the closed position.

[0304] Figure 106B It shows Figure 106A A top-down view of a silicon hinge with the connector in the open position.

[0305] Figure 107A An isometric view of a patient interface with an alternative silicon hinge connector in the closed position is shown.

[0306] Figure 107B It is shown in the open position. Figure 107A Isometric view of the silicon hinge connector shown.

[0307] Figure 108A An isometric view of the patient interface is shown, in which the headband connection of this disclosure is illustrated.

[0308] Figure 108B It shows Figure 108A A close-up perspective view of the side end of the connector for the headband connection.

[0309] Figure 108C It shows Figure 108A A cross-sectional view of the connector for the headband connection.

[0310] Figure 109A An isometric view of the headband fixing mechanism is shown.

[0311] Figure 109B A top view of the alternative headband securing mechanism is shown.

[0312] Figure 110A An isometric view of the push-in headband fixing mechanism is shown.

[0313] Figure 110B A cross-sectional view of the push-in headband fixing mechanism is shown.

[0314] Figure 111A An isometric view of a patient interface with a connector featuring a top-centered clamp design in the closed position is shown.

[0315] Figure 111B It shows Figure 111A An isometric view of the patient interface, showing the upper centered clamp design connector in the open position.

[0316] Figure 112A An isometric view of a patient interface with an extendable pivot connector in the closed position is shown.

[0317] Figure 112B It shows Figure 112A An isometric view of the patient interface, showing the extendable pivot connector in the open position.

[0318] Figure 112C It shows Figure 112A An isometric view of the patient interface, showing the extendable pivot connector in both open and extended positions.

[0319] Figure 113A An isometric view of a patient interface with a hard-stop sliding strap connector is shown, in the closed position.

[0320] Figure 113B It shows Figure 113A An isometric view of the patient interface, showing the hard-stop sliding strap connector in the open position.

[0321] Figure 114A An isometric view of a patient interface with a strap-end hardstop connector is shown in the closed position.

[0322] Figure 114B It shows Figure 114A An isometric view of the patient interface, showing the hard-stop connector at the end of the strap in the open position.

[0323] Figure 115A An isometric view of a patient interface with breakaway mating magnets and tether connectors is shown, the connectors in a closed position.

[0324] Figure 115B An isometric view of a patient interface of Figure 115A is shown, the breakaway mating magnets and tether connectors shown in an open position.

[0325] Figure 116A An isometric view of a patient interface with breakaway mating clips and tether connectors is shown, the connectors in a closed position.

[0326] Figure 116B An isometric view of a patient interface of Figure 116A is shown, the breakaway mating clips and tether connectors shown in an open position.

[0327] Figure 117A An isometric view of a patient interface with clips and continuous tether connectors is shown, the connectors in a closed position.

[0328] Figure 117B An isometric view of a patient interface of Figure 117A is shown, the clips and continuous tether connectors shown in an open position.

[0329] Figure 118A An isometric view of a patient interface with dual clips and continuous tether connectors is shown, the connectors in a closed position.

[0330] Figure 118B An isometric view of a patient interface of Figure 118A is shown, the dual clips and continuous tether connectors shown in a closed position.

[0331] Figure 119A An isometric view of a patient interface with clips and rigid tether connectors is shown, the connectors in a closed position.

[0332] Figure 119B An isometric view of a patient interface of Figure 119A is shown, the clips and rigid tether connectors shown in an open position.

[0333] Figure 120A An isometric view of a patient interface with hooks and post loop connectors is shown, the connectors in a closed position.

[0334] Figure 120B An isometric view of a patient interface of Figure 120A is shown, the hooks and post loop connectors shown in an open position.

[0335] Figure 121A An isometric view of a patient interface is shown with an alternative hook and post ring connector in a closed position.

[0336] Figure 121B An isometric view of a patient interface is shown with an alternative hook and post ring connector in a closed position. Figure 121A An isometric view of a patient interface is shown with an alternative hook and post ring connector in a closed position. DETAILED DESCRIPTION

[0337] Embodiments of systems, components, and assembly and manufacturing methods will now be described with reference to the drawings, wherein like reference numerals refer to like or similar elements throughout. While several embodiments, examples, and illustrations are disclosed throughout, it will be understood that the present application extends beyond the specifically disclosed embodiments, examples, and illustrations to other alternate embodiments, examples, and illustrations not expressly disclosed. Those skilled in the art will recognize that the present application extends beyond the specifically disclosed embodiments, examples, and illustrations to other alternate embodiments, examples, and illustrations not expressly disclosed herein. The description set forth herein is not intended to be simply a description of various embodiments of the application, and should not be interpreted as limiting the scope of the application to the specific embodiments described in the specification. The description is intended solely to be illustrative of the present application, and is not intended to be limiting beyond the scope of the appended claims to the specific embodiments described in the specification.

[0338] Certain terminology can be used in the following description for the purpose of reference only, and, thus, is not intended to be limiting. For example, terms such as "above" and "below" refer to directions in the drawings to which reference is made. Terms such as "front," "back," "left," "right," "rear," and "side" describe the orientation and / or position of portions of the component or element with respect to one another and / or to an arbitrary reference frame of the device under discussion. The terms "first," "second," "third," etc. can be used to describe separate components. Such terminology can include the words specifically mentioned above, derivatives thereof, and words of similar import.

[0339] As used herein, the term "substantially inelastic" shall mean the ability of a headgear or material to resist stretching relative to the load it can bear. Thus, a headgear or material can be substantially inelastic in one direction, while somewhat elastic in another direction. In some configurations, a headgear or material is configured to be substantially inelastic in the direction of the load applied by a therapy, which is the therapy for which the headgear or material is intended. A substantially inelastic headgear or material may, for example, resist stretching that would compromise the seal of a respiratory mask in a sealing system under normal or expected conditions. In a non-sealing system, a substantially inelastic headgear or material may, for example, resist stretching that would compromise the proper layout of a respiratory interface in response to normal or expected conditions, such as hose pull or movement of the user. When the expected loading forces are relatively small, the headgear or material can have greater elasticity, as the load will not be sufficient to cause stretching. Conversely, if it is expected that the headgear and / or material will bear high loading forces, then greater inelasticity will be required to resist stretching.

[0340] Throughout this specification, reference is made to "breakthrough" molding, methods, techniques, and components made by such molding, methods, and techniques. Reference is also made to "breakthrough internal molding" and "internal molding breakthrough." It should be recognized that all such references are general references to embodiments of the present disclosure and are not intended to be limiting in any explicit manner.

[0341] headband

[0342] Figure 1A Non-limiting exemplary embodiments of the internal molded bifurcated headgear 100 of the present disclosure are shown in use in conjunction with a respiratory device 110. "Internal molding" includes forming a component as a plastic core and a textile shell as an overall structure by applying molten plastic into the textile shell. The straps or any other component that has been "internal molded" is a component that is formed by applying molten plastic into the textile shell.

[0343] Figure 1A And Figure 1B The bifurcated headgear 100 is shown configured to be substantially inelastic and structurally three-dimensional (3D). The bifurcated headgear design is superior to a single strap design because the bifurcated headgear design has improved stability on the patient's head due to the headgear being supported in multiple locations on the user's head. As used herein, a three-dimensional structure is a structure that does not lie in a single plane, but is shaped to extend in multiple planes. In other words, a three-dimensional structure is not flat. The headgear 100 shown includes 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.

[0344] The top strap 140 has an elongated shape and includes a top strap lateral end portion 142 and a top strap central end portion 144. The top strap 140 is configured to extend upwardly from the lateral end portion 142 at a location generally over each of the user’s ears and on the user’s parietal or frontal region of the head, and then terminate at the top strap central end portion 144. The top strap central end portion 144 is configured to be positioned at or near a central point or location on the top of the user’s head. The top strap central end portions 144 of the right side 120 and the left side 130 are configured to be joined together at a location on the top of the user’s head by a top juncture 190. The top juncture 190 can include a stitching, welding, bonding, overmolding, or any other fastening arrangement, which can be permanent or removable / disconnectable. In some arrangements, the top juncture 190 can include an adjustment mechanism (not shown), such as a hook-and-loop fastener, a snap-fit connector, or the like, to allow for variation in the combined length of the top strap 140 to accommodate different sizes of the user’s head. Each top strap lateral end portion 142 is configured to be integrally formed with the bottom strap 150 at a housing or strap connection 170, as will be discussed in further detail below. In use, the connection 170 is located above or directly behind the user’s ears.

[0345] The bottom strap 150 has an elongated shape and includes a bottom strap posterior portion 152 and a bottom strap anterior portion 162. The bottom strap posterior portion 152 and the bottom strap anterior portion 162 are one integral piece and are integral with each other. The bottom strap posterior portion 152 includes that portion of the bottom strap 150 that extends from the connection 170 posteriorly and around the occipital region of the user’s head, and then terminates at a bottom strap posterior end portion 154. In use, the ear arch region 160 in the bottom strap 150 curves over the top of the patient’s ear so that the strap 150 avoids contact with the ear. The bottom strap posterior end portion 154 is configured to be positioned at or near a central point or location on the back of the user’s head. The bottom strap posterior end portions 154 of the right side 120 and the left side 130 are configured to be joined together by a bottom juncture 192. The bottom juncture 192 can include a stitching, welding, bonding, overmolding, or any other fastening arrangement, which can be permanent or removable / disconnectable. In some arrangements, the bottom juncture 192 can include an adjustment mechanism (not shown), such as a hook-and-loop fastener, a snap-fit connector, or the like, to allow for variation in the combined length of the bottom strap posterior portion 152 of the bottom strap 150 to accommodate different sizes of the user’s head.

[0346] The bottom strap front portion 162 includes a portion of the bottom strap 150 that extends forward from the junction 170 and across the user's temple toward the user's nose. In some configurations, the bottom strap front portion 162 is shorter than one or both of the top strap 140 or the bottom strap portion 152, and terminates at a bottom strap front end portion 164. The bottom strap front end portion 164 is configured to include, or at least be attached to, a mask connector 180. The bottom strap front end portion 164 includes a female recess portion 166 that engages the mask connector 180. In some configurations, the mask connector 180 can be pressed onto or overmolded onto the bottom strap front end portion 164 and into the female recess portion 166. The mask connector 180 can include a clip or retention feature configured to join to the respiratory device 110. The mask connector 180 can include a push-fit, snap-fit, or other suitable connector configured to provide a detachable connection with the mask frame 112 of the respiratory device 110. In some embodiments, the mask connector 180 can be configured to connect to an adjustment mechanism, where the adjustment mechanism provides a 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 the mask frame or yoke to form a continuous loop between the headgear 100 and the respiratory device 110.

[0347] The right side 120 and the left side 130 of the bifurcated headgear 100 are formed as substantially two-dimensional (2D) pieces, i.e., they are formed in a flat configuration. When the top strap 140 and the bottom strap 150 of the right side 120 and the left side 130 are joined together, a 3D bifurcated structure is formed (as shown in Figure 1B In some configurations, the bifurcated headgear 100 is constructed such that the 3D bifurcated structure is maintained at all times, at least when the right side 120 and the left side 130 are connected. This 3D structure can improve the ease with which a user interacts with, and dons or puts on, the bifurcated headgear 100 and the associated respiratory device 110. Because the bifurcated headgear 100 maintains its shape, the straps are less likely to become tangled, and it should be easier for a user to grasp and orient the bifurcated headgear 100. In some configurations, the bifurcated headgear 100 maintains at least partial or complete separation of the sides 120, 130. In some configurations, the bifurcated headgear 100 maintains at least partial or complete separation at least at the junctions 170 of the opposing sides 120, 130 and / or the bottom strap front portion 162.

[0348] The top strap 140 and the bottom strap 150 each include an integral plastic core 210 that is encased by and bonded to an outer shell 220. The outer shell 220 can be knitted, woven, braided, crocheted, etc. The integral plastic core 210 forms both the top strap 140 and the bottom strap 150. That is, the plastic core 210 is one integral piece between the top strap 140 and the bottom strap 150, and throughout the cleat 100. The outer shell 220 of both the top strap 140 and the bottom strap 150 can be knitted, woven, braided, crocheted, etc. to form a seamless, continuous and uninterrupted tube. That is, the outer shell 220 can have a seamless and uniform outer surface along the length of both the top strap 140 and the bottom strap 150. The outer shell 220 can be loom-woven from a spool of thread that includes wool, cotton, nylon, lycra, or a blend of natural and / or synthetic materials. In some configurations, the outer shell 220 can be loosely woven such that the outer shell 220 can be extended in length without stretching or tearing the thread. The amount of lycra within the thread can be varied to vary the elasticity of the strap.

[0349] The outer shell 220 provides a smooth, neat edge finish to the internally molded cleat 100. That is, the top strap 140 and the bottom strap 150 have a uniform shape and form without seams, providing an aesthetically pleasing appearance. Further, the straps 140, 150 formed by the outer shell 220 are easier to manufacture. The seamless, round, woven tube does not require additional stitching or bonding steps, which shortens manufacturing time and reduces manufacturing costs. Further, it is easy to produce and form a straight, woven tube of a long length, which can then be cut to length and shaped during the revolutionary internal molding process as described herein. Still further, the outer shell 220 is easily placed and positioned within the molding tool. The tubular shape and round cross-section of the outer shell 220 is self-supporting and remains open within the molding tool, providing an open flow path for the injected material through the outer shell.

[0350] The shell 220 is flexible prior to insertion of the plastic core material 210 therein, such that the shell 220 can be easily positioned within the cavity of a molding tool. The shell 220 can be knitted from a material having a soft texture, such that the top strap 140 and the bottom strap 150 feel comfortable when in contact with the user's skin. Similarly, the shell 220 can have a certain thickness and number of layers, such that the top strap 140 and the bottom strap 150 feel comfortable when in contact with the user's skin. Further, in some configurations, the shell 220 can be knitted from a material having moisture-wicking properties, to improve the comfort of the bifurcated headgear 100. Still further, in some configurations, the shell 220 can be knitted from a material having haptics properties, to reduce or inhibit the sliding of the bifurcated headgear 100 against the user's skin or hair. In some configurations, the shell 220 can be different between the top strap 140 and the bottom strap 150. For example, the bottom strap 150 can be constructed from a material having moisture-wicking properties, while the top strap 140 is constructed from a material having haptics properties. Still further, in some configurations, the shell 220 can be constructed from different materials along the length of both the top strap 140 and the bottom strap 150, such that different regions along the length of the straps 140, 150 have different properties. For example, the top strap 140 and the bottom strap 150 can have different colors.

[0351] The shell 220 of both the top strap 140 and the bottom strap 150 is filled with the integral plastic core material 210. In some configurations, the plastic core material 210 includes a relatively rectangular cross-section formed from a thermoformed or thermoset plastic material that is configured to provide the bifurcated headgear 100 with the aforementioned 3D structure. The plastic core material 210 provides a 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 is able to conform to the individual skull geometry of the user to some extent while maintaining a pre-formed shape. The plastic core material 210 has a width that is substantially greater than its depth. The illustrated cross-sectional geometry, in combination with the material selection, allows the bifurcated headgear 100 to be flexible in a direction orthogonal to the width (vertical direction in Figure 1A Figure 1A and relatively inflexible in a direction orthogonal to the depth (horizontal direction in Figure 1A This flexibility in one direction allows the bifurcated headgear 100 to conform to the user's head, while providing rigidity in the other direction to stabilize the respiratory device 110 on the user's face and minimize movement of the respiratory device on the user's face.

[0352] ​The bifurcated headgear 100 can be configured to be substantially inelastic due to, for example, the choice of material. One or more elements of the composite material can provide the substantially inelastic quality to the bifurcated headgear 100. In a first non-limiting example embodiment of the present disclosure, the plastic core material 210 is made of a substantially inelastic material such as, but not limited to, polypropylene or nylon. In embodiments where the bifurcated headgear 100 is expected to be subjected to small loading forces, the plastic core material 210 can be made of other materials such as, but not limited to, thermoplastic elastomer (TPE) or silicone. In some embodiments, the plastic core material 210 can have some degree of elasticity, and one or both of the outer shells 220 of both the top strap 140 and the bottom strap 150 can be substantially inelastic. The inclusion of a substantially inelastic material in the bifurcated headgear 100 is advantageous because the material reduces or eliminates the possibility of the headgear being stretched or pulled too far over the user’s head. If the bifurcated headgear 100 is pulled too far over the user’s head, the respiratory device can not be effectively positioned to provide therapy, and an uncomfortable force can be exerted onto the user’s head, which can cause a decrease in compliance with therapy.

[0353] Connection part

[0354] Figure 2A and Figure 2B is a close-up view of the connection between the top strap 140 and the bottom strap 150 at the junction 170. As described above, the plastic core material 210 is one continuous piece and is positioned within the outer shell 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 illustrated, the bottom strap 150 is filled with the plastic core material 210 that extends through the outer shell 220 of the bottom strap 150 at the junction 170 and then into the top strap lateral end portion 142 to fill the top strap 140. Thus, the outer shells 220 of both the top strap 140 and the bottom strap 150 are joined together by the plastic core material 210.

[0355] As illustrated in FIG. 6, the bifurcated headgear 100 is substantially inelastic. The plastic core material 210 is substantially inelastic and does not stretch or pull when the bifurcated headgear 100 is pulled over the user’s head. The substantially inelastic plastic core material 210 reduces or eliminates the possibility of the bifurcated headgear 100 being stretched or pulled too far over the user’s head. If the bifurcated headgear 100 is pulled too far over the user’s head, the respiratory device can not be effectively positioned to provide therapy, and an uncomfortable force can be exerted onto the user’s head, which can cause a decrease in compliance with therapy. Figures 2A to 3As shown, the top strap 140 and bottom strap 150 may have soft edge portions 222 that extend longitudinally along the edges of multiple portions of both the top strap 140 and bottom strap 150. The soft edge portions 222 are part of the unfilled plastic core 210 of the housing 220. Therefore, the soft edge portions 222 provide soft or cushioned edges for the top strap 140 and bottom strap 150, which are not only comfortable against the user's skin but also aesthetically pleasing. As will be described in further detail below, the soft edge portions 222 are formed by crimping the edges of the housing 220 before injecting the plastic core 210, thereby inhibiting or restricting the flow of the plastic core 210 into the multiple portions of the housing 220. The edges of the housing 220 are crimped by a portion of the molding tool adjacent to the mold cavity of the molding tool. The molding tool can press the edges of the top strap 140 and the bottom strap 150 to a depth that varies along the length of the top strap 140 and the bottom strap 150, so that the width of the plastic core material 210 ( Figure 1A The width of the plastic core 210 (vertically) can vary along the length of the top strap 140 and the bottom strap 150. Therefore, the width of the plastic core 210 can be wider in different areas of both the top strap 140 and the bottom strap 150 (such as the connecting portion 170 and the front end portion 164 of the bottom strap) to reinforce those areas and provide additional strength. Similarly, in some configurations, the width of the plastic core 210 can be narrower in certain areas along the length of both the top strap 140 and the bottom strap 150 to provide flexibility in those narrower areas. Those skilled in the art will understand that the shape and geometry of the plastic core can be varied to provide strength and stiffness to the top strap 140 and the bottom strap 150 in desired directions.

[0356] molding tools

[0357] Figure 4 An injection molding tool 300 is shown for opening / closing, configured to form either the right side 120 or the left side 130 of the forked headband 100 in a single injection molding process. In some configurations, the right side 120 and the left side 130 are identical, wherein the injection molding tool 300 can be used to form both sides 120, 130. Figure 4The diagram shows the fully formed bifurcated headband 100 after the injection molding process is completed. The injection molding tool 300 includes a first tool half 310 and a second tool half 320. The first tool half 310 is configured to align with and sit on top of the second tool half 320 to close the injection molding tool 300. The first tool half 310 and the second tool half 320 are substantially symmetrical (i.e., mirror images), therefore, for simplicity, the following discussion will refer to the second tool half 320. Figure 5 As shown, the second tool 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 housing 220 of both the top strap 140 and the bottom strap 150. Therefore, the top strap cavity 322 and the bottom strap cavity 324 are arranged in a shape corresponding to the desired shape of the left and / or right side of the forked headband 100. In some configurations, the injection molding tool 300 can be used to form both the right side 120 and the left side 130 of the forked headband 100. In some configurations, the housing 220 is cut to a certain length so as to fit within the strap cavities 322, 324 before the molding tool 300 is closed.

[0358] The connector insert 350 is inserted into the bottom strap front portion 164 of the housing 220. The connector insert cavity 370 is positioned within the second tool half 320 and has a shape corresponding to the connector insert 350. The connector insert 350 and the housing 220 are respectively positioned within the connector insert cavity 370 and the strap cavities 322, 324. When using the housing 220 to form the straps 140, 150 of the forked headband 100, the end of the housing 220 is open or formed as a hollow tube, thereby providing a channel for the plastic core material 210 to be injected into the housing 220. Therefore, the connector insert 350, positioned within the open end of the bottom strap 150, reduces or inhibits the narrowing or closing of the open end of the housing 220. The connector insert 350 includes a pre-formed component that fits inside the open end of the housing 220 and pushes the opening of the housing 220 outward toward the walls of the strap cavities 322, 324 in the first tool half 310 and the second tool half 320. The connector insert 350 has openings (not shown) aligned with flow channels 380, through which a direct flow path is provided for injecting a plastic core material into the housing 220. The connector insert 350 is also configured for use at the bottom strap tip portion 164 (see...). Figure 7An internal (female) connection geometry is formed within the face mask, which connects to an opposing male connector geometry (not shown) on the face mask frame or other face mask components. The connector insert 350 can be made of plastic or metal. If made of plastic, in some configurations, the connector insert 350 can be made of the same plastic as the core, allowing chemical bonding to be formed between the connector insert 350 and the plastic core material during a breakthrough internal molding process. Additionally, the connector insert 350 can be shaped to have additional functionality as a connector (e.g., connector 180) between headband components, adjustment mechanisms, or between the headband and the face mask.

[0359] like Figure 4 and Figure 5 As shown, the flow channel 380 fluidly connects the gate injection point 390, the front and rear end portions 154 and 164 of the bottom strap, and the central end portion 144 of the top strap. Therefore, when the plastic core material 210 is injected into the first tool half 310 and the second tool half 320, the plastic core material 210 is injected into the housing 220 through each of the front and rear end portions 154 and 164 of the bottom strap and the central end portion 144 of the top strap.

[0360] The top strap cavity 322 and the bottom strap cavity 324 have soft edge clamps 360 formed along one or both of the outer edges of the cavities 322, 324 in the lengthwise direction. The soft edge clamps 360 are raised areas that protrude into the top strap cavity 322 and the bottom strap cavity 324 in a direction substantially parallel to the closing direction of the injection molding tool 300, such that the top strap cavity 322 and the bottom strap cavity 324 narrow in the lengthwise direction along one or both of the outer edges of the cavities 322, 324 (i.e., narrow the outer edges relative to the central regions of the cavities 322, 324) when the injection molding tool 300 is closed. Thus, the soft edge clamps 360 pinch or crimp the outer edges of the outer shells 220 of both the top strap 140 and the bottom strap 150, such that the soft edge portions 222 are formed. More specifically, the soft edge clamps 360 squeeze the edges of the outer shells 220 together, such that the edges are fully crimped. Thus, when the plastic core material 210 is injected into the outer shells 220, the plastic core material 210 does not flow between the crimped edges. This creates a soft or cushioned edge finish on the internally molded bifurcated headband 100 by preventing the internally molded plastic core material 210 from filling the outer shells 220. A portion of each edge of the straps 140, 150 remains empty and soft to the touch to improve patient comfort. In some configurations, the edges of the outer shells 220 can be narrowed but not fully crimped, such that a reduced amount of plastic core material 210 (relative to the uncrimped portions of the outer shells 220) can flow between the edges of the outer shells 220.

[0361] Figure 6 FIG. 17 is a close-up view of the second tool half 320, illustrating the positioning of the top strap 140 and the bottom strap 150 relative to one another. As shown, the top strap lateral end portion 142 is positioned against or in contact with the outer shell 220 of the bottom strap 150. That is, the outer shell 220 of the top strap 140 is placed within the top strap cavity 330 such that the top strap lateral end portion 142 is against the edge of the outer shell 220 of the bottom strap 150. As will be described in greater detail below, 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 can have mid- portions or non-end portions that are in abutting contact with one another, with the straps being joined through these portions.

[0362] Molding process

[0363] The process of molding the left side 120 or right side 130 of the bifurcated headband 100 using the injection molding tool 300 includes the following steps: insert the shell, close the tool; inject the plastic; then open the tool, release the part. In some configurations, these steps are completed in this order; but in other configurations, the order can be changed and / or additional steps can be included. Such additional steps can be interposed within the above-identified steps.

[0364] In at least some embodiments, the process of molding the left side 120 or right side 130 of the bifurcated headband 100 includes a "breakthrough" molding process as described below.

[0365] A first length of the shell 220 is inserted into a bottom strap cavity 324 of the second tool half 320 of the injection molding tool 300, which is configured to form the bottom strap 150. Similarly, a second length of the shell 220 is inserted into a top strap cavity 322, which is configured to form the top strap 140. The shell 220 can be cut to length so that it fits snugly within the strap cavities 322, 324. The connector insert 350 is positioned inside the open end of the second length of the shell 220 (i.e., the bottom strap front end portion 164), aligned with the connector insert cavity 370, and then inserted into the connector insert cavity 370.

[0366] Once the shell 220 is aligned within the second tool half 320, the injection molding tool 300 is closed so that the strap cavities 322, 324 become fully enclosed. A thermoset or thermoformed plastic core material 210 is then injected into the strap cavities 322, 324 of the mold cavities via the gate 390 and the runner 380. More specifically, the plastic core material 210 is injected into the injection molding tool 300 through the gate 390. In general, the plastic core material 210 follows the path of least resistance in order to fill the strap cavities 322, 324. The plastic core material 210 travels through the runner 380 until it reaches the open end of the shell 220. The plastic core material 210 enters the top strap central end portion 144, the bottom strap rear end portion 154, and the bottom strap front end portion 164 (via the connector insert 350). Referring to FIG. 4, the plastic core material 210 fills the shell 220, and the shell 220 is molded to the shape of the strap cavities 322, 324. The plastic core material 210 is allowed to cure, and the injection molding tool 300 is opened to release the molded bifurcated headband 100. Figure 6When the outer shell 220 in the bottom strap cavity 324 is filled with plastic core material 210 (i.e., since the outer shell is filled from both open ends, as opposed to the outer shell 220 in the top strap cavity 322, which is initially filled at one end), the plastic core material 210 will break through, penetrate, and extrude through the wall of the outer shell 220 of the bottom strap 150 at the connection 170. The plastic core material 210 that penetrates the wall of the bottom strap 150 enters the open end of the outer shell 220 of the top strap 140 (i.e., the top strap lateral end portion 142), joins with the plastic core material 210 that enters the opposite end of the outer shell 220 of the top strap 140 (i.e., from the top strap central end portion), until the outer shell 220 of the top strap 140 is filled with plastic core material 210. Once the outer shells 220 of the straps 140, 150 are filled, a period of time is left for the plastic core material 210 to set, cool, and harden. Once set, the injection molding tool 300 is opened and the part is removed. Thus, the integral plastic core material 210 can be formed within the top strap 140 and the bottom strap 150 with seamless and uniform outer shells 220 of the top strap 140 and the bottom strap 150. That is, the integral plastic core material 210 of the top strap 140 and the bottom strap 150 can be formed by pushing the plastic core material 210 through the outer shell 220 of the bottom strap 150 into the top strap 140. In other words, forming the integral plastic core material 210 within the top strap 140 and the bottom strap 150 with both straps having seamless and uniform outer shells 220, and with one strap attached to a mid-portion or non-end portion of the seamless adjoining strap, has the beneficial effect of a breakthrough internal molding process. In other embodiments, the plastic core material 210 penetrates and breaks through the outer shell 220 prior to the outer shell 220 and strap cavity being filled with plastic core material 210. This can occur, for example, where the unsupported location of the outer shell 220 is closer to the injection point, the plastic core material 210 has a low density or low viscosity, the outer shell 220 has a low linear density, and / or the unsupported portion is large relative to the supported area.

[0367] The plastic core material 210 penetrates and breaks through the wall of the outer shell 220 of the bottom strap 150 because the plastic core material 210 follows the path of least resistance in order to fill the strap cavities. Where the outer shell 220 is supported, abuttingly contacted, or pressed against the surface of the injection molding tool 300, the injected plastic core material 210 will flow in the direction where the restriction is less until the cavity within the injection molding tool 300 is filled. Referring to Figure 5Once the bottom strap cavity 324 is filled with the plastic core material 210, the material flows into the top strap cavity 322 in the direction of least restriction, because the shell 220 of the bottom strap 150 is not supported by, does not abut, and is not pressed against the surface of the bottom strap cavity 324. With the shell 220 not pressed against, i.e., not supported by, the surface of the injection molding tool 300, the injected plastic core material 210 will fill the cavity by penetrating the shell 220. Penetration of the shell 220 can occur as a result of the plastic core material 210 flowing through the shell 220. That is, the threads of the shell 220 displace or elastically deform (i.e., depending on the material of the shell 220) when under pressure from the injected plastic core material 220, i.e., when not supported. Thus, the plastic core material 220 will flow through and squeeze through the gaps created between the displaced or elastically deformed threads of the shell 220. In some configurations, the pressure of the plastic core material 220 within the shell 220 can cause the threads of the shell 220 to tear or break at the unsupported portions of the shell 220. The tearing or breaking of the shell 220 can cause a hole to form within the shell 220, through which the plastic core material 210 can penetrate and break through to flow into and push into the adjoining strap.

[0368] The breaking through or penetration of the plastic core material 210 from the shell 220 can depend on the injection molding parameters and the textile characteristics of the shell 220. In terms of the injection molding parameters, whether the breaking through or penetration occurs can depend on the pressure, the injection speed, the location of the injection point and the length of the injection path, the location of the unsupported areas and the relative size of the unsupported areas relative to the supported areas, and the material characteristics of the plastic core material 210 being injected. In terms of the textile characteristics of the shell 220, whether the penetration occurs can depend on the thread count, thread size, elasticity, thread density, denier, thread strength, etc. of the shell 220. The breaking through or penetration from the shell 220 can occur at higher pressures. In at least some embodiments, the elasticity alone can or can not affect the penetration. As a non-limiting example, a high elasticity shell with a high thread count can deform / stretch (i.e., as opposed to allowing penetration) when not supported by the molding tool 300. However, as the shell 220 stretches, gaps or spaces between the threads will begin to form to provide a path for the plastic core material to penetrate the shell 220. Thus, the injection molding parameters and the textile characteristics can vary depending on the desired characteristics of the clevis strap 100 and the ability to manufacture the clevis strap 100 with the break-through internal molding process.

[0369] Alternative Arrangements

[0370] Figure 8A A second tool half of an injection molding tool 400 is shown having an alternative internal molding strap cavity arrangement for molding a clevis strap 100 in accordance with the present disclosure. Figure 8BThe illustrated connection configurations incorporate multiple straps 410, 412, 414. For comparison, Figure 8B A T-shaped connection 420 is illustrated, which is similar to the connection 170 in Figures 1A to 7 . Figure 8B An alternatively shaped connection in the form of an X-shaped connection 422 is also illustrated. As described above and illustrated in Figure 8B , the T-shaped connection 420 is formed by positioning the open end of the housing of the strap 410 in contact with the edge of the housing of the strap 412 (i.e., with the molding tool providing corresponding arranged strap cavities). In contrast, the X-shaped connection 422 is formed by overlapping the non-open end portions of the housings of the straps 410, 414. In other words, the straps 410, 414 are positioned in an overlapping orientation such that the straps 410, 414 abut in contact at some location between their open ends and form the X-shaped connection 422. In one alternative embodiment, one of the straps 414 is formed from two strap portions that are joined to the other strap 410 by joining respective ends of each of the two strap portions to the other strap 410, thereby forming the X-shaped connection. In these embodiments, the injection molding tool 400 includes corresponding shaped strap cavities for supporting the straps 410, 414. Figure 8A and Figure 8BThe positioning of the gates 430, runners 432, and injection points 434 through which the plastic core material 424 is injected into the injection molding tool 400 to fill the straps 410, 412, 414 is illustrated. The injection points 434 are positioned on one open end of the strap 410 and effectively on the opposite open end of the strap 410 (i.e., through the strap 412 via the injection points 434). In the illustrated configuration, the open end of the strap 414 is not fluidly connected to the injection points 430 other than through the X-connection 422. As the plastic core material 424 is injected into the injection molding tool 400, the plastic core material 424 enters the open end of the strap 410 and travels toward the X-connection 422. In an embodiment where one of the straps 414 is formed from two strap portions that are joined to one another of the straps 410, as the strap 414 begins to fill, the plastic core material 424 will follow the path of least resistance and penetrate the edge of the outer shell of the strap 410 and then the open end of the outer shell of the strap 414. That is, the strap cavity of the strap 414 is empty, providing the path of least resistance for the plastic core material 424. Thus, the outer shell of the strap 414 fills with the plastic core material 424 that enters the strap 414 through the X-connection 422. It will be appreciated by those of ordinary skill in the art that the above-described configuration is not limited to an injection point at the open end of one of the straps in forming the X-connection 422. In some configurations, the X-connection 422 can be formed with at least one injection point at both ends of the two straps.

[0371] As illustrated, the T-connections 420 and X-connections 422 can be used in combination to form a variety of headgear shapes and structures with multiple straps. Multiple strap connections / junctions can be formed in a single injection molding step. Such strap configurations can be used in four-point headgear structures that are commonly used in conjunction with nasal and full-face masks.

[0372] Figure 9AAn alternative internal molded strap arrangement is shown having straps 520 that are joined together by integrally formed connecting members 530 positioned between the straps 520. The connecting members 530 are formed from a plastic core material 510 that breaks through the walls of the enclosures of the straps 520 and into another region of the mold cavity. That is, an injection molding tool (not shown) can have cavities corresponding to the connecting members 530 that are fluidly connected to the strap cavities of the straps 520. Thus, when molten plastic core material 510 is injected into the injection molding tool, the plastic core material 510 enters the enclosures of the straps 520 at injection points 540. As the straps 520 begin to fill, the plastic core material 510 will follow the path of least resistance and penetrate the walls of the enclosures (i.e., at unsupported portions of the enclosures adjacent to the cavities corresponding to the connecting members 530) such that the plastic core material enters and fills the cavities corresponding to the connecting members 530. In some configurations, the plastic core material 510 can be an elastomeric material such that the connecting members 530 can stretch. Additionally, in such embodiments, the enclosures can limit the stretching of the plastic core material 510.

[0373] Figure 9B An alternative internal molded strap arrangement is shown having straps 520 that are joined together by integrally formed web portions 532 positioned between the straps 520. Similar to the connecting members 530 in Figure 9A the injection molding tool (not shown) can have cavities corresponding to the web portions 532 that are fluidly connected to the strap cavities of the straps 520. The cavities corresponding to the web portions 532 can have a shallower depth than the depth of the strap cavities of the straps 520. Thus, when molten plastic core material 510 is injected into the injection molding tool, the plastic core material 510 enters the enclosures of the straps 520 at injection points 540. As the straps 520 begin to fill, the plastic core material will follow the path of least resistance and penetrate the walls of the enclosures (i.e., at unsupported portions of the enclosures adjacent to the cavities corresponding to the web portions 532) such that the plastic core material enters and fills the cavities corresponding to the web portions 532. In some configurations, the plastic core material 510 can be an elastomeric material such that the web portions 532 can stretch. Additionally, in such embodiments, the enclosures can limit the stretching of the plastic core material 510.

[0374] Figure 10AAlternative interior molded strap arrangements are shown having a chamfered connection 620 connecting a chamfered strap 622 to an abutting strap 624 or headgear portion. The textile shell of the chamfered strap 622 has a width that radially outwardly expands, flares, and curves toward the chamfered connection 620 with the abutting strap 624 or headgear portion to provide a smooth transition between the straps 622, 624. In other words, the width or diameter of the textile shell of the chamfered strap 622 increases along the length of the chamfered strap 622 toward the end that is in abutting contact with the abutting strap 624. Thus, the chamfered connection 620 provides a greater connection area with the textile shell of the abutting strap 624, which can provide increased strength and aesthetic appeal over non-chamfered connections. Figure 10B An injection molding tool 610 is shown for forming the chamfered connection 620. As shown, the injection molding tool 610 has a chamfered strap cavity 612 having a shape that corresponds to the shape of the textile shell of the chamfered strap 622. In the illustrated embodiment, the textile shell of the chamfered strap 622 is preformed from two layers of microfiber that have been stitched together and inverted from inside to outside to form a tube that curves outward at one open end. The abutting strap 624 has a similar shell as the previously described embodiments. Additionally, the abutting strap 624 is positioned within a correspondingly shaped strap cavity 614 that is in abutting contact with the open end of the chamfered strap 622. Thus, a plastic core material 630 is injected into the open end of the chamfered strap 622 and / or the abutting strap 624. The plastic core material 630 penetrates the wall of the shell of the abutting strap 624 at the chamfered connection 620 such that the plastic core material 630 is integrally formed within the chamfered strap 622 and the abutting strap 624. As shown, the textile shell of the chamfered strap 622 can abut another interior molded strap portion (i.e., the shell of the strap 624, as shown Figure 10B or abut the uncovered plastic core material 630, as shown Figure 10A In some configurations, the shell of the chamfered strap 622 can be made as a single piece of a woven tube that is woven into a shape that includes the chamfered end.

[0375] Figures 11A to 11E Interior molded strap arrangements are shown having molded textures that are embossed into the straps. Figures 11A to 11C A strap 720 is shown having a plurality of square diamond indentations 730 arranged in rows along the length of the strap 720. As shown Figure 11C the rows are oriented along the Figure 11BThe cross-section of line 11C-11C shows indentations 730 formed on both sides of the strap 720, aligned to form a thin region 732 within the strap 720. The thin region 732 can provide a degree of stretch or elasticity to the plastic core 710. This flexibility can facilitate allowing the closed-loop headband to move over the patient's head or improve the patient's perception of the semi-rigid headband. Additionally, the textured finish of the strap 720 can improve the aesthetic appearance of the headband and its tactile appeal. That is, the strap 720 can appear less rigid and more comfortable. In some embodiments not shown, the indentations 730 can form interrupted areas where there is no plastic core 710 between the layers of the outer shell 712. These interrupted areas can improve the breathability of the strap 720, thereby improving user comfort. Figure 11D and Figure 11E Multiple hexagonal indentations 730 are shown, spaced apart in a honeycomb pattern along the length of the strap 720. It should be understood that the indentations 730 are not limited to rhomboid or hexagonal shapes, but can include various shapes, sizes, positions on the strap, geometric structures, combinations of shapes, etc. Figure 11D and Figure 11E In the center, the plastic core and honeycomb pattern do not extend all the way to the edge of the 720's outer shell. This provides a soft edge to improve user comfort.

[0376] The indentation 730 is formed during the breakthrough internal molding process in a manner similar to forming a soft edge of a strap. That is, the strap cavity of the strap 720 may include a series of protrusions on the first and second tool halves. These protrusions extend into the strap cavity and have a shape corresponding to the indentation 730. When a plastic core material is injected into the strap 720, these protrusions mold the shape of the indentation into the plastic core material.

[0377] Figures 12A to 13D The internal molded strap arrangement of the forked headband 1100 is shown, which has attachment members that increase the bonding strength at the joints between the straps. Figures 1A to 7 The forked headband shown in the image is similar to the 100. Figures 12A to 13D The forked headband 1100 includes a top strap 1140 and a bottom strap 1150. Similarly, the open end portion of the top strap 1140 is coupled to the non-end portion of the bottom strap 1150. Figures 1A to 7 Compared to the bottom strap 150, the bottom strap 1150 includes an attachment member 1156 projecting outward from the wall of the housing of the bottom strap 1150. As will be described in more detail below, the top strap 1140 is overmolded onto the attachment member 1156 to form a permanent connection between the top strap 1140 and the bottom strap 1150.

[0378] The bifurcated head strap 1100 is formed through a two-step internal molding process. That is, the bottom strap 1150 and the attachment member 1156 are internally molded using a breakthrough internal molding process, and then the top strap 1140 is internally molded onto the attachment member 1156 and the bottom strap 1150. Figure 12A and Figure 12B A first step of the breakthrough internal molding process for forming the bifurcated head strap 1100 is illustrated. As shown, the bottom strap 1150 and the attachment member 1156 are formed by positioning the outer shell 1220 of the bottom strap 1150 into the bottom strap cavity 1324 of the first molding tool 1320. The attachment member 1156 is formed from the plastic core material 1210 that has penetrated or broken through the wall of the outer shell 1220 of the bottom strap 1150, similar to the penetration and breakthrough techniques described above. Excess discussion will be excluded for brevity. Figure 13A and 13D A second step of the internal molding process for forming the bifurcated head strap 1100 is illustrated. As shown, the fully formed bottom strap 1150 is positioned within the bottom strap cavity 1326 of the second molding tool 1322. The outer shell 1220 of the top strap 1140 is positioned within the top strap cavity 1328 of the second molding tool 1322. The open end of the top strap 1140 is positioned over the attachment member 1156 of the bottom strap 1150. That is, the outer shell 1220 of the top strap 1140 is placed into the second molding tool 1322 such that the outer shell 1220 of the top strap 1140 covers and / or surrounds the attachment member 1156. The open end of the outer shell 1220 of the top strap 1140 abuts the soft edge 1222 of the bottom strap 1150. The outer shell 1220 of the top strap 1140 is filled with the plastic core material 1210 that enters the second molding tool 1322 via the injection point 1390 in the second molding tool 1322. During injection, the plastic core material 1210 within the outer shell 1220 of the top strap 1140 overmolds onto and / or around the attachment member 1156 in order to form a permanent connection between the top strap 1140 and the bottom strap 1150. Additionally, a chemical and / or mechanical connection is formed between the attachment member 1156 and the plastic core material at the connection 1170 between the top strap 1140 and the bottom strap 1150. The attachment member 1156 can include a mechanical interlocking structure that provides partial interlocking holes 1157( Figures 13A to 13B ) or interlocking holes 1158( Figures 13C to 13DThe plastic core material 1210 within the outer shell 1220 of the top strap 1140 passes through the hole. The mechanical interlock can increase the amount of surface area of the bottom strap 1150 at the junction 1170 to which the top strap 1140 can chemically or mechanically bond. Additionally, the plastic core material 1210 passing through the interlock holes 1157, 1158 can provide a mechanically interlocked connection between the plastic core material 1210 of both the top strap 1140 and the bottom strap 1150. In some configurations, the top strap 1140 can be formed using an in-mold process and attached to the bottom strap 1150. That is, the bottom strap 1150 and attachment member 1156 can be formed using an alternative strap forming technique, after which the top strap 1140 can be overmolded onto the attachment member 1156 using an in-mold process.

[0379] Figures 14A to 14D An alternative strap arrangement for a clevis strap 1400 is shown having strap-sealed end portions of the strap outer shells. The clevis strap 1400 has a top strap 1402 and a bottom strap 1404 that are similarly arranged as the top strap 140 and the bottom strap 150 of the clevis strap 100 of Figures 1A to 7 Additionally, the top strap 1402 and the bottom strap 1404 are joined at the junction 1470 using a breakthrough in-mold process, similar to the joining of the top strap 140 and the bottom strap 150 at the junction 170.

[0380] Figure 14A An outer shell 1410 of the top strap 1402 is shown having a sealed open end portion 1430. The sealed open end portion 1430 is formed by cutting the end of the outer shell 1410 with a hot knife. In the case where the outer shell is formed of synthetic textile, cutting the outer shell 1410 with a hot knife melts the edges of the outer shell 1410, which seals or joins together the loose ends of the individual threads / yarns that would otherwise be exposed and / or frayed after the outer shell 1410 is cut to length. Thus, when the sealed open end portion 1430 is joined with the bottom strap 1404, the junction 1430 is free of loose or frayed individual threads / yarns, which improves the aesthetics of the junction 1470 and the clevis strap 1400. Additionally, the sealed open end portion 1430 can reduce the excess flash formed outside the outer shell 1410 around the junction 1470 after the plastic core material 1420 penetrates the wall of the outer shell during the breakthrough in-mold process. That is, the sealed open end portion 1430 provides a substantially sealed edge or surface in contact with the outer shell 1410 of the bottom strap 1402 (i.e., as opposed to a frayed open end portion of the outer shell 1410), which prevents or inhibits the plastic core material 1420 from leaking from the outer shell 1410 of the top strap 1402 at the sealed open end portion 1430. Figure 14CA junction 1470 is shown formed between the sealed open end portion 1430 of the top strap 1402 and the edge of the shell 1412 of the bottom strap 1404. Figure 14D A cross-section along line 14D-14D of FIG. 14A is shown. The top strap 1400 and the bottom strap 1402 are joined to one another using the breakthrough internal molding technique discussed above. In alternative configurations, the open end of the top strap 1402 can be overmolded to seal the end of the top strap 1402 prior to injection molding. Figure 14C A cross-section along line 14D-14D of FIG. 14A is shown. The top strap 1400 and the bottom strap 1402 are joined to one another using the breakthrough internal molding technique discussed above. In alternative configurations, the open end of the top strap 1402 can be overmolded to seal the end of the top strap 1402 prior to injection molding.

[0381] In another embodiment, the sealed open end portion can be formed by placing the shell into a heat sealer, and then the outer portion of the shell is sealed / melted, but not cut by the heat sealer. Next, the shell is cut in the middle of the sealed area (i.e., after the sealed area has cooled), thereby forming the open end. Although the inner walls of the shell are not sealed or fused together, the individual yarns are fused on the outside of the shell (i.e., the outer wall), thereby securing the loose strands of the individual yarns, which not only provides a clean, aesthetic appearance, but also prevents or inhibits the plastic core material from leaking out of the shell at the sealed open end portion.

[0382] Figures 15A to 15D A bifurcated headgear 1500 is shown having a filament core 1550 with a core end portion 1512 anchored into a plastic core material 1510 within a bottom strap 1502. The filament core 1550 can be used in conjunction with a conversion lock arrangement as disclosed in U.S. Patent Application 14 / 856,193, which is incorporated by reference herein. The filament core 1550 and the conversion lock arrangement provide a length adjustment arrangement for adjusting the length and tension of the bottom strap of the headgear to slacken or tighten the facepiece interface against the face of the user. For example, in some configurations, a locking mechanism can engage the filament core to adjust the effective length of the bottom strap.

[0383] The bifurcated headgear 1500 has a top strap 1502 and a bottom strap 1504 that are similarly arranged as the bifurcated headgear 100 of FIGS. 1A-1C having the top strap 140 and the bottom strap 150 of FIGS. 1A-1C. Figures 1A to 7 The bifurcated headgear 1500 has a top strap 1502 and a bottom strap 1504 that are similarly arranged as the bifurcated headgear 100 of FIGS. 1A-1C having the top strap 140 and the bottom strap 150 of FIGS. 1A-1C.

[0384] As shown in FIG. 15A, the top strap 1502 and the bottom strap 1504 are joined at a junction 1570 using a breakthrough internal molding process, similar to the top strap 140 and the bottom strap 150 being joined at the junction 170. Figure 15AAs shown, the top strap 1502 is joined to the bottom strap 1504 at a connection 1570. The top strap 1502 and the bottom strap 1504 are joined via a plastic core 1510 that is integrally formed within the shell 1520 of both the top strap 1502 and the bottom strap 1504 using the breakthrough internal molding technique discussed above. Similarly, the top strap 1502 and the bottom strap 1504 have a soft edge 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 1510. The filament core 1550 is secured within the core end portion 1512 and anchored into the core end portion at a location forward of the connection 1570 (i.e., forward of the user’s ear). In some configurations, the filament core 1550 is joined to the plastic core 1510 during the breakthrough internal molding process. The filament core 1550 is surrounded by, but not attached to, the shell 1520 of the bottom strap 1504. That is, between the core end 1512 and the open end 1524 of the shell 1520, the filament core 1550 is not attached to the shell 1520. Thus, the shell 1520 can move independently over the filament core 1550, which is effectively inextensible. Additionally, similar to previous embodiments that use the breakthrough internal molding technique, the plastic core 1510 is joined to the shell 1520 of both the top strap 1502 and the bottom strap 1504.

[0385] As Figure 15B shown, the bottom strap 1504 differs from the bottom strap 150 of Figures 1A to 7 the bottom strap 1504 also has a shell 1520 that is longer in order to cover, surround, and conceal a portion of the filament core 1550. Concealing the filament core 1550 can improve the aesthetic appearance of the headband. The filament core 1550 extends forward from the core end portion 1512 of the bottom strap 1504 and has a length that is greater than the stretched or extended length of the shell 1520 of the bottom strap 1504, as Figure 15B and Figure 15C shown. Figure 15B The unstretched length of the shell 1520 of the bottom strap 1504 is shown. Figure 15C The shell 1520 of the bottom strap 1504 is shown stretched to its maximum length, while a portion of the filament core 1550 still extends further beyond the maximum length of the shell 1520. Thus, the shell 1520 of the bottom strap 1504 is configured to conceal the filament core 1550 at a range of positions between the filament core 1550 and the locking mechanism (not shown). The stretched and unstretched lengths of the shell 1520 can vary depending on the size of the headband and the range of adjustability desired.

[0386] Figure 15DA close-up view of the shell 1520 of the bottom strap 1504 in a stretched state is shown. In a preferred embodiment, the shell 1520 of the second strap 1504 is woven and includes non-elastic yarns with linear elastic elements incorporated therein. The shell 1520 is capable of extending and retracting independently of the filament core 1550. As Figure 15D As shown, in an extended state, the shell 1520 of the bottom strap 1504 necks or narrows as it is stretched from the core end portion 1512, as shown by the necked region 1526, the individual yarns of the shell 1520 align, limiting the extended length of the weave. The filament core 1550 is longer than the extended length of the weave. The linear elastic elements of the shell 1520 retract the weave when no force is applied to the weave.

[0387] Figure 16A A split headband 2000 is shown having top straps 2140 on a right side 2120 and a left side 2130 that are connected by a button and hole size adjustment system 2200. The button and hole size adjustment system 2200 can be similar to the "snap-fit" button and hole adjustment system commonly used in baseball caps, but it is integrally molded as part of the split headband 2000. The size adjustment system 2200 includes a plurality of holes 2210 (not visible in Figure 16A the left side 2130 of the top strap 2140, and a plurality of buttons 2220 that protrude from an upper surface 2222 of the top strap 2140 on the right side 2120. The positioning of the plurality of holes 2210 and the plurality of buttons 2220 can be swapped such that the plurality of buttons 2220 extend from the top strap 2140 on the left side 2130 and the plurality of holes 2210 extend through the top strap 2140 on the right side 2120.

[0388] Figure 16B is a close-up cross-sectional view of the button and hole size adjustment system 2200. That is, Figure 16B A button 2220 is shown extending through a hole 2210. With respect to features not expressly discussed, the split headband 2000 can be the same as or similar to other headbands disclosed herein. That is, the split headband 2000 has top straps 2140 and bottom straps 2150 that are similarly arranged as the split headband 100 having top straps 140 and bottom straps 150 Figures 1A to 7 Additionally, the top straps 2140 and the bottom straps 2150 are joined at a connection 2170 using a breakthrough internal molding process, similar to the top straps 140 and the bottom straps 150 being joined at a connection 170. That is, the top straps 2140 and the bottom straps 2150 are formed from a shell 2180 filled with an integral plastic core material 2190.

[0389] Figures 16C to 16D The process of opening / closing the injection molding tool 2300, configured to form the button 2220 of the hole size adjustment system 2200, is demonstrated. For simplicity, Figure 16C A portion of both a first tool half 2310 and a second tool half 2320 of an injection molding tool 2300 for forming a single button 2220 is depicted. The configuration of the molding tool 2300 and the process for forming multiple buttons 2220 are substantially similar to the process for forming a single button 2220. Furthermore, the first tool half 2310 and the second tool half 2320 are similar to... Figures 1A to 7 The first tool half 310 and the second tool half 320 are included, and a strap cavity is included for breakthrough internal molding of the plastic core material within the top and bottom straps. In other words, the plurality of buttons 2220 of the hole size adjustment system 2200 can be formed during the breakthrough internal molding process for injecting the plastic core material 2190 into the top strap 2140 and the bottom strap 2150 (i.e., in a single injection molding process).

[0390] Figure 16C A fully formed button 2220 protruding from the upper surface 2222 of the top strap 2140 is shown. A first tool half 2310 and a second tool half 2320 have strap cavities 2312 and 2322, respectively, within which the outer shell 2180 of the top strap 2140 is received and injection-formed using a plastic core material 2190. The first tool half 2310 also includes a button cavity 2314 fluidly connected to the strap cavities 2312 and 2322, having a shape corresponding to the button 2220, which 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 the techniques used to form multiple buttons 2220 can be used to form alternative features (e.g., raised grips, trademarks, connector portions, etc.) on any surface of the strap.

[0391] Figure 16D This demonstrates that during the process of forming button 2220, the first tool half 2310 and the second tool half 2320 move along... Figure 16Ccross-section of the lines 16D-16D in FIG. 16D. As shown in Step 1, the shell 2180 is positioned within the strap cavities 2312, 2322. A portion of the shell 2180 is not supported by the first tool half 2310 where the button cavity 2314 is connected to the strap cavities 2312. As shown in Step 2 and Step 3, as the plastic core material 2190 fills the strap cavities 2312, 2322, the shell 2180 is pushed by the plastic core material 2190 into the button cavity 2314. As shown in Step 4, when the shell 2180 reaches a limit of containing the plastic core material 2190, the plastic core material 2190 will break through the shell 2180 due to the presence of the remaining cavity to be filled (i.e., the button cavity 2314). That is, when the shell 2180 fills the plastic core material 2190 in an area of the shell 2180 that is not supported (e.g., not supported by the button cavity 2314 in the illustrated embodiment), the plastic core material 2190 will penetrate and break through the shell 2180 and then fill the button cavity 2314. Similar to the breakthrough internal molding process described above, the lines of the shell 2180 can shift or elastically deform under the pressure of the injected plastic core material 2190. The shifting or elastic deformation of the lines can create gaps between the lines through which the injected plastic core material 2190 can flow into the button cavity 2314. In some configurations, the lines of the shell 2180 can tear such that a hole is formed through the shell 2180 through which the injected plastic core material 2190 can flow into the button cavity 2314.

[0392] In other embodiments, the plastic core material 2190 penetrates and breaks through the shell 2180 prior to the shell 2180 and the strap cavities 2312, 2322 being filled with the plastic core material 2190. This can occur, for example, when the unsupported locations of the shell 2180 are closer to the injection point, the plastic core material 2190 has a low density or low viscosity, the shell 2180 has a low line density, and / or the unsupported portions are large relative to the supported areas.

[0393] Figure 17An adjustable strap arrangement having adjustment and usability features formed from a breakthrough internal molding process is demonstrated. The arrangement 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 within the end loop 3130 and folded back, providing a fastening arrangement to removably secure a free end of the second strap 3120. 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 secured, the inner surface 3122 of the portion of the second strap 3120 fed through the end loop 3130 of the second strap 3120 is exposed. This provides a visual and / or tactile indication of the adjusted length.

[0394] Figure 18 A non-limiting exemplary embodiment of a headgear 3200 formed according to the presently described internal molding process and / or breakthrough process is shown. The headgear 3200 includes a lower strap 3210, a middle strap 3220, and a vertical or top strap (hereinafter "vertical strap") 3230. The lower strap 3210 extends from a patient interface (not shown), under a user's ear, around the back of the user's head, under the other user's ear, and finally to the patient interface. The middle strap 3220 extends from the patient interface, over the user's ear, around the back of the headgear 3200, over the other user's ear, and finally to the patient interface. The vertical strap 3230 extends from the lower strap 3210 at a point in front of the user's ear, over the top of the user's head, and finally to a point on the lower strap 3210 in front of the other user's ear.

[0395] In Figure 18 In the embodiment shown, the lower strap 3210 is a continuous strap having a continuous shell. In other words, the shell of the lower strap 3210 is unbroken prior to the internal molding and / or breakthrough process. After the internal molding breakthrough process, a breakthrough connection is formed by the lower strap 3210. It should be noted that the continuous shell or strap can include pre-formed openings that allow the injected material to be exposed.

[0396] As Figure 18 shown, the vertical strap 3230 is a continuous strap in that the vertical strap 3230 is formed from a continuous or unbroken shell. After the internal molding breakthrough process, the end portions 3232 of the vertical strap 3230 shell are joined with a breakthrough connection and internally molded to the lower strap 3210.

[0397] The mid-portion strap 3220 is a segmented strap. In other words, the mid-portion strap 3220 is formed from multiple shells or segmented shells. The segmented shells are joined to other straps during the internal molding breakaway process. In some configurations, the segmented shells are joined to other straps during the internal molding breakaway process. Figure 18 In the illustrated embodiment, the mid-portion strap 3220 includes front portion shells 3222 that are each joined at a breakaway connection to a vertical or top strap 3230 that is spaced apart in the vertical direction from the lower strap 3210 and above the user's ear. The mid-portion strap 3220 further includes a rear portion shell 3224 that is joined at its ends during the internal molding breakaway process to the vertical strap or top strap 3230 that is also above the user's ear.

[0398] The description will now focus on the non-limiting exemplary embodiments illustrated in the drawings. For simplicity, additional features introduced in the respective drawings will be focused on. Thus, previously described features or configurations can not be included each time. In addition, features in the following non-limiting exemplary embodiments can be combined with any of the previously described non-limiting exemplary embodiments, as long as they can be combined. Figures 19 to 42

[0399] Figure 19 A headgear 4100 is shown formed using internal molding and / or breakaway processes. The headgear 4100 includes a continuous lower strap 4110 and a continuous mid-portion strap 4120. A vertical strap 4130 is formed from a breakaway junction above the user's ear, starting from an apex 4124 of the mid-portion strap 4120. In front of the ear, there is a joining strap 4140 formed from a breakaway connection between the lower strap 4110 and the mid-portion strap 4120. A rear portion 4112 of the lower strap 4110 and a rear portion 4122 of the mid-portion strap 4120 converge. A breakaway web portion 4150 joins the rear portion 4112 of the lower strap 4110 and the rear portion 4122 of the mid-portion strap 4120. In some configurations, the vertical strap 4130 and the breakaway web portion 4150 can be one integral and integrally formed.

[0400] Figure 20 Another headgear 4200 is shown formed using internal molding and / or breakaway processes. The headgear 4200 includes a continuous lower strap 4210 and a combined continuous mid-portion vertical strap 4220. An otic ring 4230 is provided around the user's ear. The lower strap 4210 is attached to the otic ring 4230 along a lower portion 4232 of the otic ring 4230. The continuous mid-portion vertical strap 4220 is attached along an upper portion 4234 of the otic ring 4230. Figure 21 A headgear 4300 is shown that is similar to the headgear 4100, except that the breakaway web portion 4150 is replaced with a breakaway strap 4350. The breakaway strap 4350 is formed from a breakaway junction above the user's ear, starting from an apex 4124 of the mid-portion strap 4120. In front of the ear, there is a joining strap 4140 formed from a breakaway connection between the lower strap 4110 and the mid-portion strap 4120. The breakaway strap 4350 joins the rear portion 4112 of the lower strap 4110 and the rear portion 4122 of the mid-portion strap 4120. Figure 18 ​The headgear 3200 shown in FIG. 32 is similar, but the webbing portion 4350 joins the rear portion 4312 of the lower strap 4310 and the rear portion 4322 of the middle strap 4320.

[0401] Figure 22 A headgear 4400 is shown that includes a continuous lower strap 4410 that extends under the user's ear, then vertically up, behind the user's ear, and forward over the user's ear to form part of a perimodiolar loop. A continuous vertical strap 4430 extends from the lower strap 4410 at a portion forward of the ear, the vertical strap 4430 forming the remainder of the perimodiolar loop. A middle strap 4420 is joined to the vertical strap 4430 by a breakaway connection. A lower rear portion 4412 of the lower strap 4410 is joined by a rear panel 4440.

[0402] Figure 23 A headgear 4500 is shown that is similar to the headgear 4400 shown in FIG. 44, however it has a smaller webbing portion 4550 that joins the lower strap 4510 and the middle strap 4520. Figure 21

[0403] A headgear 4600 is shown that includes a continuous lower strap 4610 and a combined continuous middle vertical strap 4620. The headgear 4600 further includes a combined continuous upper rear strap and second vertical strap 4630. A webbing portion 4650 extends between the first vertical strap 4620 and the second vertical strap 4630, and between a rear portion 4612 of the continuous lower strap 4610 and the upper rear strap 4630. The webbing portion 4650 also forms a perimodiolar loop around the ear. That is, the webbing portion 4650 has a hole in which the ear can be positioned. Figure 24

[0404] A headgear 4700 is shown that has a lower strap 4710 and a middle strap 4720 in the form of a closed loop structure formed by a continuous shell. The lower strap 4710 and the middle strap 4720 form part of a perimodiolar loop 4770. A webbing portion 4740 extends between the lower strap 4710 and the middle strap 4720 to form a front portion 4772 of the perimodiolar loop 4770. A vertical strap 4730 is formed by a webbing portion that extends between upper portions 4766, 4776 of right and left perimodiolar loops 4760, 4770. A rear portion 4780 of the headgear 4700 is formed by a rear webbing portion 4750 that extends between lower rear portions 4764, 4774 of the right and left perimodiolar loops 4760, 4770. Figure 25 Figure 26 A headgear 4700 is shown that has a lower strap 4710 and a middle strap 4720 in the form of a closed loop structure formed by a continuous shell. The lower strap 4710 and the middle strap 4720 form part of a perimodiolar loop 4770. A webbing portion 4740 extends between the lower strap 4710 and the middle strap 4720 to form a front portion 4772 of the perimodiolar loop 4770. A vertical strap 4730 is formed by a webbing portion that extends between upper portions 4766, 4776 of right and left perimodiolar loops 4760, 4770. A rear portion 4780 of the headgear 4700 is formed by a rear webbing portion 4750 that extends between lower rear portions 4764, 4774 of the right and left perimodiolar loops 4760, 4770. ​

[0405] Figure 27 and Figure 28 Two examples of headgear 4900 are shown having quilted fabric or material 4910 provided that is attached to portions of the headgear 4900 that come into direct contact with the user's skin or hair, for example on the user's face or at the back of the user's neck. Quilted material 4910 is similar to a duvet in that it is not only soft in texture, but also provides a cushioning padding that improves the comfort of the headgear 4900, making the user want to lay down to bed with the headgear 4900 on. The quilted material 4910 can be stitched or welded to the interior molded strap or webbing portions of the headgear 4900. The disclosed configurations are not limited to quilted material, but can include fabrics and textiles having a variety of material properties such as, but not limited to, soft, padded, breathable, moisture-wicking, and firm / tacky textures.

[0406] Figure 29 A headgear 5100 is shown that includes vertical straps 5110 and neck strap 5120 formed from a foam-Lycra laminate, such as Breath-o-prene. Breath-o-prene allows air to pass through the straps and wick away sweat excreted by the skin, thereby enhancing comfort and compliance. Additionally, Breath-o-prene provides padding to the straps to reduce pressure points on the user's head. The vertical straps 5110 include a first strap 3110 and a second strap 3120. The first strap 3110 includes a break-through end loop 3130 configured to receive the second strap 3120. The second strap 3120 is received within the end loop 3130 and folded back, providing a fastening arrangement to removably secure the free end of the second strap 3120. The second strap 3120 includes a break-through 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 secured, the inner surface 3122 of the portion of the strap that is fed through the end loop 3130 of the second strap 3120 is exposed. This provides a visual and / or tactile indication of the adjusted length.

[0407] Figure 30 A headgear 5200 is shown having a breathable moisture-wicking material 5240 on the vertical straps 5210 and neck strap 5220. The breathable moisture-wicking material 5240 can be a sport and performance knit fabric that improves the breathability of the headgear 5200 at the portions that come into contact with the user's skin or hair. The breathable moisture-wicking material 5240 can also provide an athletic and sporty appearance to the headgear 5200.

[0408] Figure 31A headgear 5300 is shown having a lower strap 5310 and a middle strap 5320 in the form of a closed loop structure formed by a continuous shell. The continuous lower strap 5310 and middle strap 5320 form a substantial portion of an otic loop 5370. The continuous lower strap 5310 and middle strap 5320 are joined by a breakaway connection 5330 in front of the ear that forms the remaining portion of the otic loop 5370 in front of the ear. A vertical strap 5340 is formed at the apex 5322 of the middle strap 5320 that is formed by exposed plastic via a breakaway injection process. Similarly, a neck strap 5350 can also be formed from exposed plastic. Alternatively, the vertical strap 5340 and neck strap 5350 can comprise an internally molded strap with a textile shell. The vertical strap 5340 and neck strap 5350 can also be chamfered at their connections to the lower strap 5310 and middle strap 5320 to improve the strength of the connection to the lower strap 5310 and middle strap 5320.

[0409] Figure 32 A headgear 5400 is shown having a bottom lower strap 5410, a middle strap 5420, and a front vertical strap 5430 in the form of a closed loop structure formed by a continuous shell. A back vertical strap 5440 and a top lower strap 5450 are also continuous straps and can form a closed loop structure. A web portion 5460 extends between the front vertical strap 5430 and the back vertical strap 5440, as well as between the top lower strap 5450 and the bottom lower strap 5410. The web portion 5460 also extends between a front portion 5412 of the bottom lower strap 5410 and the middle strap 5420. The web portion 5460 also forms an otic loop around the ear. That is, the web portion 5460 has a hole in which the ear can be positioned.

[0410] Figure 33 and Figure 34 Two examples of a headgear 5500 are shown having a lower strap 5510 and a middle strap 5520 in the form of a closed loop structure formed by a continuous shell. An upper portion 5574 of an otic loop 5570 is defined by the middle strap 5520. A lower portion 5572 of the otic loop 5570 is defined by the lower strap 5510. A web portion 5540 extends between a back portion 5512 of the continuous lower strap 5510 and a back portion 5522 of the continuous middle strap 5520 and defines a back portion 5578 of the otic loop 5570. A continuous vertical strap 5530 extends out of the lower strap 5510 at a portion in front of the ear and forms a front portion 5576 of the otic loop 5570. The middle strap 5520 overlies the vertical strap 5530. The middle strap 5520 is joined to the vertical strap 5530 by a breakaway connection or an arc weld. Figure 34A vertical strap 5530 is shown with a shell that is formed from a different material than the material used to form the intermediate strap 5520 and the lower strap 5510.

[0411] Figure 35 A headgear 5700 is shown with a lower strap 5710 and a middle strap 5720 that have a continuous shell. The lower strap 5710 extends under the user's ear, then vertically upward, behind the user's ear, and forward over the user's ear to form part of an otic ring 5770. A continuous vertical strap 5730 extends from the lower strap 5710 at a portion forward of the ear, the vertical strap 5730 forming the remainder of the otic ring 5770. The middle strap 5720 is joined to the vertical strap 5730 with a breakaway connection. A lower rear portion 5712 of the lower strap 5710 is joined by a rear panel 5740.

[0412] Figure 36 A headgear 5800 is shown with a lower strap 5810 and a middle strap 5820 that have a continuous shell in the form of a closed loop structure. The continuous lower strap 5810 and middle strap 5820 extend under the user's ear, then vertically upward and around the user's ear to form a bottom portion 5872, a rear portion 5874, and a top portion 5876 of an otic ring 5870, and then continue forward from a location forward of the user's ear to form part of the middle strap 5820. A continuous vertical strap 5830 extends from the lower strap 5810 at a portion forward of the ear, the vertical strap 5830 forming a forward portion 5878 of the otic ring 5870. The middle strap 5820 overlies the vertical strap 5830 at a portion that is substantially parallel to the vertical strap 5830 and is joined to the vertical strap 5830 with a breakaway connection. A lower rear portion 5812 of the lower strap 5810 is joined by a rear panel or web portion 5840.

[0413] Figure 37 and Figure 38Two examples of headgear 5900 are shown having a lower strap 5910 and a middle strap 5920 formed from a continuous shell. A vertical strap 5930 extends from the lower strap 5910 at a portion in front of the ear and forms an anterior portion 5972 and a superior portion 5974 of an otic ring 5970. The vertical strap 5930 extends posteriorly and connects to the lower strap 5910 at a location behind the user's ear. In some configurations, the vertical strap 5930 extends around the back of the user's head. The lower strap 5910 forms an inferior portion 5976 of the otic ring 5970. The middle strap 5920 connects to the vertical strap 5930 at a location in front of the user's ear. A neck strap 5940 is attached to both the vertical strap 5930 and the lower strap 5910 and extends along a length of a portion of the vertical strap 5930 that is posterior to the user's head. In Figure 37 In some non-limiting configurations, the neck strap 5940 is formed from a breathable, moisture-wicking material, which can be a sport and performance knit fabric. The vertical strap 5930 can be covered with a textile material or exposed plastic core material.

[0414] Figure 39 One embodiment of headgear 6100 is shown having a lower strap 6110 and a middle strap 6120 formed from a continuous shell. The lower strap 6110 and the middle strap 6120 converge at a location behind the user's ear. A break-through connection 6140 connects the lower strap 6110 and the middle strap 6120 at a location in front of the user's ear. A vertical strap 6130 is formed from the break-through junction above the user's ear, starting at an apex 6122 of the middle strap 6120. The vertical strap 6130 can be covered with a textile material or exposed plastic core material.

[0415] Figure 40 One embodiment of headgear 6200 is shown having a lower strap 6210, a middle strap 6220, and a vertical strap 6230 formed from a continuous shell. In some non-limiting configurations, the continuous straps can be formed by knitting the continuous shell entirely or joining multiple layers of textile material together.

[0416] Figure 41One embodiment of a headgear 6300 is shown having a lower strap 6310, a middle strap 6320, and a vertical strap 6330 formed from a continuous shell. The continuous strap is connected to a rear strap 6340 at two junctions: one behind the user's ear to one end of the lower strap 6310, and one at a location above the user's ear to the vertical strap 6330. A webbing portion 6350 joins the lower strap 6310 and the middle strap 6320 at a location in front of the user's ear. Alternatively, the continuous strap can join the lower strap 6310 and the middle strap 6320 at a location in front of the user's ear. A neck strap 6360 is attached to both the rear strap 6340 and the lower strap 6310 and extends along the length of a portion of the rear strap 6340 that is behind the user's head. The neck strap 6360 is formed from a breathable, moisture-wicking material, which can be a sport and performance knit fabric.

[0417] Figure 42 One embodiment of a headgear 6400 is shown having a lower strap 6410 and a middle strap 6420 formed from a continuous shell. In some configurations, the continuous strap forms a closed loop structure. The lower strap 6410 and the middle strap 6420 intersect at a location behind the user's ear. A breathable, moisture-wicking material can be positioned within an opening 6450 between the lower strap 6410 and the middle strap 6420. The lower strap 6410 and the middle strap 6420 are connected at a location in front of the user's ear by an internally molded webbing portion or strap 6440. A vertical strap 6430 is formed from a breakaway junction above the user's ear, starting at an apex 6422 of the middle strap 6420. In some configurations, the vertical strap 6430 is covered by the middle strap 6420 and extends toward the lower strap 6410 to connect the lower strap 6410 and the middle strap 6420.

[0418] Figures 43A to 43BA perspective view of one embodiment of a headgear 6510 that can be used with a patient interface 6500 is shown. 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 under the user's ear, then vertically upward, behind the user's ear, and forward over the user's ear to form part of a periauricular loop 6517. The mid strap 6512 extends from the connector above the user's ear, forming an upper portion of the periauricular loop 6517, meeting the lower strap 6511 at the connection. The mid strap 6512 extends from the connection above the user's head. The vertical member 6513 extends from the connection with the lower strap 6511 at some portion in front of the ear to the connection with the mid strap 6512 at some portion in front of the ear, forming the remainder of the periauricular loop 6517. The mid strap 6512 can include an adjustment mechanism for adjusting the fit of the headgear 6510 on the user's head. The lower strap 6511 can include an adjustment mechanism. The rear portion 6515 can include an adjustment mechanism. The adjustment mechanisms can allow the length of the straps to be adjusted so that the headgear 6510 fits a range of head sizes.

[0419] The lower strap 6511 and the mid strap 6512 are manufactured using an internal molding process that includes a shell that can be knitted from a material having a soft texture so that the mid strap 6512 and the lower strap 6511 feel comfortable when in contact with the user's skin. Similarly, the shell can have a thickness and number of layers so that the headgear 6510 feels comfortable when in contact with the user's skin. The interior of the shell includes a plastic material for providing rigidity to the headgear 6510. The mid strap 6512 and the lower strap 6511 are integrally formed at the headgear connection 6514 using a breakthrough internal molding technique. The vertical member 6513 is integrally formed with the mid strap 6512 and the lower strap 6511 at each of its connections by the same breakthrough internal molding technique.

[0420] In the embodiment shown, the mid strap 6512 and the lower strap 6511 are continuous straps having a continuous shell. In other words, the shell of the straps is uninterrupted prior to the internal molding and / or breakthrough process. It should be noted that the continuous shell or strap can include pre-formed openings that allow the injected material to be exposed.

[0421] The posterior portion 6515 of the headgear 6510 passes around the back of the user's head. It can be formed from a plastic fiber mesh made in a breakaway process. Alternatively, the posterior 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 profiles. Suitable materials can include Breath-o-prene, spacer fabric, or other stretchable and pliable fabrics. The fabric can be joined to the headgear 6510 using stitching, radio frequency welding, ultrasonic welding, adhesive bonding, or any other suitable joining mechanism.

[0422] For simplicity, additional features introduced in the respective drawings will be described in the following embodiments. Thus, previously described features or configurations can not be included each time.

[0423] Figures 44A to 44B A perspective view of one embodiment of a headgear 6520 that can be used with the patient interface 6500 is shown. The headgear 6520 includes a lower strap 6521, a middle strap 6522, and an upper, vertical, or top strap 6523. The lower strap 6521 extends from the patient interface 6500, under the user's ear, around the back of the user's head, over the other ear, and back to the patient interface 6500. The middle strap 6522 extends from the patient interface 6500, over the user's ear, around the back of the user's head, over the other ear, and back to the patient interface 6500. The vertical strap 6523 extends from a connection on the lower strap 6521 at a point in front of the user's ear to a connection with the middle strap 6522, then over the top of the user's head to another connection with the middle strap 6522, and finally to a point on the lower strap 6521 in front of the other ear. All of the connections of the illustrated configuration can be formed using breakaway internal molding.

[0424] The headgear 6520 includes a posterior mesh portion 6525 at the back of the user's head. The posterior mesh portion 6525 can be formed from breakaway internal molding. The mesh portion 6525 can be integrally formed with the headgear 6520. Alternatively, the mesh portion 6525 can be made from a more flexible material (e.g., Breath-o-prene) and joined to the lower strap 6521 and the middle strap 6522 by any suitable means (stitching, radio frequency welding, adhesive, etc.).

[0425] Figures 45A to 45BA perspective view of one embodiment of a headgear 6530 that can be used with the patient interface 6500 is shown. The headgear 6530 includes a rear fabric web portion 6535 that includes holes or voids. The holes serve to increase the flexibility and breathability of the rear portion 6535. The fabric web portion 6535 can be an internally molded plastic formed by a break-out process, or it can be an elastomeric fabric (e.g., Breath-o-prene, spacer fabric, etc.).

[0426] Figures 46A to 46C A perspective view of one embodiment of a headgear 6540 that can be used with the patient interface 6500 is shown. The headgear 6540 includes a lower strap 6541 and a middle strap 6542 in the form of a closed loop structure formed by a continuous shell. The lower strap 6541 and the middle strap 6542 form a portion of an ear loop. A vertical member 6544 extends from a connection with the lower strap 6541 at a location forward of the ear to a connection with a top strap 6543 at a location forward of the ear, thereby forming the remainder of the ear loop. The top strap 6543 spans between an upper portion of the right ear loop and an upper portion of the left ear loop. A rear strap 6545 spans between a rear portion of the right ear loop and a rear portion of the left ear loop. In at least one embodiment, at least one of the top strap 6543 and the rear strap 6545 can be made of a flexible material (e.g., Breath-o-prene) and is connected to the lower strap 6541 and the middle strap 6542 by any suitable means (stitching, radio frequency welding, adhesive, etc.). In at least one embodiment, the top strap 6543 or the rear strap 6545 can be made using a break-out internal molding process. In at least one embodiment, both the top strap 6543 and the rear strap 6545 can be made using a break-out internal molding process. The rear strap 6545 can include an adjustment mechanism.

[0427] Figures 47A to 47BA perspective view of one embodiment of a headgear 6550 that can be used with the patient interface 6500 is shown. The headgear 6550 includes a lower strap 6551 and a middle strap 6552 in the form of a closed loop structure formed from a continuous shell. The lower strap 6551 and the middle strap 6552 form part of an ear loop. A top strap 6553 is formed from a breakthrough internal molding process and extends from a connection on an upper portion of the right ear loop to a connection on an upper portion of the left ear loop. A rear strap first portion 6555 is formed from a soft quilted fabric or material. A rear strap second portion 6557 of the headgear 6550 is formed from a rear web portion that extends between a lower rear portion of the right ear loop and a lower rear portion of the left ear loop. The rear strap second portion 6557 can be made from a soft quilted fabric or material or can be made from a plastic material using an internal molding process.

[0428] Figures 48A to 48B A perspective view of one embodiment of a headgear 6560 that can be used with the patient interface 6500 is shown. The headgear 6560 includes a first lower strap 6564 that is formed from a continuous shell. The first lower strap 6564 extends laterally under the user's right ear, around the back of the user's head, to meet the middle strap 6562 at a connection on the opposite side of the user's head. The connection at which the first lower strap 6564 and the middle strap 6562 meet is generally above the user's left ear. The headgear 6560 includes a second lower strap 6566 that is a segmented strap including two shell lengths. The second lower strap 6566 extends laterally under the user's left ear, around the back of the user's head, and then intersects the first lower strap 6564 at a rear connection. The second lower strap 6566 continues from the rear connection to a connection at which it meets the middle strap 6562, which connection is generally above the user's right ear. The cores of both the first lower strap 6564 and the second lower strap 6566 are integrally formed using a breakthrough internal molding.

[0429] The middle strap 6562 extends from the patient interface 6500 to above the user's right ear to meet the second lower strap 6566 at a connection. The middle strap 6562 continues from the connection above the user's head to meet the first lower strap 6564 at another connection. The middle strap 6562 continues to the patient interface 6500.

[0430] Figures 49A to 49BA perspective view of one embodiment of a headgear 6570 that can be used with the patient interface 6500 is shown. A mid-strap 6572 extends from the patient interface 6500, over the top of a user's ear, around the back of the user's head, over the top of the other user's ear, and finally to the opposite side of the patient interface 6500. A top strap 6573 can be formed by a breakaway joint with the mid-strap 6572. A lower strap 6571 extends from the patient interface 6500, under the user's ear, around the back of the user's head, under the other user's ear, and finally to the opposite side of the patient interface 6500.

[0431] The headgear 6570 includes an ear loop 6577. The ear loop 6577 extends from the back of the user, over the front of the user's right ear, and around the front of the right ear. It extends under the user's right ear and continues to extend around the back of the user's head. It extends over and around the front of the user's left ear, continuing over and behind the user's left ear, and then meets itself at the back of the user's head.

[0432] The ear loop 6577 includes a rear webbing portion 6575 at the back of the user's head that spans between the lengths of the opposite ends of the ear loop 6577. The rear webbing portion 6575 can be formed by a breakaway inner mold. The webbing portion 6575 can be integrally formed with the headgear 6570. Alternatively, the webbing portion 6575 can be made of a more flexible material (e.g., Breath-o-prene) and attached to the lower strap 6571 and the mid-strap 6572 by any suitable means (stitching, radio frequency welding, adhesive, etc.). The ear loop 6577 is joined to the mid-strap 6572 and the lower strap 6571 of the headgear 6570 by stitching, radio frequency welding, ultrasonic welding, or adhesive bonding.

[0433] Figures 50A to 50BA perspective view of one embodiment of a headgear 6580 that can be used with the patient interface 6500 is shown. The headgear 6580 includes a lower strap 6581 that extends from the patient interface 6500 under the user's ear. A middle strap 6582 extends from the patient interface 6500 over the user's ear. The middle strap 6582 and the lower strap 6581 converge at the back of the user's head and form a back strap 6585. The middle strap 6582 and the lower strap 6581 form a periauricular loop first portion 6587. A top strap 6583 is formed by a breakaway joint above the user's ear. A periauricular loop second portion 6589 is formed by a breakaway web portion. In at least one embodiment, the periauricular loop second portion 6589 and the top strap 6583 can be integrally formed using a breakaway process and attached to the periauricular loop first portion 6587 using an appropriate method (stitching, etc.).

[0434] Figures 51A to 51B A non-limiting exemplary embodiment of a headgear 6590 that can be used with the patient interface 6500 is shown. The headgear 6590 includes a lower strap 6591 and a middle strap 6592 in the form of a closed loop structure formed by a continuous shell. The lower strap 6591 and the middle strap 6592 form a portion of a periauricular loop. A top strap 6593 is formed by a breakaway internal molding process. The top strap 6593 includes a first portion 6594 that extends from a chamfered joint on an upper portion of the right periauricular loop toward the top of the user's head and a second portion 6595 that extends from a chamfered joint on an upper portion of the left periauricular loop also toward the top of the user's head.

[0435] The first portion 6594 and the second portion 6595 of the top strap 6593 cooperate such that the length of the top strap 6593 can be adjusted by the user of the patient interface 6500. The first portion 6594 and the second portion 6595 of the top strap 6593 can cooperate with each other by including a push-fit adjustment mechanism. As shown, the push-fit adjustment mechanism can include a number of or a plurality of protrusions 6599 on the second portion 6595 of the top strap 6593 and a number of or a plurality of mating depressions 6598 on the first portion 6594 of the top strap 6593. The protrusions 6599 of the second portion 6595 can be pushed into or depressed into the depressions 6598 on the first portion 6594 to fix the length of the top strap 6593 as desired. The protrusions 6599 can be formed by the breakaway internal molding process. Any other suitable adjustment mechanism can be used to join the first portion 6594 and the second portion 6595 to set the length of the top strap 6593. Figure 51B

[0436] ​The posterior strap 6597 is formed from a breakthrough internal molding process and extends from a chamfered connection on a posterior portion of the right perimodiolar ring to a chamfered connection on a posterior portion of the left perimodiolar ring. In the illustrated configuration, the posterior strap 6597 includes a casing around a plastic core that spans the length of the strap. In at least one configuration, the posterior strap 6597 can include a plastic structure that spans the posterior of the headband 6590. In at least one embodiment, the posterior strap 6597 can include a length adjustment mechanism.

[0437] Figures 52A to 52C A perspective view of one embodiment of a headgear 6610 that can be used with a patient interface 6600 is shown. The headgear 6610 includes a mid strap 6611 and a posterior strap 6613 that are formed from a continuous casing 6601. A top strap 6612 is formed from a breakthrough internal molding process. The top strap 6612 extends from a connection 6617 on an upper portion of the mid strap 6611 and / or the posterior strap 6613 and over the top of the user's head to a connection 6617 on an upper portion of the mid strap 6611 and / or the posterior 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 chamfered connection.

[0438] The connection 6617 and adjacent portions of the mid strap 6611 and the posterior strap 6613 include a support structure 6615. Figure 52B A cross-sectional view of the connection 6617 and adjacent portions along line 52B-52B is shown, where the support structure 6615 is illustrated. In contrast, Figure 52C A cross-sectional view of the posterior strap 6613 along line 52C-52C is shown, along a portion that does not have a support structure 6615. The support structure 6615 can be arcuate, following the contours of the mid strap 6611, the posterior strap 6613, and the connection 6617. The support structure 6615 can span from a first location in front of the user's ear to a second location 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 internal molding process. The support structure 6615 can be overmolded onto the headgear 6610. The support structure 6615 can provide structure to help the headgear 6610 maintain its shape and / or contribute to the structural integrity of the headgear 6610.

[0439] Figures 53A to 53BA perspective view of one embodiment of a headgear 6620 that can be used with a patient interface 6600 is shown. The headgear 6620 includes a lower strap 6621 and a middle strap 6622 in the form of a closed loop structure formed by a continuous outer shell. The lower strap 6621 and the middle strap 6622 form part of an ear loop. The headgear 6620 includes a first rear portion 6624 and a second rear portion 6625. The second rear portion 6625, the lower strap 6621 and the middle strap 6622 are integrally formed by a breakthrough in-mold process. The lower strap 6621 and the middle strap 6622 include a textile outer shell 6601 with an in-molded plastic core 6602. The second rear portion 6625 includes a textile outer shell 6601 with an in-molded plastic core 6602. A web portion 6628 formed by the breakthrough in-mold process extends between the lower strap 6621 and the middle strap 6622 and the second rear portion 6625.

[0440] The web portion 6628 forms a plastic core of the first rear portion 6624. As shown, the first rear portion 6624 includes an overmold material 6603 on at least one face of the web. In the illustrated configuration, the first rear portion 6624 includes a soft-feel overmold material 6603 on both an outer surface and an inner surface of the first rear portion 6624. The overmold material 6603 can enhance the comfort experienced by a user of the headgear 6620. The first rear portion 6624 and the second rear portion 6625 are configured to form a top strap 6623 across the top of a user's head, and a rear strap 6627 across the back of a user's head. Figure 53B

[0441] Figures 54A to 54C A headgear 6630 is shown having a lower strap 6631 and a middle strap 6632 formed by a continuous outer shell. An upper portion of a partial ear loop is defined by the middle strap 6632. A lower portion of the partial ear loop is defined by the lower strap 6631. A web portion 6637 extends between a rear portion of the continuous middle strap 6632 and a rear portion of the continuous lower strap 6631 and defines a rear portion of the partial ear loop. Figure 54B is a close-up view of the web portion 6637. The web portion 6637 can be formed by a breakthrough in-mold process. Figure 54C A cross-sectional view of the web portion 6637 along line 54C-54C in Figure 54B is shown. The web portion 6637 includes an overmold material 6603. In at least one embodiment, the overmold material 6603 can be a soft-feel material.

[0442] ​The top strap 6633 is formed from a breakthrough internal molding process. The top strap 6633 extends from a connection on an upper portion of the middle strap 6632 and / or the rear strap 6635 on the right side of the user's head to a connection on an upper portion of the middle strap 6632 and / or the rear strap 6635 on the left side of the user's head. In at least one embodiment, the top strap 6633 can include a chamfered connection. The top strap 6633 can include a soft-feel overmold material on at least its upper surface, lower surface, or on both its upper and lower surfaces.

[0443] Figures 55A to 55C A headgear 6640 is shown that includes a continuous lower strap 6641 and a combined continuous middle vertical strap 6642. The headgear 6640 further includes a combined upper rear strap 6643. A web portion 6645 extends between the first vertical strap and the second vertical strap. The web portion 6645 extends between the first rear strap and the second rear strap. Figure 55B A cross-section of the web portion 6645 along line 55B-55B in Figure 55A is shown. Figure 55C A close-up view of the web portion 6645 is shown. In at least one embodiment, the web portion 6645 can be formed from a breakthrough internal molding process. In at least one embodiment, the straps can include a knitted tube shell 6601.

[0444] Figures 56A to 56B A headgear 6650 is shown that has a lower strap 6651 and a middle strap 6652 in the form of a closed loop structure formed from a continuous shell. The continuous middle strap 6652 and the lower strap 6651 form a substantial portion of an ear loop. A top strap 6653 extends from a connection 6655 on an upper portion of the right side of the partial ear loop to a connection on an upper portion of the left side of the partial ear loop. Similarly, a rear strap 6657 extends from a connection on a rear portion of the right side of the partial ear loop to a connection on a rear portion of the left side of the partial ear loop.

[0445] As shown in Figure 56B , the top strap 6653 and the rear strap 6657 can be chamfered or tapered at their connections to the middle strap 6652 and the lower strap 6651 to improve the strength of the connection to the middle strap 6652 and the lower strap 6651. In at least one embodiment, the top strap 6653 can be formed from exposed plastic. In at least one embodiment, the top strap 6653 can be composed of an internally molded strap with a textile shell. In at least one embodiment, the rear strap 6657 can be formed from exposed plastic. In at least one embodiment, the rear strap 6657 can be composed of an internally molded strap with a textile shell.

[0446] Figures 57A to 57C A perspective view of one embodiment of a headgear 6660 that can be used with a patient interface 6600 is shown. The headgear 6660 has a mid-portion strap 6662 that is formed from a continuous shell. The headgear 6660 has a lower strap 6661 that is formed from a continuous shell. The mid-portion strap 6662 extends from the mask assembly over the user's ears and continues to extend across the back of the user's head. An upper portion of the periauricular loop is defined by the mid-portion strap 6662. The lower strap 6661 extends from the mask assembly under the user's ears and continues to extend across the back of the user's head. A lower portion of the periauricular loop is defined by the lower strap 6661.

[0447] The headgear 6660 includes a first vertical member 6665 and a second vertical member 6666. The first vertical member 6665 spans a distance between the lower strap 6661 and the mid-portion strap 6662 in front of the user's ears, thereby forming an anterior portion of the periauricular loop. The first vertical member 6665 can be formed from a breakthrough internal molding technique. The first vertical member 6665 can be exposed plastic. As shown, the second vertical member 6666 spans a distance between the lower strap 6661 and the mid-portion strap 6662 behind the user's ears, thereby forming a posterior portion of the periauricular loop. The second vertical member 6666 can be formed from a breakthrough internal molding technique. The second vertical member 6666 can be exposed plastic 6602. Figure 57B The second vertical member 6666 is a cross-sectional view of the second vertical member 6666 along line 57C-57C in FIG. 57C. Figure 57C The second vertical member 6666 is a cross-sectional view of the second vertical member 6666 along line 57C-57C in FIG. 57C. Figure 57B The second vertical member 6666 is a cross-sectional view of the second vertical member 6666 along line 57C-57C in FIG. 57C.

[0448] The top strap 6663 extends from a connection 6668 on an upper portion of the mid-portion strap 6662 and / or the rear strap 6669 and extends over the top of the user's head to a connection 6668 on an upper portion of the mid-portion strap 6662 and / or the rear strap 6669 on an opposite side of the user's head. The top strap 6663 can be formed from a breakthrough internal molding process. The top strap 6663 can include exposed plastic.

[0449] Figures 58A to 58BA perspective view of one embodiment of a headgear 6670 that can be used with a patient interface 6600 is shown. The headgear 6670 has a mid-portion strap 6672 that is formed from a continuous shell. The headgear 6670 has a lower strap 6671 that is formed from a continuous shell. The mid-portion strap 6672 extends from the mask assembly over the user's ears and continues to extend across the back of the user's head. An upper portion of the partial circumferential loop is defined by the mid-portion strap 6672. The lower strap 6671 extends from the mask assembly under the user's ears and continues to extend across the back of the user's head. A lower portion of the partial circumferential loop is defined by the lower strap 6671.

[0450] A web portion 6677 extends between the rear portion of the continuous mid-portion strap 6672 and the rear portion of the continuous lower strap 6671 and defines a rear portion of the partial circumferential loop. The web portion 6677 can be formed from a breakthrough internal molding process.

[0451] A top strap 6673 is formed from a breakthrough internal molding process. The top strap 6673 extends from a connection on an upper portion of the mid-portion strap 6672 and / or the rear strap 6678 and extends over the top of the user's head to a connection on an upper portion of the mid-portion strap 6672 and / or the rear strap 6678 on an opposite side of the user's head. In at least one embodiment, the top strap 6673 can include a chamfered connection 6675. The top strap 6673 can be exposed plastic, can include a fabric shell, or can include at least one overmolding material.

[0452] FIGS. 59A-59C A headgear 6680 is shown that includes a continuous lower strap 6681 and a combined continuous mid-portion vertical strap 6682. The headgear 6680 further includes a combined upper rear strap 6683. A web portion 6685 extends around a rear portion of the user's ear. The web portion 6685 can be formed from a breakthrough internal molding process.

[0453] The length of the continuous mid-portion vertical strap 6682 and the length of the continuous upper rear strap 6683 are joined via an invisible joint, as FIG. 59BThe continuous upper posterior strap 6683 is formed integrally with the plastic core 6602 of the continuous upper posterior strap 6683 along the juncture. In at least one embodiment, the continuous upper posterior strap 6683 and the continuous middle posterior strap 6682 can comprise a common textile shell 6601. In at least one embodiment, the continuous upper posterior strap 6683 and the continuous middle posterior strap 6682 are formed from two independent textile shells comprising at least one contiguous surface. Further, the length of the continuous upper posterior strap 6683 and the length of the lower strap 6681 are joined via an invisible juncture.

[0454] FIGS. 60A-60B A perspective view of one embodiment of a headgear 6690 that can be used with a patient interface 6600 is shown. The headgear 6690 comprises a lower strap 6691 and a middle strap 6692 in the form of a closed loop structure formed from a continuous shell. The continuous middle strap 6692 and the lower strap 6691 form a substantial portion of a periauricular loop. A top strap 6693 extends from a connection 6695 on an upper portion of a right side portion of the periauricular loop to a connection 6696 on an upper portion of a left side portion of the periauricular loop. The top strap 6693 can be formed from a breakthrough internal molding process. In at least one embodiment, the top strap 6693 can be comprised of an internal molded strap with a textile shell.

[0455] The headgear 6690 comprises a posterior strap 6697. The posterior strap 6697 extends from a connection on a posterior portion of a right side portion of the periauricular loop to a connection on a posterior portion of a left side portion of the periauricular loop. The posterior strap 6697 can be formed from an internal molding process with a plastic core and a fabric or textile shell. The posterior strap 6697 can have a molded texture impressed onto the strap 6697 or can comprise a profile determined during the molding process. FIG. 60A The strap 6697 is shown with a plurality of hexagonal holes arranged in rows along the length of the strap 6697. FIG. 60B is a close-up view of the hexagonal holes arranged in rows along the length of the posterior strap 6697. The holes protrude through the thickness of the strap 6697. The profile can provide a degree of stretch or elasticity to the plastic core. This flexibility can be advantageous to allow the headgear 6690 to pull over the head of a patient or to improve the patient's perception of the headgear 6690. Additionally, the textured finish of the strap 6697 can improve the aesthetic appearance of the headgear 6690 as well as the tactile appeal of the strap 6697. That is, the strap 6697 can appear less rigid and more comfortable. The holes can improve the breathability of the strap 6697, which can improve the comfort of the user.

[0456] Alternatively, the posterior strap 6697 can include a plurality of hexagonal indentations arranged in rows along the length of the strap 6697. It should be appreciated that the indentations are not limited to a hexagonal shape, but can include a variety of shapes, sizes, locations on the strap, geometries, shape combinations, and the like. In at least one configuration, the plastic core of the honeycomb pattern does not extend all the way to the edge of the shell of the strap 6697. This provides a soft edge to improve comfort for the user. In at least one embodiment, the posterior strap 6697 can be exposed plastic.

[0457] FIGS. 61A-61C A perspective view of one embodiment of a headgear 7110 that can be used with a patient interface is shown. The headgear 7110 includes 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 shell. The middle strap 7112 is a continuous strap with a continuous shell. The vertical strap 7113 is a segmented strap. In other words, the vertical strap 7113 is formed from a plurality of shells or segmented shells.

[0458] In at least one embodiment, the vertical strap 7113 can be a continuous strap with a continuous shell. The vertical strap 7113 can pass underneath the middle strap 7112 as it extends over the head of the user. The vertical strap 7113 can pass over the middle strap 7112 as it extends over the head of the user. The vertical strap 7113 can be adhesively bonded to the middle strap 7112, can be connected via an appropriate connection mechanism such as a hook and loop connection system, or can be independent of the middle strap 7112.

[0459] The middle strap 7112 and the lower strap 7111 include an invisible joint across the posterior section of each strap, as shown. Along this invisible joint, the middle strap 7112 and the lower strap 7111 can include a common plastic core 7002. FIG. 61B FIG. 61C A cross-sectional view along line 61C-61C is shown. The middle strap 7112 and the lower strap 7111 can have independent textile shells or fabric shells 7001 that are configured such that the common plastic core 7002 of these straps is invisible. FIG. 61B

[0460] FIGS. 62A-62B ​​A perspective view of one embodiment of a headgear 7120 that can be used with the patient interface 7100 is shown. The headgear 7120 has a mid-portion strap 7122 that is formed from a continuous shell. The headgear 7120 has a lower strap 7121 that is formed from a continuous shell. The mid-portion strap 7122 extends from the mask assembly over the user's ears and continues to extend across the back of the user's head. An upper portion of the periauricular loop is defined by the mid-portion strap 7122. The lower strap 7121 extends from the mask assembly under the user's ears and continues to extend across the back of the user's head. A lower portion of the periauricular loop is defined by the lower strap 7121.

[0461] A top strap 7123 extends from a connection on an upper portion of the mid-portion strap 7122 and / or the rear strap 7128 and extends over the top of the user's head to a connection on an upper portion of the mid-portion strap 7122 and / or the rear strap 7128 on an opposite side of the user's head. The top strap 7123 is formed from a breakthrough internal molding process. The top strap 7123 can include a chamfered connection. The top strap 7123 can be exposed plastic, can include a fabric shell, or can include at least one overmolded material.

[0462] The headgear 7120 includes a vertical member 7125. The vertical member 7125 spans a distance between the lower strap 7121 and the mid-portion strap 7122 in front of the user's ears, thereby forming a portion of the periauricular loop. The vertical member 7125 is formed from a soft-to-the-touch material, such as a fabric or a foam. In the illustrated configuration, the vertical member 7125 includes a plurality of holes. The plurality of holes can improve the elasticity and / or flexibility of the vertical member 7125, thereby improving the perceived comfort by the user.

[0463] A web portion 7127 extends between a rear portion of the continuous mid-portion strap 7122 and a rear portion of the continuous lower strap 7121 and defines a rear portion of the periauricular loop. The web portion 7127 can be made from a soft-to-the-touch material, such as a fabric or a foam. In the illustrated configuration, the web portion 7127 includes a plurality of holes. The plurality of holes can improve the elasticity and / or flexibility of the web portion 7127, thereby improving the perceived comfort by the user.

[0464] In at least one embodiment, the vertical member 7125 can be formed from a quilted fabric. In at least one embodiment, the vertical member 7125 can be formed from a breakthrough internal molding process to include a plurality of holes. In at least one embodiment, the vertical member 7125 can include a plurality of indentations instead of a plurality of holes. In at least one embodiment, the web portion 7127 can be formed from a quilted fabric 7129, as FIG. 62BThe fiber web portion 7127 can be formed from a breakthrough in-mold process to include a plurality of holes in at least one embodiment. In at least one embodiment, the fiber web portion 7127 can include a plurality of dimples instead of a plurality of holes.

[0465] FIGS. 63A-63B One embodiment of a headgear 7130 is shown having quilted fabric or material 7132 provided that is attached to portions of the headgear 7130 that come into direct contact with the skin or hair of the user, for example on the back of the user's neck. The quilted material 7132 not only provides a soft texture, but also provides a cushioning padding that improves the comfort of the headgear 7130, making the user more likely to want to lay down to sleep with the headgear 7130 on. The quilted material 7132 can be stitched or welded to the in-molded straps or fiber web portions of the headgear 7130. The disclosed configurations are not limited to quilted material (shown in FIG. 63B (shown in FIG. 63C (shown in

[0466] FIGS. 64A-64B One embodiment of a headgear 7140 is shown having fabric or textile material provided that is attached to portions of the headgear 7140 that come into direct contact with the skin or hair of the user. The headgear 7140 includes vertical members 7142 and a rear strap 7144 that are formed from a material for providing a cushioning padding and improving the comfort of the headgear 7140. The material can be stitched or welded to the in-molded straps of the headgear 7140. The disclosed configurations are not limited to fabric or textile material, but can include quilted material (shown in FIG. 64B (shown in

[0467] FIG. 65 One embodiment of a strap trademark grip 3300 that can be used with one embodiment of the disclosed headgear is shown. The strap trademark grip 3300 can be formed from plastic using a breakthrough in-mold process.

[0468] Internally molded strap connector

[0469] FIGS. 66A-73Various views are shown of a connector 3400 positioned above the joint between two straps in an internally molded headband embodiment. The connector 3400 is used at the joint or connection 3500 between two or more adjacent straps in an internally molded headband. More specifically, the connector 3400 is used to join two or more straps together using breakthrough internal molding. The connector 3400 can be used with any type of connection 3500 between two or more straps, and the connection 3500 shown herein is merely one example. The connector 3400 provides a cleaner and stronger connection between straps and also improves the ease of aligning the straps within the molding tool.

[0470] like FIG. 66A and FIG. 67 As shown, the first strap 3710 and the second strap 3720 are connected at a T-shaped connection between the end of the first strap 3710 and the center or middle portion of the second strap 3720 (i.e., a portion between the ends of the second strap 3720). A connector 3400 is positioned above the first strap 3710 and the second strap 3720 at the connection 3500. That is, the connection 3500 is positioned within the connector 3400 such that the connector 3400 surrounds the connection 3500. The first strap 3710 and the second strap 3720 are connected via a breakthrough internal molding process, during which the plastic core 3800 is injected at the injection point 3600 (at... FIG. 66A The plastic core material 3800 is injected into the second strap 3720 at the end shown in the diagram. The plastic core material 3800 fills and propagates through the second strap 3720. Upon reaching the connecting portion 3500, the plastic core material 3800 breaks through the sidewall of the textile shell of the second strap 3720 to fill all or part of the cavity of the textile shell of the first strap 3710, as shown in the diagram. FIG. 66A The red arrow at the connection point is indicated in the diagram. In some configurations, connector 3400 has a cavity 3420 that is also filled with a plastic core 3800 that extends beyond the sidewalls of the textile outer shells of the first strap 3710 and the second strap 3720. The plastic core 3800 can also be integrated with connector 3400, such that the plastic core 3800 and connector 3400 are integrally formed. In some configurations, the plastic core 3800 and connector 3400 can be formed from the same or similar materials.

[0471] The connector 3400 houses any loose threads at the end of the straps within the connector 3400, such that the connection 3500 has a neat aesthetic appearance. That is, the loose ends of the first strap 3710 and / or the second strap 3720 are housed within the connector 3400, which prevents the straps 3710, 3720 from further fraying. Additionally, the connector 3400 can have an opaque color, thereby hiding the appearance of the loose ends, such that the connection 3500 has a more neat aesthetic appearance. Still further, the connector 3400 defines the final shape of the connection 3500, and houses any broken plastic flash that escapes from the ends of the first strap 3710 and the second strap 3720, such that the connection 3500 has a neat aesthetic appearance.

[0472] The connector 3400 also provides an abutment edge 3417 for joining 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 connection 3500 without the connector 3400), which provides a greater connection area between the first strap 3710 and the second strap 3720. That is, the connector 3400 provides a wider, chamfered connection 3500 between the end of the first strap 3710 and the housing of the second strap 3720, which provides a greater connection area, thereby increasing the strength of the connection 3500. As FIG. 67 shown, the end of the first strap 3710 is both filled with and surrounded by the plastic material, rather than having the plastic material inside the tube of the strap housing. Thus, the strength of the connection 3500 is increased.

[0473] FIGS. 68A-68D Various views of the connector 3400 are shown. As shown, the connector 3400 includes a tubular sheath having a cavity 3420 between an encircling strap end 3418 and an abutment end 3416. The connector 3400 has a body 3410, which is comprised of a first half 3412 and a second half 3414 joined along opposite edges. In the configuration shown, the first half 3412 and the second half 3414 are identical. In other configurations, the first half 3412 and the second half 3414 are different and / or asymmetric. The open ends of both the first half 3412 and the second half 3414 form the abutment end 3416 and the encircling strap end 3418 of the connector 3400. The encircling strap end 3418 receives or encircles the first strap 3710, and the abutment end 3416 receives or abuts against the second strap 3720. As FIG. 68BAs shown, 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 an abutment end 3416, while the narrower end forms an encircling strap end 3418. In some configurations, the abutment end 3416 can be twice as wide as the encircling strap end 3418.

[0474] The encircling strap end 3418 defines an oblong hole configured to fit snugly onto and in close abutment with the outer surface of the textile strap shell of the first strap 3710. When viewed from below, the abutment end 3416 forms a substantially rectangular hole with rounded ends (as shown in FIG. 68A The abutment end 3416 is curved to match the shape and curvature of the second strap 3720. The edge of the abutment end 3416 is configured to overhang and encircle the outer edge of the second strap 3720 (the area between the dashed lines in FIG. 68B and the abutment edge 3417 overhangs the second strap 3720). The edge of the abutment end 3416 is also configured to be positioned above the outer surface of the textile strap shell of the second strap 3720. In some configurations, the overhanging edge 3419 can form a loose fit with the textile strap shell of the second strap 3720 such that the connector 3400 does not restrict the flow of plastic core material 3800 through the second strap 3720.

[0475] The connector 3400 allows the end of the first strap 3710 to align and abut with the edge of the second strap 3720 without a gap between the first strap 3710 and the second strap 3720 when the first strap 3710 and the second strap 3720 are molded internally. That is, the snug fit provided by the connector 3400 to the first strap 3710 maintains the first strap 3710 aligned in the molding tool prior to injection of the plastic core material 3800. Unlike the straps 3710, 3720, the connector 3400 is semi-rigid and maintains its shape, which allows the connector 3400 to be reliably positioned within the molding tool.

[0476] During assembly of the straps 3710, 3720 with the connector 3400, the connector 3400 is positioned over the tubular textile shell of the first strap 3710. That is, as shown in FIG. 69 the connector 3400 is slid over the first strap 3710 such that the end of the first strap 3710 is positioned inside the connector 3400. Then, the abutment edge 3417 of the connector 3400 abuts with the edge of the textile shell of the second strap 3720. As shown in FIG. 70As shown, the end of the first strap 3710 is positioned within the cavity 3420 of the connector 3400 adjacent to the edge of the second strap 3720. The cavity 3420 is a hollow region defined by the first half 3412, the second half 3414, the end-encircling portion 3418, and the abutment end 3416 of the connector 3400. The connector 3400 fits tightly onto the first strap 3710 such that the connector 3400 remains fixed to the first strap 3710.

[0477] The assembled straps 3710, 3720 and connector 3400 are positioned within and aligned within an injection molding tool. The plastic core material 3800 is injected into the injection point 3600 at one end of the second textile strap 3720 and then breaks through the sidewall of the second strap 3720 to fill the first strap 3710 (see arrow in FIG. 66A FIG. 71 and FIG. 72 As shown, the cavity 3420 of the connector 3400 is also filled with the plastic core material 3800 that breaks through the sidewall of the second strap 3720. The plastic core material 3800 within the straps 3710, 3720 forms an integral structure with the cavity 3420 of the connector 3400. In some configurations, the plastic core material 3800 is bonded with the connector 3400 such that the connector 3400, straps 3710, 3720, and plastic core material 3800 are formed as an integral structure.

[0478] It will be appreciated by those of ordinary skill in the art that the connector 3400 and strap arrangement is not limited to a T-shaped connection, but rather can connect the straps 3710, 3720 with the connection 3500 at a variety of angles. Similarly, the connector 3400 can be shaped and configured to connect more than two straps together. For example, the connector 3400 can have multiple end-encircling portions 3418 or abutment ends 3416.

[0479] In an alternative configuration, the connector 3400 (substantially the same as the previously described embodiment) is integrally formed with the first strap 3710 by overmolding one end of the tubular textile strap housing, as shown in FIG. 73 The abutment end 3416 of the connector 3400 extends from the end of the textile strap such that it can be aligned with and abut the second strap 3720. The cavity 3420 of the connector 3400 remains hollow such that the plastic core material 3800 can flow through the second strap 3720 and break through 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 end-encircling portion 3418 of the connector 3400 and the first strap 3710.

[0480] ​In some embodiments, at least one of the first strap 3710 and the second strap 3720 can include a woven textile shell. The woven textile shell includes a plurality of yarns provided in at least two different colors or shades. Weaving the yarns of different colors forms color blocks within the textile shell having a random or semi-random pattern, which results in the textile shell having a mottled appearance. In some cases, this mottled appearance can mask or hide some of the physical features formed by the plastic core, such as the transition between the soft edge (222) and the core material, which makes the feature (and the headgear) appear softer. FIG. 2B

[0481] In another alternative configuration, the connector 3400 can be configured such that the connector 3400 does not overhang above the edge of the second strap 3720. Rather, the connector 3400 is configured to abut and rest directly against the edge of the second strap 3720, as shown in FIG. 73 Thus, the connector 3400 is substantially or entirely integrated with the breakthrough plastic core material 3800. That is, the overhanging portion of the previously described connector arrangement is not integrated with the plastic core material 3800 compared to the previously described connector arrangement.

[0482] Internally molded connector

[0483] FIGS. 74A-78B Various views of the internal molded straps, connections, and junctions used to form the bifurcated headgear 100 shown in FIG. 1A The bifurcated headgear 100 includes a top strap 140, a bottom strap 150, and a face mask connector 180. In some configurations, the bifurcated headgear 100 is assembled by joining the top strap 140 with the bottom strap 150. That is, each of the top strap 140 and the bottom strap 150 are formed separately via internal molding prior to joining the top strap 140 with the bottom strap 150. That is, in some configurations, the top strap 140 and the bottom strap 150 are positioned within a molding tool and joined via overmolding. Once the top strap 140 and the bottom strap 150 are formed, they are joined to form the bifurcated headgear 100. However, in some configurations, the top strap 140 and the bottom strap 150 can be moved out of alignment with each other while being disposed within the molding tool and / or during the overmolding process. FIGS. 74A-78B Various strap connectors are shown that maintain the top strap 140 and the bottom strap 150 connected and aligned during the manufacturing and molding process.

[0484] FIG. 74A The top strap 140, FIG. 74B ​The bottom strap 150 is shown prior to assembly. The top strap 140 and the bottom strap 150 are formed separately by injecting the plastic core material 210 into the knitted or woven tubular casing 220 via internal molding. As shown, the top strap 140 includes a substantially straight and continuous strap having a male connector portion 4002 formed at each end. The male connector portion 4002 is integrally formed with the plastic core material 210 and is one piece. The casing 220 is continuous throughout its length. The injection point of the top strap 140 can be at one or both of its ends. That is, one or both of the male connectors can be the location of the injection point for injecting the plastic core material 210 into the casing 220. FIG. 74A

[0485] The bottom strap 150 includes the plastic core material 210 injected into the first woven casing portion 220A and the second woven casing portion 220B. The casing portions 220A, 220B can form the left and right portions of the top strap 140 and the bottom strap 150. The casing portions 220A, 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 such that the casing portions 220A, 220B are filled with the plastic core material 210 from the first free ends 4020. The plastic core material 210 filling the casing portions 220A, 220B is integrally formed and is one piece throughout the length of the plastic core material 210. That is, the plastic core material 210 joins the casing portions 220A, 220B to connect the casing portions 220A, 220B and form the bottom strap 150.

[0486] In some configurations, the casing portions 220A, 220B are partially filled with the plastic core material 210. That is, the second ends 4022 of the casing portions 220A, 220B can 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 and house portions of the face mask connector 180 (see FIG. 1A ). That is, portions of the face mask connector 180, such as the filament core 1550 (see FIGS. 15A-15D ), can be housed within the casing portions 220A, 220B of the hollow free end 4030. In some configurations, the casing portions 220A, 220B can be filled with the plastic core material 210 through the length of the bottom strap 150. That is, the plastic core material 210 can extend between the first free ends 4020 and the second free ends 4022 of the casing portions 220A, 220B. In some configurations, portions of the face mask connector 180 can be formed on the second free ends 4022 of the bottom strap 150. ​

[0487] The bottom strap 150 includes a female connector 4004 positioned between the first free end 4020 and the second free end 4022 of the shell portions 220A, 220B. The female connector 4004 is configured to interlock with the male connector 4002 such that the top strap 140 and the bottom strap 150 are connected. The female connector 4004 is formed from the plastic core material 210 that has broken through the walls of the shell portions 220A, 220B. That is, the female connector 4004 is formed through a break-through internal molding process. The female connector 4004 is integrally formed with the plastic core material 210 within the shell portions 220A, 220B and is one piece. The female connector 4004 is positioned at the apex of the curvature 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.

[0488] FIG. 75A And FIG. 75B is a view of the male connector 4002 of the top strap 140. As shown, the male connector 4002 extends out and protrudes outward beyond the end of the shell 220. The male connector 4002 is formed from the plastic core material 210 that is positioned beyond the end 4024 of the shell 220. The male connector 4002 includes a protrusion 4040 that is configured to interlock with a slot 4042 of the female connector 4004. The protrusion 4040 has a shape that corresponds to the shape of the slot 4042 such that the male connector 4002 fits and engages with the female connector 4004 like a puzzle piece.

[0489] The protrusion 4040 includes a head 4050 and a stem 4052. The stem 4052 is an extension of the plastic core material 210 positioned between the head 4050 and the end 4024 of the shell 220. The head 4050 is illustrated as having an inverse arrowhead shape that interlocks with the slot 4042 of the female connector 4004. The shape of the slot 4042 corresponds to and interlocks with the inverse arrowhead shape of the head 4050. The head 4050 is not limited to an inverse arrowhead shape and any interlocking shape can be used.

[0490] FIG. 75B is a side view of the top strap 140. As shown, the head 4050 has a thickness T1 and the stem 4052 has a thickness T2. The thickness T1 of the head 4050 is greater than the thickness T2 of the stem 4052. The difference between the thicknesses T1 and T2 allows the overmolded plastic to flow around the head 4050 of the male connector 4002 when the top strap 140 is joined to the bottom strap 150. In some configurations, the narrower thickness T2 allows the head 4050 to be surrounded by the overmolded plastic material.

[0491] FIGS. 76A-76Care various views of a female connector 4004 of the top strap 150. The female connector 4004 has a triangular shape that extends radially outward and protrudes beyond the surface of the housing portions 220A, 220B. The female connector 4004 is formed from the plastic core material 210 that breaks through the housing portions 220A, 220B during the break-through inside molding process. The female connector 4004 includes a protrusion 4046 that is in the shape of a tab that is formed with a slot 4042. As shown, the protrusion 4046 has a central region 4044 and a peripheral region 4048 that extends outward from the central region 4044. The thickness T3 of the central region 4044 is greater than the thickness T4 of the peripheral region 4048. The greater thickness T3 of the central region increases the strength of the protrusion 4046 while allowing the overmold plastic to flow around the protrusion 4046 when joining the top strap 140 and the bottom strap 150. The thickness T3 of the central region 4044 can be equal to the thickness Tl of the head 4050 of the male connector 4002. FIG. 76C

[0492] The slot 4042 is formed within and extends through both the central region 4044 and the peripheral region 4048. The shape of the slot 4042 matches and interlocks with the reverse arrowhead shape of the head 4050. The slot 4042 is open in a direction away from the housing portions 220A, 220B such that the head 4050 is inserted into and received by the slot 4042. The slot 4042 is centrally located on the radially outermost portion of the peripheral region 4048. When the female connector 4004 is formed via the break-through injection molding process, the slot 4042 can be formed into the female connector 4004 and shaped to the shape of the female connector 4004. In other configurations, the plastic core material 210 can be removed from the female connector 4004 to form the slot 4042, such as via a cutting process.

[0493] ​The slot 4042 is configured to receive at least the head 4050 of the male connector 4002 such that the top strap 140 and the bottom strap 150 can be joined and overmolded to form a permanent joint therebetween. That is, the top strap 140 and the bottom strap 150 are loaded into an overmolding tool, the head 4050 is inserted into the slot 4052 such that the male connector 4002 and the female connector 4004 are connected and the top strap 140 and the bottom strap 150 are properly aligned. Once aligned, the overmolding tool is closed and overmolding plastic material is injected into the overmolding tool to form a permanent overmold joint over the male connector 4002 and the female connector 4004. Connecting and aligning the straps 140, 150 prior to overmolding the male connector 4002 and the female connector 4004 improves strap alignment accuracy and reduces the likelihood of the straps 140, 150 moving during overmolding, thereby improving the efficiency of the manufacturing process.

[0494] FIG. 77A It is shown that the male connector 4002 is aligned with the female connector 4004 prior to inserting the head 4050 into the slot 4042. FIG. 77B It is shown that the head 4050 is inserted into and received by the slot 4042 such that the male connector 4002 and the female connector 4004 are connected. FIG. 77C It is shown that the thicknesses of both the male connector 4002 and the female connector 4004 are compared. The increased thicknesses Tl, T3 of both the head 4050 of the male connector 4002 and the central region 4044 of the female connector 4004 are aligned and form upper and lower surfaces 4060, 4062, respectively. The upper and lower surfaces 4060, 4062 are configured to abut opposing inner surfaces of a mold cavity in an overmolding tool. This facilitates alignment of the top strap 140 and the bottom strap 150 within the overmolding tool. The upper and lower surfaces 4060, 4062 are shown as flat, planar surfaces, but are not limited thereto. Accordingly, the opposing surfaces of the mold will have a corresponding shape to engage the upper and lower surfaces 4060, 4062.

[0495] In some configurations, the head 4050 and the slot 4052 can be sized and shaped such that there is an amount of clearance between them when the head 4050 and the slot 4052 are engaged. A tight connection fit between the male and female connectors without clearance can result in no space for overmolding plastic material to flow between the connectors. This results in an overmolded connection having a weak area formed by the clearance or gap within the overmold joint, which can reduce the durability of the headband. FIG. 78A and FIG. 78BThe gap 4064 between the head 4050 and the slot 4052 is shown when the male connector 4002 and the female connector 4004 are in a connected state. FIG. 78B The gap 4064 between the head 4050 and the slot 4052 is shown when the male connector 4002 and the female connector 4004 are in a connected state. FIG. 78A The gap 4064 between the head 4050 and the slot 4052 is shown when the male connector 4002 and the female connector 4004 are in a connected state. FIG. 78A In this configuration, the gap 4064 is small, such that the connection between the male connector 4002 and the female connector 4004 has a tight fit similar to a puzzle piece. In this configuration, the gap 4064 is small, such that the top strap 140 and the bottom strap 150 are held in place by the male connector 4002 and the female connector 4004. FIG. 78B In this configuration, the gap 4064 is large, which allows the top strap 140 and the bottom strap 150 to fit more loosely and generally align within the overmolding tool. The larger gap 4064 allows the overmolding plastic to flow between the connectors 140, 150 to provide a strong joint. In this configuration, the gap 4064 is large, which allows the top strap 140 and the bottom strap 150 to fit more loosely and generally align within the overmolding tool. FIG. 78B In this configuration, the gap 4064 is preferably about 1.0 mm. In some configurations, the gap 4064 is between 0.1 mm and 1.0 mm.

[0496] FIG. 79A An alignment recess 4070 formed on the head 4050 of the male connector 4002 is shown, which is configured to receive an alignment positioning pin 4072 positioned on an opposing inner surface of a mold cavity 4076 in an overmolding tool portion 4074. FIG. 79B An overmolding tool portion 4074 is shown having a mold cavity 4076 with a positioning pin 4072 protruding from a surface of the mold cavity 4076. The positioning pin 4072 is configured to be inserted into and received by the recess 4070, such that the head 4050 of the male connector 4002 is aligned and maintained in place within the mold cavity 4076 during positioning of the top strap 140 and the bottom strap 150, as well as during the overmolding process. The positioning pin 4072 can limit movement of the head 4050 within the mold cavity 4076. The positioning pin 4072 can also inhibit or prevent the male connector 4002 from being unlocked from the female connector 4004 prior to or during the overmolding process. In some configurations, the positioning pin 4072 can hold the head 4050 in a position such that the gap 4064 between the male connector 4002 and the female connector 4004 is maintained.

[0497] In some embodiments, the recess 4070 and the positioning pin 4072 can have corresponding shapes, sizes, and geometries. The recess 4070 is shown as a triangular recess formed at an interior corner of the head 4050, but is not limited thereto. The positioning pin 4072 is shown as a cylindrical post, but is not limited thereto. The triangular recess 4070 is configured to receive the positioning pin 4072 in one of the vertices of the triangular recess, as shown in FIG. 79AAs indicated by the dashed circle in the diagram. The locating pin 4072 has cylindrical sides that are configured to abut against the side surface of the head 4050 so that the head 4050 of the male connector 4002 is aligned within the mold cavity 4076.

[0498] FIGS. 80A-80C The top strap 140 and bottom strap 150 after the overmolding process are shown. As shown, an overmolded joint 4006 is molded over the male connector 4002 and female connector 4004, permanently bonding the top strap 140 and bottom strap 150 together. In some configurations, the overmolded joint 4006 may be formed of a plastic core 210, which is the same plastic core used to form the inner cores of both the top strap 140 and bottom strap 150, as well as the plastic cores of the male connector 4002 and female connector 4004. In other configurations, the overmolded joint 4006 may be formed of a different material, such as an elastomer.

[0499] like FIG. 80A and FIG. 80B As shown, the overmolded joint 4006 has a top edge 4056 that extends above the edge of the top strap 140 and extends to the surface of the top strap 140. That is, the overmolded joint 4006 overlaps with and is bonded to the housing 220 of the top strap 140. Similarly, the overmolded joint 4006 has a bottom edge 4058 that extends above the edge of the bottom strap 150 and extends to the surface of the bottom strap 150. That is, the overmolded joint 4006 overlaps with and is bonded to the housing 220 of the bottom strap 150. Bonding the overmolded joint 4006 to the top strap 140 and the bottom strap 150 increases the connection area between the overmolded joint 4006 and the top strap 140 and the bottom strap 150, thereby increasing the strength of the overmolded joint 4006. Furthermore, the overmolded joint 4006 extends beyond the end of the housing 220, thus enclosing the end of the housing 220 within the overmolded joint 4006, thereby improving the durability and appearance of the finished headband. In other words, the loose ends of the housing are closed and bonded within the overmolded joint 4006.

[0500] like FIG. 80CAs shown, the thickness T of the overmolded junction 4006 is substantially equal to the thickness of the top strap 140 and the bottom strap 150, and also equal to the thickness of the male connector 4002 and the female connector 4004. That is, the thickness T of the overmolded junction 4006 is equal to the thickness Tl of the head 4050 and the thickness T3 of the central region 4044. Thus, because the overmolded junction 4006, as well as the top strap 140 and the bottom strap 150, have equal thicknesses, the connection and transition regions between the straps 140, 150 provide a continuous thickness across the length of the straps 140, 150, which improves the aesthetics and comfort of the headband.

[0501] Joining tab using alignment posts

[0502] FIGS. 81A-81C The bottom strap 150 is shown formed by overmolding two empty textile shells 220 of the bottom strap halves 150A, 150B together. The joining strap halves 150A, 150B are shown in the context of the bottom strap 150, but are not limited to forming the bottom strap, and can be used to form any headband strap. The bottom strap 150 is formed using a single injection molding shot overmolding the plurality of textile shells 220 together to form the integral strap 150. The textile shells 220 are connected by an integral plastic core 210 formed within the two shells 220. The joining tab 4008 is positioned between the free ends 4026 of the shells 220 and is formed from the plastic core 210. The joining tab 4008 extends between the two strap halves 150A, 150B and provides a central injection point 4010 for injecting the strap halves using the plastic core 210. The joining tab 4008 is configured for overmolding to provide a neat and durable junction between the strap halves 150A, 150B. Any excess material or gates formed at the injection point are trimmed off prior to overmolding.

[0503] The end portions of the joining tab 4008 include a pair of alignment posts 4078 that protrude and extend from the upper surface 4018 and the lower surface 4028 of the joining tab 4008 in opposite directions (e.g., the thickness direction). The alignment posts 4078 are shown as, but are not limited to, rectangular-shaped protrusions that extend across the width of both the upper surface 4018 and the lower surface 4028 of the joining tab 4008. The alignment posts 4078 are configured to abut the inner surfaces of the mold cavities of an overmolding tool such that the ends 4026 of the strap halves 150A, 150B are aligned (e.g., in the thickness direction of the strap) within the overmolding tool.

[0504] FIG. 81CAn alignment post 4078 extending from the upper surface 4018 and the lower surface 4028 of the web 4008 is shown. The web 4008 is shown as having a thickness T6. The region of the web 4008 that includes the alignment post 4078 has a thickness T5. The thickness T5 of the region that includes the alignment post 4078 is greater than the thickness T6 of the region that does not include the alignment post 4078. The alignment post 4078 can also maintain a gap between the upper surface 4018 and the lower surface 4028 of the web 4008 and the inner surface of the mold cavity, which allows the overmold plastic to flow over the web 4008 to provide a strong joint.

[0505] FIG. 81D and FIG. 81E Strap halves 150A, 150B after overmolding the web 4008 are shown. As shown, an overmold 4080 is formed over the web 4008. The overmold 4080 can be formed of the same material as the base strap 150 (e.g., the plastic core material 210) or a different material. In some embodiments, the overmold 4080 can include an elastomeric material in order to provide a flexible and comfortable feel between the overmold 4080 and the patient's head. The overmold includes an outer surface 4082 configured to face away from the patient's head in use and an inner surface 4084 configured to contact the patient's head in use.

[0506] FIG. 81D is a top view of the overmold 4080 showing the top surface 4082 of the overmold 4080 that faces away from the patient's head. FIG. 81E is a bottom view of the overmold 4080 showing the bottom surface 4084 of the overmold 4080 that faces toward the patient's head. An indicator 4088 indicating the location of the alignment post 4078 can be formed in or on the surfaces 4082, 4084 of the overmold 4080. The indicator 4088 can be visible through the surfaces 4082, 4084 because the thickness of the overmold 4080 is equal to the thickness T5 of the alignment post 4078. In other configurations, the thickness of the overmold 4080 can be greater than the thickness T5 of the alignment post 4078 such that the alignment post 4078 is not visible through the surfaces 4082, 4084 of the overmold 4080. That is, the outer surface 4082 of the overmold 4080 can be smooth and continuous such that the indicator 4088 indicating the location of the alignment post 4078 is not visible.

[0507] A product label or logo 4086 can also be formed in or on the outer surface 4082 of the overmold 4080. The logo 4086 is molded into the surface 4082 during the overmold process. In some configurations, the alignment posts 4078 can be configured to form a portion of the logo 4086. For example, in the illustrated configuration, one alignment post 4078 can have a shape that includes the letter "F" and the other alignment post has a shape that includes the letter "P." The thickness of the alignment posts 4078 and / or the overmold 4080 can be varied so that the alignment posts 4078 are visible on the surface 4082. In other configurations, the logo 4086 can be formed using a trimming process (e.g., carving, molding, stamping, etc.).

[0508] In some embodiments, a joining tab 4008 can be trimmed between the alignment posts 4078 prior to 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 thus the length of the overmold. That is, in some configurations, the distance between the alignment posts 4078 (e.g., in the lengthwise direction of the bottom strap 150) can be shortened or lengthened to shorten or lengthen the overall length of the bottom strap 150. This approach can be used to provide different headband sizes using the same bottom strap components.

[0509] Injection molded housing

[0510] FIGS. 82A-83E A strap end junction housing 4090 is illustrated into which the ends 4026 of the empty bottom strap halves 150A, 150B are inserted and internally molded to form the integral bottom strap 150. The joining strap halves 150A, 150B are illustrated in the context of a bottom strap 150, but are not limited to forming a bottom strap, and can be used to form any headband strap. The bottom strap 150 is formed using a single injection molding shot that is internally molded with the plurality of textile shells 220 to form the integral strap. Thus, the textile shells 220 are connected by an integral plastic core 210 that is formed within and extends through both of the shells.

[0511] The housing 4090 has an internal cavity 4092 configured to receive the open ends 4026 of two textile housings 220. The housing 4090 may have a shape, size, and geometry corresponding to the shape, size, and geometry of a region within the internal cavity of the internal molding tool, such that the housing 4090 fits securely within the internal molding tool. Therefore, the housing 4090 can be aligned relative to the cavity of the internal molding tool, allowing the ends 4026 of the textile housings 220 to be aligned by the housing 4090 when in the internal molding tool. The housing 4090 is not limited to a rectangular shape or geometry.

[0512] The housing 4090 has an injection port 4094 on at least one side, which provides a channel through which internal molded plastic material 210 can be injected and flow. In some configurations, the injection port 4094 may be located on multiple sides of the housing 4090. FIG. 83E Injection holes 4094 are shown on opposite sides of the housing 4090. The plastic core material 210 can be injected into both holes 4094 simultaneously, or alternatively, one hole 4094 can be blocked while the plastic material 210 is injected into the other hole 4094.

[0513] like FIG. 83D As shown, injection port 4094 is fluidly connected to internal chamber 4092, which receives the open end 4026 of textile housing 220. End 4026 of textile housing 220 opens toward injection port 4094, allowing fluid communication between the internal cavity of textile housing 220 and injection port 4094. During the internal molding process, plastic is injected into textile housing 220 using internally molded plastic core 210 injected into the port 4094 of housing 4090. Internally molded plastic core 210 flows from port 4094 to internal chamber 4092, and then from internal chamber 4092 back into textile housing 220. Housing 4090 provides a central injection point for internally molding textile housing 220. In some configurations, housing 4090 may provide an alternative of overmolding a molded joint over the end of textile housing 220. Therefore, the loose ends of the textile outer shell 220 are closed and housed within the shell 4090, which improves the aesthetics and durability of the headband.

[0514] The internal chamber 4092 has an inner cavity region 4092A located in the central region of the housing 4090. The inner cavity region 4092A has one end opening toward and leading to an injection port 4094, and a second end opening toward and leading to an outer cavity region 4092B. That is, the inner cavity region 4092A is positioned between the injection port 4094 and the outer cavity region 4092B. The injection port 4094 guides the injected plastic material 210 into the inner cavity region 4092A of the internal chamber 4092. An end portion of the housing 220 abuts the inner wall of the outer cavity region 4092B, which provides a fluid path from the injection port 4094 into the cavity of the housing 220, allowing the injected plastic material 210 to flow from the injection port 4094 into the textile housing 220.

[0515] The height D1 of the inner cavity region 4092A is less than the height D2 of the outer cavity region 4092B. The difference between the height D1 of the inner cavity region 4092A and the height D2 of the outer cavity region 4092B creates a stepped profile within the inner cavity 4092, which allows the ends 4026 of the textile outer shell 220 to be spaced apart when positioned within the housing 4090. The height D1 of the inner cavity region 4092A can be substantially equal to the thickness of the core material 210 passing through the textile outer shell 220.

[0516] In some configurations, the length L of the inner cavity region 4092A (e.g.) FIG. 83D (As shown) can be varied so that different lengths of the bottom strap 150 can be formed from the same textile shell 220. That is, different lengths of bottom straps can be formed from a textile shell 220 of a fixed length by changing the length of the shell 4090. The length L of the inner cavity region 4092A causes the ends 4026 of the textile shell 220 to be spaced closer or further apart, which increases or decreases the final length of the strap 150. For example, in some configurations, the bottom straps 150 for medium and medium-to-large headbands can be formed using a textile shell 220 of the same length and a shell 4090 with an inner cavity region 4092A of different lengths L. That is, the difference in length between the medium and medium-to-large bottom straps 150 is provided by the difference in the length L of the inner cavity region 4092A.

[0517] Strap cross section

[0518] FIG. 84A and FIG. 84BA cross-sectional view of the top strap 140 and bottom strap 150 after an internal molding process in which the textile shell 220 is filled with plastic core material 210 is shown. Both the top strap 140 and bottom strap 150 have an inner surface 4066 configured to contact the patient's head and an outer surface 4068 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 such that the outer surface 4068 has a convex curvature and the inner surface 4066 has a substantially flat, planar, or straight profile. In some configurations, the inner surface 4066 can have a concave curvature.

[0519] The flat profile of the inner surface 4066 is configured to have an increased contact area with the patient's head in order to more evenly distribute (compared to a convex profile) any load in the headgear across the patient's head. This improves the stability of the headgear and the comfort of the patient. The convex curvature of the outer surface 4068 provides the straps with a degree of rigidity and also provides the headgear with a soft or aesthetically appealing appearance.

[0520] Strap soft edge

[0521] FIG. 84A A top strap 140 and bottom strap 150 with plastic core material 210 are shown that include a flange portion 4036 that fills the outer edge portion of the textile shell 220. The flange portion 4036 provides a hard and rigid edge treatment for the top strap 140 and bottom strap 150. FIG. 84B A top strap 140 and bottom strap 150 with soft edge portions 4038 are shown that are formed due to the absence of plastic core material 210 within the soft edge portions 4038. The soft edge portions 4038 are portions of the shell 220 that are not filled with plastic core material 210 such that the textile shell 220 remains pliable and flexible. Thus, the soft edge portions 222 provide a soft or cushioned edge for the top strap 140 and bottom strap 150 that is not only comfortable when resting against a user's skin but also aesthetically pleasing.

[0522] In some configurations, the soft edge portions 4038 are formed by crimping the edges of the tubular shell 220 prior to injecting the plastic core material 210 such that the plastic core material 210 is inhibited or restricted from flowing into the crimped portions of the shell 220. The edges are crimped by portions of the molding tool that are adjacent to the mold cavity. The depth to which the edges of both the top strap 140 and bottom strap 150 are crimped by the molding tool can vary along the length of the top strap 140 and bottom strap 150 such that the width of the plastic core material 210 is greater at the center of the top strap 140 and bottom strap 150 than at the edges of the top strap 140 and bottom strap 150. FIG. 84Aand FIG. 84B The width of the plastic core 210 can vary along the length of the top strap 140 and the bottom strap 150 (e.g., in the horizontal direction). Thus, the width of the plastic core 210 can be wider at different regions of both the top strap 140 and the bottom strap 150 to reinforce and provide additional strength to those regions. Similarly, in some configurations, the width of the plastic core 210 can be narrower at certain regions along the length of both the top strap 140 and the bottom strap 150 in order to provide flexibility to those narrower regions. Those of ordinary skill in the art will appreciate that the shape and geometry of the plastic core can vary in order to provide strength and rigidity to the top strap 140 and the bottom strap 150 in desired directions.

[0523] FIG. 85 A top strap 140 is shown joined to a bottom strap 150 having a soft edge portion 4038 disposed along its length. The bottom strap 150 has a curved shape with a wavy profile to form an ear bow region 4016 that is positioned over the user's ear when in use. As shown, the width Wl of the soft edge portion 4038 at the ear bow region 4016 is greater than the width W2 of the soft edge portion 4038 at the rest of the bottom strap 150. The soft edge portion 4038 in the ear bow region 4016 has an increased width relative to the rest of the bottom strap 150 in order to provide increased softness / cushioning and comfort in the event that the ear bow region should come into contact with the patient's ear during use. The user's ear bow region is a sensitive area and contact with it can cause discomfort.

[0524] In some configurations, the headgear can include a four-point connection configuration with upper and / or lower side straps (or other configurations). In such configurations, any strap that is proximal to the patient's ear in use can include an increased soft edge width.

[0525] Combination top back strap with overmolded connection

[0526] FIG. 86A headband arrangement 5000 is shown, comprising a rear strap portion 140 and a top strap portion 150, which are integrally formed as a single halo or rear headband loop strap 5002. The headband loop strap 5002 is connected to a front strap 5004 via an overmolded engagement 5006. The front strap 5004 is formed separately from the headband loop strap 5002 and then connected to the rear headband loop 5010 via an overmolded engagement. The front strap 5004 may include an internally molded strap portion, a braided filament housing for a locking mechanism, or a combination of both. In one embodiment, the front strap 5004 of the headband arrangement 5000 may be configured to include a size adjustment mechanism comprising a locking mechanism and filaments. This is advantageous because it allows the braided strap to accommodate filaments to be manufactured and to be tested as a separate component. This reduces the complexity of manufacturing these components and prevents the headband or a large portion of the headband from being wasted if the tolerance or operation of the locking mechanism is compromised and / or defective. In other words, since the front strap 5004 is formed separately from the headband loop strap 5002, there is no need to scrap the entire headband if the locking mechanism is faulty or defective.

[0527] The ends of the headband loop 5002 are connected together by a molded overlay 5008 to form a rear headband loop 5010 (indicated by a dotted line) that receives or covers the back of the patient's head like a cup. The molded overlay 5008 is located at the top of the patient's head during use. Positioning the molded overlay 5008 at the top of the patient's head is advantageous because the top of the user's head does not contact the bed or pillow, which could exert force on the overlay 5008 and cause it to embed into the patient's head. In other words, positioning the molded overlay 5008 at the top of the patient's head may provide greater patient comfort.

[0528] like FIG. 87A As shown, the headband loop 5002 is formed from a single internally molded component that combines the top strap 140 and the rear strap 150. The headband loop 5002 is formed from a single-length textile outer shell material 220 filled with a plastic core material 210. The headband loop 5002 includes alignment tabs 5020 formed at and extending from the free ends of the top strap portion 140. The headband loop 5002 also includes a breakout tab 5030 positioned between the top strap portion 140 and the bottom strap portion 150.

[0529] Alignment patch 5020 is basically similar to FIGS. 81A-81EThe alignment tab 5020 is formed from the plastic core material 210 and is configured to align the ends of the headband loop strap 5002 within an overmolding tool used to form the overmolding joint between the top strap portions 140. Joining the ends of the top strap portions 140 together forms the closed loop of the rear headband loop 5010.

[0530] The alignment tab 5020 includes alignment posts 5022 configured to align the ends of the top strap portions 140 within the overmolding tool. As shown in FIGS. 18 and 19, the alignment posts 5022 also have raised abutment surfaces 5024 configured to abut, engage, and / or contact the inner walls of the overmolding tool cavities and align the alignment tab 5020 within the tool (e.g., in the thickness, width, and / or lengthwise direction of the headband loop strap 5002). Similar to the joining tab 4008, the alignment tab 5020 is overmolded to join the ends of the headband loop strap 5002 when the alignment tab 5020 is aligned within the overmolding tool. FIG. 88A and FIG. 88B As shown, the alignment posts 5022 also have raised abutment surfaces 5024 configured to abut, engage, and / or contact the inner walls of the overmolding tool cavities and align the alignment tab 5020 within the tool (e.g., in the thickness, width, and / or lengthwise direction of the headband loop strap 5002). Similar to the joining tab 4008, the alignment tab 5020 is overmolded to join the ends of the headband loop strap 5002 when the alignment tab 5020 is aligned within the overmolding tool.

[0531] The headband loop strap 5002 includes two breakaway tabs 5030 configured to overmold with the ends of the front strap 5004. The breakaway tabs 5030 are substantially similar to the male connector 4002 in the previous embodiments. As shown in FIGS. 20 and 21, the breakaway tabs 5030 include a head portion 5032 that engages and interlocks with the features of the overmolding joint 5006 such that the headband loop strap 5002 and the front strap 5004 are connected. The head portion 5032 consists of a protrusion that forms a raised abutment surface 5034. The abutment surface 5034 is configured to abut, engage, and / or contact the inner walls of the overmolding tool cavities and align the breakaway tab 5030 within the tool (e.g., in the thickness, width, and / or lengthwise direction of the headband loop strap 5002). The abutment surface 5034 is flush with the outer surface 5008 of the overmolding joint 5006 to provide a smooth transition between the headband loop strap 5002 and the front strap 5004. FIG. 89A and FIG. 89B As shown, the alignment posts 5022 also have raised abutment surfaces 5024 configured to abut, engage, and / or contact the inner walls of the overmolding tool cavities and align the alignment tab 5020 within the tool (e.g., in the thickness, width, and / or lengthwise direction of the headband loop strap 5002). Similar to the joining tab 4008, the alignment tab 5020 is overmolded to join the ends of the headband loop strap 5002 when the alignment tab 5020 is aligned within the overmolding tool.

[0532] The headband loop strap 5002 and the front strap 5004 are joined by overmolding the overmolding joint 5006 over the breakaway tabs 5030 and the end portions of the front strap 5004. In some configurations, the overmolding joint 4006 can be formed from the same material as the plastic core material 210 used to form the inner core of the headband loop strap 5002. In other configurations, the overmolding joint 5006 can be formed from a different material, such as an elastomer.

[0533] like FIG. 89A and FIG. 89B As shown, the head portion 5032 of the breakout tab 5030 is surrounded and held within the overmolded engagement 5006. A locking hole 5036 is formed within the overmolded engagement 5006 and configured to secure the front strap 5004 in place. The locking hole 5036 is formed into the overmolded engagement 5006 through a protrusion projecting from the inner wall of the overmolding tool cavity.

[0534] In some configurations, the headband loop strap 5002 and the front strap 5004 can be connected by a connector that engages with the push-pull tab 5030 and the end portion of the front strap 5004. Thus, while securing the end portion of the front strap 5004, the connector can also engage the head portion 5032 of the push-pull tab 5030, thereby connecting the headband loop strap 5002 and the front strap 5004.

[0535] Alignment posts, pin holes, and indentations

[0536] FIGS. 90A-92D Internally molded top straps 140 and bottom straps 150 are shown, including alignment posts 5102 protruding through a textile housing 220 and alignment recesses or pin holes 5104 recessed into the textile housing 220. Alignment posts 5102 are configured to abut against an inner surface of the overmolding tool cavity, similar to male connector head 4002 and alignment tab 5020. Alignment posts 5102 align and position the ends of the straps within the overmolding tool. Alignment posts 5102 protrude from at least one of the top surface 5112 and bottom surface 5114 of the top strap 140 and bottom strap 150. Alignment posts 5102 protrude through the textile housing 220. Alignment posts 5102 are formed into the textile housing 220 during the internal molding of the top straps 140 and bottom straps 150. FIG. 90B and FIG. 90D Alignment posts 5102 formed on the breakthrough tab 5120 are shown. The alignment posts 5102 of the breakthrough tab 5120 are formed of plastic core material 210 and are substantially similar to the alignment posts 5022 of the alignment tab 5020.

[0537] The user-facing surface (or bottom surface) 5114 includes pin holes 5104 that are partially recessed into the thickness of the straps 140, 150. The pin holes 5104 are configured to receive pins that protrude, for example, from the surface of an internal cavity of the overlay molding tool. The pins and pin holes 5140 are substantially similar to... FIG. 79A-79CThe pin holes 5104 are formed on the bottom surface 5114 so as to be invisible when in use by a wearer. In some configurations, the pin holes 5104 can be formed in one or both of the top surface 5112 and the bottom surface 5114 of the top strap 140 and the bottom strap 150. In some configurations, the depth of the pin holes 5104 can be less than the thickness of the top strap 140 and the bottom strap 150. In some configurations, the depth of the pin holes 5104 can be equal to the thickness of the top strap 140 and the bottom strap 150.

[0538] The breakaway tab 5120 and the ends of the top strap 140 and the bottom strap 150 both include indentations on the inner surface 5112 and the outer surface 5114. These indentations 5106 are recessed into the plastic core material 210 of the breakaway tab 5120 and into the textile shell 220 at the ends of the top strap 140 and the bottom strap 150. As shown, the indentations 5106 are configured to provide increased thickness and increased surface area in the area of the overmolded joint 5130 that engages with the indentations so as to form a mechanical connection between the overmolded joint 5130 and the strap 140, 150. The increased surface area provided by the indentations 5106 improves the strength of the overmolded joint 5130. FIGS. 91A-91D

[0539] FIGS. 92A-92D The top strap 140 and the bottom strap 150 are shown after the overmolding of the overmolded joint 5130 over the breakaway tab 5120 and the ends of the top strap 140 and the bottom strap 150. The overmolded joint 5130 provides a permanent overmolded connection over the top strap 140 and the bottom strap 150. The overmolded joint 5130 is formed in a similar manner to the overmolded joints previously described. Since the alignment post 5102 has the same thickness as the overmolded joint 5130, it is possible to form a logo mark in the overmolded joint 5130. In some configurations, a trademark 5150 can be formed into the overmolded joint 5130. FIG. 92C and FIG. 92D The increased thickness of the overmolded joint material provided by the indentations 5106 is shown. The overmolded joint 5130 also overlaps the edge of the bottom strap 150 to improve the strength of the joint between the top strap 140 and the bottom strap 150.

[0540] ​In some configurations, an overmolded connector 5140 can be provided on the free end of either of the straps 140, 150. The overmolded connector 5140 is formed similarly to the overmolded engagement 5130 and can engage the alignment post 5102 and the press recess 5106 of the strap 140, 150. The connector 5140 can include a loop or clip configured for connection to another headgear or mask component.

[0541] The following disclosure relates to a headgear assembly 8000 for a patient interface 8002 configured to deliver a respiratory therapy to a patient or user. FIGS. 93A-93C A non-limiting exemplary embodiment of a patient interface 8002 is shown, including a non-limiting exemplary embodiment of a headgear assembly 8000 and a mask assembly 8004. The mask assembly 8004 can be any suitable arrangement for delivering a flow of breathing gas to an airway of a patient or user. The mask assembly 8004 can include a main body and one or more sealing cushions. In some configurations, the main body is more rigid than the one or more sealing cushions. In some configurations, the main body and the one or more cushions are integrally or monolithically formed. The sealing cushions are configured to form a seal with one or both of the patient’s or user’s nose and mouth. The mask assembly 8004 may, for example, but not by way of limitation, be a full-face mask, a nasal mask, a nasal cushion, a nasal pillow, or a nasal cannula. Accordingly, the mask assembly 8004 is represented by a dashed box in the figures.

[0542] The headgear assembly 8000 includes a headgear 8006 and at least one connector 8008. In the illustrated arrangement, the at least one connector 8008 includes a first connector 8008 and a second connector 8008 (not shown). The headgear assembly 8000 is substantially symmetrical about a sagittal plane of the user. Accordingly, the second connector 8008 can be a mirror image of the illustrated first connector 8008, so the description of the first connector 8008 can equally apply to the second connector 8008. Similarly, the left side (from the perspective of the patient or user) of the headgear 8006 can be a mirror image of the right side. The first connector 8008 and the second connector 8008 are each connected to the mask assembly 8004 at an anterior portion 8008a and to the headgear 8006 at a posterior portion 8008b. In some configurations, the first connector 8008 and the second connector 8008 can be coupled to one another, or can be an integral or monolithic construction.

[0543] Headgear 8006 can include one or more of a top or vertical strap 8010, a front or forehead strap 8012, a rear or back strap 8014, and an ear loop 8016. Front strap 8012 passes substantially over a front of a user's head. That is, front strap 8012 can be positioned forward of a top of the head, such as on a forehead. Top strap 8010 passes substantially over a top of a user's head. Top strap 8010 and front strap 8012 converge at a junction 8020. Junction 8020 can be coupled to, or form a portion of, ear loop 8016. Rear strap 8014 passes substantially around a rear of a user's head. That is, rear strap 8014 can be positioned rearward of a top of the head. In some configurations, ends of rear strap 8014 form a portion of ear loop 8016. Ear loop 8016 partially or completely encircles a user's ear. In the illustrated arrangement, ear loop 8016 completely encircles a user's ear and forms a closed loop. Ear loop 8016 includes at least one connector connection surface 8022, such that headgear 8006 can be connected to first connector 8008 and / or second connector 8008.

[0544] First connector 8008 and / or second connector 8008 include at least one strap or other structure that extends between face mask assembly 8004 and headgear 8006. In the illustrated arrangement, one or both of first connector 8008 and / or second connector 8008 include a first strap 8024 and a second strap 8026. Strap 8026 is referred to herein as a lower strap 8026. Strap 8024 is referred to herein as a middle strap 8024, as it is positioned in a vertical direction between lower strap 8026 and front strap 8012 and / or top strap 8010. In use, middle strap 8024 extends from front portion 8008a and face mask assembly 8004 over and behind a user's ear. In use, lower strap 8026 extends from front portion 8008b and face mask assembly 8004 under and behind a user's ear. Middle strap 8024 meets lower strap 8026 at rear portion 8008b. In the illustrated configuration, middle strap 8024 and lower strap 8026 are integrally formed.

[0545] In at least one embodiment, the first connector 8008 and / or the second connector 8008 can include an intermediate strap in addition to, or in place of, the two straps 8024, 8026. The intermediate strap can extend from the front portion 8008a and the face shield assembly 8004 over and behind the user's ear. In at least one embodiment, the intermediate strap can extend from the front portion 8008a and the face shield assembly 8004 under and behind the user's ear. In at least one embodiment, the intermediate strap can extend from the front portion 8008a and the face shield assembly 8004 and then diverge so that it extends both over and behind the user's ear and under and behind the user's ear.

[0546] FIG. 93B A perspective view of the headgear assembly 8000 is shown with the first connector 8008 disconnected from the headpiece 8006. In use, the first connector 8008 can be disconnected from the headpiece 8006 and extend outward around the ear in order to release the face shield assembly 8004 from the user's face. The second connector 8008 can be disconnected in a similar manner (not shown) to completely disconnect the face shield assembly 8004. In some embodiments, the front portion 8008a of the first connector 8008 and / or the second connector 8008 can remain connected to the face shield assembly 8004 after the face shield assembly 8004 is removed.

[0547] When the face shield assembly 8004 and the connectors 8008 are disconnected from the headpiece 8006, the user can wear the headpiece 8006 independently before needing to connect the face shield assembly 8004. That is, the headpiece 8006 is preferably configured to be supported on the user's head in a stable manner without relying on the face shield assembly 8004 and / or the connectors 8008 to remain in place, at least when the user's head is relatively upright. To reconnect the face shield assembly 8004, one of the first connector 8008 and / or the second connector 8008 is connected to the headpiece 8006 at the associated periauricular loop 8016. The face shield assembly 8004 is positioned in the desired location. Then, the other of the first connector 8008 and / or the second connector 8008 is connected to the headpiece 8006 at the other periauricular loop 8016.

[0548] FIG. 93CA perspective view of headgear assembly 8000 is shown with first connector 8008 connected to headgear 8006. Headgear connection surface 8030 on first and / or second connector 8008 is used to facilitate the connection of first and / or second connector 8008 to headgear 8006. As described above, connector connection surface 8022 on headgear 8006 is used to facilitate the connection of headgear 8006 to first and / or second connector 8008. Connector connection surface 8022 and headgear connection surface 8030 allow first connector 8008 and / or second connector 8008 to be removably connected to headgear 8006. Headgear connection surface 8030 and connector connection surface 8022 comprise mating or complementary shapes. In some configurations, portions of each of headgear connection surface 8030 and connector connection surface 8022 have the same shape, or are configured to have shapes that overlap one another when both headgear 8006 and connector 8008 are properly positioned. See FIG. 93C As an example, connector connection surface 8022 of headgear 8006 is curved along a portion of earloop 8016. Headgear connection surface 8030 is a mating curve on first connector 8008. Connector connection surface 8022 and headgear connection surface 8030 mate to connect first connector 8008 and headgear 8006.

[0549] In some embodiments, first connector 8008 and second connector 8008 are connected to headgear 8006 through the use of a connection system. In at least one embodiment, this is a hook and loop connection system comprising hook and loop fasteners. One component of the connection system is located on headgear connection surface 8030, while the other component is located on connector connection surface 8022. The hook and loop connection system is configured to hold headgear connection surface 8030 in place around a user's ear while patient interface 8002 is in use. The connection system can easily disconnect mask assembly 8004, first connector 8008, and / or second connector 8008 when needed by the user. In addition, the connection system can easily reconnect mask assembly 8004, first connector 8008, and / or second connector 8008 to headgear 8006 when needed.

[0550] Other configurations of headgear assembly 8000 include a magnetic connection system between headpiece 8006 and connector 8008. Some configurations include one or more magnets near or on connector connection surface 8022. In these configurations, headpiece connection surface 8030 can include one or more ferrous metal structures. Thus, as illustrated, connector connection surface 8022 and headpiece connection surface 8030 can represent components of a magnetic connection system. As such, connector 8008 and headpiece 8006 are connected by the magnetic attraction between the magnets of connector connection surface 8022 and the ferrous structures of headpiece connection surface 8030. Alternatively, headpiece connection surface 8030 can provide one or more magnets, and connector connection surface 8022 can provide one or more ferrous metal structures.

[0551] In alternative configurations, first connector 8008 and / or second connector 8008 can include one or more magnets near or on headpiece connection surface 8030, and headpiece 8006 can include one or more magnets near or on connector connection surface 8022. The one or more magnets on connector connection surface 8022 can be oriented such that their polarity is generally opposite to the polarity of the magnets on headpiece connection surface 8030. This configuration ensures that magnetic repulsion indicates improper attachment.

[0552] The magnetic connection system is largely self-aligning. This helps the user to connect headpiece 8006 and first connector 8008 and / or second connector 8008 in the same position each time. Thus, the magnetic connection system enables easy donning and doffing of face shield assembly 8004 and connector 8008.

[0553] In at least one embodiment, connector connection surface 8022 and headpiece connection surface 8030 overlap when connected. In at least one embodiment, connector connection surface 8022 and headpiece connection surface 8030 are contiguous, such that the surfaces are complementary. For example, headpiece connection surface 9030 and connector connection surface 9022 can overlap along a connection region, which can be C-shaped and extend from above to below the user’s ear.

[0554] 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 adjustably connected to the face shield assembly 8004. The middle strap 8024 and lower strap 8026 can pass through corresponding holes on the face shield assembly 8004 and then fold back on themselves or each other to be adjustably secured in place. In at least one embodiment, the middle strap 8024 and lower strap 8026 are fixedly connected to the face shield assembly 8004. In at least one embodiment, the middle strap 8024 is fixedly connected to the face shield assembly 8004 and the lower strap 8026 is adjustably connected to the face shield assembly 8004. In at least one embodiment, the lower strap 8026 is fixedly connected to the face shield assembly 8004 and the middle strap 8024 is adjustably connected to the face shield assembly 8004.

[0555] Using the first connector 8008 and / or the second connector 8008 to disconnect the face shield assembly 8004 from the headgear 8006 enables the face shield assembly 8004 to be removed without adjusting the sizing of the headgear assembly 8000. The face shield assembly 8004 can be secured back in place via the first connector 8008 and / or the second connector 8008 without needing to adjust the sizing. This simplifies the donning and doffing process.

[0556] In some configurations of the headgear assembly 8000, the top strap 8010, front strap 8012, back strap 8014, or any combination of these straps include an adjustment mechanism 8040. The adjustment mechanism can be any suitable arrangement, such as a buckle. Opposing portions of the strap 8010, 8012, 8014 can pass through the buckle and fold back on themselves. The free ends of the strap 8010, 8012, 8014 can be secured to the remainder of the strap 8010, 8012, 8014 by suitable fasteners, such as hook and loop fasteners.

[0557] In at least one embodiment, the top strap 8010 and front strap 8012 form separate portions of the periauricular loop 8016. The portions of the periauricular loop 8016 defined by the top strap 8010 and front strap 8012 can be coupled to each other under and / or over the user’s ears.

[0558] In at least one embodiment, the headgear 8006 includes a top strap 8010 that crosses over the top of the user’s head, and a back strap 8014 that crosses over the back of the user’s head.

[0559] 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 disconnected from the headpiece 8006 in order to remove the mask assembly 8004. In at least one embodiment, the second connector 8008 can be fixedly connected to the headpiece 8006. In this configuration, the first connector 8008 can be disconnected from the headpiece 8006 in order to remove the mask assembly 8004.

[0560] FIGS. 94A-94C A perspective view of a patient interface 9002 is shown, which includes a headgear assembly 9000 and a 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 embodiment of FIG. 93A-93C In embodiments, the headgear assembly 9000 can be symmetrical about a sagittal plane of the user. Unspecified details of the headgear assembly 9000 can be the same as or similar to corresponding elements of the headgear assembly 8000, or can be another suitable arrangement. In this embodiment, the headgear assembly 9000 includes a partial periauricular loop 9016 FIG. 94C The first connector 9008 and the second connector 9008 each connect to the mask assembly 9004 at an anterior portion 9008a and to the headpiece 9006 at a posterior portion 9008b.

[0561] The headpiece 9006 includes a top or vertical strap 9010, an anterior or forehead strap 9012, and a posterior or back strap 9014. The anterior strap 9012 passes substantially over the front of the user’s head. The top strap 9010 passes substantially over the top of the user’s head. The posterior strap 9014 passes substantially around the back of the user’s head. The headpiece 9006 includes a connector connection surface 9022 such that the headpiece 9006 can be connected to the first connector 9008 and / or the second connector 9008.

[0562] The first connector 9008 and / or the second connector 9008 includes a mid strap 9024 and a lower strap 9026. The mid strap 9024 extends from the anterior portion 9008a and the mask assembly 9004 to above and behind the user’s ear. The lower strap 9026 extends from the anterior portion 9008a and the mask assembly 9004 to below and behind the user’s ear. The mid strap 9024 meets the lower strap 9026 at the posterior portion 9008b. In the illustrated configuration, the mid strap 9024 and the lower strap 9026 are integrally formed.

[0563] In at least one embodiment, the first connector 9008 and / or the second connector 9008 can include a middle strap. The middle strap can extend from the front portion 9008a and the face shield assembly 9004 over and behind the user’s ears. In at least one embodiment, the middle strap can extend from the front portion 9008a and the face shield assembly 9004 under and behind the user’s ears. In at least one embodiment, the middle strap can extend from the front portion 9008a and the face shield assembly 9004 and then diverge such that it extends both over and behind the user’s ears and under and behind the user’s ears.

[0564] FIG. 94B A perspective view of the headgear assembly 9000 is shown with the first connector 9008 disconnected from the headgear 9006. In use, one or both of the connectors 9008 can be disconnected from the headgear 9006 and extend outward around the ears in order to release the face shield assembly 9004 from the user’s face.

[0565] The headgear connection surface 9030 on the first connector 9008 and / or the second connector 9008 is used to facilitate connection of the first and / or second connector 9008 to the headgear 9006. The connector connection surface 9022 on the headgear 9006 is used to facilitate connection of the headgear 9006 to the first connector 9008 and / or the second connector 9008. The connector connection surface 9022 and the headgear connection surface 9030 allow the first connector 9008 and / or the second connector 9008 to be removably connected to the headgear 9006. The headgear connection surface 9030 and the connector connection surface 9022 comprise mating or complementary shapes. In FIG. 94A-94C In the illustrated embodiment, both the headgear connection surface 9030 and the connector connection surface 9022 are substantially reduced in size. The headgear connection surface 9030 and the connector connection surface 9022 are displaced rearward and in a vertical direction from the user’s ears (e.g., over the ears) and then connected along a connection line, which can be, for example, straight or slightly curved. In some configurations, the full connection between the headgear connection surface 9030 and the connector connection surface 9022 is located above the lowest extent of the user’s ears.

[0566] In at least one embodiment, the first connector 9008 can be fixedly connected to the headgear 9006. In this configuration, the second connector 9008 can be disconnected from the headgear 9006 in order to remove the face shield assembly 9004. In at least one embodiment, the second connector 9008 can be fixedly connected to the headgear 9006. In this configuration, the first connector 9008 can be disconnected from the headgear 9006 in order to remove the face shield assembly 9004.

[0567] In at least one embodiment, the first connector 8008, 9008 and / or the second connector 8008, 9008 is made from a continuous soft fabric covering with a plastic core. In some configurations, the plastic core can be an internally molded plastic core, where molten plastic is introduced into the space between or within the plurality of fabric portions or fabric layers and allowed to cool. In other embodiments, the first connector 8008, 9008 and / or the second connector 8008, 9008 can be made using a rigid polymer material. In at least one embodiment, the first connector 8008, 9008 and / or the second connector 8008, 9008 can be made using a soft polymer material, such as silicone. In at least one embodiment, the first connector 8008, 9008 and / or the second connector 8008, 9008 can be made using at least one rigid polymer material and at least one soft polymer material. Some embodiments can include the use of a fabric material. In at least one embodiment, the first connector 8008, 9008 and / or the second connector 8008, 9008 can include a combination of rigid polymer materials, soft polymer materials, ceramic materials, fabric materials, foam materials, and / or metallic materials. In at least one embodiment, the first connector 8008, 9008 and / or the second connector 8008, 9008 can be made from a foam and fabric composite.

[0568] Closed loop headband

[0569] FIG. 95 and FIG. 96 A front perspective view and a rear perspective view of a patient interface 9100 is shown, including a headgear 9102, a mask assembly 9104, and connectors 9106. The headgear 9102 is a closed loop headgear design, with no break in the loop formed by the headgear 9102 and the mask assembly 9104. As shown in the figures, an upper side strap 9108 and a lower side strap 9110 are formed from a single continuous strap. Thus, the upper side strap 9108 and the lower side strap 9110 form a closed loop connection or continuous connection between the headgear 9102 and the mask assembly 9104 that is intact throughout the process of donning and doffing the patient interface 9100.

[0570] The closed loop headgear 9102 design can be formed through an internal molding (i.e., break-out) process, in which the straps of the headgear 9102 are formed from a textile shell filled with a plastic core material. The textile shell provides a soft, comfortable contact surface for the straps, while the plastic core material provides rigidity and structure to the straps, such that the headgear 9102 maintains its shape.

[0571] Connector overview

[0572] As FIG. 95As shown, the upper strap 9108 and the lower strap 9110 are connected to the face mask assembly 9104 via connectors 9106 on each lateral side of the face mask assembly 9104. In some configurations, the straps 9108, 9110 may form part of the connector 9106. The connector 9106 is configured to act as a mechanism for securing the face mask assembly 9104 to the user's face while maintaining a closed loop between the face mask assembly 9104 and the headband 9102.

[0573] like FIG. 97 and FIG. 98 As shown, connector 9106 is configured to disengage from mask assembly 9104 (i.e., open or unlock) without damaging the closed loop between mask assembly 9104 and headband 9102, thereby increasing the effective length of the closed loop. FIG. 97 A first perspective view is shown of the connector 9106 initially disengaged from the mask assembly 9104. FIG. 98 It shows FIG. 97 A second perspective view of connector 9106, which is further disengaged from and extended from mask assembly 9104, demonstrates the effective increase in headband loop length achieved due to the disengagement of connector 9106. Preferably, the disengagement and extension of connector 9106 results in a minimum increase of 40 mm in headband loop length. This increase in headband loop allows the patient to easily put on and take off headband 9102. In some configurations, if headband 9102 has a degree of elasticity, the minimum increase in length may be less than 40 mm.

[0574] Therefore, the headband 9102, mask assembly 9104, and connector arrangement 9106 provide a closed-loop headband design that includes a symmetrical connection mechanism to the mask assembly 9104. In other words, throughout the process of putting on and taking off the patient interface 9100, the closed loop between the mask assembly 9104 and the headband 9102 remains intact. This improves the ease with which the mask 9104 is centered on the user's face, and the closed loop can be secured in place without shifting the mask 9104 by utilizing the interaction between the user and the headband 9102 and connector 9106. This closed-loop headband design requires an "over-the-head" approach to putting on the patient interface 9100, reducing the likelihood of the patient becoming confused or incorrectly putting on the interface 9100. In other words, the closed-loop headband design and connector arrangement allow the user to comfortably, efficiently, and intuitively put on and take off the patient interface headband 9102. In addition, the closed-loop headband design and connector arrangement ensure that the patient interface seal remains centered on the face when the headband 9102 is put on and taken off.

[0575] Plastic living hinge

[0576] FIG. 99A A plastic living hinge connector 9106 is shown, 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, in which the mask connector member 9112 and the headgear connector member 9114 are adjacent to (i.e., cover, fold over, etc.) or latched to the mask assembly 9104, and can be in an open position, in which the members are in an extended position. In some configurations, the connector 9106 is secured and fixed against the mask assembly 9104 in the closed position, such that the connector 9106 does not move, nor rotate. A benefit of the plastic living hinge connector 9106 is that the fastening system is self-locating, so the system is difficult to misuse.

[0577] The headgear connector member 9114 is substantially “U” shaped, with a headgear connection point 9124 at each lateral end of the headgear connector member 9114. The headgear connector member 9114 is molded as a single component. The headgear connector member 9114 can be made of a soft fabric covering 9114a with an inner molded plastic core 9114b (see, e.g., FIG. 9B). Alternatively, the headgear connector member 9114 can be made of a molded plastic component with a fabric layer on one side. In some configurations, the fabric layer can be on the outside surface of the headgear connector member 9114. In other configurations, the fabric layer can be on the inside surface of the member 9114. FIG. 101B ). Alternatively, the headgear connector member 9114 can be made of a molded plastic component with a fabric layer on one side. In some configurations, the fabric layer can be on the outside surface of the headgear connector member 9114. In other configurations, the fabric layer can be on the inside surface of the member 9114.

[0578] The mask connector member 9112 is also formed of plastic. In the illustrated embodiment, there are two separate mask connector members 9112, with the first member displaced in the vertical direction from the second 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.

[0579] The mask connector member 9112 is connected at one end to the mask frame 9126 of the mask assembly 9104. The mask connector member 9112 is connected at the other end to the headgear connector member 9114. The mask connector member 9112 can be integrally formed with the headgear connector member 9114, or can be connected using another method, such as adhesive bonding, radio frequency welding, ultrasonic welding, overmolding, snap fit mechanisms, mechanical stitching, etc. The mask connector member 9112 can also be integrally formed with the frame 9126 of the mask assembly 9104. Alternatively, the mask connector member 9112 can be connected using another method, such as those mentioned previously.

[0580] In the closed position, the illustrated connector 9106 is positioned in contact with the frame 9126 of the face shield assembly 9104, as indicated by the arrows. A recessed channel 9128 is provided on the frame 9126 and has a shape and profile that corresponds to the face shield connection member 9112 and the headband connection member 9114. In the closed position, the face shield connection member 9112 and the headband connection member 9114 fit into the recessed channel 9128. This reduces the profile of the connector 9106 on the frame 9126, as well as the overall profile of the face shield assembly 9104.

[0581] When the connector 9106 is in the closed position, the face shield assembly 9104 is secured to the user's face. The friction fit between the connector 9106 and the recessed channel 9128 when the connector 9106 is in the closed position can be used to hold the connector 9106 against the frame 9126 and within the recessed channel 9128. Alternatively, a snap fit, hook and post clip, magnets, Velcro connection system, latching mechanism, or any other connection system can be used.

[0582] In the open position, the illustrated connector 9106 is rotated in the opposite direction of the indicated arrows. In opening, the connector 9106 is rotated about both the face shield hinge 9118 and the connector hinge 9122. That is, the connector 9106 is rotated away from the frame 9126 and the recessed channel 9128. In the illustrated embodiment, the face shield hinge 9118 and the connector hinge 9122 are living hinges (i.e., flexible thin hinges made of the same material as the face shield connection member). In some configurations, as FIG. 99B As shown, the living hinges can be made in a one-piece construction.

[0583] FIG. 100 A top view of one type of living hinge 9130 that can be incorporated into the face shield connection member 9112 is shown. The living hinge 9130 includes a section of reduced thickness about which the living hinge 9130 provides rotation. Reducing the thickness of the indicated area increases the local flexibility. This allows the reduced thickness area to act as a hinge point, or "living hinge" 9130. In some configurations, the living hinge 9130 can have a constant thickness along its length while still having flexibility for providing rotation.

[0584] FIG. 101A An exploded view of the plastic living hinge face shield connector member arrangement 9106 is shown. The hinge-able regions of the face shield connection member 9112 can have a profile as FIG. 100 shown, or another profile that enables a living hinge configuration. In this configuration, the face shield connection member 9112 includes a protrusion 9132 that fits into a corresponding hole 9134 in the headband connection member 9114 to mate the two components. AsFIG. 101B As shown, the protrusion 9132 is integrally formed with the face shield connector member 9112. In some configurations, the protrusion 9132 can not be integrally formed with the connector member 9112. In other configurations, the headgear connector member 9114 can include the protrusion 9132 and the face shield connector member 9112 can include the hole 9134. Similar connection mechanisms can be used between the face shield connector member 9112 and the face shield assembly 9104, or different connection mechanisms can be used.

[0585] FIG. 102A The living hinge connector 9106 is shown with a single face shield hinge 9116, a single connector hinge 9122, a recessed channel 9128, and a recessed surface 9136. The recessed surface 9136 is configured to receive the face shield connector member 9112 when the connector 9106 is in the closed position, and the recessed channel 9128 is configured to receive the headgear connector member 9114.

[0586] FIG. 102B A cross section is also shown in the middle that depicts the core 9114b of the headgear connector member 9114, and the face shield connector member 9112. In this configuration, the headgear connector member 9114 and the face shield connector member 9112 are formed from a continuous molded plastic part 9114b. The face shield hinge spans the vertical length of the face shield connector member 9112, providing a larger surface area for the face shield hinge to abut the face shield assembly 9104 thereon. Additionally, the lengthier face shield connector member 9112 includes the connector hinge. Increasing the length of the hinge increases the durability of the connector 9106.

[0587] Hook and post retention system

[0588] FIG. 103A and FIG. 103B The plastic living hinge connector device 9106 is shown with a hook and post retention system 9140. FIG. 103A and FIG. 103B The connector 9106 of FIG. 9 is retained in the closed position with the hook and post retention system 9140. The raised post 9140a is integrally formed on the face shield assembly 9104, and the corresponding hook 9140b is located on the face shield connector member 9112. The hook 9140b encloses the post 9140a in the closed position, and retains the connector 9106 in the closed position via a snap fit or interference fit connection, or the like. In some embodiments, the raised post 9140a is integrally formed on the face shield connector member 9112, and the corresponding hook 9140b is located on the face shield assembly 9104.

[0589] In other embodiments, FIGS. 103A-103BThe connector 9106 can be held in the closed position by using a magnetic retention system. One or more magnets can be located on the connector 9106 and one or more ferrous metal structures are located on the facepiece assembly 9104. The magnetic attraction between the magnets and the ferrous structures acts to hold the connector 9106 in the closed position.

[0590] Other configurations of the connector 9106 can use a press fit, for example, including one or more mushroom-shaped protrusions on the connector 9106 and corresponding recesses on the facepiece assembly 9104. FIG. 103B The facepiece hinges 9116 and the connector hinge 9122 of the fabric living hinge connector arrangement 9142 are enclosed by dashed lines because they can be replaced by any of the aforementioned living hinge designs. In other embodiments, the hook and post retention system 9140 can alternatively be replaced with any other suitable method of holding the connector in the closed position.

[0591] Fabric living hinge

[0592] FIG. 104A and FIG. 104B A woven living hinge connector arrangement 9142 is shown, in which the connector 9106 is primarily a thick woven fabric, with plastic supports included to increase rigidity. The woven living hinge connector 9142 includes a facepiece connector member 9112, a headgear connector member 9114, two facepiece hinges 9116, and one connector hinge 9122. The facepiece connector member 9112 is substantially "U" shaped, as is the headgear connector member 9114. The facepiece connector member 9112 and the headgear connector member 9114 are made from the same piece of continuous woven fabric (i.e., this piece of woven fabric consists of two "U" shapes that are joined at the bottom of the "U"s).

[0593] The "U" shaped facepiece connector member 9112 and the headgear connector member 9114 each include plastic supports to increase their rigidity, but lack such plastic supports near the connector hinge 9122, meaning that the natural flexibility of the woven fabric is sufficient to facilitate movement of this hinge. The woven living hinge connector 9142 can be manufactured from at least one of a number of embodiments, two of which are described below.

[0594] In the first embodiment, the fabric living hinge connector 9142 includes a single piece of fabric that combines the "U" shapes of both the mask connector member 9112 and the headgear connector member 9114. The connector 9106 further includes a "U" shaped piece of plastic to reinforce the mask connector member 9112, and another "U" shaped piece of plastic to reinforce the headgear connector member 9114. There is a space between the two pieces of plastic at the connector hinge 9122 to facilitate the living hinge action between the two connector members 9112, 9114. In addition, the piece of plastic reinforcing the mask connector member 9112 does not reach the mask hinge 9116 to facilitate the fabric living hinge action between the mask assembly 9104 and the mask connector member 9112.

[0595] In the second embodiment, the fabric living hinge connector 9142 includes two pieces of fabric, where each piece of fabric combines the "U" shapes of both the mask connector member 9112 and the headgear connector member 9114 into a single piece. The two pieces of fabric are aligned so that the two "U" shaped pieces of plastic are sandwiched between the two fabric layers. The pieces of plastic are then sealed within the two pieces of fabric. The two pieces of fabric can be joined by using stitching, radio frequency welding, adhesive bonding, or any other relevant joining mechanism. Similar to the first embodiment, the pieces of plastic provide rigidity to the "U" shapes of the headgear connector member 9114 and the mask connector member 9112, while allowing the fabric to act as a living hinge at the mask hinge 9116 and the connector hinge 9122.

[0596] It should be noted that the preferred embodiment of the fabric living hinge connector 9142 includes two headgear connection points 9124. In alternative embodiments, the retaining member can join the upper and lower arms of the headgear connector member 9114 so that a different number of headgear connection points can be possible.

[0597] Silicone hinge

[0598] FIGS. 105A-107B A connector arrangement 9106 with a silicone portion is shown. The mask connector member 9112 is formed from silicone (or other soft polymer such as TPE, TPU, TPV, etc.), and the headgear connector member 9114 is formed from a rigid polymer.

[0599] FIG. 105A-105BA silicone hinge is shown in which the first end of the mask connector member 9112 is pivotably connected to the mask assembly 9104 via the mask hinge 9116. The second end of the mask connector member 9112 is pivotably connected to the headgear connector member 9114 via the connector hinge 9122. In the embodiment shown, the mask connector member 9112 rotates around a central pin connected to the mask assembly 9104, forming the mask hinge 9116. Further, the mask connector member 9112 rotates around a central pin on the connector hinge 9122 to which the headgear connector member 9114 is joined. This allows the connector 9106 to move over a wide range.

[0600] The configuration shown also includes a recessed center 9144 on the mask connector member 9112. This is an area 9144 in which the thickness of the member 9112 is reduced. This area 9144 reduces the stiffness of the mask connector member 9112, allowing it to bend to a greater degree than it would without the recessed center 9144.

[0601] The mask connector member 9112 shown is retained to the mask assembly 9104 when in the closed position via protrusions on the mask that mate with corresponding holes on the mask connector member 9112. In other embodiments, the mask connector member 9112 can include protrusions and the mask assembly 9104 can include corresponding holes. Further embodiments can include any suitable retention mechanism (magnetic retention mechanism, Velcro retention mechanism, etc.).

[0602] FIGS. 106A-106B An alternative silicone hinge arrangement is shown. Instead of using a pivot hinge as the mask hinge, the mask hinge point 9116 is fixed so that the silicone bends during the opening process, folding over on itself. Thus, the connector 9106 has a biasing force in the direction needed to close the connector 9106. This simplifies the process of securing the mask assembly 9104 to the user's face.

[0603] FIGS. 107A-107B A mask connector member 9112 with an alternative silicone hinge arrangement is shown. The mask connector member 9112 of this configuration includes a first portion 9112a of a first thickness and a second portion 9112b of a second thickness. The first portion 9112a has a thickness that is greater than the thickness of the second portion 9112b. The first portion 9112a includes provisions for the mask hinge 9118 and the connector hinge 9122. The second portion 9112b includes provisions for the connector hinge 9122. The mask hinge 9118 includes a post in the mask assembly 9104 around which the mask connector member 9112 rotates. The connector hinge 9122 rotates around the mask hinge 9118 (and similarly around the axis as indicated).

[0604] The first portion 9112a has a greater thickness than the second portion 9112b in order to minimize bending within the first portion 9112a when the connector 9106 is in the open position. The frame 9126 of the face shield assembly 9104 includes a hole 9148 to accommodate the increased thickness of the portion 9112a.

[0605] The second portion 9112b has a reduced thickness to increase the allowable bending within the second portion 9112b. Allowing bending to occur within the second portion 9112b increases the resilience of the connector 9106 when greater than desired force is applied to the connector during the opening process. The second portion 9112b of the face shield connector member 9112 includes a retention cavity 9150 configured to cooperate with a retention protrusion 9152 on the face shield assembly 9104 when the connector 9106 is in the closed position.

[0606] The headgear connector member 9114 is made of a rigid polymer. The central portion of the headgear connector 9114 includes a cavity 9154 sized to accommodate the face shield connector member 9114 when the connector 9106 is in the closed position. This cavity 9154 ensures that the profile of the connector 9106 is minimized.

[0607] The location of the connector hinge 9122 relative to the face shield connector member 9112 and the headgear connector member 9114 differs from the previously described connector arrangements. The connector hinge 9122 is offset from the ends of both the face shield connector member 9112 and the headgear connector member 9114, as indicated by the dashed lines in FIG. 107B The advantage of offsetting the hinge 9122 is that a mechanical hard stop is created at the maximum extension of the connector 9106. This hard stop is the result of the leading edge of the headgear connector member 9114 striking or contacting the inner surface of the face shield connector member 9112. This hard stop is beneficial because it prevents the user from over-rotating the headgear connector member 9114 relative to the face shield connector member 9112 at the connector hinge 9122, and thus prevents the connector 9106 from being inverted. In addition, this hard stop acts to maintain the greater width of the connector 9106 when it is open. This improves the usability of the headgear 9102 and the face shield assembly 9104 during donning and doffing because it is easier to pass the headgear 9102 over the user's ears.

[0608] In some configurations, the size of the mask connector member 9112 can be determined such that an interference 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 sizing the mask connector member 9114 to be slightly larger than the cavity 9154 of the headgear connector member 9114. Since the mask connector member 9112 is silicone (or another soft polymer), an interference fit will be formed with the headgear connector member 9114 pressed against the mask connector member 9112 when the connector 9106 is closed, thereby compressing the mask connector member 9112. This interference fit helps to stabilize the headgear connector member 9114 in the vertical direction when the connector 9106 is in the closed position. In one alternative embodiment, the mask connector member 9112 can be made of a rigid polymer.

[0609] Headband connection

[0610] FIGS. 108A-108C A headgear connection arrangement for connecting the connector 9106 to the headgear 9102 is shown. The lateral ends of the connector 9106 each include a headgear connection 9124. The headgear connection 9124 is in the form of a loop-shaped rigid structure having a hole configured to receive a strap of the headgear 9102. One or more straps of the headgear 9102 are designed to fold back on itself through the headgear connection 9124 and secured in place by one of several methods disclosed below. The headgear connection 9124 can be integrally formed with the inner molded core 9114b of the connector 9106.

[0611] Headband securing mechanism

[0612] FIGS. 109A-109B A headgear retention mechanism 9160 for securing the length of the straps 9108, 9110 is shown. As shown, after the headgear 9102 loops back on itself, the headgear can be held in place at a fixed length by using a hook-and-loop fastener arrangement 9160a, a push-fit arrangement 9160b, or a magnetic retention system 9160c. In some configurations, alternative fastening arrangements can be used.

[0613] FIGS. 110A-110B A push-fit headgear retention mechanism 9162 for securing the length of the straps 9108, 9110 is shown. The push-fit components (e.g., the protrusions 9162a and the holes 9162b) have a longer lateral profile than a vertical profile.

[0614] Upper centering clamp connector

[0615] FIGS. 111A-111BAn alternative connector arrangement 9170 with an over-center clamp design is shown. The illustrated configuration uses a combination of pivots, hinges, and plastic components to achieve over-center locking. The connector 9106 includes a mask connector member 9112, a headgear connector member 9114, a mask hinge 9118, and a connector hinge 9122. This over-center connector operates in a similar fashion to the silicon hinge; but the mask connector member 9112 is rigid. The rigid member allows a hard stop to be formed at the mask hinge 9118, as FIG. 111B illustrated. This hard stop serves to maximize the rotation that the connector 9106 can undergo during operation. One advantage of this is that the position of the hard stop can be adjusted so that the connector 9106 retains a larger width of the headgear 9102 when in the open position, allowing the headgear 9102 to more easily pass over the ears when donning and doffing. The headgear connector member 9114 includes two headgear connection points 9124.

[0616] Extendable pivot connector

[0617] FIG. 112A 、 FIG. 112B and FIG. 112C A connector configuration 9180 including an extendable pivot clamp is shown. The illustrated configuration includes a mask connector member 9112 and a headgear connector member 9114 that are coaxially aligned and configured so that the headgear connector member 9114 can move relative to the mask connector member 9112 along their common axis. The mask connector member 9112 protrudes perpendicularly from the mask hinge 9118. In the closed position, the clamp holds the connector 9106 against the mask assembly 9104. To open the connector, the user applies a lateral force to the clamp of the mask assembly to disengage it. The mask connector member 9112 and the headgear connector member 9114 are then rotated outward around the mask hinge 9118 FIG. 112B ). Once pivoted open, a telescoping motion can be performed to pull the mask connector member 9112 outward away from the mask assembly 9104, thereby extending the length of the connector 9106 FIG. 112C . In addition to increasing the length of the headgear loop, this configuration also helps to move the headgear 9102 away from the user's ears, thereby simplifying the doffing process.

[0618] Sliding strap hard stop connector

[0619] FIG. 113A and FIG. 113BA connector configuration with a hard stop slide strap connector configuration 9190 is shown. In this configuration, the lateral portions of the headgear 9102 contact the user's cheeks and incorporate into the connector 9106. The connector strap interface 9192 on the face mask assembly 9104 acts as a fixed point for the headgear straps 9108, 9110. In the illustrated configuration, both headgear straps 9108, 9110 incorporate into the connector 9106. The connection mechanism of each headgear strap 9108, 9110 at the connector strap interface 9192 is not limited. That is, this connector configuration can include multiple types of connection mechanisms. In the illustrated configuration, the straps 9108, 9110 loop back on themselves through an opening on the face mask assembly 9104. The straps 9108, 9110 can be fixedly attached to themselves once looped through the face mask assembly 9104 (e.g., by stitching), or the straps can be attached to themselves via a hook and loop fastener connection system.

[0620] Each strap 9108, 9110 passes through a first reversal point 9193a located on the headgear 9102. The strap 9108, 9110 extends past the first reversal point 9193a to a second reversal point 9193b where it loops back on itself and is secured in place. In the illustrated configuration, the strap 9108, 9110 is secured to itself via a hook and loop fastener connection system past the second reversal point 9193b. The securing system is not limited to a hook and loop fastener connection system, but can include other connection systems. Adjusting the strap length via the second reversal point 9193b is one way a user can adjust the tightness of the headgear 9102 in this configuration.

[0621] The second reversal point 9193b is located on a clip 9194. This clip 9194 acts as part of a retention mechanism for the connector 9106. A retention point 9196 is located on the face mask assembly 9104 that interacts with the clip 9194 to retain the connector 9106. In the illustrated configuration, the retention point 9196 protrudes from the face mask assembly 9104 and the clip 9194 is placed over the front face of the retention point 9196. Tension in the headgear 9102 and the connector assembly 9106 is then used to pull the clip 9194 against the retention point as shown. FIG. 113A The retention mechanism 9190 including the clip 9194 and the retention point 9196 is not particularly limited, but can include other retention mechanisms. The retention mechanism can be a hook and post connection mechanism, or any other mechanism.

[0622] Strap end hard stop connector

[0623] FIG. 114A and FIG. 114BA connector configuration with a sliding harness hard stop 9200 is shown. In this configuration, each headgear strap 9108, 9110 loops through the connector strap interface 9192 itself and is then held in place by a retention mechanism (e.g., a hook and loop fastener) on the headgear strap end. However, the headgear strap end 9202 has a larger profile than the hole through which each strap passes in the connector strap interface 9192. As such, the headgear strap ends 9108, 9110, when released, are able to extend the headgear loop by retracting back through the connector strap interface 9192, but are not easily able to pass through the mask assembly 9104. This allows the user to remove the headgear 9102 without breaking the headgear / mask assembly loop. The upper strap 9108 and lower strap 9110 can be connected to each other to allow for simultaneous adjustment of both.

[0624] Breakaway fit magnets and tether connector

[0625] FIG. 115A and FIG. 115B A connector assembly 9210 is shown, which includes two clips 9212a, 9212b, a magnetic connection 9214, and a tether 9216. In a closed position as shown in FIG. 115A , the two components of the magnetic connection 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 by using hook and post clips, magnetic assemblies, or any other relevant mechanism.

[0626] As shown in FIG. 115B , the location of the magnetic connection 9214 on the periauricular loop of the headgear 9102 allows the user to unclip the second clip 9212b when they wish to remove the mask assembly 9104, thus breaking the magnetic connection. The included tether 9216 is secured at one end to each point of the magnetic connection 9214, such that when the magnetic connection 9214 is broken, the tether 9216 acts as a bridge to prevent the lower length of the headgear 9102 from falling completely down. With the magnetic connection 9214 broken, the length of the headgear loop 9102 below the user’s ear is longer, allowing the user to not have to re-adjust the headgear 9102 when they next wish to use the mask assembly 9104 after removing the headgear 9102. In some configurations, the tether 9216 can not be included between the magnetic connections 9214.

[0627] Breakaway fit clamp and tether connector

[0628] FIG. 116A and FIG. 116BA connector assembly 9220 is shown that incorporates a hook or clip 9222, a post 9224, and a tether 9226 as shown. In the closed position, the hook 9222 is connected to the post 9224 on the face shield assembly 9104. In the open position, the user releases the hook or clip 9222, which extends 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 face shield assembly 9104. This maintains the closed loop of the headgear 9102 while extending the headgear loop a sufficient length to ensure the user's comfort when removing the headgear 9102.

[0629] Clip and continuous tether connector

[0630] Figure 117A and Figure 117B A clip and continuous tether connector 9230 is shown that incorporates a hook or clip 9232, a post 9234, and a continuous tether 9236 that connects both connectors 9230 to the face shield assembly 9104. In this configuration, each of the two connectors 9230 is connected by the common tether 9236. The tether 9236 passes through a tether channel 9238 located on the face shield assembly 9104. The tether 9236 is preferably made of an elastic material. In the closed position, the clip 9232 is secured to the post 9234 of the face shield assembly 9104. When the user desires to open the connector 9230, the clip 9232 is released and pulled apart. 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 face shield assembly 9104.

[0631] Figure 118A and Figure 118B An alternative clip and continuous tether connector 9230 is shown that incorporates a first tether 9236a and a second tether 9236b. The first tether 9236a is displaced in the vertical direction relative to the second tether 9236b. The first tether 9236a passes through a first tether channel 9238a. The second tether 9236b passes through a second tether channel 9238b. The tethers 9236a, 92...

Claims

1. A strap connector assembly for connecting a first strap and a second strap of a headband, each of the first strap and the second strap including an integral plastic core located within a textile housing, the strap connector assembly comprising: The first connector portion is positioned at the end portion of the first strap; A second connector portion positioned between the end portions of the second strap, the second connector portion including a protrusion of an integral plastic core of the second strap, the protrusion protruding through the textile outer shell of the second strap, and An overmolded joint is formed over the first connector portion and the second connector portion.

2. The strap connector assembly of claim 1, wherein the overmolded joint contacts the textile housing of the first strap and the second strap.

3. The strap connector assembly of claim 1, wherein the first connector portion includes a protrusion of an integral plastic core of the first strap, the protrusion of the integral plastic core of the first strap protruding through the textile shell of the first strap.

4. The strap connector assembly of claim 1, wherein the first connector portion further includes an alignment post projecting from the surface of the first strap, wherein the overlay molded engagement surrounds the alignment post.

5. The strap connector assembly of claim 4, wherein the alignment post protrudes through the textile housing of the first strap.

6. The strap connector assembly according to any one of claims 1 to 5, wherein the second connector portion further comprises at least one alignment post protruding from the surface of the second strap, wherein the overlay molded engagement surrounds the at least one alignment post.

7. The strap connector assembly according to any one of claims 3 to 5, wherein the first connector portion and the second connector portion are configured to have a gap between the first connector portion and the second connector portion when the first connector portion and the second connector portion are aligned to facilitate the connection of the first strap and the second strap.

8. The strap connector assembly according to any one of claims 1 to 5, wherein the first connector portion further includes a recessed area recessed in the surface of the first strap, wherein the recessed area receives overmolding material for the overmolded joint.

9. The strap connector assembly according to any one of claims 1 to 5, further comprising an alignment recess disposed on the first connector portion, the alignment recess being configured to engage a protrusion disposed on the inner surface of the molding tool to maintain the position of the first connector portion relative to the molding tool.

10. The strap connector assembly of claim 1, wherein the first connector portion includes an extension of an integral plastic core beyond the textile housing.

11. The strap connector assembly of claim 10, wherein the first connector portion extends beyond the end of the textile housing.

12. The strap connector assembly according to any one of claims 1 to 5, wherein each of the first connector portion and / or the second connector portion includes a tab.

13. The strap connector assembly according to any one of claims 1 to 5, wherein the thickness of the first connector portion is equal to the thickness of the second connector portion.

14. The strap connector assembly according to any one of claims 1 to 5, wherein the thickness of the overmolded joint is equal to the thickness of the first connector portion and the thickness of the second connector portion.

15. The strap connector assembly according to any one of claims 1 to 5, wherein the first connector portion and the second connector portion are respectively a male connector portion and a female connector portion.

16. The strap connector assembly according to any one of claims 1 to 5, wherein the textile housing has a seamless tubular shape.

17. The strap connector assembly according to any one of claims 1 to 5, wherein the textile housing is knitted.

18. The strap connector assembly according to any one of claims 1 to 5, wherein the textile housing is woven.

19. The strap connector assembly according to any one of claims 1 to 5, wherein the textile housing is woven.

20. The strap connector assembly according to any one of claims 1 to 5, wherein the textile housing is crocheted.

21. The strap connector assembly according to any one of claims 1 to 5, further comprising a label formed in the surface of the overmolded joint.

22. The strap connector assembly according to any one of claims 1 to 5, wherein the integral plastic core and textile shell of each of the first connector portion and the second connector portion are formed as an integral structure by applying molten plastic into the textile shell.

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