Strap assembly, strap connector, headgear, headgear assembly, method of forming headgear, tubular connector, patient interface, and method of joining straps

Abstract

To provide a patient interface forming a closed-loop headgear design having a connection mechanism with a mask assembly which ensures that a patient interface seal remains at the center of a user's face when donning and doffing the headgear.SOLUTION: The invention provides a large variety of methods of forming a headgear 9102 for use in combination with a breathing apparatus comprising a unitary plastic core within textile casings. In some configurations, the plastic core material penetrates or bursts through the textile casing of the straps. Some configurations include overmoldings, alignment posts, T-joints and joint housings with injection apertures. The invention also provides a large variety of connectors connecting a headgear assembly to a mask assembly 9104, where a headgear, a mask and a connector 9250 form a closed loop and the connector is disengaged from the mask assembly.SELECTED DRAWING: Figure 121B

Description

[Technical field]

[0001] Incorporation by reference of any priority application 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 entireties of which are incorporated herein by reference and made a part of this disclosure.

[0002] The present disclosure generally relates to headgear for use in combination with a respiratory device. More particularly, the present disclosure relates to the formation of three-dimensional headgear, parts of three-dimensional headgear, and processes for molding such headgear. Further applications of the molding process are also disclosed. The present disclosure also generally relates to a full-face under-the-nose patient interface having a closed-loop headgear and various components of the patient interface. [Background technology]

[0003] Patient interfaces are used to provide respiratory therapy to the airways of individuals suffering from any of a number of respiratory diseases or conditions, including, but not limited to, continuous positive airway pressure (CPAP) therapy and non-invasive ventilation (NIV) therapy.

[0004] CPAP therapy can be used to treat obstructive sleep apnea (OSA), a condition in which a patient's airway intermittently collapses during sleep, preventing the patient from breathing for periods of time. The cessation of breathing, or apnea, causes the patient to awaken. Repeated and frequent apneas can cause the patient to rarely achieve a full and restorative night's sleep.

[0005] CPAP therapy involves delivering a supply of continuous positive airway pressure to a patient's airway via a patient interface, which acts as a splint within the patient's airway, holding it in an open position so that the patient can breathe and sleep uninterrupted.

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

[0007] A patient interface at least creates a substantial "seal" on or around the user's nose and / or mouth, whereas a cannula does not provide a seal but does provide a delivery path for supplemental breathing gas delivery. As a result of creating this "seal," the enclosed area of ​​the breathing apparatus in combination with its internal pressure creates a resultant force that tends to push the breathing apparatus away from the face. To counteract this force, headgear is typically used that includes a continuous strap that passes around the back and / or top of the user's head. Summary of the Invention [Problem to be solved by the invention]

[0008] A common problem with adjustable headgear, i.e., headgear that requires making left and right connections with an under-the-nose type mask, is that the user may over-tighten one side of the headgear, which pulls the mask off-center. In other cases, the user may pull the mask off-center as a result of simply connecting one side of the mask first. Over-the-bridge masks are more centered on the apex of the mask seal, but under-the-nose style masks may be more susceptible to being pulled off-center than masks that go over the bridge of the nose because the nose area may collapse. It is therefore desirable to create a closed-loop headgear design that has a connection mechanism with the mask assembly that ensures that the patient interface seal remains centered on the user's face when donning and doffing the headgear. [Means for solving the problem]

[0009] The systems, methods and apparatus described herein have innovative aspects, none of which is essential or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the more advantageous features will now be outlined.

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

[0011] According to a further aspect, the unitary plastic core material extends through at least one of the textile casings of the top strap and the bottom strap.

[0012] According to a further aspect, the textile casing has a seamless tubular shape.

[0013] According to a further aspect, the textile casing is knitted, woven, braided or crocheted.

[0014] According to a further aspect, an end of the textile casing of the top strap abuts the textile casing of the bottom strap.

[0015] According to a further aspect, the textile casing of the apex strap extends radially outwardly along the length of the apex in a direction toward the end of the apex strap.

[0016] According to a further aspect, an end of the textile casing of the top strap has a seal, the seal being formed by cutting with a hot knife.

[0017] According to a further aspect, the headgear further includes a filament core bonded to a unitary plastic core material within the bottom strap.

[0018] According to a further aspect, the headgear further includes a strap connector disposed on an outer surface of at least one of the top strap and the bottom strap, the strap connector being formed from a unitary plastic core material.

[0019] According to at least one of the embodiments disclosed herein, a method of forming headgear in a mold is provided, the method including the steps of placing a first tubular textile casing and a second tubular textile casing in a cavity of the mold, introducing a molten plastic material into the mold and into the first tubular textile casing, forcing the molten plastic material through the first tubular textile casing and into the second tubular textile casing, and solidifying the molten plastic material within the first and second textile casings to form an integrated plastic core.

[0020] According to a further aspect, the step of forcing the molten plastic material through the first tubular textile casing and into the second tubular textile casing further includes displacing yarns of the first tubular textile casing to form gaps in the first tubular textile casing through which the molten plastic material flows into the second tubular textile casing.

[0021] According to a further aspect, the step of forcing the molten plastic material through the first tubular textile casing and into the second tubular textile casing further includes tearing threads in the first tubular textile casing to form holes in the first tubular textile casing through which the molten plastic material can flow into the second tubular textile casing.

[0022] According to a further aspect, the step of disposing the first tubular textile casing and the second tubular textile casing within the cavity of the mold further includes positioning the first tubular textile casing in contact with the second tubular textile casing.

[0023] According to a further embodiment, the open end of the first tubular textile casing abuts the second tubular textile casing at a location between the ends of the second tubular textile casing.

[0024] According to a further embodiment, the first tubular textile casing and the second tubular textile casing contact each other at a location between their ends.

[0025] According to a further aspect, an outer edge of the cavity narrows relative to a central portion of the cavity, thereby pinching the outer edges of the first and second tubular textile casings and preventing molten plastic material from flowing between the outer edges of the first and second tubular textile casings.

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

[0027] According to at least one of the embodiments disclosed herein, there is provided a method of forming headgear in a mold, the method including the steps of placing a first tubular textile casing in a cavity of a first mold, positioning a portion of the first tubular textile casing in contact with an adjacent cavity having a shape of a connector portion, introducing molten plastic material into the mold and into the first tubular textile casing, forcing the molten plastic material through the first tubular textile casing and into the adjacent cavity, and solidifying the molten plastic material within the first tubular textile casing to form a first strap portion having an inner core and a connector portion formed from a unitary plastic core.

[0028] According to a further aspect, the method further includes placing the first strap portion in a second molding die; positioning an end of a second tubular textile casing over the connector portion and in contact with the first tubular textile casing of the first strap portion; introducing molten plastic material into the second molding die and into the second tubular textile casing; and allowing the molten plastic material to solidify within the second textile casing to form the second strap portion having an inner core formed from a unitary plastic material that is connected to the connector portion of the first strap portion.

[0029] According to at least one of the embodiments disclosed herein, there is provided a headgear assembly comprising a top strap, upper side straps connected to the top strap, and lower side straps connected to the upper side strap, the upper side straps and the lower side straps being unitarily formed as a one-piece structure.

[0030] According to a further aspect, the upper and lower side straps are formed as a closed loop structure.

[0031] According to a further aspect, the top strap, upper side straps and lower side straps are unitarily formed as a one-piece structure.

[0032] According to a further aspect, the top strap, the upper side strap and the lower side strap are formed as a closed loop structure.

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

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

[0035] According to a further aspect, at least one of the top strap and the neck panel comprises a breathable moisture wicking material.

[0036] According to a further aspect, the top strap comprises a quilted textile material.

[0037] According to a further aspect, a unitary plastic core material is integrally formed within the upper and lower side straps.

[0038] According to a further aspect, a unitary plastic core material is integrally formed within the top strap, upper side straps and lower side straps.

[0039] According to at least one of the embodiments disclosed herein, a tubular connector is provided for attaching an end of a first strap to a sidewall of a second strap, the connector including a first end having a shape corresponding to a shape of the end of the first strap and contacting the end of the first strap, a second end opposite the first end having a shape corresponding to a sidewall of the second strap and contacting the sidewall of the second strap, a cavity disposed between the first end and the second end, and a plastic core material disposed within the cavity, the plastic core material unit unitarily joining the first strap and the second strap to form a unitary structure.

[0040] According to a further aspect, the first end overlaps the end of the first strap.

[0041] According to a further aspect, an end of the first strap abuts the second strap.

[0042] According to a further aspect, the second end overlaps the sidewall of the second strap.

[0043] According to at least one of the embodiments disclosed herein, a method is provided for joining an end of a first strap to a side wall of a second strap in a molding die. The method includes the steps of positioning an end of the first tubular textile casing within a cavity of the tubular connector and a portion of a sidewall of the second tubular textile casing adjacent to or within the cavity of the tubular connector; placing the first and second tubular textile casings and the tubular connector within a cavity of a molding tube mold; introducing molten plastic material into the molding mold 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 solidifying the molten plastic material within the first and second tubular textile casings and the tubular connector to form a unitary inner core from the plastic material within the first and second tubular textile casings and the tubular connector.

[0044] According to a further aspect, the positioning step includes abutting an end of the first tubular textile casing against the second tubular textile casing.

[0045] According to at least one of the embodiments disclosed herein, a strap connector assembly is disclosed for connecting a first strap and a second strap, each of the straps comprising a unitary plastic core within a textile casing, the strap connector assembly comprising a first connector portion disposed at an end of the first strap and a second connector portion disposed between an end of the second strap, the second connector portion comprising a protrusion of the unitary plastic core protruding through the textile casing of the second strap and configured to align with the first connector portion to facilitate connection of the first strap and the second strap. According to a further aspect, a thickness of the first connector portion is equal to a thickness of the second connector portion. According to a further aspect, the first connector portion and the second connector portion are configured to have a gap disposed therebetween when aligned to facilitate connection of the first strap and the second strap. According to a further aspect, the strap connector assembly further comprises an alignment recess disposed at the first connector portion configured to engage a protrusion disposed on an inner surface of the molding die to maintain a position of the first connector portion relative to the molding die. According to a further aspect, the strap connector assembly further comprises an overmolded joint overmolded onto the first connector portion and the second connector portion. According to a further aspect, a thickness of the overmolded joint is equal to a thickness of the first connector portion and a thickness of the second connector portion. According to a further aspect, the overmolded joint contacts the textile casing of the first strap and the second strap. According to a further aspect, the first connector portion and the second connector portion are shaped to interfit with each other. According to a further aspect, the first connector portion comprises an extension of the unitary plastic core beyond the textile casing. According to a further aspect, the first connector portion extends beyond an end of the textile casing. According to a further aspect, the first connector portion and the second connector portion are male and female connector portions, respectively. According to a further aspect, each of the first connector portion and / or the second connector portion comprises a tab.According to a further embodiment, the first connector portion and / or the second connector portion have a width equal to a width of the unitary plastic core of the respective first and second strap.

[0046] According to at least one of the embodiments disclosed herein, a strap connector assembly is disclosed that connects a first strap portion and a second strap portion, each of the strap portions comprising a unitary plastic core within a textile casing, the strap connector assembly comprising a joining tab comprising a portion of the unitary plastic core of one of the straps and configured to join the first strap portion and the second strap portion, an alignment post protruding from a surface of the joining tab, and an overmolded joint overmolded onto the joining tab. According to a further aspect, a thickness of the alignment post is greater than a thickness of the joining tab. According to a further aspect, a thickness of the alignment post is equal to a thickness of the overmolded joint. According to a further aspect, the overmolded joint is formed from an elastomeric material. According to a further aspect, the strap connector assembly further comprises a label formed within a surface of the overmolded joint.

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

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

[0049] In accordance with at least one of the embodiments disclosed herein, a strap assembly for headgear is disclosed, the strap assembly comprising: a textile casing including an ear arch region configured to be positioned over a user's ear; and a plastic core disposed within a cavity of the textile tubular casing, wherein a distance between the plastic core and an edge of the textile casing in the ear arch region is greater than the distance in a remainder of the strap assembly.

[0050] According to at least one of the embodiments disclosed herein, a headgear assembly is disclosed that includes a headgear loop strap configured to receive a top and a back of a user's head, the headgear loop strap including a unitary plastic core integrally formed with a textile casing, a connector tab portion formed from the unitary plastic core and projecting through the textile casing between ends of the headgear loop strap, a front strap, and a connector disposed on the connector tab portion of the headgear loop strap and the end of the front strap. According to a further aspect, the connector is overmolded onto the ends of the headgear loop strap and the front strap. According to a further aspect, a thickness of the connector is equal to a thickness of the connector tab portion. According to a further aspect, a thickness of the connector is equal to a thickness of the headgear loop strap. According to a further aspect, the headgear loop strap further includes an alignment tab extending from an end of the headgear loop strap, the alignment tab including a portion of the unitary plastic core of the headgear loop strap, and an alignment post projecting from a surface of the joining tab.

[0051] According to at least one of the embodiments disclosed herein, a strap connector assembly is disclosed that connects a first strap portion and a second strap portion, each of the strap portions having a unitary plastic core within a textile casing, the strap connector assembly including a first connector portion disposed at an end of the first strap, a second connector portion disposed between an end of the second strap and protruding through the textile casing of the second strap, and an overmolded fitting overmolded onto the first connector portion and the second connector portion. According to a further aspect, at least one of the first connector portion and the second connector portion further includes an alignment post protruding from a surface of the first strap, the overmolded fitting surrounding the alignment post. According to a further aspect, at least one of the first connector portion and the second connector portion further includes a recessed area recessed into a surface of the first strap, the recessed area receiving an overmolded material of the overmolded fitting. According to a further aspect, the strap connector assembly further includes an alignment recess formed concavely in a surface of at least one of the first strap and the second strap, the alignment recess configured to engage a protrusion disposed on an inner surface of the molding die to maintain a position of at least one of the first strap and the second strap relative to the molding die.

[0052] According to at least one of the embodiments disclosed herein, there is provided a strap connector assembly for connecting a first strap and a second strap in a molding die. The straps are formed from a unitary plastic core injected into a tubular textile casing. The strap connector assembly includes a male connector portion disposed at an end of the first strap and a female connector portion disposed between an end of the second strap, the female connector portion protruding through the textile casing of the second strap. The female connector portion is configured to engage with the male connector portion such that the first strap and the second strap are connected. The male connector portion and the female connector portion are formed from a molten unitary plastic core material. According to a further aspect, a thickness of the male connector portion is equal to a thickness of the female connector portion. According to a further aspect, the strap connector assembly further includes a gap between the male connector portion and the female connector portion. According to a further aspect, the strap connector assembly further includes an alignment recess disposed in the male connector portion configured to engage a protrusion disposed on an inner surface of the molding die to maintain a position of the male connector portion relative to the molding die. According to a further aspect, the strap connector assembly further includes an overmolded joint overmolded onto the male connector portion and the female connector portion. According to a further aspect, a thickness of the overmolded joint is equal to a thickness of the male connector portion and a thickness of the female connector portion. According to a further aspect, the overmolded joint contacts the textile casings of the first strap and the second strap.

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

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

[0055] According to a further aspect, the overmolded joint is formed from an elastomeric material.

[0056] According to a further aspect, the strap connector assembly further includes a label formed within a surface of the overmolded joint.

[0057] According to at least one of the embodiments disclosed herein, there is provided a strap connector for connecting a first strap portion and a second strap portion in a molding die. The strap portions are formed from a unitary plastic core injected into a textile casing. The strap connector includes an exterior cavity disposed at an end of the housing and configured to receive the ends of the first strap portion and the second strap portion, an interior cavity disposed between the exterior cavities, and an injection opening in fluid communication with the interior cavity and the exterior cavity and configured to receive the unitary plastic core material.

[0058] According to a further aspect, the height of the outer cavity is greater than the height of the inner cavity.

[0059] According to a further aspect, the height of the internal cavity is equal to the thickness of the unitary plastic core material within the tubular textile casing.

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

[0061] According to a further aspect, the inner surface of the textile casing has a substantially planar shape.

[0062] According to a further aspect, the inner surface of the textile casing has a concave shape.

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

[0064] According to a further aspect, the connectors are overmolded onto the ends of the headgear loop straps and the front straps.

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

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

[0067] According to a further aspect, the headgear loop strap further includes an alignment tab extending from an end of the headgear loop strap, the alignment tab comprising a portion of the unitary plastic core of the headgear loop strap, an alignment post protruding from a surface of the joint tab, and an overmolded joint overmolded onto the alignment tab and configured to connect the end of the headgear loop strap.

[0068] According to at least one of the embodiments disclosed herein, there is provided a strap connector assembly for connecting a first strap portion and a second strap portion in a molding die. The strap portions are formed from a unitary plastic core material injected into a tubular textile casing. The strap connector assembly includes a first connector portion disposed at an end of the first strap, a second connector portion disposed between an end of the second strap and protruding through the tubular textile casing of the second strap, and an overmolded fitting overmolded onto the first and second connector portions.

[0069] According to a further aspect, at least one of the first connector portion and the second connector portion further comprises an alignment post protruding from a surface of the first strap, the overmolded joint surrounding the alignment post.

[0070] According to a further aspect, at least one of the first connector portion and the second connector portion further includes a recessed area formed concavely in a surface of the first strap, the recessed area receiving an overmold material of the overmold fitting.

[0071] According to a further aspect, the strap connector assembly further includes an alignment recess formed concavely in a surface of at least one of the first strap and the second strap, the alignment recess configured to engage a protrusion disposed on an inner surface of the molding die to maintain a position of at least one of the first strap and the second strap relative to the molding die.

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

[0073] In some configurations, one or more of the top, rear, and front straps of the headpiece include separate left and right portions, each having a free end, the free ends of the left and right portions being adjustably connected to one another.

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

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

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

[0077] In some configurations, the ear loop is configured to encircle the user's ear without contacting the ear.

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

[0079] In some configurations, the at least one connector connection surface is configured to connect to the at least one headpiece connection surface along a connection line that extends upwardly and downwardly from behind the user's ear, the entire connection line being configured to be located above the lowest limit of the user's ear.

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

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

[0082] According to at least one of the embodiments disclosed herein, there is provided a patient interface, the patient interface including a headgear assembly, a mask assembly, and a connector portion connecting the headgear assembly to the mask assembly, the headgear assembly, the mask assembly, and the connector portion forming a closed loop when the connector is separated from the mask assembly.

[0083] According to a further aspect, an effective length of the closed loop is increased when the connector portion is separated from the mask assembly compared to an effective length of the closed loop when the connector portion is engaged with the mask assembly.

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

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

[0086] According to a further aspect, the hinge portion is a living hinge.

[0087] According to a further aspect, the hinge portion is formed from silicone.

[0088] According to a further aspect, the living hinge is formed from a fabric.

[0089] According to a further aspect, the patient interface further includes a hook disposed on the mask assembly and a post disposed on the connection portion, the hook receiving the post receiving the hook to engage the mask assembly.

[0090] According to a further aspect, the connector portion engages the mask assembly via a snap fit or interference fit.

[0091] According to a further aspect, the headgear assembly has straps formed from a textile casing having a unitary plastic core material integrally formed therein.

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

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

[0094] Reference numbers may be reused throughout the drawings to indicate a general correspondence between referenced elements. The drawings are provided to illustrate example embodiments described herein and are not intended to limit the scope of the present disclosure. [Brief description of the drawings]

[0095] [Figure 1A] FIG. 1 shows a side view of a bifurcated headgear configuration formed by a burst-through intra-mouling arrangement of the present disclosure. [Figure 1B] 1 illustrates a top perspective view of a bifurcated headgear configuration of the present disclosure. [Figure 2A] FIG. 13 shows an enlarged side view of the junction between the top and bottom straps of the bifurcated headgear configuration of the present disclosure. [Figure 2B] FIG. 13 shows an enlarged side view of the junction between the top and bottom straps of the bifurcated headgear configuration of the present disclosure. [Diagram 3] 1 shows a cross-sectional view of the junction between the top and bottom straps of the bifurcated headgear configuration of the present disclosure. [Figure 4] 1 shows a perspective view of an injection mold for forming the bifurcated headgear configuration of the present disclosure. [Diagram 5] FIG. 2 shows a top view of the second mold half of the injection mold. [Figure 6] FIG. 2 shows an enlarged top perspective view of a top strap and a bottom strap positioned within a second mold half of an injection mold. [Figure 7] 1 shows a bottom cross-sectional view of the fully formed bifurcated headgear section. [Figure 8A] 13A-13C show perspective views of a second mold half of an alternative molded-in strap cavity configuration for forming X-shaped and T-shaped joints. [Figure 8B] 13A-13C show top views of strap configurations having X-shaped and T-shaped junctions. [Figure 9A] 13A-13C show top views of alternative molded-in strap configurations having straps joined to one another by integrally formed connecting members disposed between the straps. [Figure 9B] 13 illustrates a top view of an alternative molded-in strap configuration having straps joined to one another by integrally formed web portions disposed between the straps. [Figure 10A] 13A-13C show top views of alternative molded-in strap configurations having filleted joints connecting the filleted straps to adjacent straps. [Figure 10B] FIG. 2 shows a top perspective view of an injection mold for forming a fillet-like joint. [Figure 11A] FIG. 13 shows a top view of a molded-in-mold strap configuration with a molded square texture imprinted into the strap. [Figure 11B] FIG. 13 shows a close-up top view of a molded square texture imprinted on the strap. [Figure 11C] 11C shows a cross-sectional view of the molded square texture imprinted into the strap along line 11C-11C of FIG. 11B. [Figure 11D] FIG. 13 shows a top view of a molded-in-mold strap configuration with a molded hexagonal texture imprinted on the strap. [Figure 11E] FIG. 13 shows a side perspective view of a molded hexagonal texture imprinted on the strap. [Figure 12A] FIG. 1 shows a top view of a first mold forming the bottom strap with attachment members for molded-in bifurcated headgear. [Figure 12B] FIG. 1 shows an enlarged top view of the first mold showing the bottom strap and attachment members. [Figure 13A] FIG. 13 is a top view of a second mold forming the top strap on the mounting member. [Figure 13B] FIG. 13 shows a close-up top view of the second mold showing the top strap attached to the bottom strap. [Figure 13C] 1 illustrates an enlarged cross-sectional view of a top strap positioned over a mounting member prior to injection of a plastic core material into the top strap; [Figure 13D] 4 shows an enlarged cross-sectional view of a top strap attached to a mounting member after injection of a plastic core material into the top strap. [Figure 14A] FIG. 1 shows an enlarged side view of a top strap having a sealed end at the juncture with the bottom strap. [Figure 14B] FIG. 2 shows an enlarged side view of a top strap having a sealed end. [Figure 14C] FIG. 1 shows an enlarged side view of a top strap having a sealed end attached to a bottom strap at a joint. [Figure 14D] 1 shows a cross-sectional view of the joint between the top and bottom straps. [Figure 15A] FIG. 13 shows an enlarged cross-sectional side view of a top strap attached to a bottom strap having a filament core coupled to the bottom strap that engages a deformation locking mechanism. [Figure 15B] FIG. 1 shows a top view of a bifurcated headgear section having a bottom strap with a filament core attached thereto. [Figure 15C] 13 shows a top view showing the casing length extension for the bottom strap. [Figure 15D] A top view showing the narrowing of the casing for the bottom strap when stretched is shown. [Figure 16A] 13 shows a side perspective view of an alternative bifurcated headgear configuration having a button and hole size adjustment system formed by the breakthrough in-molding configuration of the present disclosure. FIG. [Figure 16B]A cross section is shown for the top and bottom straps with button and hole size adjustment system. [Figure 16C] FIG. 1 is a side perspective view of an injection mold forming the buttons of the button and hole sizing system. [Figure 16D] 1 shows a cross-sectional view of a first mold half and a second mold half during the process of in-mold breaking through a button of the button and hole sizing system. [Figure 17] 13 shows an adjustable strap configuration with adjustment and usability features formed by a breakthrough in-mold process. [Figure 18] 1 shows molded-in-mold headgear having multiple straps and multiple breakthrough joints. [Figure 19] 1 illustrates an exemplary headgear incorporating an additional comfort layer along with an in-mold forming and breakthrough process. [Figure 20] Another exemplary headgear incorporating an additional comfort layer is shown along with an in-mold forming and breakthrough process. [Figure 21] 1 shows an exemplary headgear incorporating an in-mold forming and breaking through process and having a web portion joining the rear of the lower strap and middle strap. [Figure 22] 13 shows another exemplary headgear incorporating an in-mold forming and breaking through process and having a continuous lower strap. [Figure 23] 1 shows an exemplary headgear incorporating an in-mold forming and breaking through process and having a web portion joining the rear of the lower strap and middle strap. [Figure 24] 1 illustrates an exemplary headgear incorporating an in-mold forming and breaking through process and having a continuous lower strap and interlocking continuous middle and vertical straps. [Diagram 25] 1 illustrates an exemplary headgear incorporating an in-mold forming and breaking through process, with lower and middle straps formed from a continuous casing in the form of a closed loop structure. [Figure 26]13 illustrates another exemplary headgear incorporating an in-mold forming and breaking through process, with lower and middle straps formed from a continuous casing in the form of a closed loop structure. [Figure 27] An exemplary headgear is shown incorporating an in-mold forming and breaking through process and having a quilted fabric or material attached to portions of the headgear that are in direct contact with the skin or hair of the user. [Figure 28] Another exemplary headgear is shown incorporating an in-mold forming and breaking through process and having a quilted fabric or material attached to portions of the headgear that are in direct contact with the skin or hair of the user. [Figure 29] 1 illustrates an exemplary headgear incorporating an in-mold forming and breaking through process and having vertical straps and a neck strap formed from a foam-Lycra laminate material. [Diagram 30] 1 illustrates an exemplary headgear incorporating an in-mold forming and breaking through process and having breathable, moisture wicking material on the vertical straps and neck strap. [Diagram 31] 1 shows an exemplary headgear incorporating an in-mold forming and breaking through process, with lower and middle straps formed from a continuous casing in the form of a closed loop structure. [Diagram 32] 1 illustrates an exemplary headgear incorporating an in-mold forming and breaking through process, with bottom lower straps, middle straps and front vertical straps formed from a continuous casing in the form of a closed loop structure. [Diagram 33] 1 illustrates an exemplary headgear incorporating an in-mold forming and breaking through process, with lower and middle straps formed from a continuous casing in the form of a closed loop structure. [Diagram 34] 1 illustrates an exemplary headgear incorporating an in-mold forming and breaking through process, with lower and middle straps formed from a continuous casing in the form of a closed loop structure. [Diagram 35]1 shows an exemplary headgear incorporating an in-mold forming and breaking through process and having lower and middle straps with a continuous casing. [Diagram 36] 1 illustrates an exemplary headgear incorporating an in-mold forming and breaking through process, with lower and middle straps formed from a continuous casing in the form of a closed loop structure. [Figure 37] 1 illustrates an exemplary headgear incorporating an in-mold forming and breaking through process, with lower and middle straps formed from a continuous casing. [Figure 38] 13 illustrates another exemplary headgear incorporating an in-mold forming and breaking through process and having lower and middle straps formed from a continuous casing. [Figure 39] 1 illustrates an exemplary headgear incorporating an in-mold forming and breaking through process, with lower and middle straps formed from a continuous casing. [Diagram 40] 1 illustrates an exemplary headgear incorporating an in-mold forming and breaking through process, with lower, middle and vertical straps formed from a continuous casing. [Diagram 41] 1 illustrates an exemplary headgear incorporating an in-mold forming and breaking through process, with lower straps, and middle and vertical straps formed from a continuous casing. [Diagram 42] 1 illustrates an exemplary headgear incorporating an in-mold forming and breaking through process, with lower and middle straps formed from a continuous casing. [Figure 43A] FIG. 13 is a front perspective view of an exemplary headgear that can be used with the patient interface. [Figure 43B] FIG. 43B is a rear perspective view of the exemplary headgear of FIG. [Figure 44A] FIG. 13 is a front perspective view of an exemplary headgear that can be used with the patient interface. [Figure 44B]FIG. 44B is a rear perspective view of the exemplary headgear of FIG. [Figure 45A] FIG. 13 is a front perspective view of an exemplary headgear that can be used with the patient interface. [Figure 45B] FIG. 45B is a rear perspective view of the exemplary headgear of FIG. [Figure 46A] FIG. 13 is a front perspective view of an exemplary headgear that can be used with the patient interface. [Figure 46B] FIG. 46B is a side view of the exemplary headgear of FIG. [Figure 46C] FIG. 46B is a rear perspective view of the exemplary headgear of FIG. [Figure 47A] FIG. 13 is a front perspective view of an exemplary headgear that can be used with the patient interface. [Figure 47B] FIG. 47B is a rear perspective view of the exemplary headgear of FIG. [Figure 48A] FIG. 13 is a front perspective view of an exemplary headgear that can be used with the patient interface. [Figure 48B] FIG. 48B is a rear perspective view of the exemplary headgear of FIG. [Figure 49A] FIG. 13 is a front perspective view of an exemplary headgear that can be used with the patient interface. [Figure 49B] FIG. 49B is a rear perspective view of the exemplary headgear of FIG. [Figure 50A] FIG. 13 is a front perspective view of an exemplary headgear that can be used with the patient interface. [Figure 50B] FIG. 50B is a rear perspective view of the exemplary headgear of FIG. [Figure 51A] FIG. 13 is a side view of an exemplary headgear that can be used with the patient interface. [Figure 51B] FIG. 51B is a cross-sectional view of a strap portion of the exemplary headgear of FIG. 51A. [Figure 52A] FIG. 13 is a side view of an exemplary headgear that can be used with the patient interface. [Figure 52B] FIG. 52B is a cross-sectional view of a strap portion of the exemplary headgear of FIG. 52A. [Figure 52C] FIG. 52B is a cross-sectional view of a strap portion of the exemplary headgear of FIG. 52A. [Figure 53A] FIG. 13 is a side view of an exemplary headgear that can be used with the patient interface. [Figure 53B] FIG. 53B is a cross-sectional view of a strap portion of the exemplary headgear of FIG. 53A. [Figure 54A] FIG. 13 is a side view of an exemplary headgear that may be used with a patient interface and has lower and middle straps formed from a continuous casing. [Figure 54B] FIG. 54B is a close-up view of a web portion of the exemplary headgear of FIG. 54A. [Fig. 54C] 54C is a cross-sectional view of the web portion taken along line 54C-54C of FIG. 54B. [Figure 55A] FIG. 13 is a side view of an exemplary headgear that may be used with a patient interface and has a continuous lower strap combined with continuous middle and vertical straps. [Figure 55B] A cross-sectional view of the web portion of the exemplary headgear taken along line 55B-55B of FIG. 55A. [Figure 55C] FIG. 55B is a close-up view of a web portion of the exemplary headgear of FIG. 55A. [Figure 56A] FIG. 13 is a side view of an exemplary headgear that may be used with the patient interface, with lower and middle straps formed from a continuous casing in the form of a closed loop structure. [Figure 56B] FIG. 56B is a close-up view of a joint of the exemplary headgear of FIG. 56A. [Figure 57A] FIG. 13 is a side view of an exemplary headgear that may be used with a patient interface and has lower and middle straps formed from a continuous casing. [Figure 57B] FIG. 57B is a close-up view of a second vertical member of the exemplary headgear of FIG. 57A. [Figure 57C] FIG. 57C is a cross-sectional view of the second vertical member taken along line 57C-57C of FIG. 57B. [Figure 58A]FIG. 13 is a side view of an exemplary headgear that can be used with the patient interface. [Figure 58B] FIG. 58B is a close-up view of a joint of the exemplary headgear of FIG. [Figure 59A] FIG. 13 is a side view of an exemplary headgear that may be used with a patient interface and has continuous middle and vertical straps and continuous top and rear straps. [Figure 59B] FIG. 59B is a close-up view of the continuous middle and vertical straps and the continuous top and rear straps of the exemplary headgear of FIG. [Figure 59C] FIG. 59C is a cross-sectional view of the continuous middle and vertical straps and the continuous top and rear straps taken along line 59C-59C of FIGS. 59A and 59B. [Figure 60A] FIG. 13 is a side view of an exemplary headgear that can be used with the patient interface. [Figure 60B] FIG. 60B is a close-up view of the rear strap of the exemplary headgear of FIG. 60A. [Figure 61A] FIG. 13 is a side view of an exemplary headgear that may be used with a patient interface and has continuous middle and vertical straps and continuous top and rear straps. [Figure 61B] FIG. 61B is a close-up view of the rear portion of the middle and lower straps of the exemplary headgear of FIG. [Figure 61C] 61C is a cross-sectional view of the continuous middle and vertical straps and the continuous top and rear straps taken along line 61C-61C of FIG. 61B. [Figure 62A] FIG. 13 is a side view of an exemplary headgear that can be used with the patient interface. [Figure 62B] FIG. 62B is a close-up view of the exemplary headgear variation of FIG. [Figure 63A] FIG. 1 is a side view of an exemplary headgear that may be used with a patient interface and has a quilted fabric or material attached to portions of the headgear that are provided for direct contact with the skin or hair of a user. [Figure 63B]FIG. 63B is a close-up view of the quilted fabric of the exemplary headgear of FIG. 63A. [Figure 63C] FIG. 63B is a close-up view of an alternative web material of the exemplary headgear of FIG. 63A. [Fig. 64A] FIG. 13 is a side view of an exemplary headgear that may be used with a patient interface and has fabric or textile material attached to portions of the headgear that are provided for direct contact with the skin or hair of a user. [Fig. 64B] FIG. 64B is a close-up view of the fabric or textile material of the exemplary headgear of FIG. 64A. [Figure 65] FIG. 13 is a close-up view of a branded grip that can be used with the disclosed headgear embodiments. [Figure 66A] FIG. 1 is a side view of a T-shaped junction between an end of a first strap and a center or middle portion of a second strap. [Figure 66B] FIG. 66B is a close-up view of the connectors forming the T-junction of FIG. 66A. [Figure 67] FIG. 2 is a perspective view of a T-junction. [Figure 68A] FIG. [Figure 68B] FIG. [Figure 68C] FIG. [Figure 68D] FIG. [Figure 69] FIG. 13 is a side view of a T-junction showing a connector placed over a first strap such that an end of the first strap is positioned inside the connector. [Figure 70] FIG. 2 is a perspective view of a connector and a T-junction. [Figure 71] FIG. 13 is an enlarged side view of the fill connector and T-junction. [Figure 72] FIG. 13 is a cross-sectional view of a fill connector and a T-junction. [Figure 73] FIG. 13 is a side view of the fill connector and T-junction. [Fig. 74A]13A-13C show top views of the top straps of an exemplary headgear configuration having male connectors forming overmolded joints. [Fig. 74B] 13A-13C show top views of bottom straps of an exemplary headgear configuration having female connectors forming overmolded joints. [Fig. 75A] A close-up top view of the male connector of the top strap is shown. [Fig. 75B] A close-up cross-sectional view of the male connector of the top strap is shown. [Figure 76A] A close-up top view of the female connector of the bottom strap is shown. [Figure 76B] A close-up cross-sectional view of the female connector of the bottom strap is shown. [Figure 76C] A close-up perspective view of the female connector of the bottom strap is shown. [Figure 77A] A close-up top view of the aligned male and female connectors is shown. [Fig. 77B] 1 illustrates an enlarged top view of the male connector being inserted into and received by the female connector. [Fig. 77C] 1 illustrates an enlarged cross-sectional view of the male connector being inserted into and received by the female connector. [Fig. 78A] 1 shows an enlarged side view of the male and female connectors illustrating the relatively small gap between the male and female connectors. [Fig. 78B] 1 shows an enlarged side view of the male and female connectors illustrating the relatively large gap between the male and female connectors. [Figure 79A] An enlarged top view of the male connector is shown. [Figure 79B] FIG. 2 shows a perspective view of an overmold cavity of an overmold mold. [Figure 79C] 1 shows a cross-sectional view of a male connector inserted into an overmold cavity of an overmold mold. [Figure 80A] 1 shows an enlarged top view of an overmolded joint joining the top and bottom straps. [Figure 80B] FIG. 2 shows a perspective view of an overmolded joint joining the top and bottom straps. [Fig. 80C] 1 shows a bottom cross-sectional view of an overmolded joint joining the top and bottom straps. [Figure 81A] FIG. 13 shows a close-up top view of the joining tabs and alignment posts before the overmolding joins the two halves of the bottom strap. [Fig. 81B] FIG. 81B shows an enlarged bottom view of the joining tabs and alignment posts of FIG. 81A. [Fig. 81C] 81B shows an enlarged cross-sectional view of the joining tab and alignment post of FIG. 81A. [Fig. 81D] 81B shows an enlarged top view of an overmold formed over the bonding tabs and alignment posts of FIG. 81A. [Figure 81E] FIG. 81D shows an enlarged bottom view of the overmold of FIG. [Fig. 82A] FIG. 2 shows a side view of the strap end joint housing. [Fig. 82B] 82B shows a perspective view of the strap end joint housing of FIG. 82A. [Figure 83A] 82B shows a top view of the strap end joint housing of FIG. 82A. [Figure 83B] FIG. 82B shows a side view of the strap end joint housing of FIG. 82A. [Figure 83C] 82B shows an end view of the strap end joint housing of FIG. 82A. [Fig. 83D] A side cross-sectional view of the strap end joint housing taken along line 83D-83D of FIG. 83A is shown. [Figure 83E] 83E-83E shows an end cross-sectional view of the strap end joint housing taken along line 83E-83E of FIG. 83B. [Fig. 84A] FIG. 1 shows a side cross-sectional view of a strap having a D-shaped cross-section with flanges formed along the edges of the strap. [Fig. 84B] FIG. 2 shows a side cross-sectional view of a strap having a D-shaped cross-section with no flanges formed along the edges of the strap. [Figure 85] 1 shows a top view of a strap with a bottom strap having soft edges that are placed over the user's ears. [Figure 86] FIG. 13 shows a side view of a bifurcated headgear configuration formed by a breakthrough in-mold configuration with rear headgear loop straps. [Fig. 87A] FIG. 87 shows a top view of the rear headgear loop strap of FIG. [Fig. 87B] FIG. 87 shows an enlarged top view of the breakthrough tab of the rear headgear loop strap of FIG. [Fig. 87C] FIG. 87 shows an enlarged top view of the alignment tab of the rear headgear loop strap of FIG. [Fig. 88A] FIG. 87 illustrates a top view of the alignment tab of the rear headgear loop strap of FIG. [Fig. 88B] 88B shows an enlarged cross-sectional view of the alignment tab of the rear headgear loop strap taken along line 88B-88B of FIG. 87C. [Figure 89A] FIG. 13 shows a top view of the overmolded joints joining the rear headgear loop straps to the front straps. [Figure 89B] 89B shows an enlarged cross-sectional view of the overmolded joint taken along line 89B-89B in FIG. 89A. [Figure 90A] 1 shows a perspective view of a top strap having alignment posts and recesses. [Figure 90B] 90B shows a bottom view of the top strap of FIG. 90A. [Figure 90C] A top view of a bottom strap with alignment posts and recesses is shown. [Figure 90D] A top view of the bottom strap in FIG. 90C with alignment posts, post holes and recesses is shown. [Figure 91A] 90C shows a perspective view of the top strap of FIG. 90A aligned with the bottom strap of FIG. 90C. [Figure 91B] 90C shows a bottom view of the top strap of FIG. 90A aligned with the bottom strap of FIG. 90C. [Fig. 91C]90C shows a perspective view of the top strap of FIG. 90A aligned with the bottom strap of FIG. 90C. [Fig. 91D] 90C shows a cross-sectional perspective view of the top strap of FIG. 90A aligned with the bottom strap of FIG. 90C. [Figure 92A] 90C shows a bottom view of an overmolded joint joining the top strap of FIG. 90A and the bottom strap of FIG. 90C. [Fig. 92B] 92B shows a top view of the overmolded joint of FIG. 92A. [Fig. 92C] 92B shows a cross-sectional perspective view of the overmolded joint of FIG. 92A. [Fig. 92D] FIG. 2 shows a cross-sectional perspective view of an overmolded connector. [Figure 93A] 1 is a perspective view of a non-limiting exemplary embodiment of a patient interface having a headgear assembly and a mask assembly according to the present disclosure, the headgear assembly including a headpiece and one or more connectors between the headpiece and the mask assembly; [Figure 93B] FIG. 93B is a perspective view of the patient interface of FIG. 93A, with the connector separated from the headpiece. [Figure 93C] FIG. 93B is a rear perspective view of the patient interface of FIG. 93A. [Figure 94A] FIG. 1 is a perspective view of another non-limiting exemplary embodiment of a patient interface having a headgear assembly and a mask assembly according to the present disclosure. The headgear assembly includes a headpiece and one or more connectors between the headpiece and the mask assembly. [Figure 94B] FIG. 94B is a perspective view of the patient interface of FIG. 94A, with the connector separated from the head member. [Fig. 94C] FIG. 94B is a rear perspective view of the patient interface of FIG. 94A. [Figure 95] FIG. 1 shows an isometric view of a patient interface of the present disclosure including headgear, a mask assembly and a connector. [Figure 96] FIG. 96 illustrates a rear isometric view of the patient interface of FIG. [Figure 97]FIG. 1 illustrates an isometric view of the patient interface showing the connector separated from the mask assembly. [Figure 98] FIG. 98 illustrates an isometric view of the patient interface of FIG. 97 showing the connector fully extended away from the mask assembly. [Figure 99A] FIG. 1 shows an isometric view of a living hinge connector. [Figure 99B] FIG. 1 illustrates an isometric view of an alternative living hinge connector. [Figure 100] FIG. 1 illustrates a top view of a living hinge connector having a reduced thickness portion. [Figure 101A] FIG. 2 shows an exploded isometric view of a living hinge connector. [Figure 101B] 101B shows a cross-sectional view of the headgear connector member and the mask connector member of the living hinge connector of FIG. 101A. [Figure 102A] FIG. 1 illustrates an isometric view of a living hinge connector having a single mask hinge and a single connector hinge. [Figure 102B] 102B shows a top cross-sectional view of the headgear connector member and the mask connector member of the living hinge connector of FIG. 102A. [Figure 103A] FIG. 1 shows an isometric view of a patient interface having a living hinge connector with a hook and post retention system. [Figure 103B] 103B shows a front view of the living hinge connector of FIG. 103A in an open position. [Figure 104A] FIG. 13 shows an isometric view of a patient interface with a fabric living hinge connector in a closed position. [Figure 104B] FIG. 104B illustrates an isometric view of the patient interface of FIG. 104A showing the fabric living hinge connector in the open position. [Figure 105A] FIG. 13 shows an isometric view of a patient interface with a silicone hinge connector in a closed position. [Figure 105B] FIG. 105B illustrates an isometric view of the patient interface of FIG. 105A showing the silicone hinge connector in the open position. [Figure 106A]FIG. 13 shows a top view of an alternative silicone hinge with the connector in a closed position. [Figure 106B] 106B shows a top view of the silicone hinge of FIG. 106A with the connector in the open position. [Figure 107A] FIG. 13 shows an isometric view of a patient interface with an alternative silicone hinge connector in a closed position. [Figure 107B] 107B shows an isometric view of the silicone hinge connector of FIG. 107A in the open position. [Figure 108A] FIG. 1 illustrates an isometric view of a patient interface showing the headgear connection of the present disclosure. [Figure 108B] 108B shows an enlarged perspective view of the lateral end of the connector of the headgear connection portion of FIG. 108A. [Figure 108C] A cross-sectional view of the connector of the headgear connection portion of Figure 108A is shown. [Fig. 109A-B] Fig. 109A shows an isometric view of a headgear fastening mechanism, and Fig. 109B shows a top view of an alternative headgear fastening mechanism. [Figure 110A] FIG. 1 shows an isometric view of a push-fit headgear fastening mechanism. [Figure 110B] A cross-sectional view of a push-fit headgear fastening mechanism is shown. [Fig. 111A] FIG. 1 shows an isometric view of a patient interface with an over-center clip design connector in a closed position. [Fig. 111B] FIG. 111B illustrates an isometric view of the patient interface of FIG. 111A showing the over-center clip design connector in the open position. [Fig. 112A] FIG. 13 shows an isometric view of a patient interface with a telescoping pivot connector in a closed position. [Fig. 112B] FIG. 112B illustrates an isometric view of the patient interface of FIG. 112A showing the telescoping pivot connector in an open position. [Figure 112C] FIG. 112B illustrates an isometric view of the patient interface of FIG. 112A showing the telescoping pivot connector in an open and extended position. [Fig. 113A] FIG. 13 shows an isometric view of a patient interface with a hard stop sliding strap connector in a closed position. [Fig. 113B] FIG. 113B illustrates an isometric view of the patient interface of FIG. 113A showing the hard stop sliding strap connector in the open position. [Fig. 114A] FIG. 13 shows an isometric view of a patient interface with strap end hard stop connectors in a closed position. [Fig. 114B] FIG. 114B illustrates an isometric view of the patient interface of FIG. 114A showing the strap end hard stop connectors in the open position. [Fig. 115A] FIG. 1 shows an isometric view of a patient interface with a break-fit magnet and tether connector in a closed position. [Fig. 115B] FIG. 115B illustrates an isometric view of the patient interface of FIG. 115A showing the break-fit magnet and tether connector in the open position. [Fig. 116A] FIG. 1 shows an isometric view of a patient interface with a break-fit clip and tether connector in a closed position. [Fig. 116B] FIG. 116B illustrates an isometric view of the patient interface of FIG. 116A showing the break-fit clip and tether connector in an open position. [Fig. 117A] FIG. 1 illustrates an isometric view of a patient interface with a clip and continuous tether connector in a closed position. [Fig. 117B] FIG. 117B illustrates an isometric view of the patient interface of FIG. 117A showing the clip and continuous tether connector in an open position. [Fig. 118A] FIG. 13 shows a front view of a patient interface with a dual clip and continuous tether connector in a closed position. [Fig. 118B] FIG. 118B illustrates an isometric view of the patient interface of FIG. 118A showing the dual clip and continuous tether connector in an open position. [Fig. 119A] FIG. 1 shows an isometric view of a patient interface with the clip and rigid tether connector in a closed position. [Fig. 119B] FIG. 119B illustrates an isometric view of the patient interface showing the clip and rigid tether connector of FIG. 119A in the open position. [Fig. 120A] FIG. 1 illustrates an isometric view of a patient interface with a hook and post loop connector in a closed position. [Fig. 120B] FIG. 120B illustrates an isometric view of the patient interface showing the hook and post loop connector of FIG. 120A in an open position. [Fig. 121A] FIG. 13 shows an isometric view of a patient interface with an alternative hook and post loop connector in a closed position. [Fig. 121B] FIG. 121B illustrates an isometric view of a patient interface showing the alternative hook and post loop connector of FIG. 121A in an open position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

[0097] Certain terms may be used in the following description for reference purposes only, and therefore are not intended to be limiting. For example, the terms "upper" and "lower" refer to directions in the drawings to which they refer. Terms such as "front", "rear", "left", "right", "back" and "side" describe the orientation and / or location of a component or part of an element within a consistent, but arbitrary, frame of reference that becomes apparent by reference to the text and associated drawings that describe the component or element under consideration. Furthermore, terms such as "first", "second", "third" and the like may be used to describe separate components. Such terms may include the terms specifically mentioned above, derivatives thereof and terms of similar meaning.

[0098] The term "substantially inelastic" as used herein refers to the ability of a headgear or material to resist stretching with respect to loads that it may be subjected to. Thus, the headgear or material may be substantially inelastic in one direction and somewhat elastic in another direction. In some configurations, the headgear or material is configured to be substantially inelastic in a direction in which a load is applied by the therapy for which the headgear or material is intended to be used. The substantially inelastic headgear or material can, for example, resist stretching that would compromise the seal of the respiratory mask in a sealing system under normal or expected conditions. In a non-sealing system, the substantially inelastic headgear or material can resist stretching that would compromise proper placement of the respiratory interface in response to normal or expected conditions, such as hose pull or user movement. If the expected load forces are relatively low, the headgear or material can have a higher elasticity since the load will not be sufficient to cause stretching. Conversely, if the headgear and / or material is expected to be subjected to high load forces, a higher inelasticity is required to resist stretching.

[0099] Throughout this specification, reference is made to "breakthrough" moldings, processes, techniques, and components made by such moldings, processes, and techniques. Reference is also made to "breakthrough in-mold molding" and "in-mold breakthrough." It should be understood that all such references are general references to the embodiments of the present disclosure and are not intended to be particularly limiting.

[0100] headgear 1A illustrates a non-limiting exemplary embodiment of molded-in-mold bifurcated headgear 100 of the present disclosure in combination with a respiratory apparatus 110. "Molded-in-mold" includes forming components such as a plastic core and a textile casing as a unitary structure by adding molten plastic into the textile casing. "Molded-in-mold" straps or any other components are components formed by adding molten plastic into the textile casing.

[0101] 1A and 1B show that the bifurcated headgear 100 is configured to be substantially inelastic and three-dimensional (3D) in structure. The bifurcated headgear design is preferred over a single strap design due to the improved stability on the patient's head as the headgear is supported at 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 illustrated headgear 100 comprises a right side 120 and a left side 130. Both the right side 120 and the left side 130 include a top strap 140, a bottom strap 150, and a mask connector 180.

[0102] The top straps 140 have an elongated shape and include top strap lateral ends 142 and a top strap central end 144. The top straps 140 are configured to extend upward from the lateral ends 142 generally above the user's ears, across the parietal or forehead region of the user's head, and then terminate at the top strap central end 144. The top strap central end 144 is configured to be positioned at or near a central point or location on the top of the user's head. The right side 120 and left side 130 top strap central ends 144 are configured to be joined together above the top of the user's head by a top seam 190. The top seam 190 may include stitching, welding, adhesive, overmolding, or any other fastening mechanism and may be permanent or removable / separable. In some configurations, the top seam 190 can include an adjustment mechanism (not shown), such as a hook-and-loop fastener, a snap-fit ​​connector, or the like, so that the combined length of the top straps 140 can be altered to accommodate different user head sizes. Each top strap lateral end 142 is configured to be integrally formed with the base strap 150 at a casing or strap junction 170, as will be discussed in more detail below.

[0103] The bottom strap 150 has an elongated shape and includes a rear bottom strap portion 152 and a front bottom strap portion 162. The rear bottom strap portion 152 and the front bottom strap portion 162 are unitary and integral with one another. The rear bottom strap portion 152 includes the portion of the bottom strap 150 that extends rearward from a joint portion 170 and around the occipital region of the user's head before terminating at a bottom strap rear end 154. An ear arch 160 of the bottom strap 150 curves over the top of the patient's ear when in use, thereby preventing the strap 150 from contacting the ear. The bottom strap rear end 154 is configured to be positioned at or near a center point or central location at the rear of the user's head. The right side 120 and left side 130 bottom strap rear ends 154 are configured to be joined together by a bottom seam 192. The bottom seam 192 may include stitching, welding, adhesive, overmolding, or any other fastening mechanism and may be permanent or removable / separable. In some configurations, the bottom seam 192 may include an adjustment mechanism (not shown), such as a hook-and-loop fastener, snap-fit ​​connector, or the like, so that the combined length of the rear bottom strap portion 152 of the bottom strap 150 can be altered to accommodate different user head sizes.

[0104] The front bottom strap portion 162 includes a portion of the bottom strap 150 that extends forward from the junction 170 across the temple of the user toward the user's nose. In some configurations, the front bottom strap portion 162 is shorter than one or both of the top strap 140 or bottom strap portion 152 and terminates at a bottom strap front end 164. The bottom strap front end 164 includes a mask connector 180 or is at least configured to be attached to the mask connector 180. The bottom strap front end 164 includes a female recess 166 that engages with the mask connector 180. In some configurations, the mask connector 180 can be press-fit or overmolded onto the bottom strap front end 164 and into the female recess 166. The mask connector 180 can include a clip or retention mechanism configured to couple to the respiratory apparatus 110. The mask connector 180 can include a push-fit, snap-fit, or other suitable connector configured to provide a separable connection to the mask frame 112 of the respiratory apparatus 110. In some embodiments, the mask connector 180 can be configured to connect to an adjustment mechanism that provides a means to automatically or manually adjust 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 breathing apparatus 110.

[0105] 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 structure. 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 FIG. 1B ). In some configurations, the configuration of the bifurcated headgear 100 is such that the 3D bifurcated structure is always maintained when at least the right side 120 and the left side 130 are connected. This 3D structure can improve the ease with which a user can interact with and attach or wear the bifurcated headgear 100 and the associated breathing apparatus 110. As the bifurcated headgear 100 retains its shape, the straps should be less likely to tangle 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 a partial or complete separation of the two sides 120, 130. In some configurations, the bifurcated headgear 100 maintains partial or complete separation at least at the joint 170 and / or the front bottom strap portions 162 of the sides 120, 130.

[0106] The top strap 140 and the bottom strap 150 are each constructed from a unitary plastic core material 210 surrounded by and bonded to an outer casing 220. The casing 220 may be knitted, woven, braided, crocheted, etc. The unitary plastic core material 210 forms both the top strap 140 and the bottom strap 150. That is, the plastic core material 210 is unitary between the top strap 140 and the bottom strap 150 and through the bifurcated headgear 100. The casings 220 of both the top strap 140 and the bottom strap 150 may be knitted, woven, braided, crocheted, etc. into a continuous, uninterrupted tube without seams. That is, the casings 220 may have a seamless, uniform outer surface along the length of the top strap 140 and the bottom strap 150. The casing 220 can be woven from multiple turns of yarn including wool, cotton, nylon, Lycra, spandex, or a mixture of natural and / or synthetic materials. In some configurations, the casing 220 can be loosely woven to allow the yarn to extend in length without stretching or tearing. The amount of Lycra in the yarn can be varied to change the elasticity of the strap.

[0107] The casing 220 provides a clean and neat edge finish to the molded bifurcated headgear 100. That is, the top strap 140 and the bottom strap 150 have a uniform shape and form without any seams to provide an aesthetically pleasing appearance. Additionally, the straps 140, 150 formed from the casing 220 are easier to manufacture. A seamless circular woven tube does not require additional steps of sewing or gluing, reducing manufacturing time and costs. Additionally, it is easy to manufacture and form long lengths of straight woven tubes that can then be cut to length and shaped during the breakthrough mold process as described herein. Additionally, the casing 220 can be easily placed and positioned within the mold. The tubular shape and circular cross section of the casing 220 are self-supporting and remain open within the mold to provide an open flow path for injected material through the casing.

[0108] The casing 220 is flexible before the plastic core material 210 is inserted, allowing it to be more easily positioned in the mold cavity. The casing 220 can be knitted from a material that has a soft touch, so that the top strap 140 and the bottom strap 150 are comfortable when in contact with the skin of the user. Similarly, the casing 220 can have thicknesses and layers, so that the top strap 140 and the bottom strap 150 are comfortable when in contact with the skin of the user. Additionally, in some configurations, the casing 220 can be knitted from a material that has moisture wicking properties to improve the comfort of the bifurcated headgear 100. Additionally, in some configurations, the casing 220 can be knitted from a material that has tactile properties to reduce or prevent the bifurcated headgear 100 from sliding against the skin or hair of the user. In some configurations, the casing 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, and the top strap 140 is constructed from a material having tactile properties. Additionally, in some configurations, the casing 220 can be constructed from different materials along the length of the top strap 140 and 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 bottom strap 150 can have different colors.

[0109] The casings 220 of the top strap 140 and bottom strap 150 are filled with a unitary plastic core material 210. In some configurations, the plastic core material 210 comprises a relatively rectangular cross-section thermoformable or thermosetting plastic material that is configured to give the bifurcated headgear 100 the 3D structure described above. The plastic core material 210 provides the basis for the overall structure of the bifurcated headgear 100. The plastic composition of the plastic core material 210 provides the benefit of a resilient structure that can maintain a preformed shape while conforming somewhat to the individual skull shape of the user. The plastic core material 210 has a width that is substantially greater than its depth. The illustrated cross-sectional shape, in combination with the material selection, allows the bifurcated headgear 100 to be flexible in a direction perpendicular to its width (vertical in FIG. 1A) and relatively inflexible in a direction perpendicular to its depth (horizontal in FIG. 1A). This flexibility in one direction allows the bifurcated headgear 100 to conform to the user's head, while providing rigidity in another direction to stabilize the breathing apparatus 110 on the user's face and minimize dislodging it.

[0110] The bifurcated headgear 100 can be configured to be substantially inelastic, for example, as a result of material selection. One or more elements of a composite material can impart the substantially inelastic properties to the bifurcated headgear 100. In a first non-limiting exemplary embodiment of the present disclosure, the plastic core material 210 is made from a substantially inelastic material, such as, for example, without limitation, polypropylene or nylon. In embodiments in which the bifurcated headgear 100 is expected to experience low load forces, the plastic core material 210 can be made from other materials, such as, but not limited to, thermoplastic elastomers (TPEs) or silicone. In some embodiments, the plastic core material 210 can have some degree of elasticity, and one or both of the casings 220 of the top strap 140 and bottom strap 150 can be substantially inelastic. The inclusion of a substantially inelastic material in the bifurcated headgear 100 is advantageous because it reduces or eliminates the possibility of the headgear being overstretched or pulled on the user's head. If the bifurcated headgear 100 is pulled too tightly on the user's head, the breathing apparatus may not be effectively positioned to provide treatment and uncomfortable forces may be exerted on the user's head, which may result in reduced compliance with treatment.

[0111] joint 2A and 2B are close-up views of the connection of the top strap 140 and the bottom strap 150 at the juncture 170. As mentioned above, the plastic core material 210 is unitary and disposed within the casings 220 of both the top strap 140 and the bottom strap 150. FIG. 3 is a cross-sectional view of the top strap 140 and the bottom strap 150 taken along line 3-3 of FIG. 2B. As shown, the bottom strap 150 is filled with the plastic core material 210 which extends through the casing 220 of the bottom strap 150 at the juncture 170 and into the top strap lateral end 142 to fill the top strap 140. As a result, the casings 220 of the top strap 140 and the bottom strap 150 are bonded together by the plastic core material 210.

[0112] As shown in FIGS. 2A-3, the top strap 140 and the bottom strap 150 can have a soft edge 222 that extends along the edge of a portion of the top strap 140 and the bottom strap 150 in a lengthwise direction. The soft edge 222 is the portion of the casing 220 that is not filled with the plastic core material 210. As a result, the soft edge 222 provides the top strap 140 and the bottom strap 150 with a soft or cushioned edge that is comfortable against the skin of a user and is also aesthetically pleasing. As will be described in more detail below, the soft edge 222 is formed by crimping an edge of the casing 220 prior to injection of the plastic core material 210 such that the plastic core material 210 is blocked or prevented from flowing into the portion of the casing 220. The edge of the casing 220 is crimped by a portion of the mold adjacent to the mold cavity of the mold. Just as the width (vertical in FIG. 1A ) of the plastic core material 210 can vary along the length of the top and bottom straps 140 and 150, the depth of the crimping of the edges of the top and bottom straps 140 and 150 by the molding die can vary along the length of the top and bottom straps 140 and 150. Thus, the width of the plastic core material 210 can be relatively wider in different areas of the top and bottom straps 140 and 150, such as the joint 170 and the bottom strap front end 164, to reinforce and provide additional strength to those areas. Similarly, in some configurations, the width of the plastic core material 210 can be relatively narrower in some areas along the length of the top and bottom straps 140 and 150 to provide flexibility to those relatively narrow areas. One skilled in the art will appreciate that the shape and geometry of the plastic core material can be varied to provide strength and stiffness to the top and bottom straps 140 and 150 in a desired direction.

[0113] Molding tool FIG. 4 illustrates an open-close injection mold 300 configured to form the right side 120 or the left side 130 of the bifurcated headgear 100 in a single injection molding process. In some configurations, the right side 120 and the left side 130 are identical and the injection mold 300 can be used to form both sides 120, 130. FIG. 4 illustrates the fully formed bifurcated headgear 100 after completion of the injection molding process. The injection mold 300 includes a first mold half and a second mold half 320. The first mold half 310 is configured to be aligned with and placed over the second mold half 320 to close the injection mold 300. The first mold half 310 and the second mold half 320 are substantially symmetrical (i.e., mirror images), and therefore, for brevity, the following discussion will refer to the second mold half 320. As shown in FIG. 5, the second mold half 320 includes a top strap cavity 322 and a bottom strap cavity 324. The top strap cavity 322 and the bottom strap cavity 324 are configured to receive the casing 220 for both the top strap 140 and the bottom strap 150. Thus, the top strap cavity 322 and the bottom strap cavity 324 are arranged in a shape that corresponds to the desired shape of the left and / or right sides of the bifurcated headgear 100. In some configurations, the injection mold 300 can be used to form both the right side 120 and the left side 130 of the bifurcated headgear 100. In some configurations, the casing 220 is cut to length to fit within the strap cavities 322, 324 prior to closing the mold 300.

[0114] A connector insert 350 is inserted into the bottom strap front end 164 of the casing 220. A connector insert cavity 370 is disposed in the second mold half 320 and has a corresponding shape similar to that of the connector insert 350. Both the connector insert 350 and the casing 220 are disposed in the connector insert cavity 370 and the strap cavities 322, 324, respectively. When the casing 220 is used to form the straps 140, 150 of the bifurcated headgear 100, the ends of the casing 220 are open or formed as hollow tubes, which provide a path for the plastic core material 210 to be injected into the casing 220. Thus, the connector insert 350 disposed in the open end of the bottom strap 150 reduces or prevents the open end of the casing 220 from narrowing or closing. The connector insert 350 comprises a prefabricated component that fits inside the open end of the casing 220 and presses the opening of the casing 220 outwardly against the walls of the strap cavities 322, 324 in the first and second mold halves 310, 320. The connector insert 350 has an opening (not shown) that aligns with the runner 380, through which a direct flow path is provided for the plastic core material to be injected into the casing 220. The connector insert 350 is also configured to form an internal (female) connecting feature in the bottom strap front end 164 (see FIG. 7) that connects with an opposing male connector feature (not shown) on the mask frame or other mask component. The connector insert 350 can be made from plastic or metal. If made from plastic, in some configurations the connector insert 350 can be made from the same plastic as the core, allowing a chemical bond to form between the connector insert 350 and the plastic core material during the breakthrough in-mold process. Additionally, the connector insert 350 can be formed in a shape that can have the additional function of serving as a connector (eg, connector 180) between headgear components, between adjustment mechanisms, or between the headgear and the mask.

[0115] 4 and 5, the runner 380 fluidly connects the sprue injection point 390, the bottom strap front and rear ends 154, 164, and the top strap center end 144. Thus, as the plastic core material 210 is injected into the first and second mold halves 310, 320, it is injected into the casing 220 through each of the bottom strap front and rear ends 154, 164, and the top strap center end 144.

[0116] The top and bottom strap cavities 322, 324 have soft edge clamps 360 formed along one or both of the outer edges of the cavities 322, 324 in the length direction. The soft edge clamps 360 are raised areas that protrude into the top and bottom strap cavities 322, 324 in a direction substantially parallel to the closing direction of the injection mold 300 such that when the injection mold 300 is closed, the top and bottom strap cavities 322, 324 narrow along one or both of the outer edges of the cavities 322, 324 in the length direction (i.e., the outer edges narrow relative to the central region of the cavities 322, 324). The soft edge clamps 360 thus clamp or crimp the outer edges of the casing 220 against both the top and bottom straps 140, 150, thereby forming the soft edges 222. More specifically, the soft edge clamps 360 press the edges of the casing 220 together so that they are fully crimped. As a result, the plastic core material 210 cannot flow between the crimped edges when it is injected into the casing 220. This provides the molded in-mold bifurcated headgear 100 with a soft or cushioned edge finish by preventing the molded in-mold plastic core material 210 from filling the casing 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, narrowing but not fully crimping the edges of the casing 220 can allow a reduced amount of the plastic core material 210 (relative to the uncrimped portion of the casing 220) to flow between the edges of the casing 220.

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

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

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

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

[0121] Once the casing 220 is aligned within the second mold half 320, the injection mold 300 is closed such that the strap cavities 322, 324 are completely enclosed. A thermosetting or thermoformed plastic core material 210 is then injected into the mold cavity strap cavities 322, 324 via the sprue 390 and runners 380. More specifically, the plastic core material 210 is injected into the injection mold 300 through the sprue 390. Generally, the plastic core material 210 follows the path of least resistance to fill the strap cavities 322, 324. The plastic core material 210 travels through the runners 380 until it reaches the open end of the casing 220. The plastic core material 210 enters the top strap center end 144, the bottom strap rear end 154, and the bottom strap front end 164 (via the connector insert 350). 6, as the casing 220 in the bottom strap cavity 324 is filled with the plastic core material 210 (i.e., because it is being filled from both open ends, as opposed to the casing 220 in the top strap cavity 322 which is filled at one end first), the plastic core material 210 breaks through, penetrates and forces its way through the wall of the casing 220 of the bottom strap 150 at the junction 170. The plastic core material 210 that penetrates the wall of the bottom strap 150 enters the open end of the casing 220 of the top strap 140 (i.e., the top strap lateral end 142) and joins with the plastic core material 210 that enters the opposite end of the casing 220 of the top strap 140 (i.e., from the top strap center end) until the casing 220 of the top strap 140 is filled with the plastic core material 210. Once the casing 220 of the straps 140, 150 is filled, the plastic core material 210 is given time to cure, cool and solidify. Once cured, the injection mold 300 is opened and the part is removed. Thus, a unitary plastic core material 210 may be formed within the top strap 140 and bottom strap 150, along with a seamless, uniform casing 220 of the top strap 140 and bottom strap 150.That is, the unitary plastic core material 210 of the top strap 140 and the bottom strap can be formed by forcing the plastic core material 210 through the casing 220 of the bottom strap 150 and into the top strap 140. In other words, forming the unitary plastic core material 210 in the top strap 140 and the bottom strap is an advantageous effect of the breakthrough in-mold process when both straps have a seamless uniform casing 220 and one strap is attached to the middle or non-end of a seamless adjacent strap. In other embodiments, the plastic core material 210 penetrates and breaks through the casing 220 before the casing 220 and strap cavities are filled with the plastic core material 210. This can occur, for example, when the unsupported areas of the casing 220 are closer to the injection point, the plastic core material 210 has a low density or viscosity, the casing 220 has a low thread density, and / or the unsupported portions are large relative to the supported areas.

[0122] The plastic core material 210 penetrates and breaks through the walls of the casing 220 of the bottom strap 150 as it follows the path of least resistance to fill the strap cavity. If the casing 220 is supported by, abutting, or pressed against a surface of the injection mold 300, the injected plastic core material 210 will flow in the direction of less resistance until the cavity in the injection mold 300 is filled. Referring to FIG. 5, once the bottom strap cavity 324 is full of plastic core material 210, the direction of least resistance for flow is into the top strap cavity 322 because the casing 220 of the bottom strap 150 is not supported by, abutting, or pressed against a surface of the bottom strap cavity 324. When the casing 220 is not pressed (i.e., unsupported) against the surface of the injection mold 300, the injected plastic core material 210 fills the cavity by penetrating the casing 220. Penetration of the casing 220 can occur by the plastic core material 210 flowing through the casing 220. That is, when under the pressure of the injected plastic core material 220 (i.e., unsupported), the threads of the casing 220 are displaced or elastically deformed (i.e., due to the material of the casing 220). As a result, the plastic core material 220 flows and pushes through the gaps created between the displaced or elastically deformed threads of the casing 220. In some configurations, the pressure of the plastic core material 220 within the casing 220 can cause the threads of the casing 220 to tear or break in the unsupported portions of the casing 220. A tear or rupture of the casing 220 can result in the formation of a hole in the casing 220 through which the plastic core material 210 can penetrate and break through to flow and force its way into the adjacent straps.

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

[0124] Alternative configuration FIG. 8A shows a second mold half of an injection mold 400 having an alternative molded-in strap cavity configuration for joining multiple straps 410, 412, 414 in the joint configuration shown in FIG. 8B. For comparison, FIG. 8B shows a T-shaped joint 420 similar to joint 170 in FIGS. 1A-7. FIG. 8B also shows an alternative shaped joint in the form of an X-shaped joint 422. As discussed above and shown in FIG. 8B, the T-shaped joint 420 is formed by positioning the open end of the casing of strap 410 in contact with the edge of the casing of strap 412 (i.e., by the mold providing a corresponding configuration for the strap cavities). In contrast, the X-shaped joint 422 is formed by overlapping the non-open ends of the casings of straps 410, 414. In other words, the straps 410, 414 are positioned in an overlapping orientation such that they meet at a location between their open ends to form an X-shaped joint 422. In an alternative embodiment, one of the straps 414 is formed from two strap portions that are joined to the other strap 410 by joining a respective end of each of the strap portions to the other strap 410 to form an X-shaped joint. In these embodiments, the injection mold 400 includes correspondingly shaped strap cavities that support the straps 410, 414. Figures 8A and 8B show the positioning of the sprue 430, runner 432 and injection point 434 through which the plastic core material 424 is injected into the injection mold 400 to fill the straps 410, 412, 414. The injection point 434 is effectively positioned at one open end of the strap 410 and at the opposing open end of the strap 410 (i.e., via the injection point 434 through the strap 412). In the illustrated configuration, the open end of the strap 414 is not fluidly connected to the injection point 430 other than through the X-shaped joint 422. As the plastic core material 424 is injected into the injection mold 400, it enters the open end of the strap 410 and travels towards the X-shaped joint 422.In an embodiment where one of the straps 414 is formed from two strap sections joined to the other strap 410, as the strap 414 begins to fill, the plastic core material 424 follows the path of least resistance and penetrates the edge of the casing of the strap 410 and then through the open end of the casing of the strap 414. That is, the strap cavity of the strap 414 is empty, thereby providing a path of least resistance for the plastic core material 424 to flow. Thus, the casing of the strap 414 is filled with the plastic core material 424 entering the strap 414 through the X-shaped joint 422. One skilled in the art should understand that the above described configuration is not limited to a joint point located at the open end of one of the straps when forming the X-shaped joint 422. In some configurations, the X-shaped joint 422 can be formed such that both straps have at least one injection point at their ends.

[0125] As shown, T-shaped joints 420 and X-shaped joints 422 can be used in combination to form a variety of headgear shapes and configurations having multiple straps. Multiple strap joints / joints can be formed in a single injection molding step. Such strap configurations can be utilized in four-point headgear configurations commonly used with nasal and full face masks.

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

[0127] FIG. 9B illustrates an alternative molded-in strap configuration having straps 520 joined to one another by integrally formed web portions 532 disposed between the straps 520. Similar to the connecting member 530 of FIG. 9A, the injection mold (not shown) can have cavities corresponding to the web portions 532 that fluidly connect the strap cavities for the straps 520. The cavities corresponding to the web portions 532 can have a depth less than the depth of the strap cavities for the straps 520. Thus, when the molten plastic core material 510 is injected into the injection mold, it enters the casing of the straps 520 at the junction points 540. As the straps 520 begin to fill, the plastic core material follows the path of least resistance and penetrates the walls of the casing (i.e., in the unsupported portions of the casing adjacent the cavities corresponding to the web portions 532), thereby allowing the plastic core material to enter and fill the cavities corresponding to the web portions 532. In some configurations, the plastic core material 510 may be elastomeric to allow the web portions 532 to stretch. Additionally, in such embodiments, the casing may resist the stretching of the plastic core material 510.

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

[0129] 11A-11E show a molded-in-mold strap configuration with a molded texture imprinted into the strap. FIGS. 11A-11C show a strap 710 with a plurality of square diamond-shaped indentations 730 arranged in rows along its length. As shown in FIG. 11C, a cross section taken along line 11C-11C of FIG. 11B, the indentations 730 are formed on both sides of the strap 720 and are aligned to form thinned regions 732 in the strap 720. The thinned regions 732 can provide some elasticity or stretchability to the plastic core 710. Such flexibility can be beneficial in that the closed loop headgear can be pulled over the patient's head or can improve the patient's perception of a semi-rigid headgear. Additionally, the textured finish of the strap 720 can also improve the aesthetic appearance of the headgear and the tactile appeal of the strap 720. That is, the strap 720 can appear less stiff and more comfortable. In some embodiments not shown, the dimples 730 can form interrupted areas between layers of the casing 712 that are free of plastic core material 710. The interrupted areas can improve breathability of the strap 720, thereby improving comfort for the user. FIGS. 11D and 11E show a plurality of hexagonal shaped dimples 730 spaced along the length of the strap 720 in a honeycomb arrangement. It should be understood that the dimples 730 are not limited to diamond or hexagonal shapes, but can include various shapes, sizes, locations on the strap, geometric forms, combinations of shapes, etc. In FIGS. 11D and 11E, the plastic core and honeycomb pattern do not extend to the edges of the casing of the strap 720. This provides a soft edge that improves comfort for the user.

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

[0131] 12A-13D show a molded-in strap configuration for bifurcated headgear 1100 having attachment members that increase the bond strength at the junction between the joined straps. Similar to the bifurcated headgear 100 shown in FIGS. 1A-7, the bifurcated headgear 1100 of FIGS. 12A-13D includes a top strap 1140 and a bottom strap 1150. Similarly, the open end of the top strap 1140 is joined to the non-open end of the bottom strap 1150. In contrast to the bottom strap 150 of FIGS. 1A-7, the bottom strap 1150 includes an attachment member 1156 that projects outwardly from the wall of the casing 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.

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

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

[0134] 14A shows a casing 1410 for the top strap 1402 with a sealed open end 1430. The sealed open end 1430 is formed by cutting the end of the casing 1410 with a hot knife. If the casing is formed from a synthetic fiber, cutting the casing 1410 with a hot knife melts the edges of the casing 1410, thereby sealing or bonding together the excess ends of the individual threads / yarns that would otherwise be exposed and / or frayed after the casing 1410 is cut to length. As a result, when the sealed open end 1430 is bonded to the bottom strap 1404, there are no excess or frayed individual threads / yarns at the bond 1430, improving the aesthetics of the bond 1470 and the bifurcated headgear 1400. Additionally, the sealed open end 1430 can reduce excess overhang that forms on the outside of the casing 1410 around the joint 1470 after the plastic core material 1420 penetrates the wall of the casing during the breakthrough in-mold process. That is, the sealed open end 1430 provides a substantially sealed edge or surface that contacts the casing 1410 of the bottom strap 1402 (i.e., as opposed to a frayed open end of the casing 1410), thereby preventing the plastic core material 1420 from leaking through the casing 1410 of the top strap 1402 at the sealed open end 1430. FIG. 14C illustrates the joint 1470 formed between the sealed open end 1430 of the top strap 1420 and the edge of the casing 1412 of the bottom strap 1404. FIG. 14D illustrates a cross-section of the top strap 1402 and the bottom strap 1404 along line 14D-14D of FIG. 14C. The top strap 1400 and the bottom strap 1402 are bonded together using the breakthrough in-mold technique discussed above. In an alternative configuration, the open end of the top strap 1402 can be overmolded to seal the end of the top strap 1402 prior to injection molding.

[0135] In another embodiment, the sealed open end can be formed by placing the casing in a heat sealer, where the outer portion of the casing is sealed / melted but not cut by the heat sealer. The casing is then cut in the middle of the sealed area (i.e., after the sealed area has cooled) to provide the open end. The inner walls of the casing are not sealed or fused together, but the individual yarns are fused on the outside (i.e., outer wall) of the casing, thus fixing the excess threads of the individual yarns, thereby providing a clean aesthetic and preventing or inhibiting the plastic core material from leaking through the casing at the sealed open end.

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

[0137] The bifurcated headgear 1500 has top straps 1502 and bottom straps 1504 that are configured similarly to the bifurcated headgear 100 with top straps 140 and bottom straps 150 of Figures 1A-7. Additionally, the top straps 1502 and bottom straps 1504 are joined at junction 1570 using a breakthrough in-mold process, similar to the top straps 140 and bottom straps 150 at junction 170.

[0138] As shown in FIG. 15A , the top strap 1502 is joined to the bottom strap 1504 at a junction 1570. The top strap 1502 and the bottom strap 1504 are joined via a molded plastic core material 1510 that is integrally formed within the casing 1520 of the top strap 1502 and the bottom strap 1504 using the breakthrough in-mold molding techniques 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 disposed within the core end 1512 of the plastic core material 1510. The filament core 1550 is secured within and anchored within the core end 1512 at a location forward of the junction 1570 (i.e., forward of the user's ear). In some configurations, the filament core 1550 is joined to the plastic core material 1510 during a breakthrough in-mold molding process. The filament core 1550 is surrounded by, but not attached to, the casing 1520 of the bottom strap 1504. That is, between the core end 1512 and the open end 1524 of the casing 1520, the filament core 1550 is not attached to the casing 1520. Thus, the casing 1520 can move independently over the filament core 155, which is effectively inextensible. Additionally, similar to the previous embodiments formed using breakthrough in-mold techniques, the plastic core material 1510 is bonded to the casing 1520 of the top strap 1502 and the bottom strap 1504.

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

[0140] FIG. 15D shows a close-up of the casing 1520 of the bottom strap 1504 in a stretched state. In a preferred embodiment, the casing 1520 of the second strap 1504 is braided and comprises non-elastic yarns with linear elastic elements embedded therein. The casing 1520 can stretch and retract independently of the filament core 1550. As shown in FIG. 15D, when stretched, the casing 1520 of the bottom strap 1504 necks down or narrows as it is stretched, as shown by the narrowed area 1526 from the core end 1512, so that the individual yarns of the casing 1520 align, thus limiting the stretch length of the braid. The filament core 1550 is longer than the stretch length of the braid. When no force is applied to the braid, the linear elastic elements of the casing 1520 retract the braid.

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

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

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

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

[0145] 16D shows a cross section along line 16D-16D of FIG. 16C of the first mold half 2310 and the second mold half 2320 during the process of forming the button 2220. As illustrated in step 1, the casing 2180 is positioned within the strap cavities 2312, 2322. A portion of the casing 2180 is not supported by the first mold half 2310, where the button cavity 2314 is connected with the strap cavity 2312. As illustrated in steps 2 and 3, when the strap cavities 2312, 2322 are filled with the plastic core material 2190, the casing 2180 is forced into the button cavity 2314 by the plastic core material 2190. As shown in step 4, when the casing 2180 reaches its limit for containing the plastic core material 2190, the plastic core material 2190 breaks through the casing 2180 since there remains a cavity (i.e., the button cavity 2314) to fill. That is, when the casing 2180 is filled with the plastic core 2190 in an area where the casing 2180 is not supported (e.g., by the button cavity 2314 in the illustrated embodiment), the plastic core material 2190 breaks through the casing 2180 to fill the button cavity 2314. Similar to the breakthrough in-mold process described above, the threads of the casing 2180 may displace or elastically deform when under the pressure of the injected plastic core material 2190. The displacement or elastic deformation of the threads may form gaps between the threads through which the injected plastic core material 2190 may flow into the button cavity 2314. In some configurations, the threads of the casing 2180 can split such that a hole is formed through the casing 2180 through which the injected plastic core material 2190 can flow into the button cavity 2314.

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

[0147] FIG. 17 illustrates an adjustable strap configuration with adjustment and usability features formed by a breakthrough in-mold process. The configuration includes a first strap 3110 and a second strap 3120. The first strap 3110 includes a breakthrough end loop 3130 configured to receive the second strap 3120. The second strap 3120 is received and folded within the end loop 3130, and a fastening mechanism is provided to releasably fasten a free end of the second strap 3120. The second strap 3120 includes a breakthrough end or grip tab 3140. In at least one embodiment, the second strap 3120 includes an inner surface 3122 and an outer surface 3124, each of a different visual or tactile configuration. When the second strap 3120 is folded and fastened, the inner surface 3122 of the portion of the strap that is routed beyond the end loop 3130 of the second strap 3120 is exposed. This provides a visual and / or tactile indication of the adjusted length.

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

[0149] 18, the lower strap 3210 is a continuous strap with a continuous casing. In other words, the casing of the lower strap 3210 is uninterrupted prior to the in-mold and / or breakthrough process. After the in-mold breakthrough process, a breakthrough joint is formed from the lower strap 3210. It should be noted that the continuous casing or strap may include a pre-formed opening that allows the injected material to be exposed.

[0150] 18, the vertical straps 3230 are continuous straps because they are formed from a continuous or uninterrupted casing. After the mold-in-mold breakthrough process, the casing ends 3232 of the vertical straps 3230 are mold-in-mold joined to the lower straps 3210 by breakthrough joints.

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

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

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

[0154] FIG. 20 illustrates another headgear 4200 formed using an in-mold and / or punching process. The headgear 4200 includes a continuous lower strap 4210 and joined continuous middle and vertical straps 4220. Ear loops 4230 are provided to encircle the ears of a user. The lower strap 4210 is attached to the ear loops 4230 along a lower portion 4232 of the ear loops 4230. The continuous middle and vertical straps 4220 are attached along an upper portion 4234 of the ear loops 4230. FIG. 21 illustrates a headgear 4300 similar to the headgear 3200 illustrated in FIG. 18, but including a web portion 4350 joining the rear portion 4312 of the lower strap 4310 to the rear portion 4322 of the middle strap 4320.

[0155] 22 shows headgear 4400 including a continuous lower strap 4410 that extends below the user's ears and extends vertically upward, behind the user's ears and forward above the user's ears to form a portion of the ear loops. A continuous vertical strap 4430 extends from the lower strap 4410 at a point in front of the ears, the vertical strap 4430 forming the remainder of the ear loops. A middle strap 4420 is joined to the vertical strap 4430 by a breakthrough joint. A lower rear portion 4412 of the lower strap 4410 is connected by a rear panel 4440.

[0156] FIG. 23 shows headgear 4500 similar to the headgear 4300 shown in FIG. 21, but with a smaller web portion 4550 joining the lower straps 4510 and middle straps 4520.

[0157] 24 shows headgear 4600 including a continuous lower strap 4610 and a combined continuous middle and vertical strap 4620. The headgear 4600 further includes a combined continuous upper rear strap and a second vertical strap 4630. A web portion 4650 extends between the first vertical strap 4620 and the second vertical strap 4630 as well as between the rear portion 4612 of the continuous lower strap 4610 and the upper rear strap 4630. The web portion 4650 also forms ear loops that encircle the ears; i.e., the web portion 4650 has holes through which the ears can be placed.

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

[0159] 27 and 28 show two examples of headgear 4900 having a quilted fabric or material 4910 provided attached to portions of the headgear 4900 that are in direct contact with the skin or hair of the user, for example, on the user's face or at the back of the user's neck. Similar to a duvet, the quilted fabric is soft to the touch and provides cushioning padding, thereby increasing the comfort of the headgear 4900 such that the user is inclined to wear the headgear 4900 when sleeping. The quilted material 4910 can be sewn or welded to molded straps or web portions of the headgear 4900. The disclosed configurations are not limited to quilted materials and can include fabrics and textiles having various material properties such as, but not limited to, soft, padded, breathable, moisture wicking, non-slip / tacky to the touch, etc.

[0160] FIG. 29 shows headgear 5100 including vertical straps 5110 and neck straps 5120 formed from a foam-lycra laminate material such as Breath-o-prene. Breath-o-prene allows air to pass through the straps and wicks sweat away from the skin for improved comfort and compliance. Additionally, Breath-o-prene provides padding to the straps to reduce pressure points against the user's head. Vertical straps 5110 include a first strap 3110 and a second strap 3120. First strap 3110 includes a break-through end loop 3130 configured to receive second strap 3120. Second strap 3120 is received within end loop 3130 and folded back, and a fastening mechanism is provided to releasably fasten a free end of second strap 3120. 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 of which is of a different visual or tactile configuration. When the second strap 3120 is folded over and fastened, the inner surface 3122 of the portion of the strap that is routed beyond the end loop 3130 of the second strap 3120 is exposed. This provides a visual and / or tactile indication of the adjusted length.

[0161] 30 shows headgear 5200 with breathable, moisture-wicking material 5240 on the vertical straps 5210 and neck strap 5220. The breathable, moisture-wicking material 5240 can be an athletic and performance knit that improves the breathability of the headgear 5200 in areas that come into contact with the user's skin or hair. The breathable, moisture-wicking material 5240 can also give the headgear 5200 an active, athletic look.

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

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

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

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

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

[0167] 37 and 38 show two examples of headgear 5900 with lower straps 5910 and middle straps 5920 formed from a continuous casing. Vertical straps 5930 extend from the lower straps 5910 at a portion in front of the ears and form a front portion 5972 and a top portion 5974 of the ear loops 5970. The vertical straps 5930 extend rearward and connect to the lower straps 5910 at a location behind the user's ears. In some configurations, the vertical straps 5930 extend around the back of the user's head. The lower straps 5910 form a bottom portion 5976 of the ear loops 5970. The middle straps 5920 connect to the vertical straps 5930 at a location in front of the user's ears. A neck strap 5940 is attached to both the vertical straps 5930 and the lower straps 5910 and extends along a portion of the length of the vertical straps 5930 behind the user's head. 37, the neck strap 5940 is formed from a breathable, moisture wicking material and may be an athletic and performance knit. The vertical straps 5930 may be covered with a textile material or may be an exposed plastic core material.

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

[0169] 40 shows an embodiment of headgear 6200 having bottom straps 6210, middle straps 6220 and vertical straps 6230 formed from a continuous casing. In some non-limiting configurations, the continuous straps can be formed by fully knitting the continuous casing or by joining layers of textile material together.

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

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

[0172] 43A and 43B show perspective views of an embodiment of headgear 6510 that can be used with the patient interface 6500. The headgear 6510 includes a middle strap 6512, a lower strap 6511, and a vertical member 6513. The lower strap 6511 extends from the patient interface 6500 below the user's ear and extends vertically upward, behind the user's ear, and forward above the user's ear to form a portion of the ear loop 6517. The middle strap 6512 extends from a connector above the user's ear to form the top of the ear loop 6517 and joins with the lower strap 6511 at a junction. The middle strap 6512 continues from the junction over the top of the user's head. The vertical member 6513 extends from a junction with the lower strap 6511 at a portion in front of the ear to a junction with the middle strap 6512 at a portion in front of the ear to form the remainder of the ear loop 6517. The middle straps 6512 can include adjustment mechanisms to adjust the fit of the headgear 6510 on a user's head. The lower straps 6511 can include adjustment mechanisms. The rear straps 6515 can include adjustment mechanisms. The adjustment mechanisms allow the length of the straps to be adjusted so that the headgear 6510 can fit a wide range of head sizes.

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

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

[0175] The rear portion 6515 of the headgear 6510 passes around the rear of the user's head. The rear portion 6515 may be formed from a plastic web made in a punching process. Alternatively, the rear portion 6515 may be formed from an elastic material so that the headgear 6510 can be configured to fit a wide variety of user head contours. Suitable materials may include Breath-o-prene, spacer fabrics, or other stretchy and highly compliant fabrics. The fabric may be connected to the headgear 6510 using stitching, RF welding, ultrasonic welding, adhesive bonding, or any other suitable mechanism.

[0176] The following description of the embodiments will focus on additional features introduced in each figure for simplicity, and therefore the features or configurations described above may not be included every time.

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

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

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

[0180] 46A-C show perspective views of an embodiment of headgear 6540 that can be used with the patient interface 6500. The headgear 6540 includes a bottom strap 6541 and a middle strap 6542 formed from a continuous casing in the form of a closed loop structure. The bottom strap 6541 and the middle strap 6542 form a portion of the ear loop. A vertical member 6544 extends from a junction with the bottom strap 6541 in front of the ear to a junction with the top strap 6543 in front of the ear to form the remainder of the ear loop. The top strap 6543 spans between the top of the right and left ear loops. A rear strap 6545 spans between the rear of the right and left ear loops. In at least one embodiment, at least one of the top strap 6543 and the rear strap 6545 can be made from a flexible material (e.g., Breath-o-prene) and connected to the bottom strap 6541 and the middle strap 6542 by any suitable means (e.g., stitching, RF welding, adhesives, etc.). In at least one embodiment, either the top strap 6543 or the rear strap 6545 can be made using a breakthrough in-mold process. In at least one embodiment, both the top strap 6543 and the rear strap 6545 can be made using a breakthrough in-mold process. The rear strap 6545 can include an adjustment mechanism.

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

[0182] 48A and 48B show perspective views of an embodiment of headgear 6560 that can be used with the patient interface 6500. The headgear 6560 includes a first lower strap 6564 formed from a continuous casing. The first lower strap 6564 extends laterally, below the user's right ear, around the rear of the user's head, and meets with a middle strap 6562 at a junction on the opposite side of the user's head. The junction where the first lower strap 6564 and the middle strap 6562 meet is located generally above the user's left ear. The headgear 6560 includes a second lower strap 6566, which is a segmented strap that includes two casing lengths. The second lower strap 6566 extends laterally, below the user's left ear, around the rear of the user's head, and intersects with the first lower strap 6564 at a junction. The second lower strap 6566 continues from the rear juncture to a juncture with the middle strap 6562 located generally above the user's right ear. The cores of the first lower strap 6564 and the second lower strap 6566 are integrally formed using a breakthrough mold in-mold.

[0183] The middle strap 6562 extends from the patient interface 6500 over the user's right ear and meets at a junction with a second lower strap 6566. The middle strap 6562 continues from the junction over the user's head and meets at another junction with the first lower strap 6564. The middle strap 6562 continues to the patient interface 6500.

[0184] 49A and 49B show perspective views of an embodiment of headgear 6570 that can be used with the patient interface 6500. A middle strap 6572 extends from the patient interface 6500, above the user's ear, around the back of the user's head, above the user's other ear, to the opposite side of the patient interface 6500. A top strap 6573 can be formed from a breakthrough joint with the middle strap 6572. A bottom strap 6571 extends from the patient interface 6500, below the user's ear, around the back of the user's head, below the user's other ear, to the opposite side of the patient interface 6500.

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

[0186] The ear loops 6577 include rear web portions 6575 that span opposing lengths of the ear loops 6577 at the rear of the user's head. The rear web portions 6575 may be formed by breakthrough molding. The web portions 6575 may be integrally formed with the headgear 6570. Alternatively, the web portions 6575 may be made from a more flexible material (e.g., Breath-o-prene) and connected to the bottom strap 6571 and middle strap 6572 by any suitable means (such as stitching, RF welding, adhesives, etc.). The ear loops 6577 are joined to the middle strap 6572 and bottom strap 6571 of the headgear 6570 by using stitching, RF welding, ultrasonic welding, or adhesive bonding.

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

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

[0189] The first 6594 and second 6595 portions of the top strap 6593 cooperate to allow a user of the patient interface 6500 to adjust the length of the top strap 6593. The first 6594 and second 6595 portions of the top strap 6593 can cooperate by including a push-fit adjustment mechanism. As shown in FIG. 51B, the push-fit adjustment mechanism can include a number or plurality of protrusions 6599 on the second portion 6595 of the top strap 6593 and a number or plurality of cooperating recesses 6598 on the first portion 6594 of the top strap 6593. The protrusions 6599 on the second portion 6595 can be pushed or pressed into the recesses 6598 on the first portion 6594 to fix the length of the top strap 6593 as desired. The protrusions 6599 can be formed from a breakthrough in-mold molding process. Any other suitable adjustment mechanism can be implemented to connect the first portion 6594 and the second portion 6595 to set the length of the top strap 6593.

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

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

[0192] The junction 6617 and adjacent portions of the mid strap 6611 and the rear strap 6613 include a support structure 6615. FIG. 52B shows a cross-sectional view of the junction 6617 and adjacent portions along line 52B-52B illustrating the support structure 6615. In contrast, FIG. 52C shows a cross-sectional view of the rear strap 6613 along line 52C-52C, partially absent the support structure 6615. The support structure 6615 may be arcuate, following the contours of the mid strap 6611, the rear strap 6613 and the junction 6617. The support structure 6615 may 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 polymeric material 6602. The support structure 6615 may be formed from a breakthrough in-mold molding process. A support structure 6615 can be overmolded onto the headgear 6610. The support structure 6615 can provide structure that helps the headgear 6610 maintain its shape and / or contributes to the structural integrity of the headgear 6610.

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

[0194] The web portion 6628 forms a plastic core of the first rear portion 6624. As shown in FIG. 53B, the first rear portion 6624 includes an overmolded material 6603 on at least one of the surfaces of the web. In the illustrated configuration, the first rear portion 6624 includes a soft touch overmolded material 6603 on both the exterior and interior surfaces of the first rear portion 6624. This overmolded material 6603 can enhance the level of 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 that spans the top of the user's head and a rear strap 6627 that spans the rear of the user's head.

[0195] 54A-54C show headgear 6630 having lower strap 6631 and middle strap 6632 formed from a continuous casing. The upper portions of the partial ear loops are defined by the middle strap 6632. The lower portions of the partial ear loops are defined by the lower strap 6631. A web portion 6637 extends between the rear portions of the continuous middle strap 6632 and lower strap 6631 and defines the rear portions of the partial ear loops. FIG. 54B shows an enlarged view of web portion 6637. Web portion 6637 can be formed by a breakthrough in-mold process. FIG. 54C shows a cross-sectional view of web portion 6637 taken along line 54C-54C of FIG. 54B. Web portion 6637 includes overmolded material 6603. In at least one embodiment, overmolded material 6603 can be a soft-touch material.

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

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

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

[0199] As shown in FIG. 56B, the top strap 6653 and the rear strap 6657 may be filleted or tapered at their junctures with the middle strap 6652 and the bottom strap 6651 to improve connection strength with the middle strap 6652 and the bottom strap 6651. In at least one embodiment, the top strap 6653 may be formed from exposed plastic. In at least one embodiment, the top strap 6653 may be comprised of molded strapping with a textile outer casing. In at least one embodiment, the rear strap 6657 may be formed from exposed plastic. In at least one embodiment, the rear strap 6657 may be comprised of molded strapping with a textile outer casing.

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

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

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

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

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

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

[0206] 59A-C show headgear 6680 including a continuous lower strap 6681 and interdigitated continuous middle and vertical straps 6682. The headgear 6680 further includes interdigitated top and back straps 6683. Web portions 6685 extend around behind the user's ears. The web portions 6685 may be formed from a breakthrough in-mold molding process.

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

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

[0209] The headgear 6690 includes a rear strap 6697. The rear strap 6697 extends from a juncture at the rear of the right partial ear loop to a juncture at the rear of the left partial ear loop. The rear strap 6697 can be formed by in-mold molding with a plastic core and a fabric or textile casing. The rear strap 6697 can have a molded texture imprinted onto the strap 6697 or can include a contour determined during the molding process. FIG. 60A shows a strap 6697 with multiple 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 rear strap 6697. The holes protrude through the thickness of the strap 6697. This contour can provide some elasticity or stretchability to the plastic core. Such flexibility can be beneficial in that the headgear 6690 can be pulled over the patient's head or can improve the patient's perception of the headgear 6690. Additionally, the textured finish of the straps 6697 may also improve the aesthetic appearance of the headgear 6690, as well as the tactile appeal of the straps 6697. That is, the straps 6697 may appear stiffer and more comfortable. The holes may improve ventilation through the straps 6697, thereby improving comfort for the user.

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

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

[0212] In at least one embodiment, the vertical strap 7113 can be a continuous strap having a continuous casing. The vertical strap 7113 can pass underneath the middle strap 7112 as it extends over the user's head. The vertical strap 7113 can pass over the middle strap 7112 as it extends over the user's head. The vertical strap 7113 can be adhesively bonded to the middle strap 7112, can be connected via a suitable connection mechanism such as a hook-and-loop connection system, or can be separate from the middle strap 7112.

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

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

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

[0216] The headgear 7120 includes a vertical member 7125. The vertical member 7125 spans the distance between the lower strap 7121 and the middle strap 7122, in front of the user's ears, and forms a portion of the ear loop. The vertical member 7125 is formed from a soft-touch material, such as fabric or foam. In the illustrated configuration, the vertical member 7125 includes a number of holes. The number of holes can increase the elasticity and / or flexibility of the vertical member 7125 and increase the perceived comfort of the user.

[0217] A web portion 7127 extends between the rear of the continuous middle strap 7122 and lower strap 7121 and defines the rear of the ear loops. The web portion 7127 can be made from a soft touch material, such as fabric or foam. In the illustrated configuration, the web portion 7127 includes a plurality of holes. The plurality of holes can increase the elasticity and / or flexibility of the web portion 7127 and increase the perceived comfort of the user.

[0218] In at least one embodiment, the vertical members 7125 can be formed from a quilted fabric. In at least one embodiment, the vertical members 7125 can be formed from a breakthrough in-mold process to include a plurality of holes. In at least one embodiment, the vertical members 7125 can include a plurality of dimples instead of a plurality of holes. In at least one embodiment, the web portion 7127 can be formed from a quilted fabric 7129 as shown in FIG. 62B. In at least one embodiment, the web portion 7127 can be formed from a breakthrough in-mold process to include a plurality of holes. In at least one embodiment, the web portion 7127 can include a plurality of dimples instead of a plurality of holes.

[0219] 63A and 63B show an embodiment of headgear 7130 having a quilted fabric or material 7132 provided for attachment to the portion of the headgear 7130 that is in direct contact with the skin or hair of the user, e.g., at the back of the neck of the user. The quilted material 7132 is soft to the touch and provides cushioning padding, thereby improving the comfort of the headgear 7130 such that the user is inclined to wear the headgear 7130 when sleeping. The quilted material 7132 can be sewn or welded to molded straps or web portions of the headgear 7130. The disclosed configurations are not limited to quilted materials (illustrated in FIG. 63B) and can include fabrics and textiles having various material properties such as, but not limited to, soft, padded, breathable, moisture wicking, and non-slip / tacky to the touch (illustrated in FIG. 63C).

[0220] 64A and 64B show that an embodiment of the headgear 7140 has a fabric or textile material provided for attachment to the portion of the headgear 7140 that is in direct contact with the skin or hair of the user. The headgear 7140 includes vertical members 7142 and rear straps 7144 that are formed from a material that provides cushioning and enhances the comfort of the headgear 7140. The material can be sewn or welded to the molded straps of the headgear 7140. The disclosed configurations are not limited to fabric or textile materials and can include quilted materials (as shown in FIG. 64B). The material can have a variety of material properties, such as, but not limited to, soft, padded, breathable, moisture wicking, and non-slip / tacky hand feel.

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

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

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

[0224] The connector 3400 accommodates any excess threads of the ends of the straps within the connector 3400 such that the joint 3500 has a neat aesthetic appearance. That is, the excess ends of the first strap 3710 and / or the second strap 3720 are accommodated within the connector 3400, which further prevents the straps 3710, 3720 from fraying. Additionally, the connector 3400 can have an opaque color that hides the excess ends from appearing such that the joint 3500 has a neater aesthetic appearance. Additionally, the connector 3400 defines the finished shape of the joint 3500 and accommodates any breakthrough plastic extrusions from the first strap 3710 end and the second strap 3720 end such that the joint 3500 has a neater aesthetic appearance.

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

[0226] 68A-68D show various views of a connector 3400. As shown, the connector 3400 comprises a tubular sheath having a cavity 3420 between a strap encircling end 3418 and an abutting end 3416. The connector 3400 has a body 3410 made up of a first half 3412 and a second half 3414 that are joined along their opposing edges. In the configuration shown, the first half 3412 and the second half 3414 are the same. In other configurations, the first half 3412 and the second half 3414 are not the same and / or are asymmetric. The open ends of the first half 3412 and the second half 3414 form the abutting end 3416 and the strap encircling end 3418 of the connector 3400. The strap encircling end 3418 receives or surrounds the first strap 3710, and the abutting end 3416 receives or abuts the second strap 3720. As shown in FIG. 68B, the connector 3400 has a somewhat trapezoidal profile such that one end is wider than the other. The wider end of the connector 3400 forms the abutting end 3416, and the narrower end forms the strap encircling end 3418. In some configurations, the abutting end 3416 can have a width that is twice the width of the strap encircling end 3418.

[0227] The strap encircling end 3418 defines an oval opening configured to fit snugly on and against the outer surface of the textile strap casing of the first strap 3710. The abutting end 3416 forms a substantially rectangular opening with rounded ends when viewed from underneath (as shown in FIG. 68A). The abutting end 3416 is curved to match the shape and curvature of the second strap 3720. The edge of the abutting end 3416 is configured to overhang and encircle the outer edge of the second strap 3720 (the area between the abutting edge 3417 and the dashed line in FIG. 68B overhangs the second strap 3720). The edge of the abutting end 3416 is also configured to be positioned over the outer surface of the textile strap casing of the second strap 3720. In some configurations, the overhanging edge 3419 can form a loose fit with the textile strap casing of the second strap 3720 such that the connector 3400 does not restrict the flow of the plastic core material 3800 through the second strap 3720.

[0228] When the first strap 3710 and the second strap 3720 are molded in, the connector 3400 allows the end of the first strap 3710 to align and abut the edge of the second strap 3720, rather than having a gap between the first strap 3710 and the second strap 3720. That is, the snug fit with the first strap 3710 provided by the connector 3400 holds the first strap 3710 in alignment while in the mold prior to injection of the plastic core material 3800. The connector 3400, unlike the straps 3710, 3720, is semi-rigid and retains its shape, allowing the connector 3400 to be securely placed in the mold.

[0229] During assembly of the straps 3710, 3720 and the connector 3400, the connector 3400 is positioned over the tubular textile casing 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. The abutting edge 3417 of the connector 3400 then abuts the edge of the textile casing of the second strap 3720. As shown in FIG. 70, the end of the first strap 3710 is positioned adjacent the edge of the second strap 3720 within the cavity 3420 of the connector 3400. The cavity 3420 is a hollow area defined by the first half 3412, the second half 3414, the strap encircling end 3418 and the abutting end 3416. The connector 3400 fits snugly over the first strap 3710 such that the connector 3400 remains secured to the first strap 3710 .

[0230] The assembled straps 3710, 3720 and connector 3400 are positioned and aligned in an injection molding tube. A plastic core material 3800 is injected into the injection point 3600 at the end of the second textile strap 3720, penetrating the sidewall of the second strap 3720 and filling the first strap 3710 (see arrows in FIG. 66A ). Thus, as illustrated in FIGS. 71 and 72 , the cavity 3420 of the connector 3400 is also filled with the plastic core material 3800, which penetrates the sidewall of the second strap 3720. The straps 3710, 3720 and the plastic core material 3800 in the cavity 3420 of the connector 3400 form a unitary structure. In some configurations, the plastic core material 3800 combines with the connector 3400 such that the connector 3400, the straps 3710, 3720 and the plastic core material 3800 are formed as a unitary structure.

[0231] One skilled in the art will appreciate that the connector 3400 and strap configuration is not limited to T-junctions and can connect straps 3710, 3720 having junctions 3500 at various angles. Similarly, the connector 3400 can be shaped and configured to connect three or more straps together. For example, the connector 3400 can have multiple strap encircling ends 3418 or abutting ends 3416.

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

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

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

[0235] In-mold connector 74A-78B show various views of molded straps, joints and fittings that form the bifurcated headgear 100 shown in FIG. 1A. The bifurcated headgear 100 comprises a top strap 140, a bottom strap 150 and a mask connector 180. In some configurations, the bifurcated headgear 100 is assembled by joining the top strap 140 with the bottom strap 150. That is, before joining the top strap 140 with the bottom strap 150, each of the top strap 140 and the bottom strap 150 are formed separately via molded in. That is, in some configurations, the top strap 140 and the bottom strap 150 are placed in a mold and joined by overmolding. Once formed, the top strap 140 and the bottom strap 150 are joined to form the bifurcated headgear 100. However, in some configurations, the top strap 140 and the bottom strap 150 may move out of alignment with one another while placed in the mold and / or during the overmolding process. Figures 74A-78B show various strap connectors that keep the top strap 140 and the bottom strap 150 connected and aligned during the manufacturing and molding process.

[0236] FIG. 74A shows the top strap 140 prior to assembly, and FIG. 74B shows the bottom strap 150 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 braided tubular casing 220 by in-mold molding. As shown in FIG. 74A, the top strap 140 comprises a substantially straight continuous strap having a male connector portion 4002 formed at each end. The male connector portion 4002 is integrally formed and unitary with the plastic core material 210. The casing 220 is continuous throughout its length. The injection point of the top strap 140 can be located at one or both of its ends. That is, one or both male connectors can be the location of the injection point that injects the plastic core material 210 into the casing 220.

[0237] The bottom strap 150 includes a plastic core material 210 injected into a first braided casing portion 220A and a second braided 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 unitary throughout the length of the plastic core material 210. That is, the plastic core material 210 joins the casing sections 220A, 220B and connects the casing sections 220A, 220B to form the bottom strap 150.

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

[0239] The bottom strap 150 includes a female connector 4004 disposed between the first free end 4020 and the second free end 4022 of the casing portions 220A, 220B. The female connector 4004 is configured to mate 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 casing portions 220A, 220B. That is, the female connector 4004 is formed by a breakthrough in-mold process. The female connector 4004 is integrally formed and unitary with the plastic core 210 within the casing portions 220A, 220B. The female connector 4004 is positioned at the apex of the curvature of the bottom strap 150 that is positioned substantially above the ear of the user when in use. In some configurations, the female connector 4004 can be formed on a substantially straight portion of the bottom strap 150.

[0240] 75A and 75B are views of the male connector 4002 of the top strap 140. As shown, the male connector 4002 extends and protrudes outwardly beyond the end of the casing 220. The male connector 4002 is formed from a plastic core material 210 that is disposed beyond the end 4024 of the casing 220. The male connector 4002 includes a protrusion 4040 that is configured to mate 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.

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

[0242] 75B is a side view of the top strap 140. As shown, the head 4050 has a thickness T 1 and the leg 4052 has a thickness T 2 The thickness T of the head 4050 1 is the thickness T of the leg 4052 2 Greater than. 1 and T 2 The mismatch between the thickness T and the thickness T allows the overmolded plastic to flow around the head 4050 of the male connector 4002 when joining the top strap 140 to the bottom strap. 2 The thinner head 4050 allows the head 4050 to be surrounded by an overmolded plastic material.

[0243] 76A-76C are various views of the female connector 4004 of the top strap 150. The female connector 4004 has a triangular shape that extends and protrudes radially outward beyond the surface of the casing portions 220A, 220B. The female connector 4004 is formed from a plastic core material 210 that breaks through the casing portions 220A, 220B during a breakthrough in-mold process. The female connector 4004 includes a tab-shaped projection 4046 formed with a slot 4042. As shown in FIG. 76C, the projection 4046 has a central region 4044 and a peripheral region 4048 that extends outward from the central region 4044. The central region 4044 has a thickness T of the peripheral region 4048. 4 Larger thickness T 3 The thickness of the central region T 3 The greater thickness T of the central region 4044 increases the strength of the protrusions 4046 while allowing the overmolded plastic to flow around the protrusions 4046 when joining the top and bottom straps 140, 150. 3 is the thickness T of the head 4050 of the male connector 4002 1 can be made equal to

[0244] The slot 4042 is formed in and extends through both the central region 4044 and the peripheral region 4048. The slot 4042 has a shape that matches and mates with the reverse arrowhead shape of the head 4050. The slot 4042 opens away from the casing portions 220A, 220B so that the head 4050 can be inserted into and received by the slot 4042. The slot 4042 is centrally located at the radially outermost portion of the peripheral region 4048. The slot 4042 can be formed and molded into the female connector 4004 when forming the female connector 4004 via a breakthrough in-mold molding process. In other configurations, the plastic core material 210 can be removed from the female connector 4004 via, for example, a cutting process to form the slot 4042.

[0245] The slot 4042 is configured to receive at least the head 4050 of the male connector 4002 so 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 overmold mold and the head 4050 is inserted into the slot 4052 so 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 overmold mold is closed and overmold plastic material is injected into the overmold mold to form a permanent overmold joint on the male connector 4002 and the female connector 4004. Connecting and aligning the straps 140, 150 before overmolding the male connector 4002 and female connector 4004 improves strap alignment accuracy and reduces the chance of the straps 140, 150 moving during overmolding, thus improving the efficiency of the manufacturing process.

[0246] FIG 77A shows the male connector 4002 aligned with the female connector 4004 prior to inserting the head 4050 into the slot 4042. FIG 77B shows the head 4050 inserted into and received by the slot 4042 such that the male connector 4002 and the female connector 4004 are connected. FIG 77C shows the comparative thicknesses of the male connector 4002 and the female connector 4004. The increased thickness T of the head 4050 of the male connector 4002 1 and an increased thickness T 3and align to form an upper surface 4060 and a lower surface 4062, respectively. The upper surface 4060 and the lower surface 4062 are configured to abut opposing inner surfaces of a mold cavity of an overmolding mold. This helps to align the top strap 140 and the bottom strap 150 within the overmolding mold. The upper surface 4060 and the lower surface 4062 are shown as flat, planar surfaces, but this is not intended to be limiting. Thus, the opposing surfaces of the mold have corresponding shapes that engage the upper surface 4060 and the lower surface 4062.

[0247] In some configurations, the head 4050 and the slot 4052 can be sized and shaped such that there is an amount of gap between them when they are engaged. A tight connection fit with no gaps between the male and female connectors can result in no space for the overmolded plastic material to flow between the connectors. This can result in the overmolded connection having weak zones caused by gaps or voids in the overmolded joint, which can reduce the durability of the headgear. FIGS. 78A and 78B show the gap 4064 between the head 4050 and the slot 4052 when the male and female connectors 4002 and 4004 are in a connected state. The gap 4064 in FIG. 78B is larger than the gap 4064 in FIG. 78A. In FIG. 78A, the gap 4064 is small such that the connection between the male and female connectors 4002 and 4004 has a tight fit similar to puzzle pieces. In Fig. 78B, the gap 4064 is larger, which allows for a more playful fit and overall alignment of the top strap 140 and bottom strap 150 within the overmold mold. The larger the gap 4064, the more the overmold plastic can flow between the connectors 140, 150 to provide a robust joint. In Fig. 78B, the gap 4064 is preferably about 1.0 mm. In some configurations, the gap 4064 is between 0.1 mm and 1.0 mm.

[0248] FIG. 79A shows an alignment recess 4070 formed in the head 4050 of the male connector 4002 configured to receive an alignment locating pin 4072 disposed on an opposing inner surface of a mold cavity 4076 in an overmolded mold section 4074. FIG. 79B shows an overmolded mold section 4074 having a mold cavity 4076 with an alignment pin 4072 protruding from a surface of the mold cavity 4076. The alignment 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 alignment of the top strap 140 and bottom strap 150 and during the overmolding process. The alignment pin 4072 can limit movement of the head 4050 within the mold cavity 4076. The locating pins 4072 can also inhibit or prevent the male connector 4002 from disengaging from the female connector 4004 before or during the overmolding process. In some configurations, the locating pins 4072 can hold the head 4050 in place such that the gap 4064 between the male connector 4002 and the female connector 4004 is maintained.

[0249] In some embodiments, the recess 4070 and locating pin 4072 can have corresponding shapes, sizes and geometries. The recess 4070 is shown, but is not limited to, a triangular recess formed at an interior corner of the head 4050. The locating pin 4072 is shown, but is not limited to, a cylindrical post shape. The triangular recess 4070 is configured to receive the locating pin 4072 at one of the apexes of the triangular recess, as shown by the dashed circle in FIG. 79A. The locating pin 4072 has a cylindrical side that is configured to abut a side of the head 4050 to align the head 4050 of the male connector 4002 within the mold cavity 4076.

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

[0251] 80A and 80B, the overmold joint 4006 has a top edge 4056 that extends over the edge of the top strap 140 and over the surface of the top strap 140. That is, the overmold joint 4006 overlaps and is bonded to the casing 220 of the top strap 140. Similarly, the overmold joint 4006 has a bottom edge 4058 that extends over the edge of the bottom strap 150 and over the surface of the bottom strap 150. That is, the overmold joint 4006 overlaps and is bonded to the casing 220 of the bottom strap 150. Bonding the overmold joint 4006 to the top strap 140 and bottom strap 150 increases the connection area between the overmold joint 4006 and the top strap 140 and bottom strap 150, thereby increasing the strength of the overmold joint 4006. Additionally, the durability and appearance of the finished headgear is increased by extending the overmold joint 4006 beyond the end of the casing 220 such that the end of the casing 220 is encapsulated within the overmold joint 4006. That is, the excess thread ends of the casing are encapsulated and bonded within the overmold joint 4006.

[0252] 80C, the overmolded joint 4006 has a thickness T that 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 joint 4006 is less than the thickness T of the head 4050. 1 and the thickness T of the central region 4044 3 Thus, the equal thickness of the overmolded joint 4006 and the top and bottom straps 140, 150 provides a continuous thickness through the length of the straps 140, 150 and the connections and transitions between the straps 140, 150, improving the aesthetics and comfort of the headgear.

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

[0254] The ends of the splice tab 4008 include a pair of alignment posts 4078 that protrude and extend in opposite directions (e.g., in the thickness direction) from the upper and lower surfaces 4018, 4028 of the splice tab 4008. The alignment posts 4078 are shown, but are not limited to, as rectangular projections that extend across the width of the upper and lower surfaces 4018, 4028 of the splice tab 4008. The alignment posts 4078 are configured to abut against an inner surface of a mold cavity of an overmolding mold 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 mold.

[0255] 81C shows alignment posts 4078 extending from the upper surface 4018 and the lower surface 4028 of the bonding tab 4008. The bonding tab 4008 has a thickness T 6 The area of ​​the bonding tab 4008 including the alignment post 4078 is shown to have a thickness T 5 The thickness T of the region including the alignment post 4078 5 is the thickness T of the area without the alignment post 4078 6 The alignment posts 4078 can also maintain a gap between the upper surface 4018 and the lower surface 4028 of the interface tab 4008 and the interior surface of the mold cavity, allowing the overmolded plastic to flow over the interface tab 4008 to provide a robust joint.

[0256] 81D and 81E show the strap halves 150A, 150B after the joining tabs 4008 have been overmolded. As shown, an overmold 4080 is formed over the joining tabs 4008. The overmold 4080 may be formed from the same material as the bottom strap 150 (e.g., the plastic core material 210) or may be formed from a different material. In some embodiments, the overmold 4080 may include an elastomeric material to provide a flexible and comfortable contact between the overmold 4080 and the patient's head. The overmold comprises 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.

[0257] FIG. 81D is a top view of the overmold 4080 showing the top surface 4082 of the overmold 4080 facing 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 facing the patient's head. A reference mark 4088 can be formed in or on the surfaces 4082, 4084 of the overmold 4080 to indicate the location of the alignment post 4078. If the thickness of the overmold 4080 is less than the thickness T of the alignment post 4078, the overmold 4080 can be formed with a thickness T of the alignment post 4078. 5 4082, 4084. In other configurations, the thickness of the overmold 4080 is equal to the thickness T of the alignment post 4078 such that the alignment post 4078 is not visible through the faces 4082, 4084 of the overmold 4080. 5 That is, the outer surface 4082 of the overmold 4080 may be smooth and continuous such that the identification marks 4088 indicating the location of the alignment posts 4078 are not visible.

[0258] A product label or logo 4086 may 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 overmolding process. In some configurations, the alignment posts 4078 may be configured to form part of the logo 4086. For example, in the configuration shown, one alignment post 4078 may have a shape consisting of the letter "F" and the other alignment post has a shape consisting of the letter "P". The thickness of the alignment posts 4078 and / or the overmold 4080 may be altered such that the alignment posts 4078 are visible on the surface 4082. In other configurations, the logo 4086 may be formed by a finishing process (e.g., engraving, molding, stamping, etc.).

[0259] In some embodiments, the bond tabs 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 therefore the length of the overmolding. That is, in some configurations, the distance between the alignment posts 4078 (e.g., along the length of the bottom strap 150) can be shortened or lengthened to shorten or lengthen the overall length of the bottom strap 150. Using this approach, different headgear sizes can be provided using the same bottom strap components.

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

[0261] The housing 4090 has an internal chamber 4092 configured to receive the open ends 4026 of the two textile casings 220. The housing 4090 can have a shape, size, and geometry that corresponds to the shape, size, and geometry of the area within the internal cavity of the in-mold mold such that the housing 4090 has a secure fit within the in-mold mold. Thus, the housing 4090 can be aligned relative to the in-mold mold, such that the ends 4026 of the textile casings 220 can be aligned by the housing 4090 when in the in-mold mold. The housing 4090 is not limited to a rectangular shape or geometry.

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

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

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

[0265] The inner cavity region 4092A has a height D of the outer cavity region 4092B. 2 Lower height D 1 The height D of the inner cavity region 4092A 1 and the height D of the outer cavity region 4092B 2 The difference in height D of the interior cavity region 4092A creates a stepped profile within the interior chamber 4092, which allows the ends 4026 of the textile casing 220 to be spaced apart when placed within the housing 4090. 1 may be substantially equal to the thickness of the core material 210 through the textile casing 220.

[0266] In some configurations, the length L of the interior cavity region 4092A (as shown in FIG. 83D ) can be varied to allow bottom straps 150 of different lengths to be formed from the same textile casing 220. That is, by varying the length of the housing 4090, bottom straps of various lengths can be formed from a textile casing 220 having a fixed length. The length L of the interior cavity region 4092A moves the ends 4026 of the textile casing 220 closer together or further apart, thereby increasing or decreasing the finished length of the straps 150. For example, in some configurations, bottom straps 150 for medium and medium-large headgear can be formed using the same length of textile casing 220 and housings 4090 having interior cavity regions 4092A with different lengths L. That is, the difference in length of the medium and medium-large bottom straps 150 is provided by the difference in the length L of the interior cavity region 4092A.

[0267] Strap cross section 84A and 84B show cross-sectional views of the top strap 140 and bottom strap 150 as a result of an in-mold molding process in which the textile casing 220 is filled with the plastic core material 210. Both the top strap 140 and bottom strap 150 have an inner surface 4066 and an outer surface 4068, with the inner surface 4066 configured to contact the patient's head and the 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 linear profile. In some configurations, the inner surface 4066 can have a concave curvature.

[0268] The flat profile of the inner surface 4066 is configured to have an increased contact area with the patient's head so that any load on the headgear is distributed more evenly across the patient's head (than a convex profile), improving headgear stability and patient comfort. The convex curvature of the outer surface 4068 provides some stiffness to the straps and a soft or aesthetically pleasing appearance to the headgear.

[0269] Soft edges on straps FIG. 84A shows the top strap 140 and bottom strap 150 with a plastic core material 210, including a flange portion 4036 that fills the outer edge of the textile casing 220. The flange portion 4036 provides a hard and rigid edge treatment to the top strap 140 and bottom strap 150. FIG. 84B shows the top strap 140 and bottom strap 150 with a soft edge 4038 that is formed by the absence of plastic core material 210 within. The soft edge 4038 is the portion of the casing 220 that is not filled with plastic core material 210 so that the textile casing 220 remains flexible and pliable. As a result, the soft edge 222 provides the top strap 140 and bottom strap 150 with a soft or cushioned edge that is comfortable against the user's skin and aesthetically pleasing.

[0270] In some configurations, the soft edges 4038 are formed by crimping the edges of the tubular casing 220 prior to injection of the plastic core material 210, thereby preventing or restricting the plastic core material 210 from flowing into the portion of the casing 220 being crimped. The edges are crimped by the portion of the molding die adjacent the mold cavity. The depth of crimping of the top and bottom straps 140, 150 by the molding die can be varied along the length of the top and bottom straps 140, 150, thereby varying the width of the plastic core material 210 (horizontal in FIGS. 84A and 84B ) along the length of the top and bottom straps 140, 150. Thus, making the plastic core material 210 wider in different areas of the top and bottom straps 140, 150 can reinforce and provide additional strength to those areas. Similarly, in some configurations, the plastic core material 210 may be narrower in some areas along the length of the top and bottom straps 140, 150 to provide flexibility in those relatively narrow areas. One skilled in the art will appreciate that the shape and geometry of the plastic core material may be altered to provide strength and stiffness to the top and bottom straps 140, 150 in desired directions.

[0271] 85 shows the top strap 140 joined to a bottom strap 150 having a soft edge 4038 along its length. The bottom strap 150 has a contoured curved shape to form an ear arch 4016 that is positioned over the user's ear when in use. As shown, the soft edge 4038 at the ear arch 4016 is sized to fit over the width W of the soft edge 4038 on the remainder of the bottom strap 150. 2 Larger width W 1The soft edge 4038 at the ear arch 4016 has an increased width relative to other portions of the bottom strap 150 to provide increased softness / cushioning and comfort where the ear arch should contact the patient's ear during use. The arch of a user's ear is a sensitive area and contact can cause discomfort.

[0272] In some configurations, the headgear can include a four-point connection configuration with upper and / or lower side straps (or other configurations), in which any straps that are adjacent to the patient's ears in use can include an increased soft edge width.

[0273] Bonded top and back straps with overmolded connections FIG. 86 shows a headgear configuration 5000 consisting of a rear strap portion 150 and a top strap portion 140 integrally formed as a single halo or rear headgear loop strap 5002. The headgear loop strap 5002 is connected to a front strap 5004 via an overmolded joint 5006. The front strap 5004 is formed separately from the headgear loop strap 5002 and then connected to the rear headgear loop 5010 by an overmolded connection. The front strap 5004 can include an in-mold 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 headgear configuration 5000 can be configured to include a locking mechanism and a size adjustment mechanism that includes a filament. This is advantageous because the braided strap containing the filament can be manufactured and tested as an individual component. This reduces the complexity of manufacturing these components and can prevent loss of the headgear or larger portions of the headgear if the tolerances or operation of the locking mechanism are compromised and / or defective, i.e., because the front straps 5004 are formed separately from the headgear loop straps 5002, there is no need to discard the entire headgear due to a defective or defective locking mechanism.

[0274] The ends of the headgear loop straps 5002 are joined together by an overmolded joint 5008 to form a rear headgear loop 5010 that cups or receives (indicated by a dashed line) the rear of the patient's head. The overmolded joint 5008 is located on the top of the patient's head during use. Positioning the overmolded joint 5008 on the top of the patient's head is an advantageous location because the top of the user's head does not contact the bed or pillow (which could apply force to the joint 5008 and cause it to dig into the patient's head). That is, positioning the overmolded joint 5008 on the top of the patient's head may be more comfortable for the patient.

[0275] 87A, the headgear loop strap 5002 is formed from a single in-mold molded piece that joins the top strap 140 and the back strap 150. The headgear loop strap 5002 is formed from a length of textile casing material 220 that is filled with a plastic core material 210. The headgear loop strap 5002 includes an alignment tab 5020 formed in and extending from a free end of the top strap portion 140. The headgear loop strap 5002 also includes a breakthrough tab 5030 disposed between the top strap portion 140 and the bottom strap portion 150.

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

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

[0278] The headgear loop strap 5002 includes two breakthrough tabs 5030 configured to be overmolded with the ends of the front strap 5004. The breakthrough tabs 5030 are substantially similar to the male connectors 4002 of the previous embodiment. As shown in FIGS. 89A and 89B, the breakthrough tabs 5030 include a head 5032 that engages and mates with features of the overmolded connection portion 5006 such that the headgear loop strap 5002 and the front strap 5004 are connected. The head 5032 is comprised of a protrusion that forms a raised abutment surface 5034. The abutment surface 5034 is configured to abut, engage and / or contact an inner wall of an overmolding mold cavity and to align the breakthrough tabs 5030 within the mold (e.g., in the thickness, width and / or length direction of the headgear loop strap 5002). The abutment surface 5034 is flush with the outer surface 5008 of the overmold joint 5006 to provide a smooth transition between the headgear loop straps 5002 and the front straps 5004.

[0279] The headgear loop straps 5002 and the front straps 5004 are joined by overmolding an overmolded joint 5006 over the breakthrough tabs 5030 and the ends of the front straps 5004. In some configurations, the overmolded joint 4006 can be formed from the same plastic core material 210 used to form the inner core of the headgear loop straps 5002. In other configurations, the overmolded joint 5006 can be formed from a different material, such as an elastomer.

[0280] 89A and 89B, the head 5032 of the breakthrough tab 5030 is surrounded by and retained within the overmold fitting 5006. Fastening openings 5036 are formed in the overmold fitting 5006 and are configured to fasten the front strap 5004 in place. The fastening openings 5036 are formed in the overmold fitting 5006 by protrusions extending from the inner wall of the overmold mold cavity.

[0281] In some configurations, the headgear loop strap 5002 and the front strap 5004 can be joined by a connector that fastens over the break-through tab 5030 and the end of the front strap 5004. The connector can thus engage the head 5032 of the break-through tab 5030 while fastening the end of the front strap 5004 such that the headgear loop strap 5002 and the front strap 5004 are joined.

[0282] Alignment posts, pinholes and recesses 90A-92D show molded top and bottom straps 140, 150 with alignment posts 5102 that protrude through the textile casing 220 and alignment recesses or pinholes 5104 recessed into the textile casing 220. The alignment posts 5102, like the male connector heads 4002 and the alignment tabs 5020, are configured to abut the inner surface of the overmolding mold cavity. The alignment posts 5102 align and position the ends of the straps within the overmolding mold. The alignment posts 5102 protrude from at least one of the top surface 5112 and bottom surface 5114 of the top and bottom straps 140, 150. The alignment posts 5102 protrude through the textile casing 220. The alignment posts 5102 are formed in the textile casing 220 during in-mold molding of the top strap 140 and bottom strap 150. Figures 90B and 90D show the alignment posts 5102 formed in the break-through tabs 5120. The alignment posts 5102 of the break-through tabs 5120 are formed from the plastic core material 210 and are substantially similar to the alignment posts 5022 of the alignment tabs 5020.

[0283] The user facing or bottom surface 5114 includes a pin hole 5104 formed partially recessed into the thickness of the strap 140, 150. The pin hole 5104 is configured to receive a pin protruding from a surface of an internal cavity of an overmolding mold, for example. The pin and pin hole 5140 are substantially similar to the recess 4070 and locating pin 4072 of FIGS. 79A-79C. The pin engages the pin hole 5104 to hold the strap 140, 150 in a predetermined position and alignment within the overmolding mold and to prevent the molded strap 140, 150 from moving inside the overmolding mold when the overmolding plastic is injected. The pin hole 5104 is formed in the bottom surface 5114 so that it is not visible when worn by a user. In some configurations, the pin hole 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 pinhole 5104 can have a depth that is less than the thickness of the top strap 140 and the bottom strap 150. In some configurations, the pinhole 5104 can have a depth that is equal to the thickness of the top strap 140 and the bottom strap 150.

[0284] The breakthrough tab 5120 and the ends of the top and bottom straps 140, 150 both include recesses on the inner surface 5112 and the outer surface 5114. The recesses 5106 are recessed into the plastic core material 210 of the breakthrough tab 5120 and into the textile casing 220 at the ends of the top and bottom straps 140, 150. As shown in FIGS. 92A-92D, the recesses 5106 are configured to provide an increased thickness at the recess engagement area of ​​the overmolded fitting 5130 and to provide an increased surface area for forming a mechanical connection between the overmolded fitting 5130 and the straps 140, 150. The increased surface area provided by the recesses 5106 increases the strength of the overmolded fitting 5130.

[0285] 92A-92D show the top strap 140 and the bottom strap 150 after the overmolded joint 5130 has been overmolded onto the breakthrough tab 5120 and the ends of the top strap 140 and the bottom strap 150. The overmolded joint 5130 provides a permanent overmolded connection onto the top strap 140 and the bottom strap 150. The overmolded joint 5130 is formed similarly to the overmolded joints described above. The alignment post 5102 can have the same thickness as the overmolded joint 5130, resulting in a verification mark being formed in the overmolded joint 5130. In some configurations, a logo 5150 can be formed in the overmolded joint 5130. FIGS. 92C and 92D show the increased thickness of the overmolded joint material provided by the indentation 5106. The overmolded joint 5130 also overlaps the edge of the bottom strap 150 to increase the strength of the joint between the top strap 140 and the bottom strap 150 .

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

[0287] The following disclosure relates to a headgear assembly 8000 for a patient interface 8002 configured to deliver respiratory therapy to a patient or user. FIGS. 93A-93C show non-limiting exemplary embodiments of a patient interface 8002 including a headgear assembly 8000 and a non-limiting embodiment of a mask assembly 8004. The mask assembly 8004 can be of any suitable configuration for delivering a flow of respiratory gas to the airway of the patient or user. The mask assembly 8004 can include a body and one or more sealing cushions. In some configurations, the body is more rigid than the sealing cushions. In some configurations, the body and the cushions are integrally or unitarily formed. The sealing cushions are configured to form a seal with one or both of the nose and mouth of the patient or user. The mask assembly 8004 can be, for example, without limitation, a full face above-the-nose mask, a full face below-the-nose mask, a nasal mask, nasal pillows, or a nasal cannula. Thus, the mask assembly 8004 is represented in the figures by a dashed block.

[0288] The headgear assembly 8000 includes a headpiece 8006 and at least one connector 8008. In the illustrated configuration, the at least one connector 8008 comprises a first connector 8008 and a second connector 8008 (not shown). The headgear assembly 8000 is substantially symmetrical about the sagittal plane of the user. Thus, the second connector 8008 may be a mirror image of the illustrated first connector 8008, and the description of the first connector 8008 may be equally applicable to the second connector 8008. Similarly, the left side (from the patient or user's perspective) of the headpiece 8006 may be a mirror image of the right side. The first connector 8008 and the second connector 8008 each connect to the mask assembly 8004 at a front portion 8008a and to the headpiece 8006 at a rear portion 8008b. In some configurations, the first connector 8008 and the second connector 8008 may be coupled to each other or may be of integral or unitary construction.

[0289] The headpiece 8006 can include one or more of a top or vertical strap 8010, a front or forehead strap 8012, a back or back strap 8014, and an ear loop 8016. The front strap 8012 goes substantially over the front of the user's head. That is, the front strap 8012 can be located in front of the top of the head, such as the forehead. The top strap 8010 goes substantially over the top of the user's head. The top strap 8010 and the front strap 8012 meet at a junction 8020. The junction 8020 can be joined to or form a portion of the ear loop 8016. The back strap 8014 goes substantially around the back of the user's head. That is, the back strap 8014 can be located behind the top of the head. In some configurations, an end of the back strap 8014 forms a portion of the ear loop 8016. The ear loop 8016 partially or completely encircles the user's ear. In the illustrated configuration, the ear loop 8016 completely encircles the user's ear forming a closed loop. The ear loop 8016 includes at least one connector connecting surface 8022 such that the headpiece 8006 can connect to the first connector 8008 and / or the second connector 8008.

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

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

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

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

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

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

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

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

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

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

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

[0301] By decoupling the mask assembly 8004 from the headpiece 8006 using the first connector 8008 and / or the second connector 8008, the mask assembly 8004 can be removed without adjusting the size of the headgear assembly 8000. The mask assembly 8004 can be re-secured in place via the first connector 8008 and / or the second connector 8008 without the need for size adjustment, thereby simplifying the donning and doffing process.

[0302] In some configurations of the headgear assembly 8000, the top straps 8010, the front straps 8012, the back straps 8014, or any combination thereof, include an adjustment mechanism 8040. The adjustment mechanism can be of any suitable configuration, such as, for example, a buckle. Opposite sides of the straps 8010, 8012, 8014 can pass through the buckle and fold over on themselves. The free ends of the straps 8010, 8012, 8014 can be secured to the remainder of the straps 8010, 8012, 8014 by a suitable fastener, such as, for example, a hook-and-loop fastener.

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

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

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

[0306] 94A-94C show perspective views of a patient interface 9002 including 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 FIGS. 93A-93C, the headgear assembly 9000 may be symmetrical about the sagittal plane of the user. Details of the headgear assembly 9000 not explicitly disclosed may be the same or similar to corresponding elements of the headgear assembly 8000 or may be of another suitable configuration. In this embodiment, the headgear assembly 9000 includes partial ear loops 9016 (FIG. 94C). The first connector 9008 and the second connector 9008 each connect to the mask assembly 9004 at a front portion 9008a and to the headpiece 9006 at a rear portion 9008b.

[0307] The headpiece 9006 includes a top or vertical strap 9010, a front or forehead strap 9012, and a rear or back strap 9014. The front strap 9012 goes substantially over the front of the user's head. The top strap 9010 goes substantially over the top of the user's head. The back strap 9014 goes substantially around the back of the user's head. The headpiece 9006 includes a connector connecting surface 9022 such that the headpiece 9006 can connect to the first connector 9008 and / or the second connector 9008.

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

[0309] In at least one embodiment, the first connector 9008 and / or the second connector 9008 can include a mid-strap. The mid-strap can extend from the front portion 9008a and the mask assembly 9004 above and behind the user's ears. In at least one embodiment, the mid-strap can extend from the front portion 9008a and the mask assembly 9004 below and behind the user's ears. In at least one embodiment, the mid-strap extends from the front portion 9008a and the mask assembly 9004 and bifurcates to extend both above and behind, and below and behind, the user's ears.

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

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

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

[0313] In at least one embodiment, the first connector 8008, 9008 and / or the second connector 8008, 9008 are manufactured from a continuous soft fabric cover with a plastic core. In some configurations, the plastic core can be an in-mold molded plastic core, where molten plastic is introduced into the spaces between or within the fabric portions or layers and cooled. In other embodiments, a hard polymer material can be used to manufacture the first connector 8008, 9008 and / or the second connector 8008, 9008. In at least one embodiment, a soft polymer material, such as silicone, can be used to manufacture the first connector 8008, 9008 and / or the second connector 8008, 9008. In at least one embodiment, at least one hard polymer material and at least one soft polymer material can be used to manufacture the first connector 8008, 9008 and / or the second connector 8008, 9008. 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 hard polymeric materials, soft polymeric 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 manufactured from a composite material of foam and fabric.

[0314] Closed Loop Headgear 95 and 96 show front and rear perspective views of the patient interface 9100, including the headgear 9102, the mask assembly 9104 and the connector 9106. The headgear 9102 is a closed loop headgear design with no interruptions in the loops of the headgear 9102 and the mask assembly 9104. As illustrated in the figures, the upper side straps 9108 and the lower side straps 9110 are formed from a single continuous strap. Thus, the upper side straps 9108 and the lower side straps 9110 result in a closed loop or continuous connection being created between the headgear 9102 and the mask assembly 9104 that does not break throughout the process of donning and doffing the patient interface 9100.

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

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

[0317] As illustrated in Fig. 97 and Fig. 98, the connector 9106 is configured to be separated (i.e., opened or disengaged) from the mask assembly 9104 without breaking the closed loop between the mask assembly 9104 and the headgear 9102 such that the effective length of the closed loop is increased. Fig. 97 shows a first perspective view of the connector 9106 initially separated from the mask assembly 9104. Fig. 98 shows a second perspective view of the connector 9106 of Fig. 97 further separated and expanded from the mask assembly 9104, illustrating the effective increase in headgear loop length achieved by the separation of the connector 9106. Preferably, the separation and expansion of the connector 9106 increases the length of the headgear loop by a minimum of 40 mm. Such an increase in the headgear loop allows the patient to easily don and remove the headgear 9102. In some configurations, the minimum increase in length may be less than 40 mm if the headgear 9102 has some elasticity.

[0318] Thus, the headgear 9102, mask assembly 9104 and connector arrangement 9106 provide a closed loop headgear design that includes a symmetrical connection mechanism for the mask assembly 9104. In other words, throughout the process of donning and doffing the patient interface 9100, the closed loop between the mask assembly 9104 and the headgear 9102 remains unbroken, thereby improving the ease with which a user can secure the mask 9104 in place by interacting with the headgear 9102 and connector 9106 without displacing the mask 9104 when centered on the user's face. The closed loop headgear design requires an "over the head" method of donning the patient interface 9100, thereby reducing the chances that the patient will become confused or do not dock the interface 9100 correctly. That is, the closed loop headgear design and connector arrangement provide a patient interface headgear 9102 that is comfortable, effective and intuitive to don and doff. Additionally, the closed loop headgear design and connector configuration ensures that the patient interface seal remains centered on the face when the headgear 9102 is being donned or removed.

[0319] Plastic Living Hinge FIG. 99A shows a plastic living hinge connector 9106 including a mask connector member 9112, a headgear connector member 9114, a first mask hinge 9116, a second mask hinge 9118, a first connector hinge 9120 and a second connector hinge 9122. The connector 9106 can be in a closed position where the mask connector member 9112 and the headgear connector member 9114 are adjacent (i.e. overlapping, squashed on, etc.) or attached onto the mask assembly 9104, or in an open position where they are in an extended position. In some configurations, the connector 9106 is fastened and fixed to the mask assembly 9104 in the closed position, such that the connector 9106 does not move or rotate. An advantage of the plastic living hinge connector 9106 is that the fastening system is self-positioning and the system is not prone to misuse.

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

[0321] The mask connector member 9112 is also formed from plastic. In the embodiment shown, there are two separate mask connector members 9112, the first mask connector member being vertically displaced from the second mask connector member, i.e. the first mask connector member 9112 can be positioned above the second mask connector member 9112 relative to a vertical plane.

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

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

[0324] When the connector 9106 is in the closed position, the mask assembly 9104 is secured to the face of the user. A friction fit between the connector 9106 and the recessed channel 9128 may be used to hold the connector 9106 against the frame 9126 and within the recessed channel 9128 when in the closed position. Alternatively, a snap fit, hook and post clip, magnet, Velcro® connection system, latch mechanism or any other connection system may be used.

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

[0326] FIG. 100 shows a top view of one type of living hinge 9130 that may be incorporated into the mask connector member 9112. The living hinge 9130 includes a portion of reduced thickness around which the living hinge 9130 provides rotation. The reduced thickness in the illustrated area provides increased local flexibility. This allows the area of ​​reduced thickness to act as a hinge point or "living hinge" 9130. In some configurations, the living hinge 9130 may have a constant thickness along its length while still having the flexibility to provide rotation.

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

[0328] 102A shows a living hinge connector 9106 having a single mask hinge 9116, a single connector hinge 9122, a recessed channel 9128 and a recessed surface 9136. The recessed surface 9136 is configured to receive the mask 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.

[0329] 102B also shows a cross section showing the core 9114b of the headgear connector member 9114 and the mask connector member 9112. In this configuration, the headgear connector member 9114 and the mask connector member 9112 are formed from one continuous molded plastic component 9114b. The mask hinge spans the vertical length of the mask connector member 9112, providing a larger surface area where the mask hinge abuts the mask assembly 9104. Additionally, the greater length of the mask connector assembly 9112 includes the connector hinge. The increased length of the hinge increases the durability of the connector 9106.

[0330] Hook and Post Retention System 103A and 103B show a plastic living hinge connector arrangement 9106 having a hook and post retention system 9140. The connector 9106 of FIG. 103A and 103B is held in the closed position by the hook and post retention system 9140. A raised post 9140a is integrally formed on the mask assembly 9104 and a corresponding hook 9140b is located on the mask connector member 9112. The hook 9140b encapsulates the post 9140a in the closed position and holds the connector 9106 in the closed position, such as via a snap fit or interference fit connection. In some embodiments, the raised post 9140a is integrally formed on the mask connector member 9112 and a corresponding hook 9140b is located on the mask assembly 9104.

[0331] In other embodiments, a magnetic retention system can be used to hold the connector of Figures 103A and 103B in the closed position. One or more magnets can be disposed on the connector 9106 and one or more ferrous metal structures can be disposed on the mask assembly 9104. The magnetic forces between the magnets and the ferrous structures act to hold the connector 9106 in the closed position.

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

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

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

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

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

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

[0338] Silicone hinge Figures 105A-107B show a connector arrangement 9106 having a silicone portion. 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.

[0339] 105A and 105B show a silicone hinge with a first end of a mask connector member 9112 pivotally connected to the mask assembly 9104 via a mask hinge 9116. A second end of the mask connector member 9112 pivotally connected to a headgear connector member 9114 via a connector hinge 9122. In the illustrated embodiment, the mask connector member 9112 rotates about a central pin connected to the mask assembly 9104 to form the mask hinge 9116. Additionally, the mask connector 9112 rotates about a central pin on the connector hinge 9122 to which the headgear connector member 9114 is coupled. This allows a wide range of movement relative to the connector 9106.

[0340] The illustrated configuration also includes a recessed center 9144 on the mask connector member 9112. This is a region 9144 where the thickness of the member 9112 is reduced. This region 9144 reduces the stiffness of the mask connector member 9112, allowing the mask connector member 9112 to flex to a greater extent than would be possible without the recessed center 9144.

[0341] The illustrated mask connector member 9112 is retained in the closed position on the mask assembly 9104 via protrusions on the mask that mate with corresponding holes in the mask connector member 9112. In other embodiments, the mask connector member 9112 may include protrusions and the mask assembly 9104 may include corresponding holes. Further embodiments may include any suitable retention mechanism (magnets, Velcro, etc.).

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

[0343] 107A and 107B show a mask connector member 9112 having an alternative silicone hinge configuration. The mask connector member 9112 in 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 greater thickness than the second portion 9112b. The first portion 9112a includes a provision for a mask hinge 9118 and a connector hinge 9122. The second portion 9112b includes a provision for a connector hinge 9122. The mask hinge 9118 includes a post in the mask assembly 9104 about which the mask connector member 9112 rotates. The connector hinge 9122 similarly rotates about the mask hinge 9118 about an axis as shown.

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

[0345] The second portion 9112b has a reduced thickness to increase the allowable deflection in the second portion 9112b. Allowing deflection in the second portion 9112b improves the resiliency of the connector 9106 when more force is applied to the connector 9106 during the opening process. The second portion 9112b of the mask connector member 9112 includes a retention cavity 9150 configured to mate with a retention protrusion 9152 of the mask assembly 9104 when the connector 9106 is in the closed position.

[0346] The headgear connector member 9114 is manufactured from a rigid polymer. The center of the headgear connector 9114 includes a cavity 9154 that is sized to accommodate the mask 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.

[0347] The location of the connector hinge 9122 relative to the mask connector member 9112 and the headgear connector member 9114 differs from the connector configurations described above. The connector hinge 9122 is offset from the ends of both the mask connector member 9112 and the headgear connector member 9114, as shown by the dashed lines in FIG. 107B. The advantage of offsetting the hinge 9122 is that a mechanical hard stop is created at maximum extension of the connector 9106. This hard stop is a result of the front edge of the headgear connector member 9114 hitting or contacting the inner surface of the mask connector member 9112. The hard stop is beneficial because it prevents the user from over-rotating the headgear connector member 9114 relative to the mask connector member 9112 at the connector hinge 9122 and inverting the connector 9106. Additionally, the hard stop acts to hold the connector 9106 wide when opening. This allows the headgear 9102 to be more easily passed over the user's ears, improving the usability of the headgear 9102 and mask assembly 9104 during donning and doffing.

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

[0349] Headgear connection 108A-108C show a headgear connection configuration used to connect the connector 9106 to the headgear 9102. The lateral ends of the connector 9106 each include a headgear connection portion 9124 in the form of an annular rigid structure having holes configured to receive straps of the headgear 9102. The straps of the headgear 9102 are designed to be folded back on themselves through the headgear connection portion 9124 and secured in place by one of several methods disclosed below. The headgear connection portion 9124 may be integrally formed with the in-mold mold core 9114b of the connector 9106.

[0350] Headgear fixing mechanism 109A and 109B show a headgear retention mechanism 9160 used to fix the length of the straps 9108, 9110. As shown, the headgear 9102 can be looped back on itself and then held in place at a fixed length using a hook-and-loop mechanism 9160a, a push-fit mechanism 9160b or a magnetic retention system 9160c. In some configurations, alternative fastening mechanisms can be used.

[0351] 110A and 110B show a push-fit headgear retention mechanism 9162 that is used to fix the length of the straps 9108, 9110. The push-fit components (e.g., protrusions 9162a and openings 9162b) have a lateral profile that is longer than their vertical profile.

[0352] Over-center Clip Connector 111A and 111B show an alternative connector configuration 9170 with an over-center clip design. The illustrated configuration uses a combination of pivots, hinges and plastic components to achieve the over-center lock. The connector 9106 includes a mask connector member 9112, a headgear connector member 9114, a mask hinge 9118 and a connector hinge 9122. The over-center connector operates similarly to a silicone hinge, but the mask connector member 9112 is rigid. The rigid member allows a hard stop to be created at the mask hinge 9118 as shown in FIG. 17B. This hard stop acts to maximize the rotation that the connector 9106 can undergo during operation. The advantage of this is that the connector 9106 holds the headgear 9102 wider when in the operating position, and the position of the hard stop can be adjusted so that the headgear 9102 can more easily pass the ears when donning and doffing. The headgear connector member 9114 includes two headgear connection points 9124.

[0353] Telescopic Pivot Connector 112A, 112B and 112C show a connector arrangement 9180 including a telescoping pivot clip. The arrangement shown includes a mask connector member 9112 and a headgear connector member 9114 that are coaxially aligned and configured such that the headgear connector member 9114 can move along their common axis relative to the mask connector member 9112. The mask connector member 9112 protrudes perpendicularly to the mask hinge 9118. In the closed position, the clip holds the connector 9106 to the mask assembly 9104. To open, the user applies a force laterally on the clip to the mask assembly to separate the clip. The mask connector member 9112 and the headgear connector member 9114 then rotate outwardly about the mask hinge 9118 (FIG. 112B). When pivoted open, the mask connector members 9112 can be pulled outwardly, away from the mask assembly 9104 in a telescoping motion, extending the length of the connectors 9106 (FIG. 112C). In addition to increasing the length of the headgear loops, this configuration helps move the headgear 9102 away from the user's ears, simplifying the removal process.

[0354] Sliding Strap Hard Stop Connector 113A and 113B show a connector configuration having a hard stop sliding strap connector configuration 9190. In this configuration, an outer portion of the headgear 9102 contacts the cheek of the user and is integrated into the connector 9106. A connector strap interface 9192 on the mask assembly 9104 acts as a fastening point for the headgear straps 9108, 9110. In the illustrated configuration, two headgear straps 9108, 9110 are integrated into the connector 9106. The connection mechanism for each headgear strap 9108, 9110 at the connector strap interface 9192 is not limited. That is, the connector configuration can include various types of connection mechanisms. In the illustrated configuration, the straps 9108, 9110 loop back onto themselves through an opening in the mask assembly 9104. Once the straps 9108, 9110 are looped through the mask assembly 9104, they may be fixedly attached to themselves, for example by stitching, or may be attached to themselves via a hook and loop connection system.

[0355] Each strap 9108, 9110 passes through a first inversion point 9193a located on the headgear 9102. The strap 9108, 9110 passes through the first inversion point 9193a and extends to a second inversion point 9193b where it loops back over itself and is secured in place. In the configuration shown, the strap 9108, 9110 is secured to itself after the second inversion point 9193b via a hook and loop connection system. The fastening system is not limited to a hook and loop connection system and can include other connection systems. Adjusting the strap length via the second inversion point 9193b is one way a user can adjust the tightness of the headgear 9102 in this configuration.

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

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

[0358] Breakfit Magnet and Tether Connector 115A and 115B show a connector assembly 9210 incorporating 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 may be attached to the mask assembly 9104 using hook and post clips, a magnet assembly or any other related mechanism.

[0359] As shown in FIG. 115B, the location of the magnetic connections 9214 on the ear loops of the headgear 9102 allows the user to release the second clip 9212b and break the magnetic connection when the user wishes to remove the mask assembly 9104. A tether 9216 is included, with one end secured to each point of the magnetic connections 9214, such that when the magnetic connections 9214 are broken, the tether 9216 acts as a bridge to prevent the lower portion of the headgear 9102 from dropping completely. When the magnetic connections 9214 are broken, the length of the headgear loops 9102 below the user's ears is increased, allowing the user to remove the headgear 9102 without having to readjust the headgear 9102 the next time the user wishes to use the mask assembly 9104. In some configurations, the tether 9216 between the magnetic connections 9214 may not be included.

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

[0361] Clip and Continuous Tether Connectors 117A and 117B show a clip and continuous tether connector 9230 incorporating a hook or clip 9232, a post 9234, and a continuous tether 9236 that connects both connectors 9230 on the mask assembly 9104. In this configuration, each of the two connectors 9230 is connected by a common tether 9236. The tether 9236 passes through a tether channel 9238 located on the mask assembly 9104. The tether 9236 is preferably made of an elastic material. In the closed position, the clip 9232 is secured to the post 9234 of the mask assembly 9104. When the user releases the connector 9230, the clip 9232 is released and pulled. The tether 9236 allows the headgear loop length to increase due to its elasticity while maintaining a closed loop of the headgear 9102. This allows the user to effectively remove the mask assembly 9104.

[0362] 118A and 118B show an alternative clip and continuous tether connector 9230 incorporating a first tether 9236a and a second tether 9236b. The first tether 9236a is vertically displaced 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, 9236b can move approximately parallel to one another. The clip 9232 operates similarly to the first embodiment. As a result of the inclusion of the first tether 9236a and the second tether 9236b, the clip 9232 has an increased tendency to self-align during attachment and detachment. This can be due to the increased elasticity that is a result of the two tethers 9236a, 9236b.

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

[0364] Hook and Post Loop Connectors 120A and 120B show a connector assembly 9250 having a hook and post loop connector. The illustrated connector 9250 includes a fixed connector point 9252, a clip 9254, and a material portion 9256. The fixed connector point 9252 is located at the top of the mask assembly 9104. At this point, the material portion 9256 passes through a loop, folds back on itself, and is adjustably secured in place (e.g., using a hook-and-loop fastener or magnetic connection). The material portion 9256 passes through a first eyelet loop 9258, where it is redirected into a second eyelet loop 9260. An end of the material or fabric portion 9256 includes a clip 9254, which allows the end of the fabric portion 9256 to be releasably connected to the mask assembly 9104.

[0365] To open the connector 9250, the clip 9254 is separated from the mask assembly 9104. In the illustrated embodiment, the clip 9254 is a hook and post clip. The clip 9254 may alternatively be magnetic, push-fit, or another clip configuration. By releasing the clip 9254, the length of the headgear loop increases and the patient may don or remove the headgear 9102 as shown. The clip 9254 acts as a hard stop at the second eyelet loop 9260, thereby limiting the maximum length to which the headgear loop may be increased. The effective length of the material portion 9256 may be adjusted at both the fixed connector point 9252 and the clip 9254.

[0366] Material portion 9256 may be made from a flexible material, such as breath-o-prene, leather or synthetic leather, fabric, any combination of these, or any other suitable material.

[0367] Figures 121A and 121B show an alternative hook and post loop connector 9250 that is similar to the connector 9250 of Figures 120A and 120B. In Figures 121A and 121B, the clip 9254 has been modified relative to the clip 9254 of Figures 120A and 120B. In other respects, the connector 9250 of Figures 121A and 121B may be the same as or substantially similar to the connector 9250 of Figures 120A and 120B.

[0368] Unless the context clearly requires otherwise, terms such as "comprise," "comprising," and the like should be interpreted in an inclusive sense, i.e., "including, but not limited to," as opposed to an exclusive or exhaustive sense. In particular, conditional language used herein, such as "can," "could," "might," "may," "for example," and the like, is intended to generally mean that some embodiments include certain features, elements, and / or conditions, while other embodiments do not, unless specifically stated otherwise or understood otherwise within the context in which it is used. Thus, such conditional language is generally not intended to mean that the features, elements, and / or conditions are in any way required for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether or not those features, elements, and / or conditions should be included or implemented in any particular embodiment, with or without author input or prompting.

[0369] The term "plurality" refers to two or more of an item. Enumerations of quantities, dimensions, sizes, formulations, parameters, shapes, and other features should be interpreted as if the quantity, dimension, size, formulation, parameter, shape, or other feature were preceded by the term "about" or "approximately". The term "about" or "approximately" means that the quantity, dimension, size, formulation, parameter, shape, and other feature is not necessarily exact and may be approximated and / or larger or smaller as desired, reflecting acceptable tolerances, conversion factors, rounding, measurement errors, and the like, and other factors known to those of ordinary skill in the art. Enumerations of quantities, dimensions, sizes, formulations, parameters, shapes, and other features should also be interpreted as if the term "substantially" were preceded by the quantity, dimension, size, formulation, parameter, shape, and other feature. The term "substantially" means that the enumerated feature, parameter, or value is not necessarily exact and deviations or variations, including, for example, tolerances, measurement errors, measurement accuracy limits, and other factors known to those of ordinary skill in the art, may occur in an amount that does not eliminate the effect that the feature is intended to provide.

[0370] Numerical data may be expressed or presented herein in a range format. It should be understood that the range format is used merely for convenience and clarity, and thus should be interpreted flexibly to include not only the numerical values ​​explicitly recited as the limits of the range, but also to include all of the individual numerical values ​​or subranges subsumed within the range as if each numerical value and subrange were explicitly recited. By way of illustration, a numerical range of "1 to 5" should not be interpreted to include only the explicitly recited values ​​of about 1 to about 5, but also to include each value and subrange within the range set forth. Thus, this numerical range includes individual values ​​such as 2, 3, and 4, as well as subranges such as "1 to 3," "2 to 4," and "3 to 5." This same principle should also be applied to ranges reciting only one numerical value (e.g., "greater than 1"), regardless of the breadth of the range or characteristic being described.

[0371] Several items may be presented in a common list for convenience. However, these lists should be construed as if each element of the list were individually identified as a separate and unique element. Thus, any individual element of such a list should not be construed as a de facto equivalent of any other element of the same list solely based on their presentation in a common group, unless indicated to the contrary. Furthermore, when the terms "and" and "or" are used in conjunction with a list of items, they should be interpreted broadly to mean that any one or more of the listed items can be used alone or in combination with other listed items. The term "alternatively" refers to a selection of two or more alternatives and is not intended to limit the selection to only those listed alternatives or to only one of the listed alternatives at a time, unless the context clearly dictates otherwise.

[0372] The reference to any prior art in this specification is not, and should not be construed as, an acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in the field of endeavor in any country throughout the world.

[0373] Where reference has been made in the above description to whole entities or components having known equivalents, those whole entities are incorporated herein as if individually set forth.

[0374] The invention can also be broadly described as consisting in the parts, elements and features (in any or all combinations of two or more of said parts, elements or features) individually or collectively referred to or indicated in the specification of this application.

[0375] It should be noted that various modifications and changes to the presently preferred embodiments described herein will become apparent to those skilled in the art. Such modifications and changes can be made without departing from the spirit and scope of the present invention and without diminishing its attendant benefits. For example, various components can be rearranged as desired. Accordingly, such modifications and changes are intended to be included within the scope of the present invention. Moreover, not all of the features, aspects and advantages are necessarily required to practice the present invention. Accordingly, the scope of the present invention is intended to be defined solely by the scope of the following claims.

Claims

1. A method for forming at least a portion of a headgear within a molding die, The steps include: placing the first tubular textile casing inside the cavity of the first molding die; The steps include positioning a portion of the first tubular textile casing so as to contact an adjacent cavity having the shape of a connector portion, The steps include introducing molten plastic material into the first molding die and into the first tubular textile casing, The steps include pushing the molten plastic material through the first tubular textile casing into the adjacent cavity, The steps include solidifying the molten plastic material within the first tubular textile casing to form a first strap portion having an internal core and connector portion formed from a single plastic core, including, A method for forming at least a part of a headgear.

2. The steps include: placing the first strap portion inside the second molding die; The steps include positioning the end of the second tubular textile casing on the connector portion and in contact with the first tubular textile casing of the first strap portion, The steps include introducing molten plastic material into the second molding die and into the second tubular textile casing, The steps include solidifying the molten plastic material within the second tubular textile casing to form a second strap portion having an internal core made of a single plastic material that is connected to the connector portion of the first strap portion, A method for forming at least a portion of the headgear according to claim 1, further comprising:

3. A method for forming at least a portion of a headgear according to claim 1, further comprising the step of pushing the molten plastic material through the first tubular textile casing into the adjacent cavity, displacing the threads of the first tubular textile casing to form a gap in the wall of the first tubular textile casing through which the molten plastic material flows into the second tubular textile casing.

4. A method for forming at least a portion of a headgear according to claim 1, wherein the step of pushing the molten plastic material through the first tubular textile casing into the adjacent cavity further includes tearing the threads of the first tubular textile casing to form a hole in the wall of the first tubular textile casing through which the molten plastic material flows into the second tubular textile casing.

5. A method for forming at least a portion of a headgear according to claim 1, wherein the step of pushing the molten plastic material through the first tubular textile casing into the adjacent cavity further includes stretching the first tubular textile casing to form a gap or space in the wall of the first tubular textile casing through which the molten plastic material flows into the adjacent cavity.

6. A method for forming at least a portion of the headgear according to claim 1, wherein the central portion of the cavity includes a projection that presses down the surface of the first tubular textile casing, thereby integrally forming a recess on the surface of the first strap portion.

7. A method for forming at least a portion of the headgear according to claim 1, further comprising the step of inserting a connector insert into the first tubular textile casing.

8. A method for forming at least a portion of the headgear according to claim 1, further comprising the step of injecting the molten plastic material into the first tubular textile casing through the opening of the connector insert.

9. A method for forming at least a portion of the headgear according to claim 8, wherein the opening of the connector insert includes an internal connection shape configured to connect with the shape of an opposing male connector.

10. A method for forming at least a part of the headgear according to claim 1, wherein the connector insert has the shape of the connector portion.

11. A method for forming at least a portion of the headgear according to claim 1, wherein the connector insert pushes the opening of the first tubular textile casing outward toward the wall of the cavity.

12. A method for forming at least a portion of the headgear according to claim 1, wherein the width of the connector portion is equal to the width of the internal core.

13. A method for forming at least a portion of the headgear according to claim 1, wherein the outer edge of the cavity narrows relative to the central portion of the cavity, thereby tightening the outer edge of the first tubular textile casing and preventing the molten plastic material from flowing between the outer edges of the first tubular textile casing.

14. A method for forming at least a portion of the headgear according to claim 1, wherein at least one outer edge of the cavity in the longitudinal direction is narrower than the central region of the cavity, thereby tightening at least one outer edge of the first tubular textile casing to prevent the molten plastic material from flowing along at least one outer edge of the first tubular textile casing.

15. A method for forming at least a portion of a headgear according to claim 1, wherein the tightened first tubular textile casing forms a soft portion on at least one of its outer edges, which prevents the molten plastic material from flowing between the outer edges of the first tubular textile casing.

16. A method for forming at least a portion of the headgear according to claim 1, wherein the outer edge of the cavity narrows relative to the central portion of the cavity.

17. A method for forming at least a portion of the headgear according to claim 1, wherein the first tubular textile casing is knitted.

18. A method for forming at least a portion of the headgear according to claim 1, wherein the first tubular textile casing is woven, knitted, or crocheted.

19. A method for forming at least a part of the headgear according to claim 1, wherein the connector portion includes a tab.

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