CN220344907U

CN220344907U - Headgear for securing a patient interface to a patient

Info

Publication number: CN220344907U
Application number: CN202223149530.1U
Authority: CN
Inventors: 艾米莉亚·R·贝克利; 安德鲁·C·M·范; 布莱德·M·霍沃斯; 弗蕾亚·R·狄克逊; 赫曼斯·佩玛拉珠; 杰德·J·奥布莱恩; 杰玛·T·萨默维尔; 马修·I·斯玛尔; 米里亚姆·R·麦克莱恩; 奥斯卡·麦克格蒂; 萨莉·M·亨斯曼; 萨姆尔·R·R·戴维斯; 泰勒·D·G·亨德里克森
Original assignee: Fisher and Paykel Healthcare Ltd
Current assignee: Fisher and Paykel Healthcare Ltd
Priority date: 2021-10-26
Filing date: 2022-10-25
Publication date: 2024-01-16
Anticipated expiration: 2032-10-25

Abstract

The present disclosure relates to a patient interface system. A headgear for securing a patient interface to a patient has a base layer and a headgear region forming a body of the headgear. The headband region includes an outer bond layer at least partially overlapping a lower portion of the base layer, the outer bond layer being fused to the lower portion of the base layer. The headgear region has a fused material region and an unfused material region, the unfused region at least partially defining a connection region for releasably securing a connector to the headgear.

Description

Headgear for securing a patient interface to a patient

Technical Field

The present disclosure relates generally to respiratory patient interfaces, and to headgear for patient interfaces.

Background

In assisted breathing, breathing gas is supplied to a patient through a patient interface via one or more flexible breathing tubes. Such treatments may include, but are not limited to, continuous Positive Airway Pressure (CPAP) treatment (including, for example, VPAP systems and BiPAP systems), non-invasive ventilation (NIV) treatment, and high flow rate treatment.

Various types of respiratory patient interfaces may be used to provide different respiratory therapies. For example, the patient interface can be a nasal catheter, nasal mask, oral or nasal mask, tracheal catheter, or other known type of interface.

Headgear for the respiratory interface may be used to maintain the interface in an operative position on the patient's face. The headgear may include straps or other members that extend between the patient interface and the headgear. Different styles of patient interfaces may require different arrangements of straps and other components, or may require entirely different headgear.

In the description that refers to patent specifications, other external documents, or other sources of information, this is generally for the purpose of providing a context for discussing the disclosed features. Unless explicitly stated otherwise, reference to such external documents should not be construed as an admission that such documents, or such sources of information, are prior art in any jurisdiction, or form part of the common general knowledge in the art.

Disclosure of Invention

Patients may use various types of respiratory interfaces to provide different respiratory therapies. Some patient interfaces may exert pressure on the skin and facial tissue of the wearer when they are held in place for respiratory therapy. This can lead to damage to skin and facial tissue, especially for infants and neonatal patients with delicate skin and facial tissue. Furthermore, in medical applications, respiratory patient interfaces are often used for longer periods of time, such as weeks or months, thereby exacerbating the risk of skin or tissue damage.

For these reasons, it may be desirable to periodically change the type of respiratory interface that the patient wears, thereby changing the area of skin in contact with the interface. It is also desirable to design and position respiratory patient interfaces and other related patient contacting components to minimize or avoid pressure points on the wearer's skin.

In order to be able to provide respiratory therapy to a patient, the interface must be maintained to some extent with respect to the patient's mouth and/or nose. This is particularly important when respiratory therapy involves the provision of a pressurized gas; the interface must be held against the patient's face in a manner that provides a seal, at least to some extent, and prevents leakage of respiratory therapy gas from the perimeter of the interface.

Headgear may be used to hold the interface on the patient's face and to maintain the interface in a position that enables effective treatment. Headgear typically transfers force to the patient's head and so may significantly affect patient comfort. Particularly for infant and neonatal patients, the headgear and associated fixation members can apply forces that may cause skin or tissue damage. It is desirable that the headgear and associated fixation members minimize or avoid any damage to the skin or tissue.

In addition, different patients may have significantly different head and facial anatomies. For example, the head circumference, skull shape, face shape, neck shape, and facial tissue depth are all variable. This is particularly significant in the population of infants and neonatal patients because of the high rate of head growth during the first months of life. It is desirable that the headgear be adjustable or customizable to securely fit each patient in a manner that minimizes or avoids pressure points and the risk of skin or tissue damage.

In infant and neonatal patients, the head and facial anatomy of individual patients may change as the patient grows and develops. It is also desirable that the headgear be adjustable or customizable to securely adapt to the patient to accommodate such growth and development. In addition, infants and neonatal patients may have different or varying respiratory support needs. For example, as the lungs of an infant patient develop, the infant may require a lesser degree or different type of respiratory support. Some patients may experience frustration and require a higher level of respiratory support, requiring a change in treatment type. Headgear for respiratory interfaces is expected to accommodate different types of respiratory interfaces to provide different degrees of respiratory support.

In a first aspect, the present disclosure is directed to a headgear for securing a patient interface to a patient, the headgear including a base layer and a headgear region forming a body of the headgear. The headband region includes an outer bond layer at least partially overlapping a lower portion of the base layer, the outer bond layer being fused to the lower portion of the base layer. The headgear region includes a fused material region and an unfused material region, the unfused region at least partially defining a connection region for releasably securing the connector to the headgear.

The outer bond layer may be fused to the underlying portion of the base layer by Radio Frequency (RF) welding or High Frequency (HF) welding, or ultrasonic welding, vibration welding or friction welding, hot edge welding, hot air welding or induction welding.

The outer tie layer may be fused to the underlying portion of the base layer across a majority of the outer tie layer.

The outer tie layer may be fused to the underlying portion of the base layer about substantially the entire periphery of the outer tie layer.

The outer tie layer may be fused to the underlying portion of the base layer by fusion alone. That is, the layers may be bonded together without any additive material such as stitching or adhesives.

Alternatively, the outer bonding layer may be otherwise attached to the underlying portion of the base layer. For example, the outer bonding layer may be stitched to the base layer or bonded to the base layer via an adhesive. In other embodiments, the outer bond layer or base layer may include a material that is at least partially infused into the material of the other of the outer bond layer or base layer during manufacture to bond the two layers together. For example, the outer tie layer or base layer may include a heat and/or pressure sensitive film for bonding to another layer.

In an embodiment, the outer cover layer covers substantially the entire headband area. Alternatively, the outer cover may cover a majority of the headband area. As a further alternative, the outer bonding layer may cover only a portion of the headband region, such as the front and sides of the headband.

The base layer may comprise a panel, such as a rectangular panel. The panel may be a single layer of material.

The outer tie layer may comprise a single panel material. The panel may be a single layer of material.

The patient interface may be a respiratory interface, such as a respiratory mask or nasal cannula. In an embodiment, the headgear and patient interface are for an infant or neonate.

In an embodiment, the unfused material at least partially defines a connection region for releasably securing to a fastening portion of the patient-facing side of the headgear.

In an embodiment, the fused or unfused regions form a pattern comprising dots and/or stripes. For example, the stripes may be straight, curved, wavy, or angled, and they may be arranged parallel to each other, form a grid, or otherwise oriented. The dots in the pattern may be uniformly or non-uniformly arranged, for example, arranged in rows or grids, radiating from dots, or randomly arranged. Alternatively or additionally, the fused or unfused regions may form text or decorations, or an identified shape such as a logo.

In an embodiment, the unfused regions form raised engagement surfaces, while the fused regions form depressions.

In an embodiment, the headgear area includes an enlarged on-ear area shaped to at least partially cover the patient's ear.

The ear region may be configured to provide a larger engagement surface than other regions of the headgear, such as by having an unfused engagement layer of a larger area, thereby facilitating attachment of the securing member to the headgear to secure the patient interface in place.

The ear region may be configured to provide protection to the patient's ear from contact or friction with other connectors or headgear or interfaces, or related components.

In an embodiment, each of the on-ear regions includes a protrusion defined by a rounded, downwardly convex lower edge of the headband region. Additionally or alternatively, the above-the-ear regions may each comprise a rounded, upwardly projecting upper edge.

The headgear may include a bridge between the two on-ear regions for positioning at or over the nape of the neck of the patient, the bridge being narrower in height than the ear regions.

In an embodiment, the bridge is shaped to reduce pressure on the back of the neck of the patient. The lower edge of the bridge may be higher than the lower edge of the ear region and/or the lower edge of the front portion of the headband. In an embodiment, the bridge region has an arched lower edge that is highest at the center of the bridge region, such that the bridge region is narrowest at its center. In an embodiment, the lower edge of the bridge region abuts the lower edge of the ear region without abrupt transitions.

In an embodiment, the bridge minimizes or prevents creasing of the rear of the headband (such as may occur due to neck bending). This may reduce the risk of the headgear being imprinted into the patient's skin.

A portion of the base layer may extend beyond the lower edge of the bridge portion.

The headband region can also include at least one extension extending from one or both of the upper ear portions. In an embodiment, the headband region includes two extensions, each extending forward from a respective upper ear portion. The extensions may extend forwardly from the respective upper ear portions.

The headband region and the lower portion of the body are configured to wrap around the wearer's head such that opposite ends of the headband overlap and are secured to one another, thereby providing an adjustable fit to accommodate a range of head circumference. The extensions may be configured to at least partially overlap when the headgear is in use.

In an embodiment, the headgear has no internal and external seams.

The headgear may include an adjustment means through which the body of the headgear passes. The adjustment device is selectively slidable along the body of the headgear toward and away from the headgear area to adjust the wearable length of the headgear. The adjustment device is adjustable between a locked state and an adjustment state in which the adjustment device is slidable along the body of the headgear. In the locked state, the adjustment device may resist movement along the body of the headgear.

This ability to adjust the wearable length of the fabric portion of the headgear ensures that the headgear is able to accommodate a range of head sizes with the headgear area correctly located on the patient's ears. For smaller heads, the adjustment device is typically positioned closer to the headband, while for larger heads the adjustment device is farther from the headband. Such adjustment is typically used in conjunction with adjusting the circumferential overlap of the fabric and headband to ensure a comfortable fit of the headgear.

The adjustment means may comprise one or more of the features described below in relation to the third aspect of the utility model.

The headgear may include end-securing means that secure the top edges of the headgear body together at a securing point. The end fixtures may limit travel of the adjustment device along the fabric, thereby preventing unintended removal of the adjustment device from the headgear.

In an embodiment, the headgear is a cap (bonnet). In an embodiment, the end fixture forms a ball (bobble) at the apex of the cap. For larger heads, the adjustment means is typically located closer to the ball, while for smaller heads the adjustment means is farther from the ball.

The top edge of the headgear body may be gathered, pleated, folded or rolled to secure at a securing point. The end fixture preferably encloses and shields the top edge of the headgear body.

The end fixture may comprise two side layers between which the top edge of the headgear body is received. The side layers may be fused to each other, for example near the periphery of the end fixtures.

The end fixture may include an intermediate layer, such as a foam layer. The middle layer may be bonded to the side layer.

The base layer may comprise a fabric. The fabric may be a fabric exhibiting biaxial stretching in the width direction of the headgear. Alternatively, the fabric may comprise a four-way stretch fabric having stretchability in both the machine (vertical) and width directions. For example, the fabric may comprise a knitted fabric. In an embodiment, the fabric handle is soft to the touch or plush for comfort.

The outer engagement layer of the headgear area may include a complete loop (UBL) surface to engage a connector having a complementary hooked surface.

In an embodiment, the fused material regions exhibit a different stretch than the unfused material regions.

The shape and/or orientation and/or location of the fused regions may be selected to reduce or increase stretching of the corresponding regions of the headband in more than one direction.

The fused regions may be shaped to form a substantially continuous path across the respective regions of the headband in directions in which stretching is not desired. Further, the unfused regions may be shaped to form a substantially continuous path from the top edge of the headband to the bottom edge of the headband in directions in which stretching is not desired.

The headband region may include a region having increased stretch in a longitudinal direction of the headband. In some embodiments, regions of increased stretch are provided between the upper ear portions and/or at the sides of one or both of the upper ear portions. There may be no tie layer in the areas of increased stretch.

In the on-ear region of the headband, the fused material region and the unfused material region may be configured to reduce stretch in the longitudinal direction of the headband and/or in a direction that is angled or substantially diagonal (e.g., 45 degrees from the longitudinal direction).

The on-ear region may include a fused material region and an unfused material region.

In another embodiment, the outer bond layer or base layer includes more than one cut and the headband may exhibit different stretch in the area of the headband with the cut compared to the surrounding area.

The shape and/or orientation and/or location of the cuts may be selected to reduce stretching of the corresponding region of the headband in more than one direction as compared to the region without the cuts.

In an embodiment, the base layer is non-rectangular. The top edge of the base layer may be non-linear.

The height of the base layer may be greater at or near the midline of the base layer than at or near the sides of the base layer.

The base layer may have an irregular pentagonal shape with two sides of the pentagon forming the top edge of the base layer.

The two sides forming the top edge of the base layer may meet at a central vertex aligned with the region between the on-ear regions. The two sides may form an angle of about 100 degrees with the side edges of the headgear body.

The top edge of the base layer may include more than one cut, and optionally the cut may be triangular.

The top edge may be shaped such that when the top edge is gathered and secured at the fixation point, the fixation point is substantially in line with the wearer's spine.

In a second aspect, the present disclosure is directed to headgear for securing a patient interface to a patient, the headgear comprising a headgear configured to wrap around and be secured on a wearer's head to provide an adjustable fit. The headband has an on-ear region that at least partially covers the patient's ear, the on-ear region being an enlarged region, and/or the headband includes a rear bridge between the on-ear regions.

The headband region can also include at least one extension extending from one or both of the upper ear portions. In an embodiment, the headband region includes two extensions that each extend forward from a corresponding upper ear portion. The extensions may extend forwardly from the respective upper ear portions. The extensions may be configured to at least partially overlap when the headgear is in use.

In an embodiment, each ear region includes a protrusion defined by a rounded, downwardly convex lower edge of the headband.

The bridge may be narrower in height than the on-the-ear region and configured to be placed at or over the nape of the neck of the patient. The bridge may be shaped to reduce pressure on the back of the neck of the patient. The lower edge of the bridge may be higher than the lower edge of the ear region and/or the lower edge of the front portion of the headband. In an embodiment, the bridge region has an arched lower edge that is highest at the center of the bridge region, such that the bridge region is narrowest at its center. In an embodiment, the lower edge of the bridge region is continuous with the lower edge of the ear region, without abrupt transitions.

In an embodiment, the headgear includes an engagement surface for releasably securing the connector to the headgear.

In an embodiment, the headband includes a plurality of layers with the joining surface provided by an outer layer fused to more than one inner base layer. The outer bonding layer may be fused to the lower portion of the fabric body by Radio Frequency (RF) welding or High Frequency (HF) welding, or ultrasonic welding, vibration welding or friction welding, hot edge welding, hot air welding or induction welding. More than one base layer may comprise fabric.

In embodiments, the outer bonding layer covers substantially the entire headband area, or the outer bonding layer may cover a majority of the headband area. As a further alternative, the outer joint layer may cover only a portion of the headband region, such as the front and sides of the headband.

In an embodiment, the engagement surface is provided by a layer of unbroken endless (UBL) fabric.

The headgear may include a region of fused material and a region of unfused material that at least partially defines a connection region for releasably securing the connector to the headgear.

In an embodiment, the headband includes a fused material region and an unfused material region. The fused material regions may exhibit a different stretchability than the unfused material regions.

The fused regions may be shaped such that they form a substantially continuous path from the top edge of the headband to the bottom edge of the headband in directions in which stretching is not desired.

In the on-ear region of the headband, the fused material region and the unfused material region may be configured to reduce stretch in the longitudinal direction of the headband and/or in a direction 45 degrees from the longitudinal direction.

The headband may include an area with increased stretch in the longitudinal direction of the headband. In some embodiments, regions of increased stretch are provided between the upper ear portions and/or at the sides of one or both of the upper ear portions.

In embodiments, the headband region includes an outer layer and one or more inner layers, wherein the outer layer and/or the inner layer may include one or more incisions, and the headband may exhibit different stretching in the notched area of the headband compared to the surrounding area.

The shape and/or orientation and/or location of the cuts may be selected to reduce stretching of the corresponding region of the headband in more than one direction as compared to regions without cuts.

In an embodiment, the fused or unfused areas form a pattern comprising dots and/or stripes. For example, the stripes may be straight, curved, wavy, or angled, and they may be arranged parallel to each other, form a grid, or otherwise oriented. The dots in the pattern may be uniformly or non-uniformly arranged, for example, arranged in rows or grids, radiating from the dots, or randomly arranged. Alternatively or additionally, the fused or unfused regions may form text or decorations, or a recognized shape such as a logo.

For example, the pattern formed by the fused or unfused regions may include elements having an oriented arrangement, such as "Y" shapes or "V" shapes. Alternatively, they may comprise any other suitable shape.

The size and/or density of the pattern of fused and/or unfused regions may vary along the headband. For example, the pattern of fused and unfused regions may have a higher density pattern at regions where lower stretch is desired. In areas of the headband having a larger surface area, such as the on-the-ear area, the fused and/or unfused areas may be larger than other areas of the headband.

In alternative embodiments, one layer of the headband may include cuts in addition to, or instead of, the fused and unfused regions. The cut-outs may be configured to vary stretching of the headband in different areas and directions.

In an embodiment, the cuts may form a pattern comprising dots and/or stripes. For example, the stripes may be straight, curved, wavy, or angled, and they may be arranged parallel to each other, form a grid, or otherwise oriented. The dots in the pattern may be uniformly or non-uniformly arranged, for example, arranged in rows or grids, radiating from the dots, or randomly arranged. Alternatively or additionally, the fused or unfused regions may form text or decorations, or a recognized shape such as a logo.

The pattern formed by the incisions may include elements having an oriented arrangement. For example, these elements may be "Y" shaped or "V" shaped. Alternatively, they may comprise any other suitable shape, such as diamond, rectangular, oval, circular, bar, and many other shapes are contemplated.

The underside of the headgear that contacts the patient may include a region of increased friction.

The underside of the headgear that contacts the patient may include an adhesive surface. The adhesive surface may include an adhesive tape comprising a polyurethane adhesive film and a polyurethane elastic barrier (e.g., a bemis (tm) tape), neoprene, non-stick silicone, and/or thermoplastic polyurethane. The adhesive surface may comprise an adhesive surface adapted to contact the skin and may be disposed on substantially all of the underside of the headband, a majority of the underside of the headband, or may cover only a portion of the underside of the headband.

In an embodiment, the headgear includes a body panel disposed along a lower portion of the body. The body panel may comprise a layer of fabric. In one embodiment, the headgear includes a cap/cap.

In a third aspect, the present disclosure relates to an adjustment device for adjusting a size of a headgear having a flexible body, the device comprising first and second engagement members, and an intervening hinge region. The first engagement member and the second engagement member may be movable relative to each other to adjust the device between a locked state and a free state, wherein in the locked state the engagement region grips the body of the headgear to secure the device in place on the headgear, and wherein in the free state the grip is sufficiently released to enable the device to move along the fabric of the headgear to adjust the size of the headgear.

In an embodiment, the device is moved from the locked state to the free state by pressing the first and second engagement members towards each other.

The device may comprise finger grips on opposite sides of the device to facilitate pressing the first and second engagement members towards each other. The first and second engagement members may extend inwardly from the respective finger grips.

In an embodiment, the finger grip includes an area that provides increased friction or firm retention. For example, the finger grip may include a textured, contoured, and/or recessed surface, or the finger grip may include a surface material, such as rubber, with increased friction.

In an embodiment, the finger grip is provided by an opposite, outwardly facing surface. The surface is typically the side surface adjacent to the corresponding engagement member. The device may comprise two finger grips, one finger grip being provided on either side of the hinge, for example on opposite sides of the hinge area.

In an embodiment, the hinge region is elastic and the device in the locked state is in a rest state of the device. The device may be biased toward the locked state.

In embodiments, the hinge may be provided by a member or region of the device shaped to have a hinge point. For example, the hinge may be provided by a curved, arcuate or angular member. In an embodiment, the device comprises more than one arch member defining a hinge point at the apex of the arch. In one embodiment, the device includes two arch members. Alternatively, the hinge may be provided by a narrowed or thinned region or member.

In an embodiment, the first engagement member and/or the second engagement member may comprise a hole for receiving the body of the headgear.

The first engagement member and/or the second engagement member may comprise a ring defining a respective aperture. Alternatively, the first engagement member and/or the second engagement member may comprise hooks defining an area for receiving the body of the headgear. The defined aperture or region may be of any suitable shape, such as circular, oval, D-shaped, square or rectangular.

In an embodiment, both the first engagement member and/or the second engagement member define a hole. The holes may be of substantially the same size and shape.

In an embodiment, the first and second engagement members each comprise a hole for receiving the body of the headgear, and wherein in the locked position the holes are misaligned and in the free position the holes are generally aligned to allow the body to slide through the holes.

In an embodiment, the first and second engagement members each comprise a hole for receiving the body of the headgear, and wherein in the free state there is substantially more overlap between the holes of the engagement members than in the locked state.

In an embodiment, in the locked state, the body of the headgear follows a tortuous path through the device. The tortuous path may include more than one bend of flexible body material. In the locked state, the device may provide more resistance to movement along the fabric than in the free state.

In an embodiment, the second engagement member comprises a pair of spaced apart rings defining two respective apertures, and wherein the first engagement member comprises a ring configured to slide between the two second engagement member rings as the first and second engagement members move relative to each other.

In an embodiment, the loops of the second engagement member are parallel and the spacing between the loops of the second engagement member is equal to or greater than the thickness of the loops of the first engagement member.

In an embodiment, the guide hole receives and slides along the fabric of the headgear. The hinge may be provided at a side of the guide hole.

In an embodiment, the guide hole is provided between the two hinge side members. In an embodiment, the hinge side member extends between the finger grips. The hinge member may comprise two parallel arcuate members, the space between the hinge members defining the guide bore.

In an embodiment, the hinge axis of the device extends through the guide bore. In an embodiment, in the free position of the device, the guide holes are generally aligned with the engagement member holes, allowing the fabric to slide through the device following a generally straight path.

In an embodiment, the device is integrally formed. That is, the hinge and the first and second engaging members are integrally formed.

In embodiments, the device comprises one or more of acetal, nylon, suitable polymers, for example thermoplastic polymers such as Acrylonitrile Butadiene Styrene (ABS), polycarbonate, or polycarbonate/thermoplastic polymer blends.

In a fourth aspect, the present disclosure relates to an adjustable headgear system comprising a headgear according to the first or second aspect and an adjustment device according to the third aspect, wherein the adjustment device is configured to receive the body of the headgear and slide along the body of the headgear towards and away from the headgear area, thereby adjusting the dimension of the headgear in a vertical direction.

The headgear may have any one or more of the features described above with respect to the first and/or second aspects.

The adjustment means may have any one or more of the features described above in relation to the third aspect.

In a fifth aspect, the present disclosure relates to an adjustable headgear system comprising a headgear according to the first or second aspect and an adjustment device, wherein the adjustment device comprises a flexible body having first and second ends and first and second sides defining an aperture configured to receive and slide along the body of the headgear. The first engagement end and the second engagement end are movable relative to each other to adjust the device between a locked state in which the device grips the body of the headgear in the aperture to secure the device in position relative to the headgear, and a released state in which the grip of the device is sufficiently released such that the device can move along the body of the headgear toward and away from the headgear area, thereby adjusting the size of the headgear in a vertical direction.

In a sixth aspect, the present disclosure is directed to a patient interface and headgear assembly that includes a patient interface assembly, a headgear, and a side connector member for coupling the patient interface assembly to the headgear. The side connector includes a patient interface connection point for coupling to a side of the patient interface assembly, and spaced apart upper and lower connection points for coupling to the headgear.

The assembly may include two side connector members. In an embodiment, the side connector member is flexible.

The side connector member may be narrower at a first end for attachment to a patient interface assembly and wider at an opposite second end for connection to a headgear. The spaced apart upper and lower connection points may be proximate the second end and the patient interface connection point may be proximate the first end.

In an embodiment, the flexible fixation member is Y-shaped. For example, the side connector members may be wishbone-shaped.

In an embodiment, the side connector member includes a patient attachment portion bifurcated into an upper headgear connection portion and a lower headgear connection portion. In alternative embodiments, the fixation member may be generally triangular or may have a fan shape. The member may include more than one cut.

In an embodiment, the side connector member comprises a plurality of layers, at least one of the plurality of layers being a fabric layer.

In an embodiment, the flexible side connector member includes an outer fabric layer, an inner patient contacting fabric layer, and an intermediate reinforcing layer sandwiched between the fabric layers.

The reinforcing layer may comprise a polymer layer. For example, the reinforcing layer may comprise a nylon sheet.

The reinforcing layer may be bonded to at least one of the fabric layers. The reinforcing layer may be fused to at least one of the fabric layers, for example using Radio Frequency (RF) welding or High Frequency (HF) welding, or ultrasonic welding, vibration welding or friction welding, hot edge welding, hot air welding, or induction welding.

In one embodiment, the reinforcement layer is smaller than the outer and inner fabric layers such that the lower fabric forms a boundary around the perimeter of the reinforcement layer. The upper and lower fabric layers may be bonded together near the border region, for example by RF welding.

In an embodiment, the outer fabric layer comprises a complete endless (UBL) fabric.

In an embodiment, the outer fabric layer is smaller than the inner fabric layer but larger than the stiffening layer such that the inner fabric layer creates a single layer perimeter in the vicinity of the device.

In an embodiment, the inner fabric layer is a comfort layer and is sized such that an edge of the inner fabric layer extends beyond the perimeter of the reinforcing layer.

In an embodiment, the inner fabric layer also extends beyond the perimeter of the outer fabric layer, thereby forming a soft, comfortable edge around the device.

The layers of the side connector members may be fused together. For example, the layers of the side connector may be fused together using one or more of Radio Frequency (RF) welding, high frequency (RF) welding, ultrasonic welding, vibration welding or friction welding, hot edge welding, hot air welding or induction welding.

In an embodiment, the side connector member includes a region of fused material and a region of unfused material, the unfused material at least partially defining a connection region for releasably securing the connector to the headgear.

In an embodiment, the contrast between the fused and unfused areas is patterned to indicate the correct orientation of the connector.

In an embodiment, the fused or unfused areas form a pattern comprising dots and/or stripes and/or shapes. For example, the stripes may be straight, curved, wavy, or angled, and they may be arranged parallel to each other, form a grid, or otherwise oriented. The dots in the pattern may be uniformly or non-uniformly arranged, for example, arranged in rows or grids, radiating from the dots, or randomly arranged. Alternatively or additionally, the fused or unfused regions may form text or decorations or a recognized shape such as a logo.

In an embodiment, the pattern is visible on the outer surface of the connector. The pattern may correspond to a pattern on the connection region of the headgear.

In an embodiment, the patient interface connection point, the upper headgear connection point and the lower headgear connection point comprise hook connectors or loop connectors.

In an embodiment, the patient interface connection point is disposed on an outer surface of the connector, and the upper headgear connection point and the lower headgear connection point are disposed on an inner surface of the connector.

In an embodiment, the assembly includes a side arm coupling the flexible connector to the patient interface. Additionally or alternatively, the assembly may comprise two lateral side connector members arranged laterally, and two respective side arms for coupling the lateral side connector members to the patient interface. Additionally or alternatively, the assembly may include a chin strap for coupling to the headgear.

In an embodiment, the headgear may be the headgear described above with respect to the first aspect or the second aspect.

In a seventh aspect, the present disclosure is directed to a patient interface assembly including a patient interface body, a frame holding the patient interface body, and a pair of side arms. The first end of each side arm is releasably connected to the front of the frame at a respective connection region of the frame, and each connection region is located between a midpoint of the frame and a respective side of the frame.

In an embodiment, the two side arms are separate members that are individually attachable to and removable from the frame.

In an embodiment, each frame attachment region is spaced from a midpoint of the frame toward a respective side of the frame.

In an embodiment, each frame connection region is disposed closer to a respective side of the frame than to a midpoint of the frame.

In an embodiment, each frame connection region comprises more than one male connector for receipt by a respective hole or recess in a respective side arm.

In an embodiment, each frame attachment region includes a first projection having an enlarged end for receipt through an aperture in the corresponding side arm.

The first projection may include a post with the enlarged end at the top of the post. In an embodiment, the enlarged end of the first projection is configured to prevent the side arm from being unintentionally separated from the frame by resisting pull-off of the side arm. In an embodiment, the enlarged ends are not centered on the struts, but instead project toward the respective sides of the frame.

In an embodiment, the enlarged end of the projection has an area larger than the cross section of the receiving hole in the corresponding side arm. For example, in one embodiment, the enlarged end has an area at least twice the cross-sectional area of the strut. The cross-sectional area of the struts may substantially correspond to the cross-sectional area of the respective arm apertures.

In an embodiment, the hole in each arm for receiving the first projection has a recess shaped to receive the enlarged end of the projection. In an embodiment, a top surface of the enlarged end of the projection is substantially flush with a top surface of the arm when the enlarged end is located in the recess.

In an embodiment, the first projection is disposed closer to a respective side of the frame than a midpoint of the frame.

In an embodiment, each frame connection region comprises a second projection in the form of a hook-like connector for receipt in a complementary recess in the respective side arm. The connection between the hook connector and the side arm may be hidden by the front surface of the side arm.

In an embodiment, the hook connector includes a post having a hook portion extending from a top of the post at 90 degrees to the post. In an embodiment, the hook is substantially parallel to the surface of the frame. In an embodiment, the hook extends towards a midline of the frame.

In an embodiment, the complementary recess in the respective side arm for receiving the hook connector comprises an L-shaped blind hole.

In an embodiment, the top surface of the enlarged end of the hook connector is located below the top surface of the arm when the arm is coupled to the frame.

In an embodiment, the first end of the side arm comprises a flexible, resilient material for being drawn in and/or pressed in engagement with the frame connector.

In an embodiment, each arm is assembled to the frame by placing the hook-like connector in a complementary recess, and then pulling the flexible arm downward over the first projection until the enlarged portion of the first projection is placed against the surface of the arm. In the coupled configuration, the lower surface of the arm may contact the outer surface of the frame.

In embodiments, the flexible arms may include one or more of silicone, thermoplastic elastomer, or other suitable plastics (such as PET, HDPE, polypropylene, resin, polymer, or combination materials). In one embodiment, the flexible arm comprises a thermoplastic elastomer.

In alternative embodiments, the frame may include only a single tab for engaging each arm, the single tab having a post and an enlarged end. Each enlarged end may protrude beyond the respective post toward the midline of the frame to provide a hook.

In an embodiment, each strut has a generally triangular cross-section, with the apex of the triangle pointing toward the respective side of the frame. In an embodiment, the enlarged end is rectangular.

In an embodiment, the arm comprises a rigid end for attachment to a single connector. Preferably, the rigid end does not extend past the sides of the frame when the arm is engaged with the frame.

In an embodiment, the first ends of the side arms each comprise a rigid clip that engages the corresponding frame projection by a two-stage movement of the slide and snap.

In an embodiment, the rigid end or clip comprises a hard plastic, such as polypropylene. In embodiments, the flexible arms may include one or more of silicone, thermoplastic elastomer, or other suitable plastics (such as PET, HDPE, polypropylene, resin, polymer, or combination materials). In one embodiment, the flexible arm includes a thermoplastic elastomer bonded to a rigid end or clip.

In an embodiment, the body of the flexible arm is over-molded to the end or clip.

In an embodiment, the second end of each arm includes a connection surface for engaging a headgear or connector for securing the interface assembly to the patient. The connection surface may comprise a hook or loop surface.

In an embodiment, the connection surface is provided by a pad comprising an overmolded annular pad. The connection pad may be integral with the body of the flexible arm.

In an embodiment, each side arm comprises an opening between the first and second ends of the arm, said opening providing visibility of more than one element at a respective side of the frame.

In an embodiment, an assembly includes a patient interface body for coupling to a frame. The side of the patient interface may include one or more features that are at least partially visible through the opening in the side arm. In one embodiment, the assembly includes an O-ring on one side of the patient interface. The O-ring may be colored to indicate the size or other features of the patient interface.

The patient interface body may have one or more features described in relation to the seventh or ninth aspect.

In an embodiment, the assembly comprises a connector for coupling the frame to the air supply conduit or the air exhaust conduit. The assembly may include two connectors for connection to each side of the frame. In an embodiment, each connector or at least a portion of each connector is visible through an opening in the or each side arm. The connector may be a collar as described in relation to the twelfth aspect.

In an embodiment, each side arm includes an opening between the first and second ends of the arm that allows a conduit for air supply to or air removal from the frame to pass therethrough.

In an eighth aspect, the present disclosure is directed to an interface body for a patient interface assembly, the interface body comprising a patient contact portion and a coupling portion for coupling to a frame. The coupling includes a top reinforcing region and a bottom reinforcing region, each reinforcing region having a convex coupling wall to seat against a complementary surface of the frame, and wherein the convex coupling wall defines a recess for engagement with the frame.

In an embodiment, the interface body comprises a respiratory mask or nasal cannula.

In an embodiment, the interface body is for an infant or a neonate. The interface body may include a sealed or unsealed type of interface.

In an embodiment, the thickness of the reinforcing region, and thus the height of the coupling wall, varies across the width of the interface body. The height of the coupling wall may be greater toward the sides of the interface body and smaller toward the midline of the interface body.

In an embodiment, each reinforcing region includes a curved outer surface.

In an embodiment, the interface body comprises a breathing chamber, and wherein the breathing chamber is generally cylindrical proximal of the interface body in cross-section and is generally D-shaped at a midline of the interface body.

In a ninth aspect, the present disclosure relates to a patient interface assembly comprising an interface body as described above with respect to the seventh aspect and a frame comprising a coupling portion for engaging with the coupling portion of the interface body, wherein the coupling portion of the frame comprises a pair of opposing concave surfaces for engaging the coupling wall of the interface body.

When the interface body is engaged with the frame, the coupling wall of the interface body may protrude above the coupling portion of the frame.

In an embodiment, each coupling wall protrudes above the frame coupling a first distance at a side edge of the coupling wall and a second distance above the frame coupling at a midpoint of the coupling wall, wherein the first distance is greater than the second distance.

In an embodiment, the cross-sectional profile of the frame coupling varies in shape along the coupling.

In an embodiment, the cross-sectional profile has a thickness that varies across the frame coupling.

In an embodiment, the thickness of the cross-sectional profile is greater toward a midline of the interface body and smaller toward a side of the interface body.

In a tenth aspect, the present disclosure relates to an interface body for a patient interface, the interface body comprising a nasal cannula having two nasal prongs, wherein a wall of the interface body has a region of reduced thickness in a region of a person for positioning adjacent to the person of the patient in use.

In an embodiment, the region of the person is configured to provide increased compliance compared to at least one adjacent region of the patient interface, and thereby reduce stress in the patient person.

In an embodiment, the region of the person is located below the base of the nasal prongs.

In an embodiment, the region in the person is a substantially oval region.

In an embodiment, the region of the person extends generally across the interface body.

In an embodiment, the wall thickness of the region in the person is substantially constant.

In an embodiment, the region in the person has a wall thickness between about 0.2mm and about 1.0 mm. In one embodiment, the region in the person has a wall thickness of between about 0.4mm and about 0.6 mm. In one embodiment, the region in the person has a wall thickness of about 0.5 mm. In some embodiments, the wall thickness may vary across the area in the person.

The interface body may also include a flex region adjacent the base of the nasal prongs, wherein the wall of the interface body in the flex region has a reduced thickness compared to the region of the person.

The flex region may have a wall thickness of between about 0.1mm and about 1.0 mm. In one embodiment, the flex region has a wall thickness of about 0.3 mm.

In an embodiment, the flex region has a generally kidney shape.

In an embodiment, the wall of the interface body comprises four regions of different wall thickness: a nasal prong having a first wall thickness, a flex region having a second wall thickness, a person-in-person region having a third wall thickness, and a remaining body having a fourth wall thickness.

In an embodiment, the boundary of the flex region is shared by the regions in the person. I.e. the flex region and the region in the person are directly adjacent/contiguous.

In an embodiment, a septal relief recess (septal relief recess) is provided between the two nasal prongs. The recess may be recessed beyond the base of the nasal prongs and/or the front surface of the interface body at the sides of the nasal prongs. In an embodiment, the recess is sized to prevent or minimize contact between the nasal septum and the patient interface when the interface is in use. For example, the recess may be provided by a groove, depression or channel.

In embodiments, the septal recess has a depth of between about 1.5mm and about 2.5mm, preferably between about 1.8mm and about 2.2mm, from the base of the nasal prongs. In one embodiment, the septal recess has a depth of about 1.9mm from the base of the nasal prongs. In another embodiment, the septal recess has a depth of about 2.2mm from the base of the nasal prongs. The patient interface may be a respiratory interface for an infant or neonate.

In an eleventh aspect, the present disclosure is directed to an assembly for a patient interface that includes a frame holding an interface body, and a stabilizing arm connectable to the frame and connectable to a headgear. The stabilizing arm includes a flexible portion that allows the arm to flex away from the patient or headgear during assembly.

In an embodiment, the flexible portion comprises a region of the arm having a reduced wall thickness.

In an embodiment, the thickness of the arm transitions from a reduced wall thickness at the flexible portion to a greater thickness at an adjacent portion of the arm.

In an embodiment, wherein the main length of the stabilizing arm is substantially rigid. In an embodiment, the flexible portion is positioned proximate to one end of the rigid portion and is positioned proximate to the first end of the arm. In an embodiment, the substantially rigid length of the stabilizing arm has a constant thickness.

In an embodiment, the stabilizing arm includes a connection feature for connection to the frame proximate a first end of the arm, and the headgear connector is disposed at an opposite second end of the arm; wherein the headgear connector includes a pad having a hooked or looped surface.

In one embodiment, the pad has an annular surface. The arms and pads may be configured such that the lower ends of the pads overhang the lower edge of the headgear. The annular surface may reduce the risk of skin damage.

The pad may be of any suitable shape, such as oval or circular. In one embodiment, the pad is oval in shape with the long axis of the pad aligned with the longitudinal axis of the arm.

In an embodiment, the headgear connector pad is hinged to the stabilization arm.

In an embodiment, the headgear connector pad is pivotally attached to the second end of the arm about a rotational axis perpendicular to the longitudinal axis of the arm. The pivot shaft may comprise a pin. In one embodiment, the pad is oval and the pivot axis is parallel to the short axis of the pad.

In an embodiment, the pivot axis is retracted back from the bottom edge between about one-fourth and one-third of the length of the support pad.

In an embodiment, the connector pad is a flexible member. For example, the connector pad may comprise a thermoplastic elastomer.

In an embodiment, the stabilizing arm comprises a connection feature for connection to the frame, and wherein the flexible portion is proximate the connection feature.

In an embodiment, the stabilizing arm is transparent or translucent.

In an embodiment, the stabilizing arm includes a connection feature for connection to the frame, and the stabilizing arm may be configured to have a mounted position substantially aligned with a midline of the frame, and a connected/disconnected position at an angle to the midline of the frame.

The connecting features of the stabilizing arm may comprise one or more of the features described below in relation to the eleventh aspect.

The frame may comprise one or more features for engagement with the stabilizing arm, as described below in relation to the eleventh aspect.

In an embodiment, an assembly includes a patient interface body for coupling to a frame. The patient interface body may have one or more of the features described in relation to the seventh or ninth aspect.

In a twelfth aspect, the present disclosure is directed to an assembly for a patient interface, the assembly comprising a frame holding an interface body, and a stabilizing arm connectable to the frame and connectable to a headgear; wherein the stabilizing arm has a mounted position generally aligned with the midline of the frame, and an attached/detached position at an angle to the midline of the frame.

The connect/disconnect position may be between about 30 degrees and about 90 degrees, such as between about 30 degrees and about 60 degrees, or between about 40 degrees and about 50 degrees, from the midline of the frame. In an embodiment, the connect/disconnect position is about 45 degrees from the midline of the frame.

In an embodiment, the frame comprises a protrusion for coupling the stabilizing arm to the frame, and the stabilizing arm comprises a connection feature near the first end of the arm for connecting to the frame protrusion, wherein the connection feature is configured to receive the protrusion.

In an embodiment, the protrusion comprises a post having an enlarged head at an end of the post. The enlarged head may be generally square. In an embodiment, the enlarged head includes four protrusions protruding laterally from the top of the post. The protrusions may form square heads.

In an embodiment, the connection feature comprises a hole. On the lower surface of the stabilizing arm, the edges of the hole may be rounded to create a gradual transition from the lower surface to the hole.

In an embodiment, the lower surface of the stabilizing arm is a patient facing surface of the stabilizing arm.

In an embodiment, the aperture is generally square in shape and oriented such that a diagonal of the square is substantially aligned with a midline of the frame in the installed position.

In an embodiment, the top surface of the stabilizing arm comprises recesses positioned at respective sides of the square aperture, wherein the recesses are positioned to receive respective portions of the frame protrusions in the installed position.

In an embodiment, the recess comprises four generally triangular recesses to receive respective corners of the square head of the protrusion.

In an embodiment, in the connected/disconnected position, the head of the projection is aligned with the connection hole of the arm such that the hole fits over the head of the projection; and wherein in the installed position the head of the projection is seated in the recess, the post of the projection extending through the aperture.

In an embodiment, movement of the protrusion into the recess produces tactile feedback when the arm is moved to its installed position.

The lower surface of the enlarged head of the projection is movable across the top surface of the arm between the connected/disconnected and installed positions.

In an embodiment, the lower surface or side of the enlarged end interferes with the angle of the recess as the stabilizing arm moves between the connected/disconnected position and the installed position, creating a resistance to movement.

In an embodiment, the projection has a height substantially the same as the thickness of the first end of the arm such that in the installed position, a top surface of the enlarged end of the projection is substantially flush with the top surface of the arm and a lower surface of the first end of the arm is in contact with a surface of the frame.

In an embodiment, the frame projection is located on the front face of the frame at a midpoint of the frame.

In an embodiment, the stabilizing arm comprises a headgear connector at the second end of the arm, wherein the headgear connector comprises a pad having a hooked or looped surface. The headgear connector pads may be hinged to the stabilization arms.

In an embodiment, the stabilizing arm may include one or more of the features described above with respect to the tenth embodiment.

In an embodiment in which the stabilizing arm is attached to the frame, the connection hole at the first end of the arm is placed on the frame protrusion.

In a thirteenth aspect, the present disclosure is directed to an assembly for a patient interface that includes a frame holding an interface body, a conduit, and a collar connecting the conduit to the frame. The collar receives an end of the catheter, the length of the end of the catheter being fixed to the collar.

In an embodiment, the collar is coupled to the frame.

In an embodiment, the collar is over-molded to the frame.

In an embodiment, the connection between the frame and the collar is a permanent connection, and the connection between the collar and the catheter is a permanent connection.

In an embodiment, the length of the end of the conduit attached to the collar is greater than 1mm.

In an embodiment, the length of the conduit end attached to the collar is less than the length of the conduit end received in the conduit, such that there is an unbound conduit length within the collar.

In an embodiment, the length of the end of the catheter attached to the collar is at the frame end of the catheter.

In an embodiment, the length of the catheter end of the catheter attached to the collar is at the tip of the catheter.

In an embodiment, the collar comprises a flexible body.

In an embodiment, the collar comprises one or more of thermoplastic, polyurethane and/or silicone.

In a fourteenth aspect, the present disclosure is directed to a patient interface connector for coupling a patient interface assembly to a headgear, the connector having an interface attachment point on an outward facing surface of the connector proximate a first end of the connector, and a connection point on a patient facing surface of the connector for coupling to the headgear; wherein the width of the connector increases from the first end to the second end. The connector includes more than one reinforcing member, reinforcing layer and/or reinforcing region.

In an embodiment, the connector has two spaced apart headgear attachment points on a patient facing surface of the connector for connection to a headgear.

In an embodiment, the connector is flexible.

The peripheral edge of the connector may include a curved portion and may be devoid of an angular corner.

In an embodiment, the side connector member is Y-shaped. The bifurcation point of the Y-shape may be located closer to the second end than to the first end.

In an embodiment, the stiffening member is configured to prevent buckling or twisting of the member in use.

The stiffening member or feature may be positioned at least across the intermediate region of the connector and may be configured to prevent buckling or twisting of the intermediate region in use.

In an embodiment, the patient interface includes a relatively rigid reinforcing layer and a comfort layer, wherein the comfort layer is located on a patient facing side of the connector. The comfort layer may be overmolded or co-molded with the reinforcement layer.

The comfort layer may extend around the peripheral edge of the connector. In addition, the comfort layer may be rounded or tapered at the perimeter.

The comfort layer may extend over the reinforcement layer to form a lip at the periphery of the connector.

The comfort layer may be shaped to form a compliant, compressible edge of the connector. Additionally, the compressible edge may be configured to deform by deflection or folding to conform to the contours of the wearer's face.

The comfort layer may include fins and/or recesses adjacent the edges of the connector.

The stiffening layer may be more rigid than the comfort layer.

The thickness of the fins may be selected to have sufficient strength to be self-supporting and/or to prevent the fins from being inadvertently deflected toward the wearer. The thickness of the fins may also be selected such that the fins do not form pressure points and/or hard edges.

The reinforcing layer may comprise a thermoplastic material, for example polypropylene. The thermoplastic material may be inelastic.

The stiffening layer may include more than one feature to enhance rigidity in a desired direction and/or to increase flexibility in a desired direction. In some embodiments, the reinforcing layer includes cuts, score patterns, engravings, thinned regions, or other features to selectively reduce the thickness of the reinforcing layer at defined points. The cuts may comprise slits or slots, for example, a series of straight, curved or shaped slots. The slit or slots may be oriented in a generally transverse direction of the connector to enhance the flexibility and bending of the connector around the patient's face. The cuts or other features may extend to the periphery of the reinforcing layer or may terminate at points spaced inwardly from the periphery.

The comfort layer may comprise an elastomeric material, such as silicone.

In one embodiment, the comfort layer extends away from the patient-facing surface at an angle between 0 and about 90 degrees.

In an embodiment, the side connector members are curved to follow or conform to the facial contours of the wearer.

The patient facing surface of the connector may have a concave curvature.

In an embodiment, the patient interface connector includes more than one reinforced region including regions of increased material thickness.

The reinforcing region may comprise an outward projection.

The patient-facing surface of the connector may be substantially smooth and/or planar.

In an embodiment, the patient interface connector includes a hinge region between the first end of the connector and the bifurcation point.

In an embodiment, the patient interface connector includes a hinge region between the stiffening region and the first end.

The hinge region may include a region of reduced material thickness. The connector may be configured such that bending of the connector occurs at the hinge rather than elsewhere in the body of the connector.

In an embodiment, the force required to flex the connector about the hinge region is less than the force required to detach the first attachment point from the patient interface.

The hinge may be configured so as to allow the connector to adapt to the facial contours.

The interface attachment point may comprise a mechanical fastener. For example, the interface attachment points may include hook or eye-like connector pads for engaging with complementary hook or eye-like connector surfaces on the patient interface or frame of the patient interface. The headgear attachment points may include hook or eye connector pads for engagement with complementary hook or eye connector surfaces on the headgear. The connector may include a recess for receiving the hook connector pad and/or the eye connector pad.

In a fifteenth aspect, the present disclosure is directed to a component for use with a patient interface assembly and/or headgear, comprising a relatively rigid reinforcing layer, and a comfort layer, wherein the comfort layer is located on a patient facing side of the component.

In an embodiment, the comfort layer is overmolded or co-molded with the reinforcement layer.

The comfort layer may extend around the peripheral edge of the reinforcing layer. The comfort layer may be rounded or tapered at its perimeter.

In an embodiment, the edge of the comfort layer extends above the reinforcement layer, forming a lip around the periphery of the component.

The comfort layer may be shaped to form a compliant, compressible edge of the component. The compressible edge may be configured to deform by deflection or folding to conform to the contours of the wearer's face.

In an embodiment, the comfort layer comprises fins and/or recesses adjacent to the edges of the component.

The stiffening layer may be more rigid than the comfort layer.

The reinforcing layer comprises a thermoplastic material, for example polypropylene. The thermoplastic material may be inelastic.

The comfort layer may comprise an elastomeric material, such as silicone.

In a sixteenth aspect, the present disclosure is directed to a patient interface and headgear assembly including a patient interface assembly; a headgear; and

the patient interface connector according to the fourteenth aspect for coupling the patient interface assembly to the headgear, wherein a first one of the two attachment points of the patient interface connector comprises a patient interface connection point for coupling to a side of the patient interface assembly, and a second one of the two attachment points of the patient interface connector comprises a connection point for coupling to the headgear. The width of the connector increases from the first end to the second end of the connector.

In an embodiment, there are two spaced apart headgear attachment points on the patient facing surface of the connector for connection to the headgear.

In embodiments, the patient interface connection point, the upper headgear connection point and the lower headgear connection point may comprise hook or loop connectors.

In an embodiment, the assembly further comprises a side arm coupling the connector to the patient interface.

In an embodiment, the assembly comprises two patient interface connectors according to the fourteenth aspect arranged laterally, and two respective side arms for coupling the connectors to the patient interface.

In an embodiment, the assembly further comprises a chin strap for coupling to the headgear.

The patient interface may be a respiratory interface, such as a respiratory mask or nasal cannula. In an embodiment, the headgear and patient interface are for an infant or neonate. In an embodiment, the patient interface is a sealed interface.

In a seventeenth aspect, the present disclosure is directed to an adjustment device for grasping a flexible material; the device has a flexible body having a first end and a second end and defining a first sidewall and a second sidewall for receiving material, wherein the first end and the second end are movable relative to each other to adjust the device between a locked state and a free state; wherein in the locked state the device clamps the material in the aperture to secure the device in position relative to the material, and wherein in the free state the grip of the device is released sufficiently to enable the device to move along the material, thereby adjusting the position of the device relative to the material.

In an embodiment, the device is moved from the locked state to the free state by pressing the first and second ends of the device towards each other. The device may include finger grips on the first and second ends of the device to facilitate pressing the first and second ends toward each other.

In an embodiment, in the locked state to the released state, the first sidewall and the second sidewall are positioned proximate to each other.

In an embodiment, the first and second sidewalls each have an inner surface that is convex towards the aperture. The inner surfaces of the first and second sidewalls may include more than one gripping feature to enhance the gripping strength with the received material.

In one embodiment, the inner surfaces of the first and second sidewalls include oppositely projecting, complementary steps. In the locked state, the step may push the received material towards the bent state.

In an embodiment, the aperture narrows at or near the midline of the device. The aperture may include a constricted region at or near the midline of the device. In one embodiment, the aperture has an hourglass-like cross-sectional shape.

In an embodiment, the device body comprises an elastic material. The side walls may comprise an elastomeric material. In an embodiment, in the rest state, the device is in a locked state. Additionally, or alternatively, the device is biased toward the locked state.

In an embodiment, the device includes a hinge region where the side walls engage the ends. The hinge region may be elastic.

In an embodiment, the length of the device is smaller at the midline of the device than at the ends of the device. The device may include a concave curvature on the base and/or top of the device.

In an embodiment, the first and second ends of the device may include finger grips to assist the user in holding the device. For example, the finger grip may include a protrusion or a depression.

In an eighteenth aspect, the present disclosure is directed to a chin strap for a patient interface and/or headgear assembly. The chin strap includes a first portion and a second portion having two arms. The chin strap is configured to be wrapped around the patient's head, and the arms of the chin strap engage the connector on the first portion of the strap.

The chin strap may include a first end and a second end, and a bifurcation point between the first end and the second end from which two arms extend to the second end.

In an embodiment, the connector is located at or adjacent to the first end of the strap.

In an embodiment, the chin strap includes two or more layers of material that are fused or otherwise attached together. Alternatively, the chin strap may include only a single layer of material.

The chin strap may include a layer of loop material. The loop material may provide an engagement surface on the arm through an unfused region of the material. The annular material layer may be a patient facing layer. In some embodiments that include more than two layers of material fused together, the engagement surface may be provided on the arm by an unfused region of material.

The chin strap may include a constriction region adjacent the bifurcation and/or a notch between the two fixation arms at the bifurcation.

In an embodiment, the arms are shaped to wrap around either side of the headgear adjustment member or are shaped to accommodate another feature of the patient's headgear. For example, the spacing between the arms may be greater toward the bifurcation point or at the point where the arms will extend around the adjustment member and smaller at the second end of the chin strap. The shape of the arms may alternatively or additionally assist in adapting to the shape and contour of the patient's head, which may assist in stabilizing the chin strap when secured to the patient.

The utility model may also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, and any or all combinations of any two or more of said parts, elements or features. If specific integers are mentioned herein which have known equivalents in the art to which this utility model pertains, then such known equivalents are deemed to be incorporated herein as if individually set forth.

The term "comprising" as used in this specification and claims means "consisting at least in part of. When interpreting statements in this specification and claims which include the term 'comprising', other features can be present in addition to those features prefaced by the term. Related terms such as 'include' and 'comprised' will be interpreted in a similar manner.

It is intended that reference to a numerical range disclosed herein (e.g., 1 to 10) also includes reference to all of the rational numbers within that range as well as to any of the rational numbers within that range (e.g., 1 to 6, 1.5 to 5.5, and 3.1 to 10). Accordingly, all subranges from all ranges explicitly disclosed herein are explicitly disclosed herein.

The term '(s)' following a noun as used herein refers to the plural and/or singular form of the noun. The term 'and/or' as used herein means 'and' or both, where the context permits.

Drawings

Embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which:

fig. 1 illustrates an example of an exemplary respiratory system in which embodiments of a patient interface assembly may be used.

Fig. 2 illustrates an example of another exemplary system in which embodiments of a patient interface may be used.

Fig. 3A and 3B illustrate the position of an example embodiment headgear and patient interface assembly on a neonatal patient, wherein fig. 3A illustrates a system having a nasal mask with stabilizing arms, and fig. 3B illustrates a system having nasal catheters;

FIG. 4 is a top view of an assembly for a patient interface having a frame, an attachment conduit, and a connector;

FIG. 5 is a top view of an exemplary embodiment frame for a patient interface assembly, the front of the frame having a projection for coupling a stabilizing member;

FIG. 6 is a rear view of the frame of FIG. 5, showing the patient facing side of the frame;

FIG. 7 is a front view of the frame of FIGS. 5 and 6;

fig. 8 is a perspective cross-sectional view of the frame of fig. 5-7 with the projections hidden, showing the cross-sectional profile of the body member of the frame;

FIG. 9 is a top view similar to FIG. 5, but showing a section line for FIG. 10;

FIG. 10 is a cross-sectional view taken through the body member of the frame, wherein (i) is a cross-sectional view through line (i) of FIG. 9; (ii) is a cross-sectional view through line (ii) of fig. 9; (iii) is a cross-sectional view through line (iii) of fig. 9; (iv) is a cross-sectional view through line (iv) of fig. 9; (v) is a cross-sectional view through line (v) of fig. 9; (vi) is a cross-sectional view through line (vi) of fig. 9; (vii) is a cross-sectional view through line (vii) of fig. 9; and (viii) is a cross-sectional view through line (viii) of fig. 9;

FIG. 11 is a front perspective view of an embodiment patient interface body in the form of a nasal catheter;

FIG. 12 is a front perspective view of an embodiment patient interface body in the form of a nasal mask;

FIG. 13 is a perspective view of the mask of FIG. 12 showing different wall thicknesses of different regions of the mask;

fig. 14 is a top cross-sectional view taken through the plane of the top of the mask of fig. 12 and 13, showing the wall profile and shape of the patient contacting portion of the mask;

fig. 15 is a side cross-section taken through the midline of the mask of fig. 12 and 13, showing the wall profile and shape of the patient contacting portion of the mask;

FIG. 16 is a top cross-sectional view corresponding to FIG. 14, illustrating movement of the mask (dashed lines) when a force is applied to a patient contacting surface on one side of the mask;

FIG. 17 is a side cross-sectional view corresponding to FIG. 15, illustrating movement of the mask (dashed lines) when a force is applied to a patient contacting surface on one side of the mask;

FIG. 18 is a top cross-sectional view taken through the plane of the top of the mask of FIGS. 12 and 13, showing the mask being worn by a neonatal patient, and also showing a prior art mask for comparison;

fig. 19 is a bottom view showing the mask of fig. 12-17 being worn by a neonate patient;

Fig. 20 is a rear view of the mask of fig. 12-17 illustrating the shape of the patient contact seal;

FIG. 21 is a top rear view of the nasal catheter of FIG. 11, indicating the location of the flex region around the base of the nasal prongs;

FIG. 22 is a rear underside view of the nasal catheter of FIG. 21 illustrating the location of the contact area in a person;

FIG. 23 is a view corresponding to FIG. 22, illustrating the wall thickness of different regions of the nasal catheter body;

FIG. 24 is a front cross-sectional perspective view of the nasal catheter of FIGS. 21-23 illustrating the shape and location of the contact area in a person;

FIG. 25 is a view of the nasal catheter of FIGS. 21-24 illustrating the shape of the septum relief feature between the prongs;

fig. 26 is a front view of the nasal catheter of fig. 21-25;

FIGS. 27A and 27B are detailed elevation views of the septal relief of FIG. 23, wherein FIG. 27A illustrates features of a first size of a patient interface and FIG. 27B illustrates features for an exemplary larger size patient interface;

fig. 28A and 28B are bottom views of the nasal catheter of fig. 21-25, wherein fig. 28A illustrates features for identifying a first size of the nasal catheter and fig. 28B illustrates features for identifying a second size of the nasal catheter;

FIG. 29 is a partial front cross-sectional view of one side of the nasal catheter of FIG. 28A, illustrating the identification of an O-ring;

FIG. 30 is a detailed perspective view of an exemplary size recognition feature of a patient interface;

FIG. 31 is a rear view of the nasal catheter of FIGS. 21-26 with the side O-ring assembled;

FIG. 32 is a front view of the nasal catheter of FIG. 31, illustrating in phantom the edge locations of the coupling frame, transitioning from a larger offset on both sides of the frame to a smaller offset in the center;

FIG. 33 is a side cross-sectional view of the nasal catheter of FIGS. 31 and 32, taken through the mid-plane of the interface;

FIG. 34 is a side view of the nasal catheter of FIGS. 31-33;

FIG. 35 is a side view of the nasal catheter of FIGS. 31-34 coupled to an interface frame;

FIG. 36 is a side cross-sectional view of the nasal catheter of FIGS. 31 and 34 coupled to the interface frame, the cross-section taken through the mid-plane of the interface;

FIG. 37 is a rear view of the nasal cannula of FIGS. 31-34 coupled to the interface frame with the frame shown transparent;

FIG. 38 illustrates a first example embodiment frame coupled to two conduits on its sides;

FIG. 39 illustrates a collar attached to the end of one catheter for attaching the catheter to a frame;

FIG. 40 is a partial top view of one side of the frame of FIG. 38 shown attached to the collar and catheter of FIG. 39;

FIG. 41 is a top view of connectors disposed at the distal ends of respective catheters in the embodiment of FIG. 4, showing the connectors coupled with complementary receiving fixtures;

FIG. 42 is an exploded view of the connector and receiving fixture of FIG. 42;

fig. 43 is a side cross-sectional view of the body of the connector of fig. 41 and 42;

fig. 44 is a perspective view of the body of the connector of fig. 41 and 42;

FIG. 45 is a front view of a second embodiment frame with attached side connection arms for securing a patient interface to headgear;

FIG. 46 is a top view corresponding to FIG. 45;

FIG. 47 is a partial front view of the frame of FIG. 45 showing a side arm on one side, and a nasal cannula coupled to the frame;

FIG. 48 is a side view of the assembly of FIGS. 45 and 46;

FIG. 49 is a front view of a third embodiment frame with an alternate embodiment side connection arm attached for securing a patient interface to a headgear;

FIG. 50 is a top view corresponding to FIG. 49;

FIG. 51 is a top view of one side link arm of the embodiment of FIGS. 49 and 50 with a rigid end clip;

FIG. 52 is a front view of the side link arm of FIG. 51;

FIG. 53 is a perspective view of the frame of FIGS. 49 and 50 illustrating the rigid end clamps of the side arms engaged with the frame with other portions of the side arms hidden;

FIG. 54 is a partial top view of the side of the frame of FIGS. 49 and 50 showing the attachment tab of the side arm and illustrating the direction of movement for engaging the clip with the tab;

FIG. 55 is a partial front view of one side of the frame of FIGS. 49 and 50 showing the shape of the attachment tab of the side arm;

FIG. 56 is a perspective view of a stabilizing arm for coupling to the frames of FIGS. 4, 6, 7-10, 38 and 45-55;

FIG. 57 is a detailed top perspective view illustrating a hole at a first end of a stabilizing arm with a side recess for engagement with a coupling projection;

FIG. 58 is a top view corresponding to FIG. 57;

FIG. 59 is a detailed bottom view illustrating the hole at the first end of the stabilizing arm with rounded edges to position the hole on the attachment tab;

FIG. 60 is a front view of the first embodiment frame showing the attachment tab for attachment to the stabilizing arm;

fig. 61 is a top view corresponding to fig. 59;

FIG. 62 is a detailed perspective view of the coupling projection of FIGS. 59 and 60;

FIG. 63 is a detailed perspective view illustrating the stabilizing arm of FIG. 56 aligned with the frame attachment tab for attachment;

FIG. 64 corresponds to FIG. 67, but shows the stabilizing arm and tab in the connected/disconnected position;

FIG. 65 is a bottom view corresponding to FIG. 64;

FIG. 66 is a front view of the frame of FIG. 56 illustrating movement of the stabilizing arm between the connected/disconnected position and the installed position;

FIG. 67 is a detailed front view of the connection between the stabilizing arm and the frame with the stabilizing arm in a position between the connected/disconnected position and the installed position;

FIG. 68 is a detailed perspective view corresponding to FIG. 67;

FIG. 69 is a front view of the stabilizing arm of FIG. 56 coupled to a frame coupling projection in an installed position;

FIG. 70 is a detailed front view of the connection between the stabilizing arm and the frame with the stabilizing arm in the installed position;

fig. 71 is a detailed perspective view corresponding to fig. 70;

FIG. 72 is a detailed perspective view of the pivotal connection between the headgear connection pad and the body of the stabilization arm;

fig. 73 is an exploded perspective view corresponding to fig. 72;

FIG. 74 is a detailed side view of the hinge of the stabilizing arm;

FIG. 75 is a side view of the stabilizing arm of FIG. 56;

FIG. 76 is a plan view of one embodiment of a headgear having a fabric body with a lower headgear area, showing the headgear prior to assembly into the cap, and without any adjustment or end-fixture components;

FIG. 77 is a diagrammatic side view of the cap of FIG. 76 assembled with an end fixture and worn by a patient;

FIG. 78 is a perspective view of one embodiment end fixture attached to a pleated top edge of headgear fabric;

FIG. 79 is an exploded perspective view of the end fixture of FIG. 78;

FIG. 80 is a partial side perspective view of the assembled headgear of FIGS. 76 and 77 illustrating the shape of the ear regions;

FIG. 81 is a partial rear perspective view of the assembled headgear of FIGS. 76 and 77, illustrating the shape of the rear portion of the headgear;

fig. 82A and 82B illustrate an exemplary pattern of fusing two alternative embodiment headgear, wherein fig. 82A illustrates an embodiment having fusion portions in the form of curves and lines, and fig. 82B illustrates an embodiment having fusion portions in the form of dots and including size information;

FIG. 83 is a front perspective view of a first embodiment adjustment device for adjusting the size of a flexible headgear such as the cap of FIGS. 76-81, showing the adjustment device in an intermediate position corresponding to the locked state of the device;

fig. 84 is a rear perspective view corresponding to fig. 83;

FIG. 85 is a side perspective view of the adjustment device of FIGS. 83 and 85, showing the device pressed into a free state;

FIG. 86 is a side perspective view of the second embodiment adjustment device, showing the adjustment device assembled with the flexible body of the headgear and in a locked state;

FIG. 87 is a top view of one embodiment flexible securing member for coupling a patient interface to a headgear;

fig. 88 is a bottom view corresponding to fig. 87;

FIG. 89 is a top view of the securing member of FIG. 87, but with the top layer of the member hidden to illustrate the location of the intermediate reinforcing layer;

FIG. 90 is a top view of another embodiment securing member with a top layer including a UBL fused to an underlying layer, illustrating one exemplary weld pattern;

FIG. 91 illustrates some alternative shapes of fixation members;

FIG. 92 is a top view of a chin strap for holding a patient's mouth closed;

fig. 93 is a bottom view of the chin strap of fig. 92 showing the patient-facing surface of the strap;

FIG. 94 is a perspective view of an alternative embodiment side connector having a reinforcing layer and a comfort layer;

FIG. 95 is a front view of the side connector of FIG. 94;

FIG. 96 is a rear view of the side connector of FIGS. 94 and 95;

FIG. 97 is a front view of an alternative embodiment side connector showing the shape and location of the reinforcing layer;

FIG. 98 is a front perspective view of another embodiment side connector having a curved profile;

FIG. 99 is a rear perspective view of the side connector of FIG. 98;

FIG. 100 is a front and side perspective view of another embodiment side connector having a reinforced area provided by an area of increased material thickness;

FIG. 101 is a side perspective view of the side connector of FIG. 100 showing the patient facing surface of the connector;

FIG. 102 illustrates various exemplary peripheral edge features of various side connector embodiments, wherein the comfort layer extends around the edge of the stiffening layer, wherein (i) shows a simple circular lip, (ii) shows a slightly tapered lip, (iii) shows a deep tapered lip that is inclined at a steep angle, (iv) shows a wide tapered lip that is inclined at a shallow angle, (v) shows an edge with compliant peripheral fins, and (vi) shows an edge with peripheral fins of alternative shape;

103 (i) and 103 (ii) illustrate exemplary geometries of another embodiment of a peripheral edge feature;

FIG. 104 illustrates various exemplary sizes and shapes of side connectors described herein;

FIG. 105 is a side perspective view of a third exemplary adjustment device for adjusting the size of a headgear;

fig. 106 (i) and 106 (ii) are front and plan views, respectively, of the adjustment device of fig. 105;

FIG. 107 is a cross-sectional perspective view of another embodiment adjustment device for adjusting the size of a headgear, showing an internal shoulder of material for clamping the headgear;

fig. 108 (i) and 108 (ii) illustrate another exemplary adjustment device for adjusting the size of a headgear, wherein fig. 108 (i) is a perspective view and fig. 108 (ii) is a plan view;

FIG. 109 is a plan view of a second embodiment of a headgear having a flexible body with a lower headgear region, showing the fabric base without any end fixing devices;

FIG. 110 illustrates the alignment of the headgear with the wearer when the headgear is secured on the wearer's head, wherein (i) is a side view of a patient wearing the headgear of FIG. 76, and (ii) is a side view of the wearer wearing the headgear of FIG. 109;

fig. 111 shows two other embodiments of the head cap body, wherein (i) shows an embodiment with triangular cutouts along the square top edge of the head cap body, and (ii) shows an embodiment where the top edge is angled on both sides of the triangular cutouts;

FIG. 112 illustrates an exemplary upper ear portion of a headgear having a pattern of fused and unfused regions to limit stretching in a selected direction;

FIG. 113 illustrates another exemplary pattern of fused and unfused regions for limiting stretching in a selected direction in a headband;

FIG. 114 illustrates another exemplary pattern of fused and unfused regions for limiting stretching in a selected direction in a headband;

fig. 115 shows a cap-like headgear of another embodiment, showing the headgear prior to assembly into the cap, and without any adjustment or end-securing device components, with a headgear area of the headgear provided with a stretch zone between the upper ear portions, wherein (i) is a plan view of the outside of the headgear, and (ii) shows the patient-facing side of the headgear;

FIG. 116 illustrates another embodiment of a cap-type headgear showing the headgear prior to assembly into the cap, and without any adjustment or end-securing device components, the headgear area of the headgear being a downwardly angled side, wherein 116 (i) is a plan view of the outside of the headgear, and (ii) shows the patient-facing side of the headgear;

FIG. 117 is a plan view of the outside of another embodiment cap-type headgear, showing the headgear prior to assembly to the cap, without any adjustment or end-fixture components;

FIG. 118 is a plan view of another embodiment chin strap, wherein (i) shows the patient facing side of the chin strap and (ii) shows the outside of the chin strap;

FIG. 119 is a left side view of the chin strap of FIG. 118 assembled with a headgear;

fig. 120 is a right side view of the chin strap of fig. 118 assembled with a headgear;

FIG. 121 is a perspective view of another alternative embodiment side connector having a reinforcing layer and a comfort layer;

FIG. 122 is a front view of the side connector of FIG. 121;

fig. 123 is a side view of the side connector of fig. 121 and 122;

FIG. 124 illustrates various flex directions of the reinforcement layer of the side connector;

FIG. 125 illustrates three exemplary embodiments of a side connector stiffener having slits for flexibility that extend to the periphery of the stiffener;

FIG. 126 illustrates three exemplary embodiments of a side connector stiffener having slits for flexibility disposed from the perimeter of the stiffener;

FIG. 127 is a plan view of another embodiment side connector with a reinforcing layer;

fig. 128 is a side view of the connector of fig. 127; and

fig. 129 is a sectional view taken along line L129 of fig. 127.

Detailed Description

Various embodiments and methods of manufacture will now be described with reference to fig. 1-129. In the drawings, like reference numerals are used to denote like features. In the case of the figures showing several embodiments, in subsequent embodiments, the same reference numerals may be used for the same or similar features, but with multiples of 100 added, such as 2, 102, 202, etc.

The directional terminology used in the following description is for convenience in description and reference only and is not limiting. For example, the terms "front," "back," "upper," "lower," and other related terms refer to the position of a component or portion of a respiratory mask relative to a user when the respiratory mask is worn by the user. In this specification, "rear" refers to a position close to the user (when the mask is used), and in contrast, "front" refers to a position far from the user. The terms "upper" and "lower" refer to the position of a portion or component of the mask relative to the rest of the mask when the mask is in use and the user is sitting in an upright position.

Respiratory system

Fig. 1 illustrates an example respiratory system 1000 that may use embodiments of a patient interface assembly 1001 described herein. In the illustrated arrangement, the patient interface assembly 1001 receives an inspiratory flow via an inspiratory conduit 1005 a. The expiratory airflow may be directed from interface 1011 via expiratory conduit 1005b to a resistance device, which in the illustrated arrangement is a bubbler device 1100. An optional humidifier system 1200 is provided to humidify the inspiratory air stream.

The humidifier system 1200 generally includes a chamber at the top of a heater base that is supplied by a source of airflow from, for example, a hospital or other supply 1300. The humidified flow of inhalation gas is delivered to the airway of the patient via inhalation conduit 1005a and patient interface 1011. Excess and expired gases are exhausted from patient interface 1011 through expiration conduit 1005 b. Resistance device 1100 provides resistance to the flow of expiratory gases exiting system 1000 to the atmosphere to provide a desired peak expiratory pressure or Positive End Expiratory Pressure (PEEP). Those skilled in the art will appreciate that such a system may include additional and/or alternative components known in the art.

In some embodiments, the patient interface assembly 1001 includes a nasal cannula. In other embodiments, the patient interface 1011 includes a mask. For example, patient interface 1011 may include a nasal mask, an oral nasal mask, a facial mask, or a full face mask. In some embodiments, the resistance device and/or humidifier are integrated into the supply 1300. Although a water-based resistance device for managing "bubbler CPAP" is shown in FIG. 1, it should be understood by those skilled in the art that the resistance device may be any other mechanical or resistive device known in the art.

Fig. 2 illustrates another example respiratory system 2000 that includes a bubbler device and a humidifier. A humidified Positive End Expiratory Pressure (PEEP) system is shown in which patient 2400 receives humidified and pressurized gases through a patient interface 2011 connected to an inspiratory or inhalation conduit 2005 a. A flow of gas (e.g., air) is provided from a gas supply or blower 2300 to an inlet of the humidifier 2200. An inspiratory conduit 2005a is connected to an outlet of humidifier 2200 to deliver humidified gas to a patient interface 2011 worn by patient 2400. The inspiratory conduit 2005a can include a heating device or wire 2500, the heating device or wire 2500 heating the wall of the conduit to reduce condensation of humidified gases within the conduit. The excess gas then flows through an exhalation or exhalation conduit 2005b to the pressure regulator 2100.

In the illustrated embodiment, the pressure regulator takes the form of discharging an exhaled gas stream into a chamber 2100 containing a column of water, wherein the exhaled gas bubbles up in the water before exiting the chamber 2100. The gas exhaled by the patient may be directed to other devices (valves, ventilators, pressure devices, etc.) or exhausted to the patient's surroundings through a similar breathing tube. The breathing gas delivered to the patient may be heated to near body temperature (typically between 33 ℃ and 37 ℃) and/or humidified to different levels (typically saturated for medical applications) to improve comfort.

It should be understood that the present disclosure is not limited to the delivery of PEEP gas, but is applicable to other types of gas delivery systems, and does not necessarily require humidification.

Headgear and patient interface system

Fig. 3A and 3B illustrate two exemplary embodiment patient interface assemblies 1, 101 and headgear assemblies 70, 170 for a respiratory system 1000, 2000 (such as the systems described above). The patient interface assembly 1, 101 comprises a frame member 3 for coupling to the inspiratory and expiratory conduits 5a, 5b and maintaining the patient interface body 11, 111 in fluid communication with the inspiratory and expiratory conduits 5a, 5 b. As shown, the patient interface assembly 1, 101 may be coupled to the headgear 71, such as by releasably connecting the frame to the headgear 71 with a pair of side arms 51.

The inspiratory and expiratory conduits 5a, 5b are interchangeable with each other.

In alternative embodiments, the patient interface assembly 1, 101 may be fixed relative to the patient's face, for example with a skin patch. The skin patch that is adhered to the patient's skin may have a non-patient facing side with an engagement surface to releasably secure with the engagement surface of the side arm 51.

In alternative embodiments, the headgear assemblies 70, 170 described herein may be used with patient interfaces other than those described herein.

In the patient interface assembly 1 of fig. 3A, the assembly is provided with an interface body 111 comprising a nasal mask for an infant or neonate. In the patient interface assembly 101 of fig. 3B, the interface body 11 includes a nasal catheter for an infant or neonate, although other patient interface types are possible. The frame and interface body assembly enables easy assembly and disassembly of the patient interface, thereby enabling a user or clinician to exchange between different types of interface bodies (e.g., between a catheter body and a face body) or between different sized interface bodies by exchanging interface bodies coupled to the frame to improve the fit of the interface.

The headgear in the embodiment shown is a circumferential cap 71 having end fixing fixtures 81 and adjustment means 85. The headgear includes a headgear region 73 having an upper ear portion 74 that extends at least partially over the wearer's ear. The headgear 73 includes an engagement surface for attaching the connector 93 to secure the patient interface assembly 1, 101 relative to the headgear.

Headgear may be used with various types of patient interfaces, including those shown for different respiratory therapies. For example, it may be used with an interface for the delivery of CPAP, or with an interface configured to deliver high flow therapy. The nature of the headgear connectors required generally depends on the nature of the patient interface. In the embodiment of fig. 3A, two Y-shaped or wishbone-shaped side connectors 93 are provided to couple the side arms 51 of the patient interface assembly to the on-ear region 74. These side connectors 93 may be used with an optional central securing member 60 that attaches between the front surface of the frame 3 and a point on the front of the headband 73. In the embodiment of fig. 3B with a nasal catheter, only two Y-shaped or wishbone-shaped side connectors 93 are used to couple the patient interface assembly 101 to the headgear. The side connectors may have other shapes than those shown in these figures, such as discussed further below.

In some applications, a chin strap may be provided to hold or urge the patient's mouth closed, such as for CPAP delivery.

Patient interface frame

Referring now to (viii) in fig. 4 to 10, the frame 3 is provided to couple the interface body 3 to the inspiratory conduit 5a and the expiratory conduit 5b. The frame 3 comprises a coupling portion 7 for engagement with a complementary coupling portion of the interface body to securely and releasably retain the interface body relative to the frame and in fluid communication with the conduits 5a, 5b.

The coupling portion 7 of the frame 3 comprises two end regions 6a, 6b for coupling the respective conduits. The body member 8 extends between the end regions 6a, 6 b. The body member 8 may be a contoured (contoured) body member 8. The body member 8 is arranged at the front of the frame 3, forming a bridge between the two end regions 6a, 6 b. The body member 8 has an contoured inner surface for contacting a complementary coupling portion of the interface body, such as a barrel shaped to be flush against a generally cylindrical barrel, and a concave side 9 for engaging a complementary convex coupling surface on the interface body 11, 111.

With particular reference to fig. 9 and 10, the width of the body member 8 and the wall thickness of the body member 8 vary along the length of the body member 8 (i.e., from proximate the frame first end region 6a to proximate the frame second end region 6 b). The variation along the width and thickness of the member 8 is gradual, preferably without abrupt variation.

The width of the body member 8 is widest near the ends of the body member near the first and second end regions 6a, 6b of the frame and tapers to a narrowest point at the midline ML of the frame 3. The narrowing is non-linear so as to form two convex sides 9 of the body. The frame member 3 is typically a rigid component. It is desirable to minimize or avoid contact between the frame member 3 and the patient to reduce the risk of damaging facial tissue. This curved profile of the body member 8 advantageously increases the clearance between the frame components and the patient's face, reducing the chance of inadvertent contact between the frame and the patient. The contoured side may provide additional room for flexing of the patient interface body to improve fit with the patient. The contoured side may also enable the patient interface body to couple with an enhanced relief feature. In particular, the contoured side may provide space to enable the frame to couple with a nasal catheter having a septal relief recess and/or to provide clearance for the patient's septum.

In the embodiment shown, the first and second end regions 6a, 6b of the frame are annular in cross-section. The width of the ends of the body member 8 (taken as the cross-sectional chord length of the body member) is less than the diameter of the end regions 6a, 6b of the frame. At the midline ML of the body member 8, the width of the body member 8 is about 50% of the diameter of the end regions 6a, 6b of the frame, although other widths are possible, for example between about 35% and about 90% of the diameter of the end regions.

Referring to the cross-sectional views of (i) to (viii) in fig. 10, the wall thickness t of the body member 8 varies from the thinnest point (where the member is widest) adjacent the end of the body member (fig. 10 (ii)) to the thickest point (where the member is narrowest) adjacent or at the midline of the frame 3. This increase in wall thickness provides additional rigidity to compensate for the material reduction resulting from the reduced width of the member. The protrusions 53, 54, 67 on the front surface of the frame for attaching the securing members or connectors are not considered to form part of the wall thickness of the frame body member.

In the embodiment shown, the wall thickness variation is provided by the body member 8, the outer surface of which has a different surface curvature than the inner surface of the member. As shown in (ii) to (viii) of fig. 10, the cross-sectional profile of the frame body 8 is generally arched. In the illustrated embodiment, the curvature of the inner surface of the body member 8 is substantially constant along the length of the body member 8, but the curvature of the outer surface of the body member 8 varies from a maximum radius of curvature adjacent the end of the body member to a minimum radius of curvature at or near the midline ML, with the effect of increasing the wall thickness.

Fig. 10 (ii) shows the end regions adjacent the frames 6a, 6b, the outer and inner surfaces of the body member 8 being concentric. In contrast, (viii) in fig. 10 shows that at or near the midline ML, the outer and inner surfaces of the body member 8 have non-concentric curvatures such that the thickness of the body member varies along the cross-sectional profile. For example, the thickness of the body member is greater in the middle of the cross section and tapers outwardly toward the ends thereof.

In alternative embodiments, the body portion may alternatively or additionally include one or more stiffening features to compensate for the reduction in the central width of the body member, for example, one or more ribs or webs on the outer or inner surface of the body member. Suitable ribs may be integrally formed with the body member or permanently bonded thereto. For example, the shape, height, and/or width of the ribs may be varied along the length of the ribs to provide the desired reinforcement.

Patient interface body

Fig. 11-13 illustrate two example embodiment patient interface bodies 11, 111. The interface body of fig. 11 has the form of a nasal catheter, while the interface body of fig. 12 has the form of a nasal mask. The interface body 11, 111 comprises a patient contact portion 13, 113 and a coupling portion 12, 112, the coupling portion 12, 112 being shaped to couple with the coupling portion 7 of the frame 3. The patient contact 13, 113 may form a complete or partial seal with the patient's face.

The patient contact portion 13, 113 extends from the rear (patient facing) side of the manifold 14, 114. The manifold 14, 114 defines a pair of openings 14a, 14b, 114a, 114b for fluid communication with the inspiratory and expiratory conduits 5a, 5 b. The manifold openings are provided on opposite sides of the manifold for receipt by the ends 6a, 6b of the frame 3. The openings 14a, 14b, 114a, 114b allow fluid to flow laterally into and out of the manifold. The patient contact 13, 113 is fluidly coupled to the manifold, such as through a rear opening in the manifold, to facilitate flow of gas into and out of the manifold and the patient via the patient contact.

In the embodiment shown, the lateral ends of the manifold are annular for coupling with the annular ends 6a, 6b of the frame 3. The front portion of the manifold has a front outer surface extending between the ends, which is shaped as a generally semi-cylindrical front surface, coupled to the frame 3.

Annular members 22, 122 may be provided at the interface body ends 6a, 6b for forming a seal with the interface frame 3. The annular member is a ring raised relative to the manifold and is configured to provide a friction or interference fit with the inner surface of the frame 3 to provide a fluid-tight seal with the frame.

These annular members 22, 122 may be colored members for use with a transparent or translucent frame or frame portion to provide a visual indication of proper assembly between the interface body and the frame. The user or clinician can view the position and configuration of the colored ring through a transparent or translucent frame. In the illustrated embodiment, proper positioning and coupling of the frame to the patient interface body is indicated by observing that the color ring is axially aligned with the frame 3 and forms a circle. By observing the deformation of the color ring or misalignment with the frame 3, an incorrect positioning is indicated, as well as an indication that the gas seal between the frame 3 and the interface body 11 may be insufficient.

Additionally, or alternatively, different colored annular members may be used as an indication of the size of the interface body. The interface body may alternatively or additionally include a size indicator 31 on another portion of the body, such as toward the center of the manifold. The coupling portion 12, 112 of the interface body 11, 111 includes top and bottom reinforcement areas 15a, 15b, 115a, 115b on the top and bottom of the manifold 12, 112. Each reinforcing region 15a, 15b, 115a, 115b has a convex coupling wall 16a, 16b, 116a, 116b projecting upwardly from the front outer surface of the manifold.

The stiffening regions 15a, 15b, 115a, 115b provide rigidity to the coupling of the interface body to provide easier handling and assembly and reduce the likelihood of the patient interface body 11, 111 accidentally separating from the frame 3.

The convex coupling walls of the reinforcing regions 15a, 15b define, together with the front outer surface of the manifold 14, a recess 17 to receive the body member 8 of the frame 3. The recess has a shape corresponding to the shape of the frame body member 8 and the two convex sides 9 of the body 8, the width of the recess varying along the recess from the first side of the interface body to the second side of the interface body. The width of the recess is widest near the sides of the interface body and tapers to a narrowest point at the midline ML of the interface body. The narrowing produced by the two facing convex coupling walls of the reinforcing areas 15a, 15b is non-rectilinear.

The complementary shapes of the recess and the frame body member facilitate proper assembly of the interface body with the frame and reduce the likelihood of rotational misalignment. In this embodiment, the frame is symmetrical about a transverse plane so that the interface can be properly installed in the frame either face up or face down. In alternative embodiments where the frame requires a particular orientation of the interface body for proper operation, the top and bottom edges of the frame body may have different curvatures and the same asymmetric curvature is provided on the coupling portion of the interface body to ensure that the interface can only be installed unidirectionally.

With the frame 3 engaged with the interface body 11, 111, the inner surface of the frame body member 8 may generally rest against the front outer surface of the manifold 14, or may generally follow the curvature of the front outer surface of the manifold 14, leaving a small space between the components for clearance. In one embodiment, the gap may be 0.1mm to 0.2mm. However, at least a portion of each of the coupling walls 16a, 16b, 116a, 116b is configured to be located higher than the front surface of the frame body member 8 when assembled. The attachment wall may be maintained at a substantially constant distance across the frame body member above the front surface of the frame body member 8. Alternatively, the coupling wall may be raised above the front surface of the frame body member 8 by a distance that varies across the frame body member 8.

Fig. 13-17 illustrate different wall thicknesses of the nasal mask interface body 111. The coupling walls 116a, 116b of this embodiment 111 are shaped to a height of between about 2mm to about 3.5mm from the front surface of the manifold 114 such that when coupled with the frame 3 they are raised above the front surface of the frame body member 8 at a constant distance of about 0.9mm across the frame body member. In alternative embodiments, the coupling walls 116a, 116b may be between about 0mm and about 2mm above the front surface of the frame body member 8. They may be raised above the body member 8 by a constant distance, or the distance may vary across the body member.

In contrast, fig. 35 and 36 illustrate the frame body member 8 installed in the coupling recess of the exemplary nasal catheter 11, showing the cooperation of the midpoint of the frame and interface body (fig. 36) and one side of the interface body (fig. 35). In this embodiment, the coupling walls 16a, 16b are configured to transition from about 0.9mm above near the sides of the frame 3 to about 0.3mm above centrally above the front surface of the frame body member 8 at varying distances across the frame body member. In alternative embodiments, the coupling walls 16a, 16b may be raised above the front surface of the frame body member 8 at varying distances across the frame body member, transitioning from near the sides of the frame 3 to about 2mm to at least 0mm above at the center. In alternative embodiments, the coupling walls 16a, 16b may be raised above the front surface of the frame body at a constant distance across the body. It should be understood that these are exemplary dimensions and are not intended to be limiting, and that many variations of these dimensions are contemplated.

The portion of the patient interface coupling above the frame body 8 helps to reduce the risk of incorrect assembly and helps to maintain the connection between the interface coupling and the frame.

The thickness of the reinforcing regions 15a, 15b in the catheter hub body 11, as well as the height of the coupling walls 16a, 16b, may vary across the width of the hub body 11. In the illustrated interface body 11, the height of each coupling wall 16a, 16b is greater toward both sides of the interface body and smaller toward the midline of the interface body.

The thickness of the stiffening regions 115a, 115b in the mask interface body 111, as well as the height of the coupling walls 116a, 116b, are substantially constant or may vary slightly across the width of the engagement body 111.

Nose mask

Fig. 14-20 further illustrate an exemplary nasal mask embodiment of the interface body 111. The interface body 111 includes a mask cushion that extends rearward from the frame coupling 112 and manifold. The mask 111 may be applied to the patient's face to form a seal around or over the nose around the nostrils of the patient. In alternative embodiments, the mask 111 may cover the nose and mouth of the patient.

The mask cushion includes a generally hollow body defining a mask cavity 121, and a face-contacting surface 113 generally opposite the frame coupling 112, a peripheral edge 119 of the face-contacting surface 113 defining an opening. Mask cavity 121 is configured to receive a flow of gas from the manifold such that the gas may flow through the openings to the patient.

The face-contacting surface 113 is adapted to abut the face of the wearer and to encircle a portion of the nose of the patient including the nostrils. The contact surface 113 may sealingly engage around the user's nose, such as against one or more cheek surfaces and/or side surfaces of the user's nose, an upper lip region below the user's nose, and a nasal bridge region or nasal tip region across the user's nose. Alternatively, the sealing region of the mask tip may be located at or near the transition from the nasal bone to the nasal cartilage such that at least a portion of the sealing region is located above the nasal bone.

The mask cushion includes a "roll region" 117. The roll area 117 is configured to roll or flex onto the outer surface of the mask to allow the mask to accommodate facial movements or forces exerted on the mask and to accommodate different nose geometries. Scrolling of the scroll zone 117 helps alleviate pressure applied to the user's nose and/or face by scrolling more in the area of increased pressure. The roll area may also help maintain the integrity of the seal between the mask and the patient by conforming the mask to the patient's face.

In the illustrated embodiment, the roll area 117 extends along the upper and side portions of the mask 111. The contact surface 113 may be located on the bridge of the nose, sides of the nose, and above the upper lip of the user when the mask 111 is secured to the user's face in use. With the supply of positive pressure air, the contact surface 113 may expand and seal against the face of the user.

The wall thickness and/or stiffness of the mask 111 within and adjacent to the mask roll region 117 is selected to provide the desired roll and yaw characteristics. To assist in rolling or bending, the region 117 may have a varying thickness or varying stiffness. For example, the selected thickness may determine the degree of movement provided by the mask. Furthermore, varying the stiffness of the region may create hinge points or pivot points that may guide the movement of the mask.

In the illustrated embodiment, the roll area 111 includes a thin area along the top and sides of the mask at and adjacent to the patient contact surface 113, and at the front area 118 of the roll area, adjacent to the manifold. These thin regions facilitate bending or folding of the mask 111.

The reduced stiffness at the patient contacting surface causes the surface to conform to the patient's face. Furthermore, the reduced stiffness and/or thickness in the front region (top and sides of the mask) enables the mask to perform a rolling motion with a substantially flat force-displacement curve. The rolling region 117 may roll forward from a pivot point or hinge point at or adjacent the mask base when the mask cushion is compressed, such as when the mask 111 is pushed against the patient's face in use.

The mask 111 includes a stiffening feature 123 between the two regions 119 and 118. The reinforcing structure 123 may be harder than the adjacent regions 118, 119 or formed of a thicker material. The structure 123 may be continuous or complete around the circumference of the mask, or may extend partially around the circumference of the mask. In the illustrated embodiment, the structure 123 extends around the sides and top of the mask. In alternative embodiments, the structural portion 123 may extend around the sides, top and base of the mask. The structure 123 may be a strip.

In the illustrated embodiment, the wall thickness of the patient contacting surface 113 is thinner than the wall thickness of the reinforced region 123. The transition from the reinforced region 123 to the patient contacting surface 113 is a gradual transition comprising a gradual wall thickness taper. Preferably, there is no abrupt change in wall thickness from the reinforced region 123 to the patient contact surface 113. The smooth transition between these regions reduces the likelihood that the edges of the reinforced regions will contact the user's skin and/or bridge of the nose when the mask is deformed to seal against the patient.

For the transition from the stiffening region 123 to the front rolling region 118, a gradual transition is less desirable because the front edge of the stiffening region is not patient-facing.

The structure 123 may be positioned to influence the force-displacement curve of the rolling area at the top and/or sides. For example, the force profile may be relatively flat as the thin material of the reduced stiffness portion rolls until the thickness of the rolling material begins to increase (suddenly or gradually). An increase in the thickness of the rolling material will raise the force-displacement curve. The gradual thinning or tapering of the stiffness of the structure 310 may be used to allow the rolling region to roll a distance before slightly resisting displacement, rather than from a low force to a high force when the rolling region stops rolling.

In some cases, such as at higher pressures, the feature 123 may help prevent the mask from expanding. The feature 123 may also help prevent folds or creases in the thin material portions of the regions 118, 119.

The mask may be rolled on each side individually or together and pivoted about a point at or adjacent to the base of the mask. As shown in dashed lines in fig. 16 and 17, the scroll zone 117 may deflect around the front edge 120 of the scroll zone 117. As shown in fig. 17, the mask 111 is configured to hinge at the base of the mask such that there is a greater displacement toward the top of the mask.

The material thickness of the mask wall may thicken or stiffen as it moves forward of the front edge 120 of the roll region. In some embodiments, the mask may have a thickened or reinforced base that may add structure, for example, to prevent the mask from being folded in half laterally.

In some embodiments, the reduced material stiffness portion may have a thickness of about 0.5mm or less. The reduced stiffness portion of the material may have a thickness of 0.8mm or less, 0.7mm or less, 0.6mm or less, 0.5mm or less, 0.4mm or less, or 0.3mm or less. In some embodiments, the thickness ratio of the structural portion 123 to the reduced stiffness portion may be about 20: 1. 15: 1. 10: 1.5:1. 2:1 or 1.5:1.

Referring to fig. 18, the patient contact surface 113 may have a curvature in the transverse plane to provide good conformity with the transverse curvature of the patient's face, particularly with the curvature of the infant or neonate's face. Fig. 18 compares the curvature of two exemplary embodiments—the presently described embodiment 111 and the alternative mask 211 described in WO2021176338, which is incorporated herein by reference.

The greater lateral curvature of the mask may improve the contact of the mask with the patient, particularly over the patient's cheeks. In this embodiment 111, the curvature is such that the anterior-posterior depth of the patient contacting surface 113 is between about 0.5mm and about 2mm greater than the depth of the contacting surface in the embodiment illustrated in WO2021176338, measured from the foremost point of the surface 113 at the midline of the mask to the rearmost point at the lateral region of the surface 113. In one embodiment, the anterior-posterior depth of the patient contact surface 113 is between about 1mm and about 1.6mm greater than the depth of the contact surface in the embodiment illustrated in WO 2021176338. Referring to fig. 20, the opening of the mask cavity 121 has a width W of between about 10mm to about 40mm, depending on the mask size. However, other dimensions are also contemplated.

The mask interface body 111 may be made of a single material or two or more different materials. The mask body 111 may be made of silicone.

Nasal catheter

Fig. 11 and 21-34 illustrate another embodiment of a patient interface body 11 in the form of a nasal catheter. The catheter 11 includes a pair of nasal prongs 13 extending from the rear of the frame coupling 12 and manifold 14 toward the patient. Each nasal prong 13 may be shaped to extend from the manifold 14, generally up and back into the nostril of the user. Each nasal prong 13 may have a curvature that includes more than one inflection point.

The prongs 13 are shaped to form a seal with the patient's nostrils and allow gas to flow from and into the user. For example, the curvature, wall thickness, and/or cross-sectional shape of the prongs may vary from the base to the tip 19 of each prong 13. In some embodiments, the nasal prongs are shaped to seal the nostrils of an infant or neonate. The prongs 13 may be shaped and formed to minimize tissue compression and kinking of more than one prong 13 during insertion into a patient's nostrils. In the embodiment shown, the wall thickness of the nasal prongs is substantially constant from the base of the nasal prongs 13 to the tip 19.

The prongs 13 may taper inwardly from the base of each prong 13 toward the distal end 19. The cross-sectional area of the prongs may taper from the base to the end 19 of each prong 13 or between the base to the end 19 of each prong 13. This narrowing of the prongs may assist in the sealing function of the prongs 13. When the prongs 13 are pushed into the patient's nostrils, they may seal somewhere along the length of the prongs 13 due to the tapering of the prongs 13 widening towards the base 23. Narrowing may facilitate insertion of the prongs 13 as opposed to prongs of constant cross-sectional area or prongs that widen toward the outlet.

Each prong 13 defines an internal cavity with an internal cross-section that varies along the length of the prong 13. In the illustrated embodiment, the outlet of the nasal prong lumen at the prong end 19 is generally circular. In some embodiments, the outlet of the nasal prong lumen may be generally elliptical. In the illustrated embodiment, the cross-sectional dimension generally decreases along a trajectory from the base 23 to the tip 19 of each nasal prong. The cross-sectional shape may also be varied.

At the base 23 of the nasal prongs 13 and/or adjacent the base 23, the catheter body 11 includes a deflected base region 25 (shown in phantom in fig. 21). The base region 25 may form part of the catheter body 11 where the nasal prongs 13 meet the manifold 14. The base region 25 may help provide comfort and fit to the patient while also ensuring that a flow path is maintained between the manifold and the nasal prongs.

In the illustrated embodiment, the flex base region 25 includes a region of reduced wall thickness relative to the base of the nasal prongs 13 and the rest of the manifold 14. The region 25 of reduced wall thickness may completely or partially surround the base 23 of each prong and may extend between the prongs 13. In the illustrated embodiment, the base region 25 has a generally kidney-shaped form as shown in fig. 21, forming a reduced thickness strip of material around the base of each prong and between the prongs.

The region of reduced wall thickness creates a spring effect at the base of the nasal prongs 13. The thinner region of material may be formed partially or entirely at the base of the nasal prongs.

In certain embodiments, the wall section of the nasal prongs 13 transitions to a thinner wall surrounding the base region 25 of the nasal prongs. The base region 25 may have a substantially constant thickness throughout the base region. In some embodiments, the thickness of the nasal prongs 13 adjacent the base 23 may be between 0.3mm-2.0mm, 0.5mm-2.0mm, 0.6mm-2.0mm, 0.3mm-1.8mm, 0.5mm-1.8mm, 0.6mm-1.8mm, 0.7mm-1.8mm, 0.6mm-1.5mm, or 0.7mm-1.5 mm. The thickness of the base region 25 may be between 0.1mm-1.5mm, 0.2mm-1.3mm, 0.3mm-1.3mm, 0.5mm-1.2mm, or 0.5mm-1.0 mm. For example, in one embodiment, the thickness of the nasal prongs 13 may be about 0.6mm and the thickness of the base region 25 may be about 0.3mm. In such an embodiment, the thickness ratio between the nasal prongs 13 and the base region 25 may be 1:0.5. the thickness ratio between the nasal prongs 13 and the base region 25 may be any other ratio that provides the desired transition therebetween.

The flex base region 25 may provide a spring action or mechanism at the base of the nasal prongs 13. The base region 25 may help to separate movement of the housing and/or manifold 14 from movement of the nasal prongs 13. The base region 25 may provide the nasal prongs 13 with the ability to flex around the base region 25 while avoiding kinking of the nasal prongs 13. The prongs 13 may flex while remaining in position in the nostrils. For example, the base region 25 may provide spring-like motion at the base of the nasal prongs 13 and/or at regions surrounding the base of the nasal prongs 13. The base region 25 may apply a spring load to the nasal prongs to absorb some of the interface movement while maintaining the nasal prongs 13 in place in the nostrils. For example, the base region may initially be in a neutral/relaxed position (i.e., the natural state of the catheter body) without any force applied to any portion. When inserted into a nostril, the action of pushing the prongs into place (and sealing) may cause the base region 25 to flex or deflect downward into the manifold. The nasal prongs position in the nostrils may remain unchanged, particularly when the prongs are in the sealing position. If in use, the housing and/or manifold are pulled downwardly and/or away from the face (e.g., by pulling the tube), the base region 25 may move toward the neutral position. The base region 25 is still resilient enough to maintain the position of the prongs in the nostrils. For example, the spring load from the base region 25 may absorb interface movements such as cheek movements, patient movements, or headgear movements. The base region 25 may assist in movement of the or each nasal prong 13 in multiple directions to accommodate movement of the interface while also maintaining a seal sufficient to maintain therapeutic delivery.

The flex base area 25 may help accommodate different septum spacings. The base region 25 may allow one or both nasal prongs 13 to flex back and forth toward and away from the face to accommodate different facial geometries. The base region 25 may alternatively or additionally provide upward thrust into the nostrils to maintain a constant seal.

In some embodiments, base region 25 may be shaped to form a recess at septum region 29 between nasal prongs 15. The recess 29 is configured to provide clearance for the patient's septum to avoid or reduce pressure on the septum, thereby minimizing the risk of skin or tissue damage. The recess 29 may also enhance visualization of the patient's nostrils and/or septum.

Septum recess 29 is defined by the surface of base region 25 between nasal prongs 15 that extends forward from base 23 of the nasal prongs and forward from patient contact surface or cheek contact surface 30 to the side of the interface body. The recess 29 has a curved profile, formed by the concavity of the base region between the prongs 15. The wall thickness of base region 25 at septum recess 29 may be substantially constant or may vary.

In use, the nasal prongs 13 may press or squeeze into the manifold 14 due to the flexing base region. Without adequate septum 29, this may result in increased contact and/or pressure between the patient's septum and the interface. Accordingly, it is desirable that the depth t1 of the septal recess be as large as possible without adversely affecting the resistance of the gas path through the nasal prongs and without compromising the stiffness of the coupling 12 of the interface body 11.

FIGS. 27A and 27B illustrate the indicative geometry of septum recess 29 in two different sized interface bodies. In the smaller dimension shown in FIG. 27A, septum recess 29 has a depth t1 of about 1.9mm forward from base 23 of the nasal prongs. This corresponds to a distance t2 of about 3.8mm from the lower seal of the nasal prongs. In the larger dimension shown in FIG. 27B, septum recess 29 has a depth t1 of approximately 2.2mm forward from base 23 of the nasal prongs. This corresponds to a distance t2 of about 4.1mm from the lower seal of the nasal prongs 13'. It should be appreciated that these dimensions are provided as examples, and that the size of the septal recess may vary for different sized nasal prongs and/or different patient interface body 11 sizes.

The catheter body 11 may include another region 27 (represented by the dashed line in fig. 22), typically positioned below the base region 25 of the patient-facing side of the catheter body. This region 27 is configured to provide comfort and fit where the interface body 11 contacts the patient's person, reduce pressure on the skin and minimize the risk of skin damage.

The in-person contact area 27 may comprise an area of reduced wall thickness relative to the base of the nasal prongs 13 and/or the rest of the manifold 14. The in-person contact area may comprise an area of thicker wall thickness compared to the base area 25. In some embodiments, the in-person contact area 27 may comprise an area having a wall thickness equal to or greater than the wall thickness of the base of the nasal prongs 13. The wall thickness may be substantially constant throughout the region 27. In the exemplary embodiment shown and described above, the in-person contact area 27 has a constant wall thickness of approximately 0.5 mm. In another embodiment, the wall thickness at the base 23 of the nasal prongs is about 0.6mm and the contact area 27 in the person has a constant wall thickness of about 0.6 mm.

The person-in-contact area 27 is adjacent to the deflected base area 25 of the nasal prongs, wherein the upper boundary of the person-in-contact area 27 forms the lower boundary of the base area 25. Thus, the shape of the upper boundary of the contact area 27 in the person corresponds at least partly to the shape of the lower boundary of the base area 25. The deflection base region 25 may gradually transition to the in-person contact region 27, or in some embodiments, the transition may be very abrupt.

The human contact area 27 may extend to a substantial part of the width of the body. For example, the in-person contact area 27 may extend at least the width of two nasal prongs, from the side of the first nasal prong to the side of the second nasal prong 15. Alternatively, the in-person contact area 27 may extend at least the width of the base area 25.

In the illustrated embodiment, the in-person contact area 27 is shaped to be widest in the middle of the area, at the midline of interface body 11, and in line with the septum area 29 between nasal prongs 13. The contact area 27 in the person may become narrowest towards the lateral sides of the area 27. In one embodiment, the in-person contact area 27 has a generally oval shape.

In an embodiment, the wall of the catheter hub body 11 comprises at least four regions of different wall thickness: a nasal prong 15 having a first wall thickness, a flex base region 25 having a second wall thickness, a person-in-person region 27 having a third wall thickness, with the remaining body having a variable wall thickness including a fourth wall thickness. The fourth wall thickness may be greater than the first, second and third wall thicknesses. The fourth wall thickness may be the maximum wall thickness of the interface body 11. The first wall thickness may be greater than the second wall thickness and greater than or equal to the third wall thickness. The third wall thickness may be greater than or equal to the second wall thickness. The second wall thickness may be less than the first, third and fourth wall thicknesses.

Catheter-frame coupling

Fig. 38-40 illustrate an arrangement of coupling the inhalation and/or exhalation conduits 5a, 5b to the patient interface frame 3. The arrangement includes a collar 35.

The connection between the collar 35 and the frame 3 may be permanent. For example, at least a portion of collar 35 may be fused or overmolded onto frame 3.

Collar 35 may include a fusion 39 for coupling collar 35 and catheter 5 to patient interface frame 3. Alternatively, all or substantially all of collar 35 may include a fusion.

The catheter 5 may be attached to the collar 35 around the collar and the annular portion of the catheter. The connection between the catheter 5 and the collar 35 may be permanent, such as a fusion connection. The collar and the attachment ring portion of the catheter 5 are positioned adjacent to the frame 3.

The length of the annular portion of the conduit 5 attached or fused to the collar 35 is at least 1mm, for example, between about 1mm and about 5 mm. However, the length may vary depending on the size of the catheter. For a helically wound or corrugated catheter, at least a single winding or corrugation is fused with collar 35. In some embodiments, more than one wrap or corrugation may be fused with collar 35. For example, up to three windings or corrugations may be fused with the collar, or alternatively more than three windings or corrugations. The fused length of the catheter is located at or near the side of the frame end of collar 35.

In addition to the fused length, collar 35 also accommodates the free length of the catheter. That is, at least a portion of the catheter is free to move within the collar 35 within the confines of the collar. The free length may be longer than the attachment/fusion length of the catheter.

The free portion within the collar ensures that any bending of the catheter does not react at the rigid connection of the catheter ends of the collar, which may damage or lead to connection failure. Instead, the bending force is reacted by the length of unconnected tubes in the collar flexing and contacting the inner wall of the collar 35.

The inner diameter of the collar 35 may be constant or alternatively may vary along the collar, for example the diameter of the collar at the end adjacent the free conduit portion may be greater.

Collar 35 may comprise a flexible or rigid body. For example, the collar may comprise more than one thermoplastic, polyurethane, and/or silicone. In an exemplary embodiment, collar 35 comprises a pre-molded Thermoplastic Polyurethane (TPU). In an exemplary embodiment, the TPU collar 35 is overmolded with the patient interface frame 3.

Catheter connector

The conduits 5a, 5b and connectors of the patient interface assemblies 1, 11 allow fluid communication between the patient and an external device (or source of airflow). Fig. 41 to 44 show an exemplary connector 41 for use at the end of the conduit 5a, 5 b. The connector 41 may be any type of interlocking or mating connector to connect a conduit to another device 47 or additional conduit. The connector 41 may have locking fingers 45 extending from the connector body 43 to connect and secure the tubing to another device or additional tubing. In some embodiments, the locking fingers 45 may extend away from the connector body 43. The locking fingers 45 may be spaced apart and narrow along their length away from the connector. The locking fingers may have locking recesses or stops formed at least on an outer surface of each locking finger. The locking recess may be locked with a portion of the gas delivery tube connector or other connector 47. The locking fingers may interact with recesses of the gas delivery tube connector or other connector to align the connector 41 with the gas delivery tube connector or other connector.

The outer body of the connector 43 may receive a base portion 46 that supports the locking fingers of the connector and includes gripping features that facilitate gripping of the connector. In the illustrated embodiment, the body includes four gripping notches spaced 90 degrees apart from one another.

In some embodiments, a first end of one conduit 5a may be coupled with the body of the connector, as shown in fig. 41, and a first end of a second conduit 5b may include a female connector 47 for receiving a complementary connector.

Examples of connectors and/or connector assemblies may be found in international application PCT/NZ2012/000142 filed on 8/10 2012 entitled "catheter connector for patient respiratory device," the entire contents of which are incorporated herein by reference. In other embodiments, the connector may have a tapered fit to connect to another device or additional tubing.

Side arm

Referring to fig. 45-47, a pair of side arms 51 are provided for detachably connecting the patient interface frame 3 to a support headgear and/or connector to secure or support the patient interface body relative to the patient. In some embodiments, the connector may include a skin pad that is attached to the patient's face and has an engagement surface for engaging the side arm.

In some embodiments, the side arms 51 may secure the interface body to the user's face to help form and maintain a seal with the patient's face. In alternative embodiments, such as an interface for nasal high flow therapy, the sidearm may secure the interface to face the operative position to deliver gas to the patient's airway.

Each side arm 51 is a separate member having a first end 51a for attachment to the front face of the frame 3. Each first end 51a may be releasably or permanently attached to the front of the frame 3.

The provision of two separate arms is advantageous in that the area in the centre of the frame 3 is not limited by side arms and can be freely connected to other parts such as the fixing described in more detail below. The second end of each arm 51 includes a connection pad 52, the connection pad 52 having a connection surface for engaging a headgear and/or connector to secure or support the patient interface relative to the patient.

Referring to fig. 5 and 7, the front of the frame 3 includes left and right attachment areas 52a and 52b for attaching the respective side arms 52. Each attachment zone is located between a midpoint of the frame and a corresponding side of the frame.

The attachment region may include one or more attachment features to engage with the corresponding side arms 51. The attachment feature may comprise any suitable feature that facilitates a secure, optionally releasable, connection with the first end of the arm 51. The connection preferably substantially prevents movement of the first end of the side arm relative to the frame, including relative pivoting of the components.

In an exemplary embodiment, each attachment region includes one or more protrusions for receiving complementary holes or recesses on the side arms. Each projection 53, 54 for engaging a side arm 51 is located between the midpoint of the frame and the corresponding side of the frame 3. In some embodiments, some or all of the projections may be positioned closer to respective sides of the frame than a midpoint of the frame.

In the exemplary embodiment of fig. 45 to 47, each frame connection region is provided with two projections 53, 54. The first projection 53 includes a post having an enlarged end. The legs of the projection 53 project forwardly and perpendicularly from the front surface of the frame 3 such that the enlarged end of the first projection 53 is spaced from the front surface of the frame, wherein the frame has a front face that is generally parallel to the front surface of the frame. The enlarged end may be located at the centre of the post or may be off centre, for example protruding to one side of the frame 3. In the illustrated embodiment, the enlarged end of the first projection 53 is generally rectangular, oriented transversely on the frame body member 8, and projects from the post toward the corresponding side of the frame. However, it should be understood that other shapes of projections may be utilized.

The first projection 53 passes through an aperture 55 proximal to the first end of the side arm 51. On the front surface of the side arm a recess is provided, having a shape and depth corresponding to the enlarged end of the projection, aligned with the hole for placing the projection when the side arm is connected to the frame 3. The height of the first projection 53 is substantially the same as the thickness of the arm at the first end 51a such that the enlarged end of the first projection 53 is substantially flush with the front surface of the side arm 51. In other embodiments, the first protrusion may be sized to be recessed behind the front surface of the side arm 51, or protruding in front of the front surface.

The second projection 54 has the form of a hook-like connector for mounting in a complementary recess of the respective side arm. In the illustrated embodiment, the hook connector 54 includes a post with a hook projecting laterally from the post. The hooks are preferably oriented to project toward the midpoint of the frame away from the side edges of the frame so that when tension is applied to the arms, the hooks engage the arms (rather than risk disengaging). Preferably, the hook forms an angle with the post of about 90 degrees, but alternatively may be other angles depending on the rearward angle of the side arm, for example.

The hook portion and the pillar of the second protrusion may have a constant width. Alternatively, the width may vary along the projection, and/or the hook may have a different dimension than the post.

In the embodiment shown, the second projection 54 projects forward from the frame 3 a lesser distance than the first projection 53 and is shorter than the thickness of the first end 51a of the side arm, so that the hook does not extend through the entire thickness of the side arm 51, but is hidden by the front surface of the side arm. However, in alternative embodiments, the second projection may extend through the entire thickness of the side arm 51 to be visible from the front.

The side arm 51 including the first end 51a may have an elastic material portion such as an elastomer. In some embodiments, arm 51 comprises a thermoplastic elastomer such as, but not limited to, that sold by KRAIBURTM. The use of flexible material for at least a portion of the side arms 51 allows the arms to flex or bend to better accommodate variations in facial geometry and/or facial movements of an individual patient.

To assemble the side arm 51 with the frame 3, a recess (not shown) in the rear surface of the side arm engages the second projection 54. The arms are then pulled laterally outwardly, stretching the apertures 55 over the enlarged heads of the first projections 53 before the pulling arms contact the surface of the frame, and releasing the arms to allow the apertures to return to their unstretched condition. The head of the first aperture prevents movement of the arm out of contact with the front surface of the frame.

As shown in fig. 46, the side arm 51 is shaped to extend rearward from the frame 3. From the first end of the side arm 51a, the arm diverges into an upper member 56a and a lower member 56b. As shown in fig. 48, these two members diverge to define an intermediate space that allows the inhalation and exhalation conduits 5a and 5b to pass through. The space also provides at least partial visibility of the sides 6a, 6b of the frame and/or the sides 14a, 14b of the patient interface body. This allows for inspection of the coupling between the frame and the catheter, and also allows for viewing of nearby identification features, such as the color-coded annular member 22 described above. This is also advantageous during assembly of the interface body 1 to the frame 3, as for embodiments where the frame is transparent or translucent, this enables the user to see if the interface body is already correctly located within the frame 3. At the point where the upper and lower members 56a, 56b diverge, a U-shaped cutout may be provided to improve the visibility of the frame sides.

The upper and lower members 56a, 56b are twisted about one quarter turn along their length. The upper and lower members 56a, 56b twist away from each other in opposite directions. The surface of the upper member 56a parallel to the front of the frame is twisted to face upward toward the adjacent connection pad 52. Instead, the surface of the lower member 56b parallel to the front of the frame is twisted to face downward toward the adjacent connection pad 52. This twisting stabilizes the space between the components to reduce the likelihood of interference with the conduits 5a, 5 b.

The upper and lower members 56a, 56b are connected to the front surface of the connection pad 52 at spaced points on the medial side of the connection pad 52. The opposite patient-facing surface of the connection pad 52 is configured for connection to a headgear or other connector. In an exemplary embodiment, the patient facing surface of the connection pad 52 includes a hooked or looped surface to engage with a complementary hooked or looped surface. The hook or loop surface may be overmolded onto the corresponding connection pad 52 or otherwise connected. The overmolding may advantageously provide a non-patient-facing surface of the connection pad 52 that is more easily wiped or cleaned. In a preferred embodiment, the connection pad 52 comprises an annular surface, particularly in the event that there is a risk of a portion of the connection pad contacting the wearer's skin.

Fig. 49-55 illustrate an alternative embodiment of the side arm 151 wherein the first end of the arm 151a includes a rigid portion 154 to facilitate snap-fit engagement with the frame. The rigid portion 154 may include a hard plastic clip, such as a polypropylene clip. The rigid portion is permanently connected to the remainder of the side arm 151, for example by elastomer over-molding of the remaining side arm to the rigid portion.

Fig. 53-55 illustrate another embodiment frame for use with a snap-in clip. In the frame 103 of this embodiment, a single projection 53 is provided in each frame connection region. The frame projection 53 is formed to have a plurality of engagement surfaces. For example, the tab 153 includes a hook 153, the hook 153 including a tab that extends toward a midpoint of the frame, spaced from the front of the frame. The tab 153 also includes a lip 153a for capturing a portion of the clip between the lip and the front face of the frame. In the illustrated embodiment, the projections generally have an anvil shape.

The clip 157 has a hole 158 for receiving the male portion and has lips 159a, 159b for engaging the lips on the male portion 153. To assemble the side arm 151 with the frame, as shown at m1 in fig. 54, the clip 157 is slid under the hook of the boss 153 and then pressed against the boss (m 2), causing the clip to bend and snap down around the boss. The lips 153a grasp corresponding lips 159a on the clip to secure the connection. The base of the projection 153 includes an angled surface 153c that diverges toward the hook 153 b. These surfaces abut the complementary angled surfaces 159a of the clip and serve to prevent movement of the clip toward the midpoint of the frame 103.

Stabilizing arm

Fig. 56-75 illustrate one embodiment of a stabilizing arm 60 that may be connected to the frame 3 and headgear 71 to help secure or support the patient interface body relative to the patient. In some embodiments, the stabilizing arms 60 may secure the interface body to the face of the user to help the interface body form and maintain a seal with the patient's face. The length or size of the stabilizing arms may vary such that a stabilizing arm of an appropriate size may be selected to best fit a given patient and/or to select a mask or cannula. It is envisaged that the stabilizing arm is primarily for a mask-type patient interface, but in some embodiments it may be for a nasal catheter-type interface.

In the illustrated embodiment, the stabilizing arm 60 includes a coupling portion 61a near a first end of the arm having a connection feature 63 for connection to the frame 3. A support pad 65 for connection to the headgear is provided at an opposite second end of the stabilizing arm 60, wherein the bridge 61 extends between the coupling portion 61a and the support pad 65.

Support pad 65 may be a forehead support pad for connecting to a headgear adjacent to the forehead of a patient. The end 61b of the bridge 61 is pivotally attached to the front surface of the support pad 65 at a pivot axis 62, which pivot axis 62 is substantially perpendicular to the longitudinal direction of the stabilizing arm 60, thereby enabling the support pad to rotate/pitch relative to the bridge 61. In the illustrated embodiment, the support pad 65 may be rotated/pitched approximately 180 degrees relative to the bridge 61 (limited by the front of the support pad 65 contacting the front of the arm 61). This allows the stabilizing arm 60 and any attached components to be flipped over and then flipped back as desired when the support pad 65 is connected to the headgear. This allows the caregiver to remove the components to perform a care task, such as cleaning the skin, without the need to completely remove and position the components before and after such a task.

Referring to fig. 72 and 73, in the example shown, a pin 62a for extending along pivot 62a is received by a hole of the connecting end 61b of the bridge. The pin 62a may be overmolded therewith.

The interface of pin 62a and connecting end 61b may be composed of different materials, which may enhance the pivoting of the two components relative to each other and prevent the two components from fusing together. The two materials may have different shore hardness values. For example, the connection end 61b may have a shore hardness value greater than the shore hardness value of the pivot pin 62 a.

In the illustrated embodiment, the pivot 62 is disposed in a lower portion of the support pad 65. In the illustrated embodiment, the pivot 62 is retracted back from the bottom edge between about one-fourth and one-third of the length of the support pad 65. This positioning ensures that there is sufficient connection area on both sides of the pivot and thus reduces the likelihood that the front portion of the support pad will disengage under force.

The patient facing surface of the support pad 65 is used to attach a cap or other connection. In an exemplary embodiment, the patient facing surface of the support pad 65 includes a hooked or looped surface to engage with a complementary hooked or looped surface. In the exemplary embodiment, the support pad 65 includes a hooked surface and the stabilizing arm 60 is of sufficient length to ensure that the hooked surface does not overhang the headgear and contact the patient when the stabilizing arm is installed. The stabilizing arms may be of several sizes to best ensure that the hooked surface is always properly aligned with the headgear. The contour or angle of the patient facing surface of the support pad 65 may conform to the curvature of the patient's head. As shown in the embodiments of fig. 56 and 75, the curvature may be slight or may be more pronounced.

The support pad 65 may comprise a compliant material such as TPE to provide patient comfort and facilitate connection to surfaces of different contours. The hooked or looped surface is preferably integral with the support pad 65, for example, the body of the support pad 65 may be overmolded with the looped surface.

In contrast, the bridge portion 61 and the coupling portion 61a include a substantially rigid material portion such as nylon. A flexible region 64 is provided at the base of the bridge adjacent the coupling to allow the arm to flex about the flexible region away from the patient or headgear during assembly or disassembly to prevent the pad 65 from grasping the headgear. The flexible region 64 also allows the coupling region 61a to flex/move relative to the rest of the arm, which aids in the assembly of the stabilizing arm to the frame 8. This relative deflection allows the coupling region 61a to "self-align" with the frame 3, making it easier for a user to engage the stabilizing arm with the frame 3.

The flexible region includes a length of bridging portion having arms of reduced wall thickness. The flexible region 64 includes a non-zero length of constant thickness, such as a length between about 2mm and about 10 mm. The region flexes along the length with a substantially uniform bending radius rather than at the inflection point, thereby avoiding the presence of stress concentrations associated with the inflection point. This allows materials other than polypropylene or polyethylene to be used if desired.

The thickness of the flexible region may be between about 15% and about 60% of the thickness of the main portion of the arm. In some embodiments, the thickness of the flexible region may be between about 25% and about 40% of the thickness of the main portion of the arm 60. In one embodiment, this corresponds to a thickness of between about 0.3mm to about 1.2 mm.

The thickness of the arm transitions from a reduced wall thickness at the distal end of the flexible portion to a greater thickness at the proximal portion of the arm. In some embodiments, the stabilizing arm is transparent or translucent to reduce visual impact of the arm so that the patient interface assembly appears less obtrusive.

The coupling portion 61a for connection to the frame 3 is adjacent the first end of the arm and includes a connection feature 63 for engagement with a complementary engagement feature on the frame body 8. In some embodiments, the connection feature 63 includes a hole to receive a central protrusion 67 on the front face of the frame such that the coupling is attached to the frame 3.

The projection 67 is located at the midpoint of the frame. The projection 67 comprises a post with an enlarged head at the end of the post. In the illustrated embodiment, the enlarged head has a square shape, formed by four triangular projections (lobes) 68 projecting outwardly from the top of the post. In alternative embodiments, the enlarged head may include alternative polygonal shapes.

The hole 63 on the coupling portion of the stabilizing arm is square corresponding to the shape of the projection 67. However, the holes 63 are oriented such that the diagonal of the square is substantially aligned with the longitudinal direction of the stabilizing arm and also aligned with the midline of the frame when the stabilizing arm is in the installed position. That is, in the installed position, the shape of the protruding head 68 and the shape of the stabilizing arm aperture 63 are angularly offset by about 45 degrees.

The top surface of the stabilizer arm coupling portion includes four generally triangular recesses 66 located on respective sides of the square hole 63. These recesses are shaped and positioned to receive the corresponding projections of the frame protrusions 67 when the stabilizing arms are in the installed position.

The connection of the stabilizing arm 60 to the frame 3 and the disconnection of the stabilizing arm 60 from the frame 3 will now be described with reference to fig. 63 to 71. To attach the stabilizing arm 60 to the frame 3 (or disconnect it from the frame 3), the attachment hole 63 of the arm is aligned with the head of the projection 67 so that the hole fits over the head of the projection and is then pressed onto the projection until the lower surface of the arm 60 contacts the frame 3 (see fig. 63 and 4). A large radius fillet 69 (fig. 59) may be provided around the edge of the aperture 63, at least on the lower surface (patient facing side) of the stabilizing arm 60, to help guide the stabilizing arm 60 into alignment with the projection 63.

In the connected/disconnected position of this embodiment, the stabilizing arm is at an angle of about 45 degrees to the frame midline. In alternative embodiments, the connection/disconnection position of the stabilizing arms may be greater or less than 45 degrees depending on the shape, number, and/or configuration of the protrusions 68. For example, in the connected/disconnected position, the stabilizing arm may be oriented between about 30 degrees and about 60 degrees relative to the midline of the frame.

The front surface of the projection 67 may be flush with the front surface of the stabilizing arm 60 or higher than the front surface of the stabilizing arm 60.

66-68, the stabilizing arm is rotated toward the installed position, where the stabilizing arm is aligned with the frame midline and "locked" into place. As the stabilizing arm 60 rotates between the connected/disconnected and installed positions, the corners of the enlarged head of the projection 67 press against the edges of the hole and recess. These edges provide a surmountable resistance to rotation. Further force applied by the user can overcome this resistance and move the arm quickly to the installed position shown in fig. 69-71. This movement of the protrusion past the interfering edge produces tactile feedback to the user.

In the mounted position, the projections 68 of the projections 67 are located in the respective recesses 66, with the legs of the projections passing through the holes 63. In this mounted position there is some play between the stabilizing arm and the frame. That is, the protruding portion 67 of the frame 3 can move within the boundary of the recess 66 in the stabilizing arm. Some play between the components facilitates easier assembly of the stabilizing arms to the headgear and enables fine adjustments, such as tilting of the arms, to properly position the connection pads 65 on the headgear to accommodate different head geometries.

Headgear with cap

Fig. 76-90 illustrate components of a headgear assembly for securing a patient interface assembly to a patient. Patient interfaces may include those described herein, but may also include other forms of interfaces. In an embodiment, the headgear and patient interface are for an infant or neonate.

Fig. 76 shows an embodiment headgear 71 in unassembled form. The headgear includes a base layer 72 and a headgear region 73 that form the body of the headgear. The headband region includes an outer engagement layer that at least partially overlaps and is fused to the lower portion of the base layer 71.

The overall length of the headband 73 is selected so that the headgear meets the target range of head circumference sizes. For neonatal and infant applications, the length of the headband 73 may be between about 15cm and about 60 cm. Headgear and headbands can be of a variety of sizes, each of which is intended to fit within a target range of head circumference sizes. In some different sized embodiments, the headband 73 may have a length that accommodates a circumference of the headband between about 17cm and about 22cm, between about 20cm and about 26cm, between about 24cm and about 31cm, between about 29cm and about 36cm, or between about 34cm and about 45 cm.

The headband has an on-ear region 74 shaped and positioned to at least partially cover the patient's ear to protect the wearer's ear from the attachment means and connector. The on-ear region 74 also advantageously provides a larger surface area for more securely coupling with the coupling component and for enhancing the pressure distribution of forces from the patient interface component through the larger coupling area.

The on-ear region 74 may be defined by an enlarged region relative to an adjacent headband region. These on-ear regions are sized to provide sufficient surface area for connection and proper positioning of a connector, such as the connector described in more detail below for connection and support of a patient interface.

In the illustrated embodiment, each ear region 74 includes a projection defined by a rounded lower edge of the headband that projects downward. The lower edge of the headband may be arcuate or generally crescent shaped. The lower projection projects below the lower edge of the headband region adjacent the front portion 73 a.

Each ear region 74 may additionally (or in some embodiments alternatively) include an upwardly extending projection defined by an upwardly projecting circular headband upper edge. These upper projections project upwardly from the top edge of the headband region adjacent the front portion 73 a. The upper edge of the headband may be arcuate or generally crescent shaped. In the exemplary embodiment, upper protrusions 76 are smaller than lower protrusions.

The height of the enlarged ear region may be 1.5 times or more the height of the adjacent front portion 73 a. For example, in the illustrated embodiment, the enlarged ear region has a height that is approximately twice the height of the adjacent front portion 73 a. 116 (i) through 117 in fig. 116 illustrate an exemplary embodiment in which the height of the front portions 573a, 673a of the headgear 573, 673 is reduced such that the height difference between the front portions of the headgear and the enlarged ear regions 574, 674 is more pronounced.

The dimensions of the on-ear region 74 may provide a sufficient securely retained area (purchase area) for connection of the connectors shown in fig. 87-91, 94-104, 121-123, and 127-129, as described below. The on-ear region 74 may have a height at least as great as the width of the corresponding connector at its second end. For example, between about 1 and 2 times the width of the second end of the corresponding connector. In some embodiments, the height of the on-ear region 74 may be about 1 and 1.5 times the width of the corresponding connector at its second end.

The front portion 73a of the headband 73 can extend directly to the front of the upper ear, with the two front portions 73a being collinear, as shown in embodiments 71, 171, 471 of fig. 76, 109 and (i) of fig. 115. Alternatively, the front portions of the headband may be inclined with respect to the horizontal direction so as to be inclined with respect to each other. 116 (i) and (ii) in fig. 116 and 117 illustrate alternative embodiments of headgear wherein the front portion 573a of the headgear region extends at a downward angle in front of the on-ear regions 574, 674. Such tilting of the front of the headgear area may improve the fit of the headgear to the patient's head, reducing accidental lifting of the headgear from the patient's head during use.

The headband front portions 573a, 673a may be inclined downward at an angle between 0 degrees and about 45 degrees, such as between about 15 degrees and about 30 degrees. In the exemplary embodiment shown at 116 (i) through 117 in fig. 116, the front portions 573a, 673 are inclined downwardly from the horizontal at an angle α of about 20 degrees. In an alternative embodiment, the right 473a, 573a and left 473a, 573a portions of the headband are inclined downwardly at different angles from each other. For example, the right portion 473a, 573a of the headband may be inclined downward at a greater angle than the left portion 473a, 573 a.

The front portion of the headband 73a on the left side of the headgear may be the same or different in length than the portion 73a on the right side of the headgear. In embodiments 71, 171, 471 of fig. 76, 109 and (i) of fig. 115, the lengths of the left and right portions 73a, 173a, 473a are substantially the same. In contrast, 116 (i) and (ii) in fig. 116 and 117 show alternative embodiments in which the headband is asymmetric, with one front headband portion 573a, 673a being longer than the other 573a, 673 a.

In general, the longer portions may be front headband portions 573a, 673a that are configured to wrap around and engage the outer surface of the underlying headband portion. The portion of the headgear that is configured to rest against the patient may be a shorter portion. In the illustrated embodiment, the right portion 473a, 573a of the headband is shorter than the left front portion 473a, 573 a. It should be understood that in alternative embodiments, this arrangement may be reversed.

The rear bridge 73b may be disposed between the on-ear regions 74 for positioning at or over the nape of the patient's neck. The bridge portion includes a lower edge continuous with the lower edge of the on-ear region 74 and an upper edge continuous with the upper edge of the on-ear region 74. The upper and lower edges are shaped such that the rear bridge 73b is narrower in height than the upper ear region, typically the shaped lower edge provides clearance for the base of the neck, thereby reducing pressure on the wearer's neck. This shape also helps the headgear conform to the patient's head because it minimizes fabric wrinkling, which helps the headgear lie flat on the patient and sit comfortably at the nape of the neck. In an exemplary embodiment, the lower edge of the rear bridge is concave such that the narrowest height of the rear bridge 73b is located at the center point of the portion.

The height dimension of the rear bridge 73b at its narrowest point may be equal to or less than the height of the headband front 73 a. For example, the narrowest point of the rear bridge 73b may have a height between about 0.5 and about 1 times the height of the front portion 73a of the headband, e.g., between about 0.6 and about 0.8 times the height of the front portion 73a of the headband. In one example, the height of the narrowest point of the rear bridge 73b is 0.75 times the height of the headband front 73 a.

The rear bridge may span a distance between the on-ear regions 74 that is between about 0.2 and about 0.8 times the length of the front headband portion 73a or a shorter headband portion. In some embodiments, the rear bridge may span a distance between the on-ear regions 74 that is between about 0.35 and about 0.55 times the length of the front headband portion 73a or a shorter one of the headband portions. The headband region 73 may partially or fully cover a lower portion of the base layer. In the illustrated embodiment, the lower edge of the base layer 72 extends beyond the lower edge of the headband region. The underlapping lower portion forms a lower lip that can soften the edge of the headgear for more comfortable skin contact. In the illustrated embodiment, a larger depth of the non-overlapping base layer 75 is disposed between the on-ear regions 74 in the region configured to span the nape of the patient's neck. The portion 75 aids in the headgear conforming to the patient's head and provides enhanced comfort.

The base layer 72 comprises a panel of flexible material, such as a fabric panel.

The flexible material may be an at least biaxially stretched fabric, the stretching direction being the width/circumferential direction of the headgear. The base layer preferably comprises only a single panel, thereby avoiding seams that occur when multiple panels are joined. The base layer may be a single layer or multiple layers of material.

In some embodiments, the base layer 72 may comprise a fabric or the like having a complete loop (UBL) surface to engage a connector having a complementary hooked surface.

The panels in the embodiment shown in fig. 76 are generally rectangular, but other shapes are also contemplated, such as trapezoidal. Fig. 109 and 111 (i) and (ii) show alternative shapes of the head cap body. In these embodiments 171, 271, 371, the panels (excluding the upper ear) are non-rectangular. In particular, the top edge of the headgear body is non-linear and includes one or more portions that are not perpendicular to the side edges. In contrast to the first embodiment 71, the length of the headgear body 172, 272 varies across the width of the headgear.

In the embodiment shown in fig. 109, the headgear body has an irregular pentagonal shape. The top edge includes two angled portions 172a, each angled portion forming an obtuse angle with a respective side edge 172b of the body. In the illustrated embodiment, each top edge has a corner 172a forming an angle of about 100 degrees with the corresponding side edge 172b, however, in alternative embodiments, other angles are contemplated, such as between 90 degrees and about 120 degrees.

The two angled top edge portions 172a meet at a central vertex 172c, the central vertex 172c being aligned with a point between the two ear upper portions 174. The length L2 of the headgear body at the apex 172c is greater than its length L1 at the side edges.

The angled top edge portion 172a has the following effect: when the top edges are gathered into a single point and secured, for example, using an end-securing device, the position of the end-securing device is moved forward relative to the patient, as described in more detail below. Fig. 110 (i) shows the first embodiment headgear 71 (fig. 76) worn by the patient, and compares it with the present embodiment headgear 171 in fig. 110 (ii). The length of the body of the first embodiment headgear is about the same as the length L2 of the apex 172c in the present embodiment headgear 171. The fixation points of the headgear 171 of the second embodiment are generally aligned with the patient's spine, rather than with the back of the spine. Such alignment may facilitate easy mounting of the headgear to a supine patient and easy movement of the adjustment mechanism along the body of the headgear. This may also reduce the risk of discomfort caused by movement of the adjustment mechanism and/or the end fixture under the patient's head.

Fig. 117 shows an alternative embodiment in which the shape of the headgear body approximates an irregular pentagon. In this embodiment, the apex 672c at the top edge may not be centered due to the asymmetry of the headband.

In this embodiment 671, the lengths of the side edge portions 672b are equal to each other, and the lengths of the two angled top edge portions 672a are also equal to each other. Because of the different lengths of the front portions 673a and the angled orientation of these portions 673a, the top edge portion 672a of the base portion 672 is asymmetric, having different tilt angles β, θ. The tilt angles β, θ may vary between about 0.2 degrees and about 5 degrees relative to each other. In some embodiments, the tilt angles β, θ may vary between about 0.5 degrees and about 2 degrees relative to each other. In the exemplary embodiment shown, the tilt angles β, θ vary by 1.5 degrees—the top edge associated with the longer headband front 673a has a tilt angle β of 11.5 degrees, and the other top edge 672a has a tilt angle θ of 10 degrees. However, other angular combinations are contemplated.

The top edge 672a of the headgear base 672 has different angles beta, theta, but the side edges 672b have the same length, and this configuration described above better aligns the overlapping portions of the base layers with the top edge and collapses upon assembly of the headgear.

The headgear body may have other shapes and may also provide the function of positioning the fixation points on the wearer's spine. In addition, or alternatively, it may also be desirable to remove some volume from the body of the headgear to make the headgear less cumbersome and/or to allow the adjustment member to more easily slide along the headgear.

Fig. 111 (i) and (ii) show two alternative embodiments 271, 371 that utilize cutouts 275, 375 in the top edges of headgear bodies 272, 372 to provide these functions. Both embodiments include triangular cutouts 275, 375 centered on the top edge. In embodiment 271 of fig. 111 (i), top edge 272a (except for the cut) is orthogonal to side edge 272 b. In the embodiment 371 of fig. 111 (ii), the top edge 372a (except for the cutout) is non-perpendicular to the side edge 372b, forming an obtuse angle therewith.

When the head caps 271, 371 are assembled, the top edges 272a, 372a (excluding the cutout portions) of the head cap bodies 271, 371 are folded and fixed at the fixing points. During this process, the two edges 276, 376 of each triangular cutout 275, 375 are drawn together. In some embodiments, these edges 276, 376 may be joined, for example, by stitching or welding or using an adhesive, alternatively, the edges 276, 376 may not be joined.

The illustrated embodiment illustrates a headgear having a single triangular cutout, however, alternative embodiments may include more cutouts and/or cutouts of different shapes, with similar effects of reducing at least the material of the upper portion of the headgear, and with the fixation points more forward relative to the wearer.

116 (i) and (ii) in fig. 116 show another example shape of the headgear base 572 with four corners 572a at the top edge. This top edge shape (which in this embodiment generally reflects the downward angle of the front headband portion 573 a) may result in less bunching than a rectangular body, and then the top 572a is bunched. In some embodiments, a cut may be provided along the top surface to further reduce bunching of the fabric.

The headband region and the lower portion of the base layer are used to wrap around and secure the wearer's head to provide an adjustable fit. A fastener such as a hook connector is provided on the underside of the headgear facing the patient in the headgear area near the side edge 72b of the headgear for securing the headgear to itself when the headgear is wrapped around the patient's head. One edge 72b of the headgear overlaps the other edge to the extent necessary to fit the circumference of the patient's head, and the fastener is attached to the engagement surface of the headgear area.

The headgear regions 73, 173, 473 include a flexible outer engagement layer having an engagement surface for releasably securing the connector to the headgear. The outer engagement layer most commonly comprises a fabric having a complete loop (UBL) surface to engage with a connector having a complementary hooked surface. The presence of such loops may be desirable for use as loop portions of a hook and loop fastener system. By this construction, a hook and loop fastener system can be provided without having to attach any additional loop providing components to the panel. This helps, at least to some extent, to provide a reduced thickness headgear.

In one embodiment, the outer joint layer covers substantially the entire headband area, alternatively the outer joint layer may cover a majority of the headband area. Alternatively, the outer bonding layer may cover only a portion of the headband region, such as the front and back sides of the headband. The outer tie layer may be in the form of a single panel, but may alternatively be provided in the form of two or more sheets.

In manufacturing the headgear, the base plate and the bonding layer may be cut into respective desired shapes, and then overlapped and connected to each other. Such a structure may be different from conventional methods, such as in laminates such as Briathe-o- In the case of a headgear, the headgear is constructed by cutting already laminated panel portions, and then joining the panel portions together to form the headgear or portions of the headgear. However, in some forms, at least some portions of the headgear may additionally or alternatively be cut once the headgear is lapped together, and possibly once one or more lap portions are joined together.

The outer tie layer is fused to the underlying portion of the inner base layer 72 and the inner surface of the outer tie layer is fused to the adjacent facing outer surface of the base layer 72. Fusion defines the melting of the layer or at least the constituent materials of the layer. With respect to fusing two panels together, fusing refers to fusing one panel into the other panel or fusing two panels to each other, respectively. Thus, the two panels may be fused by either: a) Only one panel or mainly one panel is melted into the other panel, or b) both panels are melted into each other at the same time.

Fusion may be non-additive in that fusion involves the handling of one or more panels and does not involve the use of any additional material, such as an adhesive interposed between two panels to fuse them together. Fusion may involve the application of one or both of heat and pressure to one or more panels.

The layers may be fused by welding, including plastic welding forms such as Radio Frequency (RF) or High Frequency (HF) welding, or ultrasonic, vibration or friction welding, hot edge welding, hot air welding or induction welding. The welding process is selected to be suitable for joining the base layer material and the joining layer material. The panels to be fused should comprise a meltable material such as rayon. Similarly, when the two panels are fused together, at least one of the two panels should comprise a meltable material, such as rayon. For example, materials such as PVC, CPVC, polyurethane, EVA, PVDC, PET, and nylon are suitable for radio frequency or high frequency welding.

Conventional headgear laminates comprising a foam layer typically do not fuse by welding, as welding reduces the cell characteristics of the foam, compresses the foam and hardens it. Accordingly, welding of conventional headgear is limited to welding the peripheral portion or edge of the panel overlap region. Since headgear according to the present disclosure may exclude the inclusion of one or more foam layers, the panels may be fused together in most or even all of their overlapping areas. For example, at least a relatively wide border may be fused around the perimeter of the overlap region, as compared to conventional laminated headgear.

Unlike conventional sewn connections, which require as small a seam size as possible to reduce its impact on comfort or visibility, panels that are joined by fusion can be fused together over a large area without producing a corresponding seam volume or a change in surface finish that would result from a larger sewn area.

The panel, particularly a woven or fabric panel, fused over a substantial portion of the panel, can provide a strong yet flexible performance to the headgear. The fused area may provide a visually clean and uniform surface for the panel. Selectively fusing and unfused different portions of the panel may allow for different material properties within different regions of the same panel or panels. It may also provide for differences in surface characteristics of different areas composed of the same panel or panels.

Fusion of the panels may be advantageous over other additional methods of joining the panels together, such as by stitching or using an adhesive. In particular, the weight of the connection plate can be reduced relatively and also the thickness can be reduced. Alternatively or additionally, the outer bonding layer may be attached to the underlying portion of the base layer by other means such as stitching or bonding.

The layers may be fused together in substantially the entire overlap region. Substantially the entire overlap area may be about 90% of the overlap area, or even about 95% of the overlap area. Preferably, however, the headband region includes a fused material region and a non-fused material region. The unfused region generally provides a greater secure retention of the connector than the fused region. However, the fused area provides some reduced firm retention. The unfused region at least partially defines a connection region for releasably securing the connector to the headgear.

The comparison of the heights or surface textures of the fused and unfused regions creates a visual contrast between the fused and unfused regions. In one embodiment, the fused regions form a pattern comprising dots and/or stripes. Alternatively or additionally, the non-fused regions form a pattern comprising dots and/or stripes.

The stripes may be straight, curved, wavy, or angled, for example, they may be aligned parallel to each other, form a grid, or otherwise oriented. The dots in the pattern may be uniformly or non-uniformly arranged, for example, in rows or grids, radiating from a dot, or randomly arranged. Alternatively or additionally, the fused or unfused regions may form text or decorations or a recognized shape such as a logo, for example, shaped details shown on the headband portion 73a of the headgear in fig. 76.

Fig. 82A and 82B illustrate two exemplary patterns of bonding the bonding layer to the base layer. In the embodiment of fig. 82A, a majority of the surface area of the headband 773 is fused to provide a connection area where there are parallel lines of unfused material in the front portion 773a of the headband and wavy lines of unfused material in the on-ear area 774. In the embodiment of fig. 82B, the pattern includes a grid of points of non-fused material on a first front portion 873a of the headband 873, a region of non-fused material defining fused points in an on-ear region 874, and non-fused size identification data on a second front portion 873a of the headband. It should be understood that the welding patterns of these exemplary embodiments are only two of a myriad of possible patterns, and that many other patterns are also contemplated.

The fusion of the layers may alter one or more properties of the one or more panels. For example, melting and resolidification of the panel material may cause the panel to one or more of become thinner, denser, stiffer, less stretchable, less recoverable, or have a greater yield strength when stretched. Thus, selectively fusing the headgear in different overlap and non-overlap regions may allow for control of the headgear's performance in addition to joining the panels together. Fusion of panels, for example, where one or both panels are fused to each other or partially fused together by welding, may result in thinning of the panel laminate (layup) at the fusion area. This is especially the case when the fusion is provided by applying pressure at the portions of the panels to be fused.

In an exemplary embodiment, the base layer 72 includes stretch fabric having stretchability in the width direction of the headgear. Optionally, the fabric may also have stretchability in the vertical direction of the headgear. The fabric may comprise a knitted fabric.

The base layer may be composed of a single panel, the base layer and preferably the headgear being free of internal and external seams. The potential reduction in the number and thickness of plates in the overlap and non-overlap regions of the headgear of the present disclosure may provide a reduction in the thickness of the headgear at a particular location or a reduction in the overall thickness of the headgear when compared to conventional headgear made from a connected laminate or multi-layer material. The reduced thickness, either in a particular location or over the entire headgear, may provide the patient with a visually and/or physically felt reduced volume. The reduced thickness may also provide greater comfort to the patient wearing the headgear.

Any such reduction in the number of panels and their thickness at different points of the headgear can correspondingly reduce the overall weight of the headgear.

In contrast, the engagement layer of the headband region may include a material having similar or lower stretchability than the base layer 72. The bonding layer may comprise a substantially inelastic material. The fused material region in the headband region can have an increased stiffness as compared to the unfused region. Additionally or alternatively, the fused material regions in the headband region can have reduced stretchability as compared to the non-fused regions. Thus, the particular fusing pattern may result in the headgear area 73 having reduced overall stretch as compared to the base layer 72. The difference in stretch properties of the fused and unfused regions may be used to reduce or increase the stretchability of selected regions and/or selected directions of the headband. That is, the shape, orientation, and/or location of the fused and unfused regions may be selected to control the manner in which the headband regions stretch or limit their stretch under load.

For example, it has been found that in some instances, limiting stretching of the headband or headband region, particularly in a generally longitudinal "horizontal" direction and/or in an angled or generally diagonal direction (about 45 degrees from the longitudinal direction) of the headband, may facilitate proper fixation of the headband. Longitudinal stretching of the headband portion can result in incorrect placement of the upper ear portion during donning of the headband on a patient, such as, for example, so that the upper ear portion is not located over the ear or in a position that is most appropriate for the patient's ear. Similarly, angular, diagonal, and/or longitudinal stretching in the upper ear may also inhibit proper placement of the upper ear, and limiting stretching in one or more directions in these areas may prevent the upper ear from moving away from the ear under patient movement.

Fig. 76 and 113 (i) through 114 (iii) illustrate some exemplary configurations of fused and unfused regions in the headgear area 73 to reduce longitudinal stretching of these regions. Referring to fig. 76, darker areas represent areas of fused material and lighter areas represent areas of unfused material. The left side of the headband in fig. 76 (as viewed) includes two continuous lines of non-fused material, with the fused material on the remaining left side of the headband forming a continuous line extending from near the upper ear to the edge of the adjacent headband 72 b. In other embodiments, at least one substantially continuous strip or ribbon of material extends substantially in the longitudinal direction, substantially across the entire width of the headband between the two side edges 72 b.

The (i) of fig. 112 through (iii) of fig. 114 provide further examples of fused patterns, i.e., the shape, orientation, and/or location of the fused and unfused regions, illustrating how the fused pattern may be utilized to adjust the stretch properties of the headband. Referring to fig. 112 (i) and 113 (iii), the headband may be fused along line 178, with line 178 extending generally in a direction where little or no stretching is required. The weld line may be straight, curved or have a curved portion. The weld line may be continuous or discontinuous. In the illustrated embodiment, a generally "horizontal" and generally "diagonal" weld line 178 is provided on the on-ear region 174 to limit stretching in these directions. These fused regions may be substantially continuous over one or more regions requiring limited stretch. For example, as shown in fig. 113 (i) through (iii), the fused region may extend across the entire width of the upper portion of the ear and along the headband, and/or the fused diagonal region may extend between the two edges of the upper ear region.

The headband will be able to stretch at any break in the fused area, and thus, where minimal or reduced stretch is desired, it is desirable to minimize any break dimension of the fused area in the direction of reduced stretch, or to ensure that the break dimension does not allow for stretching beyond an allowable amount. The non-stretched continuous line need not be entirely straight.

In the embodiment of fig. 112 (i) and (ii), intersecting diagonal lines and horizontal weld lines form diamond shaped pockets of unwelded material 179. These pockets 179 can still stretch freely within the boundaries surrounding the weld area. This ensures that the headgear can still flex to conform to the patient's head, resulting in a firm fit. Other shapes of the non-fused regions are contemplated, depending on the configuration of the fused regions and any requirements for the surface of the receiving connector. Some further non-limiting example shapes of unwelded pockets are shown in fig. 113 (i) through (iv), including parallelograms (i) in fig. 113), circular pockets (ii) in fig. 113, stars, and other irregular shapes or combinations of shapes (iv) in fig. 113. As shown in (iv) of fig. 113, not all pockets need to have the same shape, and one region may contain pockets or regions of different shapes.

Fig. 114 (i) to (iii) show alternative welding modes that limit headband stretching in the same horizontal and diagonal directions. In these images, light shaded areas indicate fused material, and dark shapes indicate non-fused material areas. The fused material is disposed along a line that does not require stretching, in this case along a line that passes generally horizontally across the width of the headband, and also along the diagonal of the on-ear region.

The fusion material in the examples (i) to (iii) in fig. 114 is substantially continuous along the desired line of strength reduction. The areas of circles, dots, or other shapes of non-fused material may be placed to appear random and obscure the limited stretch lines.

In some embodiments, it may be desirable to increase stretch in at least one region of the headband. For example, it may be desirable to add stretch in the longitudinal direction (horizontal/circumferential) of the headgear to achieve a tighter fit or better fit of the headgear to the patient's head. Fig. 115 (i) through 117 show further embodiment caps 471, 571, 671 in which the headgear 473, 573, 673 has regions 475, 575, 675 of increased stretch between the upper ear parts 474, 574, 674 at the back of the headgear.

In alternative embodiments, regions of increased stretch may be provided at different portions of the headgear 473, 573, 673 and/or more than one region 475, 575, 675 of increased stretch may be provided. For example, a region of increased stretch may be provided in front of one or both of the upper ear portions 474, 574, 674. For example, on the front 473a, 573a, 673a of the headband, adjacent one of the upper ear parts 474, 574, 674. In embodiments where the stretch-increasing region is provided on only one of the front portions 473a, 573a, 673a, the stretch-increasing region may be provided on the front portion 473a, which front portion 473a is configured as a covering portion when the headgear is worn, i.e., the front portion has hook-type attachments 476, 576, 676 (for securing the headband) on the underside.

In the embodiment of fig. 115 (i) through 117, the regions 475, 575, 675 of increased stretch include a region of the headband where the base layers 472, 572, 672 of the cap are exposed by a break or slit in the outer bond layer. That is, there is no outer tie layer in the regions 475, 575, 675 of increased stretch. Alternatively or additionally, the regions of increased stretch may be provided by regions of the outer bond layer that are not fused to the base layers 472, 572, 672.

The width of the zones 475, 575, 675 of increased stretch is selected based on the amount of stretch desired and the stretch properties of the base layers 472, 572, 672. The wider area generally provides more horizontal stretch to the headband than the narrower area. The regions 475, 575, 675 of increased stretch can also provide increased stretch in other directions, particularly in embodiments where the base layers 472, 572, 672 comprise materials having four-way stretch. The width of the stretched regions 475, 575, 675 can be selected to increase to provide the desired stretch while still ensuring that the headgear has sufficient stability to interface with the respiratory interface component while the on-ear regions remain aligned with the patient's ears. Depending on the characteristics of the base layers 472, 572, 672, the gap in the outer bonding layer may be too wide, which may cause the lower edge of the base layer to curl upon stretching and/or may make the headgear prone to fatigue in areas of increased stretching of the base layer.

The length of the break or gap in the outer joint layer and/or the region of increased stretch may be between about 5% and about 50% of the length of the headband, such as between about 10% and about 35%. In one embodiment, between the on-ear regions 474, 574, 674, a gap in the outer cover layer of approximately 20% of the headband length is provided.

In one embodiment, the break or gap in the outer tie layer and/or the length of the region of increased stretch may be between about 5mm and about 35mm, for example between about 20mm and about 30 mm. In one embodiment shown in fig. 115 (i) and (ii), an outer bond layer gap of about 28mm is provided between the on-ear regions 474.

Additionally or alternatively, the pattern of fused and unfused material regions of the headband region may be configured to increase stretching of selected regions of the headband in the horizontal direction. That is, the shape, orientation, and/or location of the fused and unfused regions may be selected to control the manner in which the headband region stretches, or to provide increased stretching in the horizontal direction under load.

Referring to (i) in fig. 115, darker areas in the headband region represent fused regions and lighter areas represent unfused regions. In the on-ear region 474 of this embodiment, the fused points are arranged in the pattern such that there are parallel columns of non-fused material in a direction HS that is substantially perpendicular to the desired horizontal stretch direction. The columns of non-fused material allow for some stretching of the upper ear portion 474 in the horizontal direction. The pattern of dots is also configured to reduce or minimize stretching in the direction of the interface pull. This is accomplished by eliminating or minimizing continuous lines of any unwelded material in a direction perpendicular to the interface pull direction IP. In other embodiments, other shaped fused regions may be used instead of or in addition to the points shown in (i) in fig. 115.

It is contemplated that many other shapes and configurations may be used for the fused and unfused regions. As an example, fig. 114 (iii) shows an embodiment with a "V" shaped unfused area on the upper ear and a circular unfused area elsewhere. The shape of the non-fused regions may be selected to optimally alter the stretch, and/or may be selected to provide indicia or visual features on the corresponding surfaces. For example, the shape may indicate which component is attached to the area, and/or may indicate the correct attachment direction.

The dimensions of the fused and unfused regions may vary in various regions of the headband. For example, the enlarged on-ear region may include a larger region of less dense unwelded material. The headgear straps in front of the ear region may include a higher density of smaller unwelded regions. The difference in weld size between the upper ear portion and the remainder of the headband helps to visually distinguish these areas.

In alternative embodiments, similar restrictions on stretching in certain directions or regions may be achieved by a multi-layer headband that includes a non-stretching layer with one or more incisions. The shape and/or orientation and/or location of the cuts are selected in a similar manner as the non-fused regions of the above-described embodiments to reduce stretching of the corresponding regions of the headband in one or more directions as compared to regions without the cuts.

The underside of the headgear area that contacts the patient may include an adhesive surface to provide an area of increased friction between the headgear and the wearer and to reduce unintended movement of the headgear on the patient's head. The adhesive surface may prevent the headband from rotating sideways or forward/backward. Such movement of the headgear may cause the patient interface to move out of position and/or may cause a reduction in the seal between the interface and the patient.

Fig. 115 (ii) and 116 (ii) illustrate exemplary placement of adhesive surfaces 477, 577 on the underside of headband regions 473, 573. The height of the adhesive surface may be between about 20% and about 100% of the height of the headband in the overlap region. In the embodiment shown in fig. 115 (ii), the area 473b adjacent the bottom edge of the headband 473 is free of material that provides an adhesive surface. The adhesive surface may increase the stiffness of the headgear, so that too large an area may reduce the fit to the patient's head. Furthermore, it is contemplated that the clinician may hold half of the cap at the lower edge while pulling the other half of the cap around the head to secure. The region of the lower edge of the headgear without the adhesive surface may prevent the adhesive surface from inadvertently sticking to the fingernail or glove of the clinician during this process.

Optionally, small gripping areas 478, 578 may be provided on the outer surfaces of the headgear 473, 573. The gripping areas 478, 578 are positioned on a front portion of the headband that is configured to wrap under another (upper) front portion. The gripping areas 478, 578 are positioned to grasp the adhesive surfaces 477, 577 of the underside of the upper portion of the headgear when the headgear is wrapped around the patient's head and over the gripping areas. In addition to providing additional anchoring between the lower and upper portions of the headgear, the gripping areas may also help obtain a firm fit of the headgear by preventing or reducing slippage between these surfaces when securing the hook attachments 476, 576 to the headgear engagement layers.

The adhesive surfaces 477, 577 and/or the gripping areas 478, 578 may include an adhesive film or coating, or may include a friction layer adhered or bonded to an inner surface of the base layer at the headband region. For example, a material such as BemisTM tape. The adhesive surface may be continuous along the length of the headband region or may include discrete regions. Discrete areas may be provided in areas where increased friction is desired. The adhesive surface may comprise a linear strip or may be applied to form a pattern, for example comprising curves and/or dots.

The regions of the headband where the small gripping regions 478, 578 are disposed may be non-fused regions.

In one embodiment, the tacky surface is provided by a polyurethane elastomer, neoprene, non-stick silicone, and/or thermoplastic polyurethane layer. The adhesive surface may comprise a material suitable for contact with skin and may be disposed on substantially all of the underside of the headband, on a majority of the underside of the headband, or may cover only a portion of the underside of the headband.

End fixing device

Referring to fig. 76-78, 109, and (i) and (ii) of fig. 111, the top edges 72a, 172a, 272a, 372a of the base layers 72, 172, 272, 372 are secured together at a securing point. The top edges 72a, 172a, 272a, 372a of the base layer may be gathered, pleated, folded, rolled or otherwise gathered to reduce the width of the brim top edges 72a, 172a, 272a, 372 a.

End fixtures 81 may be provided to mechanically retain the top edge in this gathering configuration.

In one embodiment shown in fig. 78 and 79, the end securing device is a bulbous-like component having two side members 82a, 82b, the side members 82a, 82b being configured to engage one another to sandwich the gathered, pleated, folded or rolled upper edge of the substrate between the sides 82a, 82 b. The two side members 82a, 82b may comprise a soft, flexible material, such as fabric. The fabric may be one having a synthetic composition to enable the two side members to be peripherally fused using the techniques described above. In the exemplary embodiment, side members 82a, 82b comprise a knitted nylon, optionally a complete loop (UBL) material, although other materials are also contemplated. Alternatively, the side members may be attached by stitching, bonding together, or otherwise, particularly where the material does not include a synthetic or fusible component.

A compliant middle layer 83 may be provided between the two side layers. In the illustrated embodiment, the intermediate layer 83 includes a foam layer having a cutout 83a to accommodate the gathered, pleated, folded or rolled upper edge 72a of the base layer. The middle layer 83 may be attached to both side members 82a, 82b, e.g., a first surface of the middle layer 83 may be bonded to the first side member 82a and an opposite second surface of the middle layer 83 may be bonded to the second side member 82b. Alternatively, the middle layer 83 may be fused to the side members 82a, 82b, or may not be attached to the side members 82a, 82b and simply remain between the side members 82a, 82b.

In embodiments, adhesion to the intermediate layer may be provided by polyurethane elastomers and/or thermoplastic polyurethane or other suitable adhesives or tacky materials, such as copolyamide hot melt adhesive films or copolyester hot melt adhesive films. The adhesive or cohesive material may be disposed on substantially all, most, or only a portion of the respective surfaces of the intermediate member and/or the respective side members 82a, 82b. The middle layer 83 may be hot pressed with the side members 82a, 82b to fuse the layers together.

Adjusting device

An adjustment device 85 is provided for assembly with the headgear 71 to adjust the wearable length or depth of the headgear. The adjustment device is assembled to be positioned between the headband region and the end fixture 81. The flexible base layer 72 of the headgear passes through the adjustment device 85 and the adjustment device can be selectively slid along the body of the headgear toward and away from the headgear area. The end fixtures 81 limit the travel of the adjustment device along the fabric, thereby preventing the adjustment device from being inadvertently removed from the headgear.

The adjustment means 85 comprises a first engagement member 86 and a second engagement member 87 for engaging the body of the headgear at two spaced apart engagement points. The first and second engagement members 86, 87 are disposed on opposite sides of the hinge region 89 such that the first and second engagement members 86, 87 can move toward and away from each other.

The first and second engagement members 86, 87 comprise annular members extending inwardly from respective sides of the device. The annular member defines a first aperture 88a and a second aperture 88b for receiving the body of the headgear. The apertures are sufficiently sized so that the body of the headgear can fit snugly and slide through the apertures, but are small enough so that they cause the body members to gather.

The apertures 88a, 88b may have any suitable shape, such as circular, oblong, square, D-shaped, keyhole-shaped, or tear-drop-shaped.

In the embodiment of fig. 83-84, the first engagement member 86 includes a pair of spaced apart rings defining two respective collinear apertures. The two rings may be parallel, as shown, or may be convergent or divergent. Alternatively, however, the first engagement member may comprise only a single member 186, as shown in embodiment 185 of fig. 86.

The device 85 also includes a guide bore 90 to receive and slide along the body of the headgear. The aperture 90 may have any suitable shape, such as oblong, rectangular, square or circular, but is preferably symmetrical about the hinge axis 89. The aperture 90 is sufficiently sized so that the body of the headgear can fit comfortably and slide through the aperture.

The guide member 90 is defined between two hinge members 91. In the illustrated embodiment, the hinge members are arcuate members extending between the sides of the device, with the upper apex of the arch aligned with the midline of the device.

The hinge member is integral with the sides of the device but the reduced cross-sectional area at the midline of the device enables the device to hinge about the apex of the hinge member 91.

The first and second engagement members 86, 87 may be moved toward each other by pressing them toward each other, thereby flexing the device 85 about the hinge region. Finger grips 91a, 91b on either side of the hinge on opposite sides of the device 85 may provide improved secure retention for the user to facilitate pressing the first and second engagement members 86, 87 toward each other. The finger grips 92a, 92b face outwardly on the side surface from which the engagement member extends.

The finger grips 92a, 92b are regions spaced apart from the hinge 89 and may include a textured or contoured surface, or may include a layer or coating of material that provides improved friction or compliance as compared to the body of the device. As an example, in the embodiment of fig. 83-85, a first one of the finger grips 92a includes an oblong concave recess. The second one of the finger grips 92b includes two raised transverse ribs. Many other configurations of finger grips are possible.

Referring to fig. 85, the first and second engagement members 86, 87 may be moved toward each other by pressing the sides of the device toward each other at the finger grips 92a, 92 b. The first and second engagement members 86, 87 are movable to a position substantially overlapping between the first and second apertures 88a, 88 b. This is the free state of the device 85, wherein the device is free to move along the body of the headgear towards and away from the headgear area.

In the embodiment of fig. 83-85, the device 85 has two parallel first engagement members 86. The second engagement member 87 is configured to slide between the two first engagement members when the first and second engagement members are moved relative to each other.

In the free state, the first and second apertures 88a, 88b may be generally aligned with the guide aperture 90 such that the material passing through the device follows a generally straight path.

The hinge region 89 is resilient and wherein upon release of pressure from the sides of the device, the first and second engagement members 86, 87 move away from each other to the locked state shown in fig. 83, 84 and 86. This locked state is a rest state of the device, wherein the hinge biases the device into this state.

In the locked position, the first and second apertures are not aligned with each other. The first and second holes 88a, 88b may also be misaligned with the guide holes 90. For example, only a small portion of the first and second apertures 88a, 88b may overlap, or may not overlap. This misalignment causes the engagement areas of the first and second engagement members 86, 87 to grip the body of the headgear to hold the device in place relative to the material. In this state, the body of the headgear follows a coiled or tortuous path through the device 85 to provide resistance to the headgear body being pulled through the device.

By pressing the first and second engagement members towards each other, the device 85 can be adjusted from the locked state to the free state.

Fig. 105-107 illustrate an alternative embodiment adjustment device 285 for grasping the flexible body of the headgear. The adjustment device 285 is smaller and less visually intrusive than the embodiment of fig. 83-86. The adjustment device 285 includes a flexible body having opposite first and second sides 286, 287 and first and second ends 292a, 292b, the first and second sides 286, 287 and first and second ends 292a, 292b together defining an aperture 288 therebetween to receive the flexible body of the headgear.

The opposite first and second ends 292a, 292b of the device 285 are movable toward and away from each other to adjust the device 285 between the locked and free states. In the locked state, the device 285 clamps the flexible body of the headgear in the aperture 288 to hold the device in place relative to the material. In the free state, the grip of the device is released sufficiently to enable the device to move along the material, thereby adjusting the position of the device relative to the material.

The side walls 286, 287 each have convexly curved inner surfaces that are curved such that the bore 288 is narrowest at or near the center of the bore. This occurs at the midline of the device, intermediate the first end 292a and the second end 292 b. Referring to fig. 107, in the illustrated embodiment, the bore 288 has an hourglass shape with a necked down region at its center and is widest proximate the ends 292a, 292b of the device. When the device is in the locked state, the headgear is clamped between the convex side walls and held tightly by the necked down region of the device.

The device 285 is resiliently biased toward the locked state such that in the resting state, the device grips the headgear material in the aperture 288 without the application of force. To release the material, the user must press the first and second ends 292a, 292b toward each other, causing the side walls 286, 287 to flex outwardly about the end hinge points, widening the central (necked) portion of the bore 288. The first end 292a and the second end 292b may include finger grips to facilitate pressing the ends toward each other. For example, the finger grip may be provided with protrusions, depressions or a textured surface.

Optionally, the adjustment means may include internal gripping features (e.g. protrusions) to enhance the gripping of the received material by the device. Fig. 107 illustrates an embodiment device 386 in which the inner surfaces of the first and second sidewalls include protrusions in the form of oppositely protruding complementary steps 386, 387. One step 387 is positioned at or towards the top of the device and the opposite step is positioned at or near the bottom of the device. When the device is in the locked state, the headgear is clamped between the two side walls and held tightly between the two steps 386, 387. In the locked condition shown in fig. 107, the two steps 386, 387 overlap such that when the device is in the locked condition, material passing through the device bends, along a non-linear path, creating resistance to material being pulled through the locked device.

When the user presses the device into the free state, the two steps move relative to each other, enabling the device to slide along the headgear, thereby adjusting the wearable length of the headgear. In other embodiments, other forms of internal gripping features may be provided, such as alternatively shaped protrusions or steps, recesses, or textured surfaces.

In other embodiments, the internal gripping features may be provided by alternative protrusions or indentations or other recesses to assist in gripping the fabric body on one or both sidewalls. Fig. 108 (i) and 108 (ii) illustrate another embodiment including a notch in both side walls 486, 487 at the necked down region of aperture 488. In the illustrated embodiment, a pair of notches are opposite each other, approximately at the midpoint of the device 485, and opposite each other. These notches may assist in gripping the flexible body of the headgear. The notch may assist in bending or protruding the side walls 486, 487 outward when the first end 492a and the second end 492b are pressed toward each other to widen the center portion of the aperture 488. In the embodiment shown, the recess has a triangular profile, but other shapes are possible.

The top and/or bottom surfaces of the devices 285, 385, 485 may be contoured to abut curved surfaces of the wearer's head. That is, the height of the device may decrease toward the midline of the device. In the illustrated embodiments 285, 385, the top surface and/or the bottom surface are contoured. This means that the device can be used in either direction and is not inadvertently "inverted" for use.

The device comprises an elastic material, preferably a relatively soft material. Non-limiting examples include thermoplastic elastomers, silicones, or thermoset elastomers. The device may be a single component formed from a single material. Alternatively, the device may be integrally formed from more than two materials.

Side connector

A flexible connector 93 may be provided to couple an interface member (e.g., a side arm of the patient interface assembly described above) to an on-the-ear region of the headgear. Fig. 87-90 illustrate one embodiment of a flexible connector 93, wherein the connector is a multi-layer connector.

The connector includes a patient interface connection area 97 on the front surface of the connector adjacent the first end of the connector for connection to the connection pad 52 of the respective side arm. Patient interface connection region 97 may include a hooked surface connector for engaging with a looped surface.

Two spaced apart upper and lower connection regions 98a, 98b for coupling to the headgear are provided on the lower surface of the device at the second end of the device. The upper and lower attachment regions 98a, 98b may include hook-like connectors for engagement with the annular surface.

The flexible connector 93 may include outer fabric layers 94, 95 with a reinforcing layer 96 sandwiched between the outer fabric layers 94, 95. The reinforcing layer is typically a flexible polymer layer and may for example comprise a nylon sheet. The reinforcing layer is smaller than the outer fabric layers 94, 95 such that the reinforcing layer does not extend completely to the peripheral edge of the connector, thereby softening the edge of the connector. Fig. 89 illustrates the position and size of the reinforcement layer 96 relative to the patient-facing layer 94. In an embodiment, the edge 96a of the stiffening layer is spaced about 2.5mm from the edge of the patient facing layer.

The front outer fabric layer 95 may include a bonding surface to enable other components to be attached to the surface of the connector. In an exemplary embodiment, the front outer layer 95 may comprise a complete endless (UBL) fabric.

The patient facing fabric layer 94 is a comfort layer, for example, comprising a material that is soft on the skin and less likely to pinch the skin. In one embodiment, the patient-facing fabric layer 94 may comprise the same or similar fabric as the base layer 72 of the headgear 71 described above. The comfort fabric layer may be larger than the front layer 95 and the reinforcement layer such that the edge 94a of the inner fabric layer extends around the perimeter of the connector, forming a soft edge to protect the skin from the reinforcement layer 96.

In one embodiment, the reinforcement layer is offset between about 1mm and about 2.5mm inward from the perimeter of the comfort layer. For example, the reinforcement layer may be offset inwardly from the perimeter of the comfort layer by about 2.5mm and inwardly from the front layer by about. However, it is apparent that other configurations are possible.

The patient facing fabric layer 94 and/or the front outer fabric layer 95 preferably each comprise a material that is fusible using a selected fusing method. The layers should be of sufficient density so that the reinforcing layer 96 does not melt through the outer layers during the fusion process and so that the edges do not significantly fray or curl.

In some embodiments, the patient-facing fabric layer 94 and/or the front outer fabric layer 95 comprises a non-stretch fabric or a fabric having a low level of stretch. In other embodiments, the layers may be fused to minimize any stretching of the connector as a whole.

The patient contacting underside of the flexible connector 93 may include an adhesive surface to provide an area of increased friction between the headgear and the wearer to reduce the incidence of movement of the connector on the patient's face. The tacky surface may comprise an adhesive film or coating, or may comprise a friction layer bonded or bonded to the inner surface of the patient-facing fabric layer 94. The adhesive surface may be continuous along the length of the connector or may include discrete areas. The discrete areas may be provided in areas where increased friction is desired. The adhesive surface may comprise a linear strip or may be applied to form a pattern, for example comprising curves and/or dots.

In one embodiment, the tacky surface is provided by polyurethane elastomer, neoprene, non-stick silicone, and/or thermoplastic polyurethane. The adhesive surface may comprise a surface adapted to contact the skin and may be disposed on substantially all of the patient facing side of the connector, on a majority of the patient facing side of the connector, or may cover only a portion of the patient facing side of the connector 93.

The layers of the connecting member may be fused together using any of the methods described above in connection with headgear. The connecting member may include regions of fused material and regions of unfused material forming a pattern such as that shown in fig. 90. The pattern created by the fused material areas and the non-fused material areas is visible at least on the outer (non-patient facing) side. Patterning may be used to indicate the correct orientation of the connector to identify the dimensions or other characteristics of the connector side, or may be a pattern corresponding to the pattern of the headgear or the connector region.

The pattern may also be selected to provide a connection zone at the portion of the connector for attaching additional components or connectors, such as the chin strap 1500 described below. For example, such attachment areas may include a larger non-fused UBL area for a more secure attachment with the hook connector.

Fig. 94-104 and 121-123 illustrate details of an exemplary further embodiment flexible connector that includes a comfort surface and an optional stiffening member or layer at least on the patient-facing side of the connector. The comfort surface may comprise a woven or non-woven material. Such patient-facing comfort surfaces may be textured to reduce potential surface contact with the patient, thereby minimizing the likelihood of the connector feeling "tacky" or "sticky.

The width of the connector increases from the first end to the second end. A patient interface connection region is disposed near the first end of the connector and at least one connection region is disposed near the second end of the connector for attachment to a headgear.

Fig. 94-99 and 121-123 illustrate three additional embodiment flexible connectors 593, 693, 1793 that include reinforcement layers 596, 696, 1796 and comfort layers 594, 694, 1794. For the previous embodiments, the connectors 593, 693, 1793 include patient interface connection regions 597, 697, 1797 proximate to the first ends of the connectors. Two spaced apart upper and lower connection regions 598a, 598b, 698a, 698b, 1798a, 1798b are provided for coupling to headgear. The comfort layer may be a nonwoven layer.

Patient interface connection areas 597, 697, 1797 are provided on the outer, non-patient facing surface of the connector for connection to the pad 52 of the respective side arm, or to another component. Headgear connection regions 598a, 598b, 698a, 698b, 1798a, 1798b are provided on the patient facing lower surface of the connector. The patient interface connection areas 597, 697, 1797 and the upper and lower connection areas 598a, 598b, 698a, 698b, 1798a, 1798b may each include connection pads or areas. The attachment pad or area may comprise a mechanical fastener, such as a hooked attachment pad or area for engagement with a hooked surface, or a looped pad for engagement with a hooked surface.

The stiffening layers 596, 696, 1796 comprise a harder and substantially more rigid material than the material of the comfort layers 594, 694, 1794. For example, the reinforcing layer may comprise a relatively inelastic thermoplastic material, such as polypropylene, polyethylene, nylon, PET, or polyurethane, depending on the material of the comfort layer. The stiffening layers 596, 696, 1796 enable the connector 593, 693, 1793 to retain its shape while preferably still allowing some flexing of the connector and enabling the connector to transfer loads and withstand torsional loads during use without excessive buckling or twisting.

The reinforcement layers 596, 696, 1796 may extend through substantially all or most of the connectors 593, 693, 1793, or may be provided only in one or more areas where reinforcement is desired. In some embodiments, the reinforcement layer may be a single member. In other embodiments, the reinforcement layer may be composed of multiple components that may move relative to each other, for example. Fig. 97 and 121-123 illustrate two embodiments of connectors in which the stiffening layers 596, 1796 are a single member, but are not located over the entire length of the connectors 593, 1793. In these embodiments, the reinforcement layers 596, 1796 extend from the first end of the connector and through the central region of the connectors 593, 1793, but do not extend to the second end of the connector. This allows the second ends of the connectors 593, 1793 to flex for better fit and thus a more secure connection with the headgear.

Other shapes, positioning or configurations of the reinforcing layer or other reinforcing member are contemplated to prevent buckling and twisting of the connector during use. The stiffening layer is preferably provided at least in the central region CR of the connector (shown in fig. 97) where the tendency to buckling or twisting is generally highest. The reinforcing layer may follow the general shape of the connector or may have a different shape selected to support the loads experienced by the connector in use.

The stiffening layer may be generally planar, as shown by connector 593 of fig. 94-97 and connector 1793 of (iii) of fig. 121-124, or it may be curved, as shown in embodiment 693 of fig. 98 and 99. The curved profile of the connector 693 of fig. 98 and 99 is shaped to generally follow the contour of the wearer's face. That is, the patient facing surface of the connector 693 has a concave curvature, and the outwardly facing surface of the connector 693 is convex.

Such a curved profile may advantageously reduce the likelihood that the "flatness" of the arms will pull the connector from the headgear. The curved profile reduces the force required to bend/conform the arm around the face and may reduce the required connection force between the connector and the headgear and/or interface assembly. The curved profile may thus help to maintain the connection between the connector and the headgear.

The curved profile may advantageously move the intermediate region of the connector outwardly from the face proximate the patient's eye, thereby reducing the risk of contact between the connector and the eye region. It may also reduce the likelihood of pressure points forming between the intermediate region of the connector and the patient's face.

The reinforcing layer may have a substantially uniform thickness, or the thickness may vary over the connector or in different regions of the connector.

The comfort layers 594, 694, 1794 comprise a relatively soft material disposed on at least the patient facing side of the connector. The comfort layers 594, 694 may include a compliant, optional nonwoven material. The patient-facing surface of the connector is shaped to be substantially smooth and free of protrusions. The patient facing surface may include a textured surface to reduce potential surface contact with the patient, thereby minimizing the likelihood of the connector feeling "tacky" or "sticky. The comfort layer typically extends across substantially all of the connectors 593, 693, 1793 on the patient facing side and covers a larger area than the reinforcement layers 596, 696, 1796, extending beyond the periphery of the reinforcement layers 596, 696, 1796. This ensures that only the softer comfort layers 594, 694, 1794 will contact the patient, thereby protecting the patient from contacting the relatively hard edges of the stiffening layer.

As an example, in the embodiment of fig. 97, the peripheral edges 96a of the stiffening layers 596, 696 are spaced about 2.5mm from the peripheral edges of the comfort layer at their closest points. However, the spacing may be smaller or larger, depending on the characteristics and/or geometry of the connector, the characteristics and/or geometry of the comfort layer, including the presence of any edge features that will be described in more detail below.

The comfort layer may comprise an elastic material. Non-limiting examples include silicone, foamed polymer, or thermoplastic elastomer. Alternatively, the comfort layer may comprise, at least in part, a fabric. The comfort layers 594, 1794 may be overmolded or co-molded with the reinforcement layers 596, 696, 1796 to ensure a secure connection between the layers.

The geometry of the reinforcing layer may be shaped or include features such as cuts, striated features, recesses or holes to control the stiffness of the reinforcing layer and/or to strengthen the connection with the comfort layer. In some embodiments, the reinforcement layer may include a cutout adjacent the first end or the second end at the connection point. Such cuts may increase flexibility at the connection points with the interface and/or headgear, thereby increasing the strength of the connection with the interface and/or headgear. In other embodiments, the reinforcement layer may include incisions in at least a middle portion of the reinforcement layer to control the flexibility/stiffness of the reinforcement layer in different directions.

Referring to fig. 124 (i) to (iii), the reinforcing layer 1796 is rigid about its longitudinal axis in the in-plane direction B1 (fig. 124 (i)) and out-of-plane direction B2 (fig. 124 (ii)), but flexible about the transverse axis in the out-of-plane direction B3 (fig. 124 (iii)). This flexibility allows the side connector to flex to fit the patient's face and facilitates a secure connection of the two ends of the connector. The rigidity in the B1 and B2 directions enables load transmission along the connector and prevents the connector from twisting.

A cut 1790 may be provided in the reinforcement layer 1796 adjacent to the first end of the connector 1793 to enhance flexibility. The cutout 1790 may facilitate engagement of the first connection pad 179, for example if the component is overmolded.

The (i) to 127 in fig. 125 provide examples of example embodiment stiffening layers 1896, 1996, 2096, 2196, 2296, 2396, 2496 having patterns 1895, 1995, 2095, 2195, 2295, 2395, 2495 of various shapes, sizes and pattern densities of thinned regions or incisions in the form of slits to increase flexibility in direction B3 to a desired level. In embodiments such as those of fig. 125 (ii), 126 (ii) and (iii), slits or thinned regions 1995, 2295, 2395 are provided on the central portion of the connector. In other embodiments, the area with the slit may extend to the second end of the connector.

Incisions 1890, 1990, 2090 may be provided in reinforcement layers 1896, 1996, 2096 adjacent to the first end of the connector to enhance flexibility. The cutouts 1890, 1990, 2090 may facilitate engagement of the first connection pad.

In embodiments such as those in (i) through (iii) of fig. 125, slits or thinned regions 1895, 1995, 2095 may extend to the periphery of the reinforcement layer. In alternative embodiments such as those of fig. 126 (i) through 127, the slits 2195, 2295, 2395, 2495 may terminate at points spaced from the periphery of the stiffening layer, leaving the peripheral edge of the stiffening layer intact. The complete periphery may advantageously increase the stiffness in the desired direction B1, B2.

The slits or thinned regions may be substantially straight, or they may be curved or otherwise shaped, e.g., they may be straight, arcuate, semi-circular, angular, or formed from a combination of straight and curved portions. A given reinforcing layer may include various differently shaped slits or thinned regions. The non-linear slits 2295, 2395, 2495 such as those in fig. 126 (ii), 126 (iii), and 127 may each define a tab that moves relative to the remainder of the body of the reinforcement layer during flexing. This may result in a larger increase in flexibility compared to a straight slit.

The slits or thinned regions may be arranged in rows and/or columns. The rows or columns or slits or thinned regions may be aligned, for example, as shown in (ii) of fig. 125 and (iii) of fig. 126, or they may be staggered, for example, as shown in (i) of fig. 125 through (i) of fig. 126. The spacing, positioning and size of the slits or thinned regions may be such that there is minimal or no overlap between parallel rows, or such that there is significant overlap.

The slits or thinned regions may all be of the same size, or they may have different widths and/or lengths. For example, larger slits or thinned areas may be provided in a wider area of the reinforcing layer and/or where more deflection is desired. The orientation of the slits or thinned regions may be uniform or may vary across the reinforcing layer. For example, in embodiments where the rows or columns are arranged, the orientation may vary between two rows or columns. The illustration (iii) in fig. 126 shows an exemplary embodiment in which each slit 2395 has a three-sided central portion defining a generally rectangular tab or tab, with two lateral legs of the slit extending from either side of the central portion. The transition between the sides of the central portion and the lateral legs may be angled or curved. The slits of the embodiment of (iii) in fig. 126 are arranged in two longitudinal rows, symmetrical about the central longitudinal axis of the reinforcement layer. Alternatively, the reinforcement layer may include more or fewer rows or columns of slits. Adjacent columns may be aligned or staggered. In the illustrated embodiment, the size of the slit in the transverse dimension increases along the reinforcing layer as the width of the reinforcing layer increases. In alternative embodiments, the slits may all have substantially the same dimensions, or may vary in another dimension.

The slits or thinned regions may all be the same shape and/or orientation, or the shape and/or orientation may vary. For example, in the embodiment shown in fig. 127, two additional curved slits 2495b are provided at the connection point 2498b closest to the headgear. These curved slits are symmetrical and generally project toward the midline of the connector and to the corresponding headgear connection points 2498b.

Other shapes, slits, slots, striated features, recesses or holes are contemplated to accommodate the flexibility of the reinforcement layer. The shape, density, and location of these features may be selected based on the desired level of flexibility, and taking into account the size, thickness, and materials of the reinforcement layer, as well as the features of the comfort layer in combination with the reinforcement layer.

The connection pads 597, 598a, 598b, 1797, 17981, 1798b, 2498b on the connector may be overmolded with the comfort layer and/or the reinforcement layer. Optionally, the connector pad may include more than one aperture, such as at either longitudinal end of the pad, which enables the over-molding material to pass through during manufacture to create a stabilizing portion or spinal cushion along at least a portion of the length of the connection pad.

The connection pad may be positioned in the recess of the comfort layer such that only a portion of the thickness of the connection pad protrudes from the connector. In some embodiments, the connection pad may have more than one slit or slot to improve the deflection of the connection pad. In one embodiment, the connection pad includes slits in a pattern, which may include, for example, alternating columns of slits. Each column may include arcuate and/or semi-circular slits shaped to face in a direction opposite the other column and at least partially offset from the other column. A portion of the columns of slits may overlap in the longitudinal direction of the hook pad. Other arrangements of slits are possible, such as the arrangement described in PCT/NZ 2016/050041.

In some embodiments, the connector may be configured for use with a "comfort liner" made of fabric or an alternative comfort material intended to contact the patient's face. The comfort liner may be placed over at least a portion or substantially all of the connector. The comfort liner may include fleece or wicking material. The comfort liner may alternatively be provided to a clinician who prefers to use alternative materials to contact the patient with the material of the connector.

The comfort layers 594, 694, 1794 are preferably also wrapped around the peripheral edges of the reinforcement layers 596, 696, 1796 and extend beyond the periphery of the reinforcement layers 596, 696, 1796. The comfort layer may protrude forward of the front surface of the reinforcement layer and may overlap with edge regions of the reinforcement layers 596, 696, 1796 at least on the outside of the connector. This enhances the retention of the stiffening layers 596, 696, 1796 relative to the comfort layers 594, 694, 1794 and also protects the patient from contacting the edges of the stiffer stiffening layers 596, 696, 1796.

Referring to (i) through (vi) in fig. 102 and fig. 129, the peripheral edges 594a, 894a, 994a, 1094a, 1194a, 1294a, 1749a, 2494a of the comfort layer may include edge features shaped to further enhance comfort and reduce discomfort, marking, or damage due to contact or friction. The edge profile may be shaped to increase the compliance and/or flexibility and/or compressibility of the connector at its edges. The edge features may extend around the entire periphery of the connector as shown in connectors 593, 693 of fig. 94-99. Alternatively, it may extend around only a portion of the connector 1793, as shown in the embodiments of fig. 121-123 and 127-129.

In some embodiments, and as shown in fig. 121-123, it may be desirable to omit an edge feature from a portion of the connector adjacent the second end to improve the fit of the portion of the connector with the headgear. In embodiments in which the lip feature includes a protrusion, omitting the edge feature in this region may also reduce potential discomfort for a patient lying prone on the connector.

Optionally, and as shown in connector embodiment 2493 of fig. 127-129, it may be desirable to omit the edge feature from a portion of the connector adjacent the first end such that the edge feature is disposed around the periphery of the reinforced region 2496. In this embodiment, the edge feature 2494a does not extend around the connector pad 2497 at the first end. In the vicinity of the connector pad, the edge feature 2494a may smoothly transition from the tapered profile of fig. 129 to a rounded edge extending around the connector pad 2497.

Referring again to fig. 102 (i) through (iv) and 129, in its simplest form, the comfort layer 594 of the connector 593 may be rounded at its perimeter (fig. 102 (i)) and have no sharp or abrupt edges. The comfort layer also preferably encases the peripheral edges of the stiffening layers 596, 896 in the form of raised lips formed on the front surface of the connector. This raised lip provides additional protection to the edges of the reinforcing layer when the connector is deformed.

Alternatively, the comfort layers 894, 994, 1094 of the connectors 893, 993, 1093 may be tapered (fig. 102 (ii) to (iv) and 129) such that the tapered thinned edges deflect upon contact with the patient's face and/or due to movement of the patient's face. The amount of deflection and the ease of deflection depend on the profile of the edge features 894a, 994a, 1094 a. For example, a wider taper (e.g., as shown in (iv) of fig. 102) may achieve a higher degree of deflection. However, the edge features should not be so long that the edges of the connector would interfere with the facial features, such as by bringing the connector close to the wearer's eyes. In the embodiment shown in fig. 102 (iv), the width W of the taper is about 1.5mm, however in alternative embodiments the taper may be narrower or wider.

As shown in (iii) of fig. 102, a steeper taper angle away from the wearer's face may also reduce the likelihood of the connector edge interfering with facial features. The steeper taper angle may also reduce the likelihood that the edge will be inadvertently folded under the connector Fang Conger to become trapped between the patient and the underside of the connector. The steeper taper angle also allows for longer deflection edges for a given connector footprint (footprint). The longer edge allows the thickness to taper.

Additionally or alternatively, the edges 994a, 1194a, 1294a, 1394a may include flexing or articulating fins 994b, 1194b, 1294b, 1394b configured to flex, articulate, or roll upon contact with the wearer's face, thereby enhancing the fit of the connector to the contours of the wearer's face. The edge regions 994a, 1194a, 1294a, 1394a may include depressions or recesses 994c, 1194c, 1294c, 1394c that at least partially define the fins and enhance articulation of the fins and/or provide clearance into which the fins may deflect or fold inwardly when contacted or subjected to pressure from a wearer.

The thickness of the fins is selected to be sufficient to ensure that the fins are self-supporting and to prevent the fins from being inadvertently deflected towards the wearer, particularly when the connector is deflected. However, the fins should not be too thick to create pressure points or hard edges.

In some embodiments, the fins may be formed from edges having a U-shaped or V-shaped cross-sectional profile. In embodiments having a U-shaped profile, the fins extend at substantially right angles (90 degrees) to the wearer's face and can generally be easily folded inwardly. Embodiments in which the fins extend at a shallow angle from the wearer's face generally require more force to fold or deflect the fins, which may be advantageous to prevent premature folding of the fins.

Fig. 103 (i) and 103 (ii) illustrate an exemplary embodiment of a fin 1393, wherein the fin extends at a non-orthogonal angle B to the wearer. Referring to those figures, it is contemplated that in other suitable embodiments, the peripheral edge or fin of the patient-facing surface may extend at an angle B of between 0 and 90 degrees. The angle a of any recess may be any angle less than 180 degrees and the peripheral edge or fin of the connector may have a taper angle C of 0 to 30 degrees. In the illustrated embodiment, the fins have a taper angle C of about 7 degrees and a thickness of about 0.6mm, although the taper angle and/or thickness may be smaller or greater. In one embodiment, the fins have a thickness of about 0.25 mm.

The height h of the mark in fig. 103 (ii) represents the thickness of the reinforcing layer. The thickness is selected to be as thin as possible so as to minimize the overall thickness of the connector without compromising the function of the connector, so that the connector can transmit loads and withstand torsional loads during use without excessive buckling or twisting. The thickness will depend on the material characteristics, size and shape of the connector.

Fig. 100 and 101 illustrate another embodiment of a flexible connector 793 wherein the connector comprises a single material having more than one reinforcing region 796, the reinforcing region 796 being formed from more than one region of increased material thickness. The reinforcement areas function as the reinforcement layers in the previous embodiments, enabling the connector to transfer loads and withstand torsional loads during use without buckling or twisting.

For the previous embodiments, the patient-facing surface 794 of the connector 793 is preferably substantially smooth, with areas of increased thickness provided by outward protrusions on the front side of the connector. The thickness of the reinforcing region may be substantially constant over the region or may vary. For example, where more stiffness is desired and/or where the geometry requires a thicker cross-section to achieve the desired stiffness, the reinforced regions may be thicker, while where less stiffness is desired and/or where the geometry dictates that the thickness may be reduced, the reinforced regions may be less thick (but still thicker than the non-reinforced regions).

In one embodiment, the connector has a first maximum thickness in a central region of the connector, a second intermediate thickness at one or both ends of the connector, and a third thinnest thickness in a hinge region. The second intermediate thickness of the connector ends may be selected to ensure that the connector is able to flex sufficiently at the connection point.

The connector 793 may include more than one hinge region where the connector is more flexible than the surrounding portion of the connector. The hinge region 798 allows the connector 793 to flex in a predictable manner to accommodate the facial contours, with most of the flexing of the connector occurring at the hinge region rather than elsewhere in the connector body. The hinge region 798 allows the connector 793 to flex into and out of the plane of the connector in use about an axis generally coincident with the longitudinal axis of the wearer.

The hinge region may include regions of reduced material thickness, necked regions of reduced width, cuts or slits, and/or different materials (e.g., more flexible materials). In the illustrated embodiment, the hinge region 798 is disposed between the first end/interface connection point 797 and the bifurcation point 799 of the connector 793, i.e., between the first end/interface connection point and the centrally located stiffening region 796.

The force required to flex the connector 793 about the hinge region 798 should be less than the force required to separate the first connection point 797 from the patient interface. This prevents connector 793 from disconnecting from the interface when the connector is flexed and installed.

For example, the thickness of the connector 793 increases gradually from the hinge region 798 to the thickened reinforcing region 796 by rounded corners, tapers or circles at the respective edges of the reinforcing region 796. For example, the thickness of the connector 793 gradually decreases from the thickened reinforcing region 796 to the adjacent portion of the connector by a rounded or rounded shape at the respective edges of the reinforcing region 796.

The thickness of the reinforcing region may be 2-6 times greater than the thickness of the hinge region 798, for example 2.5-4 times greater. In the example embodiment shown, the stiffening region 796 has a thickness of about 2.25mm and the hinge region has a thickness of about 0.8 mm. However, other wall thicknesses and/or proportions are contemplated. The thickness of the various regions of the connector body is preferably chosen to be as low as possible while still ensuring that the connector has the thickness required to resist buckling and torsional loads during use and such that no region is at high risk of tearing during use.

The connector 793 may include any of the edge features described above with respect to the previous embodiments to reduce contact forces with the patient's face.

In the illustrated embodiment, the connector includes shallow depressions or recesses 797, 798a, 798b at each connection point to receive a corresponding hook or loop pad and facilitate bonding of the connector body and pad. The recess may be defined by a raised rim surrounding the received pad. In other embodiments, the connector may not include such a recess or depression. The thickness of the connector 793 in the areas proximate to and including the connection points 797, 798a, 798b is selected to be sufficient to bend the connector in those areas to at least an extent that ensures a secure connection. For example, the hook and/or loop pads are allowed to flex along the entire length of the pad and engage corresponding interface or headgear connectors.

For example, the connector may comprise any suitable flexible, resilient material, and an elastomer such as a thermoplastic elastomer.

The width of the connector generally increases from the first end to the second end. The widening may be non-uniform or non-linear.

The first portion of the connector adjacent the first end of the connector may have a first substantially uniform width. The second portion of the connector adjacent the second end of the connector may be progressively wider toward the second end. Such widening may be a general widening of the connector body or may include bifurcation of the connector, such as in a Y-shaped embodiment.

The length of the first portion of the connector having a substantially uniform width may be about 1/3 to about 2/3 of the length of the second portion. In one embodiment, the first portion may be about half the length of the second portion, although other shapes and configurations are contemplated.

In the embodiments of fig. 87-90, 94-101, and 121-123, the connectors 93, 593, 693, 793, 1793 are Y-shaped, similar to a wishbone, with a single arm branching into a pair of bifurcation arms at bifurcation points 599, 699, 799. The increase in width from the first end to the second end improves the stability of the connection with the rounded surface of the headgear. In embodiments having a Y-shape, the pair of arms, and thus the headgear connector, are able to move and flex relative to each other to more securely connect to a larger circular surface. However, other shapes of connectors are contemplated. In some embodiments, the connector may have an asymmetric shape.

In connectors having a Y-shape, the pair of arms may form an angle therebetween of between about 10 degrees and about 60 degrees. In some example embodiments, the angle between the connector arms is about 25 degrees, although other angles are also contemplated.

Fig. 91 (i) to (iv) show examples of four embodiment connectors 193, 293, 393, 493, and fig. 104 illustrates several different sized connectors, including single arm connectors that increase in width from a first end to a second end, as well as connectors of different sizes. By selecting an appropriately sized connector for each patient, providing multiple sized connectors enables the use of standardized interface frames and catheters for some patients of different sizes.

The connectors may include at least two spaced apart headgear connectors 198a, 198b, 298a, 298b, 398a, 398b, 498a, 498b at the wide end of the device, and a single patient interface connection point at the narrow first end of the device. Some connectors (the smallest connector as shown in fig. 104) may include only a single connection point for connection to the headgear. The wide second end, having spaced attachment points at its second end, provides greater load distribution to the headgear and resistance to twisting of the connector, while the narrow first end minimizes material located near the wearer's face. Alternative shapes of connectors may include any suitable shape that accommodates the interface and headgear connection points. The connector may include cutouts 199, 399, 499 to reduce the weight of the connector. The connector may be symmetrical or asymmetrical about a horizontal midline of the connector.

Such a single arm connector of fig. 104 may be more suitable for smaller connectors where the space required to accommodate two headgear connector pads at the second end of the connector does not allow two furcation arms.

For Y-shaped embodiments having a reinforcing layer or region, the reinforcing layer or region enables the bifurcation point of the Y-shape to be positioned closer to the second end of the connector than to the first end, as shown in fig. 104. This advantageously reduces the width of the connector in the region closest to the wearer's eye. The separation of the bifurcation arms is also minimized and selected to create a space between the connector and the wearer's eye. The reinforcement layer or region achieves this positioning of the bifurcation point and narrowing spacing of the arms without compromising the torsional stability of the connector.

All corners of the connector are preferably rounded or tapered to reduce the pressure points on the wearer. For example, in embodiment 2493 shown in fig. 127-129, the edges around the connection pads are rounded. On the patient-facing side of the connector at the first end of the connector, an angled surface 2494c is provided to reduce potential pressure points for the wearer.

Chin strap

Referring to fig. 92, 93, 118 (i) and (ii), the headgear assembly may further include chin straps 1500, 1600 for coupling to the headgear or connector for holding the mouth of the patient closed. The chin strap 1500, 1600 may be used with a nasal interface, such as illustrated for the assembly of fig. 3B, particularly for CPAP applications.

Chin strap 1500, 1600 may include multiple layers 1501, 1502; 1601. 1602. The patient-facing layers 1502, 1602 and/or the front layers 1501, 1601 may each comprise a material, such as a fabric, that is fusible using a selected fusing method. For example, fusion is performed by Radio Frequency (RF) welding or High Frequency (HF) welding, or ultrasonic, vibration or friction welding, hot edge welding, hot air welding or induction welding. Alternatively, the layers of the chin strap may be otherwise bonded together.

In an embodiment, the front layers 1501, 1601 may comprise the same or similar fabric as the base layer 72 of the headgear 71 described above.

The patient facing layers 1502, 1602 may include engagement surfaces to enable the chin strap to attach other components to the surface of the chin strap or to itself. In an exemplary embodiment, the patient facing layers 1502, 1602 may include a complete endless (UBL) fabric. The patient facing layer may be larger than the outer front layers 1501, 1601 such that the outer perimeter of the inner fabric layer extends around the outer perimeter of the outer front layers and beyond any stiffer fusion areas, forming a soft edge to protect the skin from the front layers 1501, 1601.

In some embodiments, the patient facing fabric layers 1502, 1602 and/or the front fabric layers 1501, 1601 comprise a non-stretch fabric or a fabric having a low level of stretch. In other embodiments, the layers may be fused to remove or minimize any telescoping throughout the chin strap.

The patient contacting underside of the chin strap may include adhesive surfaces 1506, 1606 to provide a region of increased friction between the headgear and the wearer to reduce the incidence of movement of the patient's face. Adhesive surfaces 1506, 1606 are preferably disposed in at least a generally central chin region of chin strap 1600.

The tacky surfaces 1506, 1606 may include an adhesive film or coating, or may include a friction layer adhered or bonded to the inner surface of the patient-facing fabric layer 94. The adhesive surface may be continuous along the entire length or a portion of the length of the chin strap 1500, 1600, or may include discrete areas. These discrete areas may be provided in areas where increased friction is desired. The adhesive surface may comprise a linear strip or may be applied to form a pattern, for example comprising curves and/or dots.

In one embodiment, the tacky surface is provided by polyurethane elastomer, neoprene, non-stick silicone, and/or thermoplastic polyurethane. The adhesive surface may comprise a surface adapted to contact the skin and may be disposed over substantially all of the patient facing side 1502, 1602 of the chin strap 1500, 1600, over a majority of the patient facing side of the chin strap, or may cover only a portion of the patient facing side 1502, 1602 of the chin strap 1500, 1602 as shown.

Referring to fig. 93, in a first embodiment, the underside of the chin strap 1500 includes two engagement surfaces 1504, 1505, with the two engagement surfaces 1504, 1505 being disposed near opposite ends of the strap 1500. These engagement surfaces 1504, 1505 may include hook surfaces for engaging with annular surfaces on other components. For example, the engagement surfaces 1504, 1505 may facilitate connection to a headgear, such as to the above-described on-ear region 74 or temple region of the headgear. Alternatively, the engagement surfaces 1504, 1505 may facilitate connection to other connectors, such as the side connector 93 described above.

Opening 1503 may be provided in chin strap 1500, preferably at or near the center of the strap. Opening 1503 may have the form of a slot or slit to allow increased movement of the chin strap adjacent opening 1503 to improve stability. This opening 1503 may also be used to receive an orogastric tube in some applications. Alternatively, more than one additional opening may be provided for receiving an orogastric tube or other respiratory component.

Fig. 118 (i) to 120 illustrate a second embodiment in which the chin strap 1600 is wrapped around the patient's head and secured to itself. The chin strap 1600 includes a first portion having an engagement surface 1604 on an outer surface of the strap and a second portion having two arms 1607a, 1607 b.

The engagement surface 1604 of the first portion may comprise a hook surface or other suitable surface for engaging with an engagement surface on the headgear. The engagement surface 1604 may be provided at or near a first end of the chin strap.

The first portion of the strap provides chin contact 1606. At a point intermediate the chin contact portion 1606 of the strap and the second end of the strap, the chin strap 1600 diverges into a first securing arm 1607a and a second securing arm 1607b. The patient facing side of each securing arm 1607a, 1607b includes more than one engagement surface 1605 of some type for engagement with the engagement surface 1604 at the first end of the chin strap 1600.

In this embodiment, the two layers 1601, 1602 of the chin strap 1600 are fused together and the engagement surface 1605 on the two arms 1607a, 1607b is a loop connector formed by areas of non-fused material. However, alternative connectors are contemplated. Alternatively, the chin strap may comprise a single layer of material or may comprise more than two layers of material fused, glued or otherwise connected together. In some embodiments, fusion or indicia may be used to identify the intended orientation or use of the engagement surface and/or chin strap.

Figures 119 and 120 illustrate a chin strap 1600 secured to a patient. To mount the chin strap 1600, a first end of the chin strap 1600 is placed on top of the headgear against one side of the patient's head in a position such that the chin slot 1603 and chin contact 1606 are located under the patient's chin. In the illustrated embodiment, the headgear 471 has an adjustment device 485 on top of the head and a first end of the chin strap 1600 is positioned between the adjustment device and the patient's ear.

In this example, the chin strap is then wrapped around opposite sides of the patient's head such that bifurcation point 1609 is positioned between the adjustment device and the patient's ear on opposite sides of the first end of strap 1600. A first arm 1607a of the plurality of arms is wrapped around the patient's head in front of the adjustment device 485 and secured to the engagement surface 1604 at a first end of the chin strap 1600, and a second arm 1607b is wrapped around the patient's head behind the adjustment device 485 and secured to the engagement surface 1604 at a first end of the chin strap and/or secured to a top surface of the first arm 1607a at a securing point. The first arm 1607a and the second arm 1607b may intersect at or near a fixed point.

It should be appreciated that in alternative embodiments, the chin strap may be wrapped such that the two arms 1607a, 1607b of the chin strap may be positioned either in front of or behind the adjustment device. Alternatively, the chin strap may be used with headgear without the need for an adjustment device.

It is contemplated that the chin strap 1600 is not limited to use with the headgear currently described. Chin strap 1600 may be used in conjunction with alternative headgear, including headgear without a top adjustment member, or in applications without headgear. The two arms 1607a, 1607b of the chin strap 1600 may be more securely or stably attached to the patient's head.

The two arms 1607a, 1607b and/or the bifurcation area of the chin strap 1600 may be shaped to ensure that the arms of the chin strap 1600 and the bifurcation area of the strap are substantially flat against the headgear 471 and can extend around the adjustment device 485 without requiring an arc bend or twist.

In the illustrated embodiment, the chin strap 1600 includes a necked area 1608 adjacent the bifurcation and/or a notch 1609 between the two arms at the bifurcation. These features allow the first arm 1607a and the second arm 1607b to move away from each other while minimizing resultant deformation of the chin strap 1600 near the bifurcation point.

The arms 1607a, 1607b of the strap may be shaped such that the spacing between the arms is greater toward the bifurcation, where the arms will extend around the adjustment member and be smaller at the second end of the chin strap 1600. This minimizes in-plane bending of the arms 1607a, 1607b in use, thereby reducing wrinkling, buckling or twisting of the arms.

The chin strap 1600 may have an increased width near the first end to accommodate a wider engagement surface 1604 to ensure there is sufficient area to comfortably engage both the first arm 1607a and the second arm 1607 b.

The preferred embodiments of the present utility model have been described by way of example only and modifications may be made thereto without departing from the scope of the utility model.

Claims

1. A headgear for securing a patient interface to a patient, the headgear comprising:

a base layer forming a body of the headgear; and

a headband region;

wherein the headband region includes an outer bond layer at least partially overlapping a lower portion of the base layer, the outer bond layer being fused to the lower portion of the base layer,

wherein the headgear region includes a fused material region and an unfused material region that at least partially defines a connection region for releasably securing a connector to the headgear.

2. A headgear for securing a patient interface to a patient, the headgear comprising a headband configured to be wrapped around and secured to a wearer's head to provide an adjustable fit, the headband having an on-the-ear region at least partially covering an ear of the patient, wherein:

The above-the-ear area is an enlarged area; and/or

The headband includes a rear bridge between the two above-ear regions.

3. A headgear for securing a patient interface to a patient, the headgear comprising:

a base layer forming a body of the headgear; and

a headband region;

wherein the headband region includes a fused material region and an unfused material region, the fused material region exhibiting a different stretchability than the unfused material region.