Cap for securing patient interface to patient, head cap and adjustment device

Abstract

The present disclosure relates to a cap for securing a patient interface to a patient, a head cap, and an adjustment device. The headgear includes a base layer forming a main body of the cap and a headband region; the headband region includes an outer bonding layer at least partially overlapping a lower portion of the base layer, the outer bonding layer fused to a lower portion of the base layer; wherein the headband region comprises a region of fused material and a region of unfused material, where the region of unfused material forms a raised surface and the region of fused material forms a recess.

Description

[0001] This application is a divisional application of a patent application with application number 2022231495301, application date October 25, 2022, and utility model name “Head cap for fixing a patient interface to a patient”. Technical Field

[0002] The present disclosure relates generally to respiratory patient interfaces, and to headgear for use with patient interfaces. Background Art

[0003] In assisted breathing, breathing gases are supplied to the patient via one or more flexible breathing tubes through a patient interface. Such therapy may include, but is not limited to, continuous positive airway pressure (CPAP) therapy (including, for example, VPAP systems and BiPAP systems), non-invasive ventilation (NIV) therapy, and high flow therapy.

[0004] Various types of respiratory patient interfaces can be used to provide different respiratory therapies.For example, the patient interface can be a nasal cannula, a nasal mask, a mouth mask or an oronasal mask, an endotracheal tube or other known types of interfaces.

[0005] A head cap for a respiratory interface can be used to hold the interface in an operating position on the patient's face. The head cap may include straps or other components extending between the patient interface and the head cap. Different styles of patient interfaces may require different arrangements of straps and other components, or may require completely different head caps.

[0006] In the specification where reference is made to a patent specification, other external document or other source of information, this is generally for the purpose of providing a context for discussing the disclosed features. Unless expressly 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. Utility Model Content

[0007] Patients may use various types of respiratory interfaces to provide different respiratory therapies. Some patient interfaces may apply pressure to the wearer's skin and facial tissue when they are fixed in place to provide respiratory therapy. This can cause damage to the skin and facial tissue, especially for infants and newborn patients who have delicate skin and facial tissue. In addition, in medical applications, respiratory patient interfaces are often used for extended periods of time, such as weeks or months, thereby increasing the risk of skin or tissue damage.

[0008] For these reasons, it may be desirable to periodically change the type of respiratory interface a patient wears, thereby changing the skin area in contact with the interface. It is also desirable to design and position a respiratory patient interface and other related patient contacting components to minimize or avoid pressure points on the wearer's skin.

[0009] In order to be able to provide respiratory therapy to the patient, the interface must be held relative to the patient's mouth and / or nose to some extent. This is particularly important when the respiratory therapy involves providing pressurized gas; the interface must be held against the patient's face in a manner that provides at least some degree of sealing and prevents leakage of respiratory therapy gas from the periphery of the interface.

[0010] The head cap can be used to hold the interface on the patient's face and maintain the interface in a position that can effectively perform treatment. The head cap generally transmits force to the patient's head and so may significantly affect the patient's comfort. Especially for infants and newborn patients, the head cap and related fixing members can apply forces that may cause skin or tissue damage. It is desirable that the head cap and related fixing members minimize or avoid any damage to the skin or tissue.

[0011] In addition, different patients may have significantly different head and facial anatomy. For example, head circumference, skull shape, facial shape, neck shape, and facial tissue depth are all variable. This is particularly significant in the population of infant and neonatal patients because of the high growth rate of the head in the first few months of life. It is desirable that the headgear be adjustable or customizable so as to securely fit each patient in a manner that minimizes or avoids pressure points and the risk of skin or tissue damage.

[0012] In infant and neonatal patients, the head and facial anatomy of an individual patient may change as the patient grows and develops. It is also desirable that the headgear be adjustable or customizable so as to fit the patient securely to accommodate such growth and development. In addition, infant and neonatal patients may have different or changing respiratory support needs. For example, as the infant patient's lungs develop, the infant may require less or different types of respiratory support. Some patients may experience frustration and require higher levels of respiratory support, requiring a change in the type of treatment. It is desirable that the headgear for the respiratory interface be able to accommodate different types of respiratory interfaces to provide varying degrees of respiratory support.

[0013] In a first aspect, the present disclosure relates to a headgear for securing a patient interface to a patient, the headgear comprising a base layer forming the body of the headgear and a headband region. The headband region comprises an outer bonding layer at least partially overlapping a lower portion of the base layer, the outer bonding layer being fused to a lower portion of the base layer. The headband region comprises an area of ​​fused material and an area of ​​unfused material, the unfused area at least partially defining a connection area for releasably securing a connector to the headgear.

[0014] The outer bonding layer may be fused to the underlying portion of the base layer 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.

[0015] The outer bonding layer may be fused to an underlying portion of the base layer across a majority of the outer bonding layer.

[0016] The outer bonding layer may be fused to an underlying portion of the base layer about substantially the entire perimeter of the outer bonding layer.

[0017] The outer bonding layer may be fused to the underlying portion of the base layer simply by fusing. That is, the layers may be bonded together without any additive material such as stitching or adhesives.

[0018] Alternatively, the outer bonding layer may be otherwise attached to the lower portion of the base layer. For example, the outer bonding layer may be sewed to the base layer or bonded to the base layer via an adhesive. In other embodiments, the outer bonding layer or base layer may include a material that is at least partially injected into the material of the other of the outer bonding layer or base layer during manufacture to combine the two layers together. For example, the outer bonding layer or base layer may include a heat-sensitive and / or pressure-sensitive film for bonding to another layer.

[0019] In an embodiment, the outer bonding layer covers substantially the entire headband area. Alternatively, the outer bonding layer may cover a majority of the headband area. As a further alternative, the outer bonding layer may cover only a portion of the headband area, such as the front and sides of the headband.

[0020] The substrate may comprise a panel, for example a rectangular panel. The panel may be a single layer of material.

[0021] The outer bonding layer may comprise a single panel material. The panel may be a single layer of material.

[0022] The patient interface may be a breathing interface, such as a breathing mask or a nasal cannula. In an embodiment, the headgear and patient interface are for infants or newborns.

[0023] 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.

[0024] In an embodiment, the fused or unfused areas form a pattern including 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 be oriented in other ways. The dots in the pattern may be arranged uniformly or non-uniformly, for example, arranged in rows or grids, radiating from the dots, or randomly arranged. Alternatively or additionally, the fused or unfused areas may form text or decoration, or an identifying shape such as a logo.

[0025] In an embodiment, the unfused areas form a convex joining surface and the fused areas form a depression.

[0026] In an embodiment, the headband region comprises an enlarged supra-ear region shaped to at least partially cover the patient's ear.Each supra-ear region may comprise an area of ​​fused material in a pattern of dots.

[0027] The ear regions may be configured to provide a larger engagement surface than other regions of the headgear, such as by having a larger area of ​​unfused engagement layer, to facilitate attachment of a securing member to the headgear to secure the patient interface in place.

[0028] The ear region may be configured to provide protection to the patient's ears from contact or friction with other connectors or headgear or interfaces, or related components.

[0029] In an embodiment, each supra-ear region comprises a protrusion defined by a rounded, downwardly convex lower edge of the headband region. Additionally or alternatively, the supra-ear regions may each comprise a rounded, upwardly convex upper edge.

[0030] The headband may include a bridge between the two supra-ear regions for positioning at or above the nape of the patient's neck, the height of the bridge being narrower than the ear regions.

[0031] In an embodiment, the bridge portion is shaped to reduce pressure on the nape of the patient's neck. The lower edge of the bridge portion may be higher than the lower edge of the ear region and / or the lower edge of the front of the headband. In an embodiment, the bridge region has an arched lower edge that is highest at the center of the bridge region so 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 an abrupt transition.

[0032] In an embodiment, the bridge minimizes or prevents creases in the rear portion of the headband (such as might occur due to bending of the neck). This can reduce the risk of the headgear imprinting into the patient's skin.

[0033] A portion of the base layer may extend beyond the lower edge of the bridge portion.

[0034] The headband region may 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 extension may extend forward from the respective upper ear portion. At least one extension may include one or more additional regions of fused material in a dotted pattern.

[0035] The headband region and the lower portion of the body are configured to wrap around the wearer's head so that the opposite ends of the headband overlap and secure each other, thereby providing an adjustable fit to accommodate a range of head circumferences. The extensions may be configured to at least partially overlap when the headgear is in use.

[0036] In an embodiment, the head cap has no internal seams and no external seams.

[0037] The head cap may include an adjustment device through which the body of the head cap passes. The adjustment device can selectively slide along the body of the head cap, toward and away from the headband area, to adjust the wearable length of the head cap. The adjustment device can be adjusted between a locked state and an adjustment state in which the adjustment device can slide along the body of the head cap. In the locked state, the adjustment device can resist movement along the body of the head cap.

[0038] This ability to adjust the wearable length of the fabric portion of the headgear ensures that the headgear can accommodate a range of head sizes, provided that the headband area is properly positioned over 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 further from the headband. This adjustment is typically used in conjunction with adjusting the circumferential overlap of the fabric and headband to ensure a comfortable fit of the headgear.

[0039] The adjustment device may include one or more of the features described below in relation to the third aspect of the present invention.

[0040] The headgear may include end fixing means that fix the top edges of the headgear body together at the fixing points. The end fixing means may limit the travel of the adjustment device along the fabric, thereby preventing the adjustment device from being accidentally removed from the headgear.

[0041] In an embodiment, the head cap is a bonnet. In an embodiment, the end fixture forms a bobble at the apex of the bonnet. For larger heads, the adjustment device is typically positioned closer to the bobble, while for smaller heads, the adjustment device is further away from the bobble.

[0042] The top edge of the headgear body may be gathered, pleated, folded or rolled to secure at the securing point.The end securing means preferably surrounds and shields the top edge of the headgear body.

[0043] 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 fixture.

[0044] The end fixing means may comprise an intermediate layer, such as a foam layer. The intermediate layer may be bonded to the side layers.

[0045] The base layer may include a fabric. The fabric may be a fabric that exhibits bi-directional stretch in the width direction of the head cap. Alternatively, the fabric may include a four-way stretch fabric that has stretch in both the longitudinal (vertical) and width directions. For example, the fabric may include a knitted fabric. In an embodiment, the fabric handle is soft or plush to the touch for comfort.

[0046] The outer engagement layer of the headband region may include a unbroken loop (UBL) surface to engage with a connector having a complementary hook surface.

[0047] In an embodiment, regions of fused material exhibit different stretch than regions of unfused material.

[0048] The shape and / or orientation and / or location of the fused regions may be selected to reduce or increase stretching of corresponding regions of the headband in more than one direction.

[0049] The fused region may be shaped to form a substantially continuous path across the corresponding region of the headband in a direction where stretching is not desired. In addition, the unfused region may be shaped to form a substantially continuous path from the top edge of the headband to the bottom edge of the headband in a direction where stretching is not desired.

[0050] The headband region may include an area with increased stretch in the longitudinal direction of the headband. In some embodiments, the area of ​​increased stretch is provided between the upper ears and / or at the sides of one or both upper ears. There may be no bonding layer in the area of ​​increased stretch.

[0051] In the above-ear region of the headband, the areas of fused material and unfused material may be configured to reduce stretch in the longitudinal direction of the headband and / or in a direction angled or substantially diagonal to the longitudinal direction (e.g., 45 degrees to the longitudinal direction).

[0052] The supra-ear region may include areas of fused material and areas of unfused material.

[0053] In another embodiment, the outer joining layer or base layer includes more than one cutout, and the headband can exhibit different stretch in the area of ​​the headband with the cutouts compared to surrounding areas.

[0054] The shape and / or orientation and / or location of the cutouts may be selected to reduce stretching of the corresponding area of ​​the headband in one or more directions compared to areas without cutouts.

[0055] In an embodiment, the base layer is non-rectangular.The top edge of the base layer may be non-straight.

[0056] 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.

[0057] The base layer may have an irregular pentagonal shape, with two sides of the pentagon forming the top edge of the base layer.

[0058] The two sides forming the top edge of the base layer can meet at a central vertex aligned with the area between the upper ear areas. The two sides can form an angle of about 100 degrees with the side edges of the head cap body.

[0059] The top edge of the base layer may include more than one cutout, and optionally, the cutouts may be triangular in shape.

[0060] The top edge may be shaped so that when the top edge is gathered and secured at the securing point, the securing point is generally in line with the wearer's spine.

[0061] In a second aspect, the present disclosure is directed to headgear for securing a patient interface to a patient, the headgear comprising a headband configured to wrap around and secure on a wearer's head to provide an adjustable fit. The headband has supra-ear regions that at least partially cover the patient's ears, the supra-ear regions being enlarged regions, and / or the headband comprising a rear bridge between the supra-ear regions.

[0062] The headband region may also include at least one extension extending from one or both ear tops. In an embodiment, the headband region includes two extensions, which extend forward from the corresponding ear tops, respectively. The extensions may extend forward from the corresponding ear tops. When the head cap is in use, the extensions may be configured to at least partially overlap.

[0063] In an embodiment, each ear region comprises a protrusion defined by a rounded, downwardly convex lower edge of the headband.

[0064] The height of the bridge portion can be narrower than the supra-ear region and is configured to be placed at or above the nape of the patient's neck. The bridge portion can be shaped to reduce pressure on the nape of the patient's neck. The lower edge of the bridge portion can be higher than the lower edge of the ear region and / or the lower edge of the front of the headband. In an embodiment, the bridge region has an arched lower edge that is highest at the center of the bridge region, so 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 an abrupt transition.

[0065] The patient interface may be a breathing interface, such as a breathing mask or a nasal cannula. In an embodiment, the headgear and patient interface are for infants or newborns.

[0066] In an embodiment, the headband comprises an engagement surface for releasably securing the connector to the headgear.

[0067] In an embodiment, the headband comprises a plurality of layers, and the joining surface is provided by an outer layer fused to one or more inner base layers. The outer joining 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. One or more base layers may comprise fabric.

[0068] In an embodiment, the outer bonding layer substantially covers the entire headband area, or the outer bonding layer may cover most of the headband area. As a further alternative, the outer bonding layer may only cover a portion of the headband area, such as the front and sides of the headband.

[0069] In an embodiment, the engagement surface is provided by a layer of unbroken loop (UBL) fabric.

[0070] The headband may include an area of ​​fused material and an area of ​​unfused material, the unfused material at least partially defining a connection area for releasably securing the connector to the headgear.

[0071] In an embodiment, the headband includes a region of fused material and a region of unfused material. The region of fused material may exhibit different stretchability than the region of unfused material.

[0072] The shape and / or orientation and / or location of the fused regions may be selected to reduce or increase stretching of corresponding regions of the headband in more than one direction.

[0073] The fused areas may be shaped so that they form a substantially continuous path from the top edge of the headband to the bottom edge of the headband in a direction where stretching is undesirable.

[0074] In the above-ear region of the headband, the areas of fused material and the areas of unfused material may be configured to reduce stretching in the longitudinal direction of the headband and / or in a direction at 45 degrees to the longitudinal direction.

[0075] The supra-ear region may include areas of fused material and areas of unfused material.

[0076] The headband may include an area with increased stretch in the longitudinal direction of the headband. In some embodiments, an area of ​​increased stretch is provided between the upper ear portions and / or at the sides of one or both upper ear portions.

[0077] In an embodiment, 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 cutouts, and the headband may exhibit different stretch in the region of the headband with the cutouts compared to surrounding areas.

[0078] The shape and / or orientation and / or location of the cutouts may be selected to reduce stretching of the corresponding area of ​​the headband in one or more directions compared to areas without cutouts.

[0079] In an embodiment, the fused areas or the unfused areas form a pattern including 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 be oriented in other ways. The dots in the pattern may be arranged uniformly or non-uniformly, for example, arranged in rows or grids, radiating from the dots, or randomly arranged. Alternatively or additionally, the fused areas or the unfused areas may form text or decoration, or an identifying shape such as a logo.

[0080] For example, the patterns formed by the fused or unfused regions may include elements having a directional arrangement, such as a “Y” shape or a “V” shape. Alternatively, they may include any other suitable shape.

[0081] The size and / or density of the pattern of fused and / or unfused areas may vary along the headband. For example, the pattern of fused and unfused areas may have a higher density pattern at areas where lower stretch is desired. In areas of the headband with larger surface areas, such as the over-ear areas, the fused and / or unfused areas may be larger than other areas of the headband.

[0082] In alternative embodiments, a layer of the headband may include cutouts in addition to or in lieu of fused and unfused areas. The cutouts may be configured to vary the stretch of the headband in different areas and directions.

[0083] In an embodiment, the cuts may form a pattern including 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 be oriented in other ways. The dots in the pattern may be arranged uniformly or non-uniformly, for example, arranged in rows or grids, radiating from the dots, or randomly arranged. Alternatively or additionally, the fused areas or non-fused areas may form text or decoration, or an identifying shape such as a logo.

[0084] The pattern formed by the cutouts may include elements having a directional arrangement. For example, these elements may be "Y" shaped or "V" shaped. Alternatively, they may include any other suitable shape, such as diamond, rectangle, oval, circle, strip, and many other shapes are contemplated.

[0085] In an embodiment, the unfused areas form a convex joining surface and the fused areas form a depression.

[0086] The underside of the headgear that contacts the patient may include an area of ​​increased friction.

[0087] The underside of the headband that contacts the patient may include a sticky surface. The sticky surface may include a tape including a polyurethane adhesive film and a polyurethane elastic barrier (e.g., Bemis™ tape), neoprene, non-stick silicone, and / or thermoplastic polyurethane. The sticky surface may include a sticky surface suitable for contact with 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.

[0088] In an embodiment, the headgear comprises a body panel with a headband arranged along a lower portion of the body. The body panel may comprise a layer of fabric. In an embodiment, the headgear comprises a cap / skullcap.

[0089] In a third aspect, the present disclosure is directed to an adjustment device for adjusting the size of a head cap having a flexible body, the device comprising a first engagement member and a second engagement member, and an intervening hinge region. The first engagement member and the second engagement member are 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 head cap to secure the device in place on the head cap, and wherein in the free state the grip is sufficiently released to enable the device to move along the fabric of the head cap to adjust the size of the head cap.

[0090] In an embodiment, the device is moved from the locked state to the free state by pressing the first engagement member and the second engagement member towards each other.

[0091] The device may include finger grips on opposite sides of the device to facilitate pressing the first and second engagement members toward each other.The first and second engagement members may extend inwardly from respective finger grips.

[0092] In an embodiment, the finger grip includes an area that provides increased friction or a secure hold. For example, the finger grip may include a textured, contoured, and / or concave surface, or the finger grip may include a surface material with increased friction, such as rubber.

[0093] In an embodiment, the finger grips are provided by opposing, outwardly facing surfaces. Said surfaces are typically side surfaces adjacent to the respective engagement members. The device may comprise two finger grips, one provided on either side of the hinge, for example on opposite sides of the hinge region.

[0094] In an embodiment, the hinge region is resilient and the device in the locked state is a resting state of the device.The device may be biased towards the locked state.

[0095] In an embodiment, the hinge may be provided by a member or region of the device that is shaped to have a hinge point. For example, the hinge may be provided by a curved, arcuate or angled member. In an embodiment, the device includes one or more arched members, defining a hinge point at the apex of the arch. In an embodiment, the device includes two arched members. Alternatively, the hinge may be provided by a narrowed or thinned region or member.

[0096] In an embodiment, the first engagement member and / or the second engagement member may include an aperture for receiving the body of the headgear.

[0097] The first and / or second engagement members may include loops defining corresponding holes. Alternatively, the first and / or second engagement members may include hooks defining an area for receiving the body of the head cap. The defined holes or areas may be any suitable shape, such as circular, oval, D-shaped, square or rectangular.

[0098] In an embodiment, both the first engagement member and / or the second engagement member define apertures. The apertures may be of substantially the same size and shape.

[0099] In an embodiment, the first and second engagement members each comprise a hole for receiving a body of the headgear, and wherein in the locked position the holes are misaligned, and in the free position the holes are normally aligned to allow the body to slide through the holes.

[0100] In an embodiment, the first engagement member and the second engagement member each comprise an aperture for receiving the body of the headgear, and wherein in the free state there is substantially more overlap between the apertures of the engagement members than in the locked state.

[0101] In an embodiment, in the locked state, the body of the head cap follows a tortuous path through the device. The tortuous path may include more than one bend in the flexible body material. In the locked state, the device may provide more resistance to movement along the fabric than in the free state.

[0102] In an embodiment, the second engagement member comprises a pair of spaced apart rings defining two corresponding apertures, and wherein the first engagement member comprises a ring configured to slide between two second engagement member rings when the first engagement member and the second engagement member are moved relative to each other.

[0103] In an embodiment, the rings of the second engagement member are parallel, and the spacing between the rings of the second engagement member is equal to or greater than the thickness of the rings of the first engagement member.

[0104] In an embodiment, the guide hole receives the fabric of the headgear and slides along the fabric of the headgear.The hinge may be provided on the side of the guide hole.

[0105] In an embodiment, the guide hole is provided between two hinge side members. In an embodiment, the hinge side member extends between the finger grips. The hinge member may comprise two parallel arched members, the space between the hinge members defining the guide hole.

[0106] In an embodiment, the hinge axis of the device extends through the guide hole. In an embodiment, in the free position of the device, the guide hole is generally aligned with the engagement member hole, thereby allowing the fabric to slide through the device following a substantially straight path.

[0107] In an embodiment, the device is integrally formed. That is, the hinge and the first and second engagement members are integrally formed.

[0108] In an embodiment, the device comprises one or more of acetal, nylon, a suitable polymer, for example a thermoplastic polymer such as acrylonitrile butadiene styrene (ABS), polycarbonate, or a polycarbonate / thermoplastic polymer blend.

[0109] In a fourth embodiment, the present disclosure relates to an adjustable head cap system, comprising a head cap according to the first embodiment or the second embodiment and an adjusting device according to the third embodiment, wherein the adjusting device is constructed to receive the main body of the head cap and slide along the main body of the head cap toward and away from the headband area, thereby adjusting the size of the head cap in the vertical direction.

[0110] The head cap may have any one or more of the features described above with respect to the first aspect and / or the second aspect.

[0111] The adjustment device may have any one or more of the features described above with respect to the third aspect.

[0112] In a fifth embodiment, the present disclosure relates to an adjustable headgear system, comprising a headgear according to the first embodiment or the second embodiment and an adjustment device, wherein the adjustment device comprises a flexible body having a first end and a second end and a first side and a second side defining a hole, wherein the hole is configured to receive the body of the headgear and slide along the body of the headgear. The first engagement end and the second engagement end can be moved relative to each other to adjust the device between a locked state and a released state, wherein in the locked state, the device holds the body of the headgear in the hole to fix the device in place relative to the headgear, and wherein in the released state, the grip of the device is fully released so that the device can move along the body of the headgear toward and away from the headband area, thereby adjusting the size of the headgear in the vertical direction.

[0113] In a sixth aspect, the present disclosure is directed to a patient interface and headgear assembly, the headgear assembly comprising a patient interface assembly, a headgear, and a side connector member for coupling the patient interface assembly to the headgear. The side connector comprises 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.

[0114] The assembly may comprise two side connector members.In an embodiment, the side connector members are flexible.

[0115] The side connector member can be narrower at a first end for attachment to a patient interface assembly and wider at an opposite second end for connection to the headgear. The spaced-apart upper and lower connection points can be proximate the second end, and the patient interface connection point can be proximate the first end.

[0116] In an embodiment, the flexible fixing member is Y-shaped.For example, the side connector member may be wishbone-shaped.

[0117] In an embodiment, the side connector member includes a patient attachment portion that bifurcates to 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 scalloped shape. The member may include more than one cutout.

[0118] In an embodiment, the side connector member comprises a plurality of layers, at least one of the plurality of layers being a fabric layer.

[0119] In an embodiment, the flexible side connector member includes an outer fabric layer, an inner patient contacting fabric layer, and an intermediate reinforcement layer sandwiched between the fabric layers.

[0120] The reinforcement layer may comprise a polymer layer. For example, the reinforcement layer may comprise a nylon sheet.

[0121] The reinforcement layer may be bonded to at least one of the fabric layers. The reinforcement 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, vibration or friction welding, hot edge welding, hot air welding, or induction welding.

[0122] In one embodiment, the reinforcement layer is smaller than the outer and inner fabric layers such that the lower fabric forms a border around the periphery of the reinforcement layer.The upper and lower fabric layers may be bonded together near the border region, for example by RF welding.

[0123] In an embodiment, the outer fabric layer comprises a unbroken loop (UBL) fabric.

[0124] In an embodiment, the outer fabric layer is smaller than the inner fabric layer but larger than the reinforcement layer such that the inner fabric layer creates a single layer perimeter about the device.

[0125] In an embodiment, the inner fabric layer is a comfort layer and is dimensioned such that an edge of the inner fabric layer extends beyond a perimeter of the reinforcement layer.

[0126] 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.

[0127] The layers of the side connector member can be fused together. For example, the layers of the side connector can 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.

[0128] 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 area for releasably securing the connector to the headgear.

[0129] In an embodiment, the contrast between the fused and unfused areas forms a pattern to indicate the correct orientation of the connector.

[0130] In an embodiment, the fused areas or unfused areas form a pattern including 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 be oriented in other ways. The dots in the pattern may be arranged uniformly or non-uniformly, for example, arranged in rows or grids, radiating from the dots, or randomly arranged. Alternatively or additionally, the fused areas or unfused areas may form text or decorations or identification shapes such as logos.

[0131] In an embodiment, the pattern is visible on the outer surface of the connector. The pattern may correspond to the pattern on the connection area of ​​the header cap.

[0132] In an embodiment, the patient interface connection points and the upper and lower headgear connection points comprise hook connectors or loop connectors.

[0133] In an embodiment, the patient interface connection point is disposed on an exterior surface of the connector and the upper headgear connection point and the lower headgear connection point are disposed on an interior surface of the connector.

[0134] In an embodiment, the assembly includes a side arm that couples the flexible connector to the patient interface. Additionally or alternatively, the assembly may include two side connector members arranged laterally, and two corresponding side arms for coupling the side connector members to the patient interface. Additionally or alternatively, the assembly may include a chin strap for coupling to the headgear.

[0135] In an embodiment, the head cap may be the head cap described above regarding the first solution or the second solution.

[0136] The patient interface may be a breathing interface, such as a breathing mask or a nasal cannula. In an embodiment, the headgear and patient interface are for infants or newborns.

[0137] In a seventh aspect, the present disclosure is directed to a patient interface assembly comprising a patient interface body, a frame holding the patient interface body, and a pair of side arms. A first end of each side arm is releasably connected to a front face of the frame at a corresponding connection region of the frame, and each connection region is located between a midpoint of the frame and a corresponding side face of the frame.

[0138] In an embodiment, the two side arms are separate components that can be individually connected to and removed from the frame.

[0139] In an embodiment, each frame connection region is spaced from a midpoint of the frame towards a respective side of the frame.

[0140] In an embodiment, each frame connection region is disposed closer to a respective side of the frame than to a midpoint of the frame.

[0141] In an embodiment, each frame connection area includes one or more male connectors for being received by corresponding holes or recesses in corresponding side arms.

[0142] In an embodiment, each frame connection region includes a first projection having an enlarged end for receipt through an aperture in a corresponding side arm.

[0143] The first projection may include a pillar with the enlarged end at the top of the pillar. In an embodiment, the enlarged end of the first projection is configured to prevent the side arm from being accidentally separated from the frame by resisting the pull-off of the side arm. In an embodiment, the enlarged end is not centered on the pillar, but protrudes toward the corresponding side of the frame.

[0144] In an embodiment, the area of ​​the enlarged end of the projection is larger than the cross-section of the corresponding receiving hole in the side arm. For example, in one embodiment, the area of ​​the enlarged end is at least twice the cross-sectional area of ​​the strut. The cross-sectional area of ​​the strut may substantially correspond to the cross-sectional area of ​​the corresponding arm hole.

[0145] 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, when the enlarged end is located in the recess, the top surface of the enlarged end of the projection is substantially flush with the top surface of the arm.

[0146] In an embodiment, the first protrusions are disposed closer to the corresponding side surface of the frame than to the midpoint of the frame.

[0147] In an embodiment, each frame connection region comprises a second projection in the form of a hook connector for receipt in a complementary recess in the corresponding side arm.The connection between the hook connector and the side arm may be concealed by the front surface of the side arm.

[0148] In an embodiment, the hook connector comprises a post having a hook extending from the 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 the midline of the frame.

[0149] In an embodiment, the complementary recess in the corresponding side arm for receiving the hook connector comprises an L-shaped blind hole.

[0150] In an embodiment, when the arm is coupled to the frame, a top surface of the enlarged end of the hook connector is located below a top surface of the arm.

[0151] In an embodiment, the first end of the side arm comprises a flexible, resilient material for being pulled and / or pressed into engagement with the frame connector.

[0152] In an embodiment, each arm is assembled to the frame by placing the hook connector in a complementary recess and then pulling the flexible arm down over the first protrusion until the enlarged portion of the first protrusion rests against the surface of the arm. In the coupled configuration, the lower surface of the arm may contact the outer surface of the frame.

[0153] In an embodiment, the flexible arm may include one or more of silicone, thermoplastic elastomer, or other suitable plastics such as PET, HDPE, polypropylene, resins, polymers, or combinations thereof. In an embodiment, the flexible arm includes a thermoplastic elastomer.

[0154] In an alternative embodiment, the frame may include only a single protrusion for engaging each arm, the single protrusion having a post and an enlarged end. Each enlarged end may protrude beyond the corresponding post, toward the midline of the frame to provide a hook portion.

[0155] In an embodiment, each strut has a generally triangular cross-section, with the vertices of the triangle pointing towards the respective side of the frame. In an embodiment, the enlarged end is rectangular.

[0156] In an embodiment, the arm comprises a rigid end for attachment to a single connector.Preferably, when the arm is engaged with the frame, the rigid end does not extend over the side of the frame.

[0157] In an embodiment, the first ends of the side arms each include a rigid clip that engages a corresponding frame tab via a two-stage motion of sliding and snapping.

[0158] In an embodiment, the rigid end or clip comprises a hard plastic, such as polypropylene. In an embodiment, the flexible arm may comprise one or more of silicone, a thermoplastic elastomer, or other suitable plastics, such as PET, HDPE, polypropylene, a resin, a polymer, or a combination of materials. In an embodiment, the flexible arm comprises a thermoplastic elastomer bonded to a rigid end or clip.

[0159] In an embodiment, the body of the flexible arm is overmoulded to the end or clip.

[0160] In an embodiment, the second end of each arm comprises a connection surface for engaging with a head cap or connector for securing the interface assembly to the patient. The connection surface may comprise a hook or loop surface.

[0161] In an embodiment, the connection surface is provided by a pad comprising an overmoulded annular pad.The connection pad may be integral with the body of the flexible arm.

[0162] In an embodiment, each side arm comprises an opening between the first and second ends of the arm, the opening providing visibility of one or more elements at the respective side of the frame.

[0163] In an embodiment, the assembly includes a patient interface body for coupling to a frame. The side of the patient interface may include one or more features at least partially visible through an opening in a side arm. In an embodiment, the assembly includes an O-ring located on one side of the patient interface. The O-ring may be colored to indicate a size or other feature of the patient interface.

[0164] The patient interface body may have one or more features described with respect to the seventh aspect or the ninth aspect.

[0165] In an embodiment, the assembly includes a connector for coupling the frame to a supply or exhaust duct. The assembly may include two connectors for connecting 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 side arm or in each side arm. The connector may be a collar as described in relation to the twelfth aspect.

[0166] In an embodiment, each side arm comprises an opening between the first and second ends of the arm, the opening allowing a conduit for supplying air to or exhausting air from the frame to pass therethrough.

[0167] In an eighth aspect, the present disclosure is directed to an interface body for a patient interface assembly, the interface body comprising a patient contacting portion and a coupling portion for coupling to a frame. The coupling portion comprises a top reinforcement region and a bottom reinforcement region, each reinforcement region having a convex coupling wall for seating against a complementary surface of the frame, and wherein the convex coupling wall defines a recess for engaging with the frame.

[0168] In an embodiment, the interface body comprises a respiratory mask or a nasal cannula.

[0169] In an embodiment, the interface body is for an infant or a newborn.The interface body may include a sealing or non-sealing type interface.

[0170] In an embodiment, the thickness of the reinforcement area, and thereby the height of the coupling wall, varies across the width of the interface body.The height of the coupling wall may be greater towards the sides of the interface body and smaller towards the midline of the interface body.

[0171] In an embodiment, each reinforced region comprises a curved outer surface.

[0172] In an embodiment, the interface body comprises a breathing chamber, and wherein the cross-section of the breathing chamber is generally cylindrical proximal to the interface body and is generally D-shaped at the midline of the interface body.

[0173] In a ninth embodiment, the present disclosure relates to a patient interface assembly, comprising an interface body and a frame as described above with respect to the seventh embodiment, wherein the frame includes a connecting portion for engaging with a connecting portion of the interface body, wherein the connecting portion of the frame includes a pair of opposing concave surfaces for engaging with a connecting wall of the interface body.

[0174] 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.

[0175] In an embodiment, each coupling wall protrudes a first distance above the frame coupling portion at a side edge of the coupling wall and a second distance above the frame coupling portion at a midpoint of the coupling wall, wherein the first distance is greater than the second distance.

[0176] In an embodiment, the cross-sectional profile of the frame coupling portion varies in shape along the coupling portion.

[0177] In an embodiment, the cross-sectional profile has a thickness that varies across the frame coupling portion.

[0178] In an embodiment, the thickness of the cross-sectional profile is greater towards the midline of the interface body and smaller towards the sides of the interface body.

[0179] In a tenth aspect, the present disclosure relates to an interface body for a patient interface, the interface body comprising a nasal catheter having two nasal prongs, wherein a wall of the interface body has an area of ​​reduced thickness in the philtrum region for positioning adjacent to the philtrum of the patient during use.

[0180] In an embodiment, the philtrum region is configured to provide increased compliance compared to at least one adjacent region of the patient interface and thereby reduce pressure on the patient's philtrum.

[0181] In an embodiment, the philtrum region is located below the base of the nasal prongs.

[0182] In an embodiment, the philtrum region is a generally oval region.

[0183] In an embodiment, the philtrum region extends substantially across the interface body.

[0184] In an embodiment, the wall thickness of the philtrum region is substantially constant.

[0185] In an embodiment, the philtrum region has a wall thickness between about 0.2 mm and about 1.0 mm. In an embodiment, the philtrum region has a wall thickness between about 0.4 mm and about 0.6 mm. In an embodiment, the philtrum region has a wall thickness of about 0.5 mm. In some embodiments, the wall thickness may vary across the philtrum region.

[0186] The interface body may also include a flexure zone adjacent to the base of the nasal prong, wherein the wall of the interface body in the flexure zone has a reduced thickness compared to the philtrum region.

[0187] The flexure zone may have a wall thickness between about 0.1 mm and about 1.0 mm. In one embodiment, the flexure zone has a wall thickness of about 0.3 mm.

[0188] In an embodiment, the flex zone has a generally kidney shape.

[0189] In an embodiment, the wall of the interface body comprises four regions with different wall thicknesses: a nasal prong having a first wall thickness, a flexure region having a second wall thickness, a philtrum region having a third wall thickness, and the rest of the body having a fourth wall thickness.

[0190] In an embodiment, the boundary of the flexure zone is shared by the philtrum region. That is, the flexure zone and the philtrum region are directly adjacent / contiguous.

[0191] In an embodiment, a septal relief recess is provided between the two nasal prongs. The recess may be recessed beyond the front surface of the interface body at the base of the nasal prongs and / or 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.

[0192] In an embodiment, the septum recess has a depth of between about 1.5 mm and about 2.5 mm, preferably between about 1.8 mm and about 2.2 mm from the base of the nasal prongs. In one embodiment, the septum recess has a depth of about 1.9 mm from the base of the nasal prongs. In another embodiment, the septum recess has a depth of about 2.2 mm from the base of the nasal prongs. The patient interface can be a breathing interface for an infant or a newborn.

[0193] In an eleventh aspect, the present disclosure is directed to an assembly for a patient interface, the assembly comprising a frame that holds an interface body, and a stabilizing arm that is connectable to the frame and to a headgear. The stabilizing arm includes a flexible portion that allows the arm to flex away from the patient or the headgear during assembly.

[0194] In an embodiment, the flexible portion comprises a region of the arm having a reduced wall thickness.

[0195] 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.

[0196] In an embodiment, wherein a major length of the stabilizing arm is substantially rigid. In an embodiment, the flexible portion is located proximate one end of the rigid portion, located proximate the first end of the arm. In an embodiment, the substantially rigid length of the stabilizing arm has a constant thickness.

[0197] In an embodiment, the stabilizing arm includes a connection feature for connecting to the frame, proximate a first end of the arm, and a headgear connector is disposed at an opposite second end of the arm; wherein the headgear connector includes a pad having a hook or loop surface.

[0198] In one embodiment, the pad has an annular surface. The arm and pad may be configured so that the lower end of the pad overhangs the lower edge of the head cap. The annular surface may reduce the risk of skin damage.

[0199] The pad may be of any suitable shape, such as oval or circular. In one embodiment, the pad is oval, with the long axis of the pad aligned with the longitudinal axis of the arm.

[0200] In an embodiment, the headgear connector pad is hinged to the stabilizing arm.

[0201] In an embodiment, the headgear connector pad is pivotally attached to the second end of the arm about a rotation axis perpendicular to the longitudinal axis of the arm. The pivot axis may include a pin. In an embodiment, the pad is oval and the pivot axis is parallel to the short axis of the pad.

[0202] In an embodiment, the pivot axis is set back from the bottom edge between about one quarter and one third of the length of the support pad.

[0203] In an embodiment, the connector pad is a flexible member. For example, the connector pad may include a thermoplastic elastomer.

[0204] In an embodiment, the stabilizing arm includes a connection feature for connecting to the frame, and wherein the flexible portion is proximate the connection feature.

[0205] In an embodiment, the stabilizing arm is transparent or translucent.

[0206] In an embodiment, the stabilizing arm includes a connection feature for connecting to the frame, and the stabilizing arm may be configured to have a mounted position substantially aligned with a centerline of the frame, and a connected / disconnected position at an angle to the centerline of the frame.

[0207] The connection features of the stabilizing arm may include one or more of the features described below with respect to the eleventh aspect.

[0208] The frame may include one or more features for engaging with the stabilizing arm, as described below with respect to the eleventh aspect.

[0209] In an embodiment, the assembly comprises a patient interface body for coupling to the frame.The patient interface body may have one or more of the features described in relation to the seventh or ninth aspect.

[0210] In a twelfth embodiment, the present disclosure relates to a component for a patient interface, the component comprising a frame for holding an interface body, and a stabilizing arm that can be connected to the frame and to a head cap; wherein the stabilizing arm has a mounting position that is roughly aligned with a midline of the frame, and a connect / disconnect position that is angled with the midline of the frame.

[0211] The connect / disconnect position may be between about 30 and about 90 degrees from the centerline of the frame, such as between about 30 and about 60 degrees, or between about 40 and about 50 degrees. In an embodiment, the connect / disconnect position is about 45 degrees from the centerline of the frame.

[0212] In an embodiment, the frame includes a protrusion for coupling the stabilizing arm to the frame, and the stabilizing arm includes a connection feature proximate the first end of the arm for connecting to the frame protrusion, wherein the connection feature is configured to receive the protrusion.

[0213] In an embodiment, the protrusion comprises a pillar with an enlarged head at the end of the pillar. The enlarged head can be generally square. In an embodiment, the enlarged head comprises four protrusions protruding laterally from the top of the pillar. The protrusions can form a square head.

[0214] 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.

[0215] In an embodiment, the lower surface of the stabilization arm is the patient-facing surface of the stabilization arm.

[0216] In an embodiment, the aperture is generally square in shape and is oriented such that a diagonal of the square is substantially aligned with a centerline of the frame in the installed position.

[0217] In an embodiment, the top surface of the stabilizing arm includes recesses positioned at respective sides of the square aperture, wherein the recesses are positioned to receive respective portions of the frame projections in the mounted position.

[0218] In an embodiment, the recess comprises four generally triangular recesses to receive corresponding corners of the square head of the projection.

[0219] In an embodiment, in the connect / disconnect position, the head of the lug is aligned with the connection hole of the arm such that the hole fits over the head of the lug; and wherein in the installed position, the head of the lug is seated in the recess and the leg of the lug extends through the hole.

[0220] In an embodiment, movement of the projection into the recess produces tactile feedback when the arm is moved to its installed position.

[0221] The lower surface of the enlarged head of the projection is movable across the top surface of the arm between a connect / disconnect position and an installed position.

[0222] In an embodiment, when the stabilizing arm moves between the connect / disconnect position and the mount position, the lower surface or side surface of the enlarged end portion interferes with the corner of the recessed portion, creating a resistance to movement.

[0223] In an embodiment, the protrusion has a height substantially the same as the thickness of the first end of the arm, such that in the installed position the top surface of the enlarged end of the protrusion is substantially flush with the top surface of the arm and the lower surface of the first end of the arm contacts the surface of the frame.

[0224] In an embodiment, the frame projection is located on the front face of the frame at a midpoint of the frame.

[0225] 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 hook or loop surface.The headgear connector pad may be hingedly connected to the stabilizing arm.

[0226] In an embodiment, the stabilizing arm may include one or more of the features described above in relation to the tenth embodiment.

[0227] In embodiments where the stabilizing arm is attached to the frame, the connection hole at the first end of the arm is placed on a frame tab.

[0228] In an embodiment, the assembly comprises a patient interface body for coupling to the frame.The patient interface body may have one or more of the features described in relation to the seventh aspect or the ninth aspect.

[0229] In a thirteenth aspect, the present disclosure is directed to an assembly for a patient interface, the assembly comprising a frame holding an interface body, a conduit, and a collar connecting the conduit to the frame. The collar receives an end of the conduit, a length of the end of the conduit being fixed to the collar.

[0230] In an embodiment, the collar is bonded to the frame.

[0231] In an embodiment, the collar is overmolded to the frame.

[0232] In an embodiment, the connection between the frame and the collar is a permanent connection, and the connection between the collar and the conduit is a permanent connection.

[0233] In an embodiment, the length of the end of the conduit attached to the collar is greater than 1 mm.

[0234] In an embodiment, the length of the catheter end attached to the collar is less than the length of the catheter end received in the catheter such that there is an unbound catheter length within the collar.

[0235] In an embodiment, the length of the catheter end attached to the collar is located at the frame end of the catheter.

[0236] In an embodiment, the length of the catheter end of the catheter attached to the collar is at the distal end of the catheter.

[0237] In an embodiment, the collar comprises a flexible body.

[0238] In an embodiment, the collar includes one or more of thermoplastic, polyurethane, and / or silicone.

[0239] In a fourteenth aspect, the present disclosure is directed to a patient interface connector for coupling a patient interface assembly to headgear, the connector having an interface attachment point on an outwardly 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 one or more reinforcement components, reinforcement layers, and / or reinforcement regions.

[0240] In an embodiment, the connector has two spaced-apart headgear attachment points on the patient-facing surface of the connector for connecting to the headgear.

[0241] In an embodiment, the connector is flexible.

[0242] The peripheral edge of the connector may include curved portions and may lack angular corners.

[0243] 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.

[0244] In an embodiment, the reinforcement component is configured to prevent buckling or twisting of the component in use.

[0245] A strengthening member or feature may be positioned across at least a central region of the connector and may be configured to prevent buckling or twisting of the central region during use.

[0246] In an embodiment, the patient interface comprises a relatively rigid reinforcement layer and a comfort layer, wherein the comfort layer is located on the patient-facing side of the connector. The comfort layer may be overmolded or co-molded with the reinforcement layer.

[0247] The comfort layer can extend around the peripheral edge of the connector. In addition, the comfort layer can be rounded or tapered at the periphery.

[0248] The comfort layer may extend over the reinforcement layer to form a lip around the perimeter of the connector.

[0249] The comfort layer can be shaped to form a conformable, compressible edge of the connector. In addition, the compressible edge can be configured to deform by deflecting or folding to conform to the facial contour of the wearer.

[0250] The comfort layer may include fins and / or recesses adjacent to the edge of the connector.

[0251] The reinforcement layer may be more rigid than the comfort layer.

[0252] The thickness of the fin can be selected to have sufficient strength to be self-supporting and / or to prevent the fin from inadvertently deflecting toward the wearer. The thickness of the fin can also be selected so that the fin does not form pressure points and / or hard edges.

[0253] The reinforcement layer may comprise a thermoplastic material, for example polypropylene. The thermoplastic material may be inelastic.

[0254] The reinforcement layer may include more than one feature to enhance rigidity in a desired direction and / or increase flexibility in a desired direction. In some embodiments, the reinforcement layer includes cutouts, scored patterns, engravings, thinned regions, or other features to selectively reduce the thickness of the reinforcement layer at defined points. The cutouts may include slits or slots, for example, a series of straight, curved, or shaped slots. The slits or slots may be oriented in a generally lateral direction of the connector to enhance the flexibility and bending of the connector around the patient's face. The cutouts or other features may extend to the periphery of the reinforcement layer, or may terminate at a point spaced inwardly from the periphery.

[0255] The comfort layer may include an elastomeric material, such as silicone.

[0256] In one embodiment, the comfort layer extends away from the patient-facing surface at an angle between 0 and about 90 degrees.

[0257] In an embodiment, the side connector members are curved to follow or adapt to the facial contours of the wearer.

[0258] The patient-facing surface of the connector may have a concave curvature.

[0259] In an embodiment, the patient interface connector comprises one or more reinforced regions comprising areas of increased material thickness.

[0260] The reinforced area may include an outward projection.

[0261] The patient-facing surface of the connector may be substantially smooth and / or flat.

[0262] In an embodiment, the patient interface connector includes a hinge region between the first end of the connector and the bifurcation point.

[0263] In an embodiment, the patient interface connector includes a hinge region between the reinforced region and the first end.

[0264] The hinge region may comprise an area 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.

[0265] In an embodiment, the force required to flex the connector about the hinge area is less than the force required to detach the first attachment point from the patient interface.

[0266] The hinge may be configured so as to allow the connector to conform to facial contours.

[0267] The interface attachment points may include mechanical fasteners. For example, the interface attachment points may include hook or eye connector pads for engaging with complementary hook or eye connector surfaces on the patient interface or a frame of the patient interface. The head cap attachment points may include hook or eye connector pads for engaging with complementary hook or eye connector surfaces on the head cap. The connector may include a recess for receiving the hook connector pad and / or eye connector pad.

[0268] 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 reinforcement layer, and a comfort layer, wherein the comfort layer is located on a patient-facing side of the component.

[0269] In an embodiment, the comfort layer is overmolded or co-molded with the reinforcement layer.

[0270] The comfort layer may extend around the peripheral edge of the reinforcement layer. The comfort layer may be rounded or tapered at its periphery.

[0271] In an embodiment, the edge of the comfort layer extends over the reinforcement layer to form a lip about the perimeter of the component.

[0272] The comfort layer can be shaped to form a compliant, compressible edge of the component. The compressible edge can be configured to deform by deflecting or folding to conform to the wearer's facial contours.

[0273] In an embodiment, the comfort layer comprises fins and / or recesses adjacent to an edge of the component.

[0274] The reinforcement layer may be more rigid than the comfort layer.

[0275] The thickness of the fin may be selected so as to have sufficient strength to be self-supporting and / or to prevent the fin from inadvertently deflecting toward the wearer. The thickness of the fin may also be selected so that the fin does not form pressure points and / or hard edges.

[0276] The reinforcement layer comprises a thermoplastic material, for example, polypropylene. The thermoplastic material may be inelastic.

[0277] The comfort layer may include an elastomeric material, such as silicone.

[0278] In a sixteenth aspect, the present disclosure is directed to a patient interface and a headgear assembly including a patient interface assembly; a headgear; and

[0279] A patient interface connector according to a fourteenth aspect, for coupling a patient interface assembly to a headgear, wherein a first of 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 of two attachment points of the patient interface connector comprises a connection point for coupling to the headgear. A width of the connector increases from a first end to a second end of the connector.

[0280] In an embodiment, there are two spaced-apart headgear attachment points on the patient-facing surface of the connector for connecting to the headgear.

[0281] In an embodiment, the patient interface connection point and the upper and lower headgear connection points may include hook or loop connectors.

[0282] In an embodiment, the assembly further comprises a side arm coupling the connector to the patient interface.

[0283] In an embodiment, an assembly comprises two transversely arranged patient interface connectors according to the fourteenth aspect, and two corresponding side arms for coupling said connectors to a patient interface.

[0284] In an embodiment, the assembly further comprises a chin strap for coupling to the headgear.

[0285] The patient interface can be a breathing interface, such as a breathing mask or a nasal cannula. In an embodiment, the head cap and the patient interface are used for infants or newborns. In an embodiment, the patient interface is a sealing interface.

[0286] In the seventeenth aspect, the present disclosure relates to an adjustment device for grasping a flexible material; the device has a flexible body, the flexible body has a first end and a second end and a first side wall and a second side wall defined for receiving the material, wherein the first end and the second end are capable of moving relative to each other, thereby adjusting the device between a locked state and a free state; wherein, in the locked state, the device clamps the material in the hole to fix the device in place relative to the material, and wherein in the free state, the grip of the device is fully released so that the device can move along the material, thereby adjusting the position of the device relative to the material.

[0287] 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 toward 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.

[0288] In an embodiment, in the locked state to the released state, the first side wall and the second side wall are positioned close to each other.

[0289] In an embodiment, the first side wall and the second side wall respectively have inner surfaces convex toward the hole. The inner surfaces of the first side wall and the second side wall may include one or more gripping features to enhance the gripping strength with the received material.

[0290] In one embodiment, the inner surfaces of the first side wall and the second side wall include oppositely convex, complementary steps. In the locked state, the steps can push the received material toward the bent state.

[0291] 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 an embodiment, the aperture has an hourglass-like cross-sectional shape.

[0292] In an embodiment, the device body comprises a resilient material. The sidewalls may comprise a resilient material. In an embodiment, in the static state, the device is in a locked state. Additionally, or alternatively, the device is biased towards the locked state.

[0293] In an embodiment, the device comprises a hinge region where the side wall joins the end.The hinge region may be elastic.

[0294] 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 comprise a concave curvature on the base and / or top of the device.

[0295] In an embodiment, the first end and the second end of the device may include finger grips to assist a user in holding the device. For example, the finger grips may include protrusions or depressions.

[0296] 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 wrap around the patient's head, with the arms of the chin strap engaging with a connector on the first portion of the strap.

[0297] The chin strap may include a first end and a second end, and a bifurcation point between the first end and the second end, with two arms extending from the bifurcation point to the second end.

[0298] In an embodiment, the connector is located at or adjacent to the first end of the strap.

[0299] In an embodiment, the chin strap comprises two or more layers of material fused or otherwise attached together. Alternatively, the chin strap may comprise only a single layer of material.

[0300] The chin strap may include a layer of loop material. The loop material may provide an engagement surface on the arm via an unfused area of ​​material. The layer of loop material may be the layer facing the patient. In some embodiments including two or more layers of material fused together, the engagement surface may be provided on the arm via an unfused area of ​​material.

[0301] The chin strap may include a constricted area adjacent the bifurcation point and / or a notch between the two securing arms at the bifurcation point.

[0302] In an embodiment, the arms are shaped to wrap around either side of the headgear adjustment member, or to accommodate another feature of the patient's headgear. For example, the spacing between the arms may be larger 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 accommodating the shape and contour of the patient's head, which may assist in stabilizing the chin strap when secured to the patient.

[0303] The utility model can also be broadly said to include the parts, elements and features mentioned or indicated individually or collectively in the specification of this application, as well as any or all combinations of any two or more of the parts, elements or features. If the specific integers mentioned herein have known equivalent alternatives in the technical field involved in the utility model, these known equivalent alternatives are deemed to be incorporated herein, as if described separately.

[0304] The term 'comprising' as used in the specification and claims means 'consisting at least in part of...'. When interpreting statements in the specification and claims including the term 'comprising', other features can be present in addition to those features preceded by the term. Related terms such as 'comprise' and 'comprised' are to be interpreted in a similar manner.

[0305] It is intended that reference to a numerical range disclosed herein (e.g., 1 to 10) also includes reference to all rational numbers within that range and ranges of any rational numbers within that range (e.g., 1 to 6, 1.5 to 5.5, and 3.1 to 10). Thus, all subranges of all ranges explicitly disclosed herein are expressly disclosed herein.

[0306] As used herein, the term '(s)' following a noun refers to the plural and / or singular form of that noun. As used herein, the term 'and / or' means 'and' or 'or' or both, where the context permits. BRIEF DESCRIPTION OF THE DRAWINGS

[0307] Embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0308] Figure 1 An example of an exemplary respiratory system in which embodiments of a patient interface assembly may be used is shown.

[0309] Figure 2 An example of another exemplary system in which embodiments of a patient interface may be used is shown.

[0310] Figure 3A and Figure 3B Figure illustrates the position of an exemplary embodiment headgear and patient interface assembly on a neonatal patient, wherein Figure 3A The figure shows a system having a nasal mask with a stabilizing arm, and Figure 3B The diagram shows a system with a nasal cannula;

[0311] Figure 4 is a top view of an assembly for a patient interface having a frame, attached conduits, and connectors;

[0312] Figure 5 is a top view of an exemplary embodiment frame for a patient interface assembly, the front of the frame having a protrusion for coupling a stabilization member;

[0313] Figure 6 yes Figure 5 A rear view of a frame showing a side of the frame facing the patient;

[0314] Figure 7 yes Figure 5 and Figure 6 A front view of the frame;

[0315] Figure 8 This is when the protrusion is hidden. Figures 5 to 7 A perspective cross-sectional view of a frame showing a cross-sectional profile of a main member of the frame;

[0316] Fig. 9 is with Figure 5 Similar top view, but showing the Fig.10 The section line of

[0317] Fig.10 is a cross-sectional view taken through the main member of the frame, wherein (i) is a cross-sectional view taken through Fig. 9 (i) is a cross-sectional view of the line; (ii) is a cross-sectional view through Fig. 9 (ii) is a cross-sectional view of the line; (iii) is a cross-sectional view of the line passing through Fig. 9 (iii) is a cross-sectional view of the line; (iv) is a cross-sectional view of the line passing through Fig. 9 (iv) is a cross-sectional view of the line through which Fig. 9 (v) is a cross-sectional view of the line through which Fig. 9 (vii) is a cross-sectional view of the line passing through Fig. 9a cross-sectional view taken along line (vii); and (viii) a cross-sectional view taken along line (vii); Fig. 9 a cross-sectional view along line (viii);

[0318] Fig.11 is a front perspective view of an embodiment patient interface body in the form of a nasal cannula;

[0319] Fig.12 is a front perspective view of a patient interface body of one embodiment in the form of a nasal mask;

[0320] Fig.13 yes Fig.12 A three-dimensional view of a mask showing different wall thicknesses in different areas of the mask;

[0321] Fig.14 It passes through Fig.12 and Fig.13 A top cross-sectional view taken through a plane of the top of the mask showing the wall contour and shape of the patient contacting portion of the mask;

[0322] Fig.15 It passes through Fig.12 and Fig.13 A side cross-section of a mask taken along the midline of FIG. 1 , showing the wall contour and shape of the patient contacting portion of the mask;

[0323] Fig.16 is with Fig.14 a corresponding top cross-sectional view illustrating the movement of the mask when a force is applied to a patient contacting surface on one side of the mask (dashed lines);

[0324] Fig.17 is with Fig.15 a corresponding side cross-sectional view illustrating the movement of the mask when a force is applied to the patient contacting surface of one side of the mask (dashed line);

[0325] Fig.18 It passes through Fig.12 and Fig.13 a top cross-sectional view taken through a plane of the top of a mask of , showing the mask worn by a neonatal patient and, for comparison, also showing a prior art mask;

[0326] Fig.19 is shown worn by a neonatal patient Figures 12 to 17 A bottom view of the mask;

[0327] Fig. 20 yes Figures 12 to 17 A rear view of a mask of FIG. 1 illustrating the shape of a patient contact seal;

[0328] Fig.21 yes Fig.11 A top posterior view of a nasal cannula indicating the location of the flexure zone around the base of the nasal prong;

[0329] Fig. 22 yes Fig.21 A posterior and inferior lateral view of a nasal cannula of FIG. 1 , which illustrates the location of the philtrum contact area;

[0330] Fig.23 is with Fig. 22 corresponding figures illustrating the wall thickness of different regions of the nasal catheter body;

[0331] Fig.24 yes Figure 21 to Figure 23 A front cutaway perspective view of a nasal cannula of FIG. 1 , which illustrates the shape and location of the philtrum contact area;

[0332] Fig.25 yes Figure 21 to Figure 24 A diagram of a nasal cannula illustrating the shape of a septum pressure relief feature between nasal prongs;

[0333] Fig.26 yes Figure 21 to Figure 25 Front view of the nasal cannula;

[0334] Fig.27A and Fig.27B yes Fig.23 Detailed elevation of a septal decompression, where Fig.27A The figure illustrates features of a first dimension of a patient interface, and Fig.27B Figures illustrate features for an exemplary larger size patient interface;

[0335] Fig.28A and Fig.28B yes Figure 21 to Figure 25 A bottom view of a nasal cannula, wherein Fig.28A The diagram illustrates features for identifying a first size of nasal cannula, and Fig.28B Figure illustrates features for identifying a second size of nasal cannula;

[0336] Fig.29 yes Fig.28A A partial front cross-sectional view of one side of a nasal cannula, which illustrates an O-ring that is identifiable;

[0337] Fig.30 is a detailed perspective view of an exemplary size identification feature of a patient interface;

[0338] Fig.31 yes Figure 21 to Figure 26 Rear view of a nasal cannula with side O-rings installed;

[0339] Fig.32 yes Fig.31 A front view of a nasal cannula of FIG. 1 , which illustrates in dashed lines the position of the edges of the coupling frame, transitioning from a larger offset on either side of the frame to a smaller offset in the center;

[0340] Fig.33 yes Fig.31 and Fig.32 A side cross-sectional view of a nasal cannula taken through the mid-plane of the interface;

[0341] Fig.34 yes Figure 31 to Figure 33 Side view of a nasal cannula;

[0342] Fig.35 yes Figure 31 to Figure 34 A side view of a nasal cannula coupled to an interface frame;

[0343] Fig.36 yes Fig.31 and Fig.34 A side cross-sectional view of a nasal cannula coupled to an interface frame, the cross-section being taken through a mid-plane of the interface;

[0344] Fig.37 This is when the frame is shown as transparent. Figure 31 to Figure 34 A rear view of a nasal cannula coupled to an interface frame;

[0345] Fig.38 The figure shows a first exemplary embodiment frame coupled to two conduits at its sides;

[0346] Fig.39 The figure shows a collar attached to the end of one of the catheters, the collar being used to attach the catheter to the frame;

[0347] Fig.40 is shown attached to Fig.39 The clamp and the catheter Fig.38 A partial top view of one side of the frame;

[0348] Fig.41 Is set in Figure 4 A top view of the connector at the distal end of each catheter in an embodiment of the present invention, showing the connector coupled to a complementary receiving fixture;

[0349] Fig.42 yes Fig.42 An exploded view of the connector and receiving fixture;

[0350] Fig.43 yes Fig.41 and Fig.42 A side cross-sectional view of a main body of a connector;

[0351] Fig.44 yes Fig.41 and Fig.42 A perspective view of a main body of a connector;

[0352] Fig.45is a front view of a second embodiment frame with attached side connecting arms for securing a patient interface to headgear;

[0353] Fig.46 is with Fig.45 The corresponding top view;

[0354] Fig.47 yes Fig.45 A partial front view of a frame showing a side arm on one side and a nasal cannula coupled to the frame;

[0355] Fig.48 yes Fig.45 and Fig.46 A side view of an assembly of

[0356] Fig.49 is a front view of a third embodiment frame with attached alternative embodiment side connecting arms for securing a patient interface to headgear;

[0357] Fig.50 is with Fig.49 The corresponding top view;

[0358] Fig.51 yes Fig.49 and Fig.50 A top view of a side connecting arm of an embodiment of the present invention, the side connecting arm having a rigid end clip;

[0359] Fig.52 yes Fig.51 A front view of a side connecting arm;

[0360] Fig.53 yes Fig.49 and Fig.50 a perspective view of a frame of the invention showing the rigid end clips of the side arms engaged with the frame with the rest of the side arms concealed;

[0361] Fig.54 yes Fig.49 and Fig.50 A partial top view of the side of the frame showing the coupling protrusions of the side arms and illustrating the direction of movement for engaging the clip with the protrusions;

[0362] Fig.55 yes Fig.49 and Fig.50 A partial front view of one side of the frame showing the shape of the coupling projections of the side arms;

[0363] Fig.56 Is used to connect to Figure 4 , Figure 6 , Figure 7-10 , Fig.38 and Figure 45-55 A perspective view of a stabilizing arm of the frame;

[0364] Fig.57 is a detailed top perspective view illustrating a hole at a first end of a stabilizing arm with an undercut for engaging a coupling protrusion;

[0365] Fig.58 is with Fig.57 The corresponding top view;

[0366] Fig.59 is a detailed bottom view illustrating a hole at a first end of a stabilizing arm with rounded edges to locate the hole on a coupling boss;

[0367] Fig.60 is a front view of the first embodiment frame showing coupling tabs for attachment to a stabilizing arm;

[0368] Fig.61 is with Fig.59 The corresponding top view;

[0369] Fig.62 yes Fig.59 and Fig.60 A detailed stereoscopic view of a coupling protrusion;

[0370] Fig.63 is shown aligned with the frame coupling tabs for attachment Fig.56 Detailed stereogram of the stabilizing arm;

[0371] Fig.64 and Fig.67 corresponding, but showing the stabilizing arm and the projection in the connected / disconnected position;

[0372] Fig.65 is with Fig.64 The corresponding bottom view;

[0373] Fig.66 yes Fig.56 A front view of a frame illustrating movement of the stabilizing arm between a connected / disconnected position and an installed position;

[0374] Fig.67 is a detailed front view of the connection between the stabilizer arm and the frame with the stabilizer arm in a position between the connected / disconnected position and the installed position;

[0375] Fig.68 is with Fig.67 Corresponding detailed stereogram;

[0376] Fig.69 is connected to the frame connection lug at the installation position Fig.56 A front view of the stabilizing arm;

[0377] Fig.70 is a detailed front view of the connection between the stabilizer arm and the frame with the stabilizer arm in the installed position;

[0378] Fig.71 is with Fig.70 Corresponding detailed stereogram;

[0379] Fig.72 is a detailed perspective view of the pivot connection between the headgear connection pad and the body of the stabilizing arm;

[0380] Fig.73 is with Fig.72 The corresponding exploded perspective view;

[0381] Fig.74 is a detailed side view of the hinge of the stabilizing arm;

[0382] Fig.75 yes Fig.56 A side view of the stabilizing arm;

[0383] Fig.76 is a plan view of one embodiment of a headgear having a fabric body with a lower headband region, showing the headgear prior to assembly into a hat and without any adjustment or end fixture components;

[0384] Fig.77 is assembled with the end fixture and worn by the patient Fig.76 A diagrammatic side view of a cap;

[0385] Fig.78 is a perspective view of one embodiment end fastener attached to a pleated top edge of a headgear fabric;

[0386] Fig.79 yes Fig.78 An exploded perspective view of an end fixing device;

[0387] Fig.80 yes Fig.76 and Fig.77 A partial side perspective view of the assembled headgear illustrating the shape of the ear area;

[0388] Fig.81 yes Fig.76 and Fig.77 A partial rear perspective view of the assembled headgear, which illustrates the shape of the rear portion of the headband;

[0389] Fig.82A and Fig.82B Figure shows an exemplary pattern for fusing two alternative embodiment headbands, wherein Fig.82A The figure shows an embodiment of a fusion portion having curved and straight forms, and Fig.82BThe figure shows an embodiment having a weld in the form of dots and including dimensional information;

[0390] Fig.83 It is used to adjust Figures 76-81 A front perspective view of a first embodiment of a device for adjusting the size of a flexible head cap of a cap-like article, showing the device for adjusting the size of the cap in an intermediate position corresponding to a locked state of the device;

[0391] Fig.84 is with Fig.83 The corresponding rear stereogram;

[0392] Fig.85 yes Fig.83 and Fig.85 A side perspective view of the adjustment device of FIG. 1 , showing the device pressed into a free state;

[0393] Fig.86 is a side perspective view of the adjustment device of the second embodiment, showing the adjustment device assembled with the flexible body of the headgear and in a locked state;

[0394] Fig.87 is a top view of one embodiment flexible securing member for coupling a patient interface to headgear;

[0395] Fig.88 is with Fig.87 The corresponding bottom view;

[0396] Fig.89 yes Fig.87 A top view of a fixed member of FIG. 1 , but with the top layer of the member hidden in order to illustrate the position of the intermediate reinforcement layer;

[0397] Fig.90 is a top view of another embodiment of a securing member having a top layer including a UBL fused to an underlying layer, illustrating an exemplary welding pattern;

[0398] Fig.91 Some alternative shapes of fixing members are shown;

[0399] Fig.92 is a top view of a chin strap used to hold a patient's mouth closed;

[0400] Fig.93 yes Fig.92 A bottom view of a chin strap showing a patient-facing surface of the strap;

[0401] Fig.94 is a perspective view of an alternative embodiment side connector having a reinforcement layer and a comfort layer;

[0402] Fig.95 yes Fig.94 A front view of a side connector;

[0403] Fig.96 yes Fig.94 and Fig.95 A rear view of the side connector;

[0404] Fig.97 is a front view of an alternative embodiment side connector, showing the shape and location of the reinforcement layer;

[0405] Fig.98 is a front perspective view of another embodiment side connector having a curved profile;

[0406] Fig.99 yes Fig.98 A rear perspective view of a side connector;

[0407] 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;

[0408] Fig.101 yes Fig.100 A side perspective view of a side connector showing a patient-facing surface of the connector;

[0409] Fig.102 Figures illustrate various exemplary perimeter edge features of various side connector embodiments wherein a comfort layer extends around an edge of a reinforcement layer, wherein (i) shows a simple rounded lip, (ii) shows a slightly tapered lip, (iii) shows a deeply tapered lip inclined at a steep angle, (iv) shows a widely tapered lip inclined at a shallow angle, (v) shows an edge with a compliant perimeter fin, and (vi) shows an edge with an alternative shaped perimeter fin;

[0410] FIGS. 103( i) and 103( ii ) illustrate exemplary geometries of another embodiment of a perimeter edge feature;

[0411] Fig.104 Figures illustrate various exemplary sizes and shapes of the side connectors described herein;

[0412] Fig.105 is a side perspective view of a third exemplary adjustment device for adjusting the size of headgear;

[0413] Figure 106(i) and Figure 106(ii) are Fig.105 The front view and plan view of the adjustment device;

[0414] Fig.107 is a cutaway perspective view of another embodiment of an adjustment device for adjusting the size of a headgear showing an internal shoulder for gripping material of the headgear;

[0415] Figure 108(i) and 108(ii) Another exemplary adjustment device for adjusting the size of a headgear is shown, wherein FIG. 108( i ) is a perspective view and FIG. 108( ii ) is a plan view;

[0416] Fig.109 is a plan view of a second embodiment of a headgear having a flexible body with a lower headband region showing the fabric base layer without any end fastening means;

[0417] Fig.110 Figure 1 shows the alignment of the headgear with the wearer when the headgear is secured on the wearer's head, wherein (i) Fig.76 and (ii) a side view of a patient wearing a head cap. Fig.109 A side view of a wearer of a head cap;

[0418] Fig.111 Two further embodiments of a head cap body are shown, wherein (i) an embodiment is shown having a triangular cutout along a square top edge of the head cap body, and (ii) an embodiment is shown in which the top edge is angled on either side of the triangular cutout;

[0419] Fig.112 Figure illustrates an exemplary upper ear portion of a headgear having a pattern of fused and unfused areas to limit stretching in a selected direction;

[0420] Fig.113 FIGURE 1 illustrates another exemplary pattern of fused and unfused areas for limiting stretch in a selected direction in a headband;

[0421] Fig.114 FIGURE 1 illustrates another exemplary pattern of fused and unfused areas for limiting stretch in a selected direction in a headband;

[0422] Fig.115 Another embodiment of a cap-like headgear is shown, showing the headgear before being assembled into a cap and without any adjustment or end fixture components, the headband area of ​​the headgear being provided with a stretch area between the upper portions of the ears, wherein (i) is a plan view of the outside of the headgear, and (ii) shows the patient-facing side of the headgear;

[0423] Fig.116 Another embodiment of a cap-style headgear is shown, which shows the headgear before being assembled into a cap and without any adjustment or end fixture components, the headband area of ​​the headgear is 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;

[0424] Fig.117is a plan view of the outside of another embodiment of a cap-type headgear showing the headgear prior to being assembled into the cap and without any adjustment or end fixture components;

[0425] Fig.118 is a plan view of a chin strap according to another embodiment, wherein (i) shows the side of the chin strap facing the patient, and (ii) shows the outer side of the chin strap;

[0426] Fig.119 It is assembled with a head cap Fig.118 Left side view of the chin strap;

[0427] Fig.120 It is assembled with a head cap Fig.118 Right side view of the chin strap;

[0428] Fig.121 is a perspective view of another alternative embodiment side connector having a reinforcement layer and a comfort layer;

[0429] Fig.122 yes Fig.121 A front view of the side connector;

[0430] Fig.123 yes Fig.121 and Fig.122 A side view of a side connector;

[0431] Fig.124 The figure shows various deflection directions of the reinforcement layer of the side connector;

[0432] Fig.125 Figures show three exemplary embodiments of a side connector reinforcement layer having slits for flexibility extending to the periphery of the reinforcement layer;

[0433] Fig.126 Figures show three exemplary embodiments of a side connector reinforcement layer having slits for flexibility, the slits being disposed from the perimeter of the reinforcement layer;

[0434] Fig.127 is a plan view of another embodiment side connector having a reinforcement layer;

[0435] Fig.128 yes Fig.127 a side view of the connector; and

[0436] Fig.129 It is along Fig.127 A cross-sectional view taken along line L129. DETAILED DESCRIPTION

[0437] Now refer to Figures 1 to 129Various embodiments and methods of manufacture are described. In the drawings, the same reference numerals are used to denote the same features. Where several embodiments are illustrated, the same reference numerals may be used for the same or similar features in subsequent embodiments, but with multiples of 100, e.g., 2, 102, 202, etc.

[0438] Directional terms used in the following description are for ease of description and reference only and are not intended to be limiting. For example, the terms "front," "rear," "upper," "lower," and other related terms refer to the position of a component or part of a respiratory mask relative to a user when the user is wearing the respiratory mask. In this specification, "rear" refers to a position closer to the user (when the mask is in use), and in contrast, "front" refers to a position away from the user. The terms "upper" and "lower" refer to the position of a portion or part 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.

[0439] Respiratory system

[0440] Figure 1 An example breathing system 1000 is shown that can use an embodiment of a patient interface assembly 1001 described herein. In the illustrated arrangement, the patient interface assembly 1001 receives an inspiratory gas flow via an inspiratory conduit 1005a. The expiratory gas flow can be directed from the interface 1011 via an 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 gas flow.

[0441] The humidifier system 1200 generally includes a chamber located on top of a heater base that is fed by a gas flow source from, for example, a hospital or other supply source 1300. The humidified inspiratory gas flow is delivered to the patient's airway through an inspiratory conduit 1005a and a patient interface 1011. Excess and exhaled gas is exhausted from the patient interface 1011 through an expiratory conduit 1005b. The resistance device 1100 provides resistance to the expiratory gas flow leaving the system 1000 to the atmosphere to provide a desired peak end-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.

[0442] In some embodiments, the patient interface assembly 1001 includes a nasal cannula. In other embodiments, the patient interface 1011 includes a mask. For example, the patient interface 1011 may include a nasal mask, an oronasal mask, a mouth mask, or a full face mask. In some embodiments, the resistance device and / or humidifier are integrated into the supply source 1300. Although Figure 1A water-based resistance device for administering "bubble machine CPAP" is shown in FIG, but those skilled in the art will appreciate that the resistance device may be any other mechanical or resistive device known in the art.

[0443] Figure 2 Another example respiratory system 2000 including a bubbler device and a humidifier is shown. A humidified positive end-expiratory pressure (PEEP) system is shown, in which a patient 2400 receives humidified and pressurized gas through a patient interface 2011 connected to an inspiratory or inhalation conduit 2005a. A gas flow (e.g., air) is provided to the inlet of the humidifier 2200 from a gas supply device or blower 2300. The inspiratory conduit 2005a is connected to the outlet of the humidifier 2200 to deliver the humidified gas to the patient interface 2011 worn by the patient 2400. The inspiratory conduit 2005a may include a heating device or heating wire 2500, which heats the wall of the conduit to reduce condensation of the humidified gas in the conduit. The excess gas then flows to a pressure regulator 2100 through an expiratory or exhalation conduit 2005b.

[0444] In the illustrated embodiment, the pressure regulator takes the form of exhausting the exhaled gas flow into a chamber 2100 containing a water column, wherein the exhaled gas is bubbled in the water before leaving the chamber 2100. The gas exhaled by the patient can be directed to other equipment (valves, ventilators, pressure devices, etc.) through a similar breathing tube or exhausted to the patient's surroundings. The respiratory gas delivered to the patient can be heated to near body temperature (usually between 33°C and 37°C) and / or humidified to different levels (usually saturated for medical applications) to improve comfort.

[0445] It should be understood that the present disclosure is not limited to the delivery of PEEP gases, but is also applicable to other types of gas delivery systems, and does not necessarily require humidification.

[0446] Headgear and Patient Interface Systems

[0447] Figure 3A and Figure 3B The figure shows two exemplary embodiments of patient interface components 1, 101 and headgear components 70, 170 for respiratory systems 1000, 2000 (such as the above-mentioned systems). The patient interface components 1, 101 include a frame component 3 for connecting 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, 5b. As shown, the patient interface components 1, 101 can be connected to the headgear 71, for example, by using a pair of side arms 51 to releasably connect the frame to the headgear 71.

[0448] The inspiratory and expiratory ducts 5a, 5b are interchangeable.

[0449] In an alternative embodiment, the patient interface assembly 1, 101 can be fixed relative to the patient's face, for example using a skin patch. The skin patch adhered to the patient's skin can have a non-patient-facing side with an engagement surface to releasably fasten with the engagement surface of the side arm 51.

[0450] In alternative embodiments, the headgear assemblies 70, 170 described herein may be used with patient interfaces other than those described herein.

[0451] exist Figure 3A In the patient interface assembly 1, the assembly is provided with an interface body 111 including a nasal mask for an infant or a newborn. Figure 3B In the patient interface assembly 101 of the embodiment of the present invention, the interface body 11 includes a nasal cannula for an infant or a neonate, however other patient interface types are possible. The frame and interface body assembly enable 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 cannula body and a mask body) or between interface bodies of different sizes by interchanging the interface bodies coupled to the frame to improve the fit of the interface.

[0452] The headgear in the illustrated embodiment is a wraparound cap 71 having end fixtures 81 and adjustment means 85. The headgear includes a headband region 73 having an over-ear portion 74 that extends at least partially over the wearer's ears. The headband 73 includes an engagement surface for attaching a connector 93 to secure the patient interface assembly 1, 101 relative to the headgear.

[0453] The headgear may be used with various types of patient interfaces, including the interfaces 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 connector required will generally depend on the nature of the patient interface. Figure 3A In the embodiment of the present invention, two Y-shaped or wishbone-shaped side connectors 93 are provided to connect the side arms 51 of the patient interface assembly to the supra-ear region 74. These side connectors 93 can be used with an optional central fixing member 60 that is attached between the front surface of the frame 3 and a point on the front of the headband 73. Figure 3B In the embodiment of the present invention, 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.

[0454] In certain applications, a chin strap may be provided to hold or encourage the patient's mouth closed, such as for the delivery of CPAP.

[0455] Patient Interface Framework

[0456] Now refer to Figures 4 to 10 In (viii), the frame 3 is configured to couple the interface body 3 to the inspiratory duct 5a and the expiratory duct 5b. The frame 3 includes a coupling portion 7 for engaging with a complementary coupling portion of the interface body to securely and releasably hold the interface body relative to the frame and to be in fluid communication with the ducts 5a, 5b.

[0457] The coupling portion 7 of the frame 3 includes two end regions 6a, 6b for coupling respective conduits. A main body member 8 extends between the end regions 6a, 6b. The main body member 8 can be a contoured main body member 8. The main body member 8 is arranged at the front of the frame 3, forming a bridge between the two end regions 6a, 6b. The main body member 8 has a contoured inner surface for contacting a complementary coupling portion of the interface body, for example, a concave side 9 formed to be flush against a generally cylindrical barrel, and a complementary convex coupling surface on the interface body 11, 111 for engaging.

[0458] Special reference Fig. 9 and Fig.10 The width of the main member 8 and the wall thickness of the main member 8 change along the length of the main member 8 (i.e., from near the first end region 6a of the frame to near the second end region 6b of the frame). The change in width and thickness along the member 8 is gradual, preferably without abrupt changes.

[0459] The width of the main body member 8 is widest near the ends of the main body member, near the first and second end regions 6a, 6b of the frame, and gradually narrows 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 main body. The frame member 3 is generally a rigid component. It is desirable to minimize contact between the frame member 3 and the patient, or to avoid contact between the frame member 3 and the patient to reduce the risk of damaging facial tissue. This curved profile of the main body member 8 advantageously increases the gap between the frame member and the patient's face, reducing the chance of accidental contact between the frame and the patient. The contoured side can provide additional space for flexing of the patient interface body to improve fit with the patient. The contoured side can also enable the patient interface body to be connected to an enhanced decompression feature. Specifically, the contoured side can provide space to enable the frame to be connected to a nasal cannula having a septum decompression recess, and / or provide clearance for the patient's septum.

[0460] In the embodiment shown, the cross-section of the first and second end regions 6a, 6b of the frame is annular. The width of the ends of the main body member 8 (taken as the cross-sectional chord length of the main body member) is less than the diameter of the end regions 6a, 6b of the frame. At the midline ML of the main body member 8, the width of the main body member 8 is about 50% of the diameter of the end regions 6a, 6b of the frame, but other widths are also possible, such as between about 35% and about 90% of the diameter of the end regions.

[0461] Reference Fig.10 In the cross-sectional views (i) to (viii) in FIG. 1 , the wall thickness t of the main member 8 is from the thinnest point near the end of the main member (where the member is widest) ( Fig.10 The thickness of the wall varies from (ii) in Figure 5 to (ii) in Figure 5 to the thickest point adjacent to or at the midline of the frame 3 (where the member is narrowest). This increase in wall thickness provides additional rigidity to compensate for the reduction in material resulting from the reduction in member width. The projections 53, 54, 67 on the front surface of the frame for attachment of fixing members or connectors are not considered to form part of the wall thickness of the main frame member.

[0462] In the embodiment shown, the wall thickness variation is provided by a body member 8 having an outer surface with a different surface curvature compared to the inner surface of the member. Fig.10 As shown in (ii) to (viii) in the figure, the cross-sectional profile of the frame body 8 is generally arched. In the embodiment shown, the curvature of the inner surface of the main body member 8 is substantially constant along the length of the main body member 8, but the curvature of the outer surface of the main body member 8 changes from a maximum radius of curvature adjacent to the end of the main body member to a minimum radius of curvature at or near the midline ML, which has the effect of increasing the wall thickness.

[0463] Fig.10 (ii) in FIG. 5 shows that the outer surface and the inner surface of the main body member 8 are concentric in the end region adjacent to the frames 6a, 6b. In contrast, Fig.10 (viii) in the figure shows that at or near the midline ML, the outer surface and the inner surface of the main member 8 have different centroidal curvatures, so that the thickness of the main member changes along the cross-sectional profile. For example, the thickness of the main member is larger in the middle of the cross section and gradually narrows outward toward its ends.

[0464] In alternative embodiments, the body portion may alternatively or additionally include one or more reinforcing 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 or permanently bonded to the body member. For example, the shape, height and / or width of the rib may vary along the length of the rib to provide the desired reinforcement.

[0465] Patient interface body

[0466] Figures 11 to 13 Two exemplary embodiment patient interface bodies 11 , 111 are shown. Fig.11 The interface body has the form of a nasal cannula, and Fig.12 The interface body of 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, which is shaped to couple with the coupling portion 7 of the frame 3. The patient contact portion 13, 113 can form a complete or partial seal with the patient's face.

[0467] The patient contacting 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, 5b. 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 lateral flow of fluid into and out of the manifold. The patient contacting portion 13, 113 is fluidly coupled to the manifold, for example, via a rear opening in the manifold, to facilitate flow of gas into and out of the manifold and the patient via the patient contacting portion.

[0468] In the embodiment shown, the side ends of the manifold are annular for coupling with the annular ends 6a, 6b of the frame 3. The front of the manifold has a front outer surface extending between the ends, which is shaped to couple with the frame 3 with a generally semi-cylindrical front surface.

[0469] An annular member 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.

[0470] These annular members 22, 122 can be colored members used with a transparent or translucent frame or frame portion to provide a visual indication of the correct assembly between the interface body and the frame. The user or clinician can observe the position and configuration of the colored ring through the transparent or translucent frame. In the illustrated embodiment, the correct positioning and connection of the frame to the patient interface body is indicated by observing that the colored ring is axially aligned with the frame 3 and forms a circle. Improper positioning is indicated by observing that the colored ring is deformed or misaligned with the frame 3, and also indicates that the air seal between the frame 3 and the interface body 11 may be insufficient.

[0471] Additionally, or alternatively, differently colored annular members may serve 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 reinforcement area 15a, 15b, 115a, 115b has a convex coupling wall 16a, 16b, 116a, 116b that protrudes upward from the front outer surface of the manifold.

[0472] The reinforced regions 15a, 15b, 115a, 115b provide rigidity to the coupling portions of the interface bodies to provide easier handling and assembly, and to reduce the likelihood of accidental separation of the patient interface body 11, 111 from the frame 3.

[0473] The protruding male coupling walls of the reinforcement areas 15a, 15b together with the front outer surface of the manifold 14 define a recess 17 to receive the main body member 8 of the frame 3. The recess has a shape corresponding to the shape of the frame main body member 8 and the two convex sides 9 of the main body 8, and the width of the recess varies 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 side of the interface body and gradually narrows to the narrowest point at the midline ML of the interface body. The narrowing caused by the two facing male coupling walls of the reinforcement areas 15a, 15b is non-linear.

[0474] The complementary shapes of the recess and frame body members facilitate proper assembly of the interface body with the frame and reduce the possibility 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 facing up or facing down. In an optional embodiment where the frame requires a specific orientation of the interface body for proper operation, the top and bottom edges of the frame body can 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 one way.

[0475] With the frame 3 engaged with the interface bodies 11, 111, the inner surface of the frame body member 8 may be roughly abutted against the front outer surface of the manifold 14, or may roughly follow the curvature of the front outer surface of the manifold 14, with a small spacing between the components for clearance. In one embodiment, the clearance may be 0.1 mm to 0.2 mm. However, at least a portion of each of the connecting walls 16a, 16b, 116a, 116b is configured to be located above the front surface of the frame body member 8 when assembled. The connecting walls may be raised above the front surface of the frame body member 8 at a distance that is maintained substantially constant across the frame body member. Alternatively, the connecting walls may be raised above the front surface of the frame body member 8 at a distance that varies across the frame body member 8.

[0476] Figures 13 to 17 The figures show different wall thicknesses of the nasal mask interface body 111. The coupling walls 116a, 116b of this embodiment 111 are formed to be between about 2 mm and about 3.5 mm high from the front surface of the manifold 114, so that when coupled with the frame 3, they are elevated above the front surface of the frame body member 8 at a constant distance of about 0.9 mm across the frame body member. In alternative embodiments, the coupling walls 116a, 116b can be between about 0 mm and about 2 mm high above the front surface of the frame body member 8. They can be elevated above the body member 8 at a constant distance, or the distance can vary across the body member.

[0477] In contrast, Fig.35 and Fig.36 The figure shows the frame body member 8 installed in the coupling portion recess of an exemplary nasal cannula 11, which shows the midpoint of the frame and the interface body ( Fig.36 ) and one side of the interface body ( Fig.35 ) in a manner consistent with the embodiment of the present invention. In this embodiment, the connecting walls 16a, 16b are configured to be raised above the front surface of the frame body member 8 by a distance that varies across the frame body member, transitioning from a height of approximately 0.9 mm near the sides of the frame 3 to a height of approximately 0.3 mm at the center. In an alternative embodiment, the connecting walls 16a, 16b may be raised above the front surface of the frame body member 8 by a distance that varies across the frame body member, transitioning from a height of approximately 2 mm near the sides of the frame 3 to a height of at least 0 mm at the center. In an alternative embodiment, the connecting walls 16a, 16b may be raised above the front surface of the frame body by a distance that is constant across the body. It should be understood that these are exemplary dimensions and are not intended to be prescriptive, and that many variations of these dimensions are contemplated.

[0478] The portion of the patient interface coupling portion that protrudes above the frame body 8 helps reduce the risk of incorrect assembly and helps maintain the connection between the interface coupling portion and the frame.

[0479] The thickness of the reinforced regions 15a, 15b in the catheter interface body 11, as well as the height of the coupling walls 16a, 16b, may vary across the width of the interface body 11. In the illustrated interface body 11, the height of each coupling wall 16a, 16b is greater toward the sides of the interface body, and is smaller toward the midline of the interface body.

[0480] The thickness of the reinforced regions 115a, 115b in the mask interface body 111, and the height of the coupling walls 116a, 116b may be substantially constant, or may vary slightly across the width of the mask interface body 111.

[0481] Nasal mask

[0482] Figures 14 to 20An exemplary nasal mask embodiment of an interface body 111 is further illustrated. The interface body 111 includes a mask cushion extending rearwardly from a frame coupling portion 112 and a manifold. The mask 111 can be applied to the patient's face, forming a seal on or around the patient's nostrils, on the nose. In an alternative embodiment, the mask 111 can cover the patient's nose and mouth.

[0483] The mask cushion includes a substantially hollow body defining a mask cavity 121, and a face contacting surface 113 generally opposite the frame coupling portion 112, with a peripheral edge 119 of the face contacting surface 113 defining an opening. The mask cavity 121 is configured to receive a gas flow from the manifold so that the gas can flow to the patient through the opening.

[0484] The face contact surface 113 fits against the wearer's face, surrounding a portion of the patient's nose including the nostrils. The contact surface 113 can be sealingly engaged 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 area below the user's nose, and across the bridge or tip of the user's nose. Alternatively, the sealing area of ​​the mask tip can be located at or near the transition from the nasal bone to the nasal cartilage, such that at least a portion of the sealing area is located above the nasal bone.

[0485] The mask cushion includes a "rolling region" 117. The rolling region 117 is configured to roll or flex onto the outer surface of the mask to allow the mask to adapt to facial movements or forces applied to the mask, and to accommodate different nose geometries. The rolling of the rolling region 117 helps relieve pressure applied to the user's nose and / or face by rolling more in areas of increased pressure. The rolling region can also help maintain the integrity of the seal between the mask and the patient by conforming the mask to the patient's face.

[0486] In the illustrated embodiment, the rolling area 117 extends along the upper and side portions of the mask 111. When the mask 111 is fixed on the user's face in use, the contact surface 113 can be located above the user's nose bridge, nose sides, and upper lip. With the supply of positive pressure air, the contact surface 113 can expand and seal on the user's face.

[0487] The wall thickness and / or stiffness of the mask 111 in and adjacent to the mask rolling region 117 is selected to provide the desired rolling and deflection characteristics. To assist in rolling or bending, the region 117 can have a varying thickness or a varying stiffness. For example, the thickness selected can determine the degree of motion provided by the mask. In addition, varying the stiffness of the region can create hinge points or pivot points that can guide the movement of the mask.

[0488] In the illustrated embodiment, the rolling region 111 includes thin areas at and adjacent to the patient contacting surface 113, and at the front region 118 of the rolling region, adjacent to the manifold, along the top and sides of the mask. These thin areas facilitate bending or folding of the mask 111.

[0489] The reduced stiffness at the patient contacting surface allows the surface to conform to the patient's face. In addition, the reduced stiffness and / or thickness in the front region (top and sides of the mask) allows the mask to perform a rolling motion with a substantially flat force-displacement curve. When the mask cushion is compressed, such as when the mask 111 is pushed toward the patient's face in use, the rolling region 117 can roll forward from the pivot point or hinge point at or adjacent the base of the mask.

[0490] The mask 111 includes a reinforcing structure 123 between the two regions 119 and 118. The reinforcing structure 123 may be harder or formed of thicker material than the adjacent regions 118, 119. 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 embodiment shown, the structure 123 extends around the sides and top of the mask. In an alternative embodiment, the structure 123 may extend around the sides, top, and base of the mask. The structure 123 may be a strip.

[0491] 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 including a gradual thinning of the wall thickness. Preferably, there is no abrupt change in wall thickness from the reinforced region 123 to the patient contacting surface 113. The smooth transition between these regions reduces the likelihood that the edge of the reinforced region will contact the user's skin and / or nose bridge when the mask is deformed to seal against the patient.

[0492] With respect to the transition from the reinforced region 123 to the front roll region 118, a less gradual transition is required because the front edge of the reinforced region is not facing the patient.

[0493] The structural portion 123 can be positioned to affect the force-displacement curve of the rolling area at the top and / or sides. For example, when a thin material of a reduced stiffness portion is rolled until the thickness of the rolling material begins to increase (suddenly or gradually), the force curve can be relatively flat. The increase in the thickness of the rolling material will cause the force-displacement curve to rise. The gradual thinning or gradual reduction in the stiffness of the structural portion 310 can be used to allow the rolling area to roll a distance before slightly resisting displacement, rather than going from a low force to a high force when the rolling area stops rolling.

[0494] In some cases, such as under higher pressures, the structure 123 can help prevent the mask from expanding. The structure 123 can also help prevent folds or creases in the thin material portions of regions 118, 119.

[0495] The mask can be rolled on each side individually or together and pivoted about a point at or near the base of the mask. Fig.16 and Fig.17 As shown by the dashed line in FIG, the rolling area 117 can be deflected around the front edge 120 of the rolling area 117. Fig.17 As shown, the mask 111 is configured to hinge at the base of the mask so that there is greater displacement toward the top of the mask.

[0496] The material thickness of the mask wall may thicken or stiffen as it moves forward of the front edge 120 of the rolling region. In some embodiments, the mask may have a thickened or reinforced base that may add structure, such as to prevent the mask from folding in half laterally.

[0497] In some embodiments, the portion of the material with reduced stiffness may have a thickness of about 0.5 mm or less. The portion of the material with reduced stiffness may have a thickness of 0.8 mm or less, 0.7 mm or less, 0.6 mm or less, 0.5 mm or less, 0.4 mm or less, or 0.3 mm or less. In some embodiments, the thickness ratio of the structure 123 to the portion of reduced stiffness may be about 20:1, 15:1, 10:1, 5:1, 2:1, or 1.5:1.

[0498] Reference Fig.18 The patient contacting surface 113 may have a curvature in the transverse plane to provide good conformity to the transverse curvature of the patient's face, especially good conformity to the facial curvature of an infant or newborn. Fig.18 The curvatures of two exemplary embodiments are compared - the presently described embodiment 111 and an alternative mask 211 described in WO2021176338, which is incorporated herein by reference.

[0499] The larger lateral curvature of the mask can improve the contact of the mask with the patient, especially above the patient's cheeks. In this embodiment 111, the curvature is such that the anterior-posterior depth of the patient contact surface 113 is between about 0.5 mm and about 2 mm greater than the depth of the contact surface in the embodiment illustrated in WO2021176338, which is measured from the anterior-posterior point of the surface 113 at the midline of the mask to the posterior-posterior 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 1 mm and about 1.6 mm greater than the depth of the contact surface in the embodiment illustrated in WO2021176338. Reference Fig. 20The opening of the mask cavity 121 has a width W of between about 10 mm and about 40 mm, depending on the mask size. However, other dimensions are also contemplated.

[0500] The mask interface body 111 can be made of a single material or two or more different materials. The mask body 111 can be made of silicone.

[0501] Nasal cannula

[0502] Fig.11 and Figures 21 to 34 Another embodiment of a patient interface body 11 in the form of a nasal cannula is shown. The cannula 11 includes a pair of nasal prongs 13 extending toward the patient from the rear of the frame coupling 12 and the manifold 14. Each nasal prong 13 can be shaped to extend from the manifold 14, generally upward and rearward into the user's nostrils. Each nasal prong 13 can have a curvature including more than one inflection point.

[0503] The nasal prongs 13 are shaped to form a seal with the patient's nostrils and allow gas to flow out of and into the user. For example, the curvature, wall thickness, and / or cross-sectional shape of the nasal prongs can vary from the base to the tip 19 of each nasal prong 13. In some embodiments, the nasal prongs are shaped to seal the nostrils of an infant or newborn. The nasal prongs 13 can be shaped and formed to minimize tissue compression and kinking of more than one nasal prong 13 during insertion into the patient's nostrils. In the illustrated embodiment, the wall thickness of the nasal prongs is substantially constant from the base to the tip 19 of the nasal prongs 13.

[0504] The nasal prongs 13 may taper inwardly from the base of each nasal prong 13 to the tip 19. The nasal prong cross-sectional area may taper from the base of each nasal prong 13 to the tip 19 or between the base of each nasal prong 13 to the tip 19. This narrowing of the nasal prongs may assist in the sealing function of the nasal prongs 13. As the nasal prongs 13 are pushed into the patient's nostrils, they may seal somewhere along the length of the nasal prongs 13 due to the taper of the nasal prongs 13 that widens toward the base 23. The narrowing may assist in the insertion of the nasal prongs 13, as opposed to nasal prongs of constant cross-sectional area or nasal prongs that widen toward the outlet.

[0505] Each nasal prong 13 defines an internal cavity whose internal cross-section varies along the length of the nasal prong 13. In the embodiment shown, the outlet of the nasal prong internal cavity at the nasal prong end 19 is generally circular. In some embodiments, the outlet of the nasal prong internal cavity can be generally elliptical. In the embodiment shown, the cross-sectional size generally decreases along the trajectory from the base 23 to the end 19 of each nasal prong. The cross-sectional shape can also be varied.

[0506] At and / or adjacent to the base 23 of the nose prong 13, the catheter body 11 includes a flexure base region 25 (e.g. Fig.21The base region 25 may form a portion of the catheter body 11 where the nasal prongs 13 meet the manifold 14. The base region 25 may help provide comfort and fit for the patient while also ensuring that a flow path is maintained between the manifold and the nasal prongs.

[0507] In the illustrated embodiment, the flex base region 25 comprises an area of ​​reduced wall thickness relative to the base of the nasal prongs 13 and the remainder of the manifold 14. The area of ​​reduced wall thickness 25 may fully or partially surround the base 23 of each nasal prong and may extend between the nasal prongs 13. In the illustrated embodiment, the base region 25 has a thickness of Fig.21 The generally kidney-shaped shape shown forms a band of material of reduced thickness around the base of each prong and between the prongs.

[0508] The area of ​​reduced wall thickness creates a spring effect at the base of the nose prong 13. The thinner area of ​​material may be formed partially or entirely at the base of the nose prong.

[0509] In some embodiments, the wall section of the nose fork 13 transitions to a thinner wall of the base region 25 surrounding the nose fork. The base region 25 can have a substantially constant thickness throughout the base region. In some embodiments, the thickness of the nose fork 13 adjacent to the base 23 can 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-1.5mm. The thickness of the base region 25 can be between 0.1mm-1.5mm, 0.2mm-1.5mm, 0.2mm-1.3mm, 0.3mm-1.3mm, 0.5mm-1.2mm, or 0.5mm-1.0mm. For example, in one embodiment, the thickness of the nose prong 13 may be about 0.6 mm, and the thickness of the base region 25 may be about 0.3 mm. In such an embodiment, the thickness ratio between the nose prong 13 and the base region 25 may be 1:0.5. The thickness ratio between the nose prong 13 and the base region 25 may be any other ratio that provides a desired transition therebetween.

[0510] The flexing base region 25 can provide a spring action or mechanism at the base of the nasal prong 13. The base region 25 can help separate the movement of the housing and / or manifold 14 from the movement of the nasal prong 13. The base region 25 can provide the nasal prong 13 with the ability to flex around the base region 25 while avoiding kinking of the nasal prong 13. The nasal prong 13 can flex while maintaining its position in the nostril. For example, the base region 25 can provide a spring-like movement at the base of the nasal prong 13 and / or in an area around the base of the nasal prong 13. The base region 25 can apply a spring load to the nasal prong to absorb some interface movement while maintaining the nasal prong 13 in the proper position in the nostril. For example, the base region can initially be in a neutral / relaxed position (i.e., the natural state of the catheter body) without any force applied to any part. When inserted into the nostril, the action of pushing the nasal prong into the proper position (and sealing) can cause the base region 25 to flex or deflect downward into the manifold. The position of the nasal prong in the nostril can remain unchanged, especially when the nasal prong is in a sealed position. If, during use, the housing and / or manifold is pulled downward and / or away from the face (e.g., by pulling on a tube), the base region 25 can move toward the intermediate position. The base region 25 remains resilient enough to maintain the position of the nasal prongs in the nostrils. For example, the spring load from the base region 25 can absorb interface motion, such as cheek motion, patient motion, or headgear motion. The base region 25 can help the or each nasal prong 13 move in multiple directions to accommodate motion of the interface while also maintaining a seal sufficient to maintain therapeutic delivery.

[0511] The flexible base region 25 can help accommodate different septum spacings. The base region 25 can 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 can alternatively or additionally provide an upward thrust into the nostrils to maintain a constant seal.

[0512] In some embodiments, the base region 25 can be shaped to form a recess at the septum region 29 between the 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 can also improve visibility of the patient's nostrils and / or septum.

[0513] The septal recess 29 is defined by the surface of the base region 25 between the nasal prongs 15, which extends forward from the base 23 of the nasal prongs and extends forward from the patient contacting surface or cheek contacting 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 nasal prongs 15. The wall thickness of the base region 25 at the septal recess 29 can be substantially constant, or can vary.

[0514] In use, due to the flexing base area, the nasal prongs 13 can be pressed toward or into the manifold 14. In the absence of sufficient septal recess 29, this may result in increased contact and / or pressure between the patient's septum and the interface. Therefore, it is desirable that the depth t1 of the septal recess is as large as possible without adversely affecting the resistance of the gas path flowing through the nasal prongs and without compromising the rigidity of the coupling portion 12 of the interface body 11.

[0515] Fig.27A and Fig.27B The diagram shows indicative geometries of the septum recess 29 in two different sizes of interface bodies. Fig.27A In the smaller dimension shown, the septum recess 29 has a depth t1 of about 1.9 mm from the base 23 of the nasal prong forward. This corresponds to a distance t2 of about 3.8 mm from the lower sealing portion of the nasal prong. Fig.27B In the larger dimensions shown, the septum recess 29 has a depth t1 of approximately 2.2 mm forward from the base 23 of the nasal prong. This corresponds to a distance t2 of approximately 4.1 mm from the lower sealing portion of the nasal prong 13'. It should be understood that these dimensions are provided as examples, and that the dimensions of the septum recess may vary for different sized nasal prongs and / or different patient interface body 11 sizes.

[0516] The catheter body 11 may include another region 27 (composed of Fig. 22 ), is generally located below a base region 25 on 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 philtrum of the patient, reducing pressure on the skin and minimizing the risk of skin damage.

[0517] The philtrum contact area 27 may include an area having a reduced wall thickness relative to the base of the nasal fork 13 and / or the rest of the manifold 14. The philtrum contact area may include an area with a thicker wall thickness compared to the base area 25. In some embodiments, the philtrum contact area 27 may include an area having a wall thickness equal to or greater than the wall thickness of the base of the nasal fork 13. The wall thickness of the entire area 27 may be substantially constant. In the exemplary embodiment shown and described above, the philtrum 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 fork is approximately 0.6 mm, and the philtrum contact area 27 has a constant wall thickness of approximately 0.6 mm.

[0518] The philtrum contact region 27 is adjacent to the flexure base region 25 of the nasal prong, wherein the upper boundary of the philtrum contact region 27 forms the lower boundary of the base region 25. Thus, the shape of the upper boundary of the philtrum contact region 27 corresponds at least partially to the shape of the lower boundary of the base region 25. The flexure base region 25 may gradually transition to the philtrum contact region 27, or in some embodiments, the transition may be quite abrupt.

[0519] The philtrum contact area 27 may extend to most of the width of the body. For example, the philtrum contact area 27 may extend at least the width of two nasal prongs, extending from the side of the first nasal prong to the side of the second nasal prong 15. Alternatively, the philtrum contact area 27 may extend at least the width of the base area 25.

[0520] In the illustrated embodiment, the philtrum contact region 27 is shaped to be widest in the middle of the region, at the midline of the interface body 11, and in line with the septum region 29 between the nasal prongs 13. The philtrum contact region 27 may become narrowest toward the lateral sides of the region 27. In one embodiment, the philtrum contact region 27 has a generally oval shape.

[0521] In an embodiment, the wall of the catheter interface body 11 includes at least four regions of different wall thicknesses: the nose prong 15 having a first wall thickness, the flexure base region 25 having a second wall thickness, the philtrum region 27 having a third wall thickness, and the rest of the body having variable wall thicknesses including a fourth wall thickness. The fourth wall thickness can be greater than the first, second, and third wall thicknesses. The fourth wall thickness can be the maximum wall thickness of the interface body 11. The first wall thickness can be greater than the second wall thickness and greater than or equal to the third wall thickness. The third wall thickness can be greater than or equal to the second wall thickness. The second wall thickness can be less than the first, third, and fourth wall thicknesses.

[0522] Conduit-frame connection

[0523] Figures 38 to 40 The figure shows an arrangement for coupling the inspiration and / or exhalation conduits 5a, 5b to the patient interface frame 3. The arrangement comprises a collar 35.

[0524] The connection between the collar 35 and the frame 3 may be permanent. For example, at least a portion of the collar 35 may be fused or overmolded to the frame 3.

[0525] The collar 35 may include a fusion 39 for coupling the collar 35 and conduit 5 to the patient interface frame 3. Optionally, the entirety or substantially all of the collar 35 may include a fusion.

[0526] The conduit 5 may be attached to the collar 35 around the collar and the annular portion of the conduit. The connection between the conduit 5 and the collar 35 may be permanent, such as a fused connection. The collar and the attached annular portion of the conduit 5 are located adjacent to the frame 3.

[0527] The length of the annular portion of the catheter 5 attached or fused to the collar 35 is at least 1 mm, for example, between about 1 mm and about 5 mm. However, the length may vary depending on the size of the catheter. For a spirally wound or corrugated catheter, at least a single winding or corrugation is fused to the collar 35. In some embodiments, more than one winding or corrugation may be fused to the collar 35. For example, up to three windings or corrugations may be fused to the collar, or alternatively more than three windings or corrugations. The fused length of the catheter is positioned to the side of or near the frame end of the collar 35.

[0528] In addition to the fused length, the collar 35 also accommodates the free length of the catheter. That is, within the boundaries of the collar, at least a portion of the catheter is free to move within the collar 35. The free length can be longer than the attached / fused length of the catheter.

[0529] The free portion within the collar ensures that any bending of the conduit will not react at the rigid connection of the collar conduit end, which could damage or cause connection failure. Instead, the bending force is reacted by the length of unconnected tubing in the collar flexing and contacting the inner wall of the collar 35.

[0530] The inner diameter of the collar 35 may be constant, or alternatively may vary along the collar, for example the diameter may be larger at the end of the collar adjacent the free conduit portion.

[0531] The collar 35 may include a flexible or rigid body. For example, the collar may include one or more thermoplastics, polyurethanes, and / or silicones. In an exemplary embodiment, the collar 35 includes a pre-molded thermoplastic polyurethane (TPU). In an exemplary embodiment, the TPU collar 35 is overmolded with the patient interface frame 3.

[0532] Catheter Connectors

[0533] 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 gas flow). Figures 41 to 44An exemplary connector 41 for use at the end of the conduits 5a, 5b is shown. The connector 41 can be any type of interlocking or mating connector to connect the tubing to another device 47 or additional tubing. The connector 41 can have a locking finger 45 extending from the connector body 43 to connect and secure the tubing to another device or additional tubing. In some embodiments, the locking finger 45 can extend away from the connector body 43. The locking fingers 45 can be spaced apart and narrow along their length away from the connector. The locking fingers can have a locking recess or stop formed at least on the outer surface of each locking finger. The locking recess can lock with a portion of a gas delivery tube connector or other connector 47. The locking fingers can interact with the recess of the gas delivery tube connector or other connector to align the connector 41 with the gas delivery tube connector or other connector.

[0534] The outer body of the connector 43 can house a base portion 46 that supports the locking fingers of the connector and includes gripping features that facilitate gripping the connector. In the illustrated embodiment, the body includes four gripping recesses spaced 90 degrees from each other.

[0535] In some embodiments, a first end of a conduit 5a may be coupled to the body of the connector, such as Fig.41 As shown, the first end of the second conduit 5b may include a female connector 47 for receiving a complementary connector.

[0536] Examples of connectors and / or connector assemblies may be found in International Application No. PCT / NZ2012 / 000142, filed on August 10, 2012, entitled "Conduit Connector for Patient Respiratory Devices," 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.

[0537] Side Arm

[0538] refer to Figures 45 to 47 A pair of side arms 51 are provided for detachably connecting the patient interface frame 3 to the supporting headgear and / or connector to fix or support the patient interface body relative to the patient. In some embodiments, the connector may include a skin pad attached to the patient's face and having an engagement surface for engaging the side arms.

[0539] In some embodiments, the side arms 51 can secure the interface body to the user's face to help the interface body form and maintain a seal with the patient's face. In alternative embodiments, such as an interface for nasal high flow therapy, the side arms can secure the interface to face the operating position to deliver gas to the patient's airway.

[0540] Each side arm 51 is a separate member having a first end 51a for connection to the front of the frame 3. Each first end 51a may be connected to the front of the frame 3 releasably or permanently.

[0541] Providing two independent arms advantageously leaves the area in the center of the frame 3 unconstrained by the side arms and free to connect to other components such as a mount described in more detail below. The second end of each arm 51 includes a 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.

[0542] See also Figure 5 and Figure 7 , the front of the frame 3 includes a left connection area 52a and a right connection area 52b for connecting the corresponding side arms 52. Each connection area is located between the midpoint of the frame and the corresponding side of the frame.

[0543] The connection region may include one or more connection features to engage with a corresponding side arm 51. The connection features may include any suitable features that facilitate a fixed, 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.

[0544] In an exemplary embodiment, each connection area includes one or more protrusions for receiving complementary holes or recesses on the side arms. Each protrusion 53, 54 for engaging the 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 protrusions may be located closer to the corresponding side of the frame than the midpoint of the frame.

[0545] exist Figure 45 to Figure 47 In the exemplary embodiment of, each frame connection area is provided with two protrusions 53, 54. The first protrusion 53 includes a pillar with an enlarged end. The pillar of the protrusion 53 protrudes forward and vertically from the front surface of the frame 3, so that the enlarged end of the first protrusion 53 is spaced apart from the front surface of the frame, wherein the frame has a front face that is substantially parallel to the front surface of the frame. The enlarged end can be located at the center of the pillar, or can be offset from the center, such as protruding to one side of the frame 3. In the illustrated embodiment, the enlarged end of the first protrusion 53 is generally rectangular, oriented transversely on the frame body member 8, and protrudes from the pillar to the corresponding side of the frame. However, it should be understood that protrusions of other shapes can be utilized.

[0546] The first protrusion 53 passes through the hole 55 proximal to the first end of the side arm 51. A recess is provided on the front surface of the side arm, the recess having a shape and depth corresponding to the enlarged end of the protrusion, aligned with the hole, for placing the protrusion when the side arm is connected to the frame 3. The height of the first protrusion 53 is substantially the same as the thickness of the arm at the first end 51a, so that the enlarged end of the first protrusion 53 is approximately flush with the front surface of the side arm 51. In other embodiments, the first protrusion can be sized to be recessed behind the front surface of the side arm 51, or to protrude in front of the front surface.

[0547] The second projection 54 is in the form of a hook connector for mounting in a complementary recess of a corresponding side arm. In the embodiment shown, the hook connector 54 comprises a post with a hook protruding laterally therefrom. The hook is preferably oriented to protrude towards the midpoint of the frame, away from the side edges of the frame, so that when tension is applied to the arm, the hook engages with the arm (rather than risking disengagement). Preferably, the hook forms an angle of approximately 90 degrees with the post, but alternatively, other angles may be possible, for example depending on the rearward angle of the side arm.

[0548] The hook and the support of the second projection may have a constant width. Alternatively, the width may vary along the projection, and / or the hook may have a different size than the support.

[0549] In the illustrated embodiment, the second protrusion 54 protrudes forward from the frame 3 a distance less than the first protrusion 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 an alternative embodiment, the second protrusion may extend through the entire thickness of the side arm 51 so as to be visible from the front.

[0550] The side arm 51 including the first end 51a may have a resilient material portion such as an elastomer. In some embodiments, the arm 51 includes a thermoplastic elastomer such as, but not limited to, that sold by KRAIBURG™. Using a flexible material for at least a portion of the side arm 51 enables the arm to flex or bend to better accommodate changes in individual patient facial geometry and / or facial movements.

[0551] To assemble the side arm 51 with the frame 3, a recess (not shown) on the rear surface of the side arm engages the second projection 54. The arm is then pulled laterally outward, stretching the holes 55 over the enlarged heads of the first projections 53 before the arm is pulled into contact with the surface of the frame, and releasing the arm to allow the holes to return to their unstretched state. The heads of the first holes prevent movement of the arm out of contact with the front surface of the frame.

[0552] like Fig.46As shown, the side arm 51 is formed to extend rearward from the frame 3. From the first end of the side arm 51a, the arm is bifurcated into an upper member 56a and a lower member 56b. Fig.48 As shown, the two members diverge to define an intermediate space that allows the inspiratory duct 5a and the expiratory duct 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 connection between the frame and the ducts, and also allows observation 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, because for embodiments in which the frame is transparent or translucent, this enables the user to observe whether the interface body has been correctly positioned within the frame 3. At the point where the upper member 56a and the lower member 56b diverge, a U-shaped cutout may be provided to improve visibility of the sides of the frame.

[0553] The upper and lower members 56a, 56b are twisted about a quarter turn along their lengths. The upper and lower members 56a, 56b are twisted 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 upwards adjacent to the connection pad 52. Conversely, the surface of the lower member 56b parallel to the front of the frame is twisted to face downwards adjacent to the connection pad 52. This twisting stabilizes the space between the members to reduce the possibility of interference with the conduits 5a, 5b.

[0554] The upper and lower members 56a, 56b are connected to the front surface of the connection pad 52 at spaced points on the middle side of the connection pad 52. The relative patient-facing surface of the connection pad 52 is configured to be connected to a head cap or other connector. In an exemplary embodiment, the patient-facing surface of the connection pad 52 includes a hook or loop surface to engage with a complementary hook or loop surface. The hook or loop surface can be overmolded to the corresponding connection pad 52 or connected in other ways. Overmolding can advantageously provide a non-patient-facing surface of the connection pad 52 that is easier to wipe or clean. In a preferred embodiment, particularly in the case where there is a risk that a portion of the connection pad contacts the wearer's skin, the connection pad 52 includes an annular surface.

[0555] Figures 49 to 55 An alternative embodiment of a side arm 151 is shown in which 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 overmolding the elastomeric body of the remaining side arm to the rigid portion.

[0556] Figure 53 to Figure 55Another embodiment frame for use with a snap-on clip is shown. In this embodiment frame 103, a single protrusion 53 is provided in each frame connection area. The frame protrusion 53 is shaped to have a plurality of engagement surfaces. For example, the protrusion 153 includes a hook 153, which includes a protrusion extending toward the midpoint of the frame, spaced apart from the front of the frame. The protrusion 153 also includes a lip 153a, which is used to grasp a portion of the clip between the lip and the front of the frame. In the embodiment shown, the protrusion generally has an anvil shape.

[0557] The clip 157 has a hole 158 for receiving the projection and has lips 159a, 159b for engaging with lips on the projection 153. To assemble the side arm 151 with the frame, as shown Fig.54 As shown in m1 in the figure, the clip 157 is slid under the hook of the protrusion 153 and then pressed on the protrusion (m2), causing the clip to bend and snap down around the protrusion. The lip 153a catches the corresponding lip 159a on the clip to secure the connection. The base of the protrusion 153 includes an angled surface 153c that forks toward the hook 153b. These surfaces abut the complementary angled surfaces 159a of the clip and are used to prevent the clip from moving toward the midpoint of the frame 103.

[0558] Stabilizing arm

[0559] Figure 56 to Figure 75 An embodiment of a stabilizing arm 60 is shown that can be connected to the frame 3 and the head cap 71 to help secure or support the patient interface body relative to the patient. In some embodiments, the stabilizing arm 60 can secure the interface body to the user's face to help the interface body form and maintain a seal with the patient's face. The length or size of the stabilizing arm can vary so that a stabilizing arm of an appropriate size can be selected to best fit a given patient and / or selected mask or cannula. It is contemplated that the stabilizing arm is primarily used for mask-type patient interfaces, but in some embodiments, it can be used for nasal cannula-type interfaces.

[0560] In the illustrated embodiment, the stabilizing arm 60 includes a coupling portion 61a proximate a first end of the arm having a connection feature 63 for connecting to the frame 3. A support pad 65 for connecting to the headgear is provided at an opposite second end of the stabilizing arm 60, with a bridge portion 61 extending between the coupling portion 61a and the support pad 65.

[0561] The support pad 65 may be a forehead support pad for connecting to a head cap adjacent to the patient's forehead. The end 61b of the bridge portion 61 is pivotally attached to the front surface of the support pad 65 at a pivot axis 62, which is approximately perpendicular to the longitudinal direction of the stabilizing arm 60, so that the support pad can rotate / pitch relative to the bridge portion 61. In the illustrated embodiment, the support pad 65 can rotate / pitch almost 180 degrees relative to the bridge portion 61 (limited by the front of the support pad 65 contacting the front of the arm 61). When the support pad 65 is connected to the head cap, this enables the stabilizing arm 60 and any attached components to be flipped over as needed and then flipped back. This allows the caregiver to move the components out of the way to perform care tasks such as cleaning the skin without having to completely remove and place the components before and after such tasks.

[0562] See also Fig.72 and Fig.73 In the example shown, a pin 62a for extending along the pivot axis 62a is received by a hole in the connecting end 61b of the bridge portion. The pin 62a may be overmolded therewith.

[0563] The interface of the pin 62a and the connecting end 61b can be made of different materials, which can enhance the pivoting of the two parts relative to each other and prevent the two parts from fusing together. The two materials can have different Shore hardness values. For example, the Shore hardness value of the connecting end 61b can be greater than the Shore hardness value of the pivot pin 62a.

[0564] In the illustrated embodiment, the pivot 62 is disposed at the lower portion of the support pad 65. In the illustrated embodiment, the pivot 62 is set back from the bottom edge between approximately one quarter 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.

[0565] The patient-facing surface of the support pad 65 is used to connect to a headgear 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 an exemplary embodiment, the support pad 65 includes a hooked surface and the stabilizing arm 60 has a 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 arm can have 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 can conform to the curvature of the patient's head. Fig.56 and 75 The curvature may be slight, or may be more pronounced, as shown in the embodiments of FIG.

[0566] The support cushion 65 may comprise a compliant material such as TPE for patient comfort and ease of attachment to surfaces of varying contours. The hook or loop surface is preferably integral to the support cushion 65, for example, the body of the support cushion 65 may be overmolded with the loop surface.

[0567] In contrast, the bridge portion 61 and the coupling portion 61a comprise a substantially rigid material portion such as nylon. A flexible region 64 is provided at the base of the bridge portion, adjacent the coupling portion, to allow the arm to bend around the flexible region away from the patient or headgear during assembly or disassembly to prevent the pad 65 from catching 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 assembling the stabilizing arm to the frame 8. This relative flexing 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.

[0568] The flexible region comprises a bridge section of the arm having a reduced wall thickness. The flexible region 64 comprises a non-zero length of constant thickness, for example a length between about 2 mm and about 10 mm. The region flexes along the length with a substantially uniform bend radius, rather than bending at an inflection point, thereby avoiding the presence of stress concentrations associated with an inflection point. This allows the use of materials other than polypropylene or polyethylene, if desired.

[0569] 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 0.3 mm and about 1.2 mm.

[0570] The thickness of the arm transitions from a reduced wall thickness at the end of the flexible portion to a greater thickness at an adjacent portion of the arm. In some embodiments, the stabilization arm is transparent or translucent to reduce the visual impact of the arm so that the patient interface assembly appears less obtrusive.

[0571] The coupling portion 61a for connecting to the frame 3 is near the first end of the arm and includes a connecting feature 63 for engaging with a complementary engaging feature on the frame body 8. In some embodiments, the connecting feature 63 includes a hole to receive a central protrusion 67 on the front face of the frame so that the coupling portion is attached to the frame 3.

[0572] 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 lobes 68 protruding outwardly from the top of the post. In alternative embodiments, the enlarged head may include an alternative polygonal shape.

[0573] The hole 63 on the coupling portion of the stabilizing arm is square shaped corresponding to the shape of the protrusion 67. However, the hole 63 is oriented so that the diagonal of the square is substantially aligned with the longitudinal direction of the stabilizing arm and also aligned with the centerline 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 hole 63 are angularly misaligned by about 45 degrees.

[0574] The top surface of the stabilizing arm coupling portion includes four generally triangular shaped recesses 66 located on respective sides of the square aperture 63. These recesses are shaped and positioned to receive corresponding protrusions of the frame projection 67 when the stabilizing arm is in the installed position.

[0575] Now refer to Figures 63 to 71 The connection of the stabilizing arm 60 to the frame 3 and the disconnection of the stabilizing arm 60 from the frame 3 are described. To connect the stabilizing arm 60 to the frame 3 (or disconnect it from the frame 3), the connection hole 63 of the arm is aligned with the head of the protrusion 67 so that the hole fits on the head of the protrusion and is then pressed onto the protrusion until the lower surface of the arm 60 contacts the frame 3 (see Fig.63 and 4 ). Large radius fillet 69 ( Fig.59 ) can be provided around the edge of the hole 63 , at least on the lower surface (patient-facing side) of the stabilization arm 60 , to help guide the stabilization arm 60 into alignment with the protrusion 63 .

[0576] In the connected / disconnected position of the present embodiment, the stabilizing arm is at an angle of approximately 45 degrees to the centerline of the frame. In alternative embodiments, the connected / disconnected position of the stabilizing arm may be greater than 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 approximately 30 degrees and approximately 60 degrees relative to the centerline of the frame.

[0577] The front surface of the protrusion 67 may be flush with the front surface of the stabilizing arm 60 or higher than the front surface of the stabilizing arm 60 .

[0578] Reference now Figures 66 to 68 , the stabilizing arm is rotated toward the installed position, in which the stabilizing arm is aligned with the frame centerline and "locked" in place. As the stabilizing arm 60 is rotated between the connected / disconnected position and the installed position, the corners of the enlarged head of the projection 67 press against the edges of the hole and recess. These edges provide surmountable resistance to rotation. Further force applied by the user can overcome this resistance and quickly move the arm to Figures 69-71 Mounting position shown. This movement of the projection past the interference edge creates tactile feedback for the user.

[0579] In the mounted position, the projections 68 of the projections 67 are located in the corresponding 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 projections 67 of the frame 3 can move within the boundaries of the recesses 66 in the stabilizing arm. Some play between the components facilitates easier assembly of the stabilizing arm to the headgear, and enables fine adjustments, such as tilting of the arm, to properly position the connection pads 65 on the headgear to accommodate different head geometries.

[0580] Headgear

[0581] Figures 76 to 90 Components of a headgear assembly for securing a patient interface assembly to a patient are shown. The patient interface may include those described herein, but may also include other forms of interfaces. In an embodiment, the headgear and patient interface are for infants or newborns.

[0582] Fig.76 One embodiment headgear 71 is shown in an unassembled form. The headgear comprises a base layer 72 forming the body of the headgear and a headband region 73. The headband region comprises an outer joining layer at least partially overlapping and fused to a lower portion of the base layer 71 .

[0583] The total length of the headband 73 is selected so that the head cap conforms to the target range of head circumference size. For newborn and infant applications, the length of the headband 73 can be between about 15 cm and about 60 cm. The head cap and headband can have a variety of sizes, wherein each size is intended to fit the target range of head circumference size. In some different sized embodiments, the headband 73 can have a length that adapts to the head circumference size, and the head circumference size is between about 17 cm and about 22 cm, between about 20 cm and about 26 cm, between about 24 cm and about 31 cm, between about 29 cm and about 36 cm, or between about 34 cm and about 45 cm.

[0584] The headband has an over-ear region 74 that is shaped and positioned to at least partially cover the patient's ears to protect the wearer's ears from the attachment components and connectors. The over-ear region 74 also advantageously provides a larger surface area for more secure connection with the coupling component and for enhancing the pressure distribution of forces from the patient interface component through a larger connection area.

[0585] The ear regions 74 may be defined by an enlarged area relative to the adjacent headband region. These ear regions are sized to provide sufficient surface area for connecting and properly positioning connectors, such as connectors for connecting and supporting a patient interface as described in more detail below.

[0586] In the illustrated embodiment, each ear region 74 includes a protrusion defined by a rounded lower edge of the headband that protrudes downwardly. The lower edge of the headband may be arcuate, or generally crescent-shaped. The lower protrusion protrudes below the lower edge of the adjacent front portion 73a of the headband region.

[0587] Each ear region 74 may additionally (or in some embodiments optionally) include an upwardly extending protrusion defined by an upwardly projecting circular upper edge of the headband. These upper protrusions project upwardly from the top edge of the adjacent front portion 73a of the headband region. The upper edge of the headband may be arcuate, or generally crescent-shaped. In an exemplary embodiment, the upper protrusion 76 is smaller than the lower protrusion.

[0588] The height of the enlarged ear region may be 1.5 times or more the height of the adjacent front portion 73a. For example, in the illustrated embodiment, the height of the enlarged ear region is approximately twice the height of the adjacent front portion 73a. Fig.116 116(i) to Fig.117 An exemplary embodiment is shown in which the height of the front portion 573a, 673a of the headband 573, 673 is reduced so that the height difference between the front portion of the headband and the enlarged ear region 574, 674 is more pronounced.

[0589] The size of the supra-ear area 74 may be Figures 87-91 , Figures 94-104 , Figures 121-123 and Figures 127-129 The connection of the connectors shown provides sufficient purchase area to be securely held, as described below. The above-ear region 74 can have a height at least as large as the width of the corresponding connector at its second end. For example, between about 1 and 2 times the width of the corresponding connector at its second end. In some embodiments, the height of the above-ear region 74 can be about 1 and 1.5 times the width of the corresponding connector at its second end.

[0590] The front portion 73a of the headband 73 may extend directly to the front of the upper ear, wherein the two front portions 73a are collinear, such as Fig.76 , 109 and Fig.115 As shown in the embodiments 71, 171, 471 of (i). Optionally, the front parts of the headbands can be tilted relative to the horizontal direction so as to be tilted towards each other. Fig.116 116(i) and (ii) of Fig.117 An alternative embodiment of headgear is shown in which the front portion 573a of the headband region extends at a downward angle in front of the above-ear region 574, 674. This tilting of the front portion of the headband region can improve the fit of the headgear to the patient's head and reduce accidental lifting of the headband from the patient's head during use.

[0591] The headband front portion 573a, 673a may be tilted downward at an angle between 0 degrees and about 45 degrees, such as between about 15 degrees and about 30 degrees. Fig.116 116(i) to Fig.117 In the exemplary embodiment shown, the front portion 573a, 673 is tilted downward from the horizontal at an angle α of approximately 20 degrees. In alternative embodiments, the right portion 473a, 573a and the left portion 473a, 573a of the headband are tilted downward at different angles from each other. For example, the right portion 473a, 573a of the headband can be tilted downward at a greater angle than the left portion 473a, 573a.

[0592] The front portion of the headband 73a on the left side of the headgear may be the same or different length than the portion 73a on the right side of the headgear. Fig.76 , 109 and Fig.115 In the embodiments 71, 171, 471 of (i), the lengths of the left and right parts 73a, 173a, 473a are substantially the same. In contrast, Fig.116 116(i) and (ii) of Fig.117 An alternative embodiment is shown in which the headband is asymmetrical, with one front headband portion 573a, 673a being longer than the other 573a, 673a.

[0593] Typically, the longer portion may be the front headband portion 573a, 673a, which is configured to wrap around and engage with the outer surface of the lower headband portion. The front headband portion configured to abut against the patient may be the shorter portion. In the illustrated embodiment, the right portion 473a, 573a of the headband is shorter than the left front portion 473a, 573a. It should be understood that in alternative embodiments, this arrangement may be reversed.

[0594] The rear bridge portion 73b can be disposed between the supra-ear regions 74 for positioning at or above the nape of the patient's neck. The bridge portion includes a lower edge that is continuous with the lower edge of the supra-ear region 74 and an upper edge that is continuous with the upper edge of the supra-ear region 74. The upper and lower edges are shaped so that the rear bridge portion 73b is narrower in height than the supra-ear region, and 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 headband conform to the patient's head because it minimizes fabric wrinkles, which helps the headband lie flat on the patient and comfortably sit at the nape of the neck. In an exemplary embodiment, the lower edge of the rear bridge portion is concave so that the narrowest height of the rear bridge portion 73b is located at the center point of the portion.

[0595] The height dimension of the rear bridge portion 73b at its narrowest point may be equal to or less than the height of the headband front portion 73a. For example, the height of the rear bridge portion 73b at its narrowest point may be between about 0.5 and about 1 times the height of the headband front portion 73a, for example, between about 0.6 and about 0.8 times the height of the headband front portion 73a. In one example, the height of the rear bridge portion 73b at its narrowest point is 0.75 times the height of the headband front portion 73a.

[0596] The rear bridge portion may span a distance between the above-ear regions 74 that is between about 0.2 and about 0.8 times the length of the front headband portion 73a or the shorter one. In some embodiments, the rear bridge portion may span a distance between the above-ear regions 74 that is between about 0.35 and about 0.55 times the length of the front headband portion 73a or the shorter one. The headband region 73 may partially or completely cover the 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 unlapped lower portion forms a lower lip that can soften the edge of the head cap so that it contacts the skin more comfortably. In the illustrated embodiment, in the region that is constructed to span the nape of the patient's neck, a larger depth of unlapped base layer 75 is provided between the above-ear regions 74. This portion 75 helps the head cap conform to the patient's head and provides enhanced comfort.

[0597] The base layer 72 comprises a panel of flexible material, such as a fabric panel.

[0598] The flexible material may be a fabric that is stretched in at least two directions, the stretch direction being the width / circumference of the head cap. The base layer preferably comprises only a single panel, thereby avoiding seams that would occur when connecting multiple panels. The base layer may be a single layer or a multilayer material.

[0599] In some embodiments, the base layer 72 may include a fabric or the like having a unbroken loop (UBL) surface to engage with a connector having a complementary hook surface.

[0600] Fig.76 The panels in the illustrated embodiment are generally rectangular, but other shapes are contemplated, such as trapezoidal. Fig.109 and Fig.111 (i) and (ii) in show optional shapes of the head cap body. In these embodiments 171, 271, 371, the panel (excluding the upper part of the ear) is non-rectangular. In particular, the top edge of the head cap 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 head cap body 172, 272 varies across the width of the head cap.

[0601] exist Fig.109In the illustrated embodiment, the head cap body has an irregular pentagonal shape. The top edge includes two corners 172a, each of which forms an obtuse angle with a corresponding side edge 172b of the body. In the illustrated embodiment, each top edge corner 172a forms an angle of approximately 100 degrees with a corresponding side edge 172b, however, in alternative embodiments, other angles can be envisioned, such as between 90 degrees and approximately 120 degrees.

[0602] The two angled top edge portions 172a meet at a central vertex 172c, which is aligned with a point between the two upper ear portions 174. The length L2 of the headgear body at the vertex 172c is greater than its length L1 at the side edges.

[0603] The angled top edge portion 172a has the effect that when the top edges are brought together into a point and secured, such as with an end fixture, as described in more detail below, the position of the end fixture moves forward relative to the patient. Fig.110 (i) shows a first embodiment of a headgear 71 ( Fig.76 ) and compare it with Fig.110 172c in the head cap 171 of the present embodiment in (ii). The length of the main body of the head cap of the first embodiment is approximately the same as the length L2 of the vertex 172c in the head cap 171 of the present embodiment. The fixing point of the head cap 171 of the second embodiment is roughly aligned with the patient's spine, rather than with the back of the spine. This alignment can help to easily mount the head cap on a supine patient and easily move the adjustment mechanism along the main body of the head cap. This can also reduce the risk of discomfort caused by movement of the adjustment mechanism and / or end fixtures under the patient's head.

[0604] Fig.117 An alternative embodiment is shown in which the shape of the headgear body approximates an irregular pentagon. In this embodiment, due to the asymmetry of the headband, the vertex 672c at the top edge may not be located in the center.

[0605] In this embodiment 671, the lengths of the side edges 672b are equal to each other, and the lengths of the two angled top edge portions 672a are also equal to each other. Due to the different lengths of the front portion 673a and the angled orientation of these portions 673a, the top edge portion 672a of the base 672 is asymmetrical, having different tilt angles β, θ. The tilt angles β, θ can vary between about 0.2 degrees and about 5 degrees relative to each other. In some embodiments, the tilt angles β, θ can 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 portion 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 angle combinations can be envisioned.

[0606] The top edge 672a of the head cap base 672 has different angles β, θ, but the side edges 672b have the same length. The above-mentioned structure better aligns the overlapping parts of the base layer and the top edge and gathers them when assembling the head cap.

[0607] The head cap body may have other shapes, and may also provide the function of locating the fixing point on the wearer's spine. In addition, or alternatively, it may also be desirable to remove some volume from the body of the head cap to make the head cap less bulky and / or allow the adjustment member to slide more easily along the head cap.

[0608] Fig.111 (i) and (ii) in Figure 2 show two alternative embodiments 271, 371 that utilize a cutout 275, 375 in the top edge of the head cap body 272, 372 to provide these functions. Both embodiments include a triangular cutout 275, 375 located in the center of the top edge. Fig.111 In the embodiment 271 of (i) above, the top edge 272a (except for the cutout) is orthogonal to the side edge 272b. Fig.111 In the embodiment 371 of (ii), the top edge 372a (except for the cutout) is not perpendicular to the side edge 372b, but forms an obtuse angle therewith.

[0609] When assembling the head cap 271, 371, the top edges 272a, 372a of the head cap body 271, 371 (excluding the cutout portion) are gathered and fixed at the fixing point. In this process, the two edges 276, 376 of each triangular cutout 275, 375 are pulled together. In some embodiments, these edges 276, 376 can be joined, for example, by sewing or welding or using an adhesive, and optionally, the edges 276, 376 may not be joined.

[0610] The illustrated embodiment illustrates a headgear having a single triangular cutout, however, alternative embodiments may include more cutouts and / or cutouts of different shapes having a similar effect of reducing material at least in the upper portion of the headgear and moving the attachment point further forward relative to the wearer.

[0611] Fig.116 116 (i) and (ii) in FIG. 116 show another example shape of the headgear base layer 572, with four corners 572a at the top edge. Compared to the rectangular body, this top edge shape (which in this embodiment generally reflects the downward angle of the front headband portion 573a) can produce less bunching, and then the top 572a is gathered. In some embodiments, cuts can be set along the top surface to further reduce fabric bunching.

[0612] 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-like connector, is provided on the underside of the headgear facing the patient near the side edge 72b of the headgear in the headband region 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 engaging surface of the headband region.

[0613] The headband region 73, 173, 473 includes a flexible outer engagement layer having an engagement surface for releasably securing the connector to the headgear. The outer engagement layer most commonly includes a fabric having a full loop (UBL) surface to engage with a connector having a complementary hook surface. The presence of such a loop may be expected to function as a loop portion of a hook and loop fastener system. With this construction, a hook and loop fastener system may be provided without having to attach any additional loop providing components to the panel. This helps, at least to some extent, to provide a headgear with reduced thickness.

[0614] In one embodiment, the outer bonding layer covers substantially the entire headband area, and optionally, the outer bonding layer may cover a majority of the headband area. Alternatively, the outer bonding layer may cover only a portion of the headband area, such as the front and back sides of the headband. The outer bonding layer may be in the form of a single panel, but may alternatively be provided in the form of two or more pieces.

[0615] When manufacturing the headgear, the base plate and the bonding layer can be cut into the desired shapes, and then overlapped and connected together. This structure can be different from the traditional method, such as in the laminated material such as In some embodiments, the head cap is constructed by cutting already laminated panel portions, which are then connected together to form the head cap or portions of the head cap. However, in some forms, once the head cap is overlapped together, and possibly once one or more overlapping portions are connected together, at least some portions of the head cap may additionally or alternatively be cut.

[0616] The outer bonding layer is fused to the bottom layer portion of the inner base layer 72, and the inner surface of the outer bonding layer is fused to the adjacent facing outer surface of the base layer 72. Fusion defines the melting of a layer or at least the constituent materials of the layer. With respect to fusing two panels together, fusing refers to melting one panel into the other panel or melting the two panels into each other, respectively. Thus, the two panels can be fused by either a) melting only one panel or predominantly one panel into the other panel, or b) melting both panels into each other simultaneously.

[0617] Fusing may be non-additive in that fusing involves processing of one or more panels and does not involve the use of any additional material, such as an adhesive, inserted between two panels to fuse them together. Fusing may involve applying one or both of heat and pressure to one or more panels.

[0618] The layers may be fused by welding, including forms of plastic welding, 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 material and the joining layer material. The panels to be fused should include a fusible material, such as a synthetic fiber. Similarly, when two panels are fused together, at least one of the two panels should include a fusible material, such as a synthetic fiber. For example, materials such as PVC, CPVC, polyurethane, EVA, PVDC, PET and nylon are suitable for RF or high frequency welding.

[0619] Conventional head cap laminates that include foam layers are typically not fused by welding because welding would degrade the cellular properties of the foam, compress the foam and cause it to harden. Therefore, welding of conventional head caps is limited to welding the peripheral portions or edges of the overlapping areas of the panels. Because the head caps according to the present disclosure can exclude the inclusion of one or more foam layers, the panels can be fused together over most or even all of their overlapping areas. For example, compared to conventional laminated head caps, at least a relatively wide border can be fused around the perimeter of the overlapping area.

[0620] Unlike traditional stitched joints, which require the seam size to be minimized to reduce its impact on comfort or visibility, panels joined by fusion can be fused together over a large area without the corresponding seam volume or the change in surface finish caused by a larger stitching area.

[0621] Panels, particularly textile or fabric panels, fused over a large portion of the panel can provide strong yet flexible properties to the headgear. Fused areas can provide a visually clean and uniform surface to the panel. Selectively fusing and unfusing different portions of the panel can allow for different material properties in different areas of the same panel or panels. It can also provide differences in surface characteristics of different areas composed of the same panel or panels.

[0622] Compared to other additional methods of connecting panels together (such as by sewing or using adhesives), fusing panels can have advantages. In particular, the weight of the connecting panel can be relatively reduced and the thickness may also be reduced. Alternatively or additionally, the outer bonding layer can be connected to the underlying portion of the base layer by other means such as sewing or bonding.

[0623] The layers may be fused together over substantially the entire overlapping area. Substantially the entire overlapping area may be about 90% of the overlapping area, or even about 95% of the overlapping area. However, preferably, the headband area includes an area of ​​fused material and an area of ​​non-fused material. The non-fused area generally provides a greater secure hold for the connector than the fused area. However, the fused area provides some reduced secure hold. The non-fused area at least partially defines a connection area for releasably securing the connector to the head cap.

[0624] The contrast of the height or surface texture of the fused and non-fused regions creates a visual contrast between the fused and non-fused 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.

[0625] The stripes may be straight, curved, wavy or angled, for example, they may be arranged parallel to each other, form a grid, or be oriented in other ways. The points in the pattern may be arranged uniformly or non-uniformly, for example, in rows or grids, radiating from a point, or randomly. Alternatively or additionally, the fused or non-fused areas may form text or decoration or identification shapes such as logos, for example displayed on Fig.76 Molding details on the headband portion 73a of the mid head cap.

[0626] Fig.82A and 82B Two exemplary patterns for welding the joining layer to the base layer are shown. Fig.82A In the embodiment of the headband 773, most of the surface area is fused to provide a connection area with parallel lines of non-fused material at the front 773a of the headband and wavy lines of non-fused material at the above-ear area 774. Fig.82B In the embodiment of the present invention, the pattern includes a grid of dots of non-fused material on the first front portion 873a of the headband 873, an area of ​​non-fused material defining fusion points in the above-ear region 874, and non-fused size identification data on the second front portion 873a of the headband. It should be understood that the welding patterns of these exemplary embodiments are only two of countless possible patterns, and many other patterns are also contemplated.

[0627] The fusion of layers may change one or more properties of one or more panels. For example, melting and resolidification of the panel material may cause the panel to become thinner, denser, harder, less stretchable, less recoverable or have a greater yield strength when stretched. Therefore, in addition to connecting the panels together, selectively fusing the head cap at different overlapping and non-overlapping areas may allow the properties of the head cap to be controlled. The fusion of panels, for example where one or two panels are fused or partially fused together to each other by welding, may cause the panel layup to be thinned in the fusion zone. This is particularly the case where the fusion is provided by applying pressure at the portions of the panels to be fused.

[0628] In an exemplary embodiment, the base layer 72 comprises a 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.

[0629] The base layer may be comprised of a single panel, with the base layer and preferably the head cap having no internal and external seams. The potential reduction in the number and thickness of panels in overlapping and non-overlapping areas of the disclosed head cap can provide a reduction in thickness of the head cap at specific locations or overall when compared to conventional head caps made from connected laminates or multiple layers of material. The reduced thickness, whether at specific locations or across the entire head cap, can provide the patient with a visual and / or physical sensation of reduced bulk. The reduced thickness can also provide greater comfort to the patient wearing the head cap.

[0630] Any such reduction in the number of panels and their thickness at various points on the headgear may provide a corresponding reduction in the overall weight of the headgear.

[0631] In contrast, the bonding layer in the headband region may include a material having similar or lower stretchability than the base layer 72. The bonding layer may include a substantially inelastic material. The fused material areas in the headband region may have increased hardness compared to the non-fused areas. Additionally or alternatively, the fused material areas in the headband region may have reduced stretchability compared to the non-fused areas. Thus, a particular fusion pattern may result in the headband region 73 having reduced overall stretch compared to the base layer 72. The difference in the stretch properties of the fused and non-fused areas may be used to reduce or increase the stretchability in selected areas and / or selected directions of the headband. That is, the shape, orientation, and / or position of the fused and non-fused areas may be selected to control the manner in which the headband regions stretch or to limit their stretching under load.

[0632] For example, it has been found that in some cases, limiting the stretch of the headband or headband area, particularly limiting the stretch in the generally longitudinal "horizontal" direction of the headband and / or the angled or generally diagonal direction (about 45 degrees to the longitudinal direction), can facilitate the correct fixation of the headband. Longitudinal stretch of the headband portion can lead to incorrect placement of the upper ear portion during the process of donning the headband on the patient, such as causing the upper ear portion to not be located above the ear or not be located in a position that best fits the patient's ear. Similarly, angled, diagonal and / or longitudinal stretch in the upper ear portion may also inhibit the correct placement of the upper ear portion, and limiting the stretch in these areas in one or more directions can prevent the upper ear portion from moving away from the ear under patient movement.

[0633] Fig.76 and Fig.113 (i) to Fig.114 (iii) in FIG. 7 shows some exemplary configurations of fused and non-fused regions in the headband region 73 to reduce longitudinal stretching in these regions. Fig.76 , the darker areas represent fused material areas, and the lighter areas represent non-fused material areas. Fig.76 The left side of the middle headband (as shown) includes two continuous lines of non-fused material, and the fused material on the remaining left side of the headband forms a continuous line extending from near the upper portion of the ear to the edge adjacent to the headband 72b. In other embodiments, at least one generally continuous strip or band of material extends generally in the longitudinal direction, spanning substantially the entire width of the headband between the two side edges 72b.

[0634] Fig.112 (i) to Fig.114 (iii) in the figure provides more examples of fusion patterns, i.e., the shape, orientation and / or position of fusion areas and non-fusion areas, illustrating how the fusion patterns can be used to adjust the stretch properties of the headband. Fig.112 (i) and Fig.113 In (iii), the headband can be fused along lines 178 that extend generally in directions where little or no stretch is desired. The fusion lines can be straight or curved or have curved portions. The fusion lines can be continuous or discontinuous. In the illustrated embodiment, generally "horizontal" and generally "diagonal" weld lines 178 are provided in the above-ear regions 174 to limit stretching in these directions. These fusion regions can be substantially continuous in one or more regions where limited stretch is desired. For example, as Fig.113 As shown in (i) to (iii) in FIG. 1 , the fused area may extend across the entire width of the above-ear region and extend along the headband, and / or the fused diagonal area may extend between the two edges of the above-ear region.

[0635] The headband will be able to stretch at any breaks in the fused zone, so where minimal or reduced stretch is desired, it is desirable to minimize the size of any breaks in the fused zone in the direction of reduced stretch, or to ensure that the break size does not allow stretching beyond the allowable amount. The continuous line of non-stretch need not be perfectly straight.

[0636] exist Fig.112 In the embodiments of (i) and (ii) of FIG. 1 , the intersecting diagonal and horizontal weld lines form diamond-shaped pockets of unwelded material 179. These pockets 179 are still free to stretch within the boundaries surrounding the welded areas. This ensures that the headband can still flex to conform to the patient's head, thereby obtaining a secure fit. Other shapes of non-fused areas are contemplated, depending on the configuration of the fused areas and any requirements for the surface of the receiving connector. Fig.113 (i) to (iv) show some further non-limiting example shapes of unwelded pockets, including parallelograms ( Fig.113 (i) in), circular concave holes ( Fig.113 (ii) in the above), star-shaped and other irregular shapes or combinations of shapes ( Fig.113 (iv) in the above. Fig.113 As shown in (iv) in FIG. 5 , not all recesses need to have the same shape, and a region may contain recesses or regions of different shapes.

[0637] Fig.114 (i) to (iii) in Figure 1 show alternative welding patterns that limit headband stretch in the same horizontal and diagonal directions. In these images, the light shaded areas indicate fused material and the dark shapes indicate areas of non-fused material. The fused material is arranged along lines where stretch is not desired, in this case, roughly along lines that pass roughly horizontally through the width of the headband and also along diagonal lines in the supra-ear region.

[0638] Fig.114 The fused material in the embodiments (i) to (iii) of is substantially continuous along the desired line of reduced strength. Circular, dotted or other shaped areas of non-fused material may be placed to appear random and obscure the line of finite stretch.

[0639] In some embodiments, it may be desirable to increase stretch in at least one area of ​​the headband. For example, it may be desirable to increase stretch in the longitudinal direction (horizontal / circumferential direction) of the headband to obtain a tighter fit or better fit between the headband and the patient's head. Fig.115 (i) to Fig.117Further embodiment bonnets 471 , 571 , 671 are shown wherein the headband 473 , 573 , 673 has an area of ​​increased stretch 475 , 575 , 675 at the rear of the headgear, above the ears 474 , 574 , 674 .

[0640] In alternative embodiments, the area of ​​increased stretch may be provided at different portions of the headband 473, 573, 673, and / or more than one area of ​​increased stretch 475, 575, 675 may be provided. For example, the area 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 portion 473a, 573a, 673a of the headband, adjacent to one of the upper ear portions 474, 574, 674. In embodiments where the area of ​​increased stretch is provided on only one front portion 473a, 573a, 673a, the area of ​​increased stretch may be provided on the front portion 473a that is configured as a covering portion when the headgear is worn, i.e., the front portion has a hook-type attachment 476, 576, 676 (for securing the headband) on the underside.

[0641] exist Fig.115 (i) to Fig.117 In the embodiment of the invention, the area of ​​increased stretch 475, 575, 675 comprises an area of ​​the headband where the base layer 472, 572, 672 of the headgear is exposed through a break or gap in the outer bonding layer. That is, there is no outer bonding layer in the area of ​​increased stretch 475, 575, 675. Alternatively or additionally, the area of ​​increased stretch can be provided by an area where the outer bonding layer is not fused to the base layer 472, 572, 672.

[0642] The width of the region of increased stretch 475, 575, 675 is selected based on the desired amount of stretch and the stretch properties of the base layer 472, 572, 672. Wider regions generally provide more horizontal stretch to the headband than narrower regions. The region of increased stretch 475, 575, 675 may also provide increased stretch in other directions, particularly in embodiments where the base layer 472, 572, 672 includes a material with four-way stretch. The width of the region of increased stretch 475, 575, 675 may be selected to provide the desired stretch while still ensuring that the headband has sufficient stability to interface with the respiratory interface component while the over-ear region remains aligned with the patient's ears. Depending on the characteristics of the base layer 472, 572, 672, a gap in the outer joining layer that is too wide may cause the lower edge of the base layer to curl when stretched and / or may cause the head cap to fatigue easily in the region of increased stretch of the base layer.

[0643] The length of the breaks or gaps in the outer bonding layer and / or the area of ​​increased stretch may be between about 5% and about 50% of the length of the headband, for example between about 10% and about 35%. In one embodiment, a gap in the outer bonding layer of about 20% of the length of the headband is provided between the above-ear regions 474, 574, 674.

[0644] In one embodiment, the length of the breaks or gaps and / or areas of increased stretch in the outer bonding layer may be between about 5 mm and about 35 mm, such as between about 20 mm and about 30 mm. Fig.115 In one embodiment shown in (i) and (ii) above the ear, an outer bonding layer gap of approximately 28 mm is provided between the above-ear regions 474.

[0645] Additionally, or alternatively, the pattern of fused and non-fused material areas in the headband region may be configured to increase horizontal stretch in selected areas of the headband. That is, the shape, orientation, and / or location of the fused and non-fused areas may be selected to control the manner in which the headband region stretches, or to provide increased horizontal stretch under load.

[0646] refer to Fig.115 In (i), the darker areas in the headband area represent fused areas and the lighter areas represent non-fused areas. In the above-ear area 474 of this embodiment, the fusion points are arranged in a pattern so that there are parallel columns of non-fused material in a direction HS that is substantially perpendicular to the desired horizontal stretch direction. These columns of non-fused material allow the above-ear portion 474 to have some stretch in the horizontal direction. The pattern of points is also constructed to reduce or minimize stretching along the interface pull direction. This is achieved by eliminating or minimizing any continuous lines of unwelded material in a direction perpendicular to the interface pull direction IP. In other embodiments, other shapes of fusion areas may be used instead of or in addition to Fig.115 The point shown in (i) in .

[0647] It is contemplated that many other shapes and configurations may be used for the fused and non-fused regions. As an example, Fig.114 (iii) in FIG. 1 shows an embodiment having a "V" shaped non-fused area on the upper portion of the ear and circular non-fused areas elsewhere. The shape of the non-fused area may be selected to optimally vary the stretch, and / or may be selected to provide markings or visual features on the corresponding surface. For example, the shape may indicate which component is attached to the area, and / or may indicate the correct direction of attachment.

[0648] The size of the fused and non-fused areas may vary in various areas of the headband. For example, the enlarged above-the-ear area may include a larger area of ​​less dense un-welded material. The headband straps in front of the ear area may include a smaller un-welded area of ​​higher density. The difference in weld size between the above-the-ear area and the rest of the headband helps to visually distinguish these areas.

[0649] In an alternative embodiment, similar limitation of stretch in certain directions or regions may be achieved by a multi-layer headband including a non-stretch layer having one or more cutouts. The shape and / or direction and / or location of the cutouts are selected in a similar manner as the non-fused regions of the above-described embodiments to reduce stretch in one or more directions in the corresponding region of the headband compared to the region without the cutouts.

[0650] The underside of the headband area that contacts the patient may include a tacky surface to provide an area of ​​increased friction between the headband and the wearer and reduce unintended movement of the headband on the patient's head. The tacky surface may prevent the headband from rotating sideways or forward / backward. Such movement of the headband may cause the patient interface to move out of position and / or may cause a reduced seal between the interface and the patient.

[0651] Fig.115 (ii) and Fig.116 Figure (ii) in Figure 4 shows an exemplary placement of the adhesive surface 477, 577 on the underside of the headband region 473, 573. The height of the adhesive surface can be between about 20% and about 100% of the height of the headband in the overlap region. Fig.115 In the embodiment shown in (ii) of FIG. 4 , the area 473b adjacent to the bottom edge of the headband 473 is free of material providing a sticky surface. The sticky surface may increase the hardness of the head cap, so an area that is too large may reduce the fit to the patient's head. In addition, it is envisioned that the clinician may hold one half of the cap at the lower edge while pulling the other half of the cap around the head to secure it. The area at the lower edge of the head cap without a sticky surface may prevent the sticky surface from inadvertently sticking to the clinician's fingernails or gloves during this process.

[0652] Optionally, a small gripping area 478, 578 may be provided on the outer surface of the headband 473, 573. The gripping area 478, 578 is positioned on the front portion of the headband that is configured to wrap under the front portion of the other (upper layer). The gripping area 478, 578 is positioned to grip the adhesive surface 477, 577 on the underside of the upper layer portion of the headband when the headband is wrapped around the patient's head and over the gripping area. In addition to providing additional anchoring between the lower and upper layer portions of the headband, the gripping area can also help obtain a secure fit of the headgear by preventing or reducing slippage between these surfaces when the hook attachments 476, 576 are secured to the headband engagement layer.

[0653] The sticky surface 477, 577 and / or gripping area 478, 578 may include a sticky film or coating, or may include a friction layer adhered or bonded to the inner surface of the base layer at the headband area. For example, a material such as Bemis™ tape. The sticky surface may be continuous along the length of the headband area, or may include discrete areas. Discrete areas may be provided in areas where increased friction is desired. The sticky surface may include a straight strip, or may be applied to form a pattern, for example including curves and / or dots.

[0654] The area of ​​the headband where the small gripping areas 478, 578 are provided may be a non-fused area.

[0655] In one embodiment, the sticky surface is provided by a layer of polyurethane elastomer, neoprene, non-stick silicone, and / or thermoplastic polyurethane. The sticky surface may include a material suitable for contact with the skin and may be provided 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.

[0656] End fixing device

[0657] Reference Figure 76 to Figure 78 , Fig.109 as well as Fig.111 In (i) and (ii), the top edges 72a, 172a, 272a, 372a of the base layers 72, 172, 272, 372 are fixed together at the fixing points. The top edges 72a, 172a, 272a, 372a of the base layers can be gathered, pleated, folded, rolled or otherwise gathered to reduce the width of the top edges 72a, 172a, 272a, 372a of the head cap.

[0658] End fixtures 81 may be provided to mechanically retain the top edge in this gathered configuration.

[0659] exist Fig.78 and Fig.79In one embodiment shown, the end fixture is a bobble-like component having two side members 82a, 82b, which are constructed to engage with each other to clamp the upper edge of the base layer, which is gathered, pleated, folded or rolled, between the two sides 82a, 82b. The two side members 82a, 82b can include soft, flexible materials, such as fabrics. The fabric can be a fabric with a synthetic component so that the two side members can be fused at the periphery using the above-mentioned technology. In an exemplary embodiment, the side members 82a, 82b include knitted nylon, optionally a complete loop (UBL) material, but other materials can also be envisioned. Alternatively, the side members can be attached by sewing, bonding together, or otherwise attached, particularly when the material does not include a synthetic or fusible component.

[0660] A conformable middle layer 83 may be provided between the two side layers. In the illustrated embodiment, the middle layer 83 comprises a foam layer having cutouts 83a to accommodate the gathered, pleated, folded or rolled upper edge 72a of the base layer. The middle layer 83 may be attached to the two side members 82a, 82b, for example, 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.

[0661] In an embodiment, the bonding to the middle layer can be provided by a polyurethane elastomer and / or a thermoplastic polyurethane or other suitable adhesive or tacky material, such as a copolyamide hot melt adhesive film or a copolyester hot melt adhesive film. The adhesive or tacky material can be provided on substantially all, most, or only a portion of the respective surfaces of the middle member and / or the respective side members 82a, 82b. The middle layer 83 can be heat pressed together with the side members 82a, 82b to fuse the layers together.

[0662] Adjustment device

[0663] An adjustment device 85 is provided for assembly with the head cap 71 to adjust the wearable length or depth of the head cap. The adjustment device is assembled to be positioned between the headband area and the end fixing device 81. The flexible base layer 72 of the head cap passes through the adjustment device 85 and the adjustment device can be selectively slid along the body of the head cap toward and away from the headband area. The end fixing device 81 limits the travel of the adjustment device along the fabric, thereby preventing the adjustment device from being inadvertently removed from the head cap.

[0664] The adjustment device 85 comprises a first engagement member 86 and a second engagement member 87 for engaging the main body of the head cap at two spaced engagement points. The first engagement member 86 and the second engagement member 87 are arranged on opposite sides of the hinge area 89 so that the first engagement member 86 and the second engagement member 87 can move towards and away from each other.

[0665] The first and second engagement members 86, 87 comprise annular members extending inwardly from respective sides of the device. The annular members define first and second holes 88a, 88b for receiving the body of the head cap. The size of the holes is sufficiently designed so that the body of the head cap can fit comfortably and slide through the holes, but is also small enough so that they cause the body members to gather.

[0666] The apertures 88a, 88b may have any suitable shape, such as circular, oblong, square, D-shaped, keyhole-shaped, or teardrop-shaped.

[0667] exist Figure 83 to Figure 84 In the embodiment of the present invention, the first engaging member 86 includes a pair of spaced apart rings defining two corresponding co-linear holes. As shown, the two rings can be parallel, or can converge or diverge. However, alternatively, the first engaging member can include only a single member 186, such as Fig.86 As shown in Example 185.

[0668] The device 85 also includes a guide hole 90 to receive and slide along the body of the head cap. The hole 90 can have any suitable shape, such as oblong, rectangular, square or circular, but is preferably symmetrical about the hinge axis 89. The size of the hole 90 is sufficiently designed so that the body of the head cap can fit comfortably and slide through the hole.

[0669] A guide member 90 is defined between two hinge members 91. In the embodiment shown, the hinge members are arched members extending between the sides of the device, with the upper apex of the arch aligned with the midline of the device.

[0670] The hinge members are integral to the sides of the device, but the reduced cross-sectional area at the midline of the device enables the device to articulate about the apex of the hinge member 91 .

[0671] The first and second engagement members 86, 87 can be moved toward each other by pressing them toward each other, thereby flexing the device 85 about the hinge area. Finger grips 91a, 91b on opposite sides of the device 85, either side of the hinge, can provide an improved secure hold for the user to facilitate pressing the first and second engagement members 86, 87 toward each other. Finger grips 92a, 92b face outwardly on the side surfaces from which the engagement members extend.

[0672] The finger grips 92a, 92b are areas 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 compared to the main body of the device. Figure 83 to Figure 85 In the embodiment of the present invention, the first of the finger grips 92a comprises an oblong concave recess. The second of the finger grips 92b comprises two raised transverse ribs. Many other configurations of the finger grips are possible.

[0673] refer to Fig.85 , the first engagement member 86 and the second engagement member 87 can be moved toward each other by pressing the sides of the device toward each other at the finger grips 92a, 92b. The first engagement member 86 and the second engagement member 87 can be moved to a position of substantial overlap between the first hole 88a and the second hole 88b. This is the free state of the device 85, in which the device can freely move along the body of the headgear toward and away from the headband area.

[0674] exist Figure 83 to Figure 85 In the embodiment of the present invention, 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 engagement member and the second engagement member move relative to each other.

[0675] In the free state, the first and second apertures 88a, 88b may be generally aligned with the guide aperture 90 such that material passing through the device follows a generally linear path.

[0676] The hinge area 89 is resilient and wherein upon release of pressure from the sides of the device, the first engagement member 86 and the second engagement member 87 move away from each other to Fig.83 , Fig.84 and Fig.86 The locked state is shown. This locked state is the resting state of the device, wherein the hinge biases the device into this state.

[0677] In the locked position, the first hole and the second hole are not aligned with each other. The first hole 88a and the second hole 88b may also be misaligned with the guide hole 90. For example, only a small portion of the first hole 88a and the second hole 88b may overlap, or there may be no overlap. This misalignment causes the engagement area of ​​the first engagement member 86 and the second engagement member 87 to grip the body of the head cap to hold the device in place relative to the material. In this state, the body of the head cap passes through the device 85 along a winding or tortuous path to provide resistance to the head cap body being pulled through the device.

[0678] The device 85 may be adjusted from the locked state to the free state by pressing the first engagement member and the second engagement member toward each other.

[0679] Figures 105 to 107 An alternative embodiment adjustment device 285 for gripping the flexible body of the head cap is shown. Figure 83-Figure 86 The adjustment device 285 is smaller and less visually intrusive than the embodiment of the headgear. The adjustment device 285 includes a flexible body having opposing first and second sides 286, 287 and first and second ends 292a, 292b, the first and second sides 286, 287 and the first and second ends 292a, 292b together defining an aperture 288 therebetween to receive the flexible body of the headgear.

[0680] The opposed first and second ends 292a, 292b of the device 285 can be moved toward and away from each other to adjust the device 285 between a locked state and a free state. In the locked state, the device 285 grips the flexible body of the head cap in the hole 288 to hold the device in position relative to the material. In the free state, the grip of the device is fully released to enable the device to move along the material, thereby adjusting the position of the device relative to the material.

[0681] The side walls 286, 287 each have a convexly curved inner surface, curved so that the aperture 288 is narrowest at or near the center of the aperture. This occurs at the midline of the device, intermediate the first end 292a and the second end 292b. Fig.107 In the illustrated embodiment, the hole 288 has an hourglass shape with a necked-down region in its center and is widest at the ends 292a, 292b closest to the device. When the device is in a locked state, the head cap is clamped between the convex side walls and is tightly held by the necked-down region of the device.

[0682] The device 285 is resiliently biased toward a locked state so that in a static state, without the application of force, the device grips the headgear material in the hole 288. To release the material, the user must press the first end 292a and the second end 292b toward each other, causing the side walls 286, 287 to bend outwardly around the end hinge points, thereby widening the central (necked) portion of the hole 288. The first end 292a and the second end 292b may include a finger grip to facilitate pressing the ends toward each other. For example, the finger grip may be provided with a protrusion, a depression, or a textured surface.

[0683] Optionally, the adjustment device may include internal gripping features (eg, protrusions) to enhance the device's grip on received material. Fig.107An embodiment device 386 is illustrated wherein the inner surfaces of the first and second side walls include protrusions in the form of opposing, complementary steps 386, 387. One step 387 is positioned at or toward the top of the device and the opposing step is positioned at or near the bottom of the device. When the device is in a locked state, the head cap is clamped between the two side walls and is held tightly between the two steps 386, 387. Fig.107 In the locked condition shown, the two steps 386, 387 overlap so 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.

[0684] When the user presses the device to the free state, the two steps move relative to each other, allowing the device to slide along the head cap, thereby adjusting the wearable length of the head cap. In other embodiments, other forms of internal gripping features may be provided, for example, alternative shaped protrusions or steps, recesses or textured surfaces.

[0685] In other embodiments, the internal gripping feature can be provided by alternative protrusions or notches or other recesses to help grip the fabric body on one or both side walls. Figures 108 (i) and 108 (ii) illustrate another embodiment, including notches at the necking area of ​​the hole 488 in the two side walls 486, 487. In the embodiment shown, a pair of notches are opposite to each other, approximately at the midpoint of the device 485 and opposite to each other. These notches can help grip the flexible body of the head cap. When the first end 492a and the second end 492b are pressed toward each other to widen the center of the orifice 488, the notches can help the side walls 486, 487 to bend or protrude outward. In the embodiment shown, the notches have a triangular profile, but other shapes are also possible.

[0686] The top and / or bottom surfaces of the device 285, 385, 485 can be contoured to fit against the curved surface of the wearer's head. That is, the height of the device can decrease toward the midline of the device. In the illustrated embodiments 285, 385, the top and / or bottom surfaces are contoured. This means that the device can be used in either orientation and cannot be inadvertently used "upside down."

[0687] The device comprises an elastic material, preferably a relatively soft material. Non-limiting examples include thermoplastic elastomers, silicones, or thermosetting elastomers. The device can be a single component formed from a single material. Alternatively, the device can be integrally formed from two or more materials.

[0688] Side connector

[0689] A flexible connector 93 may be provided to couple an interface component (such as the side arms of the patient interface assembly described above) to the supra-ear region of the headgear. Figures 87 to 90 An embodiment of a flexible connector 93 is shown, wherein the connector is a multi-layer connector.

[0690] The connector includes a patient interface connection area 97 on a front surface of the connector adjacent a first end of the connector for connection to a connection pad 52 of a corresponding side arm. The patient interface connection area 97 may include a hook surface connector for engaging with a loop surface.

[0691] Two spaced apart upper and lower connection areas 98a, 98b for coupling to the head cap are provided on the lower surface of the device at the second end of the device. The upper and lower connection areas 98a, 98b may include hook connectors for engaging with the annular surface.

[0692] The flexible connector 93 may include outer fabric layers 94, 95 with a reinforcement layer 96 sandwiched between them. The reinforcement layer is typically a flexible polymer layer and may include, for example, a nylon sheet. The reinforcement layer is smaller than the outer fabric layers 94, 95 so that the reinforcement layer does not extend completely to the peripheral edge of the connector, thereby softening the edge of the connector. Fig.89 The figure shows the position and size of the reinforcement layer 96 relative to the patient-facing layer 94. In an embodiment, the edge 96a of the reinforcement layer is spaced approximately 2.5 mm from the edge of the patient-facing layer.

[0693] The front outer fabric layer 95 may include an engagement surface to enable other components to be attached to the connector surface. In an exemplary embodiment, the front outer layer 95 may include a unbroken loop (UBL) fabric.

[0694] 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 head cap 71 described above. The comfort fabric layer may be larger than the front layer 95 and the reinforcement layer, so that the edge 94a of the inner fabric layer extends around the periphery of the connector, forming a soft edge to protect the skin from the reinforcement layer 96.

[0695] In one embodiment, the reinforcement layer is offset inwardly from the periphery of the comfort layer by between about 1 mm and about 2.5 mm. For example, the reinforcement layer can be offset inwardly from the periphery of the comfort layer by about 2.5 mm and inwardly from the front layer by about 1 mm. However, other configurations are obviously possible.

[0696] The patient-facing fabric layer 94 and / or the front outer fabric layer 95 preferably each comprise a material that is fusible using the selected fusion method. These layers should have sufficient density so that the reinforcement layer 96 does not melt through the outer layer during the fusion process and so that the edges do not significantly wear or curl.

[0697] In some embodiments, the patient-facing fabric layer 94 and / or the front outer fabric layer 95 comprise a non-stretch fabric or a fabric with a low level of stretch. In other embodiments, these layers may be fused to minimize any stretching of the connector as a whole.

[0698] The patient contacting underside of the flexible connector 93 may include a sticky 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 sticky surface may include an adhesive film or coating, or may include a friction layer bonded or bonded to the inner surface of the patient-facing fabric layer 94. The sticky surface may be continuous along the length of the connector, or may include discrete areas. Discrete areas may be provided in areas where increased friction is desired. The sticky surface may include straight strips, or may be applied to form a pattern, for example including curves and / or dots.

[0699] In one embodiment, the adhesive surface is provided by a polyurethane elastomer, neoprene, non-stick silicone, and / or thermoplastic polyurethane. The adhesive surface may include a surface suitable for contact with the skin and may be provided 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.

[0700] The layers of the connecting member may be fused together using any of the methods described above in connection with the headband of the headgear. The connecting member may include regions of fused material and regions of non-fused material, forming a connection such as Fig.90 The pattern created by the areas of fused material and non-fused material is visible on at least the exterior (non-patient facing) side. The patterning can be used to indicate the proper orientation of the connector, to identify the size or other characteristics of the connector side, or can be a pattern that corresponds to a pattern on the head cap or connector area.

[0701] The pattern may also be selected to provide a connection zone at a portion of the connector for attaching another component or connector, such as the chin strap 1500 described below. For example, such a connection zone may include a larger non-fused UBL area for a more secure attachment with a hook connector.

[0702] Figures 94 to 104 and Figure 121 to Figure 123The figure shows details of an exemplary further embodiment flexible connector, which includes a comfort surface and optional reinforcement components or layers at least on the patient-facing side of the connector. The comfort surface may include fabric or non-fabric materials. Such a patient-facing comfort surface may be textured to reduce potential surface contact with the patient, thereby minimizing the possibility that the connector feels "tacky" or "sticky".

[0703] 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 the headgear.

[0704] Figures 94 to 99 as well as Figure 121 to Figure 123 The figure shows three additional embodiment flexible connectors 593, 693, 1793, which include a reinforcement layer 596, 696, 1796 and a comfort layer 594, 694, 1794. For the previous embodiments, the connector 593, 693, 1793 includes a patient interface connection area 597, 697, 1797 near the first end of the connector. Two spaced upper and lower connection areas 598a, 598b, 698a, 698b, 1798a, 1798b are provided for coupling to the headgear. The comfort layer can be a non-woven layer.

[0705] The patient interface connection area 597, 697, 1797 is arranged on the surface of the outside of the connector that does not face the patient, for connecting to the pad 52 of the corresponding side arm, or connecting to another component. The head cap connection area 598a, 598b, 698a, 698b, 1798a, 1798b is arranged on the lower surface of the connector facing the patient. The patient interface connection area 597, 697, 1797 and the upper and lower connection areas 598a, 598b, 698a, 698b, 1798a, 1798b can each include a connection pad or area. The connection pad or area may include a mechanical fastener, such as a hook-shaped connection pad or area for engaging with an annular surface, or an annular pad for engaging with a hook-shaped surface.

[0706] The reinforcement layer 596, 696, 1796 comprises a material that is harder and substantially more rigid than the material of the comfort layer 594, 694, 1794. For example, the reinforcement 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 reinforcement layer 596, 696, 1796 enables the connector 593, 693, 1793 to maintain its shape while preferably still allowing some flexing of the connector, and enables the connector to transfer loads and withstand torsional loads during use without excessive buckling or twisting.

[0707] The reinforcement layer 596, 696, 1796 can extend through substantially all or most of the connector 593, 693, 1793, or can be disposed only in one or more areas where reinforcement is desired. In some embodiments, the reinforcement layer can be a single component. In other embodiments, the reinforcement layer can be composed of multiple components that can move relative to each other, for example. Fig.97 and Figure 121 to Figure 123 The figures show two embodiments of connectors in which the reinforcing layer 596, 1796 is a single component but is not located along the entire length of the connector 593, 1793. In these embodiments, the reinforcing layer 596, 1796 extends from the first end of the connector and through the central area of ​​the connector 593, 1793, but does not extend to the second end of the connector. This allows the second end of the connector 593, 1793 to flex to obtain a better fit, thereby providing a more secure connection to the headgear.

[0708] Other shapes, positioning or configurations of the reinforcing layer or other reinforcing components are contemplated to prevent buckling and twisting of the connector during use. The reinforcing layer is preferably provided at least in the central region CR of the connector (in the Fig.97 ), in this central region CR, the tendency to buckle or twist is generally highest. The reinforcement 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.

[0709] The reinforcement layer can usually be planar, e.g. Figures 94 to 97 Connector 593 and Figures 121 to 124 As shown in the connector 1793 of (iii) in FIG. 1 , or it may be as shown in FIG. Fig.98 and Fig.99 As shown in embodiment 693, it is curved. Fig.98 and Fig.99 The curved profile of the connector 693 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.

[0710] This curved profile can advantageously reduce the likelihood that the "flatness" of the arm will pull the connector off the headgear. The curved profile reduces the force required to bend / fit the arm around the face and can reduce the connection force required between the connector and the headgear and / or interface assembly. The curved profile can therefore help maintain the connection between the connector and the headgear.

[0711] The curved profile can advantageously move the middle region of the connector outward from the face near the patient's eyes, thereby reducing the risk of contact between the connector and the eye region. It can also reduce the likelihood of pressure points forming between the middle region of the connector and the patient's face.

[0712] The reinforcement layer may have a substantially uniform thickness, or the thickness may vary across the connector or in different areas of the connector.

[0713] Comfort layer 594,694,1794 comprises relatively soft material arranged on at least the patient-facing side of connector.Comfort layer 594,694 can comprise compliant, optional non-woven material.The patient-facing surface of connector is shaped to be generally smooth and without protrusion.The surface facing the patient can comprise a textured surface to reduce potential surface contact with the patient, thereby minimizing the possibility that connector feels "sticky" or "sticky".Comfort layer generally extends across all connectors 593,693,1793 on the patient-facing side and covers a larger area than reinforcement layer 596,696,1796, extending beyond the periphery of reinforcement layer 596,696,1796.This ensures that only softer comfort layer 594,694,1794 will contact with patient, thereby protecting patient from contacting the relatively hard edge of reinforcement layer.

[0714] As an example, in Fig.97 In the embodiment of the present invention, the peripheral edge 96a of the reinforcement layer 596, 696 is spaced approximately 2.5 mm from the peripheral edge of the comfort layer at their closest point. However, this 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 described in more detail below.

[0715] The comfort layer may include an elastic material. Non-limiting examples include silicone, foam polymers, or thermoplastic elastomers. Alternatively, the comfort layer may at least partially include fabric. The comfort layer 594, 1794 may be overmolded or co-molded with the reinforcement layer 596, 696, 1796 to ensure a secure connection between the layers.

[0716] The geometry of the reinforcement layer can be shaped as or include features such as cutouts, striped features, recesses, or holes to control the stiffness of the reinforcement layer and / or to strengthen the connection with the comfort layer. In some embodiments, the reinforcement layer may include a cutout adjacent to the first end or the second end at the connection point. Such a cutout can increase the flexibility at the connection point with the interface and / or head cap, thereby improving the strength of the connection with the interface and / or head cap. In other embodiments, the reinforcement layer may include a cutout in at least the middle portion of the reinforcement layer to control the flexibility / stiffness of the reinforcement layer in different directions.

[0717] Reference Fig.124 In (i) to (iii), the reinforcing layer 1796 is in the in-plane direction B1 ( Fig.124 (i)) and out-of-plane direction B2 around its longitudinal axis ( Fig.124(ii)) is rigid, but is flexible about the transverse axis in the out-of-plane direction B3 ( Fig.124 (iii) in Figure 1). This flexibility allows the side connector to bend to fit the patient's face and helps to ensure a secure connection at both ends of the connector. The stiffness in the B1 and B2 directions allows loads to be transferred along the connector and prevents the connector from twisting.

[0718] A cutout 1790 may be provided in the reinforcement layer 1796 adjacent 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.

[0719] Fig.125 (i) to 127 provide examples of exemplary embodiment reinforcement layers 1896, 1996, 2096, 2196, 2296, 2396, 2496 having patterns 1895, 1995, 2095, 2195, 2295, 2395, 2495 of thinned areas or cutouts in the form of slits with various shapes, sizes, and pattern densities to increase flexibility in direction B3 to a desired level. Fig.125 (ii) Fig.126 In those embodiments of the embodiments in (ii) and (iii), the slit or thinned area 1995, 2295, 2395 is 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.

[0720] A cutout 1890, 1990, 2090 may be provided in the reinforcement layer 1896, 1996, 2096 adjacent the first end of the connector to enhance flexibility. The cutout 1890, 1990, 2090 may facilitate engagement of the first connection pad.

[0721] In such Fig.125 In those embodiments of (i) to (iii) of the present invention, the slits or thinned regions 1895, 1995, 2095 may extend to the periphery of the reinforcement layer. Fig.126 (i) to Fig.127 In an alternative embodiment to the embodiment in, the slits 2195, 2295, 2395, 2495 may terminate at a point spaced apart from the periphery of the reinforcement layer, leaving the peripheral edge of the reinforcement layer intact. A complete periphery can advantageously increase the stiffness in the desired directions B1, B2.

[0722] The slits or thinned areas may be substantially straight, or they may be curved or otherwise shaped, for example, they may be straight, arcuate, semicircular, angular, or formed by a combination of straight and curved portions. A given reinforcement layer may include slits or thinned areas of various shapes. In a reinforcement layer such as Fig.126 (ii) Fig.126 (iii) and Fig.127 Those non-linear slits 2295, 2395, 2495 in the can each define a tab that moves relative to the rest of the body of the reinforcement layer during flexure. This can result in a greater increase in flexibility than straight slits.

[0723] The slits or thinned areas may be arranged in rows and / or columns. The rows or columns or slits or thinned areas may be arranged in rows and / or columns. Fig.125 (ii) and Fig.126 or they may be aligned as shown in (iii) of Fig.125 (i) to Fig.126 The spacing, positioning and size of the slits or thinned regions can be such that there is minimal or no overlap between the parallel rows, or such that there is significant overlap.

[0724] The slits or thinned areas 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 wider areas of the reinforcement layer and / or where more flexure is desired. The orientation of the slits or thinned areas may be consistent or may vary across the reinforcement layer. For example, in those embodiments arranged in rows or columns, the orientation may vary between two rows or columns. Fig.126 Figure (iii) in Figure 2395 shows an exemplary embodiment in which each slit 2395 has a three-sided central portion defining a generally rectangular wing 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 can be angled or curved. Fig.126 The slits of the embodiment of (iii) 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, as the width of the reinforcement layer increases, the size of the slits in the lateral dimension increases along the reinforcement layer. In alternative embodiments, the slits may all have substantially the same size, or may vary in another dimension.

[0725] The slits or thinned areas may all be the same shape and / or orientation, or the shape and / or orientation may vary. Fig.127 In the illustrated embodiment, two additional curved slots 2495b are provided closest to the head cap connection point 2498b. These curved slots are symmetrical and generally bulge toward the midline of the connector and bulge to the corresponding head cap connection point 2498b.

[0726] Other shapes, slits, slots, stripe features, recesses or holes are contemplated to accommodate the flexibility of the reinforcement layer. The shape, density and location of these features can be selected based on the desired level of flexibility, taking into account the size, thickness and material of the reinforcement layer, as well as the features of the comfort layer combined with the reinforcement layer.

[0727] The connection pads 597, 598a, 598b, 1797, 17981, 1798b, 2498b on the connector can be overmolded with the comfort layer and / or reinforcement layer. Optionally, the connector pad can include more than one hole, such as at either longitudinal end of the pad, which allows the overmolding material to pass through during manufacturing to create a stabilizing portion or spinal cushion along at least a portion of the length of the connection pad.

[0728] The connection pad may be positioned in a recess in the comfort layer so 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 flexing of the connection pad. In one embodiment, the connection pad comprises slits in a pattern, which may include, for example, alternating columns of slits. Each column may include arched and / or semicircular slits that are shaped to face in a direction opposite to the columns on the other side and at least partially deviate from the columns on the other side. A portion of the columns of slits may overlap in the longitudinal direction of the hook pad. Other arrangements of the slits are possible, such as the arrangements described in PCT / NZ2016 / 050041.

[0729] In some embodiments, the connector can be configured for use with a "comfort sleeve" made of fabric or an alternative comfort material that is intended to contact the patient's face. The comfort sleeve can be placed over at least a portion or substantially all of the connector. The comfort sleeve can include plush or wicking materials. The comfort sleeve can be provided as an option to clinicians who prefer to use an alternative material to contact the patient with the material of the connector.

[0730] The comfort layer 594, 694, 1794 preferably also wraps around the peripheral edge of the reinforcement layer 596, 696, 1796 and extends beyond the periphery of the reinforcement layer 596, 696, 1796. The comfort layer may protrude forwardly from the front surface of the reinforcement layer and may overlap the edge region of the reinforcement layer 596, 696, 1796 at least on the outer face of the connector. This enhances the retention of the reinforcement layer 596, 696, 1796 relative to the comfort layer 594, 694, 1794 and also protects the patient from contacting the edge of the stiffer reinforcement layer 596, 696, 1796.

[0731] refer to Fig.102 (i) to (vi) and Fig.129The peripheral edge 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 caused by contact or friction. The edge profile may be shaped to increase the compliance and / or flexibility and / or compressibility of the connector at its edge. The edge features may extend around the entire periphery of the connector, such as Figures 94 to 99 Alternatively, the connector 1793 may extend only around a portion of the connector 1793, as shown in FIG. Figure 121 to Figure 123 as well as Figure 127 to Figure 129 As shown in the embodiment.

[0732] In some embodiments, and as Figure 121 to Figure 123 As shown, it may be desirable to omit edge features from the portion of the connector adjacent to the second end to improve the fit of that portion of the connector to the headgear. In embodiments where the lip features include protrusions, omitting edge features in this area can also reduce potential discomfort for patients lying prone on the connector.

[0733] Optionally, and as Figure 127 to Figure 129 As shown in the connector embodiment 2493 of FIG. 1 , it may be desirable to omit edge features from a portion of the connector adjacent the first end so that the edge features are disposed around the periphery of the reinforcement region 2496. In this embodiment, the edge features 2494a do not extend around the connector pad 2497 at the first end. The edge features 2494a may be disposed from the connector pad adjacent the first end. Fig.129 The tapered profile transitions smoothly into a rounded edge that extends around connector pad 2497.

[0734] Reference again Fig.102 (i) to (iv) and Fig.129 In its simplest form, the comfort layer 594 of the connector 593 may be circular around its perimeter ( Fig.102 The comfort layer also preferably wraps around the peripheral edge of the reinforcement layer 596, 896 in the form of a raised lip on the front surface of the connector. This raised lip provides additional protection for the edge of the reinforcement layer when the connector is deformed.

[0735] Alternatively, the comfort layer 894, 994, 1094 of the connector 893, 993, 1093 may be tapered ( Fig.102 (ii) to (iv) and Fig.129), so that the tapered thinned edge deflects when in 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 feature 894a, 994a, 1094a. For example, a wider taper (e.g., Fig.102 A higher degree of deflection can be achieved as shown in (iv) of FIG. 1 . However, the edge feature should not be so long that the edge of the connector interferes with facial features, such as by bringing the connector close to the wearer's eyes. Fig.102 In the embodiment shown in (iv) of FIG. 1 , the width W of the taper is approximately 1.5 mm, however in alternative embodiments the taper may be narrower or wider.

[0736] like Fig.102 As shown in (iii) in FIG. 1 , a steeper taper angle away from the wearer's face can also reduce the likelihood of the connector edge interfering with facial features. A steeper taper angle can also reduce the likelihood that the edge will be inadvertently folded under the connector and thus stuck between the patient and the underside of the connector. For a given connector footprint, a steeper taper angle also allows for a longer deflection edge. A longer edge allows the thickness to taper gradually.

[0737] Additionally or alternatively, the edge 994a, 1194a, 1294a, 1394a may include flexing or articulating fins 994b, 1194b, 1294b, 1394b that are configured to flex, articulate, or roll when in contact with the wearer's face, thereby enhancing the conformability of the connector to the wearer's facial contours. The edge region 994a, 1194a, 1294a, 1394a may include depressions or recesses 994c, 1194c, 1294c, 1394c that at least partially define the fins and enhance the articulation of the fins and / or provide a void into which the fins can deflect or fold inwardly when in contact with the wearer or under pressure from the wearer.

[0738] The thickness of the fin is selected to be sufficient to ensure that the fin is self-supporting and to prevent the fin from being inadvertently deflected toward the wearer, particularly when the connector is deflected. However, the fin should not be so thick as to create pressure points or hard edges.

[0739] 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 approximately a right angle (90 degrees) to the wearer's face and are generally able to fold inward easily. Embodiments in which the fins extend from the wearer's face at a shallower angle generally require a greater force to fold or deflect the fins, which may be advantageous in preventing the fins from folding prematurely.

[0740] Figure 103(i) and 103(ii)An exemplary embodiment of a fin 1393 is shown in which the fin extends at an angle B that is non-orthogonal to the wearer. With reference 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 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 embodiment shown, the fin has a taper angle C of approximately 7 degrees and a thickness of approximately 0.6 mm, but the taper angle and / or thickness may be smaller or larger. In one embodiment, the fin has a thickness of approximately 0.25 mm.

[0741] The height h marked in Figure 103(ii) represents the thickness of the reinforcement layer. This thickness is selected to be as thin as possible to minimize the overall thickness of the connector without compromising the connector's functionality, so that the connector can transmit loads and withstand torsional loads without excessive buckling or twisting during use. The thickness will depend on the material properties, size, and shape of the connector.

[0742] Fig.100 and Fig.101 Another embodiment of a flexible connector 793 is shown, wherein the connector comprises a single material having one or more reinforced regions 796 formed by one or more regions of increased material thickness. The reinforced regions function in the same manner as the reinforcement layers in the previous embodiments, enabling the connector to transfer loads and withstand torsional loads during use without buckling or twisting.

[0743] For the previous embodiments, the patient-facing surface 794 of the connector 793 is preferably substantially smooth, with the area of ​​increased thickness provided by the outward protrusion on the front side of the connector. The thickness of the reinforced area can be substantially constant over the area, or can vary. For example, where more rigidity is needed and / or the geometry requires a thicker section to achieve the desired rigidity, the reinforced area can be thicker, while where less rigidity is needed, and / or where the geometry dictates that the thickness can be reduced, the reinforced area can be less thick (but still thicker than the non-reinforced area).

[0744] In one embodiment, the connector has a first maximum thickness in the center area of ​​the connector, a second intermediate thickness at one or both ends of the connector, and a third thinnest thickness at the hinge area. The second intermediate thickness at the end of the connector can be selected to ensure that the connector can fully flex at the connection point.

[0745] The connector 793 may include one or more hinge regions where the connector is more flexible than surrounding portions of the connector. The hinge regions 798 allow the connector 793 to flex in a predictable manner to accommodate facial contours, with the majority of the flexing of the connector occurring in the hinge regions rather than elsewhere in the connector body. The hinge regions 798 allow the connector 793 to flex into and out of the plane of the connector in use about an axis that is generally coincident with the longitudinal axis of the wearer.

[0746] The hinge region may include an area of ​​reduced material thickness, a necked region of reduced width, a cutout or slit, and / or a different material (e.g., a more flexible material). 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 positioned reinforcement region 796.

[0747] 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 the connector 793 from disconnecting from the interface when the connector is flexed and installed.

[0748] For example, by rounding, taper or rounding at the corresponding edges of the reinforced area 796, the thickness of the connector 793 gradually increases from the hinge area 798 to the thickened reinforced area 796. For example, by rounding or rounding at the corresponding edges of the reinforced area 796, the thickness of the connector 793 gradually decreases from the thickened reinforced area 796 to the adjacent portion of the connector.

[0749] The thickness of the reinforcement area can be 2-6 times greater than the thickness of the hinge area 798, for example 2.5-4 times greater. In the example embodiment shown, the reinforcement area 796 has a thickness of about 2.25 mm and the hinge area has a thickness of about 0.8 mm. However, other wall thicknesses and / or ratios are contemplated. The thickness of the various areas of the connector body is preferably selected 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 that no area is at high risk of tearing during use.

[0750] The connector 793 may include any of the edge features described above with respect to previous embodiments to reduce contact forces with the patient's face.

[0751] In the illustrated embodiment, the connector includes a shallow depression or recess 797, 798a, 798b at each connection point to receive a corresponding hook or loop pad and to facilitate the combination of the connector body and the pad. The recess can be defined by a raised edge around the received pad. In other embodiments, the connector may not include such a depression or recess. The thickness of the connector 793 in the area near and including the connection points 797, 798a, 798b is selected to be sufficient to bend the connector in those areas to at least ensure a secure connection. For example, the hook and / or loop pad is allowed to flex along the full length of the pad and engage the corresponding interface or head cap connector.

[0752] For example, the connector may include any suitable flexible, resilient material and an elastomer such as a thermoplastic elastomer.

[0753] The width of the connector generally increases from the first end to the second end. The widening may be non-uniform or non-linear.

[0754] A first portion of the connector adjacent to the first end of the connector may have a first substantially uniform width. A second portion of the connector adjacent to the second end of the connector may gradually widen toward the second end. This widening may be a general widening of the connector body, or may include a bifurcation of the connector, such as in a Y-shaped embodiment.

[0755] 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, but other shapes and configurations are contemplated.

[0756] exist Figures 87 to 90 , Figure 94-Figure 101 as well as Figure 121 to Figure 123 In an embodiment, connectors 93, 593, 693, 793, 1793 are Y-shaped, similar to a wishbone, with a single arm branching into a pair of bifurcated 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 to the circular surface of the head cap. In embodiments having a Y-shape, the pair of arms and thus the head cap connector are able to move and flex relative to each other to more securely connect to a larger circular surface. However, connectors of other shapes are contemplated. In some embodiments, the connector may have an asymmetric shape.

[0757] In a connector having a Y-shape, the pair of arms may form an angle between them between about 10 degrees and about 60 degrees. In some example embodiments, the angle between the connector arms is about 25 degrees, but other angles are also contemplated.

[0758] Fig.91(i) to (iv) in FIG. 1 give examples of connectors 193, 293, 393, 493 of four embodiments, and Fig.104 Several different sized connectors are shown, including a single arm connector that increases in width from a first end to a second end, and connectors of different sizes. Providing multiple sized connectors enables the use of a standardized interface frame and catheter for a number of patients of different sizes by selecting the appropriate sized connector for each patient.

[0759] The connector 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 (e.g. Fig.104 The smallest connector shown in ) may include only a single connection point for connecting to the headgear. A wide second end having spaced apart attachment points at its second end provides greater load distribution for the headgear and resistance to twisting of the connector, while the narrow first end minimizes material located near the wearer's face. Connectors of alternative shapes may include any suitable shape to accommodate 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.

[0760] Fig.104 Such a single arm connector may be more suitable for smaller connectors where the space required to accommodate two header cap connector pads at the second end of the connector does not allow for two bifurcated arms.

[0761] For Y-shaped embodiments with a reinforcement layer or region, the reinforcement layer or region enables the bifurcation point of the Y-shape to be positioned closer to the second end of the connector than the first end, such as Fig.104 This advantageously reduces the width of the connector in the area closest to the wearer's eyes. The spacing of the bifurcated arms is also minimized and selected to create space between the connector and the wearer's eyes. The reinforcement layer or reinforcement area achieves this positioning of the bifurcation point and the narrowed spacing of the arms without compromising the torsional stability of the connector.

[0762] All corners of the connector are preferably rounded or tapered to reduce pressure points on the wearer. Figure 127 to Figure 129 In the illustrated embodiment 2493, the edges around the connection pad 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.

[0763] Chin strap

[0764] refer to Fig.92 , Fig.93 , Fig.118 In (i) and (ii) of the embodiment, the headgear assembly may further include a chin strap 1500, 1600 for connecting to the headgear or connector to keep the patient's mouth closed. The chin strap 1500, 1600 may be used with a nasal interface, for example, for Figure 3B The components are illustrated, particularly for CPAP applications.

[0765] The chin strap 1500, 1600 may include multiple layers 1501, 1502; 1601, 1602. The patient-facing layer 1502, 1602 and / or the front layer 1501, 1601 may each include a material, such as a fabric, that is fusible using a selected fusing method. For example, fusing 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 multiple layers of the chin strap may be bonded together in other ways.

[0766] In an embodiment, the front layer 1501, 1601 may include a fabric that is the same or similar to the base layer 72 of the head cap 71 described above.

[0767] The patient facing layer 1502, 1602 may include an engagement surface 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 layer 1502, 1602 may include a full loop (UBL) fabric. The patient facing layer may be larger than the outer front layer 1501, 1601 so that the periphery of the inner fabric layer extends around the periphery of the outer front layer and extends beyond any harder fused areas, thereby forming a soft edge to protect the skin from contacting the front layer 1501, 1601.

[0768] In some embodiments, the patient-facing fabric layer 1502, 1602 and / or the front fabric layer 1501, 1601 include a non-stretch fabric or a fabric with a low level of stretch. In other embodiments, these layers can be fused to remove or minimize any stretching in the entire chin strap.

[0769] The underside of the chin strap that contacts the patient may include an adhesive surface 1506, 1606 to provide an area of ​​increased friction between the headgear and the wearer, thereby reducing the incidence of movement of the patient's face. The adhesive surface 1506, 1606 is preferably disposed in the chin region of at least the approximate center of the chin strap 1600.

[0770] The adhesive surface 1506, 1606 may include an adhesive film or coating, or may include a friction layer adhered or bonded to the inner surface of the fabric layer 94 facing the patient. 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 include a straight strip, or may be applied to form a pattern, which may include, for example, curves and / or dots.

[0771] In one embodiment, the adhesive surface is provided by a polyurethane elastomer, neoprene, non-stick silicone, and / or thermoplastic polyurethane. The adhesive surface may include a surface suitable for contacting 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.

[0772] refer to Fig.93 In a first embodiment, the underside of the chin strap 1500 includes two engagement surfaces 1504, 1505, which are disposed near opposite ends of the strap 1500. These engagement surfaces 1504, 1505 may include hook surfaces for engaging with looped surfaces on other components. For example, the engagement surfaces 1504, 1505 may facilitate connection to headgear, such as to the supra-ear region 74 or the temple region of the headgear described above. Alternatively, the engagement surfaces 1504, 1505 may facilitate connection to other connectors, such as the side connector 93 described above.

[0773] An opening 1503 may be provided in the chin strap 1500, preferably at or near the center of the strap. The opening 1503 may be in the form of a slot or slit to allow for increased movement of the chin strap near the opening 1503, thereby improving stability. The opening 1503 may also be used in some applications to receive an orogastric tube. Alternatively, one or more additional openings may be provided for receiving an orogastric tube or other respiratory system components.

[0774] Fig.118 Figures (i) to 120 in Figure 120 show a second embodiment in which a 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 the outer surface of the strap and a second portion having two arms 1607a, 1607b.

[0775] The engagement surface 1604 of the first portion may include a hook-type surface or other suitable surface for engaging with an engagement surface on the headgear. The engagement surface 1604 may be disposed at or near the first end of the chin strap.

[0776] The first portion of the strap provides a chin contact portion 1606. At a point intermediate the chin contact portion 1606 of the strap and the second end of the strap, the chin strap 1600 bifurcates into a first fixation arm 1607a and a second fixation arm 1607b. The patient-facing side of each fixation arm 1607a, 1607b includes one or more engagement surfaces 1605 of a certain type to engage with the engagement surface 1604 at the first end of the chin strap 1600.

[0777] In this embodiment, the two layers 1601, 1602 of the chin strap 1600 are fused together and the engagement surfaces 1605 on the two arms 1607a, 1607b are ring-type connectors formed by non-fused areas of material. However, alternative connectors are contemplated. Alternatively, the chin strap comprises a single layer of material or may comprise more than two layers of material that are fused, bonded, or otherwise connected together. In some embodiments, fusion or markings may be used to identify the engagement surfaces and / or the intended orientation or use of the chin strap.

[0778] Fig.119 and Fig.120 The figure shows the chin strap 1600 secured to a patient. To install the chin strap 1600, the first end of the chin strap 1600 is placed on the top of the headgear against the side of the patient's head, in a position so that the chin slot 1603 and the chin contact portion 1606 are located below the patient's chin. In the illustrated embodiment, the headgear 471 has an adjustment device 485 on the top of the head, and the first end of the chin strap 1600 is positioned between the adjustment device and the patient's ear.

[0779] In this example, the chin strap is then wrapped around opposite sides of the patient's head so that the bifurcation point 1609 is positioned between the adjustment device and the patient's ear on opposite sides of the first end of the 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 the 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 the first end of the chin strap and / or secured to the top surface of the first arm 1607a at the securing point. The first arm 1607a and the second arm 1607b may cross at or near the securing point.

[0780] It should be understood that in alternative embodiments, the chin strap can be wrapped so that the two arms 1607a, 1607b of the chin strap can be positioned in front of or behind the adjustment device. Alternatively, the chin strap can be used with headgear without the adjustment device.

[0781] It is contemplated that the chin strap 1600 is not limited to use with the headgear currently described. The 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 connected to the patient's head.

[0782] The two arms 1607a, 1607b and / or the bifurcated region of the chin strap 1600 may be shaped to ensure that the arms of the chin strap 1600 and the bifurcated region of the strap lie substantially flat against the head cap 471 and are able to extend around the adjustment device 485 without arcuate bending or twisting.

[0783] In the illustrated embodiment, the chin strap 1600 includes a necked region 1608 adjacent to the bifurcation point and / or a notch 1609 between the two arms at the bifurcation point. These features allow the first arm 1607a and the second arm 1607b to move away from each other while minimizing the resultant deformation of the chin strap 1600 near the bifurcation point.

[0784] The arms 1607a, 1607b of the strap may be shaped so that the spacing between the arms is larger towards the bifurcation point where the arms will extend around the adjustment member, and smaller at the second end of the chin strap 1600. This minimizes in-plane bending of the arms 1607a, 1607b during use, thereby reducing wrinkling, buckling or twisting of the arms.

[0785] The chin strap 1600 may have an increased width near the first end to accommodate the wider engagement surface 1604 to ensure that there is sufficient area to comfortably engage with both the first arm 1607a and the second arm 1607b.

[0786] The preferred embodiments of the present invention have been described by way of example only and modifications may be made thereto without departing from the scope of the present invention.

Claims

1. A cap for fixing a patient interface to a patient, characterized in that: The cap includes a base layer and a headband region forming the body of the cap; the headband region including an outer bonding layer at least partially overlapping a lower portion of the base layer, the outer bonding layer being fused to an underlying portion of the base layer; The headband region includes a fused material region and an unfused material region, wherein the unfused material region forms a convex surface and the fused material region forms a concave surface.

2. The cap according to claim 1, characterized in that: The fused material areas and the unfused material areas form a pattern including dots and / or stripes.

3. The cap according to claim 1, characterized in that: The pattern formed by the areas of fused material or the areas of unfused material may vary in size and / or density along the headband.

4. The cap according to claim 1, characterized in that: The headband has supra-auricular regions that at least partially cover the patient's ears, wherein each supra-auricular region includes an area of ​​fused material in a pattern of dots.

5. The cap-shaped article according to claim 4, characterized in that: The points are arranged to form parallel columns of unfused material.

6. The cap according to claim 4, characterized in that: The headband region includes at least one extension extending from one or both upper ear portions, the at least one extension including one or more further areas of fused material in a dotted pattern.

7. The cap according to claim 1, characterized in that: An area of ​​increased stretch is included, the area of ​​increased stretch including an area of ​​the headband where the base layer of the headgear is exposed through a break or gap in the outer bonding layer.

8. A headgear for securing a patient interface to a patient, characterized in that: The headgear includes a headband configured to be wrapped around and secured on a wearer's head, the headband comprising: a pair of supra-auricular regions at least partially covering the patient's ears, and Two extensions, each extending forwardly of a corresponding upper ear portion at a downward angle.

9. The headgear according to claim 8, characterized in that: Each extension is inclined downwardly at an angle between 0 and 45 degrees from the horizontal.

10. The headgear according to claim 8, characterized in that: A first one of the extensions has a different length than a second one of the extensions.

11. The headgear according to claim 8, characterized in that: The headband includes a region of increased stretch between two supra-ear regions.

12. The headgear according to claim 11, characterized in that: The region of increased stretch is between 5% and 50% of the length of the headband.

13. The headgear according to claim 8, characterized in that: Each supra-ear region includes a protrusion defined by a rounded, downwardly convex lower edge of the headband region.

14. The headgear according to claim 8, characterized in that: The headband includes a bridge portion between the two above-ear portions, and the height of the bridge portion is narrower than the above-ear regions.

15. The headgear according to claim 8, characterized in that: The headband includes a bridge portion between the above-ear portions, the bridge portion including an area of ​​increased stretch compared to the above-ear portions.

16. The headgear according to claim 8, characterized in that The head cap includes a cap-shaped object.

17. An adjustment device for an adjustable headgear system, characterized in that: The adjusting 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 adjustment device between a locked state and a released state; wherein in the locked state, the adjustment device grips the body of the head cap in the hole to fix the adjustment device in place relative to the head cap; and Wherein in the released state, the grip of the adjustment device is fully released so that the adjustment device can move along the body of the head cap toward and away from the headband area, thereby adjusting the size of the head cap in the vertical direction.

18. An adjustment device for gripping the flexible material of a head cap, characterized in that: The adjusting device comprises: a flexible body having first and second ends and first and second side walls defining an aperture for receiving the flexible material, wherein the first and second ends are movable relative to each other to adjust the adjustment device between a locked state and a free state; wherein in the locked state, the adjustment device grips the material in the hole to fix the adjustment device in position relative to the material; and wherein in the free state, the grip of the adjustment device is sufficiently released to enable the adjustment device to move along the material, thereby adjusting the position of the adjustment device relative to the material; and The adjustment device is moved from the locked state to the free state by pressing the first end and the second end of the adjustment device toward each other.

19. The adjustment device according to claim 18, characterized in that In the locked state to the free state, the first side wall and the second side wall are located close to each other, and wherein the first side wall and the second side wall respectively have inner surfaces convex toward the hole.

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