Patent Description:
The present technology relates to a patient interface, or mask, system for treatment of sleep disordered breathing (SDB).

Treatment of sleep disordered breathing (SDB), such as obstructive sleep apnea (OSA), by continuous positive airway pressure (CPAP) flow generator systems involves the continuous delivery of air (or other breathable gas) pressurized above atmospheric pressure to the airways of a human via a conduit and a mask. Typically, the mask fits over or in the mouth and/or nose of the patient. Pressurized air flows to the mask and to the airways of the patient via the nose and/or mouth. Pressurized air is delivered to the mask by a conduit connected to the CPAP device and the mask.

The mask should be comfortable and unobtrusive so that a patient may tolerate therapy and maintain usage. Some patients may prefer a pillows or prongs type mask (as known in the art), or a nasal mask or a full face mask. Some patient's may prefer to use one or a combination of these masks interchangeably. However, this would require the purchase of a number of different mask systems, which may be expensive and/or may not be covered by insurance.

In addition, masks including oro-nasal masks typically include a rigid frame. Patients may not find this comfortable. The frame may also dislodge the sealing portion of the mask away from the face of the patient if it is contacted or forced by bed clothing, pillows, etc..

<CIT> relates to a face mask comprising a sealing collar extending around the mouth with a shelf extending under the nose supporting a gel insert that makes sealing contact between the nostrils and a passage through the shelf. It is said that a curved, rigid window is a push fit in a central opening of the collar and has a gas inlet attached with it so that the window can be removed or connected with the sealing collar as necessary, wherein the collar supported on the head by a harness has two triangular portions on opposite sides encircling respective ears.

<CIT> relates to a patient interface that provides an oral-nasal mask that includes an integrated nasal interface.

<CIT> relates to a breathing arrangement including a patient interface, at least one inlet conduit, and a headgear assembly.

<CIT> relates to a respiratory mask for continuous positive airway pressure treatment including a cushion adapted to be positioned against the face of a patient.

One aspect of the present technology relates to patent interface, or mask, systems that provide integrated nose and mouth seals that are less obtrusive than currently available systems.

Another aspect of the present technology relates to patient interface systems that have reduced part counts compared to currently available systems.

A further aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that provide a visible mouth region of the patient.

Still another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that do not obstruct the patient's line of sight.

Further aspects of the present technology relate to patient interface systems, for example oro-nasal masks, that are easier and/or more intuitive to assemble, fit, and use by patients, dealers, and clinicians, and provide improved fitting and sealing.

Yet another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that provide size selection from remote locations, and without assistance and/or instruction.

Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that are considered physiologically non-threatening and will increase patient selection of the system and adherence to therapy.

Further aspects of the present technology relate to patient interface systems, for example oro-nasal masks, that seal the mouth and nasal airways but have no nasal bridge touch points and/or fewer total points of contacts with the patient's face than current systems.

Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that comprises a substantially planar fascia that may provide a visible mouth region of the patient.

Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that comprises a substantially curved and/or smooth fascia that may provide a visible mouth region of the patient.

Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that comprises a substantially curved and/or smooth fascia that may have no ridges, connector portions or other obstructions in the region of the patient's mouth, so that the fascia may provide a visible mouth region of the patient.

Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that comprises a substantially smooth fascia that may have no complex shapes, connector portions or other obstructions in the region of the patient's mouth, so that the fascia may provide a visible mouth region of the patient.

Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that comprises an air delivery tube connection, the air delivery tube connection positioned on the cushion.

Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that comprises an air delivery tube connection, the air delivery tube connection positioned on the fascia and offset from the centre of the fascia, that may provide a visible mouth region of the patient.

Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that are substantially comprised of flexible components.

Another aspect of the present technology relates to patient interface systems, for example oro-nasal masks, that are stabilised at the nose sealing portion separately to the mouth sealing portion.

A patient interface structure for delivery of respiratory therapy to a patient according to an example embodiment of the present technology comprises a front plate configured to conform to the shape of the patient's face; a mouth cushion defining a breathing chamber and provided to the front plate and configured to seal around the patient's mouth; and a nasal cushion configured to seal the patient's nasal airways, wherein the nasal cushion is supported by the mouth cushion, does not contact a bridge of the patient's nose in use, and extend at least partially into the breathing chamber.

A patient interface structure for delivery of respiratory therapy to a patient according to an example embodiment of the present technology comprises a front plate configured to conform to the shape of the patient's face; a mouth cushion defining a breathing chamber and provided to the front plate and configured to seal around the patient's mouth; and a nasal cushion configured to seal the patient's nasal airways, wherein the nasal cushion is supported by the mouth cushion, does not contact a bridge of the patient's nose in use, and is raised above the breathing chamber.

A patient interface system according to an example embodiment of the present technology comprises a patient interface structure according to the present technology and a patient interface structure positioning system configured to position, stabilize and secure the patient interface structure in sealing engagement with the patient's face.

A patient interface system according to an example embodiment of the present technology comprises a cushion adapted to sealingly engage with a patient's airways, the cushion comprising a slot adapted to receive a headgear connecting portion of a fascia.

Other aspects, features, and advantages of this technology will become apparent from the following detailed description when taken in conjunction with the accompanying drawings, which are a part of this disclosure and which illustrate, by way of example, principles of this technology.

The accompanying drawings facilitate an understanding of the various embodiments of this technology. In such drawings, in which like reference symbols indicate like features:.

The following description is provided in relation to several embodiments which may share common characteristics and features. It is to be understood that one or more features of any one embodiment may be combinable with one or more features of the other embodiments. In addition, any single feature or combination of features in any of the embodiments may constitute additional embodiments.

The term "air" will be taken to include breathable gases, for example air with supplemental oxygen. It is also acknowledged that the blowers described herein may be designed to pump fluids other than air.

Referring to <FIG> and <FIG>, a patient interface system or mask system <NUM> in accordance with an example embodiment of the present technology comprises a patient interface structure or mask structure <NUM> that is positioned, stabilized and secured on a patient's head in sealing engagement with the patient's mouth and nasal airways by a patient interface positioning system <NUM>, e.g. a headgear. The patient interface structure <NUM> comprises a fascia or lens or front plate or frame <NUM> having a mouth seal, or cushion <NUM> that is connected to the front plate <NUM>. The front plate <NUM> includes patient interface positioning system connectors <NUM> (e.g. headgear connectors) to connect the patient interface positioning system (e.g. headgear) <NUM> to the patient interface structure (e.g. mask) <NUM>. The patient interface structure further comprises a nasal seal, or cushion <NUM> connected to the mouth seal, or cushion <NUM> to seal the patient's nasal airways. A vent <NUM> may be provided in the front plate <NUM> to vent exhaled gases in a breathing chamber defined by the front plate <NUM>, the mouth cushion <NUM> and the nasal cushion <NUM>. The vents may be provided in the front plate <NUM> proximate the nares and/or mouth of the patient to improve CO<NUM> washout. The array of vent holes <NUM> may be laser cut, molded or otherwise formed in an upper region of front plate <NUM>.

The patient interface positioning system <NUM> comprises a crown strap <NUM> adapted to cup or encircle the crown of the patient's head. Top, or upper side straps <NUM> extend from the crown strap <NUM> and connect to the front plate <NUM> through slots <NUM>. The ends <NUM> of the top side straps <NUM> may be looped through the slots <NUM> and connect to the top side straps <NUM> by, for example, hook and loop material. It should also be appreciated that other connections, for example buckles, may be used to secure the ends <NUM> of the top side straps <NUM>. The top side straps <NUM> may be thickened or widened at the region where they connect to the crown strap <NUM> to allow ends <NUM> a larger space to connect to and also a range of angles to position ends <NUM> relative to slows <NUM>, thereby improving the fit range of the headgear <NUM>. Such an arrangement may also improve comfort and/or to assist in stabilizing and positioning the top side straps <NUM> on the patient's cheek bone regions.

The crown strap <NUM> may further comprise a loop <NUM> through which a right bottom, or lower side strap <NUM> may pass and connect to a left bottom, or lower side strap <NUM>. It should also be appreciated that the loop may be formed in the lower strap(s) <NUM> and/or <NUM>, for example as shown in <CIT>and <CIT>.

It should further be appreciated that other headgear may be used with the patient interface system, for example as disclosed in <CIT>.

The bottom right side strap <NUM> may comprise a first end <NUM> in the form of a loop or slot and a first end <NUM> of the bottom left side strap <NUM> may connect to the first end <NUM> by passing through the loop or slot and connecting through hook and loop material or buckles or other connectors. The second end <NUM> of the bottom left side strap <NUM> and the second end <NUM> of the bottom right side strap <NUM> may be connected to the front plate <NUM> through slots <NUM> in the connectors <NUM>.

Headgear <NUM> may be formed from a composite e.g. fabric and foam, which may be flame laminated and may be ultrasonically die cut or welded along its edge to create a rounded, more comfortable edge.

The front plate <NUM> is configured to conform to or accommodate the shape of the patient's face. The front plate <NUM> may be flexible to allow the front plate to follow the shape of the patient's face. The front plate <NUM> may be formed of, for example, a flexible polymer that is able to bend and conform around the patient's mouth once the front plate <NUM> is connected to the patient interface positioning system <NUM> and fitted to the patient. The front plate <NUM> may also be malleable to allow the front plate to conform to the shape of the patient's face. A rib(s) <NUM> may be provided to the front plate <NUM>. The ribs <NUM> may be provided along the top and bottom of the front plate <NUM> and aid in alignment and engagement with the cushion <NUM>, as well as providing strength to the fascia.

Front plate <NUM> may be substantially planar, curved and/or smooth. Masks known in the art tend to include complex shapes and/or structures on the frame, and these complex shapes and/or structures make it difficult to see the patient's mouth clearly and to clean the frame. For example, these complex shapes and/or structures may include elbows, elbow connectors, ports, ridges, contours, headgear connectors, etc. Front plate <NUM> is adapted to be substantially smooth and without complex shapes or structures i.e. having a substantially planar surface in the region of the patient's mouth, to act as a window to permit clear visibility to the patient's mouth.

As shown on <FIG> and <FIG>, the patient interface structure <NUM> may be generally rectangularly or trapezoidally shaped and comprise the front panel <NUM> that wraps across the face of the patient <NUM>, and the cushion <NUM>, <NUM> attached to the front plate <NUM>. The cushion <NUM> may comprise the integrated mouth seal or cushion <NUM> and the nasal seal or cushion <NUM>. The front plate <NUM> may be generally convex when viewed from the non-patient contacting side, curved or rounded shaped and adapted to follow the contour of the patient's face. The bottom side strap connector slots <NUM> and the top side strap connector slots <NUM> of the connectors <NUM> on either side of the front plate <NUM> may receive the headgear straps <NUM>, <NUM>, <NUM> and the tension or force from the headgear straps <NUM>, <NUM>, <NUM> may bend or flex the front plate <NUM> to conform to the shape of the patient's face. The top side strap connector slots <NUM> are directed generally upwards and are adapted to aid sealing of the nasal cushion <NUM> and direct the headgear away from the patient's eyes <NUM>, and the bottom side strap connector slots <NUM> are adapted to aid sealing of the mouth cushion <NUM> and direct the headgear straps <NUM>, <NUM> under the ears <NUM> of the patient <NUM>.

The fascia or lens or front plate <NUM> is positioned in front of the patient's mouth, and is adapted to provide support to the other components of the patient interface system <NUM> and aid in positioning these other components, for example the front plate has headgear connectors <NUM> and a cushion connection portion adapted to receive the patient interface positioning system <NUM> and a cushion <NUM> and position these components relative to one another. The front plate <NUM> also provides some structure to the patient interface system <NUM> due to the comparatively greater rigidity of the front plate <NUM> when compared to the cushion <NUM>.

The front plate <NUM> may take the form of a lens made from a clear material such as nylon, polycarbonate or nearly clear material such as polypropylene. The lens may be shaded, selectively shaded (e.g. gradient, patterned, random assortment of shapes), printed on or otherwise coloured. The lens may also have colour changing properties e.g. it may be clear when the light is on, and may be opaque when the light it off. The lens may also be customizable. The lens may be provided with a skin or adhesive layer that may customize or otherwise alter the lens. The lens may be surface treated e.g. frosted. The lens may be die cut, drape formed, vacuum formed, molded, cast, ultrasonically cut or formed in any other method to create the desired shape. The lens may also be formed with vent holes. The vent holes may be molded in, laser cut or otherwise formed with the lens. The lens may be flexible or capable of being shaped to fit the patient's face.

Referring to <FIG>, the cushion or seal of the patient interface system may comprise two components - the mouth cushion or seal <NUM> and the nasal cushion or seal <NUM>. The cushions <NUM>, <NUM> may be molded together or otherwise permanently attached (e.g. glue, weld). The mouth cushion <NUM> provides the mouth sealing portion and also the support for the nasal cushion <NUM>. The mouth cushion <NUM> also connects to the front plate <NUM>. The nasal cushion <NUM> is a nares sealing portion that may be molded from the same or alternative material to mouth cushion <NUM>. Separating the cushion into two components allows use of a lower durometer (i.e. lower hardness) material for the nasal seal or cushion <NUM>, and the tooling required to mold the nasal seal or cushion <NUM> with the mouth seal or cushion <NUM> is difficult, so molding them in two steps rather than one facilitates manufacturing.

The cushions <NUM>, <NUM> may be made from a single material such as silicone, TPE, TPU. However, combinations of materials and/or hardnesses of materials may be used. For example, the mouth seal or cushion <NUM> may have a TPE or silicone body, with a seal portion or flap adapted to interface with the patient. The nasal seal <NUM> may comprise a seal portion formed of an alternative material, for example a lower hardness silicone, TPU, fabric, etc..

Referring to <FIG>, the mouth cushion <NUM> comprises a groove or channel <NUM> around a front portion <NUM> that is adapted to receive the front plate <NUM>. The channel <NUM> may have a flap <NUM> around the inner side of the channel that is adapted to seal against the face of the patient around the patient's mouth. The flap <NUM> may comprise a single wall seal, although it should be appreciated that the flap <NUM> may comprise more than one wall, for example two or three walls. The mouth cushion <NUM> may be constructed from a deformable material such as TPE, TPU, silicone, foam (skinned or unskinned), or gel.

It should be appreciated that the mouth cushion <NUM> may be insert, over, or co-moulded to the front plate <NUM>. It should be further appreciated that a cushion clip may be provided to the cushion to clip to the front plate <NUM>. The clip may be insert, over, or co-moulded into the cushion <NUM> as one part. The cushion clip may add stiffness and rigidity to the cushion <NUM> where required, provide patient interaction points, and allow for a locating and attaching method of the cushion <NUM> to the front plate <NUM>, e.g. the cushion clip may snap onto the front plate <NUM>. The cushion clip may simplify the process of attaching the cushion <NUM> to the front plate <NUM> by reducing stretching and warping of the cushion <NUM> during assembly.

Slots <NUM> are provided in side walls <NUM> of the cushion <NUM> and are adapted to receive the connectors <NUM> of the front plate <NUM>. Slots <NUM> may be generally rectangular, however any other shape may be possible, such that slots <NUM> may be complimentary to the shape of connectors <NUM>. Connectors <NUM> may sealingly engage with side walls <NUM>, for example side walls <NUM> may comprise a lip seal or other arrangement adapted to seal against connectors <NUM>.

The upper portion <NUM> of the mouth seal or cushion <NUM> has a greater depth when compared with the lower portion <NUM> of the mouth seal or cushion <NUM>, i.e. the distance of the seal portion to the clip portion of the upper portion may be longer than the distance from the seal portion to the clip portion of the lower portion, to tilt the cushion <NUM> when in use to reduce the profile of the mask <NUM> when in use. The upper portion <NUM> of the mouth seal or cushion <NUM> may also have a greater depth than the lower portion <NUM> to accommodate nasal seal or cushion <NUM> and patients with long noses.

Flaps <NUM> are provided on nares support portions <NUM> to assist in positioning and stabilizing the nasal seal or cushion <NUM> to engage with the sides of the patient's nose or the patient's top lip. Raised portions <NUM> on the nares support portion <NUM> aid in positioning the nasal seal <NUM> against the flares of the patient's nostrils. Indents or apertures <NUM> are formed in the nasal support portions <NUM> and are adapted to receive lugs <NUM> on nasal seal or cushion <NUM> to aid in alignment.

A channel <NUM> may be provided around the nares support portions <NUM> to form a flexible region (e.g. could be localized thinning of material) adapted to permit movement of the nasal seal or cushion <NUM> to accommodate varying anthropometrics.

The side walls <NUM> of the mouth seal or cushion <NUM> may have a "question mark" cross section, i.e. the mouth seal portion does not have a straight wall section but rather has a gusseted side wall that acts as a built-in spring so that the mouth seal portion can flex to fit varying patient anthropometrics. Such a side wall cross section is disclosed in, for example, <CIT>.

The front portion <NUM>, the side walls <NUM> and the flap <NUM> of the mouth cushion <NUM> may have different hardnesses. For example, the front portion <NUM> may have a Shore A durometer of about <NUM>-<NUM>, for example about <NUM>. The side walls <NUM> and/or the flap <NUM> may have a Shore A durometer of <NUM>-<NUM>, for example about <NUM>.

Referring to <FIG>, the cushion or seal may be formed of a foam, gel, or low durometer material to seal with the patient. Two gusset or spring portions <NUM>, <NUM> may be formed behind the seal portion to aid in adjustment of the positioned of the seal portion. The corner <NUM> of the nose region may be raised to ensure the seal abuts the patient's face and seals in this region.

Referring to <FIG>, a gusset type arrangement may be provided to permit flexibility of the cushion and aid sealing under air pressure, with the seal portion <NUM> turning outwards. This arrangement may increase the fit range.

Referring to <FIG>, the nasal seal or cushion <NUM> may comprise lugs <NUM> adapted to be received in indents <NUM> of the nare support portions <NUM> of the mouth seal or cushion <NUM>. The nasal seal or cushion <NUM> may have a geometry the same as or similar to that disclosed in, for example, <CIT>.

The nare support portions <NUM> and the cradle wall <NUM> form a trampoline type join with the nasal seal or cushion <NUM>. The nasal seal or cushion <NUM> may have a Shore A durometer of about <NUM>-<NUM>, for example about <NUM>. The nasal seal or cushion <NUM> may have a Shore A durometer of about <NUM>-<NUM>, for example about <NUM>.

Referring to <FIG>, in the assembled condition, the flaps <NUM> of the nares support portions <NUM> of the mouth seal or cushion <NUM> attach to the respective sides of the nasal seal or cushion <NUM>. A central portion <NUM> of the nasal seal or cushion <NUM> is left unsupported by the nares support portions <NUM> to allow the flexibility of the central portion <NUM> accommodate varying shaped lip regions of patients. As shown in <FIG>, the top portion <NUM> of the mouth seal or cushion <NUM> is generally in line with or vertically aligned to the nasal seal or cushion <NUM> so the patient's nose is likely to rest inside the cushion. The nasal seal or cushion <NUM> is positioned to reside within the mouth cushion <NUM> which reduces visual bulk and streamlines the outer edge of the mask. As shown in <FIG>, the slots <NUM> for the connectors <NUM> of the front plate <NUM> are positioned below the nasal seal <NUM> so as to direct the headgear straps <NUM>, <NUM> along or below the patient's cheeks. It should be appreciated that the patient interface system may comprise a number of nasal seals or cushions <NUM>. For example, a single mouth cushion <NUM> may be provided to fit a large percentage of the patient population and two or more nasal seals or cushions <NUM> may be provided to provide a more custom fit for individual patients nose sizes.

Referring to <FIG>, it should be appreciated that a nasal seal or cushion comprising nasal pillows may be provided to the mouth cushion. It should be appreciated that a plurality of nasal seals or cushions having different size nasal pillows may be provided to the patient interface system.

Referring to <FIG>, the tube connector may comprise an elbow <NUM> that is rotatably connected to the front plate <NUM>. Elbow <NUM> may be lockable in the two positions as show, i.e. left and right horizontal orientations.

Referring to <FIG>, the patient interface structure <NUM> may include an anti-asphyxia valve <NUM> provided in the front plate <NUM>.

Referring to <FIG>, the front plate <NUM> may include a receptacle <NUM> configured to receive a clip <NUM> provided on a strap <NUM> of the patient interface positioning system. As shown in <FIG>, the front plate <NUM> may include receptacles <NUM> on opposing sides, each configured to receive a clip <NUM> attached to a strap <NUM>, <NUM>. The clips and receptacles may also be magnetic.

Referring to <FIG>, <FIG>, a seal or cushion assembly includes a mouth seal or cushion <NUM> and a nasal seal or cushion <NUM>. The cushion assembly may be similar to that disclosed with respect to <FIG> except as otherwise described herein. The cushion assembly may comprise a cushion clip <NUM> attached to the cushion assembly and configured to attach the cushion assembly to a fascia or front plate or lens as described herein. The cushion clip <NUM> may comprise detents <NUM> on opposite sides to retain the cushion assembly on the fascia. As shown in, for example, <FIG>, the cushion clip <NUM> may have a curved portion <NUM> that curves away from the cushion assembly to allow the nasal seal <NUM> to have a greater depth than a top surface of the mouth cushion <NUM>. This may allow the nasal seal <NUM> to accommodate long noses. As shown in <FIG>, the central portion <NUM> of the mouth cushion <NUM> may dip or curve downwards towards the patient's lip to avoid contacting the patient's septum. As shown on <FIG>, nasal seal <NUM> may comprise raised upper corner regions, these raised upper corner regions adapted to engage a patient's nostrils or nasal flares, thereby reducing the force on the patient's nose tip.

Referring to <FIG>, the height of the aperture in the mouth cushion may be about <NUM>-<NUM>. Preferably, the height of the aperture on the mouth cushion may be about <NUM>-<NUM>. The height is measured from the lowest portion of the opening at the chin region to the dip or curve of the opening at the top lip region. The height of the aperture may increase towards the cheek or left and ride side regions.

Refererring to <FIG>, the height of the aperture in the nose cushion may be about <NUM>-<NUM>. Preferably, the height of the aperture in the nose cushion may be about <NUM>-<NUM>. The height of the aperture in the nose cushion may be less in the central region of the aperture compared to the height of the aperture at the side regions. That is, the nose cushion aperture may have a dip or curved portion at the central region. Such an arrangement may aid in alignment of the cushion, avoid placing excess pressure on the patient's septum and/or ensure that the lower portion of the nasal cushion is not under tension and therefore may not exert pressure on the patient's top lip.

Referring to <FIG>, the width of the aperture in the mouth cushion may be about <NUM>-<NUM>. Preferably the width of the aperture in the mouth cushion may be about <NUM>-<NUM>. Such a width may accommodate varying mouth widths of patient's.

Referring to <FIG>, the total width of the nose and mouth cushion may be about <NUM>-<NUM>. Preferably, the total width of the nose and mouth cushion may be about <NUM>-<NUM>. Such a width may accommodate varying patient anthropometrics.

Referring to <FIG>, the total height of the nose and mouth cushion may be about <NUM>-<NUM>. Preferably, the total height of the nose and mouth cushion may be about <NUM>-<NUM>. Such a height may accommodate varying patient anthropometrics.

The patient contacting portion of the nose and/or mouth cushions may be about <NUM>-<NUM> thick. Preferably, patient contacting portion of the nose and/or mouth cushions may be about <NUM>-<NUM> thick. Such a thickness may ensure conformability of the cushion and comfort for the patient.

Referring to <FIG>, the height of the clip may be about <NUM>-<NUM>. Preferably, the height of the clip may be about <NUM>-<NUM>. The height of the clip may be greater than the height of the mouth cushion aperture. Such an arrangement may be simpler to engage the clip with a fascia (for example) and may increase the structural integrity of the cushion.

Referring to <FIG>, the width of the clip may be about <NUM>-<NUM>. Preferably, the width of the clip may be about <NUM>-<NUM>. The width of the clip may be greater than the width of the mouth cushion aperture. Such an arrangement may be simpler to engage the clip with a fascia (for example) and may increase the structural integrity of the cushion.

As shown in, for example, <FIG>, the cushion clip may be generally trapezoidal, with the top portion being wider than the lower portion. Such an arrangement may mean that the overall shape of the mask is shaped to match the general shape of a humans face i.e. taper from a greater width at the top lip region to a lower width at the chin region. The top portion may be, for example, about <NUM>-<NUM> wide. The lower portion may be, for example, about <NUM>-<NUM> wide.

As shown in, for example, <FIG>, the cushion may be integrally formed in one piece. The mouth cushion <NUM> may have a single wall <NUM> and the nasal cushion <NUM> may have a dual wall construction comprising a sealing wall <NUM> and a supporting wall <NUM>. It should be appreciated that the mouth cushion <NUM> and the nasal cushion <NUM> may each include a single wall, or each may include multiple walls. The sealing walls <NUM> and <NUM> of the mouth cushion <NUM> and the nasal cushion <NUM> may curve inwards toward a breathing chamber or cavity formed by the cushions. As shown in <FIG>, only a portion of the supporting wall <NUM> of the nasal cushion <NUM> may be present, for example, at the tip of the nose region and not at the top of the lip region. Referring to <FIG>, a parting line <NUM> of the mould used to form the cushion assembly may be provided so as to be above the patient contacting areas of the cushion assembly.

Referring to <FIG>, the cushion assembly and the cushion clip <NUM> may be formed integrally in one piece. The cushion assembly may be insert, over, or co-moulded into the cushion <NUM> as one part. Alternatively, the cushion assembly and the cushion clip <NUM> may be chemically or mechanically bonded together. The cushion assembly and cushion clip <NUM> may also be repeatably attachable and detachable from one another. For example, the cushion clip <NUM> may include a flange configured to be received in a channel in the cushion assembly.

As shown in <FIG>, <FIG>, the cushion clip <NUM> may include a flange or rib <NUM> to increase the surface area of the cushion clip <NUM> to enhance the bond between the cushion clip <NUM> and the cushion assembly. The cushion assembly, for example the mouth cushion <NUM>, may include a thickened region <NUM> to provide support for the seal wall <NUM> and to improve the bond to the cushion clip <NUM>. Rib <NUM> may have a varying height around the perimeter of the cushion clip <NUM>. This varying height may support the cushion more in some regions (i.e. the regions with a greater rib height such as sensitive regions of the face such as the top lip) compared to support in other regions (i.e. regions with a lower rib height such as less sensitive regions of the face such as the cheeks).

Referring to <FIG>, a cushion assembly including a mouth cushion <NUM> and a nasal cushion <NUM> may comprise a continuous sealing surface <NUM>. As show in <FIG>, the sealing surface <NUM> is continuous with the mouth cushion sealing wall <NUM> and the nasal cushion sealing wall <NUM>. The curvature of the sealing surface <NUM> may be constant or approximately constant. Such an arrangement may be comfortable for the patient as there are no ridges or undulations that may mark or otherwise irritate the patient's skin. In this arrangement, the definition between the nose and mouth seal portions is not distinct, such that the seal is continuous.

Referring to <FIG>, a cushion assembly including a mouth cushion <NUM> and a nasal cushion <NUM> includes separate sealing surfaces <NUM>, <NUM>. A channel <NUM> is provided to separate the nasal sealing surface <NUM> from the mouth sealing surface <NUM>. Such an arrangement may be preferable as the nose and mouth seal portions are visually distinct which may assist the patient with aligning the device.

Referring to <FIG>, a patient interface system <NUM> according to an example embodiment of the present technology includes a delivery hose, or tube, or conduit <NUM> that is connected to the front panel <NUM> by a connector <NUM>, e.g. a swivel connector. The tube <NUM> may be as disclosed in, for example, <CIT>.

The front panel includes an air inlet or elbow <NUM> that may be integrally formed with the front plate <NUM>. It should be appreciated that the elbow <NUM> may be formed separately from the front plate <NUM> and attached or connected to the front plate <NUM> or the cushion <NUM>, for example by adhesive or mechanical fasteners. The elbow <NUM> is positioned behind or adjacent to the connector <NUM> of the front plate <NUM> on the left side, although it should be appreciated that the elbow <NUM> may be provided on the right side of the front plate <NUM>. The shape of the elbow <NUM> is curved to avoid obscuring the headgear connector <NUM>. However other configurations would be possible if the headgear connector <NUM> was located in an alternative position.

The tube connection portion of the elbow <NUM> is adapted to receive the tube <NUM> in a longitudinal (e.g. vertical) direction, however other orientations are possible. The elbow <NUM> is not visible from the front as it is hidden behind the headgear connector <NUM> of the front plate <NUM>. This arrangement is advantageous as it is reduces the part count (i.e. no separate elbow is required) and the design may be more visually appealing. The tube <NUM> is connected at the side of the patient interface or mask system <NUM> so as to permit clear view to the patient's mouth. Because the tube connection is positioned behind the headgear connector <NUM> at the front plate <NUM>, the tube <NUM> is less obtrusive. The eyes <NUM> of the patient <NUM> are unobstructed and in the case of the front plate <NUM> being in the form of a lens, for example a clear polymer (e.g. polycarbonate), the patient's mouth would also be visible.

The elbow <NUM> may comprise a lip or protruding edge <NUM>, in the form of for example a chamfer, adapted to receive a slot or aperture of the cushion. The cushion <NUM> may comprise a slot that may be positioned to abut or align with the chamfer to aid alignment, and also ensure an air tight seal between the cushion <NUM> and the front plate <NUM> is achieved.

The patient interface structure <NUM> sits under the patient's nose <NUM> and the nasal cushion <NUM> seals around or in the nares. The mouth cushion <NUM> sits in the crease of the patient's chin <NUM>. The crown strap <NUM> of the headgear <NUM> is positioned over the top of the patient's crown and generally in line with the patient's ears <NUM>, although it should be appreciated that the positioning of the crown strap <NUM> may vary between patients.

Although the front plate <NUM> shown in <FIG> includes only the bottom side strap connector slots <NUM>, it should be appreciated that the embodiment shown in <FIG> may also comprise top sides strap connector slots <NUM>. It should also be appreciated that the front plate <NUM> may be provided with a vent, or alternatively another component, such as the tube <NUM>, the connector <NUM>, or the elbow <NUM> may have a vent.

Referring to <FIG>, a tube connector <NUM> may be positioned either on the front plate <NUM> or molded with the cushion <NUM>. The tube connector <NUM> may receive an intermediate portion or portion <NUM> of a tube <NUM> that may interface with the tube connector <NUM> by an interference fit. The interference fit may be achieved by pinching or otherwise misshaping the intermediate portion or portion <NUM> of the tube <NUM> and placing it within the tube connector <NUM>. When the pinch or other force is released, the intermediate portion or portion <NUM> of the tube <NUM> may resiliently flex back to its original shape and interface with an inner surface of the tube connector <NUM>. In an alternative arrangement, tube <NUM> that may interface with the tube connector <NUM> by an interference fit such as an isometric taper or a quarter turn lock.

Referring to <FIG>, a patient interface system <NUM> according to another example embodiment of the present technology comprises a patient interface structure <NUM> comprising a front plate <NUM>, a mouth cushion <NUM> provided to the front plate <NUM>, and a nasal cushion <NUM> provided to the mouth cushion <NUM>. The front plate <NUM> comprises a tube connector <NUM> on a front surface that is configured to receive a tube in a horizontal direction.

A tube may connect directly to the tube connector <NUM> or may have an intermediate structure such as an elbow or swivel between the tube and the tube connector <NUM>, possibly shaped to avoid the tube obscuring the headgear connector <NUM>. The tube connector <NUM> may have vent holes <NUM> molded or otherwise formed in it. The tube connector <NUM> may also have a lip or protruding edge <NUM>, which may aid in sealing the tube connector <NUM> to the tube or intermediate structure. The tube connector <NUM> may have an anti-asphyxia valve (AAV) in form of a flap built in (described in more detail below) that may occlude or block some of the vent holes <NUM> when air is delivered from the tube and through the tube connector <NUM>. When air pressure is not supplied, the AAV may flip away from the vent holes to permit the patient to breath in sufficient atmospheric air.

The rear face of the front plate <NUM> may have an aperture <NUM> adapted to permit the flow of air from the tube connector into the mask. The vents <NUM> may have a thicker cross section than the rest of the tube connector <NUM> (e.g. they are on a raised rectangular portion) to improve manufacturability. This may also be to increase the length of the vent holes <NUM> as longer vent holes are typically quieter than comparatively shorter vent holes. The tube connector <NUM> may follow the same general curvature of the front plate to reduce the visual bulk (i.e. more streamlined look) of the mask and aid in tube management.

Referring to <FIG>, a patient interface system <NUM> according to another example embodiment of the present technology may comprise an elbow <NUM> connected substantially perpendicular to the front plate <NUM>. The elbow <NUM> may be a swivel elbow or may be a ball joint elbow. The elbow <NUM> may be removably attachable or molded with the front plate <NUM>.

Referring to <FIG>, a patient interface system <NUM> may comprise a front plate <NUM> having a vent <NUM> comprising a plurality of vent holes provided around a perimeter of the front plate <NUM>. The perimeter arrangement aids diffusivity of the exhaust gases and reduces the visibility of the vent <NUM>.

Referring to <FIG>, a patient interface system <NUM> may comprise a front plate <NUM> having a vent <NUM> that comprises micro-perforated holes over the front surface of the front plate <NUM>.

Referring to <FIG>, a tortuous vent path through front plate <NUM> may be provided for reducing noise. The tortuous path will slow down the exhaled gases <NUM> as it moves through the tortuous path, thereby having a lower sound power. The mouth seal may have an interface seal <NUM> and a flap or castellation <NUM> that obstructs the vent holes <NUM>, with the exhaled gases <NUM> moving through the vented pathway <NUM> of a raised portion <NUM> of the front plate <NUM> rather than directly out of the vent holes <NUM> to increase the length of the path for exhaled gases to get out of the mask.

Referring to <FIG>, a patient interface system <NUM> may include a mouth cushion <NUM> having a tube cuff <NUM> attached to, for example, the side wall <NUM> of the cushion <NUM>. The tube cuff <NUM> may be moulded onto the side wall <NUM> and may have a hardness greater than that of the side wall <NUM>.

Referring to <FIG>, a tube cuff <NUM> may be moulded onto the cushion <NUM> that is configured to be connected to a connector <NUM>, e.g. a swivel connector, that is configured to be connected to a tube <NUM>, for example a tube as disclosed in <CIT>.

It should be appreciated that the tube cuff <NUM> may be connected to the cushion by, for example, adhesive or mechanical connectors.

Referring to <FIG>, a gap <NUM> between a tube connector <NUM> and a cuff <NUM> (having less width when compared to the tube connector for example) may be adapted to receive a headgear strap that extends in a substantially vertical direction. The cuff <NUM> may include a link or slot <NUM> to receive a headgear strap that extends in a substantially horizontal direction. The cuff <NUM> may be soft or relatively flexible. The cuff <NUM> may be glued on or otherwise attached to the tube connector <NUM>. The cuff <NUM> may be formed with the tube connector <NUM>.

Referring to <FIG>, a patient interface system <NUM> may comprise a front plate or lens <NUM> having a hole <NUM>. An anti-asphyxia valve in the form of a flap <NUM> formed in the mouth seal or cushion <NUM> is forced against the front plate <NUM> and covers the hole <NUM> when a flow of pressurized gas is delivered through a tube or hose or conduit <NUM>. In the absence of the flow, the flap <NUM> is released from contact with the front plate <NUM> and uncovers the hole <NUM>, allowing the patient to breathe ambient air through the hole <NUM> in the front plate <NUM>.

Referring to <FIG>, a patient interface system <NUM> may comprise a front plate <NUM> having a tube connector <NUM> configured for connection with a tube or hose or conduit <NUM>. The tube connector <NUM> comprises an aperture or window <NUM> that may be closed by an anti-asphyxia valve <NUM>. The anti-asphyxia valve <NUM> comprises a flap <NUM> that is configured to open and close the aperture <NUM>. The flap <NUM> may comprise a vent <NUM> for venting exhalation gases when the flap <NUM> closes the aperture <NUM>. The anti-asphyxia valve further includes a tab <NUM> that secures the anti-asphyxia valve <NUM> in the tube connector <NUM> through a slot <NUM> in the tube connector <NUM>. The flap <NUM> is pivotably connected to the tab <NUM> by a hinge <NUM>, e.g. a living hinge. As shown in <FIG>, in the absence of a flow of gas in the tube connector <NUM>, the flap <NUM> extends across the tube connector, and the patient may breathe through the aperture <NUM>. When gas flow <NUM> is delivered to the tube connector <NUM>, the pressure of the gas flow <NUM> pivots the flap <NUM> in the direction shown by arrow <NUM> to close the aperture <NUM>. Exhalation gases may be vented through the vent <NUM>. Referring to <FIG>, the flap <NUM> may include elongated vent holes <NUM> to reduce venting noise and increase diffusivity of the vent flow.

Referring to <FIG>, the cushion may have a flap or thin portion <NUM> around its perimeter that interfaces or otherwise abuts the front plate. The flap may be pressure activated i.e. when air is delivered under pressure into the mask, the flap may be forced to abut the front plate causing an air tight seal. If air is no longer delivered to the mask, the flap may relax and permit air from atmosphere into the mask via a gap <NUM> created between the flap and the front plate.

Referring to <FIG>, a patient interface system <NUM> may comprise a polyester front plate or window <NUM> having a TPE "macro" seal <NUM> and a low durometer nasal seal <NUM> comprising pillows, or a seal as disclosed in <CIT>.

A foam "micro" seal <NUM> may be attached to the seal <NUM>. A TPE or TPU headgear <NUM> may be provided to position the patient interface system on the patient's head. Elastic webbing or ultrasonic die cut spacer fabric <NUM> may be provided. A tube connect <NUM> may be connected to a textile sock <NUM>.

Referring to <FIG>, a headgear strap, e.g. a lower headgear strap that is positioned under the patient's ears and loops through a slot in the crown strap, may be connected to an air delivery tube <NUM>. The air delivery tube <NUM> may connect to an end of the headgear strap <NUM>, with gases being delivered through the headgear clip <NUM>. The clips <NUM>, <NUM> may interface with the front plate. As shown in <FIG>, the headgear strap <NUM> may be configured to deliver gases through an air delivery tube <NUM> and the clips <NUM>, <NUM> may be formed in such a way that the strap <NUM> can be oriented either left (<FIG>) to right or right to left (<FIG>).

Referring to <FIG>, the front plate <NUM> may include a plurality of attachment locations <NUM> for the patient interface positioning system, e.g. headgear, and/or a rotatable attachment location <NUM> that provides adjustment of the angle between the patient interface structure, e.g. mask, and the patient interface positioning system, e.g. headgear. The attachment locations may be in the form of rings <NUM>.

The fascia, frame or lens portion may comprise a fixed elbow connection, the elbow connection directed horizontally. Such an arrangement can be seen in, for example, <FIG>. The fascia be structured and arranged to be flipped or rotated, such that the direction of the elbow may be changed from pointing to the left, for example, to pointing to the right. This means that the fascia may be symmetrical.

Claim 1:
A patient interface structure (<NUM>) for delivery of respiratory therapy to a patient, comprising:
a front plate (<NUM>) configured to conform to the shape of the patient's face;
a mouth cushion (<NUM>) defining a breathing chamber and provided to the front plate and configured to seal around the patient's mouth;
a nasal cushion (<NUM>) configured to seal around the patient's nares, and
headgear (<NUM>) comprising a headgear strap (<NUM>);
wherein the nasal cushion is supported by the mouth cushion; wherein the nasal cushion does not contact a bridge of the patient's nose in use;
wherein the mouth cushion comprises a front portion (<NUM>) adapted to receive the front plate;
wherein the mouth cushion comprises a rear portion;
wherein the front plate has a comparatively greater rigidity than the mouth cushion; and
characterized in that
the headgear comprises a clip (<NUM>) configured to interface with the front plate;
the headgear is configured to deliver gases to the face plate through the clip; and
the rear portion of the mouth cushion comprises at least one flap or membrane (<NUM>) configured to seal against the patient's face.