Patent Description:
The invention relates to the delivery of respiratory therapy to a patient. Examples of such therapies are Continuous Positive Airway Pressure (CPAP) treatment, Non-Invasive Positive Pressure Ventilation (NIPPV), and Variable Positive Airway Pressure (VPAP). The therapy is used for treatment of various respiratory conditions including Sleep Disordered Breathing (SDB) such as Obstructive Sleep Apnea (OSA).

Typically, respiratory therapy is delivered in the form of a mask system positioned between a patient and apparatus providing a supply of pressurized air or breathing gas. Mask systems in the field of the invention differ from mask systems used in other applications such as aviation and safety in particular because of their emphasis on comfort. This high level of comfort is desired because patients must sleep wearing the masks for hours, possibly each night for the rest of their lives. In addition, therapy compliance can be improved if the patient's bed partner is not adversely affected by the patient's therapy and wearing of the mask generally.

Mask systems typically, although not always, comprise (i) a rigid or semi-rigid portion often referred to as a shell or frame, (ii) a soft, patient contacting portion often referred to as a cushion, and (iii) some form of headgear to hold the frame and cushion in position. If the mask system does in fact include multiple components, at least some assembly and adjustment may be required, which can be difficult for patients who may suffer from lack of dexterity, etc. Further, mask systems often include a mechanism for connecting an air delivery conduit. The air delivery conduit is usually connected to a blower or flow generator.

A range of mask systems are known including nasal masks, nose & mouth masks, full face masks and nasal prongs, pillows, nozzles & cannulae. Masks typically cover more of the face than nasal prongs, pillows, nozzles and cannulae. Nasal prongs, nasal pillows, nozzles and cannulae all will be collectively referred to as nasal prongs.

There is a continuous need in the art to provide mask systems with a high level of comfort and usability.

Preferred embodiments are matter of the dependent claims.

Subject-matter referred as embodiments, aspects and/or disclosures, which do not fall under the scope of the claims are not part of the invention.

One aspect of the disclosure relates to a patient interface including a sealing arrangement adapted to provide an effective seal with the patient's nose, an inlet conduit arrangement adapted to deliver breathable gas to the sealing arrangement, and a cover that substantially encloses the sealing arrangement and/or the inlet conduit arrangement.

The cover and/or the sealing arrangement may include one or more portions constructed of a textile and/or foam material. The sealing arrangement may have a laminated or multi-layer construction. The sealing arrangement may seal under, around, and/or slightly within the patient's nose. The sealing arrangement may take the form of a nasal cradle, nasal cushion, or nasal prongs. The sealing arrangement may include a "leaky" seal to allow breathing, avoid moisture, and/or allow gas washout.

The cover and/or inlet conduit arrangement, and in particular the surface that engages the patient's face/head, can be modeled from a cross-section of a elliptically shaped conic member. The cross-section may have a width that defines a tapered surface adapted to engage the patient's head. The tapered surface converges in a direction forward of the patient's face.

The cover may incorporate one or more regions having different colors (color contrast), patterns, and/or surface texture, e.g., a two-tone color scheme.

In an embodiment, the patient interface may provide minimal adjustment, e.g., one or no adjustment points.

The cover and/or inlet conduit arrangement may have a contour that blends or forms an organic extension of the patient's face/head, e.g., non-circular or tapered.

The inlet conduit arrangement may integrally include the cover or the cover may integrally include the inlet conduit arrangement.

Another aspect of the disclosure relates to a method for fitting a patient interface to a patient including locating a sealing portion of the patient interface with respect the patient's nose and/or mouth, and rotating or pivoting the patient interface about the sealing portion onto the patient's head until the patient interface self locates onto the patient's head. The method may include additional adjustment, e.g., adjustment of a rear strap, to further secure the patient interface onto the patient's head.

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. In such drawings:.

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.

While patient interfaces are described as including nasal cradles, nasal cushions, or nasal prongs of the type described below, the patient interfaces may be adapted for use with other suitable breathing arrangements. That is, the breathing arrangements are merely exemplary, and aspects of the present invention may be applicable to other breathing arrangements, e.g., full-face masks, mouth masks, etc..

Embodiments of the technology are directed towards moving from uncomfortable, unattractive mask systems to sleek patient interfaces that are soft, comfortable, lightweight, functional, therapy enhancing, fashionable, easy to fit and adjust with little or no adjustment, shape holding, low impact, low profile, individualized or customized, and/or are more appealing and much less objectionable by patients and bed partners alike. The subject patient interfaces are less obstructive and seem to be an organic extension of and/or blends with the patient, rather than a bulky, mechanical extension affixed to the patient which can appear to be ungainly or unattractive. This can help the patient and the patient's bed partner more readily sleep during treatment. Moreover, the patient interface can improve the overall perception such that the patient is simply wearing a garment like a night cap or bed clothes, etc. rather than being treated for a respiratory illness. This improved perception can help increase the chances that the patient will actually wear the patient interface and better comply with therapy, which increases the chances that the therapy will be effective. There is also the possibility that the bed partner will more readily participate in the patient's therapy by encouraging use of an easy to use/adjust, more attractive and/or appealing interface.

<FIG> illustrate a patient interface <NUM> according to an embodiment of the present disclosure.

As illustrated, the patient interface <NUM> includes a sealing arrangement <NUM> adapted to provide an effective seal with the patient's nose, an inlet conduit arrangement <NUM> (<FIG>) adapted to deliver breathable gas to the sealing arrangement <NUM>, and a cover <NUM> (also referred to as a sock or covering) that substantially encloses the sealing arrangement <NUM> and optionally the inlet conduit arrangement <NUM>. Specifically, the cover <NUM> is structured to expose a sealing portion <NUM> of the sealing arrangement <NUM> adapted to form a seal with the patient's nose and optionally a connector or manifold <NUM> (<FIG>) of the inlet conduit arrangement <NUM> adapted to connect to an air delivery tube <NUM>. The cover <NUM>, as well as internal tubing, etc., helps to provide the patient interface <NUM> with a self-holding form so that the patient interface <NUM> can retain its shape whether on or off the patient's head (e.g., see <FIG> and <FIG>). The cover <NUM> could also be structured to cover only a smaller portion of the patient interface.

In embodiments, the cover <NUM> and the sealing portion <NUM> are constructed of a textile (e.g., woven or non-woven textile) and/or foam material. This arrangement provides a "total soft" configuration adapted to intimately engage the patient's face. In addition, the "total soft" configuration is visually appealing and stylistic to help remove the stigma of wearing of a mask.

In the illustrated embodiment, the sealing arrangement <NUM> is in the form of a nasal cradle having the sealing portion <NUM> that provides an effective seal under the patient's nose in use. The sealing portion <NUM> may be supported by a support or frame that is enclosed within the cover <NUM>, e.g., such as the rigid shell shown in <FIG>.

The sealing portion <NUM> is constructed of a porous material, e.g., textile or foam, such that the sealing portion <NUM> provides a breathable seal or a "leaky" seal with intentional/controllable leak. In an embodiment, the material of the sealing portion may be selected to manage moisture, e.g., avoid moisture in some regions and encourage moisture in other regions, e.g., near nose for humidification. Hydropholic and hydroplylic materials (or treatments resulting in similar properties) are some options.

The sealing portion <NUM> may have other suitable configurations, e.g., nasal cushion, nasal prongs, etc..

In an embodiment, the sealing portion <NUM> is formed with foam and provides a foam seal or interface under the patient's nose in use (not up the nose). Due to foam's construction, the foam seal provides a breathable seal such that condensation buildup and associated irritation can be avoided at the contact interface between the patient and sealing portion. The foam provides "a leaky" seal with intentional/controllable leak through the foam structure/matrix that helps to create air circulation to keep the contact surfaces relatively dry and comfortable. The foam seal is constructed to leak within predictable and predetermined limits. In an embodiment, the foam vent provides the necessary volume of CO<NUM> washout, which may obviate the need for separate CO<NUM> washout vents. However, CO<NUM> vent holes may be used in conjunction with the foam seal.

The foam seal provides an "unskinned" arrangement that does not grip or stick to the patient's skin, does not stretch or need to stretch, and provides controllable leak. Thus, the foam seal minimizes skin breakdown and contaminants. In addition, the foam seal is breathable to keep the patient's face relatively dry in use.

The foam seal provides a warming sensation to the patient's nares upon exhalation, e.g., similar to breathing into a blanket on a cold night. This arrangement reduces the "frozen nose" effect experienced by some users of nasal prong interfaces. In an embodiment, the foam seal may include extended side portions that extend along sides of the patient's face, e.g., along upper cheek regions between the air delivery conduits and the patient's cheeks near or extending from the mouth, to provide the warming sensation to other areas of the patient's face. In an exemplary embodiment, the extended side portions may connect with the connector.

The foam seal provides an extremely soft (but reinforced) viscoelastic foam interface with the patient. The foam seal provides ultimate comfort and unobtrusiveness due to its highly unobtrusive design, e.g., similar to nasal prong interfaces. However, unlike nasal prong interfaces, the foam seal does not include the intrusive feeling of prongs sticking up the patient's nose. In addition, the foam seal eliminates the jetting effect of nasal prong interfaces, since the foam helps to diffuse the gas.

Also, the foam seal provides ultimate compliance as the region of sealing is less complex and has less anthropometric variation compared to conventional nasal and full face interfaces. The foam can deform to the appropriate size and shape without compromising the seal and without adding discomfort to the patient. In addition, the highly compliant foam fits and seals a broader range of population variation for a given size (e.g., especially compared to silicone interfaces). Further, the foam seal is more compliant because it is less reliant on strap tension from headgear.

The foam seal may have a closed cell or open cell arrangement. Also, the foam seal may provide gradual opening in use. In embodiments, the foam seal may have selected volume and surface properties.

Other advantages of the foam seal include ease of formation, relatively cheap material and tooling costs, and lightweight.

In an alternative embodiment, the sealing portion <NUM> may be constructed of a textile material to provide a textile seal or interface under the patient's nose in use. The textile seal also provides a breathable seal or a leaking seal with intentional/controllable leak.

As shown in <FIG>, the sealing arrangement may include a cylindrical support or base <NUM>, e.g., constructed of silicone, and a textile seal <NUM> provided to the cylindrical support <NUM>, e.g., attached with RTV silicone. The cylindrical support <NUM> may be attached to a frame adapted to connect to inlet conduits of the inlet conduit arrangement <NUM>. The cylindrical support <NUM> may have a substantially similar structure to the base portion of a nozzle assembly (with the nozzles removed and only the divider <NUM> (<FIG>) therebetween remaining) as disclosed in <CIT>. The flexibility of the cylindrical support <NUM> adds compliance to the seal. The support may have a split base to be connected with a channel in a frame member preferably within the cover or sock. However, the support can be a tube with an aperture and seal around at least a portion of the aperture. In an embodiment, the foam seal may be provided with a support such as cylindrical support <NUM>.

As illustrated, the textile seal <NUM> includes a single layer of textile material, e.g., polar fleece. An opening is provided in the middle of the textile seal <NUM> to allow air flow. As noted above with respect to the foam seal, the textile seal <NUM> may provide a warming sensation around the nose upon exhalation.

As shown in <FIG>, the sealing arrangement may include a cylindrical support or base <NUM>, e.g., constructed of silicone, and a multi layer textile seal <NUM> provided to the cylindrical support <NUM>.

As illustrated, the textile seal <NUM> includes multiple layers, e.g., <NUM>, <NUM>, or <NUM> layers (four layers in this example), of textile material, e.g., polar fleece, attached to one another. An opening is provided in the middle of the textile seal <NUM> to allow air flow. In an embodiment, some of the textile may be carved away around where the tip of the patient's nose would rest, e.g., to relieve some of the pressure.

As shown in <FIG>, the sealing arrangement may include a rigid shell <NUM> and a textile seal <NUM>, e.g., polar fleece, provided to the rigid shell <NUM>. The rigid shell <NUM> provides the textile seal with a rigid mounting surface to rest on. The compliance in the textile is utilized to create a seal in use.

In an embodiment, foam, e.g., EVA foam, may be provided between the rigid shell <NUM> and the textile seal <NUM>.

Also, the rigid shell <NUM> includes tubes <NUM> that are adapted to engage a respective inlet conduit, elbow, cap, and/or headgear. As illustrated, the cut out area in the frame for the patient's nose is deeper then that for the patient's upper lip.

<FIG> illustrate another embodiment of a sealing arrangement including a rigid shell <NUM> and a textile seal <NUM>, e.g., polar fleece, provided to the rigid shell <NUM>, e.g., glued using RTV silicone. In this embodiment, the rigid shell <NUM>, e.g., formed of Perspex sheeting, is provided to a tube <NUM>, e.g., polyolefin tube.

As shown in <FIG>, the sealing arrangement may include a semi-rigid or hinged and/or bendable shell <NUM>, e.g., formed of silicone, and a textile seal <NUM>, e.g., polar fleece, provided to the semi-rigid or hinged shell <NUM>.

The shell <NUM> may have any suitable cross-section, e.g., D-shaped, and includes a central rib <NUM> for rigidity. A hinge point, e.g., opening covered by flat silicone sheet, is provided on each side of the central rib <NUM> that allows the shell <NUM> to hinge or bend about two points (see <FIG>). The hinged shell may facilitate sealing around the sides of the patient's nose as the hinged shell allows the textile seal to at least partially wrap around the nose. Other exemplary hinged and/or bendable shells are disclosed in <CIT>.

<FIG> illustrate a sealing arrangement including a cylindrical shell <NUM> and a textile seal <NUM>, e.g., silicone coated textile, provided to the cylindrical shell <NUM>. The textile seal <NUM> may be wrapped around the shell <NUM>, and the orifice <NUM> in the textile seal <NUM> is aligned with a cut-out <NUM> in the shell <NUM>. As illustrated, the orifice <NUM> in the textile seal <NUM> is generally triangular (with concave sides) and may be provided in different sizes, e.g., L (large), MW (medium wide), and MN (medium narrow) as shown in <FIG>. The textile seal may be mounted on a substrate to allow quick fastening and removal to the shell, for example, hook and loop fastener, or the substrate may be in the form of a C-shaped semi-rigid member that can flex to fit over the shell.

In an alternative embodiment, an overlapping textile seal may be improve fit and stability. The overlapping textile seal may be formed by stacking different orifice sizes. The outside layer may include a large hole, and subsequent layers would get smaller. There may be a gap between each layer. In use, the patient's nose may slide into the seal and stop when a seal is achieved, e.g., like dropping a ball into a funnel.

Also, elastic elements may be added to the tips of the triangle-shaped orifice to aid in sealing and fit range. A larger orifice could be used, and the elastic elements would pull the points together helping in restricting leak.

In addition, the shell may be structured to allow more clearance for the patient's nose. For example, the shell may include a curve adapted to substantially clear the tip of the patient's nose.

The inlet conduit arrangement <NUM> is communicated with the sealing arrangement <NUM> to deliver breathable gas to the sealing arrangement <NUM>. In the illustrated embodiment, the inlet conduit arrangement <NUM> includes one or more inlet conduits and a connector coupled to the inlet conduit(s). In one embodiment, a single inlet conduit can communicate between the inlet conduit and the sealing arrangement. However, it is preferred that two inlet conduits be used, so that the size of each conduit can be reduced and provide less obtrusiveness to the patient.

Each inlet conduit includes a first end adapted to engage a respective end of the frame that supports the sealing portion <NUM>. For example, the frame may be structured like the frame shown in <FIG>, and the inlet conduits are adapted to engage respective tubes provided on opposing ends of the frame, e.g., via friction fit. In use, the inlet conduits are supplied with pressurized breathable gas, and the pressurized breathable gas is delivered into opposing ends of the sealing arrangement <NUM>.

The inlet conduits (and hence tubes on the frame) may have any suitable cross-sectional shape, e.g., cylindrical, elliptical, flatter section, etc. The cross-sectional shape of the inlet conduits at least partially determines the shape of the cover that encloses the inlet conduits. In the illustrated embodiment, the inlet conduits have a non-cylindrical cross-sectional shape which provides a blending contour to blend with the patient's face, as described in greater detail below. The conduits may have a flat configuration with anti-crush ribs such as tubes disclosed in <CIT>.

As best shown in <FIG> and <FIG>, a connector or manifold <NUM> is provided to interconnect the inlet conduits and provide continual flow from the air delivery tube <NUM> to the inlet conduits. As illustrated, the connector <NUM> is generally T-shaped and includes a base portion <NUM> and an inlet tube portion <NUM> that is movably coupled (e.g., via a ball joint, hinge, general flexibility, etc.) to the base portion <NUM>.

The base portion <NUM> includes a first tube 35a to engage one inlet conduit, e.g., via friction fit, and a second tube 35b to engage the other inlet conduit, e.g., via friction fit. The cross-sectional shape of the first and second tubes 35a, 35b may be non-circular and corresponds to the cross-sectional shape of the inlet conduits. The base portion <NUM> may be curved to match the shape of the patient's head and is otherwise suitably contoured such that it can rest and sit substantially flush with the top of the patient's head in use. In addition, the base portion <NUM> has a low profile which provides a low moment in use. As shown in <FIG>, the base portion <NUM> is substantially covered by the cover <NUM> to provide an integrated look.

As shown in <FIG>, the inlet tube portion is angled towards the rear of the head. The inlet tube portion can be fixed, or the inlet tube portion <NUM> can be movable coupled, e.g., swivel, to the base portion <NUM> so that the inlet tube portion <NUM> can be angled with respect to the base portion <NUM> in use. The inlet tube portion <NUM> has an inlet tube <NUM>, e.g., <NUM> diameter, adapted to connect to an air delivery tube connected to a flow generator. The inlet tube <NUM> is relatively long to facilitate connection with the air delivery tube. Also, base <NUM> of the inlet tube portion <NUM> has an exterior curvature continuous with the base portion <NUM>.

In an embodiment, the connector <NUM> may be flocked (e.g., lots of little bits of yarn or fluff adhered to it). Alternatively, a textile wrap-over may be provided to the connector <NUM> to achieve a smooth surface. The base portion <NUM> and/or inlet tube portion <NUM> may incorporate one or more stops to limit rotation of the inlet tube portion <NUM> in use.

In an alternative embodiment, the connector <NUM> and inlet conduits may be integrally formed as a one-piece structure, e.g., to reduce the number of parts.

In the illustrated embodiment, the connector <NUM> is positioned at the top of the patient's head. In alternative embodiments, the connector <NUM> maybe offset from the top of the patient's head, e.g., positioned at a side of the patient's head. This offset arrangement may provide more comfort as there may be less drag.

The length of the inlet conduits may be selected to adjust the connector to a position where the patient can view and more easily manipulate air delivery tube connections.

In an embodiment, the connector <NUM> may have an adjustable connection, e.g., sliding coupling, so that two or more positions of the connector <NUM> may be selected.

As shown in <FIG>, the cover <NUM> substantially encloses the inlet conduits of the inlet conduit arrangement <NUM> and the frame of the sealing arrangement <NUM>, thereby only exposing the sealing portion <NUM> that forms a seal and the inlet tube <NUM> that connects to the air delivery tube. The covered patient interface appears more like clothing and provides an organic form which is more appealing as described in more detail below.

As illustrated, the cover <NUM> includes a lower portion <NUM> that covers the frame of the sealing arrangement <NUM>, side portions <NUM> that cover the inlet conduits and the base portion <NUM> of the connector <NUM>, and a rear portion <NUM> that extends across the side portions <NUM>. The lower portion <NUM> provides an opening to expose the sealing portion <NUM> and the side portions <NUM> provide an opening to expose the inlet tube <NUM>.

The cover <NUM> holds the sealing arrangement <NUM> and the inlet conduit arrangement <NUM> such that the side portions <NUM> guide the inlet conduits from the sealing arrangement <NUM> along the sides of the patient's head, over the patient's ears, and to the top of the patient's head. The side portions <NUM> hold the connector <NUM> at the top of the patient's head for connection to the air delivery tube. The rear portion <NUM> extends across the rear of the patient's head.

The rear portions <NUM> may be in the form of an adjustable strap that is selectively adjustable to adjust its length. For example, the rear strap <NUM> may include an adjuster <NUM> similar to a baseball cap (see <FIG>). This arrangement provides a good fit range with minimal sizes. However, other suitable adjustment mechanisms are possible, e.g., hook and loop material, ladder lock, elastic, etc..

The cover <NUM> helps to maintain the sealing arrangement <NUM> and the inlet conduit arrangement <NUM> in a desired position. That is, the cover <NUM> includes structural integrity or a self-holding form so it holds the patient interface's shape, e.g., shape memory, whether the patient interface is on or off the patient's head. In addition, the cover is formed of a material, e.g., textile or foam, that provides intimate and comfortable contact with the patient's face. The cover provides a warming effect, i.e., non-clinical feeling like an article of clothing rather than medical equipment.

The cover <NUM> may be constructed of a textile material (woven or non-woven textile), e.g., fleece, fabric material. Exemplary materials include Polar Fleece Materials and in particular their "Power Stretch" Material. The textile material is preferably soft in appearance and touch, and relatively easy to incorporate colors. Also, non-woven textile may be moldable, e.g., Novolon.

In an embodiment, the cover <NUM> is constructed of material that is non-reflective or has low reflectivity. Non or low reflectivity is a characteristic that could be used to broadly distinguish textile covered patient interfaces from plastic masks. Also, non or low reflectivity is advantageous in terms of not reflecting too much light.

In an alternative embodiment, the cover may be constructed of a foam, cardboard, or paper material.

In another alternative embodiment, the patient interface, the air delivery conduit, and/or the flow generator may have a similar surface material which may provide continuity in surface finish.

The cover <NUM> may incorporate one or more regions having different colors (color contrast), patterns, and/or surface texture. In the illustrated embodiment, the cover includes a two-tone color scheme, e.g., a dark color D and a light color L. As illustrated, the dark color D is positioned adjacent the field of vision. This arrangement provides a low impact, sleek look.

The two-tone textile cover <NUM> slims the perception of the size of the patient interface <NUM> on the patient's face. That is, this arrangement has the functional advantage that lighter colors, e.g., white, can be incorporated into the cover <NUM> that make the relevant region look smaller, slimmer, or less bulky. Thus, the patient interface <NUM> has a lower visual impact (e.g., less aesthetically obtrusive). In addition, the patient interface may be more fashionable like clothing. In alternative embodiments, one or more light colored lines, e.g., white lines, may be incorporated into the cover <NUM>.

Different colors, patterns, and/or surface texture may be selected for different users. In an embodiment, the cover <NUM> may be transparent or selected to blend in with the patient's skin, e.g., camouflaged or skin color. For example, if the patient has relatively darker skin, the cover <NUM> could be black or dark brown to blend with the patient's skin. In an alternative embodiment, the color and/or texture of the cover <NUM> may be selected to match the patient's hair.

In an embodiment, the cover <NUM> may be removable from the sealing arrangement <NUM> and the inlet conduit arrangement <NUM> for cleaning and/or replacement. The cover <NUM> may incorporate a zipper and/or Velcro®, for example, to facilitate removal/attachment. This arrangement allows different colored, patterned, and/or textured covers to be interchanged for aesthetics or replacement.

The material of the cover <NUM> may be selected such that the cover <NUM> can be washable, e.g., machine washable. For example, the cover <NUM> may be washed when removed from the sealing arrangement <NUM> and the inlet conduit arrangement <NUM>. In an embodiment, the entire patient interface <NUM> may be constructed such that the entire assembly may be washable, e.g., machine washable.

In the illustrated embodiment, the cover <NUM> provides a blending contour or free form with no sharp edges or straight lines. The blending contour is smooth and blends or tapers the cover <NUM> with or into the contours of the patient's head, e.g., less obtrusive. In addition, the blending contour has no sharp edges that could cause skin irritations or abrasions.

The contour of the cover <NUM> may vary non-uniformly with location around the patient's head. For example, the cover <NUM> may provide flatter regions in certain areas, e.g., where the patient rests on the cover during sleep. In this way, the cover can be said to be an organic extension of the patient's facial contours.

<FIG> illustrates an exemplary cross-section of the cover <NUM>. As illustrated, the cover <NUM> provides an internal surface <NUM>, an external surface <NUM>, and an interior form <NUM> defined between the internal and external surfaces <NUM>, <NUM>.

The internal surface <NUM> is adapted to sit substantially flush against the patient's face in use. As described in greater details below, the internal surface <NUM> has a tapered configuration form an inner edge to an outer edge to provide a comfortable fit for a wide range of patients. The internal surface <NUM> provides a relatively large surface area which results in a more even load distribution. This arrangement is less likely to create pressure points in use. Also, the internal surface <NUM> may have grip-like material to help stabilize the patient interface on the patient's face.

The external surface <NUM> has a smooth contour that blends with the patient's face. That is, the external surface <NUM> has a profile or organic form with edges that blend into the patient's face, e.g., in a tangential manner, to prevent any edges from catching on bedclothes, pillows, etc., during sleep (e.g., when the patient rolls over).

The interior form <NUM> of the cover is determined at least in part by the sealing arrangement <NUM> and/or the inlet conduit arrangement <NUM> extending therethrough. For example, <FIG> illustrates a side portion <NUM> of the cover in which the inlet conduit <NUM> extends therethrough. As illustrated, the inlet conduit <NUM> has a generally elliptical shape and the interior form <NUM> of the cover encloses the inlet conduit <NUM>.

The cross-section of the cover may vary along its length, e.g., by changing the cross-section of the inlet tube and/or the interior form <NUM>.

<FIG> illustrate alternative cross-sections of the cover. As shown in <FIG>, the cover may provide a gap <NUM> in the internal surface <NUM>, e.g., to allow air flow or breathing of the cover. As shown in <FIG>, the cover may have a D-shaped cross-section. While less preferred than the cross-sections shown in <FIG>, the cross-section of <FIG> would be more preferable than a normal cylindrical conduit for its blending contour. However, other cross-sectional shapes are possible, e.g., oval.

In embodiments, the overall cross-sections in <FIG> may represent the shape of the inlet conduit per se, and the cover is simply formed to cover, preferably in a conforming way, the shape of the inlet conduit. In an alternative embodiment, the "cover" could just be provided on the inside surface of the inlet conduit, i.e., the side in contact with the patient's face.

The patient interface <NUM> is structured such that little or no adjustment is needed to fit the patient interface <NUM> to the patient's head. Thus, the patient interface <NUM> is relatively self-locating. For example, the inlet conduits and/or the side portions <NUM> of the cover <NUM> extending from the sealing assembly <NUM> to the crown of the patient's head at least in part define a generally truncated elliptical cone or funnel, thus forming a tube-cover ring. <FIG> illustrates a an oval-shaped cone that can be used as a template for designing purposes. The cone tapers from a smaller ellipse to a larger ellipse along axis A. The cross-section is selected along axis A to fit the largest possible population, given that the shape will be generally fixed. The shaded region <NUM>' on the conical shape in <FIG> substantially represents an embodiment of the internal surfaces of the conduits and/or cover, in particular hoop-shaped side portions <NUM> of the patient interface. As shown in <FIG>, the internal surfaces define an inner elliptical edge I that tapers to an outer elliptical edge O. A tapering surface or conical-elliptical ring is provided between the inner and outer edges to define a contact surface that engages the patient. The outer elliptical edge O has larger major and minor axes D<NUM>, D<NUM>, than the major and minor axes d<NUM>, d<NUM> of the inner elliptical edge I. The width of the internal surfaces may vary.

At least a portion of the internal surfaces of the cover are adapted to engage the patient's head in use, and the tapered or angled configuration of the internal surfaces allows the patient interface to fit a variety of differently shaped heads.

Specifically, the cover is oriented such that the larger edge O faces inwardly towards the patient. As the patient interface is fitted to the patient's head, the patient's head will extend through the larger edge O towards the smaller edge I. Depending on the size of the patient's head, the tapered internal surfaces will engage the patient's head in different positions. For example, if the patient has a larger head, patient interface may sit higher up on the patient's head. If the patient has a smaller head, the patient interface may sit more towards a rear portion of the patient's head. Once fit, the patient may adjust the rear portion <NUM> as necessary. Thus, the patient may require a single adjustment to fit the patient interface to his/her head.

In alternative embodiments, the internal surfaces may taper along one or selected portions. Also, the internal surfaces may symmetric or asymmetric, e.g., side portions may have a bend. This may be designed using <FIG>, e.g., by angling the upper portion of the cross-section either forwards <NUM> or rearwards <NUM> along the axis A, depending on where the top portion of the conduit/cover is intended to contact the patient.

<FIG> illustrate an exemplary method for fitting the patient interface to a patient. As shown in <FIG>, the sealing arrangement <NUM> may first be located under the patient's nose. Then, as shown in <FIG>, the cover and inlet conduit arrangement enclosed therewithin may be rotated about the sealing arrangement onto the patient's head. The patient interface is rotated, e.g., for X°, until the tapered side portions <NUM> engage the patient's head and prevent further movement. Finally, as shown in <FIG>, the rear portion <NUM> of the cover may be adjusted as necessary to secure the patient interface on the patient's head.

In the illustrated embodiment, the patient interface <NUM> includes a single adjustment point, e.g., adjustable rear portion <NUM>. In an embodiment, the rear portion <NUM> may be tailored or modified to fit the patient at the point of sale, and then altered to prevent further adjustment, e.g., tear off.

In an alternative embodiment, the patient interface <NUM> may have a non-adjustable slip-on shape, e.g., like a shoe, with little or no elasticity. In this arrangement, the patient interface <NUM> may be provided in many different sizes, e.g., up to <NUM> different sizes, <NUM>, <NUM>, <NUM>, or any other number of sizes. This arrangement is aided by compliance of the seal.

In an embodiment, the inlet conduits may be provided by the cover <NUM> itself. That is, the side portions <NUM> of the cover <NUM> may be structured to form conduits that deliver air from the connector <NUM> to the sealing arrangement <NUM>. For example, the cover may be generally elastic until pressure is applied, and then expand and become inelastic upon the application of pressure. Such an alternative embodiment is discussed below. Also, inflatable conduit headgear is disclosed in PCT application no.

In an alternative embodiment, the entire patient interface may be constructed from foam. In this arrangement, the foam patient interface may be pre-formed to provide a custom fit with the patient.

The patient interfaces described above and below are structured to improve patient quality of life by improving their quality of sleep. This is achieved by developing a patient interface with an unobtrusive, friendly look and feel (e.g., eliminating self-consciousness and "medical" perception and associated negative connotations), enhanced usability (e.g., simple and intuitive to fit and maintain), and enhanced comfort.

The patient interfaces described above and below may each include one or more of the following advantages, features, and options. In addition, any single advantage, feature or option may constitute additional independent embodiments of the present technology.

The following patents and applications may include options or features that may be incorporated into one or more of the patient interfaces described above and below.

The patient interface may be divided into functional areas (e.g., sealing, support, etc.) as opposed to components. Each functional area may be best implemented using a material selected to perform the desired function. In one embodiment, a single material can meet all functional requirements in all functional areas.

The following properties may apply to all materials in all functional areas:.

The sealing region is the area of the patient interface that joins the shell or support of the patient interface to the patient's skin, specifically in and/or around the nose. This connection creates a volume of pressurized air that the patient is able to breath.

The following properties may apply to the material in the sealing region:.

The following materials may be possible solutions for sealing. For each material, properties are listed that may make the material work.

The material may have controlled elasticity across the seal section that uses the patient interface air pressure to create the form and hold the seal against the face. To achieve this, the elasticity may be varying across the material, but controlled. The seal may act in a similar way to known bubble cushions; the frame (shell) may not provide the sealing vectors, but simply translate the sealing force from the headgear to the cushion (seal).

The seal may be a flexible flat piece and the shell provides form to the seal. This flat piece may be cut with the required profile to negotiate the nose. Since the material is flexible and has no rigid elements, it may follow the form of the shell, and all sealing vectors may be between the patient and the shell (as apposed to the patient and the seal). To achieve this, the shell may have elements integrated into it to provide the reaction force for the seal. These rigid elements may be foam, inflexible sections, inflexible inserts, etc..

Multiple flat sections may be joined (e.g., by gluing, stitching, welding, etc) to form a three dimensional object. Each flat section may have different properties from one another, e.g., elasticity, flexibility, thickness, texture, etc..

The seal may be woven using three-dimensional weaving techniques. This may allow a three dimensional object to be created from one piece of material without seams. The material may have varying properties in different areas of the seal. This may be possible by using different threads/yarns. Properties to be changed may include elasticity, flexibility, texture, thickness (friction, feel, etc), air permeability, etc..

The gas venting region is the area of the patient interface that allows flow to atmosphere with the goal of washing away exhaled air. The flow should be low enough to create backpressure within the patient interface, and should not be affected significantly with humidification or create excessive noise.

The following properties may apply to the material in the gas venting region:.

The following materials may be possible solutions for gas venting. For each material, properties are listed that may make the material work.

A textile with similar properties to CoolMax may be used as the vent. The material may have the property that moisture evaporates more readily then it condensates (resulting in no restriction of flow due to condensation of moisture in the vent). If the material is stretchy, the flow should not be effected when stretched (i.e., gaps between the yarns must not change significantly enough to effect the flow).

A textile that is coated with a Gore-Tex membrane may be used as the vent. This would allow moisture to move through the material and evaporate into atmosphere.

A plastic insert may be used to contain a vent. The vent shape may be similar to our current technology, possibly using multi hole technology.

Holes may be sewn into the shell to be used as vents.

Punching holes into the shell may be possible. These holes should not fray the shell when stretched.

Disposable membrane inserts may be used, e.g., mesh vent.

The shell itself may have a diffuse flow over its entirety hence eliminating the need for a separate venting area.

The gas supply connects the breathable volume around the patient interface to the gas delivery hose.

The following properties may apply to the material in the gas supply:.

The following materials may be possible solutions for gas supply. For each material, properties are listed that may make the material work.

A silicone, polyethylene or other material may be molded to form an elastic tube that is impermeable to air. If touching the skin, the outside surface of the tube may have a soft finish.

The molded tube could be laminated with a textile to give it a textile appearance.

A textile tube may be created by either a three dimensional weaving technique or by using a seam.

The surface of the textile may be laminated with a membrane or other material to control the permeability to air and moisture.

The textile may have a surface treatment applied to it (such as a resin) to control the permeability to air and moisture.

Malleable textiles that retain their shape (metallic textiles for example) may be used (or laminating malleable elements to the tube) to achieve form and provide assistance in achieving the correct sealing vectors. "Solid" sections may be incorporated into the design (such as spacer fabrics) to help provide form. Pockets for solid materials (like ribs in a sail) may be incorporated to allow structural elements to be added, these materials could come with multiple options to allow for personalization of the patient interface. Temporary laminating of rigid elements (like a Velcro system) could also be used to achieve a personalized fit.

The anchoring provides stability and location to all other elements of the patient interface. The anchoring may be integrated with other functional areas.

The following properties may apply to the material in the anchoring:.

The shell connects all parts together and provides form to the patient interface, particularly around the nose to hold the sealing portion in place.

The following properties may apply to the material in the shell:.

The following materials may be possible solutions for the shell. For each material, properties are listed that may make the material work.

Multiple flat sections of textiles may be joined (e.g., by gluing, stitching, welding, etc.) to form a three dimensional object. Each flat section would potentially have different properties from one another, e.g., elasticity, flexibility, thickness, texture, etc. The quilt may require a surface treatment to modify the material's permeability to air and moisture. The quilt may be laminated with other materials to provide form or rigidity (like a foam or adhesive plastic for example). Laminating with membranes may also be used to modify surface properties of the quilt such as permeability to air and moisture or even modify the surface to comply with biocompatibility requirements. Malleable textiles that retain their shape (metallic textiles for example) may be used (or laminating malleable elements to the quilt) to achieve form and provide assistance in achieving the correct sealing vectors. "Solid" sections may be incorporated into the design (such as spacer fabrics) to help provide form. Pockets for solid materials (like ribs in a sail) may be incorporated to allow structural elements to be added, these materials could come with multiple options to allow for personalization of the patient interface. Temporary laminating of rigid elements (like a Velcro system) could also be used to achieve a personalized fit.

A three dimensional weave may be essentially the same as the quilted textile method of creating a three dimensional shape. All possible methods listed above may be used with a one piece option with the advantage of having no seams. Possibilities in addition to the ones listed above may include:.

Molded self skinning open cell foam may be used.

Molded open cell foam using a textile or other film as the skin may be used. The skin may be put in the mold first, then foam molded into this skin.

Form may be achieved by thermo forming of vacuum forming sheets of the desired foam. When forming the foam, wall section thickness variations may result in varying density and hence rigidity. For example, if the foam is pressed thinner in an area, it may have a higher density than an area with a larger wall section. This may result in a rigid rib that could be used to control sealing vectors. The shell and cushion may be formed in one piece, this would result in only one seam. More than one seam may increase the chance of a poor join and inadvertent leak. To achieve the required surface properties of the shell, the foam may be laminated with other materials (such as a textile or film) before forming.

The following are possible designs for the patient interface.

A self-locking linear clutch may be used in conjunction with the cover/inlet conduits (may be referred to as conduit headgear) to provide the user with a convenient method for adjusting the conduit headgear. The mechanism would be located within the conduit headgear, and would use the pressure in the conduit to drive an actuator. The conduit would include a sleeve and an insert. The insert would be elastic only in the radial direction (i.e., inelastic along its axis), and the sleeve would be inelastic in both radial and axial directions. The insert would be allowed to be moved along its axis in the sleeve, this movement limiting the amount of fit possible on the patient interface. To prevent the insert from being completely removed from the sleeve and to provide a seal, the end of the insert would be attached to the inside wall of the sleeve with a very elastic material. In a similar manner, the end of the sleeve would be attached to the outside wall of the insert with a very elastic material.

In addition to preventing the insert being removed from the sleeve and providing a seal, the elastic joiners will provide a return force to slide the insert back into the sleeve. The insert will be free to move when there is no pressure in the conduit, however, when the flow generator is activated and pressure is created in the conduit, the insert will expand and lock against the sleeve in a similar manner as a linear clutch. This locking action will mean that the headgear can no longer be extended or reduced.

The above-described mechanism would remove the need for traditional methods for adjusting headgear (e.g., buckles, Velcro tabs, etc). The user would simply pull the patient interface over their head and the elasticity in the joiners would adjust the headgear to the correct length. Once the flow generator is activated, the headgear would lock and all adjustment will have been completed.

The contact surfaces of the sleeve and insert may need to have a rough finish or other elements to increase resistance to ensure that the mechanism locks. Other methods of ensuring the clutch locks could be a ratchet type lock, pins and holes, etc. The sleeve may also need to be porous (or at least allow air flow) so that the gap between the sleeve and insert has atmospheric pressure (this will create a larger pressure differential between the conduit and gap). This may be required to ensure that the insert expands.

Pockets may be made in the shell for inserts. These inserts may be used to provide structure to the shell, and possibly a custom fit.

The fit of the shell may be adjusted by using a pull chord. The chord may be attached to the end of a semi rigid beam that may bend when the chord is pulled, locking the pulled chord off may force the beam to stay bent and hence adjust the form of the shell.

A web made of a flexible inextensible material may be used to create a skeleton for the shell. The web may be designed in a way that interacts with the headgear area and may not allow any supporting material to move away from the face during treatment. The web may create anchoring points for other shell materials. These anchoring points may provide the reaction forces to create a seal.

As shown in <FIG>, overlapping rigid elements may be used to allow flexing in one plane but prevent it in the opposite plane, e.g., similar to technology used in Adidas finger saver goalkeeping gloves. The overlapping elements would be used in the shell to control flexing, e.g., under the eyes and around the nasal bridge. The elements could be used in a way that creates a rigid section when attached to the face, but when not on the face the shell can still be rolled up. <FIG> shows how the system would work. It is noted that the location of the hinges provides the constraint on what direction flexing is allowable.

By locating the hinge at the other corner of the rigid element, the flex will be constrained in the opposite plane to the one illustrated.

The following illustrates patient interfaces according to alternative embodiments of the present invention. As illustrated, the patient interface may include a nasal cradle that seals under the nose as described above, a nasal cushion that seals around the nose, or nasal prongs that seal around and/or within the patient's nares.

The following illustrates embodiments of patient interfaces including a nasal cradle such as that described above.

<FIG> illustrates a patient interface <NUM> according to another embodiment of the technology.

The patient interface includes a sealing arrangement <NUM> in the form of a nasal cradle, a cover <NUM>, and a T-shaped connector or manifold <NUM>. The patient interface <NUM> is completely soft except for the T-shaped manifold <NUM>.

In an embodiment, the sealing arrangement may include a foam sealing portion provided to a flexible cylindrical support, e.g., such as the support shown in <FIG>. In an embodiment, the support may be formed of a textile.

The cover <NUM> forms conduits that deliver air from the manifold <NUM> to the sealing arrangement <NUM>. The cover <NUM> may be formed of different sections that are contoured or curved to match the contours of the patient's face. The cover <NUM> is inflatable when pressurized to hold its form, and becomes flexible when not pressurized, e.g., drapes similar to a piece of clothing when not pressurized. An elastic strap <NUM>, e.g., lycra, is provided to the cover <NUM> to secure the patient interface on the patient's head. The flexible form of the patient interface enhances decoupling of headgear forces from sealing forces. The flexible form of the patient interface also enhances "cradling" and conformance of the patient interface to facial contours.

The patient interface <NUM> provides a ggood fit range as the anchoring is completely disassociated from the conduit. The patient interface <NUM> is very comfortable and soft when fitted as the forces are very low. The conduit length may be adjustable and squeezed onto the manifold. The patient interface may be fully reversible, e.g., may be put on completely upside down to change tube routing direction.

The following options may be considered in alternative embodiments:
Inserting cuff means that the manifold could be soft non-occluding rubber.

<FIG> illustrate a patient interface <NUM> according to another embodiment of the technology. The patient interface includes a sealing arrangement <NUM> in the form of a nasal cradle, an inlet conduit arrangement <NUM>, headgear, and a cover <NUM>.

In an embodiment, the patient interface may incorporate one or more components from <CIT>. For example, the headgear, inlet conduits, and sealing arrangement in <CIT> may be modified to incorporate a nasal cradle, e.g., formed of foam. Then, the modified assembly may be covered by the cover, e.g., formed of lycra, to provide a softened patient interface with a good balance of unobtrusiveness, functionality, stability, and intuitiveness of form when off the patient's head. <NUM> Third Illustrated Embodiment.

<FIG> illustrates another embodiment of a patient interface <NUM> including a sealing arrangement <NUM> in the form of a nasal cradle, a cover, <NUM>, and inlet conduits defined by or covered by the cover <NUM>. In an embodiment, the inlet conduits may have a D-shaped cross-section, and the cover may be formed of a stretch lycra material. A back strap <NUM> may be provided to secure the patient interface on the patient's head.

The patient interface <NUM> maximizes aesthetic look and demonstrates optimization of sleekness and unobtrusiveness for the intended inlet conduit routing. That is, the patient interface <NUM> provides a smooth, sleek, continuous form under the patient's nose. In an embodiment, the cover may be internally reinforced to maintain form and gently grip the patient's head.

The following options may be considered in alternative embodiments:.

<FIG> illustrate another embodiment of a patient interface <NUM> including a sealing arrangement <NUM> in the form of a nasal cradle. In this embodiment, substantially the entire patient interface is constructed of foam, e.g., foam sealing portion <NUM> and foam cover <NUM> that defines inlet conduits, to provide a softened look and feel. The patient interface is ultra lightweight, and may grip the cheeks so as to not require a back strap.

The texture of the foam looks softer, e.g., compared to shiny materials. Also, the flexibility at front of patient interface allows it to seal without any rotational adjustment.

<FIG> illustrate another embodiment of a patient interface <NUM> including a sealing arrangement <NUM> in the form of a nasal cradle with a foam sealing portion <NUM>. In this embodiment, the foam sealing portion <NUM> is incorporated into an existing nasal assembly such as that disclosed in <CIT>. For example, the nozzles may be removed from the existing assembly, and the remaining base portion may be modified to incorporate the foam sealing portion <NUM>. <FIG> and <FIG> illustrate foam sealing portion <NUM> on base portion <NUM>. The viscoelastic foam interface gently cradles the external nares and provides superior comfort and easy first time seal. Also, the foam seal may require lower headgear tension than the existing nasal assembly with nozzles, and eliminates jetting effect provided by nozzles. Further, the foam is compliant and exhibits a much larger fit range than silicone-type interfaces.

The following illustrates embodiments of patient interfaces including a nasal cushion.

<FIG> illustrates an embodiment of a patient interface <NUM> including a sealing arrangement <NUM> in the form of a nasal cushion. In this embodiment, the entire sealing arrangement is constructed of foam, e.g., foam cushion <NUM> and foam cushion shell <NUM>. The sealing arrangement <NUM> is maintained on the patient's head by headgear <NUM>. In an embodiment, the headgear may also be constructed of foam.

<FIG> illustrates another embodiment of a patient interface <NUM> including a sealing arrangement <NUM> in the form of a nasal cushion. As illustrated, a cover <NUM> is provided to enclose the sealing arrangement and inlet conduits to provide an integrated look. In an embodiment, the nasal cushion and shell may be formed of a fabric material. The patient interface may be adjustable to fit a large range of head sizes, e.g., rear strap slides along covered conduits.

<FIG> and <FIG> illustrate another embodiment of a patient interface <NUM> including a sealing arrangement <NUM> in the form of a nasal cushion. In an embodiment, the nasal seal may be formed of silicone and the shell and conduits may be formed of foam. In another embodiment, the nasal seal, shell, and conduits maybe formed of foam.

The foam conduits make the patient interface fell like one single construction, e.g., garment like. Also, the foam material folds its shape, and the texture and/or matte finish of the material looks wanner, e.g., compared to shiny materials. The patient interface provides an intuitive fit and is lightweight. The patient interface material may be grippy or tactile to hold on the patient's skin. In an embodiment, the patient interface may be formed of one flat dark colour to reduce bulk. Also, the patient interface may be formed of a "Non-medical" color (such as green) to assist in providing the patient interface with a non-medical look.

The following illustrates embodiments of patient interfaces including nasal prongs.

<FIG> and <FIG> illustrate an embodiment of a patient interface <NUM> including a sealing arrangement <NUM> in the form of nasal prongs. In an embodiment, the patient interface <NUM> may be similar to an existing nasal assembly such as that disclosed in <CIT> In contrast, the patient interface <NUM> includes cover portions or socks <NUM>, e.g., formed of lycra, to cover inlet conduits of the patient interface <NUM>.

In an alternative embodiment, the nasal prongs may be supported by a foam or textile shell.

<FIG> and <FIG> illustrate another embodiment of a patient interface <NUM> including a sealing arrangement <NUM> in the form of nasal prongs. In an embodiment, the patient interface <NUM> may be similar to an existing nasal assembly such as that disclosed in <CIT>. In contrast, the patient interface <NUM> includes a cover or sock <NUM>, e.g., one piece sock formed of lycra, to cover the patient interface <NUM>.

The sock <NUM> softens the appearance of the existing assembly, and the assembly is more sleek by encapsulating the inlet tube in the "up" position with the sock <NUM>. That is, the existing assembly looks more architectural, smooth, and streamlined, with no edges or seams. The patient interface <NUM> holds it shape when removed from the patient's head and has a high quality appearance. The sock <NUM> may have one flat dark color to reduce bulk.

Also, the lateral inlet tube position demonstrates excellent tube force decoupling. The existing headgear may be modified to incorporate the sock, e.g., removal of headgear tabs on rear strap removed and rear strap cut and stitched together.

In an alternative embodiment, the nasal prongs may be supported by a foam or textile shell. Also, the inlet tube may have a D-shaped section or squashed shape. The sock <NUM> may provide adjustment, e.g., baseball cap style adjustment. The sock may have a multi tone/texture/color, e.g., <NUM> tone, to slim down profile and bulk.

The following are advantages provided by one or more of the embodiments described above:.

The following options may be considered in alternative embodiments of one or more of the embodiments described above:.

The patient interface described above may be modified to include one or more options that enhance and/or facilitate the treatment session. For example, the patient interface may include sleep enhancing or lifestyle options, e.g., integrated headphones (e.g., with noise cancellation), integrated eye covers, heating/cooling effects, partner version, etc..

Exemplary lifestyle options are disclosed in <CIT>.

Other exemplary lifestyle options are shown in <FIG>.

In each embodiment described below, the inlet conduit arrangement may include tubing, straps, and/or a cover to support the interface on the patient's head and deliver breathable gas to the sealing arrangement.

For example, <FIG> illustrate lifestyle options for a full-face patient interface (e.g., removable/integrated/reconfigurable eye cover or ear piece, different colors (color contrast), patterns, and/or surface texture).

In <FIG>, the sealing arrangement <NUM> of the full-face patient interface <NUM> is adapted to provide a seal with the patient's nose and mouth. As illustrated, the sealing arrangement <NUM> may include two or more different materials (e.g., materials A and B as shown in <FIG>) with different properties (e.g., surface texture, hardness, thickness, etc.) that contact the patient's nose, e.g., to improve seal and/or stability. The inlet conduit arrangement <NUM> of the full-face patient interface <NUM> may also include two or more different materials (e.g., materials C and D as shown in <FIG>), e.g., for aesthetic reasons and/or stability. In addition, an ear piece <NUM> (e.g., audio piece, ear plug) may be provided to the inlet conduit arrangement <NUM> and adapted to engage the patient's ear.

<FIG> is similar to <FIG> (and indicated with similar reference numerals), but without the ear piece <NUM>.

<FIG> is similar to <FIG> (and indicated with similar reference numerals), but without the ear piece <NUM>. Also, in this embodiment, the full-face patient interface of <FIG> includes an eye cover <NUM>. The eye cover <NUM> may be separate from, retro-fit to, or integrated with the sealing arrangement <NUM> and/or inlet conduit arrangement <NUM> of the full-face patient interface <NUM>. As illustrated, the eye cover <NUM> may include a different material than other portions of the interface, e.g., for aesthetic reasons and/or stability. In use, the eye cover <NUM> is structured to stop air getting into the patient's eyes. In an embodiment, the eye cover <NUM> may be provided to the full-face patient interface shown in <FIG>.

<FIG> illustrate lifestyle options for a nasal patient interface (e.g., removable/integrated/reconfigurable eye cover and/or ear piece, chin strap, different colors (color contrast), patterns, and/or surface texture).

In <FIG>, the sealing arrangement <NUM> of the nasal patient interface <NUM> is adapted to provide a seal with the patient's nose. As illustrated, the sealing arrangement <NUM> may include two or more different materials (e.g., materials A and B as shown in <FIG>) with different properties (e.g., surface texture, hardness, thickness, etc.) that contact the patient's nose, e.g., to improve seal and/or stability.

A rear portion of the inlet conduit arrangement <NUM> includes two or more different materials (e.g., materials C and D as shown in <FIG>) with different properties that contact the rear of the patient's head. As illustrated, a strip of material C is provided between upper strap <NUM> and lower strap <NUM> to keep the straps <NUM>, <NUM> apart and improve stability. In addition, the strip of material C is constructed of a suitable material so that it does not crush the patient's hair in use. The strip of material C may include opacity, e.g., for aesthetic reasons.

Also, the nasal patient interface <NUM> includes a chin strap <NUM>. As illustrated, ends <NUM> of the chin strap <NUM> are provided to portions of the inlet conduit arrangement <NUM> that are proximal to the sealing arrangement <NUM>. The chin strap <NUM> may be separate from, retro-fit to, or integrated with the inlet conduit arrangement <NUM>. In use, the chin strap <NUM> is structured to engage under the patients chin (e.g., and close the patient's mouth) and create vectors to improve stability of the nasal patient interface <NUM> on the patient's head.

<FIG> is similar to <FIG> (and indicated with similar reference numerals). In contrast, ends <NUM> of the chin strap <NUM> are provided to portions of the inlet conduit arrangement <NUM> that are distal from the sealing arrangement <NUM>.

<FIG> is similar to <FIG> (and indicated with similar reference numerals), but without the chin strap <NUM>. Also, in this embodiment, the nasal patient interface of <FIG> includes an ear piece <NUM> (e.g., audio piece, ear plug) provided to the inlet conduit arrangement <NUM> and adapted to engage the patient's ear.

<FIG> is similar to <FIG> (and indicated with similar reference numerals), but without the chin strap <NUM>.

<FIG> is similar to <FIG> (and indicated with similar reference numerals), but without the strip of material C between upper strap <NUM> and lower strap <NUM>. In this embodiment, the upper strap <NUM> is constructed of material E having different properties (e.g., surface texture, hardness, thickness, etc.) than material D of lower strap <NUM>, e.g., for aesthetic reasons and/or stability.

<FIG> is similar to <FIG> (and indicated with similar reference numerals). In contrast, ends <NUM> of the chin strap <NUM> are provided to portions of the inlet conduit arrangement <NUM> that are distal from the sealing arrangement <NUM>, e.g., similar to the chin strap shown in <FIG>.

<FIG> is similar to <FIG> (and indicated with similar reference numerals), but without the chin strap <NUM>. Also, in this embodiment, the nasal patient interface of <FIG> includes an eye cover <NUM>, e.g., similar to the eye cover shown in <FIG>.

<FIG> is similar to <FIG> (and indicated with similar reference numerals), but without the chin strap <NUM>. Also, in this embodiment, the upper and lower straps <NUM>, <NUM> are constructed of a similar material E, which have different properties (e.g., surface texture, hardness, thickness, etc.) than material D of side strap <NUM>. For example, materials E and D may be different materials or colors for functional or aesthetic purposes. In an embodiment, material E may be constructed of a material that includes coloring similar to the patient's hair color to blend in with the patient's head, aids stability, rigidity, and/or gripping, is breathable, and/or aids intuitiveness for ease of fitting (e.g., identifies back to front and/or upside-down).

<FIG> illustrate lifestyle options that may or may not be incorporated into patient interfaces (e.g., removable/integrated/reconfigurable eye cover or ear piece, rear strap arrangements).

<FIG> illustrates an interface <NUM> for a bed partner of a patient receiving respiratory therapy. That is, the interface <NUM> is structured to enhance sleep and does not provide breathable gas to the nose and/or mouth of the bed partner. However, it should be appreciated that the interface may be suitably modified to include structure for supplying breathable gas.

In the illustrated embodiment, the interface <NUM> includes a strap arrangement including an upper strap <NUM> that passes over the top of the bed partner's head and a lower strap <NUM> that passes under the bed partner's ears and behind a lower portion of the bed partner's head. An ear piece <NUM> (e.g., audio piece, ear plug) is provided to the strap arrangement and is adapted to engage the bed partner's ear. Also, an eye cover <NUM> is provided to the strap arrangement. As illustrated, the eye cover <NUM> and upper strap <NUM> may include a different material with different properties than that of the lower strap <NUM> and ear piece <NUM>, e.g., for aesthetic reasons and/or stability.

<FIG> is similar to <FIG> (and indicated with similar reference numerals), but without the eye cover <NUM>.

<FIG> illustrates a strap arrangement <NUM> for a patient interface. As illustrated, the strap arrangement includes an upper strap <NUM> that passes over the top of the patient's head and a lower strap <NUM> that passes under the patient's ears and behind a lower portion of the patient's head. An air delivery conduit <NUM> is provided to the upper strap <NUM> at the top of the patient's head. In the illustrated embodiment, the air delivery conduit <NUM> may be coupled to the upper strap <NUM> by a manifold <NUM> adapted to rotate about its longitudinal axis, e.g., transverse to the upper strap <NUM> at the top of the patient's head. The upper strap <NUM> may be constructed of a material having different properties (e.g., surface texture, hardness, thickness, etc.) than a material of the lower strap <NUM>, e.g., for aesthetic reasons and/or stability. Such strap arrangement may enhance patient comfort because no strap extends across the back of patient's head and/or different vectors are provided for stability of seal.

<FIG> illustrates a strap arrangement <NUM> for a patient interface including an upper strap <NUM> that passes over the top of the patient's head and a lower strap <NUM> that passes over the patient's ears and behind the patient's head. An air delivery conduit <NUM> is provided to the upper strap <NUM> at the top of the patient's head, e.g., via a manifold <NUM> similar to that in <FIG>. Also, the upper and lower straps may be constructed of materials having different properties.

<FIG> illustrates a strap arrangement <NUM> for a patient interface including an upper strap <NUM> that passes over the top of the patient's head and a lower strap <NUM> that passes over the patient's ears and behind the patient's head. An air delivery conduit <NUM> is provided to the upper strap <NUM> at the top of the patient's head. In the illustrated embodiment, the air delivery conduit <NUM> may be coupled to the upper strap <NUM> by a manifold <NUM> adapted to rotate about an axis that extends through coronal and transverse planes at the top of the patient's head.

A strip of material C is provided between upper strap <NUM> and lower strap <NUM> to keep the straps <NUM>, <NUM> apart and improve stability. As illustrated, the strip of material C may be constructed of a material having different properties (e.g., surface texture, hardness, thickness, etc.) than a material D of the upper and lower strap <NUM>, <NUM>, e.g., for aesthetic reasons and/or stability.

<FIG> illustrates a strap arrangement <NUM> for a patient interface including an upper strap <NUM> that passes over the top of the patient's head and a lower strap <NUM> that passes under the patient's ears and behind a lower portion of the patient's head. An air delivery conduit <NUM> is provided to the upper strap <NUM> at the top of the patient's head, e.g., via a manifold <NUM> similar to that in <FIG>. Also, a strip of material C extends from the upper strap <NUM>, e.g., for stability.

<FIG> illustrates a strap arrangement <NUM> for a patient interface including an upper strap <NUM> that passes over the top of the patient's head and a lower strap <NUM> that wraps around the patient's ears, i.e., lower strap <NUM> passes behind and under the patient's ears and towards the patient's face. A strip of material <NUM> is provided to the lower strap <NUM> adjacent each ear. As illustrated, the strip of material <NUM> extends across the front of the patient's ear to retain the lower strap <NUM> adjacent the patient's ear.

An air delivery conduit <NUM> is provided to the upper strap <NUM> at the top of the patient's head, e.g., via a manifold <NUM> similar to that in <FIG>. Also, a rear strap <NUM> extends across the back of the patient's head, e.g., for stability. As illustrated, ends of the rear strap <NUM> are provided to a portion of the lower strap <NUM> adjacent each ear.

<FIG> is similar to <FIG> (and indicated with similar reference numerals), but without the rear strap <NUM>. In this embodiment, the strap arrangement only uses the patient's ears to retain.

<FIG> illustrates a strap arrangement <NUM> (e.g., for an interface for a patient and/or bed partner) including an upper strap <NUM> that passes over the top of the patient's head and a lower strap <NUM> that passes under the patient's ears and behind a lower portion of the patient's head. An ear piece <NUM> (e.g., audio piece, ear plug) is provided to the strap arrangement and is adapted to engage the bed partner's ear. The ear piece <NUM> may help to retain the arrangement on the patient's head. Also, the upper and lower straps <NUM>, <NUM> may be constructed of materials having different properties, e.g., for stability and/or aesthetics.

<FIG> illustrate other exemplary lifestyle options or patient interfaces to enhance and/or facilitate the treatment session.

For example, <FIG> illustrate a patient interface <NUM> including a soft shield <NUM> structured to flip up and flip down, e.g., similar to a welder's helmet. A sealing arrangement <NUM>, e.g., nasal prongs, is provided to the shield <NUM> and adapted to provide an effective seal with the patient's nose when the shield <NUM> is flipped down (<FIG>). As shown in <FIG>, the sealing arrangement <NUM> is hidden from view when the shield <NUM> is flipped down. In addition, the shield <NUM> provides an eye mask to enhance and/or facilitate the treatment session as well as sleep. The shield <NUM> may be flipped up (<FIG>) for quick vision.

An inlet conduit arrangement <NUM> is communicated with the sealing arrangement <NUM> and maintains the patient interface in an operative position on the patient's head. An air delivery conduit <NUM> is attached to the inlet conduit arrangement <NUM>, e.g., behind the patient's ear on either side, as shown in <FIG>.

In an embodiment, the shield <NUM> and/or inlet conduit arrangement <NUM> may be constructed of a soft silken quilted fabric with a flexible structure (e.g., TPE) sewn in for rigidity.

<FIG> illustrate another embodiment of a patient interface <NUM> including a sealing arrangement <NUM>, e.g., nasal prongs <NUM>, adapted to provide an effective seal with the patient's nose, an inlet conduit arrangement <NUM> including inlet conduits <NUM> (e.g., each having a generally oval cross-sectional configuration) adapted to deliver breathable gas to the sealing arrangement <NUM>, and a cover <NUM> that substantially encloses the sealing arrangement <NUM> and the inlet conduit arrangement <NUM> (e.g., cover <NUM> structured to expose nasal prongs <NUM> and manifold <NUM> adapted to connect to an air delivery tube <NUM>).

<FIG> illustrates the sealing arrangement <NUM> and inlet conduit arrangement <NUM> removed from the cover <NUM>, <FIG> is an isolated view of the cover <NUM>, <FIG> illustrates the patient interface <NUM> with the conduits <NUM> arranged in the cover <NUM> so that the air delivery tube <NUM> extends from an upper strap of the cover <NUM> at the top of the patient's head in use, and <FIG> illustrates the patient interface <NUM> with the conduits <NUM> arranged in the cover <NUM> so that the air delivery tube <NUM> extends from a bottom strap of the cover <NUM> at the bottom of the patient's head in use.

The patient interface <NUM> provides a smooth, clean, one-piece structure with no "dangling" tubes. The cover <NUM> may include an outer shell <NUM> and an inner lining or insert <NUM>. The outer shell <NUM> may be a relatively hard shell or a textile soft-touch cover, and the inner lining or insert <NUM> may be a relatively soft and padded textile, e.g., for comfort. The cover <NUM> may be stain resistant and/or washable. Also, the cover <NUM> may include a two-tone color scheme (e.g., with a company logo). In addition, the cover <NUM> may provide an extra soft portion <NUM> adjacent the patient's ears, e.g., for comfort.

The cover <NUM> may include one or more adjustors <NUM> that allow the size of a strap of the cover to be adjusted for fit and comfort. As shown in <FIG>, the adjustor <NUM> may be manually squeezed or pressed and then slid along the strap to adjust the length of the strap. This arrangement provides an easy, clean strap adjustment. In addition, the adjustor <NUM> may be relatively flexible or soft, e.g., for comfort.

<FIG> illustrate another embodiment of a patient interface <NUM> including a sealing arrangement <NUM>, e.g., nasal prongs <NUM>, adapted to provide an effective seal with the patient's nose, an inlet conduit arrangement <NUM> including inlet conduits <NUM> adapted to deliver breathable gas to the sealing arrangement <NUM>, and a soft cover <NUM> that substantially encloses the sealing arrangement <NUM> and the inlet conduit arrangement <NUM>.

<FIG> illustrates the patient interface <NUM> positioned on the patient's head, <FIG> illustrate the patient interface <NUM> removed from the patient's head, and <FIG> illustrates the sealing arrangement <NUM> and inlet conduit arrangement <NUM> (e.g., the CPAP assembly) removed from the cover <NUM>. In the illustrated embodiment, the cover <NUM> includes ear pieces <NUM> (e.g., audio pieces, ear plugs, noise reduction) that are adapted to engage the patient's ears and help to maintain the patient interface in an operative position on the patient's head. In an embodiment, at least one of the ear pieces <NUM> may provide a locking mechanism adapted to lock or block the flow of air passing through the adjacent inlet conduit to the sealing arrangement, e.g., so that air flows down only one of the inlet conduits in use.

When the sealing arrangement <NUM> and inlet conduit arrangement <NUM> (e.g., the CPAP assembly) is removed from the cover <NUM>, the cover <NUM> alone may be used as an interface for a bed partner to enhance sleep (e.g., CPAP assembly may be removed leaving the functionality of a partner version). For example, <FIG> illustrates a partner version with the cover <NUM> and an eye mask <NUM> provided to the cover <NUM> (e.g., eye mask clips to cover or attaches via Velcro), and <FIG> illustrates a partner version without an eye mask. <FIG> illustrates a partner version with a filter <NUM> adapted to engage the patient's nose and/or mouth, e.g., partner version that does not provide pressurize air but does provide filtered or clean air.

<FIG> illustrate another embodiment of a patient interface <NUM> including a sealing arrangement <NUM> adapted to provide an effective seal with the patient's nose and an inlet conduit arrangement <NUM> adapted to deliver breathable gas to the sealing arrangement <NUM>. A soft cover may substantially enclose the sealing arrangement <NUM> and the inlet conduit arrangement <NUM>.

As illustrated, the inlet conduit arrangement <NUM> includes inlet conduits <NUM> that pass across the patient's cheeks, wrap behind the patient's ears, and pass over the top of the patient's head. Such conduit arrangement avoids pressure points or sensitive facial regions, e.g., cheek bones. A strip of material <NUM> extends across the front of the patient's ear to retain the interface in an operative position.

The sealing arrangement <NUM> provides an upper portion <NUM>, e.g., constructed of a breathable material, that passes over an upper portion of the nose and a lower portion <NUM> that covers the nose and provides a seal. Such arrangement avoids "medical" image presented by known masks,.

As shown in <FIG>, an adjustor <NUM> may be provided along the conduit. The adjustor <NUM> may be manually squeezed or pressed and then slid along the conduit to adjust the length of the strap.

In an embodiment, the conduits <NUM> may constructed of ultra thin tubing to provide a streamlines interface. Such arrangement improves aesthetics, which results in improved compliance by the patient.

<FIG> illustrates the patient interface <NUM> with an eye mask or visor attachment <NUM>, and <FIG> illustrates the patient interface <NUM> with ear pieces <NUM> (e.g., audio pieces or headphones, ear plugs).

<FIG> and <FIG> illustrate another embodiment of a patient interface <NUM> that provides two products in one (e.g., with no "add ons"). Specifically, the patient interface <NUM> may be in the form of a nasal interface or nasal mask adapted to provide pressurized air to the patient's nose (e.g., see <FIG> and <FIG>), or the patient interface <NUM> may be in the form of an eye mask (e.g., see <FIG>), e.g., nasal mask converted to eye mask by removing the nasal prong arrangement <NUM> provided within the interface cover <NUM>. <FIG> illustrates the patient interface <NUM> removed from the patient's head.

In each configuration, the patient interface <NUM> provides ear pieces <NUM> or ear-located headgear that is adapted to engage the patient's ear and retain the interface on the patient's head. In an embodiment, such ear pieces may also provide audio, ear plug, etc. Also, portions of the patient interface (e.g., portions adjacent the patient's eyes in use) may provide moisturizing aspects in use.

<FIG> illustrate another embodiment of a patient interface <NUM> that provides a multi-function head band or retention system <NUM>. Specifically, the multi-function retention system <NUM> is structured to support a selected one of multiple modular interfaces or sleep enhancing features so that the patient interface can assume one of multiple configurations.

As illustrated, the retention system <NUM> includes a front strap <NUM> that passes over the patient's nose, side straps <NUM> that pass along respective sides of the patient's face, and a top strap <NUM> that passes over the top of the patient's head.

<FIG> illustrates a nasal mask or interface <NUM> provided to the retention system <NUM>, <FIG> illustrates an eye mask or visor <NUM> provided to the retention system <NUM> with the nasal mask removed, and <FIG> illustrates a full-face mask or interface <NUM> provided to the retention system <NUM> (e.g., full-face mask <NUM> may provide aromatic scents, a filter, and/or moisturizing aspects). However, it should be appreciated that the retention system <NUM> may support other modular interfaces (e.g., pillows, prongs, nasal cradle) or sleep enhancing features (e.g., ear pieces).

<FIG> illustrates another embodiment of a patient interface <NUM> including a sealing arrangement <NUM> supported by lower side straps <NUM>, upper side straps <NUM>, and a vertical strap <NUM> that connects the upper and lower side straps <NUM>, <NUM>.

The upper, lower, and vertical straps <NUM>, <NUM>, <NUM> may be a one piece integrated structure, e.g., formed of textile. In use, the vertical strap <NUM> provides a vertical vector, e.g., to aid stability and sealing. The patient interface <NUM> provides a sleek, close to face, out of line of sight, and hence unobtrusive interface.

<FIG> illustrate a patient interface similar to that shown in <FIG> and <FIG> (and indicated with similar reference numerals). As illustrated, the patient interface <NUM> provides a simple, one-wrap band design that uses the patient's ears to provide vertical retention. <FIG> provides a view of the air delivery tube <NUM> and the sealing arrangement <NUM>.

<FIG> illustrates another embodiment of a patient interface <NUM> including an inlet tube <NUM> that provides a seal or interface with the patient's nose and wraps around an upper portion of the patient's neck, and a single thin strap <NUM> that extends from the inlet tube <NUM> and passes over the top of the patient's head to secure the inlet tube <NUM> on the patient's head. The inlet tube <NUM> itself also forms a strap to secure the interface in position. In an embodiment, the inlet tube <NUM> may be constructed of a relatively soft textile material that is adapted to flatten for comfort, e.g., like a fire hose, so that the patient may lie on one side of the tube while the other side provides a sufficient supply of gas.

<FIG> illustrates another embodiment of a patient interface <NUM> including a flexible adjustable support <NUM> provided to one of the inlet tubes <NUM> thereof. As illustrated, the flexible adjustable support <NUM> includes first and second arms <NUM>(<NUM>), <NUM>(<NUM>) with first and second soft pads <NUM>(<NUM>), <NUM>(<NUM>) at respective distal ends. The first arm <NUM>(<NUM>) is arranged so that the first pad <NUM>(<NUM>) engages the patient's forehead, and the second arm <NUM>(<NUM>) is arranged so that the second pad <NUM>(<NUM>) engages the patient's cheek. However, other suitable pad arrangements are possible.

<FIG> illustrates a single-sided patient interface <NUM> in which side straps and head/neck pads <NUM> are provided to one side of the patient's head.

<FIG> illustrates another embodiment of a patient interface <NUM> which incorporates a sleeping mask <NUM> as well as a sealing arrangement <NUM> adapted to provide a seal with the patient's nose. An inlet opening <NUM> is provided to a rear portion of the interface and allows air to enter the interface and travel along a hidden tube in the interface to the sealing arrangement <NUM>.

<FIG> illustrates another embodiment of a patient interface <NUM> that is incorporated into a pillow <NUM>, e.g., soft fabric pillow. As illustrated, the patient interface <NUM> includes an elongated arm <NUM> that is suitably contoured or bent so that the arm <NUM> is adapted to wrap around one side of the patient's face as the patient lies on the pillow <NUM>. The distal end of the arm <NUM> supports a sealing arrangement, e.g., nasal interface, and an inlet tube is hidden within the arm. The arm <NUM> may be spring biased so that it fits tightly around the patient's face and effects a seal.

The proximal end of the arm <NUM> is provided to the pillow <NUM> and adapted to communicate with an air delivery tube. In an embodiment, the pillow <NUM> may include an inlet opening <NUM> that allows the inlet tube to communicate with an external air delivery tube. In another embodiment, the air delivery tube, air pump, and optional filter may be may be housed within the pillow <NUM>.

<FIG> illustrates another embodiment of a patient interface <NUM> which includes a soft, floppy hood or headwear <NUM> that extends over the top of the patient's head. The hood <NUM> encloses or hides the strap arrangements or tubing of the interface. As illustrated, the air delivery conduit <NUM> protrudes from a floppy, rear portion of the hood <NUM>.

<FIG> illustrate a patient interface <NUM> including a hood <NUM> that can be pulled over the top of the patient's head as well as a nose/mouth cover <NUM> that can be pulled over the patient's nose and mouth. The hood <NUM> and nose/mouth cover <NUM> encloses or hides the strap arrangement, tubing, and seal arrangement of the interface so no tubing or "hard" parts are visible on the patient's head.

<FIG> illustrates another embodiment of a patient interface <NUM> including a sealing arrangement <NUM>, e.g., over the nose seal or interface, adapted to provide an effective seal with the patient's nose, inlet conduits <NUM> adapted to deliver breathable gas to the sealing arrangement <NUM>, and an elastic strap <NUM> that passes over the patient's head to help maintain the patient interface in an operative position. The patient interface <NUM> also includes ear pieces <NUM> (e.g., audio pieces, ear plugs, noise reduction) that are adapted to engage the patient's ears and help to maintain the patient interface in an operative position on the patient's head. In an embodiment, the inlet conduits <NUM> may be constructed of a clear material, e.g., to blend into the patient's face.

<FIG> illustrate another embodiment of a patient interface <NUM> including a sealing arrangement <NUM> adapted to provide an effective seal with the patient's nose, inlet conduits <NUM> adapted to deliver breathable gas to the sealing arrangement <NUM>, and an upper strap <NUM> that passes over the patient's head and an intermediate strap <NUM> (extending between the upper strap <NUM> and the conduit <NUM>) to help maintain the patient interface in an operative position. As shown in <FIG>, the sealing arrangement <NUM> is in the form of an under the nose seal or interface (e.g., nasal inserts <NUM>) that provide less visual bulk of the interface and surrounding mask architecture.

<FIG> illustrates an embodiment of a patient interface <NUM> wherein the sealing arrangement <NUM> and inlet conduit arrangement <NUM> (e.g., the CPAP assembly) are removably coupled to the cover <NUM>.

<FIG> illustrates another embodiment of a patient interface <NUM> including a sealing arrangement <NUM>, e.g., over the nose seal or interface, adapted to provide an effective seal with the patient's nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes a forehead strap <NUM> that extends across the patient's forehead and side straps <NUM> that extend along the patient's cheeks and up towards the forehead strap <NUM> at the top of the patient's ears. Also, an optional linking strap <NUM> may extend between the forehead strap <NUM> and an upper portion of the sealing arrangement <NUM>. In an embodiment, the straps <NUM>, <NUM>, <NUM> may include multi-plane rigidizers, e.g., formed from a rigid, thermo-formed structure.

<FIG> illustrates a patient interface <NUM> with eye glasses or an eye cover <NUM>, and <FIG> illustrates the patient interface <NUM> with eye glasses or an eye cover <NUM> along with a chin strap <NUM>.

<FIG> illustrates another embodiment of a patient interface <NUM> including a sealing arrangement <NUM>, e.g., over the nose seal or interface, adapted to provide an effective seal with the patient's nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes a forehead strap <NUM> that extends across the patient's forehead and side straps <NUM> that extend along the patient's cheeks and under the patient's ears. Also, a linking strap <NUM> may extend between the forehead strap <NUM> and an upper portion of the sealing arrangement <NUM>.

<FIG> illustrates another embodiment of a patient interface <NUM> including a sealing arrangement <NUM>, e.g., over the mouth and nose seal or full-face interface, adapted to provide an effective seal with the patient's mouth and nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes a forehead strap <NUM> that extends across the patient's forehead and a linking strap <NUM> that extends between the forehead strap <NUM> and an upper portion of the sealing arrangement <NUM>.

<FIG> illustrate embodiments of patient interfaces having a "ski-mask" type structure adapted to wrap closely around the patient's eyes and nose. As shown in <FIG>, the patient interface <NUM> includes a sealing arrangement <NUM>, e.g., under the nose seal or interface, adapted to provide an effective seal with the patient's nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes an upper strap <NUM> that extends across a lower portion of the patient's forehead (e.g., just above the patient's eyebrows) and side straps <NUM> that extend along an upper portion of the patient's cheeks and up towards the forehead strap <NUM> at the top of the patient's ears. <FIG> illustrates the patient interface <NUM> with prescription eye glasses or an eye cover <NUM> (e.g., for sleeping) attached thereto, e.g., clip-in eye glasses or eye cover.

In <FIG>, the patient interface <NUM> includes a sealing arrangement <NUM>, e.g., over the nose seal or interface, adapted to provide an effective seal with the patient's nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes an upper strap <NUM> that extends across a lower portion of the patient's forehead (e.g., just above the patient's eyebrows) and side straps <NUM> that extend along an upper portion of the patient's cheeks and up towards the forehead strap <NUM> at the top of the patient's ears. As illustrated, a logo <NUM>, e.g., company logo, may be provided to a side of the interface. <FIG> illustrates the patient interface <NUM> with a linking strap <NUM> extending between the forehead strap <NUM> and an upper portion of the sealing arrangement <NUM>. Such linking strap <NUM> provides vertical vectors for seal retention. In an embodiment, eye glasses or an eye cover may be attached to the interface, e.g., similar to <FIG>.

<FIG> illustrates a patient interface <NUM> with a similar structure to that shown in <FIG>. In contrast, the patient interface <NUM> of <FIG> may provide additional lining <NUM> along the side straps.

<FIG> illustrates a patient interface <NUM> including a sealing arrangement <NUM>, e.g., over the nose seal or interface, adapted to provide an effective seal with the patient's nose, and a stabilizing arrangement to maintain the interface in a stable and secure position on the patient's head. The stabilizing arrangement includes a cap portion <NUM> that conforms to the top of the patient's head, side straps <NUM> that wrap around the patient's eyes to the sealing arrangement <NUM>, and a linking strap <NUM> extending between the cap portion <NUM> and an upper portion of the sealing arrangement <NUM>.

<FIG> illustrates a patient interface <NUM> with a less obtrusive configuration, e.g., compared to <FIG>. As illustrated, the patient interface <NUM> includes a sealing arrangement <NUM>, e.g., under the nose seal or interface, adapted to provide an effective seal with the patient's nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes an upper strap <NUM> that extends upwardly from the sealing arrangement <NUM> and over the top of the patient's head, and side straps <NUM> that extend along the patient's cheeks towards the patient's ears. In this embodiment, the end of the side straps <NUM> are adapted to wrap around the patient's ears, e.g., like sunglasses frames.

<FIG> illustrates a patient interface <NUM> including a sealing arrangement <NUM>, e.g., over the nose seal or interface, adapted to provide an effective seal with the patient's nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes an upper strap <NUM> that extends across the patient's forehead and over the top of the patient's head, side straps <NUM> that extend along the patient's cheeks towards the patient's ears, and a linking strap <NUM> that extends between the upper strap <NUM> and an upper portion of the sealing arrangement <NUM>. In this embodiment, the end of the side straps <NUM> are adapted to wrap around the patient's ears, e.g., like sunglasses frames. Also, the linking strap <NUM> fits intimately to the patient's skin and provides a low profile so that the patient cannot see the interface in the field of view.

<FIG> illustrates a patient interface <NUM> including a sealing arrangement <NUM>, e.g., over the mouth and nose seal or full-face interface, adapted to provide an effective seal with the patient's mouth and nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes a forehead strap <NUM> that extends across the patient's forehead, and side straps <NUM> that extend along the patient's cheeks towards the patient's ears. As illustrated, the interface wraps around the patient's chin to provide chin support. Also, a nose piece <NUM> is provided to the sealing arrangement and adapted to pinch the patient's nose. A cooling system <NUM> (e.g., fan device, cool pack, phase change material) may be provided to a side of the interface for cooling the patient's face in use.

The patient interface <NUM> may be structured such that adaptable or retrofitable accessories may be attached to the interface. For example, <FIG> illustrates an eye mask <NUM> that may be attached to the interface (e.g., eye mask clips onto interface with magnets), and a pad <NUM> that may be attached to a lower portion of the interface. Such pad <NUM> may be structured to improve comfort and may include moisturizers and/or aromas (e.g., dry powder, scents, cleansers, etc.).

<FIG> illustrates another embodiment of a patient interface <NUM> including a sealing arrangement <NUM>, e.g., over the nose seal or interface, adapted to provide an effective seal with the patient's nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes side straps <NUM> that extend along the patient's cheeks towards the patient's ears, and an upper strap <NUM> that passes over the patient's head. In an embodiment, the side straps <NUM> and sealing arrangement <NUM> may be constructed of a clear material, e.g., to provide an "invisible" mask that blends into the patient's face. However, the sealing arrangement <NUM> may be constructed of a material having white coloring, e.g., to hide steam. Also, a logo <NUM>, e.g., company logo, may be provided to a side strap of the interface.

<FIG> illustrates another embodiment of a patient interface <NUM> including a sealing arrangement <NUM>, e.g., over the mouth and nose seal or full-face interface, adapted to provide an effective seal with the patient's mouth and nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes a rear cap portion <NUM> that conforms to a rear portion of the patient's head and side straps <NUM> that extend along the patient's cheeks. In addition, the strap arrangement includes a cooling system or cooling cover <NUM> that wraps around the patient's chin, jaw, and neck. The cooling system or cooling cover <NUM> provides support for the interface and includes climate control attributes, e.g., phase change materials that provide a cooling effect in the summer and a warming effect in the winter.

<FIG> illustrates another embodiment of a patient interface <NUM> including a sealing arrangement <NUM>, e.g., over the nose seal or interface, adapted to provide an effective seal with the patient's nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes a forehead strap <NUM> that extends across the patient's forehead and side straps <NUM> that extend along the patient's cheeks and under the patient's ears. Also, a linking strap <NUM> extends between the forehead strap <NUM> and an upper portion of the sealing arrangement <NUM>.

<FIG> illustrates another embodiment of a patient interface <NUM> including a sealing arrangement <NUM>, e.g., over the mouth and nose seal or full-face interface, adapted to provide an effective seal with the patient's mouth and nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes side straps <NUM> that extend over the patient's ears, and an upper strap <NUM> that passes over a rear portion of the patient's head. As illustrated, the sealing arrangement <NUM> wraps around the front of the patient's face, e.g., over the patient's nose, mouth, chin, and cheeks.

<FIG> illustrates another embodiment of a patient interface <NUM> including a sealing arrangement <NUM>, e.g., over the nose seal or interface, adapted to provide an effective seal with the patient's nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes side straps <NUM> that extend around the patient's ears (e.g., opening provided in strap to receive respective ear), and an upper strap <NUM> that passes over a rear portion of the patient's head. As illustrated, the sealing arrangement and strap arrangement may formed as a one-piece, semi-rigid structure that is adapted to clip onto the patient's face and head, e.g., like headphones.

<FIG> illustrate a patient interface <NUM>, e.g., adapted to provide an under the nose seal or interface, and a pillow accessory <NUM> provided to the patient interface <NUM>. In an embodiment, the pillow accessory <NUM> may be an inflatable air pillow or plenum. As illustrated, the pillow accessory <NUM> is structured to wrap around the patient's neck to support the interface on the patient's head as well as support the patient's head or neck, e.g., during a plane trip.

<FIG> illustrates a patient interface <NUM>, e.g., adapted to provide an under the nose seal or interface, and a head covering or balaclava <NUM> provided to the patient interface <NUM>. The head covering or balaclava <NUM> provides a close-fitting covering for the patient's head and neck, e.g., for warmth, that leaves only the patient's eyes exposed. <FIG> illustrates the patient interface <NUM> with the head covering or balaclava <NUM> removed.

<FIG> illustrates another embodiment of a patient interface <NUM> including a sealing arrangement <NUM>, e.g., over the nose seal or interface, adapted to provide an effective seal with the patient's nose, and a strap arrangement to maintain the sealing arrangement <NUM> in an operative position. The strap arrangement includes side straps <NUM> that extend over the patient's ears, and a rear cap portion <NUM> that covers a rear portion of the patient's head. As illustrated, the rear cap portion <NUM> may provide a cooling system or cooling cover that includes climate control attributes, e.g., phase change materials.

<FIG> illustrates the patient interface <NUM> with an additional upper cap portion <NUM> that covers an upper portion of the patient's head. The upper cap portion <NUM> may provide a cooling system or cooling cover that includes climate control attributes, e.g., phase change materials.

<FIG> illustrates the patient interface <NUM> enclosed by a head cover <NUM> that covers the patient's head and leaves only the patient's eyes exposed. The cover <NUM> provides stability, e.g., like a helmet, while it wraps around the patient's skull and provides an intimate fit. A nose piece <NUM> may be provided to the cover <NUM> and adapted to pinch the patient's nose. In an embodiment, the cover <NUM> may be removed to allow ventilation, without affecting stability.

<FIG> illustrates the interface <NUM> and head cover <NUM> of <FIG> with additional accessories, such as an eye shade <NUM>, ear pieces <NUM> (e.g., for music), and a lower cover <NUM> for the patient's mouth and chin.

<FIG> illustrates another embodiment of a patient interface <NUM> including a relatively loose hood <NUM> that can be pulled over the top of the patient's head, e.g., for warmth. The hood <NUM> hides and supports tubing <NUM> (e.g., without providing marks on the patient's face) that delivers breathable air to nasal prongs or inserts <NUM>, e.g., foam nasal prongs adapted to provide an interference fit inside the patient's nose. As illustrated, the tubing <NUM> extends from respective sides of the hood <NUM>.

<FIG> illustrates the patient interface <NUM> with the tubing <NUM> extending from a lower edge of the hood <NUM>.

<FIG> illustrates the patient interface <NUM> with the hood <NUM> having a more tight or conforming fit to the patient's head. For example, the hood <NUM> may be provided with cinching straps to tighten the hood on the patient's head.

<FIG> illustrates a patient interface <NUM> including a hood <NUM> that provides a close-fitting covering for the patient's head and neck that leaves only the patient's eyes exposed.

<FIG> illustrates a hood <NUM> that may be retrofit to a patient interface <NUM>, e.g., adapted to provide an over the mouth and nose seal or full-face interface.

<FIG> illustrates another embodiment of a patient interface <NUM> including ear pieces <NUM> adapted to engage the patient's ears, and tubes <NUM> extending from respective ear pieces <NUM> and adapted to deliver breathable air to nasal prongs or inserts <NUM>. The tubes <NUM> are structured to wind-up into respective ear pieces <NUM> to provide personalized fitting (e.g., length of tubes can be selectively adjusted) and storage (e.g., tubes can be completely wound up into respective ear pieces <NUM>).

<FIG> illustrate another embodiment of a patient interface <NUM> including ear pieces <NUM> adapted to engage the patient's ears, and tubes <NUM> extending from respective ear pieces <NUM> and adapted to deliver breathable air to nasal prongs or inserts <NUM>. As illustrated, the tubes <NUM> are relatively long so that they hang downwardly from the patient's face without providing marks on the patient's face. In addition, the patient's face is more open as the interface provides minimal coverage. As shown in <FIG>, the ear pieces <NUM> are coupled to one another to provide a back-of-head clip, e.g., headphone attachment. Also, the nasal prongs or inserts <NUM> may be coupled to one another, e.g., by a connector <NUM> as shown in <FIG>.

<FIG> illustrates another embodiment of a patient interface <NUM> including a single ear piece <NUM> adapted to engage one of the patient's ears, and a single tube <NUM> extending from the ear piece <NUM> and adapted to deliver breathable air to a sealing arrangement, e.g., under the nose seal or interface <NUM>. This arrangement provides a single tube interface with minimal coverage on the patient's face.

<FIG> illustrates another embodiment of a patient interface <NUM> including ear pieces <NUM> adapted to engage the patient's ears, and tubes <NUM> extending from respective ear pieces <NUM> and adapted to deliver breathable air to a sealing arrangement, e.g., over the nose seal or interface <NUM>. As illustrated, the tubes <NUM> are relatively long or loose so that they hang downwardly from the patient's face without providing marks on the patient's face. In addition, the patient's face is free of pressure points. In an embodiment, an adhesive seal <NUM> may be provided to the sealing arrangement to enhance the seal around the patient's nose.

<FIG> illustrates another embodiment of a patient interface <NUM> including a head band or forehead strap <NUM> that extends across the patient's forehead and tubes <NUM> extending from the forehead strap <NUM> and adapted to deliver breathable air to nasal prongs or inserts <NUM>. In an embodiment, nasal prongs or inserts <NUM> may be snap-fit to respective tubes <NUM>, e.g., to facilitate replacement or cleaning.

<FIG> illustrates another embodiment of a patient interface <NUM> including neck mounted tubing. As illustrated, the patient interface <NUM> includes an annular neck tube <NUM> adapted to wrap around the patient's neck and inlet tubing <NUM> that extends upwardly from the neck tube <NUM> and adapted to deliver breathable air to the sealing arrangement, e.g., under the nose seal or interface <NUM>.

While the technology has been described in connection with what are presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications included within the scope of the appended claims. Also, the various embodiments described above may be implemented in conjunction with other embodiments, e.g., aspects of one embodiment may be combined with aspects of another embodiment to realize yet other embodiments. Further, each independent feature or component of any given assembly may constitute an additional embodiment. In addition, while the invention has particular application to patients who suffer from OSA, it is to be appreciated that patients who suffer from other illnesses (e.g., congestive heart failure, diabetes, morbid obesity, stroke, barriatric surgery, etc.) can derive benefit from the above teachings. Moreover, the above teachings have applicability with patients and non-patients alike in non-medical applications.

Claim 1:
A patient interface (<NUM>) comprising:
a sealing arrangement (<NUM>) adapted to provide an effective seal with the patient's nose; and
an inlet conduit arrangement (<NUM>) extending from the sealing arrangement to the crown of the patient's head and adapted to deliver breathable gas to the sealing arrangement,
characterised in that
the inlet conduit arrangement extending from the sealing arrangement to the crown of the patient's head at least in part defines a truncated elliptical cone.