Patent Description:
It is well known to deliver aerosolized medicaments to a patient via various devices, including nebulizers and aerosol dispensing devices, such as pressurized Metered Dose Inhalers (PMDI's), in order to treat various conditions and diseases, including but not limited to various respiratory conditions and diseases such as asthma. In some embodiments, the patient interface is configured as a mask, which typically is fitted around the nose and mouth of the user so as to maximize and ensure inhalation of the aerosolized medicament into the lungs of the user. Such masks, however, may not ensure treatment of the upper respiratory airways. Treating only the lower respiratory airways may not be sufficient to treat the entirety of the symptoms, for example diseases residing in the upper respiratory airways. In addition, such masks may have a relatively large dead space. Document <CIT> relates to a respirator having separated chambers to surround the nose and mouth of the wearer respectively, inlet means permitting entry of air into the chamber surrounding the nose, outlet means permitting exit of air from the chamber surrounding the mouth, and a non-return valve permitting air to pass from the chamber surrounding the nose into that surrounding the mouth. Document <CIT> relates to a breathing mask covering the mouth and the nose of invalid, comprising a chamber for the mouth and a chamber for the nose, said chambers being rigidly connected and separated from each other by an air-tight partition in the nose-part of the mask, and means for adjusting the width of said opening. Document <CIT> relates to a nasal ventilation mask having one or more attachment ports located adjacent to and overlying an upper lip of a patient when worn. Document <CIT> relates to a ventilation system including a flow generator that can be connected to a gas supply tube. The gas supply tube is in fluid communication with a ventilation interface. At least a portion of the gas supply tube has a divider within the channel of the tube forming a nasal passageway and an oral passageway. A nasal breathing chamber and an oral breathing chamber are defined in the ventilation interface. The nasal breathing chamber is in fluid communication with the nasal passageway, and the oral breathing chamber is in fluid communication with the oral passageway. Document <CIT> relates to a surgical mask for administering and/or scavenging medical gases including a nasal mask and an oral mask that envelops the nasal mask. The nasal mask is secured to the oral mask and may be removable from it. Document <CIT> relates to a face mask including a body having a peripheral edge for placement against the face of a wearer. The peripheral edge defines a single chamber over the nose and the mouth of the wearer. An inlet opening is formed on a surface of the body for supplying inhalation gas to the nose through the chamber. A vent assembly inwardly extends from the surface of the body to the chamber and seals around the mouth for passing exhalation gas to the exterior of the body.

The above drawback is solved by a mask according to claim <NUM>.

The various aspects and embodiments provide significant advantages over other masks. For example and without limitation, the mask and assembly provide for treating both the upper and lower respiratory airways. Moreover, drug delivery at the nasal cavity allows for larger aerosol droplets to be deposited first, with finer/smaller aerosol droplets being deposited downstream in the lungs, thereby treating both target areas at the same time.

In addition, the mask minimizes the dead space within the mask while achieving a good seal around the nose and face and accommodating most typical nose sizes. The ability to introduce a therapeutic substance, such as a nasal aromatic decongestant, further enhances the treatment process by enhancing the user's smell sensation and delivering a decongestant, thereby providing better drug delivery, providing decongestion, and improving the overall user satisfaction. Moreover, in one embodiment, the therapeutic substance may be administered first, thereby opening up the airways prior to administering the drug/medicament.

The present embodiments of the invention, together with further objects and advantages, will be best understood by reference to the following detailed description taken in conjunction with the accompanying drawings.

It should be understood that the term "plurality," as used herein, means two or more. The term "coupled" means connected to or engaged with, whether directly or indirectly, for example with an intervening member, and does not require the engagement to be fixed or permanent, although it may be fixed or permanent. It should be understood that the use of numerical terms "first," "second," "third," etc., as used herein does not refer to any particular sequence or order of components; for example "first" and "second" cavities may refer to any sequence of such features, and is not limited to the first and second cavities of a particular configuration unless otherwise specified. It should be understood that the terms "input end," "output end" and "inlet" refer to the function of those features during an inhalation phase, and that the inlet may serve the opposite function (removal or exit) during an exhalation phase. The phrase "fluid communication" refers to the ability of a fluid, whether a gas or liquid, to flow or pass from one component or feature to another component or feature, including intermittently, for example when a valve is open to permit such flow. The phrase "ambient environment" is the environment or atmosphere, e.g. air, surrounding the component or feature, including for example the mask. As used herein, the term "upstream" refers to the direction from which a flow of gas is originating while the term "downstream" refers to the direction toward which the flow is traveling, for example during inhalation, air flows from an upstream medicament delivery device to a downstream user.

Referring to <FIG> and <FIG>and <FIG>, various medicament delivery assemblies <NUM> are shown as including a medicament delivery device, configured for example as a holding chamber <NUM> in one embodiment. The medicament delivery device may alternatively be configured as a nebulizer <NUM> as schematically illustrated in <FIG>. The holding chamber may have various antistatic properties. The holding chamber has an input end <NUM> configured to mate with a delivery device <NUM>, such as a pressurized metered dose inhaler. The holding chamber further includes an output end <NUM> configured with a baffle <NUM> and a one-way inhalation valve <NUM> in one embodiment. The output end <NUM> may further include an annular flange <NUM> or tube, configured as a mouthpiece in one embodiment, which is shaped to engage and support a user interface. The holding chamber may be configured with a visual indicator <NUM> that provides visual indicia when the user is exhaling and/or inhaling. Various suitable holding chambers are disclosed in <CIT>, <CIT>, <CIT>. The holding chamber may further include an input end that is suitable for connection to a ventilator circuit or other oxygen supply. Such holding chambers are further described and disclosed in <CIT> and <CIT>.

As shown in <FIG>, the user interface <NUM> is configured as a mask <NUM>, <NUM>, <NUM>. In one embodiment according to the invention, shown in <FIG>, the mask <NUM> has a body configured with an outer shell <NUM> having an interior surface <NUM> defining a cavity <NUM> and an exterior surface <NUM> exposed to an ambient environment. The body defines an opening <NUM> shaped to receive the face <NUM> of a user. In the embodiment of <FIG>, the opening has a tear-drop shape, with a curvilinear bottom edge <NUM> and curvilinear side edges <NUM> extending upwardly from the bottom edge and meeting at a narrowed apex <NUM>. The shell has a corresponding wall defining the cavity, including a bottom wall portion <NUM> that transitions into opposite curved side wall portions <NUM> and an upper curved wall portion <NUM> defining the apex.

A barrier <NUM> has an upwardly extending vertical portion <NUM> that extends upwardly from bottom wall portion <NUM> and spans between the opposite side wall portions <NUM>, and a forwardly extending horizontal portion <NUM> spanning between the opposite side wall portions <NUM> and terminating at a user interface edge <NUM> positioned adjacent a plane <NUM> defined by the bottom and side edges. The interface edge <NUM> is positioned to engage, or be disposed adjacent to, a user's upper lip <NUM> as shown in <FIG> and <FIG>. The barrier <NUM> separates the cavity <NUM> into an upper nasal cavity <NUM> and a lower oral cavity <NUM>, with the barrier precluding fluid communication therebetween, except as may transpire between the edge <NUM> and the upper lip <NUM>. The barrier <NUM> thereby helps minimize the dead space in the upper nasal cavity <NUM>.

Referring to <FIG>, the mask <NUM>, <NUM> is configured as a nasal mask (not claimed as such) having a body configured with a shell <NUM>, <NUM> having an interior surface <NUM>, <NUM> defining a cavity <NUM>, <NUM> and an exterior surface <NUM>, <NUM> exposed to the ambient environment. The cavity is relative small and minimizes the dead space associated with the mask. The body defines an opening <NUM>, <NUM> shaped to receive the nose <NUM> of a user. The opening has a generally triangular shape, with a curvilinear bottom edge <NUM>, <NUM> joined to curvilinear side edges <NUM>, <NUM> at corners <NUM>, <NUM> and extending upwardly from the bottom edge and meeting at an apex <NUM>, <NUM>. The shell has a corresponding wall defining the cavity, including a bottom wall portion <NUM>, <NUM> defining the cavity that transitions into opposite curved side wall portions <NUM>, <NUM>. The user's nose <NUM> fits in the opening <NUM>, <NUM>, with the nostrils <NUM> extending past the bottom edge <NUM>, <NUM> into the cavity <NUM>, <NUM> formed in the mask. The apex <NUM>, <NUM> fits over the top of the patient's nose. As shown in <FIG>, in one example, the distance D1 between the top and bottom of the mask is between and including <NUM> to <NUM>, while the distance D2 between the bottom comers <NUM>, <NUM> of the mask is also between and including <NUM> to <NUM>, meaning the mask has an perimeter with a generally equilateral triangular shape, albeit with a curved sides, bottom, corners and apex.

In the example of <FIG>, the opening <NUM> has forwardly facing upper portion <NUM>, and a downwardly and forwardly facing lower portion <NUM>. In this example, the bottom edge <NUM> extends rearwardly from the side edges <NUM>. The upper portion <NUM>, and the side edges thereof, define a face or plane that is angled slightly relative to a vertical plane, for example at <NUM> degrees, with the longitudinal axis of the holding chamber defining a horizontal axis. The lower portion <NUM>, and the bottom edge thereof, define a second plane that is angled relative to the vertical plane, for example at <NUM> degrees, such that the planes defined by the upper and lower portions <NUM>, <NUM> define an angle therebetween of <NUM> degrees. In other embodiments, the upper portion may define a vertical plane, or be angled forwardly from the vertical plane, or angled rearwardly at other angles for example between <NUM> and <NUM> degrees. The second plane of the lower portion may also be angled at other angles relative to the vertical plane, for example between <NUM> and <NUM> degrees. The bottom edge <NUM> engages an upper lip of the user, or the portion of the user's face between the mouth and the nose. The side edges <NUM> may be angled relative to a centerline axis at an angle a, which may be between <NUM> and <NUM> degrees, and more preferably between <NUM> and <NUM> degrees, as shown in <FIG>. As noted, the shape of the mask minimizes the dead space volume inside the mask, while also providing a periphery that comfortably mates with the face of the user.

In all embodiments or examples of <FIG>, the mask <NUM>, <NUM>, <NUM> includes an annular mounting flange/tubular mounting portion, or tube <NUM>, <NUM>, shaped and configured to receive the end portion <NUM> of the holding chamber or other substance delivery device, whether by being inserted in the end portion <NUM> or by surrounding the end portion <NUM>. For example, the tube may <NUM> have an obround or elliptical cross section, or the tube may be cylindrical with a circular cross section. The tube <NUM>, <NUM> defines a flow channel between the holding chamber and cavity <NUM> through which an inhalable substance, such as an aerosolized medicament, may flow. The tube <NUM>, <NUM> defines an inlet <NUM>, <NUM> to the cavity <NUM>, <NUM>, with inlet <NUM> being in fluid communication with only the upper nasal cavity <NUM> of the mask <NUM>, or with the cavity <NUM>, <NUM> of nasal mask <NUM>, <NUM>. An annular flange <NUM> extends radially outwardly from the tube <NUM>, and may define a stop member in one example as explained in more detail below. The edge portions of the mask are configured with a flexible sealing edge <NUM>, formed by an inwardly curved lip of the mask, which mates with the chin, cheeks and nose of the user in the embodiment of <FIG>, or with the upper lip and nose of the user in the embodiments of <FIG>. The sealing edge <NUM> may be made of soft seal silicone, which may be over-molded on a front portion of the shell, also made of silicone, as shown in <FIG>, or be integrally formed therewith as shown in <FIG>. The sealing edge may have a width of about <NUM>. The various features and components of the mask may be made of various materials, including silicone rubber, ABS, liquid silicone rubber, and/or PBT.

Referring to <FIG> and <FIG>, the mask is configured with a one-way exhaust valve assembly <NUM> in the bottom wall portion defining in part the lower oral cavity, while the nasal mask is configured with a one-way exhaust valve assembly <NUM>, <NUM> in the bottom wall portion defining in part the cavity. In one embodiment, the valve assembly is configured as a flap valve covering one or more exhaust ports <NUM>, <NUM> (shown as two) formed in the bottom wall portion of the shell, although the valve may be configured as a center opening annular donut valve, a slit valve, a center-post valve, or other know and suitable valve configurations.

In the example of <FIG>, the valve assembly <NUM> includes a valve seat <NUM> defining the exhaust ports <NUM> and a valve <NUM>, configured with a pair of flaps <NUM> that may pivot relative to a center portion defining a centerline, coupled to the body with a tether <NUM>, or other flexible member. The tether <NUM> extends from the center portion along one edge (e.g., bottom) of the valve, and may have a thinned region defining a living hinge, permitting the valve to be pivoted about an axis defined by the living hinge (e.g., for cleaning) while remaining tethered to the mask. The valve may be made of silicone, and may have a thickness, for example and without limitation, of between and including <NUM> to <NUM>. The valve <NUM> includes a post <NUM> extending from the center portion, while the seat defines a pair of ports <NUM> and a center opening <NUM>. The post <NUM> is inserted into the opening <NUM> and is secured thereto with a friction fit, or with a catch or detent, such that the flaps <NUM> may pivot or move away from the ports <NUM> during exhalation, but seal against the valve seat <NUM> around the ports <NUM> during inhalation, with the valve assembly <NUM> thereby defining a one-way exhalation valve. It should be understood that the valve may be a one-piece molded component preassembled with the mask.

In the embodiment of <FIG>, the mask is also configured with a one-way exhaust valve <NUM> in one of the side wall portions defining in part the upper nasal oral cavity. In one embodiment, the valve <NUM> is configured as a center post valve having a peripheral edge that moves away from a circumferential valve seat <NUM>. A valve hub <NUM> is connected to the seat with spokes <NUM>, which define exhaust ports <NUM> therebetween, with a center post of the valve secured in the hub. It should be understood that the valve may be configured as a flap valve, a center opening annular donut valve, a slit valve, a center-post valve, or other know and suitable valve configurations.

As shown in the embodiment of <FIG>, the mask is not configured with an exhaust valve communicating with the upper nasal cavity. The exhaust valves <NUM>, <NUM> allow the user to breath in and out, or complete repeated breathing cycles, without having to remove the mask from their nose or face. Air may also be exhausted through an exhaust valve <NUM> located on the holding chamber, solely or in combination with the exhaust valve(s) located on the mask. In some embodiments, the mask body does not include any exhaust valves, but rather exhalation gases are passed through the inlet <NUM> and out through the medicament delivery device, for example through the exhaust valve <NUM> of the holding chamber, or the user simply exhales through their mouth when using the nasal mask.

Referring to <FIG>, the mask is configured with various examples of a therapeutic substance dispenser <NUM>, <NUM>, <NUM> which holds for example a therapeutic component <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and dispenses a therapeutic substance, which may be configured as and including a medication, for example an aerosolized nasal aromatic decongestant that has an aroma, or pleasant and distinctive smell. The therapeutic component and substance may be configured as an aromatic component and substance alone, a combined aromatic component and substance and medication (e.g. decongestant), or a medicament such as a decongestant without an aroma. One suitable aromatic nasal decongestant component is a Vicks® Vapoinhaler™ inhaler stick <NUM>, or Vicks® VapoPatch™ patches, which includes an aromatic nasal decongestant, and emits an aromatic nasal decongestant substance. The therapeutic component may also be configured as an aromatic crystal <NUM>, shown for example in <FIG>.

Referring to <FIG>, the dispenser <NUM> includes a receptacle <NUM> that extends partially interiorly into the cavity <NUM>, but does not interfere with the user's nose during use. The receptacle <NUM> defines an interior cavity <NUM> or reservoir that is in direct fluid communication with the upper nasal cavity <NUM> of the mask or the cavity <NUM> of the nasal mask at a location spaced apart from the inlet <NUM>, and downstream (during inhalation) thereof. The location of the communication is also spaced apart from the exhaust valve <NUM>, <NUM>. It should be understood that the receptacle may be configured in other locations on the mask, including for example on the tube <NUM> or in communication with the inlet <NUM>, or in or on a medicament delivery device upstream (during inhalation) of the inlet. For example, as shown in the embodiments of <FIG>, a receptacle <NUM> communicates with the cavity <NUM> adjacent the inlet <NUM>, and along/around a periphery <NUM> thereof. In one embodiment, shown in <FIG> the receptacle has an orifice <NUM>, <NUM> that opens directly into the cavity <NUM>, <NUM>, <NUM> and is in direct fluid communication between the cavities <NUM>, <NUM>, <NUM>, <NUM> at a location spaced apart from the inlet, and downstream (during inhalation) thereof. The orifice is positioned or spaced above a bottom of the cavity <NUM> a distance "d" (see <FIG>) such that the therapeutic component does not block the orifice or leak out of the orifice and into the cavity <NUM>, <NUM> of the mask, but rather is diffused or entrained in the air passing through the orifice <NUM>, which provides for a fluid communication of the therapeutic component with the cavity <NUM>, <NUM>.

In one embodiment, the orifice <NUM>, <NUM> has a diameter between and including <NUM> and <NUM>. The orifice <NUM>, <NUM> may have a non-circular cross- section, with a cross-sectional area of between and including <NUM><NUM> and <NUM><NUM>. The size of the orifice <NUM>, <NUM> ensures a slow release of the therapeutic substance, such as an aromatic decongestant substance, during inhalation in order to provide a pleasant experience to the user. In the embodiment of <FIG>, the inhaler stick <NUM> is inserted into the cavity <NUM> of the receptacle. The therapeutic substance, such as the aerosolized nasal decongestant, may pass through the orifice <NUM> and into the cavity <NUM>, <NUM>, either through natural diffusement into the air or by entrainment with air passing through the inhaler stick and/or cavity <NUM> during a user breathing cycle. The cavity <NUM> has a cylindrical shape to accommodate the stick <NUM>, although it should be understood that other shapes would also work.

Referring to <FIG>and <FIG>, the therapeutic component may be configured as a liquid <NUM>, which may be deposited in the receptacle reservoir or cavity <NUM>, for example with an eye dropper <NUM>, bottle or other dispenser. The end of the reservoir may be open to the ambient environment, or closed with a plug <NUM> or cap having a second orifice <NUM> allowing for air flow or fluid communication between the cavity <NUM> and the ambient environment such that entrainment may occur. The second orifice <NUM> may be same size as the first orifice <NUM>, or a different size, e.g. smaller or larger. The therapeutic substance, such as an aromatic nasal decongestant, may pass through the orifice <NUM>, either through natural diffusement into the air or by entrainment with air passing through the reservoir <NUM> from the second orifice <NUM> during a user breathing cycle.

Referring to <FIG>and <FIG>, the plug <NUM> may be impregnated with a therapeutic component <NUM>, such as a liquid. The plug, which may include an orifice <NUM>, is inserted into the cavity <NUM>. The therapeutic substance, such as an aromatic nasal decongestant, may pass through the orifice <NUM> and into the cavity <NUM>, <NUM>, either through natural diffusement into the air or by entrainment with air passing through the cavity <NUM> during a user breathing cycle.

Referring to <FIG>, a therapeutic component strip <NUM>, e.g., an aromatic decongestant strip, is disposed in the cavity <NUM>, which may be left open, or closed with a plug <NUM> or cap having an orifice <NUM>. Again, the therapeutic substance, such as an aromatic nasal decongestant, may pass through the orifice <NUM> and into the cavity <NUM>, <NUM>, either through natural diffusement into the air or by entrainment with air passing through the cavity <NUM> during a user breathing cycle.

Referring to <FIG> and <FIG>, a receptacle <NUM> is configured with a cavity <NUM> having an access window <NUM> exposed to the ambient environment. In one example, the cavity has a rectangular shape defined by side walls <NUM> and upper and bottom walls <NUM>, <NUM>, with an orifice <NUM> extending through an interior wall <NUM> and communicating the cavity of the mask. Again, the orifice is spaced above the lower wall <NUM>. The therapeutic component, such as a liquid <NUM> or strip <NUM>, may be deposited in the cavity, for example with an eye dropper <NUM>, bottle or other dispenser. The therapeutic substance may pass through the orifice <NUM> and into the cavity <NUM>, <NUM>, either through natural diffusement into the air or by entrainment with air passing through the cavity during a user breathing cycle.

Referring to <FIG> and <FIG>, the receptacle <NUM> is formed on the interior of the cavity <NUM> and is in fluid communication therewith, but is not in fluid communication with the ambient environment. The receptacle defines a cavity <NUM> or reservoir, and may be configured for example as a pouch having a front wall <NUM>, a pair of side walls <NUM> and a bottom wall <NUM>, with a rear wall <NUM> defined by the side wall of the shell. The cavity <NUM> is open to the top of the receptacle <NUM>. The front wall has one or more openings <NUM> defining a grid, with a bottom of the openings <NUM> being spaced upwardly from the bottom wall <NUM>, such that the therapeutic component <NUM>, <NUM> is retained in the cavity. The therapeutic substance, such as a nasal decongestant, may pass through the openings <NUM> in the front wall, or through the open top <NUM>, to the cavity of the nasal mask or to the upper nasal cavity, for example through natural diffusement into the air or by entrainment with air passing through the cavity during a user breathing cycle, for example air entering through the open top <NUM> and out of the openings <NUM>, or air entering in through one of the openings and out through one or more openings or the open top <NUM>. The therapeutic component, such as a liquid <NUM> or strip <NUM>, may be deposited in the cavity <NUM>, for example with an eye dropper <NUM>, bottle, tweezers or other dispenser.

Referring to <FIG>, the therapeutic substance dispenser <NUM>, including receptacle <NUM>, is in fluid communication with the cavity <NUM> adjacent the inlet <NUM>, and preferably along or about a periphery <NUM> of the inlet. The receptacle <NUM> includes a cavity <NUM> formed along a portion of an inner periphery of the tubular mounting portion and is defined in part by the inner surface <NUM> of the tubular mounting portion. In one example, the receptacle includes a pair of circumferentially spaced cavities <NUM> formed along portions of the inner periphery of the tubular mounting portion. In other embodiments, the receptacle may include only a single cavity, or may include more than two cavities. Each cavity includes a front/downstream wall <NUM> having at least one orifice <NUM> formed therein. In one example, the wall includes five orifices, although a central one of the orifices may be used as an anchor hole for receiving an anchor post of a one-way valve coupled to the wall. In one embodiment, each orifice <NUM> has a diameter between and including <NUM> and <NUM>, and may have a non-circular cross-section, with a cross-sectional area of between and including <NUM> mm2 and <NUM><NUM>.

As shown in <FIG>, a pair of one-way valves <NUM> each include a planar flap <NUM> having a curved shape defined by a concave inner edge <NUM> and a convex outer edge <NUM>, with the anchor post <NUM> extending orthogonally from the flap along a centerline thereof closer to the outer edge than the inner edge. The flap, including end portions <NUM> thereof and the inner edge <NUM>, may twist or deform in response to a flow through the orifices <NUM>, moving between a closed position, wherein the flap <NUM> covers the orifices <NUM>, and an open position, wherein one or more of the orifices <NUM>, or portions thereof, are not covered by the flap <NUM>. The anchor post <NUM> may have a radially enlarged portion (e.g., mushroom head) that frictionally engages the interior wall of one of the orifices to locate the valve <NUM> over the orifices <NUM>. Airflow through the valved holding chamber and mask creates a low pressure region that opens the valves <NUM>, which are very thin (e.g., <NUM> to <NUM>). When closed, the valves <NUM> limit the release of the decongestant aroma, for example on demand when a low pressure region is created by inhalation. It should be understood that the valves <NUM> are optional, meaning the mask maybe configured without the valves, with the aroma from the decongestant being freely dispersed due to airflow through the mask.

The cavity <NUM> is further defined by an annular, curved wall <NUM> spaced apart from the wall defining the tubular mounting portion. A free end of the wall <NUM> may be tapered, or include a ramped surface to engage an exterior surface of the mouthpiece <NUM>. The curved wall extends rearwardly in an upstream direction from the downstream front wall <NUM>. The annular wall and tubular mounting portion define a mouth <NUM> of the cavity therebetween. A pair of side walls <NUM> extend between the annular wall and tubular mounting portion to further close off and define the cavity.

The mouthpiece <NUM> is inserted into the tube <NUM>, with an outer surface of the mouthpiece engaging the inner surface of the wall <NUM> and the inner surface <NUM> of the tube <NUM> and thereby further defining the receptacle and cavity <NUM> as shown in <FIG>. The mouthpiece <NUM> seals against the tube <NUM>, thereby preventing ambient air (outside of the mask and valved holding chamber) from entering (or exiting) the flow path defined by those components. Air, however, may make its way into the cavity <NUM> to entrain the therapeutic substance <NUM> as air passes from the cavity <NUM> through the orifice(s) <NUM> as the flap opens <NUM> in response to the flow during inhalation and into the cavity <NUM>, whereinafter it may be inhaled by the user through the opening <NUM>. In particular, air flows upstream from the mask cavity <NUM> though a passageway defined between the outer surface of the end of the mouthpiece <NUM> and the inner surface <NUM> of the tube at a location downstream from where the mouthpiece <NUM> and tube <NUM> are sealed, for example through a gap formed between the side of the mouthpiece <NUM> and a side portion of the inner surface <NUM> of the tube between the sidewalls <NUM> defining the top and bottom cavities <NUM>. The air circles around the edges of the sidewalls <NUM> and curved wall <NUM> and into the cavity <NUM> thereby passing by and entraining the therapeutic substance whereinafter the air exits the orifice(s) <NUM> as the flap <NUM> opens.

Referring to <FIG>, a receptacle <NUM> defines a cavity <NUM> having a general open top <NUM> that is open to the ambient environment. The receptacle has a bottom wall <NUM> spaced apart from an exterior or outer surface <NUM> of the tubular portion, and defining a gap <NUM> therebetween. The receptacle further includes a pair of side walls <NUM> and a pair of end walls <NUM> connected to the side wall to define a bowl.

A cover <NUM> includes a ring <NUM> that surrounds or is disposed around and axially slidable along the outer surface <NUM> of the tubular mounting portion <NUM> extending from the body. The cover further includes first and second cover portions <NUM>, <NUM>, configured as panels or lids, that are spaced apart and form a gap <NUM> therebetween. The lower panel <NUM>, or first cover, is dimensioned to be received in the gap <NUM>, with the receptacle <NUM> disposed in the gap <NUM> between the panels <NUM>, <NUM>, while the upper panel <NUM>, or second cover, is disposed over the top <NUM> of the receptacle. The cover <NUM> may be moved, including translating or sliding the cover in a longitudinal direction <NUM> relative to the tubular mounting portion and receptacle. The first cover portion is moveable relative to a passageway <NUM> defined between a bottom surface of the bottom wall <NUM> of the receptacle <NUM> and the at least one orifice <NUM>. The passageway <NUM> includes a plurality of ports <NUM> opening in the bottom of the cavity <NUM>. The cover <NUM> may move between a first position, wherein the ports <NUM> are uncovered and the passageway <NUM> is open, and a second position, wherein the ports <NUM> are covered and the passageway <NUM> is closed. In this way, the cover <NUM> is movable between a use position (<FIG>), wherein the cavity <NUM> is in fluid communication with the orifice <NUM> by way of the ports <NUM> being uncovered and the passageway <NUM> being open, and a storage position (<FIG>), wherein the cavity <NUM> is not in fluid communication with the orifice <NUM> by way of the ports <NUM> being covered and the passageway <NUM> therefore being closed. The cover <NUM> is further moveable to a loading position (<FIG>), wherein the receptacle <NUM>, and in particular the top <NUM> thereof, is open to the ambient environment. The ring <NUM> abuts a rear surface of the flange <NUM> in the storage position as shown in <FIG>, is spaced apart from the flange <NUM> a first distance D1 in the use position (<FIG>) and is spaced apart from the flange a second distance D2 in the loading position (<FIG>), with D2 being greater than DI. In the loading position, an aromatic crystal <NUM>, or other therapeutic substance such as a decongestant, may be disposed or loaded into the cavity <NUM>. The cover <NUM> may then be moved to a storage position, wherein the receptacle <NUM> is not open to the ambient environment. It should be understood that in the storage position, there receptacle is not hermitically sealed, or air tight, meaning some air may enter the receptacle through various gaps between the cover <NUM> and receptacle <NUM>, but that the open top <NUM> of the cavity is generally covered and closed such that the therapeutic substance may not fall out or be dislodged. The first and second cover portions <NUM>, <NUM> are fixedly coupled by way of a rear wall <NUM>, which is configured as a portion of the ring <NUM> in one example, and are moveable with each other between the loading, storage and use positions.

It should be understood that the masks of <FIG> may incorporate and include any of the therapeutic dispenser examples disclosed and shown in <FIG>.

In operation, the medicament delivery device is positioned such that the nasal mask <NUM>, <NUM> or the upper nasal cavity <NUM> surrounds or overlies the nasal passageways of the user. When situated in these configurations, the user may breath normally through their nose <NUM> and nasal passageways, with air and an inhalable substance flowing through the medicament delivery device, for example through the output end <NUM> as the inhalation valve <NUM> opens, through the inlet <NUM> and into the open space defined by the cavity <NUM>, <NUM>. The inhalable substance, such as an aerosolized medicament, may be dispensed by actuating the pressurized metered dose inhaler <NUM>. For example, the container <NUM> of a MDI may be reciprocally moved relative to an actuator boot <NUM> so as to release a metered dose of aerosolized medicament through the mouthpiece <NUM> coupled to the inlet. The medicament is drawn into the mask <NUM>, <NUM>, <NUM> wherein the aerosolized medicament is inhaled by the user. The device may be actuated one or more times as needed and prescribed. The medicament or other inhalable substance, such as oxygen and/or an aromatic substance in vapor form, may be administered by a metered dose inhaler or nebulizer, and may be positioned in a ventilator circuit, or other system providing an oxygen supply.

Prior to, or at the same time, the inhalable substance is being administered, a therapeutic component <NUM>, <NUM>, <NUM>, <NUM>, <NUM> is disposed in the receptacle, with a therapeutic substance being drawn into the cavity <NUM>, <NUM>, <NUM> through diffusement into the air or by entrainment during inhalation and thereafter drawn into the nose or nasal passageways.

During exhalation, the air passes back through the cavity <NUM>, <NUM>, <NUM>, <NUM> and through one or both of the exhaust valve assemblies <NUM>, <NUM>, <NUM>. During inhalation, the one-way exhalation valves <NUM>, <NUM>, <NUM> are closed, while during exhalation, the one-way inhalation valve <NUM> is closed, thereby creating a back pressure and forcing the exhaled gases out through the one or more one-way exhaust valves <NUM>, <NUM>, <NUM>, or through an exhaust valve in the medicament delivery device such as the holding chamber <NUM>. The caregiver, whether the provider soothing the user, or a third party observer, may monitor the exhaust valves or flow indicator <NUM>, and in particular, the movement thereof, to confirm the patient is exhaling. Movement of the exhaust valves may also provide information about the quality of the seal between the mask and the user's face.

Referring to <FIG>, the cover <NUM> is moved to the loading position, wherein the receptacle <NUM> is open to the ambient environment. The therapeutic substance <NUM>, e.g. an aromatic crystal or other decongestant material, is disposed or loaded into the cavity <NUM>. The cover <NUM> is thereafter moved to a storage position, wherein the receptacle <NUM> is not open to the ambient environment or in flow communication with the cavity <NUM>, and the cover <NUM> prevents the aromatic crystal or other decongestant material from falling out of the receptacle, for example when transporting or storing the mask and/or holding chamber. When it is time to administer a medicament, for example when the patient is notified by the device or through a Smart device, the cover <NUM> is moved from the storage position to the open/use position, for example by translating or sliding the cover in the longitudinal direction <NUM> relative to the tubular mounting portion <NUM> and receptacle <NUM>, and thereby exposing the ports <NUM> and passageway <NUM>, which is closed by the cover <NUM> in the storage position. In the open/use position, the cavity <NUM> is in fluid communication with the orifice <NUM> by way of the passageway <NUM> being open. The user may thereafter inhale through the mask, and thereby draw the therapeutic substance into the cavity <NUM> through the orifice(s) <NUM> past the open valve <NUM> by way diffusement into the air flow and/or by entrainment during inhalation, and thereafter draw the therapeutic substance into the nose or nasal passageways from the cavity <NUM>.

Referring to <FIG>, the valve post <NUM> may be removed from the center opening <NUM>, while the valve <NUM> remains tethered to the mask, such that the valve may be pivoted away from the valve seat <NUM> to a disengaged position, whereinafter the valve, valve seat and mask may be cleaned. The valve may be reengaged with the valve seat by inserting the post <NUM> into the opening <NUM> and engaging the mask. Preferably, the valve <NUM> remains tethered to the mask with the tether, configured as a living hinge, at all times such that the valve is not misplaced.

Referring to <FIG> and <FIG>, the mask may be configured with a controller <NUM>, for example coupled to the mounting portion. The controller <NUM>, or other component of the mask, may include a microprocessor, a microphone, a flow sensor in fluid communication with, or capable of sensing the flow in, the flow path, a speaker and/or a haptic feedback feature, for example a vibrator. The controller, or other component of the mask, may also include a volatile organic compound (VOC) sensor. VOC's are gases that are emitted into the air from products or processes, for example from the decongestant. The VOC sensor measures the concentration of the aromatic decongestant, with the concentration of the decongestant being tracked and logged by an application. Specifically, the VOC sensor measures the ambient concentration of a broad range of "reducing gases," for example and without limitation, alcohols, aldehydes, ketones, organic acids, amines, organic chloramines, aliphatic and aromatic hydrocarbons. If a decongestant intensity limit falls below a specific predetermined level, or pre-set limit, the controller, via the application, will communicate a reminder to the user, for example through a user interface <NUM>, or by way of indicators located on the mask, providing indicia or instructing the user to replace the therapeutic substance, or decongestant component, with a fresh supply, e.g., stick, pad, crystal, etc. In one operation sequence, a timer informs the user to breathe the therapeutic substance, or decongestant, in/out through the mask before the medicament or drug treatment in order to open the nostrils as a pre-treatment. In operation, the user would pick up the mask <NUM>, whether separate or attached to a medicament delivery device such as a holding chamber, press a first button A to start the clock, with LED lights/indicators B pulsating green while counting down a predetermined "pretreatment" time period, after which the device is ready for the medicament delivery treatment. When the pre-treatment is completed, the LED indicator B would turn to solid green to indicate that drug can now be administered. The solid green LED indicator B will then timeout after a few seconds after the medicament treatment sequence is completed or finished.

In another example (not claimed), following an automatic solution sequence, a timer informs the user to breathe decongestant in/out through the mask <NUM> before the drug treatment in order to open the user' s nostrils as a pre-treatment. The user would pick up the mask <NUM>, with an accelerometer sensor automatically starting a timer or countdown clock and with the LED indicator, B lighting up in a pulsating green count down mode signaling the device is ready for pre-treatment. When the pre-treatment is completed, the LED indicator B would turn to solid green to indicate that drug may be administered. The LED indicator B will then timeout after a few seconds after the drug delivery treatment is finished. In one example, a user interface <NUM>, including without limitation one or more of a smart phone, tablet or computer, may connect to the controller <NUM> via Bluetooth, allowing the user to interface with the user interface <NUM>, and initiate the operation sequence for pretreatment and treatment and receive feedback about the treatment. As set forth in <FIG>, the mask <NUM> and controller <NUM>, for example through the speaker(s), may provide audio instructions about how to use the device and proceed with treatment.

In various embodiments, the inhalable substance is an aerosolized medication that may be administered using the medicament delivery assembly and device, which medication may include, without limitation, corticosteroids, such as beclamethasone, budesonide, fluni-solide, cilcesonide, and fluticasone, and bronchodilators, such as albuterol, proventil, leval-buterol, salmeterol and pirbuterol.

Claim 1:
A mask (<NUM>) comprising:
a body comprising:
a shell (<NUM>) defining a cavity including a bottom wall portion (<NUM>) that transitions into opposite curved side wall portions (<NUM>), and an upper curved wall portion (<NUM>) defining an apex;
a barrier (<NUM>) separating an upper nasal cavity (<NUM>) shaped to receive a user's nose and a lower oral cavity (<NUM>) adapted to be in fluid communication with the user's mouth;
an exterior surface (<NUM>) exposed to an ambient environment;
an inlet (<NUM>) in fluid communication with only the upper nasal cavity (<NUM>); and
a one-way exhaust valve (<NUM>) in fluid communication between the lower oral cavity (<NUM>) and the ambient environment,
characterized in that the barrier (<NUM>) has an upwardly extending vertical portion (<NUM>) that extends upwardly from the bottom wall portion (<NUM>) and spans between the opposite side wall portions (<NUM>), and a forwardly extending horizontal portion (<NUM>) that spans between the opposite side wall portions (<NUM>) and terminates at a user interface edge (<NUM>) positioned adjacent an upper lip (<NUM>) of the user.