WO2025073003A1

WO2025073003A1 - Nebulizer mask

Info

Publication number: WO2025073003A1
Application number: PCT/AU2024/051045
Authority: WO
Inventors: Anushi Rajapaksa; Nathan BATHAM; Sanjana Naveen PRASAD; Maxwell William AINSWORTH JONES; Jodie Gay HOBBS; Tai-Jie Yun; John William Richard Nicholl; Mark Phillip STAMBAUGH
Original assignee: Misti Labs Pty Ltd
Current assignee: Misti Labs Pty Ltd
Priority date: 2023-10-03
Filing date: 2024-10-03
Publication date: 2025-04-10
Anticipated expiration: 2026-04-03

Abstract

A mask (100) for delivery of a nebulized fluid to a patient for inhalation. The mask defines a cavity configured to at least partially receive a nose and/or mouth of the patient. The mask (100) comprises a mask body (200) comprising an internal chamber (210). A nebule retainer (300) is at least partially located in the chamber (210), and configured to retain a nebule containing liquid to be nebulized. A nebulizer mechanism (400) is at least partially located in the chamber (210), the nebulizer mechanism (400) configured to nebulize liquid from the nebule. The mask body (200) defines a chamber outlet through the mask body (200) for delivery of the nebulized liquid from the chamber (210) to the cavity for inhalation.

Description

"Nebulizer mask"

Technical Field

[0001] The present disclosure relates to the field of medical devices and, more particularly to a mask for delivery of a nebulised fluid to a patient.

Background

[0002] Pulmonary drug therapy may aid in the treatment of respiratory diseases, such as asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis or respiratory infections. Inhalation therapy provides an efficient method for the treatment and prevention of lung diseases, for example by administration of medicaments or vaccines, due to the accessibility and large surface area of the lung. Further, pulmonary delivery provides a pain-free, non-invasive delivery route, which circumvents challenges and risks associated with parenteral administration routes.

[0003] Nebulizers are machines used to atomise liquids into a fine mist. A nebulizer allows for pulmonary delivery of aerosolised substances directly to the airways of a patient by inhalation, allowing for effective and targeted drug delivery. Conventional nebulizer systems are typically equipped with a medicament reservoir, a nebulization mechanism (for example, a jet or ultrasonic nebulizer) and an aerosol chamber for containing the aerosolised medication. The aerosol chamber is connected, usually via intermediate tubing, to a mouthpiece or a face mask for delivery of the nebulized medication to the patient for inhalation.

[0004] Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of each of the appended claims. Summary

[0005] The present disclosure relates to a nebuliser mask.

[0006] According to one aspect of the present disclosure, there is provided a mask for delivery of a nebulized fluid to a patient for inhalation, the mask defining a cavity configured to at least partially receive a nose and/or mouth of the patient, the mask comprising: a mask body comprising an internal chamber, a nebule retainer at least partially located in the chamber, and configured to retain a nebule containing liquid to be nebulized; and a nebulizer mechanism at least partially located in the chamber, the nebulizer mechanism configured to nebulize liquid from the nebule; wherein the mask body defines a chamber outlet through the mask body for delivery of the nebulized liquid from the chamber to the cavity for inhalation.

[0007] The mask may define one or more apertures through the mask for providing airflow to the cavity. The mask may comprise at least one air inlet and at least one air outlet and a flow path defined between the inlet and the outlet and in fluid communication with the cavity. The air inlet and/or the air outlet may comprise a valve configured to inhibit airflow in one direction.

[0008] The mask body may comprise an outer shell portion and an inner shell portion. The shell portions may be connectable to each other to define the chamber therebetween.

[0009] The mask body may comprise an opening configured to allow insertion of a nebule to the chamber. In the present disclosure, the terms nebule and ampoule may be used interchangeably. The mask may comprise a cover portion movable between an open position and a closed position to open or close the opening. The cover portion may be hingedly connected to the mask body and/or removably attachable to the mask body. The opening may extend through an outer portion of the mask body. For example, the opening may extend through the outer shell portion.

[0010] The mask may comprise a mask insert releasably attachable to the mask body. The mask insert may be configured to contact the patient’s face. The mask body and the mask insert may be configured to be at least partially nested relative to each other when assembled.

[0011] The mask insert may define an opening in fluid communication with the outlet of the mask body. The mask insert may comprises a sealing rim. The sealing rim may extend around a periphery of the mask insert. The sealing rim may be configured to contact the patient’s face to seal around the nose and/or mouth of the patient. The sealing rim may be formed from silicone.

[0012] The mask insert may be configured to be cleanable. For example, the mask insert may be cleanable in a domestic dishwasher machine. Additionally or alternatively, the mask insert may be cleanable by hand using water, detergent, ethanol, and/or cleaning wipes, for example.

[0013] The mask may comprise one or more sensors. The one or more sensors may comprise at least one sensor configured to sense data indicative breathing of the patient. The one or more sensors may comprise flow sensor configured to sense data indicative of airflow and/or pressure.

[0014] The nebulizer mechanism may be configured to be activated to nebulize the liquid in response to sensed data indicative of inhalation. The nebulizer mechanism may be configured to automatically deactivate to stop nebulizing the liquid. For example, the nebulizer mechanism may be configured to automatically deactivate upon fluid flow from the nebule falling below a predetermined level. The nebulizer mechanism may be configured to automatically deactivate to stop nebulizing the liquid after a predetermined time, after a predetermined amount of fluid has been nebulized and/or according to a predetermined time and/or dosing schedule. [0015] The nebulizer mechanism may comprise an acoustic nebulizer. The nebulizer mechanism may comprise at least one piezoelectric substrate. The nebulizer mechanism may comprise at least one electroacoustic transducer configured to generate an acoustic wave in the substrate for nebulization of the liquid.

[0016] The mask may include one or more filters. The filters may be configured to inhibit particulate matter from entering the mask and/or to inhibit moisture from contacting electronic components of the mask. The filters may be configured to filter air exiting the mask. For example, the filters may be configured to inhibit medication from exiting the mask.

[0017] The mask may include a communication unit configured to communicate with at least one external computer.

[0018] Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

Brief Description of Drawings

[0001] Embodiments will now be described by way of example only with reference to the accompanying drawings in which:

[0002] Figure 1 shows a front perspective view of a mask according to one example of the present disclosure;

[0003] Figure 2 shows a perspective, exploded view of the mask of Figure 1;

[0004] Figure 3 shows a rear perspective view of the mask of Figure 1;

[0005] Figure 4 show a rear view of the mask of Figure 1; [0006] Figure 5 shows a rear perspective view of the mask of Figure 1, with a mask insert removed;

[0007] Figure 6 shows a rear view of the mask of Figure 1 with the mask insert removed;

[0008] Figure 7 shows a front perspective view of the mask of Figure 1, with a front cover in an open position;

[0009] Figure 8 shows a top view of the mask of Figure 1, with the front cover in an open position;

[0010] Figure 9 shows a cross-sectional view taken along line A-A of Figure 8;

[0011] Figure 10 is an exploded view of a mask body according to another example of the present disclosure;

[0012] Figure 11 is an rear view of the mask body of Figure 10, with the inner shell portion removed;

[0013] Figure 12 is a schematic front view of a mask according to another example of the present disclosure;

[0014] Figure 13 is a schematic right side cross-section of the mask of Figure 12;

[0015] Figure 14 is a front perspective view of a mask body according to another example of the present disclosure;

[0016] Figure 15 is a rear perspective view of the mask body of Figure 14;

[0017] Figure 16 is a top view of the mask body of Figure 14;

[0018] Figure 17 is a bottom view of the mask body of Figure 14, [0019] Figure 18 is a perspective view of a portion of the mask body 200 according to another example of the present disclosure including a detail call out of an air inlet port and a flow sensor;

[0020] Figure 19 is a perspective view of the mask body 200 according to another example of the present disclosure including a detail call out indicating a flow path past a heat sink;

[0021] Figure 20 is a schematic representation of the mask 100 according to another example of the present disclosure indicating positioning of a flow sensor and filter;

[0022] Figure 21 is a cross-sectional view of a valve according to one example of the present disclosure;

[0023] Figure 22 is a perspective view of a nebulizer unit according to one example of the present disclosure;

[0024] Figure 23 is a schematic front view of a mask according to another example of the present disclosure; and

[0025] Figure 24 is a schematic right side cross-section of the mask of Figure 23.

Description of Embodiments

[0026] A mask 100 for delivery of a nebulized fluid to a patient for inhalation according to the present disclosure is shown in Figure 1. The mask 100 defines a cavity configured to at least partially receive a nose and/or mouth of the patient.

[0027] As best shown in Figures 7-9, the mask comprises a mask body 200 defining an internal chamber 210 (as shown in Figure 9, for example). A nebule retainer 300 is at least partially located within the chamber 210, and configured to retain a nebule containing liquid to be nebulized. A nebulizer mechanism 400 is at least partially located in the chamber 210 and is configured to nebulize liquid from the nebule. [0028] The mask body 200 defines a chamber outlet 220 through the mask body 200, as shown in Figures 5 and 6 for example, for delivery of the nebulized liquid from the chamber 210 to the patient’s nose and/or mouth for inhalation.

[0029] In some examples, the chamber 210 may have a tapered shape. For example, as shown in the example mask 100 of Figure 13, the chamber 210 may include walls which taper outward from the position of the nebulizer mechanism 400 toward the chamber outlet 220. The tapered shape may promote diffusion of the nebulized liquid as it is delivered toward the patient’s nose and/or mouth for inhalation.

[0030] In the illustrated examples, the mask 100 has a curved shape, defining a concave cavity configured to receive part of the patient’s face including the nose and/or mouth of the patient. In some examples, The mask 100 may include, or may be configured to be attachable to, one or more retaining members, such as straps or headgear, configured for retaining the mask 100 on the face of the patient. The straps may be elastic or inelastic. The retaining member may be formed from any suitable material, including one or more of fabric (such as nylon), silicone or rubber. The retaining member may include a fastening member, such as a hook-and-loop closure, a buckle, latch, catch or other suitable fastening member. The mask 100 may configured to be light enough to be retained by the retaining member on the user’s face for at least the duration of use. In some examples, the total weight of the mask 100 may be configured to be less than about 300 g, less than about 250 g, less than about 200 g, less than about 150g, or less than about 100g. The weight of the mask may be configured, for example by choice of materials for forming the various components of the mask. In some examples, one or more components of the mask may be formed from plastics, composite and/or textile materials. In some examples, the mask 100 may be configured to be held against the face of the patient by the hand of the patient, a caregiver or clinician.

[0031] The mask 100 may be configured to minimise dead volume within the concave cavity and/or within airflow paths of the mask 100. Dead volume refers to the volume of air within the airflow paths and/or the volume enclosed between the mask 100 and the user’s face. A larger dead volume may decrease the effectiveness of the mask for delivering moisturised gas and/or medication to the user and may be undesirable. The mask 100 may therefore be configured to minimise a distance between an inner surface of the mask insert and the patient’s skin, and/or to seal in close proximity around the patient’s nose and/or mouth.

[0032] Figure 2 shows various components of the mask 100 in an disassembled configuration.

[0033] In the illustrated examples, the mask body 200 comprises an inner shell portion 250 and an outer shell portion 260. The inner and outer shell portions 250 and 260 are connectable to each other to define the mask body 200. Each of the shell portions 250, 260 has a curved shape, defining a concave cavity. The shell portions 250, 260 are configured to be at least partially nested relative to each other when in an assembled configuration. The curvature of the inner shell portion 250 may differ from that of the outer shell portion 260. As shown in the example of Figure 2, the inner shell portion 250 includes a central region of reduced curvature relative to a central region of the outer shell portion 260, such that a gap is maintained between the inner and outer shell portions 250, 260 when assembled, defining the internal chamber 210. The inner and outer shell portions 250, 260 may have substantially corresponding shapes at peripheral edge regions thereof. The inner and outer shell portions 250, 260 may be configured to form a seal around a peripheral region thereof when assembled, to inhibit egress of nebulized fluid, other than through the chamber outlet 220 of the chamber 210. In the illustrated example, the chamber outlet 220 of the chamber 210 is in the form of an open aperture through the inner shell portion 250.

[0034] One or both of the shell portions 250, 260 may be configured to be at least partially transparent to enable viewing of the nebule retainer 300, nebule 1 and/or nebuliser mechanism 400 within the chamber 210.

[0035] The shell portions 250, 260 may comprise one or more connection features configured to secure the shell portions together when assembled 250, 260. The connection features may be configured to prevent relative movement between the shell portions 250, 260 when connected. The shell portions may include respective locating and/or locking mechanisms. For example, one of the shell portions may comprise one or more locating and/or locking features (such as one or more protrusions) connectable with a respective one or more locating and/or locking features (such as a corresponding projection) on the other shell portion.

[0036] As shown in Figure 6 for example, the shell portions 250, 260 may be keyed to one another. The inner shell portion 250 ,may comprise protrusions 251 configured to be received in correspondingly shaped slots 261 in the outer shell portion 260. Additionally or alternatively, the inner shell portion 250 may comprise one or more posts 252 (as shown in Figure 2, for example) configured to be received in bores 262 (as shown in Figure 6, for example) on the outer shell portion 260. Reversed configurations of protrusions and slots, and/or posts and bores is also contemplated.

[0037] The mask body 200 may define an opening 270 configured to allow insertion of a nebule to the chamber 210. The opening 270 may extend through an outer portion of the mask body. For example, as indicated in Figures 2, 10, 13 and 14 the opening 270 extends through the outer shell portion 260.

[0038] In some examples, a cover portion 280 may be provided to cover and/or seal across the opening 270. The cover portion may be openable and/or removable to enable access to the chamber 210. In the example mask 100 of Figures 1 to 9, the cover portion 280 is hingedly connected to the mask body 200 and movable between an open position (as shown in Figures 7-9) and a closed position (as shown in Figure 1). In some examples, the cover portion 280 may be slidable, or at least partially removable from the mask 100 to facilitate access to the chamber 210. The cover portion 280 may be removably attachable to the mask body 200, for example by a magnetic connection, or by a connecting mechanism such as a clip. The mask 100 may be configured to substantially enclose the nebule retainer 300 with received nebule and the nebulizer mechanism 400 within the chamber 210 when the cover portion is in the closed position. [0039] In some examples, the cover portion 280 may be removable from the mask body 200. For example, the cover portion 280 may be movable between an open position (i.e. removed from the mask body 200) and a closed position (i.e. inserted to the opening) to open or close the opening 270. In some examples, the cover portion 280 may comprise a nebulizer housing. The cover portion 280 may be configured to receive and retain the nebulizer unit 400 within the mask. The cover portion 280 may comprise the nebule retainer 300. For example, as shown in Figure 10, the cover portion 280 may be configured to receive nebule 1 to interface the nebule 1 with the nebulizer unit 400.

[0040]

[0041] The nebule retainer 300 is configured to receive and retain the nebule within the mask 100. In some examples, the mask 100 is configured for use with a custom nebule. In other examples, the mask 100 may be configured for use with off-the-shelf or pre-existing nebules. The nebule retainer 300 may be shaped and/or sized to correspond to a shape and/or size of the nebule. The nebule retainer 300 may be configured to position the nebule for fluid delivery to the nebulizer mechanism. The nebule retainer 300 may be located adjacent to the nebulizer mechanism 400. For example, the nebule retainer 300 may be located at or adjacent to either end, or both sides of the nebulizer mechanism 400.

[0042] The nebule retainer 300 may be configured to receive a disposable nebule. The nebule may contain a predetermined quantity of liquid. In some examples, the mask 100 is configured to receive a nebule having a volume of about 1 mL, 2 mL, about 3 mL about 4 mL, about 5 mL, about 6 mL, about 7 mL, about 8 mL, about 9 mL, about 10 mL or more.

[0043] In the illustrated examples, as shown in Figures 1-4, 7-9, 12 and 13, , the mask 100 comprises a mask insert 500, which is releasably attachable to the mask body 200. The mask body 200 and the mask insert 500 may be configured to be at least partially nested relative to each other when assembled. Figures 3 and 4 show the mask 100 with the insert 500 assembled with the mask body 200. Figures 5 and 6 show an example of the mask body 200 with the insert 500 removed. In this example, the mask body 200 and insert 500 each have a similar curved shape and each define a respective concave cavity. The mask insert 500 is configured to be partially received within the concave cavity defined by the mask body 200 in a nested configuration.

[0044] The mask insert 500 may be configured to contact the face of the patient and/or to inhibit contact between the mask body 200 and the face of the patient. In some examples, such as shown in Figures 3 and 4, the mask insert 500 comprises an insert body portion 511 and a sealing rim 510 extending around a periphery of the body portion 511. The sealing rim 510 may be configured to contact the patient’ s face to at least partially seal around the nose and/or mouth of the patient.

[0045] As can be seen in Figure 4, the mask insert 500 defines an opening 520 through the mask insert. The opening 520 is configured to be in fluid communication with the chamber outlet 220 of the chamber 210 of the mask body 200 when the mask insert 500 and mask body 200 are assembled. The opening 520 enables air entraining nebluized fluid flowing out of the chamber 210 to reach the mouth and/or nose of the patient for inhalation.

[0046] The mask insert 500 may be configured to maintain its shape under negative internal pressures. Although CPAP masks may have similar valve configurations to the presently disclosed mask, they are designed to work under positive pressure and would collapse if used as intended for the presently disclosed mask 100.

[0047] The mask 100 may define one or more apertures through the mask 100. The apertures may extend through the mask body 200 and/or the mask insert 500 to the cavity, to enable airflow to and/or from the mouth and/or nose of the patient when the mask 100 is sealed around the nose and/or mouth of the patient. The mask may comprise one or more apertures allowing for inflow of air from outside of the mask as the patient inhales. The mask may comprise one or more apertures allowing for outflow of air exhaled by the patient. The mask may comprise one or more air inlets 110 and one or more air outlets 530. [0048] The mask 100 may comprise a flow path defined between the air inlet(s) 110 and the air outlet(s) 530. The flow path may be configured to maintain moisture (e.g. from nebulised fluid or air exhaled by the patient) separate from one or more electronic components of the mask.

[0049] In the example shown in Figures 1 to 9, a pair of air inlets 110 are provided through the mask 100 and a pair of outlets 530 are provided through the mask insert 500 (for example as indicated in Figures 3 and 4). In other examples, the mask may comprise a greater or lesser number of apertures configured as air inlets and/or outlets. For example, the mask 100 may comprise a single air inlet 110 and a single air outlet 530.

[0050] The air inlet(s) 110 allows air to flow into the internal cavity 210 and around the nebulizer mechanism 400. Air entraining nebulised fluid from the nebule (such as medication or saline) then flows through the chamber outlet 220 and the mask insert opening 520 to be inhaled by the patient. As the patient exhales, air flows out of the mask through the air outlet(s) 530.

[0051] In the examples shown in Figures 10 to 17, the air inlet 110 and air outlet 530 each extend through the mask body 200. The air inlet 110 may comprise an air inlet port 111 extending through the inner shell 250 of the mask 100 in fluid communication with one or more apertures 112 extending through the outer shell portion 260 of the mask 100. The air outlet may comprise an air inlet port 531, extending through the inner shell 250 of the mask 100, in fluid communication with one or more apertures 532 extending through the outer shell portion 260 of the mask 100. As indicated in Figure 13, the air inlet 100 and air outlet 530 are configured to extend through the mask insert 500.

[0052] In some examples, the air inlet 110 and/or the air outlet 530 may be configured to control a direction of airflow through the mask 100. For example, air inlet 110 and/or the air outlet 530 may be configured to restrict or inhibit airflow through the air inlet 110 and the air outlet 530 to one direction. The air inlet 110 and/or the air outlet 530 may be configured such that, in use, air is enabled to flow into the mask 100 through the air inlet 110 as the patient inhales, and out of the mask 100 through the air outlet 530 as the patient exhales. One or both of the air inlet and the air outlet may include valves 620. The valves 620 of the air inlet 110 and/or the air outlet 530 may be unidirectional. In the examples shown in Figures 10 to 17, the mask 100 includes a valved air inlet 110 and a valved air outlet 530. The valves 620 may comprise any valve type suitable for limiting air flow to one direction may be used, such as an umbrella valve, ball valve, gate valve, butterfly valve, globe valve, needle valve, check valve, pinch valve or similar.

[0053] In the example shown in Figure 10, the valves 620 each comprise a valve housing 621 and a valve body 622. The valves 620 are configured to be received within an air inlet port 111 and air outlet port 351 extending through the inner shell portion 250 of the mask 100. The valves 620 may include sealing members, such as O-rings 632 for sealing the valve housing within the air inlet port 111 or air outlet port 351 to inhibit air flow other than through the valve body 622.

[0054] The air inlet 110 and the air outlet 530 may be configured to allow a desired rate of airflow through the mask. For example, the size and/or shape and/or valves 620 of the air inlet 110 and the air outlet 530 may be configured to provide a desired rate of airflow. The air inlet 110 and the air outlet 530 may be configured to enable a patient to breathe at a relaxed rate with minimal perceived effort. The valves 620 may be configured to minimise airflow resistance. A diameter D of the valves 620 may be configured to be large enough to allow for sufficient airflow and small enough so as not to occupy too much space within the mask. The valves 620 may have a diameter D between about 15 mm and about 25 mm, such as about 20 mm. In one example, the air inlet 110 and the air outlet 530 comprise 19mm umbrella valves 620. An example valve 620 is shown in Figure 21. Subjective user testing confirmed that the valves 620 allowed for relaxed breathing of the patient. The housings 621 in which the valves are mounted allow for a minimum diameter of 19mm and may include an expanded region 624 in areas where the valves 620 open to prevent bottlenecking. [0055] Proper operation of umbrella valves requires that pressure is controlled and maintained on the working side of the valve.

[0056] Exhaled air contains moisture and may be detrimental to the longevity of PCBs and electrical components, proving a need for this moist exhaled air to be directed way from the electronic components of the mask 100. This may be achieved by a valve on the air inlet port 111, configured to inhibit exhaled air from flowing back past the air flow sensor 620 and into the chamber 210 of the mask body 200. In some examples, all inlet(s) and outlet(s) are valved to ensure the inside of the mask 200 is sealed from atmosphere.

[0057] The exhale port 351 provides a passage for exhaled air from inside the mask 100, all the way to the exterior of the mask 100, inhibiting any contact of moist exhaled air with the PCB and other electrical components, except for the nebulizer mechanism 400.

[0058] The mask 100 may be configured to be wholly or partially re-usable. The mask 100 may comprise a disposable portion and a re-usable portion. In some examples, at least the mask body 200 may be configured to be re-usable. The mask 100 may be configured such that all electronic components of the mask 100 are located within the mask body 200. In some examples, the mask insert 500 may be disposable. In other examples, the mask insert 500 may be configured to be re-usable. The mask insert 500 may be configured to be re-usable a predetermined number of times or for a predetermined period.

[0059] One or more components of the mask 100 may be disconnectable from each other. In some examples, the mask insert 500 may be configured to be disconnectable from the mask body 200 by a user. The insert 500 may be configured to be releasably retained with the mask body 200 by one or more connection features. For example, the mask insert 500 may be retained by a snap-fit connection with the mask body 200. In the illustrated example, the mask insert includes a pair of projections 555 (as best shown in Figure 2) receivable in a pair of correspondingly shaped recesses 265 (as best shown in in Figure 5) for retaining the mask insert 500 in connection within the mask body 200. The projections 555 may be resiliently deformable. For example, the projections 555 may have a desired degree of flexibility to allow for temporary deforming of the projections during connection of the mask insert 500 and mask body 200, before the projections 555 snap into the recesses. In other examples, the mask insert 500 and the mask 200 may be configured to attach to each other by alternative or additional means, such as by one or more clips or by friction fit. The mask insert 500 includes projecting tabs 540 as shown in Figures 3 and 4. The tabs 540 are configured to project beyond a periphery of the mask body 200 for manipulation by a user to facilitate disassembly of the mask insert 500 from the mask body 200. For example, a user may apply pressure to move the tabs 540 toward each other to release the projection 555 of the mask insert 500 from the recess 265 of the mask body 200.

[0060] The mask insert 500 may be configured to be removable for cleaning, separate from the mask body 200. The mask insert 500 may be configured to be cleanable by hand (for example, using wipes or water and/or detergents or other cleaning agents), or by machine, such as in a domestic dishwasher machine or steriliser unit. In some examples, the sealing rim 510 of the mask insert may be separable (as shown in Figure 2) from a body portion 511 of the mask insert. The separability of components of the mask for cleaning may enable cleaning and/or sterilisation of portions of the mask 100 that are configured to contact the face of the patient, while minimising the risk of damage to electronic components of the mask.

[0061] One or more portions of the mask 100 may be formed from a biocompatible and/or food safe material. For example, portions of the mask 100 configured to contact the face of the patient may be formed from a material suitable for prolonged contact with human skin and/or configured to minimise irritation of the skin. In some example, at least the sealing rim 510 of the mask insert 500 may be formed from a biocompatible material. For example, the sealing rim may be formed from a plastics, polymer or composite material. In some examples, the sealing rim 510 of the mask insert 500 is formed from silicone. The sealing rim 510 may additionally or alternatively be configured to have a desired degree of flexibility and/or compressibility, to enable partial conforming of the sealing rim 510 to the shape of the patient’s face. This may enhance the seal around the patient’s nose and/or mouth and/or may enhance patient comfort in wearing the mask 100.

[0062] The mask body 200 may be configured for compatibility with a plurality of mask inserts 500 of varying shapes and/or sizes. The mask 100 may be size-adjustable by selection of a specific insert size and/or shape. This may allow custom mask fitting, based on the size and/or shape of the patient’s face and, further, may allow adjustment of fit to accommodate for changes in the size and/or shape of the patient’s face over time (for example, due to growth of a child).

[0063] In some examples, the mask 100 may include one or more filters. The one or more filters may be configured to inhibit particulate matter from entering the mask. For example, one or more filters may be provided in connection with the air inlet(s) 110. Additionally or alternatively, one or more filters may be configured to inhibit moisture and/or particulate material from contacting electronic components of the mask 100. Additionally or alternatively, one or more filters may be configured to inhibit medication (for example, as contained in flow from the nebulizer unit 400 or residual medication in air exhaled by the patient) from exiting the mask 100. For example, one or more filters may be provided in connection with the air outlet(s) 530. In some examples, a filter may be provided in connection with one or more of the valves 620.

[0064] Figure 20 shows a schematic diagram of the mask 100 indicating locations of a filter 680. The filter 680 may comprise a HEPA filter. The filter 680 may be fitted to the exhalation port, before exiting the mask 100, but after the valved port 351.

[0065] The one or more filters may comprise a filter body housed in a filter housing. For example, the one or more filters may comprise a fabric filter layer housing in a shell formed from plastics or other suitable material. In some examples, the filters may be removable from the mask. The filters may be configured to be replaceable. The filters may be configured to be re-usable. For example, the filters may be configured to be re-used a predetermined number of times and/or for a predetermined period. The mask 100 may include apertures, such as slots (e.g. air inlets 110), configured to receive the filters, for example as shown in Figure 3.

[0066] In some examples, the nebulizer mechanism 400 may comprise an acoustic nebulizer. For example, the nebulizer mechanism may comprise a substrate and a vibrating element for generating vibrations in the substrate to nebulize fluid coming into contact with the substrate. In some examples, the nebulizer mechanism 400 may include at least one piezoelectric substrate and at least one interdigital transducer (IDT) on the substrate. The IDT may be configured to generate an acoustic wave in the substrate for nebulization of liquid in contact with the substrate. The liquid may be nebulized by the formation and destabilization of a capillary wave in the substrated. The acoustic wave may be a standing or travelling acoustic wave. The wave may be uni-directional or multi-directional).

[0067] One example of a nebulizer mechanism 400 is shown in Figure 22. In this example, the nebulizer mechanism 400 includes a piezoelectric substrate 420 mounted between two PCB holders 430. The nebulizer mechanism 400 utilises diametrically opposed pogo pins on a sandwich of PCBs that pin and suspend the piezo substrate 420 between them. An O-ring may be positioned between the outermost PCB and the nebuliser holder to create an airtight seal.

[0068] The nebulizer mechanism 400 may be configured to control power to the vibrating element (for example, the IDT) to control one or more parameters of the vibrations. The nebulizer mechanism may be configured to provide an alternating current signal to the IDT. The alternating current signal may have a frequency of between about 1 MHz and about 100 MHz. For example, the alternating current signal may have a frequency of about 1 MHz, about 10 MHz, about 20 MHz, about 30 MHz, about 40 MHz, about 50 MHz, about 60 MHz, about 70 MHz, about 80 MHz, about 90 MHz, about 100 M

[0069] The nebulizer mechanism 400 may be configured to eject nebulized fluid at an angle optimized for direction of the nebulized fluid towards the user’s nose and/or mouth. In some examples, the nebulizer mechanism 400 may be configured to eject the nebulized fluid at an angle relative a longitudinal axis of the patient’s body, when the mask 100 is fit to the patient’s face. The nebulizer mechanism 400 may be configured such that the substrate (such as the piezoelectric substrate) is positioned at a predetermined angle relative to the longitudinal axis of the patient’s body when the mask 100 is fit to the patient’s face. The predetermined angle may be between about 5° and about 60°, between about 10° and about 50°, between about 20° and about 40°, or between about 25° and about 35°, such as about 10°, about 20°, about 30° about 40° about 50° or about 60°. In some examples, the angle of the substrate may be determined in combination with an angle at which the fluid is nebulized from the substrate of the nebulizer mechanism 400. For example, in an acoustic nebulizer unit, fluid coming into contact with the substrate may be nebulised at a characteristic angle (the Rayleigh angle, 23°) relative to the plane of the substrate. The substrate may be positioned, taking into account the angle at which fluid will leave the plane of the substrate when nebulized, such that the fluid is directed toward the patient’s nose and/or mouth. The position and/or angle of the substrate of the nebulizer mechanism 400 may be optimised such that the distance from the substrate to the patient’s nose and/or mouth is minimised.

[0070] From Figure 9, it can be appreciated that, in this example, when the cover 280 is closed the substrate of the nebulizer unit 400 will form an angle of approximately 10° relative to vertical based on the orientation of the mask 100 as illustrated (and thus relative to the longitudinal axis of the patient’s body, as the orientation of the mask 100 as illustrated in the Figures approximates the orientation of the mask 100 when the mask 100 is fit to the patient’s face and the patient is upright). By contrast, in the example mask 100 shown in Figure 13, the substrate of the nebulizer unit 400 forms an angle of approximately 30° relative to vertical (and thus relative to the longitudinal axis of the patient’s body when the mask 100 is fit to the patient’s face). The cover 280 shown in Figures 10, 14, 16 and 17 may be configured to retain the nebulizer unit 400 within the mask body 200 to position the substrate at the predetermined angle. [0071] In some examples, the air inlet 110 may be defined through the opening 270. For example, the air inlet 110 may be defined through the cover 280 as shown in Figures 23 and 24. In such examples, the mask 100 may not include a separate inlet port 111.

[0072] The mask 100 may comprise a liquid transport member configured to facilitate transport of liquid from the nebule in the nebule retainer 300 to the nebulizer mechanism 400. In some examples, the liquid transport member may comprise a wick. The wick may be formed from a hydrophilic material. For example, the wick may comprise cotton thread, nitrocellulose and/or other suitable materials. In some examples, the wick may be configured to control a flow rate of liquid along the wick. The wick may be configured to facilitate variable control of the flow rate. For example, the wick may comprise charged particles to enable control of a flow rate of the liquid along the wick (for example, by varying a porosity of the wick) in response to one or more electrical signals, for example as received from a controller of the mask 100.

[0073] The mask 100 may be configured for connection to a power supply, such as mains electricity or for connection to a portable power source, such as a battery unit. In some examples, the mask 100 may include a battery unit attached to the mask 100 and/or located at least partially within the mask 100. The mask 100 may include a power switch between the battery and the controller, allowing the battery to be easily replaced if required. The mask 100 may include a USB charging port.

[0074] In some examples, the mask 100 may be configured for connection to a battery unit external from the mask 100. The mask may include a port configured to receive a connector of a power cable for connection to the external battery unit. A nebuliser system according to the present disclosure may include the mask 100 as described herein and a battery unit. The battery unit may be configured to attach to clothing of a user and/or to fit in a user’s pocket. The mask 100 may include a power switch 660 (as indicated in Figures 14-16, for example) on the mask 100 and/or on the battery unit for powering the mask on and/or off. The power switch 600 may be located on an exterior surface of the mask body 200 In some examples, the nebuliser system includes a holder for the battery unit. The holder may be configured to be comforting for a patient using the nebuliser system. For example, the battery holder may be provided in the form of a soft pillow, or stuffed toy, such as a teddy bear or similar. The pillow or soft toy may comprise an internal compartment configured to receive the battery. The pillow or soft toy may include a closing mechanism, such as a button or zipper for securing the battery unit within the pillow or toy and/or for facilitating removal of the battery unit from the pillow or toy.

[0075] The mask 100 may include one or more sensors. For example, the one or more sensors may include a sensor 610 configured to sense data indicative of breathing of a patient. For example, the sensor 610 may comprise a flow sensor configured to sense airflow and output data indicative of airflow within the mask 100. For example, the sensor 610 may be configured to output sensed data indicative of a volume and/or velocity of air passing through the flow path. Additionally or alternatively, the sensor 610 may comprise a pressure sensor configured to sense air pressure and/or pressure changes within the mask 100 and to output sensed pressure data. The sensor 610 may be provided in fluid connection with the flow path defined between the air inlet 110 and the air outlet 530. In the example shown in Figure 10, the sensor 610 is positioned proximal to the valved air inlet 110. For example, the sensor 610 may be positioned closer to the air inlet 110 than to air outlet 530. In some examples, the nebulizer mechanism may be configured to be activated to nebulize the liquid in response to sensed data indicative of inhalation.

[0076] In some examples, the sensor 610 may include a digital flow sensor. The sensor 610 may be a PCB surface mounted component and as such would require air to flow past the PCB on which it is mounted. It has a very small cross-sectional area for sensing and the inhaled air flow must be allowed to pass through it, but not restricted to the sensing area alone. An example flow sensor 610 is shown in Figure 18, positioned adjacent to the valved air inlet port 111.

[0077] The mask 100 may include, or may be communicatively coupled with, one or more controllers. The controller may be configured to control one or more functions or parameters of the mask 100. The controller may be configured to receive sensed data from the one or more sensors of the mask 100. The controller may be configured to effect control of one or more features or functions of the nebulizer mechanism 400 and/or other electronic components of the mask 100. The controller and/or other and/or other electronic components of the mask 100 may be provided in one or more PCBs 650, such as indicated in Figures 10 and 11.

[0078] The controller may be configured to effect control of the cause activation and/or cause deactivation of the nebulizer mechanism 400. Control of the nebulizer mechanism 400 by the controller may be based at least partially on received sensed data from the one or more sensors. In some examples, the controller may be configured to cause activation of the nebulizer mechanism 400 based on received sensed data indicative of at least one inhalation of the patient. The controller may be configured to cause deactivation of the nebulizer mechanism 400 after a predetermined period of time following activation, after a predetermined period of time in which no sensed data indicative of inhalation is received, and/or upon receiving user input. Powering the nebulizer mechanism 400 selectively as the user breathes may be beneficial for power saving, preventing build-up of condensation within the mask and/or optimising medication delivery (for example by dose sparing and/or reducing wastage and thereby reducing cost to the patient).

[0079] In some examples, the nebulizer mechanism 400 may be configured to automatically deactivate to stop nebulizing the liquid. For example, the nebulizer mechanism 400 may be configured to automatically deactivate to stop nebulizing the liquid after a predetermined time, after a predetermined amount of fluid has been nebulized and/or according to a predetermined time and/or dosing schedule. In some examples, upon fluid flow from the nebule falling below a predetermined level. For example, the nebulizer mechanism 400 may be configured to detect a change in impedance in the nebuliser mechanism 400 indicative of reduced fluid flow (due to a reduction in energy transfer to the fluid) and may be configured to automatically deactivate once the sensed impedance rises above a predetermined level or beyond a predetermined change from baseline. [0080] In some embodiments, the mask 100 may include at least one processor.

Additionally or alternatively, the mask 100 may be configured for communication with an external processor. A processor according to the current disclosure may include any number of modules for performing one or more of receiving data, storing data, processing data and controlling one or more features or functions of the mask 100. The elements or modules of the processor may be collocated in a single unit, or may be provided by a combination of discrete processing units. A processor may include one or more computer systems such as a mobile phone, desktop computer, laptop computer, tablet, smartphone or other types of devices. The at least one processor may be configured to process received data from the one or more sensors, the battery, a communication unit and the nebulizer. In some examples, the mask 100 may include wireless (Bluetooth Low Energy) communication to a smartphone/tablet/computer and a companion mobile app capable of both monitoring key metrics (e.g., dosage) and/or remotely controlling the mask (e.g., remote triggering).

[0081] The mask 100 may include at least one communication unit configured to communicate with an external processor. The external processor may include a mobile device, such as a smart phone operable to execute an application (app) compatible with the mask 100. The communication unit may be communicatively coupled with the one or more the sensors, the controller, the nebulizer unit and/or the battery. The communication unit may be configured to transmit data relating to output from one or more of the sensors of the mask 100. For example, the communication unit may transmit data relating to one or more of a condition of the device, a state of the device or an identity of the device. The communication unit may be configured to transmit data to device users, payers, pharmacists, physicians, nurses, family members or other parties. The communication unit may be configured to communicate with the external processor via radio frequency signal or other communication means.

[0082] In some embodiments, the communication unit may be configured to transmit signals to and/or from the controller of the mask 100. The communication unit may be configured to receive one or more signals from an external computer to cause modifying of one or more parameters of the mask 100. [0083] The mask 100 may include a data storage unit. For example, the data storage unit may be provided as an on-board data storage unit. The data storage unit may be configured to receive data from one or more of the sensors, the controller, the processor and/or the battery. The data storage unit may be configure to at least temporarily store the received data. For example, the data storage unit may be configured to store received data for a period of time while battery power is low and/or while the communication unit is not communicatively connected to a processor. Upon reestablishing of power supply and/or re-establishing communication with the external processor, the communication unit may be configured to transmit the stored data from the data storage unit to the processor.

[0084] The mask 100 may be configured for communicative connection with a monitoring unit. The monitoring unit may include the processor and/or may be configured for communication with an external processor, such as a mobile phone or similar.. The monitoring unit may be configured to receive data from the mask 100 (for example via the communication unit) and display the received sensed data for a user to view. The monitoring unit may include a user interface. In some examples, the monitoring unit may be provided in the form of an external processing device, such as a mobile phone. The monitoring unit may provide feedback to a user to indicate one or more of a condition of the device, a state of the device or an identity of the mask 100. In some examples, a monitoring unit is provided in the form of a smart phone operable to execute an application (app) compatible with the mask 100. The smart phone app may be configured to display data relating to mask status, usage and/or dosage information.

[0085] Additionally or alternatively, the mask 100 may include one or more indicators, such as a visual, haptic and/or auditory indicators, for providing feedback to a user to indicate the condition or state of the device. The feedback may be in the form of one or more stimuli, such as visual, audible or tactile stimuli, to indicate to the user the state or condition of the device. In some examples, the mask 100 includes one or more indicator lights 120, as shown in Figure 3. The indicator lights may comprise LED lights. The lights may be configured to illuminate one or more indicia, a logo or an image on the mask to indicate a status of the mask 100 and/or a progress of therapy delivery. In other examples, the mask 100 may, additionally or alternatively, include an electronic screen for displaying information to a user.

[0086] The mask 100 may comprise one or more cooling members. The electronic components of the mask 100 may generate heat. In some examples, the mask 100 includes a cooling member in the form of a heat sink 670 configured to draw heat away from one or more electronic components of the mask 100. The heat sink 670 may be provided in fluid connection with the flow path between the air inlet 110 and the air outlet 530. The flow path may be configured to enable airflow to pass over the heat sink 670 to cool the heat sink 670. The heat sink 670 may be positioned proximal to the intake apertures 112 extending through the outer shell portion 260 of the mask 100, for example as shown in Figure 19. The heat sink 670 may be positioned in the flow path between the apertures 112 and the valved air inlet port 111, such that air can be drawn in with little resistance through the apertures 112 over the heat sink 670 through the air flow sensor 610 and into the mask 100 for breathing. An example airflow path past the heat sink 670 is indicated by the dark arrow in Figure 19.

[0087] In use, a user (such as a patient or caregiver) may insert a selected mask insert 500 to the mask body 200. The insert 500 may be selected from a plurality of inserts 500 of different sizes, and may be selected to provide a secure sealing fit around the nose and mouth of the patient (in other examples, the mask may fit around only the nose or mouth of the patient).

[0088] The user would then open the cover 280 of the mask 100 and insert a nebule into the nebule retainer 300. The user would then closing the cover 280 to enclose nebule and nebuliser unit 400 within the chamber 270. The mask 100 may be applied to the face of the patient (for example, a child in need of nebulised drug delivery), forming at least a partial seal around the nose and/or mouth of the patient. The mask may be optionally secured to the patient’s head, for example by one or more straps. The user may then power on the mask 100 and activate the nebuliser mechanism 400 to begin nebulisation of the fluid from the nebule within the mask 100. Alternatively, the nebuliser mechanism 400 may automatically activate to begin nebulisation upon detection of inhalation by the patient. The nebuliser mechanism 400 may automatically deactivate to cease nebulisation after a predetermined dose has been delivered, a predetermined time has elapsed and/or the nebule is exhausted. The make 100 may then be removed from the patient’s face and the insert 500 removed from the mask body 200 for cleaning. The cover 280 of the mask may be opened to allow removal of the used nebule, which may be disposed of appropriately.

[0089] Masks according to the present disclosure allows for nebulisation within the mask itself, without need for a nebulising unit or nebuliser chamber external to the mask or connected to the mask. Masks, or nebuliser systems including a mask according to the present disclosure may have significantly reduced size compared to conventional nebuliser systems having a nebuliser chamber external to the mask. This may enhance usability for a user desiring to use a nebuliser system. The mask may also provide increased freedom of movement for the user during pulmonary drug therapy. Further, the compact nature and portability of the mask, or systems incorporating the mask, may make it less intimidating for a user.

[0090] It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the above-described embodiments, without departing from the broad general scope of the present disclosure. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

CLAIMS:

1. A mask for delivery of a nebulized fluid to a patient for inhalation, the mask defining a cavity configured to at least partially receive a nose and/or mouth of the patient, the mask comprising: a mask body comprising an internal chamber, a nebule retainer at least partially located in the chamber, and configured to retain a nebule containing liquid to be nebulized; and a nebulizer mechanism at least partially located in the chamber, the nebulizer mechanism configured to nebulize liquid from the nebule; wherein the mask body defines a chamber outlet through the mask body for delivery of the nebulized liquid from the chamber to the cavity for inhalation.

2. The mask of claim 1, wherein the mask comprises at least one air inlet, at least one air outlet and a flow path defined between the inlet and the outlet and in fluid communication with the cavity.

3. The mask of claim 1 or claim 2, wherein the mask body comprises an outer shell portion and an inner shell portion.

4. The mask of claim 3, wherein the shell portions are connectable to each other to define the chamber therebetween.

5. The mask of any one of the preceding claims, wherein the mask body comprises an opening configured to allow insertion of a nebule to the chamber.

6. The mask of claim 5, comprising a cover portion movable between an open position and a closed position to open or close the opening.

7. The mask of claim 6, wherein the cover portion is hingedly connected to the mask body and/or removably attachable to the mask body.

8. The mask of any one of claims 5 to 7, wherein the opening extends through an outer portion of the mask body.

9. The mask of any one of the preceding claims, further comprising a mask insert releasably attachable to the mask body, the mask insert configured to contact the patient’s face.

10. The mask of claim 9, wherein the mask body and the mask insert are configured to be at least partially nested relative to each other when assembled.

11. The mask of claim 9 or claim 10, wherein the mask insert defines an opening in fluid communication with the chamber outlet of the mask body.

12. The mask of any one of claims 9 to 11, wherein the mask insert comprises a sealing rim extending around a periphery of the mask insert, the sealing rim configured to contact the patient’s face to seal around the nose and/or mouth of the patient.

13. The mask insert of claim 12, wherein the sealing rim is formed from silicone.

14. The mask of any one of claims 9 to 13, wherein the mask insert is configured to be cleanable in a domestic dishwasher machine.

15. The mask of any one of the preceding claims, comprising a sensor configured to sense data indicative of airflow and/or air pressure to detect breathing of the patient.

16. The mask of claim 15, wherein the nebulizer mechanism is configured to be activated to nebulize the liquid in response to sensed data indicative of inhalation.

17. The mask of any one of the preceding claims, wherein the nebulizer mechanism is configured to automatically deactivate to stop nebulizing the liquid upon fluid flow from the nebule falling below a predetermined level.

18. The mask of any one of the preceding claims, wherein the nebulizer mechanism comprises an acoustic nebulizer.

19. The mask of claim 18, wherein the nebulizer mechanism comprises at least one piezoelectric substrate and at least one electroacoustic transducer configured to generate an acoustic wave in the substrate for nebulization of the liquid.

20. The mask of any one of the preceding claims including one or more filters.

21. The mask of any one of the preceding claims, including a communication unit configured to communicate with at least one external computer.