FIELD

This specification describes a mask and an atomiser module for use with such a mask.

BACKGROUND

Following the outbreak of the SARS-CoV-2 pandemic, the use of masks globally has grown substantially. Masks provide wearers with protection against breathing in airborne, infectious particles and the like. Masks may be categorised under known international standards such as FFP1, FFP2 and FFP3 masks of which FFP3 masks provide the highest protection. Even higher protection is provided by masks of positive pressure systems and military grade masks. Some masks are disposable whereas others may be multi-use and require sterilisation between uses. In high-risk environments such as point- of-care environments in hospitals and clinics, masks may be provided with an airtight seal where the mask touches the wearer’s face to prevent airflow around the edge of the mask. In such masks, one or more valve assemblies having filters therein are provided to allow the wearer to breath. In many point-of-care and public-facing environments, temperature and humidity conditions are not pleasant for workers. Temperatures in such environments can get very high. Excess heat, moisture in exhaled breath, and perspiration may build up under the mask which becomes particularly problematic towards the end of a worker’s shift. It is known that some healthcare workers may work up to twelve or more hours without a break while wearing the same mask and/or other personal protective equipment (PPE) that is intended to be worn for only four or fewer hours. Whilst wearing the same mask may not be best practice, global and local equipment shortages during pandemics leave some workers with no choice but to wear the same mask for longer than is best practice. Warm, humid environments inside the mask also allow viral and/or bacterial concentration to build up on the inside surface of the mask. Eventually, the build-up of moisture in the mask leads to the path of least resistance being around the edges of the mask resulting in the mask being ineffective.

One of the inventors has previously described in WO2019/025763 an apparatus for dispensing a scent from a voice activated, wearable device worn by a patient having speech characteristics associated with mania or depression. SUMMARY

According to one aspect there is provided a mask including at least one atomiser, e.g. at least one atomiser module. In implementations the mask is configured to fit over the nose and mouth of a wearer; it may have edges or surfaces which are configured to fit against the skin so as to inhibit air flow in or out of the mask around the edges. The mask includes an atomiser coupled to a liquid reservoir to spray the liquid into a space enclosed by the mask e.g. to deliver a scent to the wearer’s nose and/or mouth or to deliver a spray of therapeutic liquid into the wearer’s lungs. The mask may include a manual or automatic trigger system to trigger delivery of the spray. Example triggers are described later.

In some implementations the mask comprises a mask front, e.g. comprising an external cover piece, having an inlet and an outlet. The outlet may comprise an outlet valve assembly e.g. configured to be positioned in front of the nose and mouth of a wearer i.e. over (rather than to one side of) the nose and/or mouth of the wearer. The mask may include a sealing structure e.g. having an opening facing the outlet valve assembly allowing air to flow from the inlet through the opening to the nose of the wearer, and a sealing surface to seal against a face of the wearer. In implementations the mask includes at least one atomiser, in implementations comprising or consisting of an atomiser module e.g. positioned at an edge of the internal sealing structure where the internal sealing structure joins the mask front e.g. where the internal sealing structure joins the external cover piece. In use, spray from the atomiser is entrained in the air (flowing from the inlet to the nose or mouth of the wearer) e.g. to deliver a scent to the wearer’s nose or to deliver a spray of therapeutic liquid into the wearer’s lungs.

Providing such an atomiser module facilitates giving the wearer a degree of control over the environment inside their mask. For example, if an unpleasant odour is building up in the mask, the atomiser module may produce a scented spray to counteract the unpleasant odour. It is believed that scented oils sprayed into the mask may impact wellbeing, improved cognition and reduce stress and anxiety of the wearer. In another example, the atomiser module may release an anti-microbial and/or anti-viral spray to combat viral and/or bacterial particle build up either in the mask or in the nose, mouth or lungs of the wearer. In some implementations, the mask comprises: a securing mechanism to secure the mask to the face of the wearer, and a trigger configured to activate the atomiser module responsive to operation of the securing mechanism on donning and/or doffing of the mask by the wearer. The securing mechanism may comprises, for example, a clasp or clip, and one or more straps, whereby the operation of the securing mechanism comprises unclasping or unclipping of the clasp or clip when the wearer dons or doffs the mask.

The trigger may comprise electronics configured to send a signal to the controller responsive to the securing mechanism being (i) secured (i.e. when the mask is donned by the wearer) and/or (ii) released (i.e. when the mask is doffed by the wearer), for example one or more switches or sensors activated upon detection that the securing mechanism has been operated (for example the opposing parts of a clip, clasp or buckle have been joined together or pulled apart).

A particular, recent problem with existing masks, particularly in high workload, under resourced hospitals during pandemics, is that clinicians working under extreme stress conditions during excessively long shifts fail to or are unable to correctly adhere to mask donning and/or doffing safety protocols due to tiredness and exhaustion. In the example of clinicians working on Covid19 wards, there are numerous reported cases where clinicians were infected with Covid19 not during ward rounds but during the brief periods where clinicians doffed their mask at the end of a shift.

Even if a hospital’s PPE doffing safety protocol includes the clinician manually spraying an anti-viral spray around the room or for inhalation, there is a likelihood that an exhausted clinician may forget to adhere to this part of the protocol and thus he or she risks infection. This is something that may prove fatal in a hospital environment where staff are unnecessarily put at risk and staff absence due to illness may comprise patient safety. Accordingly, the present disclosure mitigates this problem by linking the activation of the trigger to the donning and doffing of the mask. As the clinician will always don their mask at the beginning of a shift and always doff their mask at the end of a shift regardless of exhaustion levels (i.e. taking uncomfortable PPE off at the end of a shift is often welcome relief for the clinician), adherence to the safety protocol is effectively taken out of the hands of the exhausted clinician. As the world has not experienced a pandemic of the scale of Covid19 in recent history, non-adherence to mask donning and doffing protocols due to exhaustion is a new phenomenon which the trigger of the present disclosure is able to effectively mitigate.

In some implementations, the mask comprises a chassis fixed to an inside surface of the mask and wherein the atomiser module is releasably secured to the chassis when in use.

Advantageously, this allows the atomiser module to be reused as the spent component of the mask (i.e. the cartridge with wick as will be described later) can be easily released and replaced with a refilled or new cartridge simply by releasing the atomiser module from the chassis. Further, it advantageously allows the atomiser to be used for different use cases, for example by allowing the use of a variety of interchangeable spray types and/or combinations thereof for different use cases. As will be described below, when the atomisable liquid in a cartridge is spent, the wearer need only release the atomiser module from the chassis thereby providing access to the cartridge with wick which can then be replaced with a new one. For example, where a wearer wishes to replace a scented oil cartridge with an anti-microbial one, the wearer need only to remove the scented oil cartridge and replace it with an anti-microbial wash cartridge.

In some implementations, the cartridge comprises a wick soaked in an atomisable liquid releasably secured to the atomiser module when in use.

Advantageously, the wick traps particulates and other impurities in the atomisable liquid as it is drawn through the wick. Thus, the risk of such particulates and other impurities blocking a dispensing hole of the atomiser module through which the spray is produced is reduced. This greatly enhances the reliability of the atomiser module. Optionally, the wick itself may be releasable from the cartridge. Advantageously, providing the cartridge itself with a releasable wick improves the environmentally friendly characteristics of the atomiser module as spent cartridges may be refilled either by opening of the cartridge and applying fresh atomisable liquid to the wick, for example with a pipette, or simply by releasing the wick from the cartridge and replacing it with a newly soaked wick. Thus, the entire cartridge need not be disposed of when it is spent. In some implementations, the atomiser module comprises an ultrasound generator to configured to generate ultrasound to atomise the atomisable liquid to release said spray from the atomiser module.

Advantageously, an ultrasound generator such as a disk driven by a voltage to vibrate at ultrasound frequencies comprises a plurality of dispensing holes, for example hundreds or thousands of dispensing holes. If one of the dispensing holes becomes blocked by particulates and other impurities in the atomisable liquid, the device is still able to function effectively as the other dispensing holes remain unblocked. This greatly enhances the reliability of the atomiser module. Accordingly, the combination of the features of a wick which traps particulates and other impurities with an ultrasound generator with a plurality of dispensing holes which prevent a small number of blockages from effecting the dispensing synergistically work together greatly improve reliability of the device. Further, an ultrasonic disk provides for faster delivery of a given volume of atomisable liquid (compared to single nozzle delivery methods) which may be necessary when an atomisable liquid has been diluted to reduce its concentration. Further, the dispensing holes in an ultrasonic disk are too small for the atomisable liquid to exit when the disk is not vibrating. Thus, advantageously, no additional components are required to prevent leaks from the atomiser module dispensing holes.

In some implementations the mask has an atomiser mount on an inside surface of the mask. The atomiser module may, but need not, be an ultrasonic atomiser module comprising an atomiser plate, e.g. a piezoelectric plate, with one or more holes through which the spray is dispensed. For example in some implementations the atomiser may have a single nozzle rather than e.g. a plate with multiple apertures functioning as nozzles. In implementations the atomiser module includes a removeable cartridge comprising a wick to hold an atomisable liquid for the spray. The removeable cartridge is configured to seal the wick against the atomiser plate (or nozzle/nozzle assembly) when installed in the atomser module e.g. using an O-ring. When the removeable cartridge is installed in the atomiser module without sealing the wick against the atomiser plate, e.g. because the removeable cartridge screws into the atomiser module and is insufficiently screwed in, a portion of the removeable cartridge protrudes from the atomiser module and inhibits the atomiser module from fully engaging with the atomiser mount. This helps ensure correct use of the mask, particularly for untrained users, and can reduce liquid wastage, both of which are useful for some of the described the applications.

In some implementations the mask comprises a controller communicatively coupled with the ultrasound generator and configured to control the ultrasound generator responsive to a signal received from a trigger e.g. from an electronic trigger system responsive to a condition or action of the user.

Advantageously, atomising the atomisable liquid with ultrasound controlled by a controller in the mask allows a high volume of spray to be dispensed over a very short period of time, for example between 0.5 - 3 seconds, preferably around 0.7 seconds. Thus the atomiser module provides a higher and shorter intensity scent peak than other dispensing methods. The present disclosure is accordingly particularly useful in scenarios where there is a desire to avoid a constant, low inhalation of atomised liquid but instead to provide short, intense bursts. Further, the controller advantageously allows for a degree of control over the dispensing rate. For example, the spray volume required to adequately scent the inside of a mask using scented oil cartridge may be very different to the spray volume required to decontaminate the inside of the mask or the inside of a wearer’s nose with an anti-microbial spray. The ultrasound generator controlled by a controller is able to provide a degree of control of spray volume that allows the atomiser module to be used with different spray types that require different doses.

In some implementations, the controller comprises an integrated circuit and a recharchable battery on a printed circuit board (PCB) mounted in the mask and communicatively coupled to the ultrasound generator in the atomiser module.

Advantageously, by providing the controller and its components on a PCB in the mask, rather than in the atomiser module, it allows the atomiser module itself to be made compact and lightweight. Thus, when the wearer releases and/or replaces the atomiser module, the atomiser module is small, compact and lightweight and can be stored, for example, in the wearer’s pockets until the wearer is able to reach a suitable cartridge refill or disposal station to prepare the atomiser module for fresh use. Whilst it is primarily envisaged that the trigger is linked to the securing mechanism of the mask so that the challenging problems of non-adherence to mask donning and doffing protocols is mitigated, other trigger examples are also possible and may provide other advantages in different situations. For example, in other implementations the trigger comprises a wearable sensor and/or a button. For example, the trigger may be a button sewn or otherwise integrated into a collar, a sleeve cuff, PPE, or other item of clothing of the wearer. When the wearer wishes to generate spray inside the mask, the wearer presses the button to send a signal to the controller to cause the ultrasound generator to generate spray which becomes entrained in the air entering the mask through the inlets which is then inhaled by the wearer. Alternatively, the trigger may be a wearable sensor such as a microphone able to record a wearer’s voice. A known speech recognition algorithm may then be used to recognise a command word or words to send a signal from the trigger to the controller to cause the ultrasound generator to generate the spray. A signal from the microphone indicating an increasing sound volume may be used to detect proximity of an approaching person that may act as a trigger to provide, for example, anti-Covid19 protection in crowded places where social distancing is difficult to maintain. Other wearable sensors envisaged include: a moisture or humidity sensor inside the mask that sends a signal to the controller when a threshold moisture level is reached, a temperature sensor that sends a signal to the controller when a threshold temperature level is reached, a proximity sensor or location sensor to trigger on entry/exit of a known hazardous location such as a Covid19 ward or crowded public transport, a V02 sensor that sends a signal when a threshold oxygen level is reached, and/or a pressure sensor. In the case where an oxygen level sensor is used, this may be incorporated as part of a hypoxia scented warning system for, e.g. a pilot in an aircraft. Whereby a scent is released when dangerously low levels of oxygen are detected to alert the pilot.

Additionally or alternatively, a timer may be incorporated into the trigger to send a signal to the controller to generate a spray at predetermined intervals. In some implementations a control system may be configured to deliver a sequence of sprays of one or more scented liquids e.g. with a determined duration and/or interval and/or scent sequence, e.g. for post-COVID “smell training”. For example, a dosage may be delivered and, after a 5 minute wait, the timer triggers a further dose. This has been found to be beneficial in a number of nasal spray studies (e.g. using esketamine and/or a vaping system). In some implementations, it is envisaged that data from one or more of the pressure sensor, temperature sensor and/or humidity sensor may be used to determine if the mask is operating correctly. For example, the pressure sensor can detect pressure changes during inhalation and exhalation cycles. If the pressure during these cycles exceeds a predetermined threshold, it may be indicative that there is a blockage in one or both of the valve assemblies or that a filter is full and requires replacing. Alternatively, if the pressure drops below a predetermined threshold, it may be indicative of a leaky mask, for example because of an incorrect fit or a damaged valve. Detection of inhalation and exhalation cycles may also be used to ensure a spray is dispensed during or (slightly) before an inhalation cycle to avoid wasting atomisable liquid; more generally the system may be configured such that a timing of the spray is dependent upon a pressure signal from the pressure sensor, optionally in conjunction with one or more other trigger signals. Electronics to process said data may be provided on the mask, for example with an application specific integrated circuit and/ora processor. In some cases, it may be that the ultrasound generator takes a short time, for example around 0.5-0.7 seconds, to reach a target frequency before a suitable volume of spray is dispensed. The detection of inhalation and exhalation cycles may be used to pre-empt the next inhalation cycle to allow the short delay to occur during the exhalation cycle, allowing the spray to be timed to coincide with the beginning of an inhalation cycle.

Advantageously, by using a trigger comprising a wearable sensor and/or a button, the wearer can easily activate the ultrasound generator without needing to remove the mask and/or other PPE he or she may be wearing thus minimising the risk of inadvertent infection that otherwise results from mask or other PPE removal. Additionally, the wearer need not think about carrying the trigger with him or her thus providing a completely hands-free solution. For example, in the voice activation example, where a surgeon is unable to take his hands off a patient during a surgery, he may simply use the microphone trigger to activate the atomiser module to allow him to continue his surgery uninterrupted. Although it will be appreciated that care must be taken that the mask and atomiser module do not interfere with equipment such as nearby MRI scanners.

It is envisaged that in some implementations, multiple triggers may be used, for example the trigger in the securing mechanism may be present in addition to one or more of the other triggers described above. In some implementations, the trigger is communicatively coupled with the controller using a shortwave radio, Bluetooth, or other wireless communication protocol, and/or a wired connection.

For example, the controller may comprise communication components such as a radio module, a Bluetooth module, or other wireless communication protocol module and/or port for a wired connection to communicate with the trigger having corresponding components. Advantageously, in the case where the communication is wireless, the wearer need not worry about wires becoming entangled and or taking up space on or around the wearer. For example, a surgeon need not worry that trigger wires will interfere with a surgery.

As described in the examples above, the spray may comprise atomised scented oil, and/or an atomised anti-microbial cleansing wash such as ear, nose, throat (ENT) liquids such as saline-sprays and the like that provide the nose as a route to therapy. It is also envisaged that the spray may comprise other atomised ENT liquids such as medical cannabis vapour sprays, including cannabidol (CBD) and tetrahydrocannabidol (THC) sprays and/or other hemp oil vapour sprays. Advantageously, the mask of the present invention allows the use these to be interchangeable simply by replacing the cartridge with one that generates the desired spray type.

In some implementations, the inlet comprises an inlet valve assembly. In some implementations the inlet and/or outlet valve assemblies may be one-way valve assemblies..

In some implementations, the mask comprises a plurality of the above atomiser modules. In some implementations, the respective wicks of the plurality of the cartridges of the atomiser modules are soaked in different atomisable liquids to allow the mask to provide blends of said atomisable liquids in said spray.

Advantageously, this allows a wearer to customise a mix or blend of different spray types or, if a plurality of the same spray type cartridges are used, provides for longer use times before the reloading with a new or refilled cartridge is required. For example, it is envisaged that one atomiser module having a scented spray may be used in combination with an atomiser module having an anti-microbial spray thereby providing a spray blend. Additionally and/or alternatively, each individual atomiser module and the potential combinations thereof allow a higher number of unique scents to be provided to reduce the risk of smell blindness occurring (that is, where a wearer becomes so used to a given scent that they are less sensitive to it and require a higher intensity to experience the same sensation).

In some implementations, the mask comprises one or more of:

(i) an optical indicator e.g. a light emitting diode (LED) configured to emit a light sequence on release of said spray by the atomiser module, the light sequence being indicative of a breathing pattern for the wearer to follow. The indicator may be located on the mask or remotely e.g. the mask may be coupled to a mobile electronic device such as a mobile phone or computing device to provide feedback.

(ii) a haptic feedback generator configured to generate haptic feedback for the wearer on release of said spray by the atomiser module, the haptic feedback being indicative of a breathing pattern for the wearer to follow. The haptic feedback may be delivered via a transducer or the mask may be coupled to a mobile electronic device such as a mobile phone or computing device to provide feedback.

(iii) a sound generating device, e.g. a speaker, in the mask or in an associated device, configured to generate an audible sound on release of said spray by the atomiser module, the audible sound being indicative of a breathing pattern for the wearer to follow.

(iv) a vagus nerve stimulator configured to stimulate the vagus nerve with a pulse of electricity on release of said spray by the atomiser module.

Advantageously, these stimuli may provide active direction and guidance to the mask wearer to follow a specific breathing pattern thereby acting as a breathing coach, and/or to induce calm by a sensory stimulus in a wearer who is otherwise undergoing a panic attack. For example the mask may include a control system configured to control an indicator e.g. as described in (i)-(iv) above, to provide a breathing indication to the user e.g. to indicate when the user should breath in (e.g. when the user should start or finish breathing in), and/or hold breath, and/or breath out (e.g. when the user should start or finish breathing in). The breathing indication may indicate one or more different breathing patterns; data indicating the breathing pattern(s) may be stored in memory. Many such patterns are known, e.g. 4-7-8 pattern (breath in for 4 seconds, hold breath for 7 seconds, breath out for 8 seconds) for relaxation; or the pattern may simply indicate a normal resting or active human breathing pattern.

Accordingly, the described mask may be used to reduce panic in real-time (for example during a panic attack). It may also be used to treat longer term breathing problems because the wearer does not need to actively think of a breathing pattern to follow and can instead simply follow the stimuli provided by the mask, slowly allowing muscle memory to take over again. It is thus envisaged that the mask may be helpful for patients with many types of breathing difficulty e.g. in teaching patients suffering from long Covid19 breathing problems to breath normally again. For example, this type of breath work (using e.g. a WimHof Method, coherence breathing, hyperbaric oxygen (HBO) therapy) may help to reduce brain fog, and inflammation, boost energy levels, and help those suffering long Covid.

For example, the indicator e.g. LED (or LEDs) may provide a predetermined sequence indicating set by the wearer or their physician. An example predetermined indicator e.g. LED sequence may be as follows. First, a red LED is turned on at the same time as the spray is released indicating the wearer must take a deep breath through their nose for 4 seconds. Second, a blue LED is turned on indicating the wearer must hold their breath 7 seconds. Third, a yellow LED is turned on indicating the wearer must exhale slowly over 8 seconds. One of the inventors has found this sequence results in a calm, relaxed and grounded feeling in the wearer. Other time sequences and LED colours are also envisaged. Synergistically, combining scent stimuli of the spray with one or more other stimuli may improve the ability of the patient to breathe without needing to actively think about it.

Whilst it is envisaged that the LED, haptic feedback generator and/or speaker are embedded in the mask, they may instead be provided as wearable items connected to the mask with a wired or wireless connection, for example attached to glasses, a watch, earphones. In the case of the vagus nerve stimulator, this may be connected to the mask through a wireless or wired connection and to the user e.g. via an ear clip. In some implementations, the mask may be an eye mask rather than a PPE mask. A sound generating device may be provided with the eye mask to in a similar manner and with similar functionality to that described above to provide an eye mask that provides both scent and sound to the wearer

According to another aspect, there is provided an atomiser module for use in a mask, such as the mask of any of the implementations described above, or any other mask such as simple surgical masks and those without any valve assemblies. The atomiser may be provided with a chassis fixed to an inside surface of the mask, and a cartridge comprising a wick soaked in an atomisable liquid releasably secured to the atomiser module when in use. The atomiser module comprises an ultrasound generator to generate ultrasound to atomise the atomisable liquid to release said spray from the atomiser module into the mask. The ultrasound generator may be communicatively coupled to a controller, for example in the mask or elsewhere on a wearer, and may be configured to control the ultrasound generator responsive to a signal received from a trigger.

In some implementations, the chassis is fixed to an inside surface of the mask and the atomiser module is configured to directly release the spray inside the mask. In other implementations, the atomiser module comprises a conduit, for example a flexible tube, to communicate the spray from the atomiser module into said mask. It is envisaged that such an arrangement is particularly useful for smaller, lighter-weight masks that do not have the space to hold the atomiser module. Accordingly, advantageously, this allows the atomiser module to be secured to the wearer without using a chassis inside the mask thereby providing a space saving inside the mask.

In some implementations, the wick of the atomiser module comprises one or more capillaries configured to hold the atomisable liquid therein. In some implementations, the wick is housed in a cap having a screw thread for mating engagement with a corresponding screw thread in the cartridge to provide said releasable securing to the cartridge.

In some implementations of this and other aspects of the system the wick is split longitudinally along part of all of its length. That is the wick may divided into two or more parts by a division extending in a longitudinal direction from a tip of the wick (which tip, in use, contacts the plate or nozzle of the atomiser module) towards a base of the wick, optionally completely dividing the wick into two or more portions. Then each portion may be loaded with a different liquid to be atomised e.g. with a pipette; and/or the wick may contact a reservoir similarly divided into two or more portions each to hold a different liquid for dispensing. The reservoir may be provided by a base of the cap.

Whether or not the wick is divided, in some implementations the reservoir e.g. in the cap, may extend laterally beyond a width of the wick, to provide additional volume for storing liquid for dispensing.

In some implementations a tip of the wick i.e. an end of the wick which, in use, contacts the plate or nozzle of the atomiser module, may be conical or dome-shaped. This can facilitate better engagement of the wick with the nozzle or plate, and can direct liquid to be dispensed towards the nozzle or towards holes in the plate (which are typically centrally located), thus facilitating efficient use of the liquid to be dispensed. This shape of wick can also provide some compliance e.g. where a mechanism is provided to ensure that the atomiser module can only be fixed in the chassis or holder when the removeable cartridge is fully installed in the atomiser module e.g. when the cap is fully tightened.

In another aspect an atomiser assembly for a mask comprises an atomiser mount and an ultrasonic atomiser module. The ultrasonic atomiser module may, but need not, comprise an atomiser plate, e.g. a piezoelectric plate, with one or more holes through which a spray of liquid is dispensed. For example in some implementations the ultrasonic atomiser module may have a single nozzle rather than e.g. a plate with multiple apertures functioning as nozzles. The atomiser module may include a removeable cartridge comprising a wick to hold an atomisable liquid for the spray. The removeable cartridge may be configured to seal the wick against the atomiser plate (or nozzle/nozzle assembly) when installed in the atomser module. In implementations when the removeable cartridge is installed in the atomiser module without sealing the wick against the atomiser plate a portion of the removeable cartridge protrudes from the atomiser module and inhibits the atomiser module from fully engaging with the atomiser mount.

There is also provided a mask comprising the atomiser assembly or previously described atomiser module. In implementations the spray is dispensed such that it is entrained in air within the mask. For example the atomiser assembly or atomiser module may be within the mask or a spray output of the assembly or module may be connected to the mask i.e. to an air space between the mask and the user’s face.

The atomiser module and atomiser assembly can provide the advantages described in connection with the mask above.

Features and aspects of the above described mask may be combined e.g. to meet the requirements of a particular application.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects of the invention will now be further described, by way of example only, with reference to the accompanying figures in which:

Figures 1 a and 1 b show perspective views of a mask according to the present disclosure.

Figure 2 shows an exploded view of the mask of Figures 1a and 1b.

Figure 3 shows a cut-away view of the mask of Figures 1a and 1b.

Figures 4a and 4b show perspective views of an atomiser module according to the present disclosure.

Figure 5 shows a cross-section of the atomiser module of Figures 4a and 4b.

Figure 6 shows an illustrative view of an eye mask with incorporated atomiser modules according to the present disclosure.

Like elements are indicated by like reference numerals.

DETAILED DESCRIPTION

Figures 1a, 1b, 2 and 3 variously show perspective, exploded and cut-away views of a mask 100 according to the present disclosure. The mask 100 comprises a mask front or external cover piece 101, for example a silicon mask front or “chassis”, with an inlet 102 and an outlet 103. The inlet 102 and outlet 103 respectively provide a path for air to enter and exit the inside of the mask when it is sealed to a wearer’s face. It is envisaged that a plurality of inlets 102 may be provided on the mask 100, for example two inlets 102 positioned symmetrically on either side of the outlet 103. The outlet 103 comprises an outlet valve assembly 104 configured to be positioned in front of, more particularly over, and in implementations in proximity to, the nose of a wearer when the mask 100 is being worn. The mask 100 further comprises an internal sealing structure 105 having an opening 106 facing the outlet valve assembly 104 and a sealing surface arranged to seal against a surface of a wearer’s face when the mask 100 is being worn. The internal sealing structure 105 may accordingly be shaped to fit over the nose and mouth portions of the wearer’s face. In some implementations, the internal sealing structure 105 may be integral with the mask front e.g. external cover piece 101 but resiliently deformable, for example when comprised of silicon, to provide access to the other components inside the mask. In other implementations, the internal sealing structure 105 may be removably connected to the mask front e.g. external cover piece 101 with a push fit configuration.

The mask 100 further comprises one or more atomiser modules 107, two in the illustrated example. The atomiser modules 107 in Figure 1a are not shown as they are hidden behind the internal sealing structure 105. The atomiser module is shown in Figures 2 and 3. In implementations the atomiser module 107 is positioned at an edge of the internal sealing structure 105 where the internal sealing structure 105 joins the mask front (external cover piece) 101. The cut-away view of Figure 3 illustrates the atomiser module 107 positioning relative to the internal sealing structure 105 and mask front (external cover piece) 101. When the wearer inhales, air is drawn through the inlet, over the edge of the opening 106 of the internal sealing structure 105 and to the nose or mouth of the wearer. When the atomiser module 107 produces a spray, it disperses into the air flowing from the inlet 102 through the opening 106 of the internal sealing structure 105 until it reaches the wearer. When the spray is made up of atomised scented oil particles, the wearer will experience a pleasant smell sensation as the particles enter the nose. When the spray is made up of atomised anti-microbial particles, for example an anti-microbial mist, these may enter the wearer’s nose and inactivate viral, bacterial and/or fungal particles in the wearer’s nose. It is envisaged that a plurality of atomiser modules 107 may also be provided. For example, where two inlets 102 are provided, two atomiser modules 107 may also be provided symmetrically on either side of the internal sealing structure 105. The mask 100 may optionally be provided with a plastic shell 108 and/or breathable cosmetic fabric cover 109 secured to the mask front e.g. external cover piece 101 using one or more attachment points 110. The mask 100 can be secured to the wearer’s face using one or more straps (not shown) using one or more attachment points 111 on the mask front e.g. external cover piece 101 and/or on plastic shell 108. The plastic shell 108 is provided with air holes 112 to allow air to reach the inlet 102.

The mask 100 of Figures 1a, 1b, 2 and 3 further comprises a controller 113 communicatively coupled to the atomiser module 107 when in use and comprising an integrated circuit 114 and a rechargeable battery 115 on a printed circuit board (PCB) 116 mounted in the mask 100, for example between the internal sealing structure 105 and the mask front e.g. external cover piece 101. A battery port 117 and battery port cover 117 are provided to allow a power source to be connected to the battery 115 to recharge it. The battery port may comprise a USB port which, in addition to allowing recharging of the battery, allows a wired connection to be established to the integrated circuit 114.

The inlet 102 or plurality of inlets where present each comprise an inlet valve assembly 119, and one or more filters (for example FFP1 , FFP2, or FFP3 filters) and/or be one way valve assemblies to reduce the risk of inadvertently allowing external particles from entering the inside of the mask.

Figures 4a, 4b and 5 variously show perspective views and a cross-sectional view of an atomiser module 107 according to the present disclosure. An atomiser mount or chassis 200 is configured to be fixed to an inside surface of the mask 100, or is provided as part of the mask 100, and the atomiser module 107 is releasably secured to the chassis 200 when in use. The atomiser module 107 may comprise two outer housing components 201a, 201b joined with a snap fit connection, and a resiliently deformable tab or clip 202 with a protrusion 202a which the wearer may press to release the protrusion 202a from an opening 200a in the chassis 200. Thus a convenient “click-in-click-out” mechanism is provided to allow the atomiser module 107 to be releasably secured to the chassis 200. As described above and shown in Figure 3, the chassis 200 may be fixed to an inside surface of the mask 100 by, for example, being squeezed between a portion of the internal sealing structure 105 that folds in on itself at an edge and the mask front e.g. external cover piece 101 and/or by using an adhesive such as glue. It is also envisaged that the chassis may be moulded integrally with the mask front e.g. external cover piece and/or internal sealing structure of the mask.

The atomiser module 107 comprises a cartridge 201 comprising a wick 203 soaked in an atomisable liquid, for example a scented oil or an anti-microbial liquid, and held in a cap 204 releasably secured to the atomiser module 107 by the engagement of a threading on the cap 203 with corresponding threading on the inside of the atomiser module 107. To ensure the atomisable liquid does not leak out of the cartridge 201 , the wick 203 is held in a glass liner or vial in the cap 204 and one or more suitable gaskets 205, such as O-rings, are provided to provide a liquid tight seal. Alternatively, the liner or vial may be made of a bioplastics material, if any solvent in the atomisable liquid permit use of bioplastics, for improved recyclability. It is envisaged that the length of the thread may be determined by the position of where the protrusion 202a of the clip 202 connects to the opening 200a in the chassis 200. Thus, when the cap 204 is fully screwed into the atomiser module 107, it is flush with an outer surface (for example a lower surface) of the housing 201b of the atomiser module 107 allowing the atomiser module 107 to fit correctly into the chassis 200. If the cap 204 is not fully screwed into the atomiser module 107, for example due to user error or because of an ill-fitting wick, the cap 204 will not flush with the housing 201b. This prevents the protrusion 202a from clicking into the opening 200a on the chassis 200 and thus indicates to the user that the cap 204 and/or wick are not fitted correctly before use. Accordingly, if the cartridge 201 is not correctly or fully fitted to the atomiser module 107, the atomiser module 107 will not fit in the chassis 200,

The atomiser module 107 further comprises an ultrasound generator 207 to generate ultrasound to atomise the atomisable liquid to release the spray from the atomiser module 107. The ultrasound generator 207 comprises an ultrasonic disk 208, for example a piezoelectric disk (with a plurality of dispensing holes therein) that deforms in response to an electric signal. By providing an electric signal of a suitable frequency to the ultrasonic disk 208, the disk 208 vibrates at an ultrasound frequency against an upper surface of the wick. This atomises the atomisable liquid in the wick which passes through one or more of the dispensing holes in the ultrasonic disk 208 and disperses into the air in the mask 100. The atomiser module 107 is accordingly provided with one or more wires 209 and connectors 210, for example pogo pin connectors, and an internal PCB 211 joining them to communicate a signal to the ultrasonic disk 208. When the atomiser module is secured to the chassis 200, the connectors 210 communicatively couple the ultrasound generator 207 to the controller 113 in the mask 100 which provides a control signal of a desired frequency.

In some implementations, the chassis 200 comprises its own PCB 212 having contact pads or conductive traces thereon that lead to the controller 113. In other implementations, the PCB 116 of the controller extends into the chassis 200 allowing direct coupling of the connectors 200 to the PCB 116.

As will be appreciated, the present disclosure provides a way to dispense a spray to provide a bio-synchronised scent bubble in a mask according to vital signs, environmental information, and emotional or sensory clues that are analysed for context that may provide protection from, for example, anxiety, panic attacks, and PTSD to reduce psychological trauma. As well as anti-viral protection in environments with a high viral load such as medical wards, hospitals and the like.

Figure 6 illustratively shows a mask 300 according to the present disclosure where the mask is an eye mask. The mask comprises a eye-covering portion 301, one or more atomiser modules 302a, 302b of the type described above, and an audio generator to provide audio stimulation to the wearer. In the example of Figure 6, there atomiser modules with scent cartridges. Sound from the audio generators is generated at the ears of the user and may be controlled by an external source, such as sensors around the user’s environment. It is envisaged that scent is released from the modules down towards the nose in response to sound and physiological and psychological response as detected by the various sensors embedded in the environment around the user. This example eye mask has applications such as those described above and below, but could be used in conjunction with seat/bed in an aircraft for long flights to aid sleep and restlessness or reset circadian rhythms, and so on. A further use of such an eye mask may be, for example, in psychedelic assisted psychotherapy settings.

No doubt many other effective alternatives will occur to the skilled person. It will be understood that the invention is not limited to the described embodiments and encompasses modifications apparent to those skilled in the art lying within the scope of the claims appended hereto. For example, it is envisaged that the trigger referred to herein may comprise one or more of a:

• a button (e.g. sewn into or otherwise integrated into a collar, sleeve cuff, PPE or other item of clothing);

• temperature sensor inside the mask;

• a microphone;

• a moisture sensor inside the mask;

• a location sensor detecting entry/exit to a hazardous location (such as a Covid19 hospital ward or public transport);

• a proximity sensor (including, for example a microphone detecting increasing volume indicating approaching person);

• playing of a sound such as music from a playlist (for example from a smartphone music app);

• biometric sensors (including heart rate variability (HRV), electroencephalogram (EEG), skin conductance / Galvanic skin response (GSR), ECG, humidity, and the like);

• electronic nose sensor configured to detect emotional body odour (such as emotional stress composition in sweat)

• sensors configured to detect one or more external factors such as blue light presence or intensity, social media/text signals, predictive signals/voice analytics to determine mood, HCI data and the like.

For example, it is envisaged that the atomisable anti-microbial liquid may comprise one or more of:

• scented oils;

• decongestants (including menthol-and eucalyptus-based);

• anti-microbial cleansing washes (such as ENT liquids including HOCI);

• vaping fluids;

• medical cannabis produces (including CBD and THC sprays and other hemp oil vapour sprays);

• psycho-active substances - delivered intranasally: psilocybin, ketamine, 5- methoxy-N,N-dimethyltryptamine (5-MEO-DMT); • intranasal pharmacologically active compounds with poor stability in gastrointestinal fluids, poor intestinal absorption or unfavourable gastrointestinal and hepatic pre-systemic metabolism;

• a peptide drug as a nasal spray (hormone replacement) treatments in different diseases;

^• a drug to treat a nasal disorder e.g. an implementation of a mask as described herein may be used as a wearable nebuliser e.g. to administer a drug to treat a nose bleed (e.g. Hereditary Hemorrhagic Telangiectasia), a nasal polyp, or nasal cavity damage from drug abuse ;

• ENT saline-sprays in chronic rhinosinusitis (CRS);

• ENT liquids for CNS and endocrine disorders;

• sea-water solution (Isotonic nasal hygiene) supplemented with/without algal extracts for Allergic Rhinitis (AR), for example as described in Dror, A. A. et al. Reduction of allergic rhinitis symptoms with face mask usage during the COVID-19pandemic. J. Allergy Clin. Immunol. Pract (2020);

• corticosteroids or corticosteroid /LABA combination effectively inhaled into both mouth and nose at same time for asthma;

• anti-viral molecules for the reduction of COVID-19 transmission (for nasal administration or otherwise), for example as described in Ku, Z., Xie, X., Hinton, P.R. et al. Nasal delivery of an IgM offers broad protection from SARS-CoV-2 variants. Nature (2021) “Nasal delivery of an IgM offers broad protection from SARS-CoV-2 variants”;

• syntocinon nasal spray containing oxytocin is used to increase duration and strength of contractions during labour;

• adrenalin for, for example, anaphylaxis therapy;

• nicotine nasal spray - an aqueous solution of nicotine intended for administration as a metered spray to the nasal mucosa;

• intranasal antihistamine (INAH) spray formulations

• intranasal anticholinergic agents (INAA) can lead to the reduction of rhinorrhoea in Allergic Rhinitis (AR);

• nasal lysine aspirin treatment after desensitization (nATAD) has been used to treat N-ERD patients;

• nasal rescue medicines (nasal forms of benzodiazepines);

• N-acetylcysteine (NAC) for treatment of mild traumatic brain injury (mTBI) using intranasal administration for direct nose-to-brain delivery. • Mescaline, 3,4-methylenedioxymethamphetamine (MDMA), Lysergic acid diethylamide (LSD), N, N-dimethyltryptamine (DMT), noribogaine, Ayahuasca, etc.

• Red seaweed (carrageen), brown seaweed (fucoidan), etc. The former has been shown to protect in some cases against Covid, for example as described at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8493111/ (red seaweed has been proven to protect against SARS-CoV-2 infection in health care personnel treated with an iota-carrageenan nasal spray).

• scented oils; examples with evidence-based on inhalation include e.g. lavender and neroli

• nootropics and cognitive-enhancing substances, etc.

• AR (augmented reality) or VR (virtual reality) based systems, e.g. to deliver a liquid with a smell (or other "active" property) to the user under the control of an external AR/VR system e.g. to enhance an immersive experience or guided VR meditation or to alter states of consciousness.

• Flavours - to enhance the olfactory experience (gastronomy), enhance appetite and for diet.

• Mouth spray (oromucosal sprays) to treat muscle stiffness and spasms (spasticity) caused by MS.

• Breath actuated sensors (as in vaping devices)

• Microdosing substances

As will be appreciated by the skilled person, administering the above atomisable liquids may be advantageous compared to other methods of administering. For example, while the intranasal administration of drugs for the treatment of nasal diseases is well- established, intranasal drug delivery is increasingly recognized as being a useful and reliable alternative to oral and parenteral application of drugs for systemic diseases and the nasal mucosa has emerged as a therapeutically viable route for systemic drug delivery. In particular, nasal delivery are understood to be able to circumvent the blood- brain barrier allowing direct drug delivery in the biophase of central nervous system- active compounds. The mask according to the present disclosure is accordingly particularly suitable for, although not limited to, such use.

For example, the mask and the atomiser module may be manufactured using recycled materials and/or be made wholly or partly of biocompostable materials. For example, the length of the pulse emitting the spray can be shortened or increased to provide a suitable dose of spray, for example for individual requirements or for a specific dilution of the atomisable liquid contained in the cartridge. The length of the pulse may be limited for safety reasons and to prevent a wearer becoming dependent on the scent. Similarly, it is envisaged there may be a minimum time before a repeat spray dose can be activated for the same reasons.

For example, the atomiser module may be controlled from a software application in a smart phone or other handheld device.

For example, it is envisaged the cartridge may also be provided with a storage or refill container for it to be screwed into when not in use with the atomiser module. The container may itself contain a source of refill atomiser liquid for the wick to absorb to refill the wick. The wearer may then simply unscrew the cartridge from the atomiser module, screw it into the container, wait a predetermined time for sufficient atomisable liquid to be absorbed into the wick for the cartridge to be refilled for fresh use.

For example, the mask of the present disclosure may be incorporated into or as part of other items of headwear including, for example, helmets (such as emergency service worker helmets, motorcycle helmets, astronaut helmets), visors (such as full face visors used in clinical settings such as Covid19 wards), and oxygen therapy masks.

As will be appreciated, an advantage of the present disclosure is that a means of issuing a dose of very fine mist, which provides a strong immediate scent that dissipates quickly is provided.

Variations on the described mask are possible. For example in some implementations a transparent panel may be included over the lips, e.g. to facilitate lip reading whilst the mask is worn. Some implementations of the mask may form part of an AR (augmented reality) or VR (virtual reality) system, e.g. to deliver a liquid with a smell to the user under control of an external AR/VR system e.g. to enhance an immersive experience.

It will be appreciated that the mask of the present disclosure aims to promote intelligent breathing via the vagus nerve linking digestion with brain and heart biochemistry and harmony via the use of scent. Where the mask is is described as “configured to” implement a particular feature, in the case of a mechanical feature e.g. a mechanical feature with a particular function, this may be implemented by appropriate hardware design. In the case of a control or operational feature this may be implemented e.g. by an electronic system, for example using dedicated hardware, or software stored in non-volatile memory controlling the operation of a processor, or using a combination of the two.

Features of the mask which have been described or depicted in combination e.g. in an embodiment, may be implemented separately or in sub-combinations. Features from different embodiments may be combined. Each disclosed or illustrated feature may be incorporated in the invention, alone or in any appropriate combination with any other feature disclosed or illustrated herein.

The described embodiments are illustrative only and the claims are not limited to these but encompass modifications and alternatives contemplated as within the scope of the claims.