WO2022118047A1

WO2022118047A1 - Respirator mask apparatus and method for testing the same

Info

Publication number: WO2022118047A1
Application number: PCT/GB2021/053186
Authority: WO
Inventors: Lee Taylor; Alex VESCIO
Original assignee: Ldt Design Ltd
Priority date: 2020-12-04
Filing date: 2021-12-06
Publication date: 2022-06-09
Also published as: GB202117604D0; GB2603281A

Abstract

The invention relates to improvements to a respirator mask which can be provided in a single use or multiple use configuration. The mask can be provided with a substantially transparent body and is preferable provided to be compliant with FFP3 standards for use. The body may also be provided with an anti- fogging feature so as to allow the transparency of the body to be maintained during use. In one embodiment the apparatus and method allows the fitness for use of the mask with respect to a specific intended wearer of the mask to be determined.

Description

Respirator Mask Apparatus and method for testing the same

The invention to which this application relates is to apparatus commonly referred to as respirator masks which are worn by a person so as to protect the person from inhaling potentially harmful components, such as bacteria, from their surrounding environment and also, typically to prevent a person from exhaling potentially harmful components into their surrounding environment.

The invention further relates to apparatus and a method for use in checking that the respirator masks are fit for use in terms, particularly, of providing a satisfactory seal between the mask and the face of the person so as to ensure that the respirator mask is effective in use.

The use of respirator masks in certain industries and medical environments, is well- known and there has been a significant increase in the use of the same in conditions in which viruses may be present in everyday life. This has meant that the wearing of masks, which previously had been considered to be of use in specialist environments, is now relatively widespread.

Regardless of the particular use, in order for the respirator mask to be effective, there is required to be a seal between the mask edge and the face which is of a sufficient level so as to prevent the movement of particles such as virus particles and the like, between the environment within the respirator mask and the external environment in which the person wearing the mask is present at that time.

Although there are many different types of respirator masks available, with variations in terms of durability, shape, portion of the face with which the same seals, and the like, in all cases, it is generally regarded as beneficial for the wearers’ face to be as visible as possible as this aids social interaction and provides additional ability for interpretation of the wearer’s intentions and aids in a better understanding of any instructions that the wearer may issue such as for example if the wearer is a health professional. While it is known to provide masks which have a body with at least a transparent portion it is found that these masks are typically inferior and may be unfit for use and this can be the case regardless of whether the masks are provided for multiple or single use.

In the design of respirator masks the same can be split into two groups, a single use Clear FFP3 compliant mask and a reusable clear FFP3 compliant mask. The single use clear respirator mask is more easily adopted by end consumers, such as healthcare workers for example, as it does not disrupt the current working practices of fitting, wearing and disposing of single use respirator masks. However the reusable option is more beneficial in the long term but does require the implementation of a standard cleaning infrastructure and other processes to support the introduction of the reusable respirator mask into wide scale use.

In both groups there is a need to ensure that the respirator masks which are available to use by the end consumer can be of different sizes and shapes and can be readily available for selection and use so as to best suit the particular wearer’s face shape so that it is effective in terms of the seal to the wearer’s face and is it is comfortable to wear during, typically, an 8-hour shift. It is also important to minimise fogging of the mask body in order to ensure that the advantages of providing a transparent body are achieved during use.

A further problem experienced is whether in fact the respirator mask is fit for use with respect to the particular person who intends to wear the particular mask. Apparatus and methods for checking the fit for use of the mask are known but those which are currently available, tend to be relatively complex, with a requirement to introduce pressurised gas into the environment within the mask and then check the leakage or pressure of gas which leaves the interior environment of the mask over a defined time period. The relative complexity of the apparatus, means that the same is expensive and therefore is not available for use in many locations and, even if the apparatus is available, it is frequency the case that the apparatus is not used to check whether the mask is fit for use.

As a result, it is believed that while many persons have to and/ or are relatively willing to wear such a mask, the effectiveness of the wearing of the respirator mask is unknown and unchecked. Thus variations in the type and shape of mask which is being worn and their suitability to the shape of the wearer’s face means that a respirator mask which is suitable to be worn by one person may not be fit for use when worn by another person. As such, the effectiveness of wearing the respirator mask may have little impact and be of little benefit to the person wearing the respirator mask and/ or other persons in their environment.

More specifically, in relation to respirator masks for use in the healthcare services the problem of the mask being fit for use, comfort and allow easy distribution and compliance and in particular, to meet the requirements of respiratory protective equipment (RPE) such as Regulation FFP3 and facial protection is problematic. Typically, these types of respiratory masks must be worn when a patient is admitted with a known or suspected infectious agent or disease spread by airborne or droplet routes.

Conventionally, there is no test procedure which can be repeatedly easily used by a person each time they fit a respirator mask to validate that they have a suitable fit around the nose, mouth and face area. This is a major problem because the healthcare worker does not know if they are safe and suitably protected before they help an individual with an infection and, if the healthcare worker themselves have an infection, there is a risk that they may then spread the same via other patients that they come into contact with.

In the conventional test procedures which are available when the healthcare professional is first fitted with the respirator mask a test is performed but this is required to be carried out by a qualified member of staff, is time-consuming and, as a result, the test is typically only carried out annually or if the person has significant changes to their appearance such as, for example, due to weight loss. Thus, when a large healthcare workforce is required to use the respirator masks and for the same to be rapidly deployed there is little or no time to perform the fit test procedures and, even if the test is performed, once the healthcare worker passes a test and is discharged with the allocated respirator mask, the test is not re -performed for a significant period of time, if at all. At present therefore, users rely on their own and colleagues views on whether the respirator mask appears to fit well, or not. Apart from the fact that the view is often incorrect, the fit test is not regulated and there is no real control on the suitability of the respirator mask when worn in terms of the seal between the external environment and the internal environment within the mask and around the user’s mouth and nose .

While there are a number of respirator masks manufacturers and a number of fit test procedures to follow when initially checking a user has the correct respirator mask, the actual fit of the respirator mask to a person’s face can vary each time they replace the product.

In addition to the fitness for use test problems further problems include the fact that the respirator mask, when worn, covers the mouth with a solid material which means that the persons mouth cannot be seen and causes communication issues. Furthermore the traps that pull the respirator mask to the face are positioned in such a way that they cause discomfort to the user’s face, especially after repeated use.

As already stated, the shape of the face of users changes significandy between different cultures, male and female and thus a variety of different respirator masks and sizes are available on the market with the hope that one of these models can be chosen to fit a particular persons face. This can lead to confusion with regard to the number of different options and how to choose the correct model and indeed what criteria should be referred to, to ensure that the particular respirator mask model chosen will fit correctly.

At present, a paper based procedure for recording the results of the fit test is currently used and digital base systems are emerging. However, records are poorly managed and do not adequately provide Health & Safety records to prove that a healthcare worker is complying with Health & Safety protocols. Furthermore, the selection and usage of current respirator masks is not controlled particularly well, and this leads to stock management and logistic issues.

While there are many forms of respirator masks available for purchase and use, it is found that in many cases, problems exist, some of which can be due to the economics of use of the mask with, for example, certain masks being provided to be used for a single use, masks being provided to be used for a number but a relatively small number of uses and other masks being provided of a form so as to be repeatedly used but, with, for example, the filters of the mask being replaced from time-to-time. Thus, there are a wide range of respirator masks designs which are provided to achieve different aims and purposes and, in addition to the level of use of a respirator mask, other relevant parameters may include any or any combination of the level of filtration which can be achieved by the mask, the comfort of the mask to the wearer with reference to the amount of time which a person may be expected to wear the mask, and/ or available materials from which the mask is manufactured.

An aim of the invention is to provide the mask in a form which allows the majority of the portion of the face which is shielded by the mask body when the respirator mask is worn, which is typically the lower part of the face, to be visible to third parties in the surrounding environment when the mask is being worn thereby improving communication between wearers of the masks which can be important especially when the mask has been worn by an individual who may, for example, be providing advice or care or instruction to said third parties.

An aim of the present invention is to provide a respirator mask which has improved features which allow the utility of the same to the wearer to be improved and also, to allow the mask to be provided in a form to meet predetermined criteria. A further aim is to provide the mask in a form which allows the same to be donned in a relatively easy manner and to allow the means of attachment and location to be adjusted by the user so as to fit the mask efficiently in terms of performance to the wearer’s face and also to allow improved comfort when the mask is being worn.

In a first aspect of the invention, there is provided a respirator mask to be worn and sealed against the face of a person so as to create a first environment formed between the interior surface of the respirator mask body and the person’s face and a second, external environment to the exterior of the respirator mask body and wherein, the respirator mask include a body portion of which the majority is formed of a substantially transparent material.

Typically said mask meets the requirements of the standard FFP3.

Typically, said mask body has a peripheral edge provided to be substantially sealed against the surface of part of a face of a wearer to define a cavity between the wearer’s skin and the interior surface of the mask body, location means which allow the said mask body to be retained in position and wherein the location means include retention portions provided integrally with or attached to the mask body and one or more elongate members which pass from the retention portions to form a first loop around the head of the wearer and a second loop around the head of the wearer so as to retain the mask in position.

In one embodiment, the first and second loops are elasticised or resiliently stretchable so that when released the same are biased into contact with the head to retain the mask body in position once the elongate member has been passed around the head and is in position. In one embodiment the lengths of the respective loops are selected and adjustable by the wearer of the mask body so as to allow secure and comfortable retention of the mask body in position.

In one embodiment the retention means further include a locking means which retains the elongate member has been moved to the correct length

In one embodiment, the said retaining means allow the sliding movement of the elongate member between first and second apertures which are located on the said retaining means so as to allow the size of the respective first and second loops to be changed to aid the donning and/ or removal of the mask.

In one embodiment, the said retaining means are provided so as to allow the second loops to be respectively located at the top and bottom of the mask body and typically a first loop being located above the ears of the wearer and the second loop located below the ears of the wearer with reference to the position of the mask body when in position.

In one embodiment, the peripheral edge of the body includes a deformable material which has a level of deformability which is greater than that of the material from which the mask body is manufactured.

Typically, the deformability of the peripheral portion is sufficient so as to allow the same to at least partially take-up and/ or absorb the shape of the face of the particular wearer of the mask and thereby allow the mask to be adaptable to the particular shape of the face.

In one embodiment, the mask body is manufactured from a substantially transparent material so as to allow the mouth of the wearer to be visible from externally of the mask.

In one embodiment, the whole of the mask body is formed of transparent material so that the nose, mouth, and adjacent surface of the face is visible externally of the mask. Typically, the mask body incorporates one or more ports or portions via which air is allowed to pass between the interior cavity and the exterior environment to prevent misting or fogging of the mask body.

Typically, the large proportion of all of the air which is provided to aid the breathing of the wearer of the mask passes through at least one filter assembly such that the air which passes between the said interior cavity and the external environment, has to pass through the filter assembly and thereby allow potentially harmful material carried in the air, to be filtered to a required extent for the required performance of the mask.

Typically, first and second filter assemblies are provided at spaced apart locations.

Typically the filter assemblies are selectively removable from the mask body so as to allow one or more filter layers to be replaced when its lifetime of effective use has expired and/ or to allow a specific type of filter to be fitted with regard to the specific use of the mask so as to thereby provide the mask with the required performance characteristics.

The aim of the present invention is to provide apparatus and a method which allows an effective check on the suitability of the mask for that person to be undertaken when the mask is being worn by that person so as to ensure that the respirator mask is effective within predetermined parameters. A further aim is to provide the apparatus and method in a form which is relatively easy to use and therefore encourage use of the same by a person wearing the same upon each instance of wearing the mask or at least on a relatively frequent basis.

A further aim is to provide the apparatus and method for checking the fitness for use in a form which is relatively economical to purchase and/ or implement and thereby, again encouraging the use of the apparatus and method.

In a first aspect of the invention, there is provided a respirator mask be worn and sealed against the face of a person so as to create a first environment formed by the interior surface of the respirator mask and the person’s face and a second, external environment to the exterior of the respirator mask and wherein, the respirator mask include a body portion of which the majority is formed of a substantially transparent material. In one embodiment, the said material from which the body of the mask is formed, is a plastics material.

In one embodiment the respirator mask meets the requirements of FFP3 as defined by the European standard EN 149.

In one embodiment the respirator mask includes a body with a peripheral gasket to seal against the face of the wearer. In one embodiment the dimensions of the body are kept constant but different sizes of gasket can be selectively fitted to the body so as to create a range of respirator mask sizes so that the appropriate size can be selected for use for a particular wearer.

In one embodiment retaining means are provided in the form of an elongate member which is formed via engagement with the mask body and/ or gasket into two loops which pass around the head of the wearer to retain the body in position.

Typically, a first loop is positioned closer to the neck of the wearer than the other of said loops.

Typically, the said elongate member passes along the external face of the body on a first side and is guided by at least first and second members formed on the body and passes to the opposing side of the body via first and second guide means so as to define the two loops which extend to the rear of the body and around the user’s head.

In one embodiment, the strap is manufactured from a silicone/ TPE skin safe material that does not easily harbour bacteria and it can be easily cleaned with a suitable soap detergent and water and left to dry.

In one embodiment, the mask body includes at least one, but typically first and second filter assemblies, said assemblies including a cartridge and which defines therein, a cavity in which is located a disposable or washable single or multi-layer filter and said cartridges are attachable to the mask body in a manner so as to allow the same be removed and replaced by the user of the mask.

Typically filter assemblies are provided on opposing sides of the body or towards the bottom portion of said body In one embodiment, the filter assembly is attached to the body of the mask via a bayonet fitting but other forms of engagement can be used, with the aim being to allow the wearer of the mask to attach and remove the filter assemblies as and when required to allow changes of the filter layer or layers and/or the filter type to be achieved.

In one embodiment the said filter assembly includes or is provided in communication with a one way valve so as to allow the passage of air only in the direction from external of the mask to the interior of the mask body.

In one embodiment the filter is formed of a multilayer construction.

In one embodiment, the filter is a HEPA filter.

In one embodiment, the body incorporates an exhalation valve. In one embodiment the exhalation valve is mounted substantially centrally of the body and/ or towards the lower edge of the same.

In one embodiment, the exhalation valve includes a cover which is mounted to be positioned externally of the body and which includes at least one aperture therein to direct the exhaled air from the interior side of the valve to the exterior of the mask.

In one embodiment, the said one or more apertures in the cover, are located on sidewalls of the cover so as to direct exhaled air from the interior of the mask body to the exterior in a direction downwardly or sideways when the mask is being worn rather than being exhaled directly outwardly from the valve. This arrangement prevents exhaled air being emitted direcdy towards persons in the surrounding environment such as, for example, a person who may be positioned in front of the wearer of the mask at that time.

In one embodiment, the exhalation valve cover has a filter fitted on the underside to provide additional protection to, for example, a patient if the wearer of the respirator mask has diseases that can be transferred by air.

Typically, the wearer of the mask will inhale air from the external environment which passes through the one or more filter assemblies via a one way valve, such as an umbrella valve assembly and hence through the filter media therein and is exhaled through the exhalation valve only which is also fitted with a one way valve which again can be an umbrella valve, so as to reduce heat and moisture build-up within the body of the respirator mask.

In one embodiment the said respirator mask is formed of a plurality of engaged components, at least some of which can be selectively detached to allow at least some of the components to be recycled at the end of life and/ or replaced as appropriate and thereby avoid the requirement for the entire mask to be discarded before it reaches its end of life.

In one embodiment, the said components are formed of different materials to increase the overall performance of the product in relation to fit and comfort for the user and/ or, due to the ability to separate the components, each of the components can be recycled in the most appropriate manner, when recycling is possible for that particular material. Conventionally, this has not been possible as masks have been provided as a unitary integral construction and which as a result cannot be recycled

In one embodiment the said respirator mask includes a portion which is changeable between a first condition and a second condition so as to provide a detectable indication of the effectiveness of the said seal of the respirator mask against the face of the said person when being worn.

In one embodiment, the change in condition is for said portion to move with respect to the remainder of the respirator mask.

Typically, the said portion is provided with an element which allows the change in condition or movement to be detected by monitoring means.

Typically, the movement or extent of movement, when detected, is used as a means to determine whether the said respirator mask is fit for person when being worn by the specific person.

Typically, the determination is made with respect to a predetermined parameter or set of parameters by processing means connected to and/ or in communication with the said monitoring means.

In one embodiment, the test is repeated each time the mask is being worn or when a new mask is being worn, or when a new design of mask is to be worn by the said person. Typically the said test results are personal to the particular person and thereby to that person’s shape of face.

In one embodiment, the respirator mask or mask design and/ or person are provided with unique ID codes so as to be able to create a match of the respirator mask or mask design to a particular person and thereby provide a record of the test having been performed and the result of the same.

This is particularly important with regard to environments where historical data and checks are required to be kept such as, for example, medical environments in hospitals, doctors etc.

In one embodiment, the test is performed by the user inhaling when wearing the respirator mask for a predetermined period of time so as to move the said portion to a first position and the condition of the mask is monitored for a predetermined period of time and, if the said portion changes position during that predetermined period of time then this indicates leakage between the respirator mask and the person’s face and the extent of the change of position is determined with respect to predetermined parameters to decide whether the mask is fit for use.

In a further aspect of the invention there is provided a respirator mask apparatus, said respirator mask including a body which, when worn on a wearer’s face, encloses the mouth and nose to create an internal environment between the person’s face and the interior surface of the mask body and wherein said mask further includes a portion which is moveable between first and second conditions, with movement to the second condition being achievable upon the wearer inhaling and holding their breath for a predetermined period and the mask being worn correctly, to indicate that the mask is fit for use to be worn by said person.

In one embodiment the said respirator mask includes monitoring means positionable adjacent to said portion of the mask to detect the movement of the said portion from the first to second condition and determine whether said movement is to a sufficient extent to allow the said mask to be determined to be fit for use, or not.

In a further aspect of the invention there is provided a method of donning a respirator mask, said method including the steps of providing first and second loops of an elongate member in attachment to a body of the mask, via spaced apart retaining portions so that the first loop is located further from the portion of the body to be worn adjacent the user’s nose than the second loop, placing the first loop over the user’s head and moving the same to lie around the neck region, moving the second loop over the user’s head and locating the same thereon to retain the mask in position.

In one embodiment locking means engage portions of the elongate member together and said locking means are slidingly movable along the elongate member to define the size of the loops to suit different sized users heads and thereby ensure that a sealed fit is achieved and retained between the mask and the wearers face.

In one embodiment the elongate member includes a degree of elasticity so as to be able to exert a gripping force against the users head and neck when the mask body is in position for use.

In one embodiment the method of donning the respirator mask includes a step of checking that the mask is fit for use

In a further aspect of the invention there is provided a method for performing a fit for use test on a respirator mask when being worn by a person, said method including the steps of: identifying the said person, the person dons the mask in the required position to enclose the mouth and nose and create an internal environment between the persons face and the interior surface of the mask, providing a monitoring means located in proximity to mask to detect a change in condition of the mask wherein at commencement of the test the person inhales and holds their breath for a predetermined period of time and which serves to move a portion of the said mask adjacent to which the monitoring means is located and during said predetermined time the monitoring means detects any change in position of said portion and determines if said movement is to a sufficient extent to allow the said mask to be determined to be fit for use, or not.

Typically, if there is no movement or the extent of movement is relatively small and below a predefined limit, the mask is deemed to have passed as there is a sufficient seal between the mask and the face of the wearer so to minimise the passage of air and bacteria between the internal and external environments. Should the extent of movement be greater than the predefined limit then the seal is determined to be insufficient and the mask is deemed to have the failed the fit for use test. In one embodiment the said portion of the mask is a diaphragm provided as part of the mask cup and a magnet is located therewith so as to enable the monitoring means to detect the movement of the said diaphragm.

Typically, during the test, any apertures which allow air to enter the interior environment, such as through filters are blocked.

Specific embodiments of the invention are now described with reference to the accompanying drawings wherein:

Figures la-c illustrate views of one form of a respirator mask in accordance with the invention;

Figure 2 illustrates the mask of Figures la-c being worn;

Figures 3a and b illustrate a monitoring means in accordance with one embodiment of the invention;

Figures 4a and b illustrate the mask of Figures la-c with the monitoring means of Figures 3a and b fitted thereto for performance of the fit for use test;

Figures 5a and b illustrate an embodiment of a smart terminal in accordance with the invention.

Figures 6a-g illustrate the performance of the method of the fit for use test in accordance with the invention.

Figure 7 illustrates an elevation of a mask in accordance with another embodiment of the invention from the front;

Figure 8 illustrates an elevation of the mask of Figure 7 from the rear;

Figure 9 illustrates a side elevation of the mask of Figures 7 and 8;

Figures 10 and 11 illustrate front and rear perspective views of the mask in accordance with Figures 7-9; Figures 12a and b illustrate sectional views of the mask along lines A- A;

Figure 13 illustrates the components of the filter assembly of the mask of the embodiment according to Figures 7-12;

Figures 14a and b illustrates sectional views of the filter assembly of Figures 7-13 along line B-B;

Figure 15 illustrates the mask in the embodiment shown in Figures 7-14b used in combination with goggles.

Figure 16 illustrates a mask in accordance with a further embodiment of the invention being worn;

Figure 17 illustrates the mask of Figure 16 with the filter assemblies removed;

Figure 18 illustrates a side perspective view of the mask of Figure 16;

Figure 19 illustrates an exploded diagram of the components of the mask of Figure 16;

Figure 20 illustrates the arrangement of the strap of the respirator mask of Figure 16;

Figure 21 illustrates a mask filter assembly in accordance with one embodiment of the invention;

Figure 22 illustrates one embodiment of a respirator mask body and gasket assembly in accordance with the invention;

Figures 23a-e illustrate possible embodiments of attachment of the filter assemblies to the mask body;

Figures 24a-d illustrate examples of attachment of the strap to the mask; Figures 25a-b illustrates and embodiment of forming the mask using injection moulding to form the body with an over moulded elastomeric gasket;

Figures 26a-b illustrate embodiments for the provision of anti-fogging feature of the transparent body of the mask;

Figures 27a-f illustrate examples of fitting the filter assemblies to the body of the mask which has been injection moulded;

Figure 28 illustrates a further embodiment of attaching the filter material to a filter assembly frame;

Figure 29 illustrates the manner in which the same mask body can be used in conjunction with gaskets of different dimensions in order to allow a range of mask sizes to be created;

Figure 30 illustrates one embodiment of a HEPA filter assembly; and

Figures 31a and b illustrate embodiments for the exhalation of air from the mask body interior when no exhalation valve is provided.

Referring now to the Figures 7-15 there is illustrated a mask 102 in accordance with one embodiment of the invention. The mask includes a mask body 104 which can be made from a clear transparent material and to be semi rigid so as to hold and retain its own structure and thereby keep the mask body spaced from the users face for comfort but also allow sufficient flexibility to allow the person to comfortably speak. The mask body 4 can be formed from a relatively rigid transparent polymer which allows a reliable and controlled manufacture of the respirator mask body 104.

The mask body may be dosed with anti- fogging agents to help prevent condensation build up and/or may be provided with an exhalation valve 106 to thereby prevent fogging or misting of the surface of the mask body 104 and ensuring that the transparent mask body allows the wearer’s mouth 108 and facial expressions to be seen very easily by third party onlookers and also assist in communication with a patient and/ or other health care professionals. The relatively large area of transparency is achieved by positioning the required filter assemblies 110,112 to either side of the mouth area, making them low profile and so they do not obstruct peripheral vision and the position of the exhalation valve 106 is under the chin area as shown in Figure 7.

The filter assemblies 110,112 are removable and in one embodiment offer FFP3 protection levels which means that the filter assemblies remove at least 99% of airborne particles sized 0.3 microns and above. In the arrangement shown each filter assembly is replaceable and includes a plastic moulded frame 124 to which is welded two layers of meltblown polypropylene filter material and two layers of Spunbond nonwoven Polypropylene material to protect the meltblown PP filter material. This filter construction 126 of filter and protective layers will be attached to the frame 124 via ultrasonic welding. The ultrasonic welding creates a reliable and repeatable seal between the filter construction 126 and the polymer frame 124 it sits on. The frame creates a flat and consistent surface to seal against location means 120 on the mask body 104. Typically the filter frame 124 can locate with the location means 120 in only one way so as to prevent the same being fitted incorrectly and therefore potentially not providing the filtering effect. The location means 120 include 102 soft sealing beads of elastomer material in the mask to create the seal and the filter cap 122 fits over the filter material/ frame and compresses it against the sealing beads to form a reliable seal.

The exhalation valve 106 is a one-way valve that opens as the wearer exhales, this stops a build up of heat and expels the majority of dead air built up in the mask during breathing to avoid C02 build up within the mask body cavity 128. It also allows heat to escape to stop the build-up of condensation in the transparent mask body 104 keeping it clear at all times. When the wearer is breathing in, this same valve is closed and the air is pulled in through the filter assemblies 110,112. The valve is an elastomer-based umbrella type 130 that flexes open when air is expelled towards it. It is protected from getting blocked or damage by air inlet holes 132 found within the plastic cup.

At the peripheral edge of the mask body 104 there is provided a gasket 114 of suitable material which is bonded with the mask body 104 typically during the moulding process which means a reliable construction and manufacture process and the provision of a relatively soft pliable construction provides comfort for long periods of use by healthcare professionals. In one embodiment the material used for the gasket is a Liquid Silicone rubber or special formulated TPE. The gasket also allows the same to take the size and shape of different shapes of face more easily without needing to provide different sized masks to the market and allow a better chance in creating a seal with the face. Preferably two mall slits 116,118 in the gasket top and bottom allow it to move with a person’s face without gathering the material and causing gaps in the gasket where air borne diseases might pass.

The mask body 104 is held in location on the wearers face via first and second loops 134, 136 formed by an elongate member 138 which has free ends, 140, 142 and which are located together by a locking member 144 which can be slidingly moved along the elongate member as indicated by arrows 156,158 to allow adjustment of the overall size of the loops 134, 136. The elongate member is engaged with the mask body via spaced part retaining portions 150, 152 and which allow the elongate member to be removed from the mask body 104 if they are damaged and need replacing and for cleaning purposes.

When the locking member 144 is in position the elongate member is attached to the retaining portions to thereby be formed into first and second loops depending to the rear of the mask body 104. The loops 134, 136 can be pulled to the front of the mask body 104 in the direction of the arrow 156 and in reverse of this direction as indicated by arrow 158. This makes it extremely easy to adjust and put the mask body on and take off the wearer’s head. To put the mask body on and position the same the lower loop 134 is placed over the head and lowered to the back of the neck region. The top loop 136 is then pulled over the head and the locking means 144 is adjusted so as to adjust the size of the loops 134, 136 to suit different sized users heads and thereby ensure that a sealed fit is achieved and retained between the gasket 114 and the wearers face. The routing of the loops 134, 136 and their position on the head provide an even distribution of pressure across the face gasket 114, so improving the sealing of the gasket against the face. Also, the positioning of the retaining portions 150,152 on the body is important in order to ensure that substantially uniform and even pressure is applied by the gasket 114 onto the face.

In one embodiment as shown in Figure 15 the mask body 104 can be formed so that the nose area 154 size, shape and features on the outer surface allows a custom pair of goggles 160 to fit comfortably with the respirator mask and so form a substantially unitary and integral mask assembly 162.

The mask as herein described is easy to clean and maintain: The elongate member can be removed and put to one side, and the old filter assemblies can be removed and incinerated and the mask body can be dipped in a bucket of warm water and detergent, wipe and clean, place on the side to dry. Of course this could be performed by an automated cleaning process and apparatus. The elongate member can be cleaned with appropriate wipes and allowed to dry and refitted along with new filter assembled and it is ready to re-use with there only being four main parts to the construction, the mask body, filter, filter cap and elongate member. The materials provide an ultra-light weight mask in conjunction with the engineering: wall thickness of materials, materials selected, means of applying the face and filter sealing gaskets and low-profile light weight filters. This means that the mask is comfortable to wear for long shifts, transparent and provided with FFP3 protection and re-usable.

Referring now to Figures 16-18, there is illustrated a further embodiment of respirator mask 202 in accordance with the invention. The mask includes a body 204, first and second filter assemblies 206,208 attached thereto on opposing sides of the body when the mask is being worn by a person on their head 210 as shown. Also provided on the body, towards the lower edge 212 of the same is an exhalation valve 214 and the body, filter assemblies and exhalation valve are retained in position via a strap 220 formed of two loops 222,224 and the strap passes across two parts 226, 228 of the body 204 as shown. It will be appreciated that when the mask is worn, the nose and mouth of the wearer is enclosed within a cavity 230 to the interior of the body.

The filter assemblies 206, 208 can be selectively detached from the body via a bayonet engagement means 232,234 which include one way inhalation valves 252 therein as shown in Figure 17. Typically, each filter assembly 206,208 will be removed to allow the filter layers therein to be replaced. An example of the filter assembly is shown in Figure 21 to comprise a first and second cartridge portions 236,238 which form a cavity therein in which can be received suitable filter layers 242,244,246,248 comprising in one embodiment, an inner layer of spunbond material, that provides protection for a meltblown PP material layer, and an outer spunbond material layer which provides further protection for the meltblown PP layer, and a frame respectively. The layers 242,244,246 are typically heat sealed to the frame 248 that is manufactured from a thin film PVC, PP or similar. Typically, the construction of the filter is designed to meet FFP3 filtering efficiency and may be provided to be sufficiently economical to provide so as to enable the filter to be disposable. In one embodiment the layers can be produced on a die cutting and heat sealing machine to any size or shape required. Typically, the inner part 236 of the cartridge, includes engagement means 250 formed thereon which allow engagement with the engagement means 232, 234 on the body so as to secure the filter assembly in position. It will be appreciated that the filter layers can be changed or replaced to use the appropriate filter materials. Typically the filter cover 238 includes indirect venting means so as to help reduce the risk of direct liquid spillages into the cavity in which the filter layers are located. It should be appreciated that other means of achieving protection from liquid ingress is possible.

It should also be appreciated that the shape and dimensions of the cartridge portions 236 and 238 may be selected to the suit specific filter types and shapes without affecting the operation or design features of the mask.

Figures 18 and 20 illustrate the manner of the two loops 222,224 of the retaining means elongate member or strap 220 being formed, with the free ends 254,256 of the strap being secured through aperture 259 of a retention means 258 to be worn towards the rear of the head and which allow adjustments of the length of the loops by moving the free ends 254,256 through the retention channels 260,262 on each side of the retention means 258. The retention means 258 also acts as a neck comfort band as it lies intermediate the skin of the wearer and the straps of the mask.

Figure 19 illustrates the components of the respirator mask in accordance with one embodiment of the invention and illustrates the manner in which as the separate components are separable they can be formed of materials which are best suited for the particular task for each component. Thus, in this embodiment, the body is formed from an inner shell 264 and an outer shell 266, with both the inner and outer shells formed of PETG or PP typically substantially transparent plastics material. A face gasket 268 is provided and retained in position between the inner and outer shells and this is formed typically of a silicon rubber and provides a more comfortable fit as this portion acts as the interface between the body 204 of the mask and the person’s face. The face gasket 268 includes sealing features to create a seal between the outer shell 266 and the inner shell 264. It also has sealing features built into it to form a seal between the filter cartridge portion 236 and the engaging means 234.

The exhalation valve 214 cover 270 is shown as having apertures 272 which direct exhaled air to the side and downwardly as indicated by arrow 274 rather than exhaled air being directed outwardly directly in front of the mask. The cover can be formed of PETG or PP, typically substantially transparent, plastics material.

The body also incorporates inhalation valves 252 which are mounted on the inner gasket between the filter assemblies 206,208 and the cavity of the body and this can be formed of ABS material with an umbrella valve member 276 which may be formed of silicone or a flexible TPE material that is relatively soft and pliable in nature.

It will therefore be appreciated that in order to form the body, retention means are required to be provided and this is achieved, by providing retention protrusions 278,280,282 on the outer shell 266 which are provided to pass through apertures 284 provided in the gasket 268 and into retaining means 86 provided on the inner shell 264. Once these are engaged, the inner and outer shells 264, 266 and gasket 268 components are engaged to effectively form the body 204.

The invention therefore provides a respirator mask with a body portion which is substantially transparent and, preferably meets FFP3 standards. Typically, the respirator mask can be formed as a single use mask in which case the same is discarded or recycled after a single period of use or is provided as a reusable mask in which case the same can be washed and made available for use once more. The provision of the usable version of the mask will require a standardised cleaning schedule so as to allow the support of the introduction of the reusable mask into an organisation.

Typically, the mask, in either version, can be provided in the range of sizes and shapes suitable for different users in terms of face shape and size and for different uses so that in any case, the mask is comfortable to wear during a single use which typically be an 8-hour shift. In one embodiment, the body will be formed of a uniform size so as to form the smallest size of respirator mask that is required and varying sizes and shapes of the gasket element which is located around the periphery of the body are available so as to alter the size of the respirator mask to suit different face sizes. The use of different gaskets therefore allow the adaptation of the body to provide for example, small, medium and large sized masks.

Typically, the mask will include means to maintain the transparency of the body through use by preventing or minimising fogging which can be created when breathing. The possible alternatives are dip coating the transparent body in an antifog treatment, using an antifog film adhered to the inside surface of the body, using an additive which is added to the raw material such as a clear polymer from which the body is subsequently formed or to have the user of the mask to spray the body with an antifog spray additive that lasts for a period of time such as a sufficient period of time to last for the duration of the shift.

Typically, the mask will implement a filter material that is FFFP3 rated and is relatively easy to breath in and which has an area suitable to be located within the body.

Typically, for single use masks in particular, the manufacturing costs of the same needs to be relatively low and there is required to be a balance between the manufacturing process, the material used to form the mask body, the application of the antifog treatment and the integration of the filter medium in order to provide a mask which is effective but also economical to use.

Turning now to Figure 22 there is illustrated a thermoformed transparent cup and Foam Gasket. The body is formed as a thermoform transparent body 301 using a rotary vacuum forming process which achieves high volume output at low cost. An antifogging agent can be impregnated into the transparent sheet material used to form the body so the body does not fog during what is typically a 8 hour shift of use. The gasket which is provided in engagement with the body can be an integral skin foam 302 which forms a tough denser outer skin and a softer core and which is formed using a one shot process. Various densities and hardness of the materials are available giving varied mechanical and physical properties to ensure the fit to different face profiles and also create a suitable seal and render the mask comfortable to wear. Typically, the material used for the gasket is a skin safe grade so that the risk of irritation is reduced and are bio compatible and the foam structure gasket is semi permanently bonded to the body so that it can be removed at the end of life and the body recycled. The gasket can also be surface treated with antibacterial additives which are useful with respect to their usage within the healthcare environment.

Preferably, the reception of the filter assemblies is achieved by having two apertures in the side areas of the mask 303 in order to fit a separate filter assembly rather than having a filter area built into the surface of the body itself. In one embodiment, two apertures 303 on a set diameter are located in each side of the cup and these can be stamped out with a cutting tool in the body whilst the periphery of the cup is trimmed in the same action. The transparent body has a small finishing edge 304 to allow a cutting tool to finish the part and the same area can be used to adhere the gasket 302 to the surface. Typically, the actions can all be carried out from the front of the body to avoid complicated tooling and manufacturing setups.

In one embodiment, the filter assembly includes a separate frame 315 which is positioned as shown in Figure 23b to hold the filter medium 306. The frame has features in the area 310 on it to allow the filter material 316 to be welded to the frame around its periphery of point 320. Item 317 is an injection moulded ring with a triangular bead 317a, the frame 315 is connected to item 317 via an ultrasonic welding which melts the bead 317a and this connects items 315 and 317 permanently into the transparent body 311. This assembly creates a permanent sealed and robust attachment of the filter assembly to the transparent body. This example is a relatively low cost production method and can be used with electrostatic filter material with a high breathability efficiency.

In alternative example shown in Figure 23c, in order to compensate for the limited features created on a thermo formed cup 311, a separate ring part 318 is positioned as shown and a filter medium is welded to it at point 321. The filter medium 316 is used to create a bag structure to allow more air to pass through it in all directions (direction of air into filter bag illustrated by arrows). The two pieces of filter material are welded around its periphery at point 320 to create the bag. Within the bag structure there is a recirculatory open cell foam 319 to stop the bag collapsing and restricting airflow. Item 317 is an injection mould ring with a triangular bead 317a. The ring part 318 which the bag is connected to is connected to item 317 via ultrasonic welding which melts the bead 317a and this connects items 318 and 317 permanently into the transparent body 311.

This assembly method creates a permanent, sealed and robust attachment of the filter assembly to the transparent body. In this example, the filter portions are offset to the body surface to allow air to pass through the filter medium from any direction utilising the entire surface area and hence allows the filters to be efficient and the smaller size possible to pass FFP3 breathability tests.

As an alternative to welding the filters to the transparent body another possibility is to snap fit them into the body as shown in Figure 23 e. Item 324 is a stiffening ring used to offer support in the area where the filter frame will connect. Item 324 is snapped onto item 323 and this is a permanent snap feature to attach the filter to the transparent cup. Item 325 is a foam gasket material to strap between the two parts snapped together and the transparent cup 320 to create an airtight seal.

There are a number of options for the attachment of the retaining means elongate member or strap to the mask and these are described as follows with reference to Figures 24a-d.

In Figures 24a and b, a first option is shown in which a TPE compressor or injection moulded retaining means loop 336 is provided. This strap is sandwiched between items 327 and 325 and, when welded together, they trap the loop 336 to maintain it in position. The strap material also creates an airtight seal between the filter frame 325 and the clear body 321. It will be appreciated that this method of attaching the elongate member or strap provides two functions in one manufacturing operation in that it attaches the strap to the transparent body and provides a seal between the filter assemblies that are attached to the body via ultrasonic welding and so reduces the number of operations and parts and costs during the manufacturing process.

In Figure 24c, a second option is shown in which the strap loop 336 is strapped and permanently attached to the transparent body 321. In this option, the item 325 filter frame has a weld bead on its surface 327a and item 327 has a similar feature on its surface 327a. When the items 325 and 327 are brought together during the ultrasonic welding process, the strap 336 and transparent cup 321 materials are melted together to form one integral item. This has the benefit in that it creates an airtight seal and fixes the strap to the transparent body in one process.

In Figure 24d, there is illustrated a third option to fix the strap loop 336 through a cut-out feature 337 on the rim 322 of the transparent body 321. This method of attaching the straps allows the straps to pull evenly towards the face in a uniform way as the strap features are positioned evenly on the four corners of the clear transparent body 321. The strap loop 336 can be manufactured in any suitable material and is threaded through the cut-out features and then joined.

Turning now to Figures 25a and b, another form of manufacture of the mask is to provide an injection moulded body with an over-moulded elastomeric gasket. The transparent body 341 is formed of either a polypropylene random copolymer or PET polymer with twin shot TPE gasket 342 with a 30-50 shore A-hardness range which may vary depending on the comfort on the face and the release of the part from the tool during manufacture. The method of over moulding a TPE gasket to a transparent body is new with regard to the process of manufacturing an FFP3 transparent respirator mask in that it is cost effective and scalable process. There are two ways to incorporate the strap into this method of manufacture as shown. Figure 25a shows a first method by using four holes 359 formed into the transparent body moulding which requires a separate strap to hook through these areas and onto the wearer’s ears. In Figure 25b there is shown an alternative method which is to mould the strap 358 with the gasket over mould which means that there are only two parts of the assembly which has a manufacturing and cost benefit.

Typically, it is envisaged that any respirator mask will fog up to a degree even when air is moving inside the body to the outside environment via the filters. Even if the filters are very efficient it is still the case that the inside of the transparent cup will fog up and so it is necessary to keep the transparent cup from fogging for it to be effective so as to be able to see the user’s mouth and facial expressions through the transparent body. By applying an antifog capability to the inside surface of a transparent body with an over moulded gasket is not straightforward but there are suggestions set out below.

One option is to provide an additive in the material during injection moulding that will last long enough, while the product is in either storage or subsequent use to provide an antifogging effect to the material. Another option is to dip the transparent body into an antifog additive bath or spraying a post process additive to the surface of the transparent body with the TPE over moulded gasket required to be masked off during the application methods.

Another method is to use an antifog wipe or spray that is applied to the surface of the transparent body by the user before wearing and this relies on the user putting this treatment on before wearing which is an extra process and not ideal in a professional healthcare setting.

Turning now to Figures 26a and b a further method is shown in which a transparent antifog film 360 with an adhesive backing and this material can be adhered to the internal face of the transparent body 361 creating an antifog surface within the transparent cup for a minimum of the required period of time of use. It is advantageous to design the front surface 381 of the body to be largely flat and curved in one plain only so that the film can be applied easily for high volume manufacture. It is possible to apply an adhesive antifog thin film to the inside of the transparent body if it is curved in more than one direction but the antifog film would need to be reconstructed with a more complex cut pattern 382 to follow the contours as shown in Figure 26b.

A further and preferred method of achieving an antifog effect is to provide a clear PET film adhered to the inside of the body, particularly with respect to a single use version of the mask until it is technically possible to add an antifog additive into the transparent polymer. One such antifog material is a nano material coated polycarbonate film or polyester film with permanent antifog and anti-scratch properties.

With regard to the fitting of filter assemblies to the body, with an injection moulded body, tools can be used from the side and from inside to create complex features, surfaces and areas within the body. These areas can then be used to attach a curved filter assembly of a reasonable surface area. With the correct filter medium being used, and area and shape, it is possible to build a filter into the surface of the body and it can be attached and sealed to the body using a clip feature and a sealing gasket or an ultrasonic welded process. It is important to balance the size, shape in position of the filter on the transparent respirator body to ensure that it is cost effective to manufacture and it sits correctly to form a seal between the transparent cup and the filter material. It is also important to provide the filter assembly or assemblies in a manner which allows the other advantages and uses of a transparent body to still be achieved and in one embodiment, the filter material can be welded directly to the transparent body which requires the areas where the filter material is located to be of a certain size and shape to achieve the welding manufacturing successfully as is now described.

In Figures 27a- f, the transparent body 371 has shaped areas 392 which can be straight or curved to follow the surface contours of the transparent body 371. Weld bead features 393 will be moulded into the surface of the shaped 392 areas to allow a filter frame 394 carrying the filter material 376 to be welded into the transparent body 371 to form a reliable seal between the transparent body and the filter frame material.

In Figure 27d, the filter area 392 that accepts the filter frame 394 shape can be of any form as long as the majority of the outer surface of the shape can be accessed via a welding horn. This is likely to be from sides A and B of the transparent body. The shaped filter area has a welding bead on its surface that would be melted during the ultrasonic welding process with the intention to leave the mouth area 395 clear when the filter assemblies are in position.

In Figure 27e, the filter area 392 that accepts the filter frame 394 shape is of a form that comes from the sides A and B of the respirator body and under the chin area 396 to maximise the surface area of the filter material but not joining in the centre. The majority of the outer surface of the body shape can be accessed via a welding horn which is likely to be from sides A and B of the transparent body and the shaped filter area has a welding bead on its surface that would melt during the ultrasonic welding process with, once again, the intention being to leave the mouth area 395 clear when the filters are in position.

In Figure 27f, the filter is welded into the transparent body with constraints put in place in that the filter shape can be of any size and shape that fits within the size and shape of the transparent body and ensuring the welding tools 397 and 399 can access the welding areas from the inside and outside of the transparent body. The tool to weld the inside of the filter to the transparent body 371 is created using the tool 397 which absorbs energy to the area within the tool 398. It moves in the direction of arrow C. On the outside of the body a side moving tool 399 is moved into the transparent cup from side B and transmits energy to the filter area 392 for a period of time until the filters are welded to the surface of the transparent cup 371.

In Figure 28, another configuration is shown in which the filter material 386 is welded to a subframe 404 of a shape that follows the shape of the transparent respirator body 381 and the subframe 404 is snapped into the transparent body 381 in the single use version of the mask so that it cannot be removed by the end-user. The snapping of the subframe 404 compresses the sealing material 408 to form the seal.

An alternative to this and the method used on the reusable version of the respirator mask is to use a top cap 407 that is plugged into the pocket 409 and compresses the face of the filter frame 404 to the wall of the transparent body 381 that has an elastomeric sealing part 408 located within it, thus forming a seal. The cap 407 can therefore also be removed by the user to replace the filter when required.

In Figure 29, the ability to generate a range of sizes of masks whilst using a standard size of body throughout, is illustrated. There is provided a single size transparent body 391 moulding and then various sizes of gasket 392 are available to be selected to fit to the periphery of the body. The gaskets can be made in as many different sizes as required in order to generate the required range of sizes and shapes to suit the user but the transparent body and filters remain the same across all different size mask products, three of which are shown in Figure 29.

It is also possible to use different filter types for the filter assemblies and as shown in Figure 30, the filter material 410 can be of a HEPA filter type and sealed to the transparent body 401 by creating a liquid seal frame 411 around the pleated HEPA filter 410. This method is appropriate because it fills all the areas between the regular pleated areas 412 with elastomeric material which creates a seal between the HEPA filter material and also forms the frame 411. The sealed unit is then inserted into a suitable shaped and size pocket 406 within the transparent body 401. The liquid sealing frame 411 is also manufactured from a rigid polymer material that is bonded to the HEPA filter 410 where the bonding material would form a seal between the polymer frame 411 and the HEPA filter 410 during the bonding process. In this case, the pocket 406 that holds the HEPA filter assembly is manufactured from an elastomeric material to form a seal between the filter frame 411 and the respirator mask.

The mask can also include exhalation valves which can be useful to allow expelled air from the person to escape quickly and hence avoiding the build-up of heat and moisture within the cup area. This is likely to have less fogging compared to a transparent mask that does not have an exhalation valve present. However, the problem with this is that the air that is exhaled by the person wearing the mask escapes via the exhalation valve and if this air is contaminated could pass to patients there in close proximity with. The exhalation valve can therefore be removed or provided with a one-way system that allows air to escape but not to return back into the cup area.

In one configuration the exhalation valve is removed completely to allow the wearer’s mouth 445 to be even more visible and instead the inhaled and exhaled air as indicated by arrows, is forced through the same filter material 426 to protect any persons who are in close proximity of the wearer of the mask from being exposed to the potentially contaminated exhaled air. This method protects both the wearer and the non wearer from contaminated air. To ensure that this configuration passes breathability and dead air tests, the filter material is of a suitable construction and is positioned suitably within the cup design. It also relies on an airtight seal between the transparent body and the filter. If the air does not exit the body efficiently, CO2 will build-up within the mask and cause harm to the wearer. One such filter material that may achieve the required configuration is Technostat which is an electrostatic filter media which behaves more efficiently and is easier to breath in than other filter materials.

Figure 31b illustrates another configuration of the mask in which it is beneficial to wrap side filters 426 around the underside of the mask 447 to move the air escape route via the filters 426 closer to the user’s mouth.

Turning now to Figures la-c there is illustrated another embodiment of respirator mask according to the invention and which is provided to have the facility to allow the same to be tested to ascertain whether the respirator mask is fit for use when worn by a specific wearer. In this embodiment the respirator mask 12 is shown and in Figure 1c is shown in cross section along line A-A. The mask has a soft hypoallergenic face seal or gasket 1 around the periphery of the same. Leading from the seal, there is a semi-rigid face body 2, which in one embodiment is formed of a substantially transparent material. Filters 3 and 6 are provided on opposing sides of the cup 2.

In accordance with the invention in this embodiment, a diaphragm 4 including a magnet 13 located therewith, is provided as a portion of the body 2 and is typically substantially centrally located. The diaphragm portion is retained in position on the cup, in this embodiment using a clamp 5.

There are also provided one or more holes 7 at the filters to allow the selective blocking of the airflow between the internal environment within the cup and the external environment during the performance of the fit check and test.

The mask is retained in position via fabric straps 8 which are provided to engage around the user’s ears. An ID label 9 can be provided so as to allow ease of identification of the mask and there may also be provided a detectable tag 10, such as an RFID tag, on the mask to allow the location of the mask to be tracked and also the option of other data relating to the mask to be communicated.

Figure 2 illustrates the respirator mask 12 in accordance with the embodiment shown in Figure 1, being worn on the face 14 of a user in the position for use so that the nose 16 and mouth 18 of the person are enclosed in the internal environment 20 within the body 2. The body, which can also be referred to as a cup, is typically formed of a relatively rigid material and the diaphragm 4 is formed of a more flexible material that expands and contracts in reaction to the introduction of air into and removing air from the internal environment 20. The surface area of the expandable element of the diaphragm is limited so that it is relatively sensitive to changes of air pressure in the internal environment 20. This means that it will react to the addition of air into the internal environment 20 at a fast rate if there is a relatively large gap between the face of the user and the seal 1. In one embodiment, a micro hole can be provided in the face seal and so the diaphragm will then fill at a slower rate.

The test apparatus of the invention includes a monitoring means 26 as shown in Figures 3 and b which, when the test is being performed, engages with the cup of the mask adjacent to the diaphragm and magnet provided therewith and which moves along with the diaphragm. The monitoring means 26 is shown in position on the respirator mask 12 in the Figures 4a and b and is retained in position by mechanical engagement means 29 which engage with the clamp 5. The monitoring means 26 detects a change in position of the magnet 13 via a Hall sensor 27 located on the monitoring means 26 and as a result determines the state of the diaphragm 4 and a reading is generated to represent the diaphragm position and/ or change in condition during the test, by firmware of the monitoring means or mask in further detail.

In Figures 5a and b, there is provided a further part of the apparatus in the form of a smart terminal 30 which can receive the readings data from the monitoring means 26 and thereby allow an indication to be provided to the user via the smart terminal screen 32 as to whether the mask which they are wearing is fit for use when worn by them.

In one embodiment, the fit for use test method in accordance with the invention is illustrated with respect to Figures 6a-g and includes the steps of:

The person enters the test area and uses an ID card 34 with the smart terminal 30 NFC pad 36so as to register their details. The smart terminal indicates an acknowledgement of who the user is such as by displaying a screen message 32 and a photo indicating that the process has started as shown in Figure 6a. The smart terminal may also instruct the person to select a new respirator mask 12 from an available supply as shown in Figure 6b. The smart terminal then accesses a camera, so the person is able to see themselves whilst donning the mask on the smart terminal. Once the mask is selected, the person taps the mask on the smart terminal NFC pad to register the respirator mask to the person and this also acts to deduct from the stock numbers the respirator mask which has been taken so as to allow improved stock control.

The smart terminal 30 will then prompt the person to locate the monitoring means 26 onto the respirator mask 12 to be adjacent to the diaphragm 4 as indicated in Figure 6c and when in position, this will turn the monitoring means 26 on in this embodiment via a microswitch. The person fits the respirator mask on their face and adjusts the same until they are happy with the comfort of the fit on their face.

The person can then initiate the start of the check for fitness by tapping a start button such as may be provided on the smart terminal 30 and a countdown commences before the start of the check. When the check starts, the monitoring means 26 will indicate this, and the person will block the two holes 7 at the filters so as to block air entering the internal environment 20 of the mask during the test. The person will then inhale as indicated by arrow 36 in Figure 6d and hold their breath such that the person sucks their breath in for a period of time and holds it. This moves the diaphragm inwardly 38 to the position B shown in Figure 6e and a good seal will then retain the diaphragm in this position for a predetermined time period.

The user will then be instructed to release their breath as normal.

A pass or fail result is calculated with respect to the extent of the movement of the diaphragm from position B to A during the said predetermined time period. The proximity of the magnet 13 embedded in the diaphragm to the Hall Sensor 27 changes with, and represents, a change in condition of the diaphragm during the predetermined time period. This change of position is detected by the Hall sensor Typically, the diaphragm 4 is moved at the start of the test by the inhaling of the person to a collapsed position B and any air that subsequently enters the internal environment 20 of the respirator mask inflates the diaphragm until it reaches state A which moves the magnet close to the hall sensor. Measurements are taken during this process. The monitoring means will then display indication of Pass or Fail of the fit for use test such as a red or a green light with green indicating pass and red indicating fail and the monitoring means 26 will transfer the information to the smart terminal 20 via suitable communication such as Bluetooth at the same time and this displays pass or a fail result on the terminal display 32 as indicated in Figure 6f. The smart terminal can push the results to a back-office administration system 40 where the time, data test and pass-fail results and stock levels will be logged.

If the result is a fail in that as shown in Figure 6g sufficient air 42 has entered the internal environment 20 through the seal 1 between the mask 12 and the face of the person so as to cause the diaphragm to move 44 too far towards the position A, when the person is still holding their breath during the test procedure, then the person can start the test again and repeat until a pass is achieved or, alternatively, the smart terminal 30 instructs the user to select an alternative model of respirator mask.

Other possible apparatus can be provided to perform the test in a similar manner and this includes providing a pressure sensor in the internal environment of the mask that detects a drop in pressure and hence indicates leakage of air at the seal 1. Capacitive sensing could be built into the seal 1 between the mask 12 and the face so that when the area in contact with the skin reduces it highlights that the fit was not guaranteed.

A further possibility is to monitor warm moisture from the persons breath which passes through an area of the face seal causing a build-up of warm moisture. A smart material outside the seal area and any warm moisture escaping the seal would be detected by the smart material.

At the seal 1 a thermal ink can be provided so that if there is a hole in the seal it would indicate a change in temperature and the seal colour would change highlighting a seal leak.

In addition or alternatively a strain gauge could be attached to the surface of the diaphragm and when the diaphragm changes shape the strain gauge sensor changes its reading which is detected by firmware and provides a pass/ fail.

One or more smart sensor tags can be used which are passive and require no power.

They have an antenna built into them and a measurement means built in to another part of their structure and these could be used instead of the monitoring means as herein described. The sensor includes a sheet of metal foil suspended over a portion of the antenna by a piece of compressible foam. When the foam is compressed by weight or air pressure, the metal gets closer to the antenna structure and causes an impedance and Sensor Code changes. It is known that mechanical distortion of the antenna can cause a change in resonant frequency of the antenna, and means can be provided to adjust to accommodate the change. In any RF system, the ability to communicate depends on an electrical (impedance) match between the antenna and the transmitter/receiver. When the impedance match is good, the antenna can deliver enough power to the chip to support the chip's operation and response. This sensor could be used as a low-cost passive option and it can be stuck to the inside of the respirator mask. When it is in a certain area and matched to a reader it would power the sensor up and take a reading and transfer that reading to the reader. This is a sticker with RF and measurement built into it and is powered when in close match/ proximity to the reader.

Claims

33 CLAIMS

1. A respirator mask to be worn and sealed against the face of a person so as to create a first environment formed between the interior surface of the respirator mask body and the person’s face and a second, external environment to the exterior of the respirator mask body and wherein, the respirator mask include a body portion of which the majority is formed of a substantially transparent material.

2. A respirator mask according to claim 1 wherein the respirator mask meets the requirements of the standard FFP3.

3. A respirator mask according to any of the preceding claims wherein the body has a peripheral edge provided to be substantially sealed against the surface of part of a face of the wearer to define the first environment and location means which allow the said mask body to be retained in position, said location means including retention portions provided integrally with or attached to the mask body and one or more elongate members which pass from the retention portions to form a first loop around a head of the wearer and a second loop around the head of the wearer so as to retain the mask in position.

4. Apparatus according to claim 3 wherein the lengths of the respective loops are selected and adjustable by the wearer of the mask body so as to allow secure and comfortable retention of the mask body in position.

5. Apparatus according to either of claims 3-4 wherein the retention means include a locking means which retains the elongate member once it has been moved to a correct length.

6. Apparatus according to any of the preceding claims wherein the said retaining means are provided so as to allow the first and second loops to be respectively located at the top and bottom of the mask body with the first loop being located above the ears of the wearer and the second loop located below the ears of the wearer with reference to the position of the mask body when in use. 34

7. Apparatus according to any of the preceding claims wherein the peripheral edge of the body is formed by a gasket formed of a relatively deformable material to seal against the face of the wearer.

8. Apparatus according to any of the preceding claims wherein the transparency of at least part of the body is sufficient so as to allow at least the mouth of the wearer to be visible externally of the mask.

9. Apparatus according to any of the preceding claims wherein the body includes one or more ports or portions via which air is allowed to pass between the interior cavity and the exterior environment to minimise misting or fogging of the mask body.

10. Apparatus according to any of the preceding claims wherein the body is manufactured from a material which includes a component material to minimise misting or fogging of the body surface and/ or has a layer of material applied thereto which acts to minimise the misting or fogging of the body surface and/or has a material sprayed or wiped thereon to act to minimise the misting or fogging of the body surface.

11. Apparatus according to any of the preceding claims wherein the majority of air which enters the internal cavity of the mask passes through at least one filter assembly provided on the body.

12. Apparatus according to any of the preceding claims wherein first and second filter assemblies are provided at spaced apart locations on the body.

13. Apparatus according to claim 11 or 12 wherein the filter assembly is selectively removable from the mask body so as to allow one or more filter material layers to be replaced when its lifetime of effective use has expired and/ or to allow the filter material to be washed and reused and/ or a specific type of filter material to be fitted with regard to the specific use of the mask.

14. Apparatus according to any of the preceding claims wherein the mask includes a portion which is changeable between a first condition and a second condition so as to provide a detectable indication of the effectiveness of the said seal of the respirator mask against the face of said person when being worn.

15. Apparatus according to claim 14 wherein the change in condition is movement of said portion with respect to the remainder of the respirator mask.

16. Apparatus according to claim 14 or 15 wherein the said portion is provided with a component which allows the change in condition or movement to be detected by monitoring means.

17. Apparatus according to claim 16 wherein the monitoring means determine whether the respirator mask is fit for use with respect to the particular wearer of the mask.

18 Apparatus according to any of claims 14-17 wherein the respirator mask and/ or wearer have unique ID codes so as to be able to create a match of the respirator mask to the particular wearer and provide a record of the test having been performed and the result of the same.

19. Apparatus according to any of the preceding claims wherein the said mask body includes an exhalation valve.

20 Apparatus according to claim 19 wherein the exhalation valve includes a cover which is mounted to be positioned externally of the body and includes at least one aperture therein to allow the exhalation of air from the interior environment cavity to the exterior environment.

21. Apparatus according to claim 20 wherein the said one or more apertures are located on the sidewalls of the cover so as to direct exhaled air from the interior of the mask body to the exterior in a direction downwardly or sideways when the mask is being worn.

22 Apparatus according to any of the preceding claims wherein the respirator mask is formed of a plurality of engaged components, at least some of which are selectively detachable to allow at least some of the components to be independently recycled at the end of life and/ or replaced.

23. A respirator mask according to the preceding claim wherein the said components are formed of different materials to increase the overall performance of the products in relation to fit and comfort for the user and/ or improved recyclability of components separately.

24. Apparatus according to any of the preceding claims wherein the respirator mask is provided in a form for a single use by a person prior to disposal and/ or recycling

25 Apparatus according to any of the claims 1-23 wherein the respirator mask is provided in a form for use on a plurality of occasions prior to disposal and/or recycling.

26. Apparatus according to any of the preceding claims wherein the mask includes one or more filter assemblies which are engaged by welding to the said body.

27. A respirator mask which includes on opposing sides of the mask and attached to a body of the same first and second filter assemblies, said filter assemblies including a cartridge in which is located a single or multilayer filter material and said cartridges are attachable to the mask body via releasable engagement means to allow the same to be removed and replaced by the wearer of the mask to allow changes of the filter material and/ or type of filter material.

28. Apparatus according to claim 27 wherein the said filter assembly includes or is provided in communication with a one-way valve to allow the passage of air only in the direction from externally of the mask to the interior of the mask body.

29 A respirator mask apparatus, said respirator mask including a body which when worn on a wearer’s face encloses the mouth and nose to create an internal environment between the person’s face and the interior surface of the mask body and wherein said mask further includes a portion which is moveable between first and second conditions, with movement to the second condition being achievable upon the wearer inhaling and holding their breath for a predetermined period and 37 the mask being worn correctly, to indicate that the mask is fit for use to be worn by said person.

30 A respirator mask apparatus according to claim 29 wherein the apparatus includes monitoring means positionable adjacent to said portion of the mask to detect the movement of the said portion from the first to second condition and determine whether said movement is to a sufficient extent to allow the said mask to be determined to be fit for use, or not.

31. A method of donning a respirator mask, said method including the steps of providing first and second loops of an elongate member and attachment to the body of the mask, via spaced apart retaining portions so that the first loop is located further from the portion of the body to be worn adjacent to the user’s nose in the second loop, placing the first loop over the user’s head and moving the same to lie around the neck region or lower head region, moving the second loop over the user’s head and locating the same thereon to retain the mask in position.

32. A method according to claim 31 wherein the locking means engage portions of the elongate member together and said locking means are slidably moveable along the elongate member to define the size of the loops to suit different size wearers heads and ensure a sealed fit is achieved and retained between the mask and the wearer’s face.

33. A method for performing a fit for use test in the respirator mask when being worn by a person, said method including the steps of identifying the said person, the person donning the mask in the required position to enclose mouth and nose, creating an internal environment between the person’s face and the interior surface of the mask, providing a monitoring means located in proximity to the mask to detect a change and condition of the mask wherein, a commencement of the test, the person inhales and holds their breath for a predetermined period of time to move a portion of the said mask adjacent to said monitoring means, and during the said predetermined time, the monitoring means detects any change in position of the said portion and determines the said movement is to a sufficient extent to allow the said mask to be determined to be fit for use, or not. 38

34. A method according to claim 33 wherein when there is no movement or the extent of movement is relatively small and below a predefined limit, the mask is deemed to have passed or should the extent of movement be greater than the predefined limit then the seal between the mask and wearer’s face is deemed to be insufficient and the mask is deemed to have failed the fit for use test for that person.

35. A method according to any of the claims 33-34 wherein during the test, any apertures which allows air to enter the interior environment are blocked.