PERSONAL USE"

Cross-Reference to related applications

This patent application claims priority from Italian patent application no. 102020000007231 filed on 6/04/2020, the entire disclosure of which is incorporated herein by reference.

Technical field of the invention

The present invention concerns personal protective equipment (PPE) for protection of the respiratory tract, with particular innovative characteristics in terms of production and use thereof .

Technical Background

The personal protective equipment (PPE) for protection of the respiratory tract of a known type, certified according to the FFP protection classes, has uniform characteristics. Said pieces of PPE are commonly referred to as "face masks" can be substantially divided into two categories:

• Equipment in which the structure itself or the carcass is the filtering element, therefore the equipment is manufactured by assembling the filtering element through seams or heat welding. Said equipment may or may not be provided with a valve which opens due to the pressure difference generated when the wearer exhales. Said equipment is for the most part considered disposable, since it is subject to wear and becomes clogged in the course of a few hours; furthermore, since it is provided with said outlet valves it allows the spread of viruses, bacteria etc. through the breath of a person who may be infected. Moreover, it is not perfectly ergonomic, particularly at the face between bridge of the nose, lower eyelid and mid cheek. Furthermore, it is important to highlight the ethical/environmental problem of the production cycle and average life of this category of PPE, since in practice the equipment is disposable or in any case can be used for a predefined number of hours, depending also on the conditions of use. This means that these pieces of equipment have a finite life, they cannot be re-used several times and once their cycle of use has come to an end they must be disposed of, at least theoretically by specific methods. In reality, tons of this equipment are simply recognised and disposed of daily as non- recyclable waste, creating a considerable impact on the environment, in particular in view of a future scenario where possible pandemics, problems connected with atmospheric pollution etc. could be a daily occurrence, engendering increased public awareness such that users may begin to use said equipment on a daily basis.

• Equipment in which a filtering element external to the surface of the carcass, and often replaceable, is assembled on the basic structure or carcass made of plastic material, characterized by considerable overall dimensions and weight, making the use thereof difficult for periods other than only a few hours. This equipment is usually provided with a valve that opens due to the pressure difference generated when the wearer exhales. This equipment is for the most part re-usable but, being provided with said outlet valves, allows the spread of viruses, bacteria etc. through the breath of a person who may be infected.

The majority of PPE for protection of the respiratory tract represent a significant criticality especially in medical contexts, given their inadequacy in potentially hazardous environments such as departments specializing in infectious diseases, where the possibility of being infected increases considerably .

It should furthermore be added that the majority of PPE are not made with antibacterial materials, which is not ideal in terms of hygiene, in particular since this equipment is used in the vicinity of areas highly sensitive to infections or via which it is possible to inhale viruses, bacteria and dust. It should also be added that the equipment available so far entails important limitations in terms of wearer and user communication, since it covers the mouth; for example for deaf-mute persons, the fact that they cannot lip-read the person wearing PPE represents a huge obstacle, which can lead to situations potentially endangering the safety of said person or in any case creating a significant empathetic barrier in said person who is unable to visually analyse the expressions of the person with whom he/she is communicating: e.g. hazardous working environments, medical environments and doctor-patient relations, daily communication. These elements can result in potential isolation or marginalization or even danger for deaf- mute persons; also able-bodied persons can entail communication difficulties and significant weakening of the involuntary communication mechanisms represented by facial expression.

Lastly, the filtering materials currently used for the production of PPE are able to filter, and therefore retain, only particles larger than approximately 0.4 micron and, only in the case of electrostatic filters, up to 0.2 micron; these values allow the passage of smaller particles, for example viruses.

Summary of the invention

One object of the present invention is to solve or at least alleviate the problems described above.

A further object of the invention is to simplify the production process to meet the needs of a large number of users.

A further object of the invention is to provide personal protective equipment with characteristics substantially transversal to the separate categories of PPE currently on the market. Based on the invention, a personal protective equipment (PPE) is therefore provided as defined in the attached claims.

In particular, the personal protective equipment according to the invention comprises a carcass or structure, preferably moulded in one single piece in a synthetic plastic material which is at least partly elastomeric, for example of a silicone type. The carcass or structure is shaped so as to reproduce the shape of the human face and is provided with at least one zone having through micro-holes designed to guarantee the inflow and outflow of air necessary for respiration; preferably, said perforated zone is located in an anterior and centre-line portion of the carcass or structure.

At the perforated zone, preferably located in the anterior part of the carcass or structure, a seat is provided designed to house an interchangeable and therefore replaceable filter.

A removable cover provided with through holes and lockable in the above-mentioned seat can be inserted from an inner face of the carcass or structure, facing, in use, a user that wears the protective equipment. The removable cover is configured to keep in place the filter, which will be locked between the carcass and the cover. In a possible embodiment, the filter can be obtained integrated in and forming one single piece with the cover which, in this case, will also be replaceable and disposable .

Openings for the auricles are located on the sides of the carcass or structure. Furthermore, an adjustable closing system is situated in the rear part of the carcass or structure, which is open to allow the user to put the PPE on easily and the opposite ends of which are preferably configured as a belt or strap, so that they can be interconnected and fastened to each other. According to an important aspect of the invention, the replaceable filter consists of a sheet membrane, for example of rectangular or circular shape and having an extension such that it extends peripherally well beyond the perforated zone and all around it, made of a filtering material with purely mechanical action having nodule and fibril structure, configured to provide in the filter a very twisty section for passage of the air formed of a non-linear succession of empty spaces in a quantity such as to ensure an overall porosity of the filter ranging from 70% to 85% and retain particles up to 0.01 micron.

According to a preferred embodiment of the invention, the filter is a membrane made of two-way expanded polytetrafluoroethylene (e-PTFE) sheet.

Generally, the membrane made of e-PTFE sheet can be laminated on a support and has a thickness ranging from 0.1 to 20 micron.

The invention therefore also relates to the use of an e-PTFE membrane as an interchangeable filter for personal protective equipment (PPE) shaped as a half mask that can be applied to a user's face in front of the nose and mouth to retain by pure mechanical action particles suspended in the air having dimensions greater than or equal to 0.01 micron.

It is also possible to use for the filter, as a replacement or in addition to the e-PTFE, a non-woven fabric having the above physical-chemical characteristics.

According to a last aspect of the invention, the materials with which the carcass or structure, the filter and the cover are made are all entirely transparent or translucent, coloured or colourless, so that the face of the user wearing the protective equipment can be seen from the outside. Brief description of the drawings

Further characteristics and advantages of the invention will become clearer from the following description of a preferred but not exclusive non-limiting embodiment of the protective equipment according to the invention, provided purely as an example and with reference to the figures of the attached drawings, in which:

Fig.l schematically shows a lateral elevation view of a possible first embodiment of the protective equipment according to the invention;

- Fig. 2 schematically shows the protective equipment of figure 1, in the same lateral elevation view as figure 1 but cut away according to a trace plane II-II (visible in Fig. 5);

- Fig. 3 schematically shows, on an enlarged scale, a detail of the cutaway lateral view of figure 2 of the protective equipment of the invention;

Fig. 4 schematically shows, in axonometric view cut away according to the trace plane II-II, an exploded view of the complex of elements composing the protective equipment of figure

1;

- Fig. 5 schematically shows a frontal elevation view of the protective equipment of figure 1;

- Fig. 6 schematically shows, in an orthogonal lateral elevation view, a cover forming part of the component elements of the protective equipment as shown in figure 4;

- Fig. 7 schematically shows, in an orthogonal frontal elevation view, the cover shown in figure 6;

- Fig. 8 schematically shows, in an orthogonal frontal elevation view, a filter forming part of the component elements of the protective equipment as shown in figure 4;

- Fig. 9 schematically shows, frontally in axonometric view, the protective equipment of figure 1 in its entirety and in an open configuration, applied on the head of a user, shown for merely illustrative and non-limiting purposes; - Fig. 10 schematically shows, at the rear in axonometric view, the protective equipment of figure 1 in its entirety and in a closed configuration, applied around the profile of a human head of a possible user, shown for merely illustrative and non limiting purposes;

- Fig. 11 schematically shows a front, overhead and exploded three-quarter axonometric view of a second embodiment of the protective equipment of the invention, illustrating all of the component elements thereof;

- Fig. 12 schematically shows the same exploded axonometric view as figure 11 but cut away according to a trace plane XII-XII; and

- Fig. 13 illustrates a SEM photograph of the structure of the replaceable filter used in the protective equipment according to the invention.

Detailed disclosure

With particular reference to figures 1 to 10, the number 1 indicates, as a whole, a personal protective equipment consisting of a half mask that can be applied to the face of a user in order to protect and cover the mouth and nose, as illustrated in figures 9 and 10.

The protective equipment 1 comprises a structure or carcass or base body 2, comprising a cup-shaped anterior part or portion 20 having an anatomical profile, in which a plurality of through holes or micro-holes 3 are provided.

The carcass or structure 2 is shaped, at least at the anterior part or portion 20 thereof, so as to reproduce the shape of the human face and has at least a zone 30 provided with the through micro-holes 3 designed to guarantee the inflow and outflow of air necessary for respiration.

According to the non-limiting but preferred embodiment example illustrated, said perforated zone 30 is located at the anterior portion 20, along the centre-line, so that in use it is in front of the user's mouth and/or nose.

Respective opposite bands 21 provided with through openings 4 configured to house the auricles of a user extending in a cantilever fashion from opposite sides of the anterior part 20.

The structure or carcass 2 is open at the rear, at its opposite ends 200, so that the protective equipment 1 can be easily put on by a user. The rear ends 200 are defined by the terminal parts or ends of the bands 21, they are opposite to the anterior part or portion 20 and are provided with a size adjustment system or device 5 of any suitable type, for example known per se and illustrated only schematically for the sake of simplicity.

Preferably, the opposite ends 200 are configured as a belt or strap, so as to be interconnected and fastened to each other thanks to the size adjustment system or device 5.

Preferably, the structure or carcass 2 is moulded in one single piece in an at least partly elastomeric synthetic plastic material, for example of a silicone type, or a styrene-based thermoplastic elastomer.

According to the preferred embodiment, therefore, the anterior part 20 and the bands 21 with the rear ends 200 and the size adjustment device 5 are obtained integral with each other and in one single piece.

According to the invention, the equipment 1 further comprises, advantageously jointed to the structure or carcass 2, at least one interlocking cover 8, also provided with a plurality of holes or micro-holes 3 and at least one filter 7 which is pack- assembled between the anterior part or portion 20, in particular at the perforated zone 30, and the perforated cover 8, which is preferably configured to internally support, in the anterior part thereof, the at least one filter 7.

The adjustment system or device 5 operates according to a predefined travel and can be locked at predefined and non- predefined points, thus adapting to various individuals with different cranial circumferences. The at least one cover 8 can be expediently released from the carcass 2 in order to replace the at least one filter 7.

The lateral openings 4 expediently furthermore delimit a small strip of material defined by the upper solid part of the bands 21 which rests on the upper part of the auricle guaranteeing a uniform distribution of the weight of the equipment 1.

With particular reference to the embodiment shown merely by way of example in the accompanying figures 1-10, the air inlet and outlet holes 3 located in the anterior part can have many different regular and non-regular geometric shapes and dimensions: circle, hexagon, pentagon, various closed irregular shapes, and said holes can be located in every zone of the anterior part of the equipment and can in turn have a non-unique arrangement.

The at least one perforated cover 8 is made of a synthetic plastic material more rigid than the one of which the carcass or structure 2 is made, for example LDPE, and can have any shape and dimension, and any appropriate system for fixing it to the carcass 2 of the equipment 1, on which carcass it couples in a removable manner from the inner part of the carcass 2, in an appropriate seat or housing 6.

The at least one filter 7 and the at least one cover 8 can be stand-alone elements or, if deemed expedient at the design and subsequent utilization stages, can be obtained integral in one piece and therefore form one single unit, in order to avoid any contamination of the filter by the user's hands during replacement .

The lateral openings 4 on the bands 21 can have many different geometric shapes and dimensions, designed to favour the ergonomics of the protective equipment 1.

The adjustment system or device 5 located in the rear part of the carcass 2 of the equipment 1 can have a non-exclusive shape and locking mechanism, therefore it can have fastening buttons, buckles, self-locking devices, slots or other solutions that can be used for the purpose.

An important characteristic of the invention lies in the at least one interchangeable filter 7, designed to be replaced when saturated, by simply releasing the at least one perforated cover 8 from the seat or housing 6.

For said purpose, in the embodiment of figures 1-10, the anterior part 20 of the structure or carcass 2 is provided internally, all around the perforated zone 30 and at a pre-set distance from the same, with an elastically deformable annular projection 31 (figure 3) defining the seat 6 and provided peripherally on the outside with a radial groove 32 snap-coupled to a peripherally internal annular projection 33 of a protruding peripheral radial edge 34 of the cover 8, which is therefore cup-shaped, so as to contain inside the at least one filter 7.

The at least one replaceable filter 7 is composed of/consists in a sheet membrane, for example rectangular or circular shaped and with extension such as to extend peripherally well beyond the perforated zone 30 and all around it, for example as far as the radially internal surface of the elastically deformable annular projection 31, on which the protruding edge 34 of the cover 8 is snap-coupled, radially on the outside.

According to an important aspect of the invention, the at least one replaceable filter 7, namely the sheet membrane of which it consists, is made of a filtering material with purely mechanical action composed of interlaced and randomly overlapped polymer filaments with nodule and fibril structure, as illustrated in the SEM microphotograph of figure 13.

Said interlaced and randomly overlapped polymer filaments with nodule and fibril structure are configured to create in the filter 7 a very twisty section for passage of the air formed of a non-linear succession of empty spaces in a quantity such as to ensure an overall porosity of the filter 7 ranging from 70% to 85% and retain particles up to 0.01 micron, and therefore also viruses.

According to a preferred embodiment of the invention, the filter 7 is a membrane made of two-way expanded polytetrafluoroethylene (e-PTFE) sheet.

Generally, the e-PTFE sheet membrane 7 can be laminated on a support, for example on the cover 8, and has a thickness ranging from 0.1 to 20 micron.

Alternative polymer materials, provided they configure the mechanical micro-structure described above, are possible, although not preferred. For example, the at least one filter 7 can also consist of a multilayer assembly of non-woven fibres and fabrics, for example made of PE or PP also and not only with specialized characteristics and in any case with breathable, anallergic and antibacterial properties in addition to providing non-exclusive filtering in the order of magnitude of a few microns, thus blocking undesired elements such as, according to the field of use and application: dust, viruses, solvents etc. Clearly, it is possible to create a filter 7 composed of the overlapping of various filtering sheets or membranes made of different materials, for example an e-PTFE membrane laminated on a non-woven sheet.

The at least one filter 7 is preferably designed to avoid the use of an outlet valve operated by the pressure difference between the inside and the outside of the protective equipment 1 and generated by the exhalation of the individual wearing the equipment 1.

This allows the use of the equipment 1 also by individuals infected by potential viruses, so that the virus does not leak out of the equipment, isolating the patient and allowing easier treatment thereof, considerably reducing potential airborne infections .

Figures 11 and 12, where details similar or equal to those already described are indicated for the sake of simplicity by the same reference numbers, illustrate a variation 100 of the protective equipment according to the invention.

The equipment 100 differs from the equipment 1 only due to the type of size adjustment system or device 5 used to lock the opposite rear ends 200 of the carcass or structure 2 to each other and, above all, due to the coupling system between perforated zone 30 and cover 8 with the relative at least one filter 7.

According to this embodiment, the anterior portion or part 20 of the structure or carcass 2 is provided internally, all around the perforated zone 30, with an elastically deformable annular projection 31 provided radially on the inside with an annular groove 32. The filter pad 7 is housed inside the cover 8, within a seat 41 peripherally delimited on the outside by a radially protruding annular edge or projection 40 of the cover 8 configured to snap- couple inside the groove 32. In this way it is possible for a user to replace the filter 7 without ever coming into direct contact with it, resulting in considerable advantages in terms of hygiene.

The equipment 1,100 according to the invention occupies an innovative position in terms of use between FFP2 equipment and FFP3 equipment.

The production process of the equipment 1 is designed to obtain said equipment by injection moulding, the mould being purposely manufactured to specifications deemed ideal in the state of the art. The carcass or structure 2 of the equipment 1, 100 made in a non-exclusive manner in one single part will furthermore be made of plastic material having the consistency of silicone and featuring antibacterial properties.

The perforated cover 8 can be made in a non-exclusive manner with the same technologies and the same or other synthetic materials .

According to a non-secondary aspect of the invention, lastly, the synthetic material used to make both the structure or carcass 2, preferably in one single piece, the cover 8 and even the filter 7 can also be transparent or translucent, coloured or colourless, thus allowing wider use of the equipment of the invention, meeting the needs of a greater number of users; more specifically, and non-exclusively, deaf-mute individuals will be able to easily lip-read the persons talking to them, eliminating the visual barrier usually represented by ordinary face masks. For said purpose, also the material purposely selected for the filter 7, namely the e-PTFE, at the thickness indicated previously, is semi-transparent and in any case has a transparency sufficient to allow the mouth of the user wearing the protective equipment 1,100 to be seen from the outside.

The protective equipment according to the invention can be used by doctors and healthcare professionals during the treatment of patients so as to facilitate empathetic facial expressions, one of the most spontaneous methods of communication; it can also be used during recognition of the individual wearing it, for example at airports, check-ins, police checks etc. .

Furthermore, in this perspective the transparency will make it easier for the wearer to use facial recognition systems, which are expected to develop rapidly over the coming years.

The protective equipment described can also be made largely of a mono-material, for example for the structure or carcass 2 and, once the mould for producing it has been made, it will be easy and inexpensive to reproduce while at the same time being efficient and safe.

In periods of crisis or pandemic emergency, this peculiarity would undoubtedly be a fundamental element in preventing the contagion or death of millions of people. Due to said characteristics, furthermore, the invention can be re-used with long life cycles, since in order to ensure maximum efficiency, the at least one filter 7 is simply replaced with a new one. Furthermore, the protective equipment according to the invention can be easily washed in order to guarantee maximum hygiene of the surfaces thereof. The carcass 2 of the equipment 1, the at least one filter 7 and the at least one cover 8 can furthermore be produced in different dimensions, with at least three sizes: small (children), medium and large. The entire equipment 1, 100, if made of the materials indicated above or in any case of polymers designed to be chemically inert and resistant to temperatures up to at least 120°C, can be easily sterilized, by steam, in an autoclave, by boiling or with chemical disinfectants.

The structure of the carcass 2, due to its design, is also characterized by being very lightweight, an element that will make the equipment more comfortable to wear; a further strength of the equipment is its line which, although non-exclusive, is attractive in purely aesthetic terms, thus limiting or eliminating any embarrassment when wearing PPE.

The invention thus illustrated becomes to all intents and purposes, albeit in secondary terms irrelevant for the purposes of the innovation, a fashion item, since the equipment can also be made in a wide range of colours.

The invention, conceived as above, is subject to numerous modifications and variations all falling within the scope of the inventive concept; furthermore, all the details can be replaced by other technically equivalent elements. In the embodiment examples illustrated, single characteristics, reported in relation to specific examples, can in reality be interchangeable with other different characteristics existing in other embodiment examples. In practice any materials and dimensions can be used according to requirements and the state of the art.

All the objects of the invention are therefore achieved.