IT202000030125A1 - IMPROVED MASK. - Google Patents

Description

DESCRIPTION

of the invention entitled:

"Mask perfected?

The present invention relates to a mask for covering the respiratory tract.

To protect the respiratory tract from dust, smog and particulates generally present in the air, such as pollen for example, as well as from viruses, bacteria and/or other contaminants and pathogens present in the air, protective masks are used, also called half-masks or filtering facial devices, identified with the code ?FF? or as medical devices. In particular, the masks are generally configured to be applied in front of the mouth and nose, and preferably also the chin, thus covering the skin. part of the face of the person wearing them.

Among the well-known masks, there are masks for medical use (so-called ?surgical?), which are considered as a class 1 medical device, according to the provisions of directive 93/42 EEC and subsequent amendments, and are suitable for creating an appropriate barrier anti-microbial to reduce the emission of infectious agents into the environment. These masks can be TYPE I and II; those of Type II are also indicated for use in healthcare procedures as required by the UNI EN 14683 technical standard.

Am I otherwise? known masks designed manufactured and certified to act as personal protective equipment (PPE). In particular, there are those made with one or more? layers of filtering fabric, such as for example the anti-dust ones, or of the FFP1 type according to the classification envisaged by the European standard UNI EN 149. However, these masks have a rather poor filtering effectiveness, generally filtering about 78-80% of environmental particles with diameter? 0.6 ?m, and therefore they are not particularly suitable for protecting, in particular from bacteria present in the surrounding environment, the respiratory tract of the wearer of the mask itself.

Among the personal protective equipment there are also filtering face masks with higher filtering efficiency ? classified as of the FFP2 or FFP3 type (according to the classification established by the European standard UNI EN 149), and having respectively a filtering efficiency of 92-95% and 98% of environmental particles with a diameter of ? 0.3 - 0.6 µm - which on the one hand allow suitable protection of the respiratory tract of the wearer of the mask itself, but on the other hand are currently rather complicated and expensive to produce.

Among the masks with greater filtering efficiency there are also? those classified as type N95 (according to US classification NIOSH-42CFR84), type KN95 (according to Chinese classification GB2626-2006), type P2 (according to classification of Australia/New Zealand AS/NZA 1716:2012), typology ?Korea 1st class? (according to the Korean classification KMOEL - 2017-64) and of type DS (according to the Japanese classification JMHLW-Notification 214, 2018).

How ? Is it known, during the pandemic caused by the SARS-Cov-2 virus (also known as COVID-19), the use of the well-known masks, of all the aforementioned types,? been made mandatory or in any case highly recommended to contain the spread of infections.

However, currently, the known masks, in particular the surgical ones, are configured to have exclusively and only a filtering function on the outlet (i.e. towards the external environment) and, for the FFP2 or FFP3 types or the other types mentioned above, also in entrance (i.e. towards the wearer?s respiratory tract). In other words, the well-known masks act exclusively as personal protective equipment or for others, thus avoiding the spread of the SARS-Cov-2 virus.

Purpose of the invention? that of proposing a mask for covering the respiratory tract which solves, at least in part, the aforesaid drawbacks present in traditional solutions.

Another purpose of the invention? to propose a mask that has an additional function with respect to the filtering function in the expiratory phase.

Another purpose of the invention? to propose a mask that has an additional function with respect to the filtering functions in the expiratory and inspiratory phases.

Another purpose of the invention? to propose a mask that is flexible and resistant.

Another purpose of the invention? that of proposing a mask that presents a high filtering efficiency to the particulates present in the air.

Another purpose of the invention? that of proposing a mask that protects the wearer from inhaling environmental particles with a diameter of ? 0.1 ?m, preferably greater than 0.3 - 0.6 ?m.

Another purpose of the invention? that of proposing a mask that protects the wearer?s respiratory tract from droplets and/or aerosols which are vectors of viruses, bacteria and/or other contaminating and pathogenic agents or microorganisms present in the air.

Another purpose of the invention? to propose a mask that has properties? bacteriostatic and/or bactericidal.

Another purpose of the invention? that of proposing a mask covering the respiratory tract that is comfortable to use.

Another purpose of the invention? that of proposing a mask covering the respiratory tract that can be worn for a particularly long period.

Another purpose of the invention? to propose a mask that can be mass-produced in large quantities? and at a competitive cost.

Another purpose of the invention? to propose a mask that is highly environmentally friendly.

Another purpose of the invention? to propose a mask that has an alternative and/or improved characterization, both in constructive and functional terms, compared to the traditional ones.

Another purpose of the invention? to propose a mask that can be obtained simply, quickly and at low cost.

All these aims, considered both individually and in any combination thereof, and others which will result from the following description are achieved, according to the invention, with a mask with the characteristics indicated in claim 1, 2 and/or 6.

The present invention is hereinafter further clarified in some of its preferred embodiments shown for purely exemplifying and non-limiting purposes with reference to the attached drawings, in which:

figure 1 shows a front perspective view of a mask according to the invention,

figure 2 is a side perspective view of the mask of fig. 1 in a partially folded and ready to wear condition,

figure 3 is a front view of the inside of the mask of fig. 1 in a first variant,

figure 4 is a front view of the inside of the mask of fig. 1 in a second variant,

figure 5 is a front view of the inside of the mask of fig. 1 in a third variant,

Figure 6 shows a perspective view of a different embodiment of the mask according to the invention,

figure 7 is a front view of the inside of the mask of fig. 6.

As can be seen from the figures, the mask (also called half-mask or facial filtering device) according to the invention, indicated as a whole with the reference number ?1?, for covering the respiratory tract comprises a portion 7, in particular with a laminar development , that ? configured to cover at least partially, preferably completely, the respiratory tract of the wearer, in particular for the coverage of the cavities? nasal and cavity? oral of the latter. Preliminarily, it should be noted that for ?laminar development? here we mean a product in which the extension of the thickness ? much smaller than that of the other two dimensions (length and width).

In particular, the mask 1 according to the invention ? configured to at least partially cover the face of a wearer, and in particular pu? be of the type to be applied directly to the face of the wearer to cover his nose and mouth, to thus cover his respiratory tract. Preferably, the mask? configured to also cover the wearer's chin.

Conveniently, the laminar portion 7 of the mask 1 ? flexible or ? semi-rigid.

In particular, in the embodiment of figs. 1 ? 5, the laminar portion 7 ? configured to pass from a substantially flat condition (corresponding to the initial configuration before its use) to a substantially curved condition (corresponding to the configuration in which it is worn).

Conveniently, in the embodiment of figures 6 and 7, the laminar portion 7 can be concave (i.e. shaped substantially like a cup) and be configured to cover, once the mask 1 ? worn, the airways of the subject wearing said device. Conveniently, once worn, the concavit? of the laminar portion 7 ? facing the face of the wearer.

Conveniently, the laminar portion 7 can be configured to pass from a substantially flat condition and folded centrally on s? itself (corresponding to the initial configuration before its use) to a substantially curved or concave condition (corresponding to the configuration in which it is worn), in which the two opposite and free edges are separated from each other.

The laminar portion 7 comprises at least one layer for filtering environmental particles present in the air, in at least one crossing direction thereof, preferably in both crossing directions thereof, and/or for creating/providing an anti-microbial barrier.

Conveniently, the laminar portion 7 comprises at least one fabric layer.

Conveniently, the laminar portion 7 can include one or more layers that give the mask a filtering function. Advantageously, portion 7 can? include one or more layers suitable for conferring the filtration efficacy of a surgical mask according to the classification of the UNI 14683 and ASTM F2100 standards or of a device of the type FFP1 or FFP2 or FFP3, according to the classification set forth by the European standard UNI EN 149, or of the N95 types , KN95, P2, ?Korea 1st class? or DS according to the corresponding classifications mentioned above.

Preferably, portion 7 can? comprise at least one fabric layer having a filtration effectiveness, at least in one direction, greater than and equal to approximately 92% (for example up to 95% or 98%) for environmental particles and/or bacteria and/or droplets with a diameter ? 0.3 - 0.6 ?m, to give cos? to the mask 1 a filtering effectiveness, at least at the entrance, ? 92% (e.g. up to 95% or 98%) for environmental particles and/or bacteria and/or droplets with diameter ? 0.3 - 0.6 ?m.

Preferably, portion 7 can? comprise at least one fabric layer having a filtration effectiveness, at least in one direction, greater than and equal to approximately 98% for environmental particles and/or bacteria and/or droplets with a diameter ? 0.1 ?m, to give cos? to the mask 1 a filtration efficiency, at least at the entrance, ?98% for environmental particles and/or bacteria and/or droplets with diameter ? 0.1 ?m.

Preferably, at least one layer of portion 7 comprises a fabric obtained by weaving and/or a fabric obtained by knitting and/or a non-woven fabric (TNT, i.e. with fibers joined together, even in a disorderly way, by means of various systems, e.g. mechanical, hydrodynamic, aerodynamic, etc.). In particular, said at least one layer of fabric can? include natural vegetable, animal, synthetic, or metallic fibers or any combination thereof. Conveniently, said at least one layer pu? comprising at least a fabric area obtained by weaving threads, and/or a fabric area obtained by knit weaving and/or a non-woven fabric area (TNT).

Pi? in detail, the fabric layer can? be made of natural vegetable fibers or polyester or nylon or polypropylene microfibres.

Advantageously said portion 7 can? understand a plurality of layers, substantially the same or different from each other. In particular, portion 7 of the mask 1pu? consist of a multilayer fabric.

Fittingly, portion 7 ? breathable, and in particular allows the passage of air, in both directions, filtering / retaining for? the particulate matter and droplets and/or aerosol vectors of viruses or bacteria present in the air itself and having dimensions approximately greater, and in particular of approximately 2.9 ?m. Preferably portion 7 ? composed of at least two, and preferably of three or more? layers associated with each other in order to effectively filter the air that passes through the portion itself.

The layers of the portion 7 of the mask 1 can be associated to each other in a preferably non-removable manner, and for example can be associated by sewing or by gluing or by ultrasonic or infrared, full field or spot welding, or other traditional joining/fixing systems.

Advantageously, the portion 7 of the mask 1, and in particular at least one of the fabric layers that compose it, can understand a plurality of inserts and/or inclusions in bacteriostatic and/or antibacterial materials, in order to reduce the risk of infection by the user. For example, said bacteriostatic and/or antibacterial materials can comprise micro particles of suitable compounds which are dispersed within the portion 7. Furthermore, said inserts can comprise a plurality of of threads which can be woven inside the weft and/or warp of the fabric which makes up the portion 7. For example, said compounds can be made with metal elements, metal alloys, compounds of said metal elements and/or compounds with non-hazardous and/or harmful to health or safety.

Preferably, the layer pi? inside of the laminar portion 7 of the mask 1 (that is, the layer which is configured to be closest to the user?s face and preferably to substantially come into contact with the user?s face)? in a soft material, in order to improve the comfort of use, and for example pu? be made of polypropylene or cotton.

Preferably, at least one intermediate layer or the top layer? outside of the laminar portion 7 of the mask 1 are made of filtering fabric, for example non-woven fabric or fabric obtained by weaving threads.

Preferably, the fabric layers of the laminar portion 7 can have a thickness of about 0.6 - 1.2 mm. Conveniently, the fabric layers can have a weight ranging from a few grams/m2 to about 300 grams/m2. Conveniently, the fabric layers of the laminar portion 7 can have about 10? 100 threads/cm, preferably around 30 ? 60 threads/cm. Advantageously, the fabric layers can have a mesh size (i.e. the distance between the threads) of about 0.2? 1,5 ?m.

Conveniently, the fabric layers of the laminar portion 7 can be preliminarily subjected to a dyeing and printing step, to thus confer the desired color.

Conveniently, the mask 1 according to the invention can have a shape and dimensions corresponding to any traditional mask in which the portion 7 ? shaped and sized to cover the nose and mouth, and advantageously also the chin, of the wearer.

Advantageously, the laminar portion 7 of the template 1 can have a substantially rectangular or trapezoidal plan shape, and preferably in the shape of an isosceles trapezoid. Conveniently, in the latter case, the major base ? configured to be positioned upwards, and cio? towards the forehead of the user, while the minor base ? configured to be positioned downwards and in particular to be passed under the user?s chin. Conveniently, said mask 1 pu? be hexagonal in shape.

Advantageously, in order to better adapt to the user's face, and also simplify the folding and therefore the storage, the portion 7 of the mask 1 can? present a plurality of stitching 6 or inserts/elasticated areas to facilitate folding. Conveniently, seams 6 or inserts/elastic areas can be obtained on the portion 7 to give a particularly ergonomic shape and favor the adherence of said portion to the face of the wearer.

Advantageously, the mask 1 also comprises means 10 associated with said portion 7 and configured to be positioned and/or hooked behind the ears and/or around the wearer's head to keep said portion 7 stably in the position of covering the wearer's airways. In particular, said means 10 are defined by at least two ribbons or cords 11, preferably elasticated, which are associated with the portion 7 in correspondence with two mutually opposite regions and which are configured to be positioned/hooked behind the ears and/or around the head of the wearer in order to keep the portion 7 stably in position. In particular, the extremities of each tape or string 11 are fixed to the portion 7. Conveniently, said tapes or strings 11 can be configured to be each positioned/hooked around one ear of the user. Preferably, two ribbons or cords 11 can be provided which, when the mask 1 is worn, are intended to be positioned/hooked around the head respectively below and above the ears. Preferably, the ribbons or cords 11 are for example made of natural or artificial elastomer, for example of elasticized polyester.

Advantageously, in the area intended to be positioned around the nose of the wearer, it can be expected a nose clip insert, which preferably ? defined by a rigid element (for example by a sheet of metal) positioned centrally on the edge of the portion 7 between the layers of fabric.

Within the scope of the present invention for ?genetic material? means DNA or RNA, double-stranded or single-stranded, monopartite or multipartite, linear or circular, in its entirety or in fragments.

In the context of the present invention the terms ?COVID-19? and ?SARS-Cov-2? are used interchangeably to refer to severe acute respiratory syndrome coronavirus 2.

The mask according to the invention, in one embodiment? used for the ex-vivo/in-vitro diagnosis of the presence of a pathogen in the subject wearing the mask.

By way of non-limiting example, the pathogens according to the invention are Adenovirus, Bocavirus, Coronavirus HKU1, Coronavirus NL63, Coronavirus 229E, Coronavirus OC43, Coronavirus SARS?CoV-2, influenza viruses of different types, for example type A H1N1, H1N1 pdm09 (2009 strain), H3N2 (influenza), Respiratory syncytial viruses (RSV), Parainfluenza viruses 1, 2, 3, 4, Enterovirus, Human Metapneumovirus, Rinovirus, Bordetella pertussis (pertussis) and Bordetella parapertussis, Chlamydophyla pneumoniae, Mycoplasma pneumoniae , Streptococci, staphylococci, Klebsiella pneumoniae, Legionella pneumophila, Haemophilus influenzae, pneumococcus.

In a possible embodiment, the mask 1 comprises, in correspondence with at least one area 20 of the internal surface (i.e. the surface which ? when the mask is worn ? is intended to be turned and/or in contact with the wearer's face) of the laminar portion 7, a solution or a chemical substance suitable for preserving and stabilizing the genetic material of a pathogen, preferably a virus, more? preferably of the SARS-Cov-2 virus, present in the droplets of saliva that come out of the cavities? breathing of the subject wearing the mask itself.

Preferably but not limited to, the genetic material of the virus to be preserved and stabilized? that (i.e. RNA) of the SARS-Cov-2 virus (also known as COVID-19).

In a possible embodiment, the mask 1 comprises, in correspondence with at least one area 20 of the internal surface (i.e. the surface which ? when the mask is worn ? is intended to be turned and/or in contact with the wearer's face) of the laminar portion 7, a solution or a chemical substance suitable for preserving and stabilizing the antigen of a pathogenic agent, preferably of a virus, more preferably of the SARS-Cov-2 virus, present in the droplets of saliva that come out of the cavities? breathing of the subject wearing the mask itself.

In a possible embodiment, the mask 1 comprises, in correspondence with at least one area 20 of the internal surface (i.e. the surface which ? when the mask is worn ? is intended to be turned and/or in contact with the wearer's face) of the laminar portion 7, a solution or a chemical substance suitable for preserving and stabilizing antibodies which are produced by the user of the mask, which are directed against the antigen of a pathogenic agent, preferably of a virus, more? preferably of the SARS-Cov-2 virus, and which are present in the droplets of saliva that come out of the cavities? breathing of the subject wearing the mask itself.

Conveniently, the droplets generally have diameters greater than about 5 microns and are emitted by the wearer of the mask while speaking, coughing, sneezing or even while breathing. Conveniently, in a possible embodiment, in addition to the aforementioned droplets, the pathogen, preferably the virus, can also be present in particles, smaller than 5 microns, and suspended in the air, also known as ?bioaerosol?, which is emitted during breathing and/or speaking, and/or which comprises the dry residue of saliva droplets remains after evaporation.

Conveniently, the laminar portion 7 comprises inserts impregnated with said chemical substance or solution.

Conveniently, the laminar portion 7 comprises at least one layer of fabric, which defines the internal surface of the laminar portion itself, which is impregnated with said substance or chemical solution.

The solutions or chemical substances for use according to the invention are in no way harmful to the wearer, even if inhaled by the latter and/or even if in contact with or absorbed through the skin.

In a preferred embodiment, said chemical solution can be sterile phosphate buffered saline (PBS).

In a preferred embodiment, said chemical solution ? a sterile saline solution containing 0.9% W/V NaCl.

In a preferred embodiment, the chemical solution contains protease inhibitors and/or RNase inhibitors in concentrations which are not dangerous for the user.

In a possible embodiment, said chemical composition can be of any type of transport medium commonly used in diagnostics (for example Universal Transport Medium - UTM or Viral Transport medium - VTM) known to the person skilled in the art also suitably modified for use according to the invention.

Advantageously, in a possible embodiment, said inserts are provided/mounted on the area 20 of the portion 7. Preferably, the inserts can be dissociated from the previously worn portion 7 of the mask 1.

In one embodiment, the inserts on area 20 of portion 7 are composed of synthetic fibers, preferably polyester or nylon, and optionally structured to form a spongy layer. In a possible alternative embodiment, the inserts on the area 20 of the portion 7 are composed of natural fibers, preferably cotton, optionally structured to form a spongy layer.

In a possible embodiment, in correspondence with said zone 20, said inserts and/or at least one tissue layer of the inner surface of said laminar portion 7 comprises/comprise a strip formed by a membrane, preferably of nitrocellulose, preferably for immunochromatography at flow, suitable for the diagnosis of one or more? respiratory pathogens. By way of non-limiting example, said membrane comprises non-immobilized nanoparticles labeled with an antigen of a pathogen capable of binding to IgM and IgG antibodies directed against the pathogen itself, non-immobilized nanoparticles labeled non-human control antibodies, IgM antibodies anti- immobilized human, immobilized anti-human IgG antibodies, immobilized antibodies appropriate for generating the control signal for use in diagnosing the presence of said pathogen in saliva droplets. In a preferred embodiment the membrane ? a nitrocellulose membrane and the pathogen? SARS-CoV-2.

In a possible embodiment, the inserts and/or said at least one fabric layer of the inner surface of the laminar portion, which are made of synthetic or natural fibers can optionally be impregnated with the solution or chemical substance defined above. In particular, the inserts and/or said at least one layer of fabric made of synthetic or natural fibers and provided/assembled on the area 20 of the portion 7 can be initially (i.e. when the mask is worn) impregnated by droplets of saliva and , subsequently (once the mask has been removed from the face, to thus remove it from the respiratory tract) they are impregnated with this solution or chemical substance to be used in specific tests to highlight what is the positivity? to the pathogen, preferably the SARS-Cov-2 virus, of the subject who has previously worn the mask and who has therefore impregnated said inserts and/or said at least one layer of fabric with his saliva.

Preferably, these spongy inserts optionally impregnated with said solution or chemical substance are configured to be dissociated from the portion 7 of the mask 1 previously worn, to be so subsequently used in specific tests to highlight cos? the presence of a pathogen, preferably a virus, more? preferably of the SARS-Cov-2 virus, in the subject who has previously worn the mask.

In one embodiment, the spongy inserts so made and/or said at least one layer of fabric, optionally impregnated, can be used for the extraction of the viral genetic material to be used in molecular tests for the identification of the SARS-Cov-2 virus.

Can these tests be carried out directly on the inserts or more? in general on said at least one layer of fabric of the portion 7 facing the user and, in particular, they can be performed on the saliva with or without an impregnating solution suitably separated from the mask.

By way of non-limiting example, viral genetic material can be extracted using conventional methods or commercially available kits recommended for nucleic acid extraction and known to one skilled in the art.

The extracted genetic material can be subsequently analyzed by basic techniques for identification and analysis of nucleotide sequences, arrays, PCR, RT-PCR qPCR, RT-qPCR, ddPCR and other nucleic acid amplification assays (NAATs), including isothermal amplification, for diagnostics and in particular for the diagnostics of SARS-Cov-2 known to the expert in the field.

By way of example, the viral genetic material extracted from the inserts and/or from said at least one internal tissue layer is mixed with reagents containing primers of target genes, probes and master mixes for PCR, RT-PCR, qPCR or RT-qPCR and amplified . Depending on the type of probe used, PCR products can be detected during the amplification process (quantitative PCR, qPCR) or after its completion.

In one embodiment the spongy inserts described above or directly said at least one layer of internal tissue of the laminar portion 7, optionally impregnated, can be used directly for the analysis with NAAT techniques based on isothermal amplification, with isothermal amplification techniques mediated by loop (LAMP) or with appropriately adapted nicking endonuclease amplification (NEAR) or RPA techniques. In a preferred embodiment the inserts are used for LAMP analysis which advantageously allows a visual reading of the test using indicators sensitive to metals or pH sensitive dyes.

In one embodiment, the spongy inserts described above and/or said at least one layer of internal fabric (i.e. intended to face the wearer) of the laminar portion 7, optionally impregnated, can be used for direct or indirect execution of immunological tests.

In one embodiment, the immunoassays are aimed at identifying an antigen of a pathogen, preferably a virus, more preferably of the SARS-Cov-2 virus. These tests can be performed directly on the inserts and/or on the portion of the mask facing the user and in particular on the portion 7 or they can be performed on the saliva with or without an impregnating solution suitably separated from the mask.

In one embodiment, the immunoassays are aimed at identifying antibodies directed against a pathogen, preferably a virus, more preferably the SARS-Cov-2 virus, produced by the person who used the mask. These tests can be performed directly on the inserts and/or on the portion of the mask facing the user and in particular on the portion 7 or they can be performed on the saliva with or without an impregnating solution suitably separated from the mask.

For example, saliva alone or in combination with the solution or chemical substance that impregnates the inserts and/or the internal surface of the mask? separated from the inserts themselves or from the internal surface of the mask after the use of the mask by the subject, for example by centrifugation, and the supernatant can? be subsequently used in techniques based on chromatographic, immunoenzymatic assays, chemiluminescence-based tests preferably CLIA or ELISA. By way of example, CLIA assays or ELISA assays based on the use of the SARS-CoV-2 N protein as capture antigen (N-ELISA) and/or the other are preferred for the diagnosis of the presence of SARS-Cov-2 virus SARS-CoV-2 recombinant protein S (S-ELISA)

By way of example, saliva alone or in combination with the solution or chemical substance which impregnates the inserts and/or said at least one layer of internal tissue? separated from the remaining part of the mask after the latter has been used by the subject, for example by centrifugation, and the supernatant can subsequently be used in virus neutralization assays or antigen detection assays.

In another possible embodiment, as mentioned, the chemical substance or solution suitable for stabilizing the antibodies, the antigen, and/or the genetic material of the pathogen ? applied/impregnated, in correspondence with area 20, directly on the layer pi? interior of portion 7.

In one possible embodiment, ? Is it possible to apply directly on the inserts and/or on the pi layer? inside the portion 7 of the mask (previously worn and then appropriately removed and away from the wearer's respiratory tract) a suitable liquid containing a reagent for the analysis of the SARS-Cov-2 virus and capable of also causing a chromatic reaction at ambient or increased T, with or without an incubation period, in order to highlight cos? the positivity? to at least one pathogen, preferably a virus, plus? preferably to the SARS-Cov-2 virus of the person who wore the mask.

Preferably, in particular, the stabilizing substance or solution ? made to react with a reagent that contains specific oligonucleotide primers for the amplification of genetic material of at least one pathogen, preferably a virus, plus? preferably the SARS-Cov-2 virus or specific polyclonal or monoclonal antibodies, specific peptides (protein portions) for example of the S (Spike) or N (nucleocapsid) protein present on the viral surface of SARS-CoV-2.

Advantageously, in a possible embodiment, the mask 1 comprises, in correspondence with at least one area 20 of the internal surface (i.e. the surface which ? when the mask is worn ? is intended to be facing and/or in contact with the face of the wearer) of the laminar portion 7, one or more? chemicals or compositions such that, upon contact with at least one antigen of a pathogen, preferably a virus, more? preferably the SARS-Cov-2 virus present in the droplets of saliva that come out of the cavities? breathing of the subject wearing the mask itself, generate a chromatic reaction, thus highlighting the promptly the positivity? to the pathogen of the subject who wore the mask.

Conveniently, this substance or composition can? be applied on a support substrate (for example a strip) that ? mounted/applied to the inner surface of the laminar portion 7 and/or on inserts in turn applied to said laminar portion. In one embodiment, the support substrate ? a membrane for flow immunochromatography comprises by way of non-limiting example

- non-immobilized nanoparticles labeled with the pathogen's antigen capable of binding to IgM and IgG antibodies directed against the pathogen itself, - non-immobilized nanoparticles labeled non-human control antibodies, - immobilized anti-human IgM antibodies,

- immobilized anti-human IgG antibodies,

- immobilized antibodies appropriate to generate the control signal, for use in the diagnosis of the presence of a pathogen in saliva droplets.

Conveniently, in a possible embodiment, said zone 20 ? that ? treated with said substance or chemical solution, and/or what? configured to be impregnated by droplets of saliva - includes the entire surface development of the internal surface of the laminar portion 7.

Conveniently, in another possible embodiment, the zone 20 is that ? treated with said substance or chemical solution, and/or what? configured to be impregnated by droplets of saliva - includes at least one part, preferably a plurality of mutually spaced parts, of the surface development of the inner surface of the laminar portion 7.

Advantageously, in another possible embodiment, the zone 20 is that ? treated with said substance or chemical solution ?? that ? treated with said substance or chemical solution, and/or what? configured to be impregnated by droplets of saliva - ? defined in the vicinity? of the area of the internal surface of the laminar portion 7 which, when the mask is? worn, ? destined to be in contact and/or in proximity? of the cavities? nasal or cavity? oral of the wearer.

The mask 1 according to the invention is particularly advantageous since, in addition to the traditional filtering function, it also integrates a function of support and collection of biological material of the wearer of the mask himself, and what? in order to perform subsequent analyzes to diagnose the positivity? to a pathogen, preferably a virus, preferably SARS-Cov-2.

The mask 1 according to the invention is particularly advantageous since, in addition to the traditional filtering function, it also integrates substantially a function of diagnosis (operating thus? from a buffer) of positivity? to a pathogen, preferably to a virus, preferably to SARS-Cov-2, by the wearer of the mask himself.

Furthermore, these further advantageous functions are performed during normal use of the mask according to the invention, i.e. just by wearing it.

The mask 1 according to the invention? been described here in particular in its configuration and use for the diagnosis of the SARS-Cov-2 virus (or COVID-19), however ? understood that it can be configured and then used, through obvious adaptations within the reach of the person skilled in the art, for the diagnosis of other viruses.

The present invention also relates the use of the mask as described above in the in vitro diagnosis of in the in vitro diagnosis of SARS-Cov-2.

The present invention ? been illustrated and described in some of its preferred embodiments, but it is understood that executive variants can be applied to them in practice, without however departing from the scope of protection of the present patent for industrial invention.

Claims (10)

1. Mask (1) for the protection of the wearer's respiratory tracts, comprising a portion (7) with a laminar development, which ? configured to cover at least partially, preferably completely, the respiratory tract of the wearer, said portion (7) comprising at least one layer of filtering fabric, and characterized in that it comprises, in correspondence with at least one area (20) of the surface of said portion laminar (7) intended to be directed towards the wearer, a solution or chemical substance designed to preserve and stabilize: - the genetic material of a pathogen, preferably a virus, plus? preferably of the SARS-Cov-2 virus, present in the droplets of saliva and/or in the aerosol that come out of the cavities? breathing of the person wearing the mask itself, and/or - the antigen of a pathogen, preferably a virus, plus? preferably of the SARS-Cov-2 virus, present in the droplets of saliva and/or in the aerosol that come out of the cavities? breathing of the person wearing the mask itself, and/or - antibodies directed against the antigen of a pathogen, preferably a virus, more? preferably of the SARS-Cov-2 virus produced by the subject using the mask and present in the droplets (droplets) of saliva and/or in the aerosol that come out of the cavities? breathing of the subject wearing the mask itself. 2. Mask (1) for protecting the wearer's respiratory tracts, comprising a portion (7) with a laminar development, which ? configured to cover at least partially, preferably completely, the respiratory tract of the wearer, said portion (7) comprising at least one layer of filtering fabric, and characterized in that it comprises, in correspondence with at least one area (20) of the surface of said portion laminar (7) intended to be directed towards the wearer, a solution or a chemical substance such as to cause a chromatic reaction when it receives and/or? in touch with: - the genetic material of a pathogen, preferably a virus, plus? preferably of the SARS-Cov-2 virus, present in the droplets of saliva and/or in the aerosol that come out of the cavities? breathing of the subject wearing the mask itself, and/or - the antigen of a pathogen, preferably a virus, plus? preferably of the SARS-Cov-2 virus, present in the droplets of saliva and/or in the aerosol that come out of the cavities? breathing of the subject wearing the mask itself, and/or - antibodies directed against the antigen of a pathogen, preferably a virus, more preferably of the SARS-Cov-2 virus produced by the subject using the mask and present in the droplets (droplets) of saliva and/or in the aerosol that come out of the cavities? breathing of the subject wearing the mask itself. 3. Mask according to one or more? of the preceding claims, characterized in that on said area (20) of portion (7) inserts of natural and/or synthetic fibers are provided, preferably structured to form a spongy layer, configured to be impregnated with said droplets of saliva and/or in the aerosol that come out of the cavities? breathing of the subject wearing the mask itself. 4. Mask according to one or more? of the preceding claims, characterized in that said inserts and/or at least one layer of fabric of the inner surface of said laminar portion (7) is/are impregnated with said substance or chemical solution. 5. Mask according to one or more? of the preceding claims, characterized in that, in correspondence with said area (20), said inserts and/or at least one layer of fabric of the inner surface of said laminar portion (7) comprises/comprise a strip formed by a membrane, preferably a flow immunochromatography membrane. 6. Mask (1) for protecting the wearer's respiratory tracts, comprising a portion (7) with a laminar development, which ? configured to cover at least partially, preferably completely, the respiratory tract of the wearer, said portion (7) comprising at least one layer of filtering fabric, and characterized in that it comprises, in correspondence with at least one area (20) of the surface of said portion laminar (7) intended to be directed towards the wearer, - inserts in natural and/or synthetic fibers, preferably structured to form a spongy layer, configured to be impregnated with the droplets of saliva and/or in the aerosol that come out of the cavities? breathing of the subject wearing the mask itself, and/or - at least one tissue layer configured to be impregnated with droplets and/or saliva aerosol coming out of the cavities? breathing of the subject wearing the mask itself. 7. Mask according to one or more? of the preceding claims, characterized by the fact that said zone (20) affects a part of the surface development of the inner surface of the laminar portion (7), preferably affects the zones intended to be in contact with and/or in proximity of the cavities? nasal or cavity? oral of the wearer. 8. Mask according to one or more? of the preceding claims, characterized in that said inserts are configured to be dissociated from the portion (7) of the mask (1) previously worn, to be so? subsequently used in tests to highlight the positivity? to the virus, preferably to the SARS-Cov-2 virus, of the subject who has previously worn the mask. 9. Mask according to one or more? of the preceding claims, characterized in that said laminar portion (7) comprises at least one fabric layer having a filtration efficiency, at least in one direction, which is? ? 92% for environmental particles and/or bacteria and/or droplets with diameter ? 0.3 -0.6 ?m, or what? ? 98% for environmental particles and/or bacteria and/or droplets with diameter ? 0.1 ?m. 10. Mask according to one or more? of the preceding claims for use in the in vitro diagnosis of a virus, preferably of the SARS-Cov-2 virus.