IT202000027864A1 - USE OF CHLORHEXIDINE FOR THE CREATION AND USE OF VIRUCIDIAL CHEMICAL FILTERS AGAINST CORONAVIRUS CONTAGION (COVID-19) WHICH RETURN AND/OR PRODUCE AIR DECONTAMINATED BY VIRUSES, FOR MASKS, FACE MASKS, AND AIR TREATMENT SYSTEMS OF ANY KIND. - Google Patents

Description

DESCRIPTION OF THE INDUSTRIAL INVENTION

TITLE Use of chlorhexidine for the creation and use of virucidal chemical filters against the contagion from coronavirus (Covid-19) which return and/or produce air decontaminated by viruses, for masks, facial masks, and air treatment systems of any type.

STATE OF THE ART

In this patent we will talk about virucidal chemical filters applicable to all PPE and more, also offering the possibility? of a virucidal chemical filtration (by internal imbibition) to those masks that don't have filters. So these are virucidal chemical filters against contagion from the virus crown, to be applied to any PPE, and/or air conditioning systems.

On the market there are various types of filters, masks, half masks, masks and systems as detailed below, but only fabric masks or similar are ?considered? suitable against contagion, without any assessment of their effective virucidal efficacy. The current production partially follows the UNI EN 149:2001 A1:2001 standard with subsequent amendments, but there is a whole production of masks (mouth/nose) for, let's say "civil" consumption, which do not comply with strict workplace regulations , but according to the guidelines of the individual manufacturers. With the result that the effectiveness of use, despite being imposed by law, is? free from controls of any kind. So much?? which are in fact ?accepted? even those made at home (do it yourself) with cotton, silk and other waste, or adorned with ostentatious magnificence. In this ?normative and non-normative? situation, this patent aims to be able to provide excellent ?anti-viral? even with all the products mentioned above provided that the individual producers adopt virucidal chemical filters made with chlorhexidine. Said antiviral protection ? also obtainable by simple internal imbibition of unidentifiable fabric masks, provided that the manufacturer verifies that the mask is chemically inert to chlorhexidine and that it supplies, combined with it, what is necessary for imbibition with relative instructions and precautions to be taken. (see claim 1.

The standard for surgical masks, UNI EN 14683:2019 provides for characteristics and test methods, indicating the requirements of: resistance to liquid splashes; breathability; bacterial filtration efficiency; cleaning from microbes.

From the foregoing for those defined ?surgical? FFp2 or FFp3, even if regularly approved and marked, isn't it? is it possible to talk about antiviral protection why? no control ? never actually been possible. In fact, on the latter, although there are laboratory tests with methodologies tending to verify that the infected droplets are actually arrested (trapped) in the mask, do not there? certain proof of the effective retention of the individual viruses, and in any case even if the viruses were effectively arrested, the mask itself would have become infected. Therefore a source of possible contagion. All this with the current patent? passed, how and why? we will see more ahead when we will present the origin of the current invention. (See also claims 1, 2, 3, 4, 5 and 6)

From what has just been mentioned? already clear how large is the market for ?anti-convid-19 protection? on the market today, to which this patent is addressed, proposing the ?definitive? solution? of the problem. To do what? ? necessary a sort of classification of the ?equipment? destined to receive this novelty, whether these are parts of fixed systems for the treatment of the air, or self-contained breathing apparatus intended for single people, whether these workers or simple civilians.

To use the air we breathe when it presents dangers to our health, we use PPE ?Personal Protective Equipment?, which are self-contained breathing apparatus (masks). These can also be forced circulation with an electric fan connected. When, on the other hand, is the ambient air not? for temperature and/or humidity?, then air conditioners are used, or systems for its replacement. In all of these the ?filtration? of solid particles or aerosols occurs dimensionally due to the texture of the fabric or non-woven fabric or due to the porosity? of other material used. But when it comes to PM10, PM 5 particles or very dangerous gases? Chlorine, ammonia, phosgene and others? the filter container? made of chemically inert material, both metal and plastic, suitably perforated for the passage of air. Inside which v?? of the material with the task of neutralizing ?absorb, retain, convert? what is present in the air as it passes through the filter. The shape of these filters in general? cylindrical of adequate thickness with air flow parallel to the central axis, but there are also different shapes, hexagonal, octagonal, trapezoidal parallelepipeds or other shapes.

All of that? can you? summarize in the six ways? of air filtration existing today and briefly described below.

mode 1, type 1 masks (made with fabrics and non-wovens, or other unidentifiable materials) without inhalation and exhalation valves and without virucidal filters with pendular breathing, in the sense that the inhaled air is returned to the environment from where? ticket. How does it work, i.e. the retention of infected droplets? attributed only to the texture of the fabric and to the sponge effect that this type of mask causes. In this case, the mask after use? to be considered infected.

mode 2, type 2 masks (made with fabrics and non-wovens, or other unidentifiable materials) with only exhalation valves, without virucidal filter. The flow of air in this case? directional, in the sense that it enters through the fabric of the mask which acts as a filter and exits through the exhalation valve. In this case, since the sponge effect is not present, the retention of the virus would be attributed only to the texture of the fabric. The mask after use? to be considered infected.

mode 3, type 3 masks (i.e. rubber semi-face masks for workers) with inhalation valves with non-virucidal filter and exhalation valves without a filter. Directional airflow from filter to exhalation valve. These masks are also arranged for P1, P2 and P3 protection filters for fine dust, or other contaminants such as aerosols, toxic gases or the like. These masks are autonomous filter respirators. It must be specified that some advertising? did you define them as capable of retaining viruses, but without any reference to laboratory tests, anyway? of course they are all without a virucidal chemical filter. In this case, the filter after use? to be considered infected, but not the mask.

mode 4, type 4 masks with valves like the type 3 above with forced ventilation of ambient air. In this case the filter is not ? connected directly to the mask, but to a small fan that can be transported by the operator himself. The filtered air reaches the mask via a flexible tube connected to the fan. Also in this case the air filter is not ? virucidal. In addition to having the type 4 mask, the operator also has a transparent screen that protects the parts uncovered by the mask, eyes and a portion of skin. The same fan supplies air between the mask and the screen, creating a sort of barrier. The filter ? always non-virucidal. In this case, the filter after use? to be considered infected.

mode 5, face mask type 5. this type of protection would be the most? effective against the infectious agent such as the covid-19 coronavirus which recent studies have attributed to be probable that the infection also occurs through the mucous membranes of the eyes. From there? the facial mask would be the most? protective, why? its ?cover? includes the whole face, therefore including the eyes. ? used by professional operators, and ? combined with filters as described for type 3 above. In this case the filters after use are to be considered infected.

mode 6, all type 6 conditioning and/or air conveying systems, despite being equipped with unidentifiable filters (dust, pollen, etc.), are today totally excluded from the ?competition? against the contagion from coronavirus covid-19, while if they were equipped with virucidal chemical filters (see claim 6) that are easily achievable for each type of machinery, they would make a far from irrelevant contribution to this pandemic which today appears uncontrollable, as producers of decontaminated air.

Concluding. To date, all these masks are free of virucidal chemical filters against coronavirus infection, while the protection? left only to chance? that the infected droplets are retained by the sponge effect or by the texture of the fabric of the mask itself. The mask once used, as already? said ? become infected, and ? probable source of infection.

The use of the mask? prescribed by government decision, but not c?? Ad hoc tests have been disclosed which attest to the degree of effective efficiency. Also in all these masks there is no?? one that prevents the infected person from returning the consumed air to the environment through a virucidal and therefore decontaminated barrier. ? It is possible that, whatever mask it is, it can retain the virus in the inhalation phase, but the efficiency, officially due to the sponge effect or the texture of the fabric, is not? never been declared.

However it results from a study of the Mahidol University of Bangkok and of the university? of Oxford published on 28 September 2020 that, the ?mask? (unidentified) would only reduce the contagion from coronavirus by 77% when? in contact with a positive. And this actually represents the ?Achilles heel? of the current protection system.

NEW? OF THE FOUND.

? A study has been published (Journal of Hospital Infection) on the persistence of coronaviruses on inanimate surfaces and their inactivation with known biocidal agents. The study shows that sodium hypochlorite at a concentration of 0.21% leads to a reduction in infectivity in 30s. to the value of 4. While with a concentration of the same product of 0.01% it leads in 10 minutes to a reduction of the infectivity? to the value of only 2.3. The same study and for the same viral load (inoculum 10<6>) verifies that chlorhexidine gluconate at a concentration of 0.02% leads to a reduction (register 10) of infectivity in 10 minutes. to the value of 0.7?0.8. So with a reduction cos? low viral load this product does not appear advisable and with that concentration, for the sanitation of surfaces, but is it? very different thing if we use the same product at a concentration 150 times higher to make filters for breathing air. So what has just been reported, certified by laboratory tests, leads to an obvious consideration. If with 0.02% chlorhexidine it reduces about 100 units of inoculum by 10<6> in 10 minutes, with a concentration 10 times higher than 0.2% the result will be? very different.

So from there? the first assumption of the novelty? inventiveness ?increasing concentration? of the biocide increases its effectiveness.

Moreover ? been published on ?Sportface.it? the result of the viral loads of the swabs performed that in July 2020 those detected were less than 10,000 units? per ml, while on the following August 18 cases of 10<6 >(1,000,000) units had been detected? viral and beyond, up to one billion (10<9) >per ml of buffer. Well, to have this? Last pathogenicity? a droplet expelled from an infected person should have a viral load of approximately 2.6x 10<3 >units?.

There? established ? the case of inserting what has been ascertained by some doctors by analyzing the saliva, before and after a mouthwash, of two hospitalized covid-19 patients. The article ? published in KOREAN MED SCI.25 May 2020. and reading the relative diagram it can be seen that the viral load in the saliva before the mouthwash was close to 10<9>units, while after the 0.12% chlorhexidine gluconate mouthwash, with 15 ml for 30 seconds, the value of the viral load in the saliva was out of range after two hours. So zero or close to that value.

At this point the genius? dell?inventiva rests on five scientific data: -the first? that chlorhexidine ? hardly absorbed by the human body;

- the second which has a permanence time in the oral mucous membranes of several hours; -the third ? that the presence of chlorhexidine ? well tolerated by the human body;

-fourth- Analysis according to KOREAN MED. SKI. have ascertained that the virucidal action? was due to direct contact between the virus and chlorhexidine on the oral mucous membranes; -fifth. This use of chlorhexidine does not imply contact with the mucous membranes, therefore there are no limits to its usable concentration for the creation of filters, also given that by increasing its concentration, the virucidal effect is amplified.

The foregoing brings the conclusion of the effectiveness of the novelty? of this patent. In fact, placing droplets of high contagiousness? (2,6x10<3 >unit?) in contact with chlorhexidine before they have to infect, by means of filters soaked in liquid or granular chlorhexidine, the total inactivation of the viruses is obtained.

Therefore, if we equip the masks in the inhalation and exhalation phases with virucidal chemical filters with granular chlorhexidine according to claim 1 and 2; or imbibed with chlorhexidine digluconate according to claims 1 and 3 (for example) at a concentration even 150 times that reported by the above mentioned study; we would have obtained 100% efficiency of the mask and more, why? in the case of expiration equipped with a virucidal filter of the subject already? infected, return? to the environment decontaminated air according to claim 1.

Chlorhexidine? a chemical principle well known in medicine, but until now dedicated only to the generic disinfection of oral mucous membranes (? Chlorhexidine is a synthetic disinfectant, active against gram-positive, gram-negative bacteria and fungi? (see Wikipedia and others that exclude covid-19 virus).Chlorhexidine, IUPAC name ?1,1?-hexamethylenebis[5-(p-chlorphenyl)biguanide]?, crude formula C22CL2N10H30, is commercially available, as chloride, diacetate and dichlorohydrate.For medical applications? digluconate is usually used. Said active principle is present on the market, in various concentrations and in various combinations with many other active principles, excipients of various types, in relation to the final destination of the product. The concentration of this active principle in the products ranges from 0.005% up to 3% and more for medical use.

OBJECTIVE OF THE PATENT OF USE

This user patent claims the use of both liquid and powdered chlorhexidine as a virucidal agent for the purposes that follow:

- creation of any virucidal chemical filter, for masks, half masks, facial masks, conveying and air conditioning systems;

- the production of decontaminated air coming out of the virucidal chemical filters indicated above; - that after use, the provisions of this patent do not apply infected material; -possibility? control by the authorities? responsible for the correct use of the end users of the effectiveness time of the filters.

It also sets itself the goal of providing ci? that ? already on the market the possibility? concrete to adapt to the novelty?, but ? also promoter of a whole new line of products aimed at forming filters to be made and used for new needs and productions.

Chlorhexidine? on the market, as already? said, for various applications, such as chloride or acetate and for medical applications ? digluconate is usually used in a form also associated with other active ingredients, excipients of various types which do not have any virucidal effect relating to the present patent. Therefore ? the case of ?chlorhexidine digluconate solution? which we take as an example in this description/demonstration.

The use of this product? compatible for human physiology, in fact pu? stationed in the cavities? orally for several hours without any contraindication, as demonstrated by the use made up to now, but in the present patent the continued presence on the skin must be considered, as we will see later (? the case of the soaked masks) of this active principle. Which would lead, for? Repeated use, to sensitivity problems? more or less serious. So the? use may? be done following some safety precautions which will be described in the implementation of the patent.

Method of implementation of the patent for use.

Example of virucidal chemical filter by imbibition (spraying) for disposable masks.

All the type 1 masks indicated above are disposable. Considering that their maximum time of use? of about six (6) hours, the simple internal imbibition (see claim 4) ? possible by spraying the masks with a solution containing (for example 1%) chlorhexidine gluconate, with other excipients such as polyoxyethylene-hydrogenated castor oil, ethyl alcohol, purified water or other. These masks do not have dedicated filters, as they themselves perform the filtration of the air, therefore the imbibition will take place at a later time. for the whole mask, except for the areas in intimate contact with the skin, with a concentration (1%). Concentration this what? 50 times higher than described above in the study, necessary to ensure 100% efficiency. The internal imbibition action, if necessary, will be able to be repeated over the period of use. With the following examples we obtain the results that are the way of implementation of the patent and at the same time the news? of the found:

NEW? OF THIS PATENT

First novelty. The USE OF CHLORHEXIDINE identified by claims 1, 2 and 3 for the production of filters for masks, semi-masks and assisted facial masks and not by fans for the modalities? of use described in numbers one, two, three, four and five above.

Second novelty. FILTERS REALIZATION with chlorhexidine referred to in the first novelty? that precedes for the PPE whose modalities? of use are described in numbers one, two, three, four and five above. Filters, whether these are for internal (liquid) imbibition of type 1 and 2 masks or the dedicated filter made with granular chlorhexidine. Said filters for type 2, 3, 4 and 5 masks will be easily made by a qualified panel, with any inert, non-toxic material, with chlorhexidine powder or liquid, with fabric, cloth, tnt, fabrics of any material and with any shape, activated carbon, sponge and more.

Third novelty. The first and second novelty? bring the following ADVANTAGES:

- both masks and filters are not infected after correct use;

- return the used air to the environment decontaminated by viruses.

Fourth novelty. Are the filters made with chlorhexidine referred to in claims 1, 2 and 3 by imbibition or made with granular chlorhexidine, for air treatment and conditioning systems referred to in the sixth mode? all produce virus-free air.

Fifth news? The fourth novelty? above brings the ADVANTAGE that in the environments served by these systems it will not be? necessary the use of personal protective equipment (for the negatives), whether these are masks, semi-masks, face masks or other protection.

Sixth novelty. All the filters of the present patent will bear the effective time of protection provided and what? will I bring? the ADVANTAGE that all users will be aware of the duration of the antiviral protection offered.

Seventh novelty. In relation to the sixth novelty? which precedes a further ADVANTAGE must be added, i.e. the possible and eventual verification and control of users by the bodies appointed by the State.

EIGHTH NEW. ? common knowledge and awareness that the real sources of contagion, despite the use of the mask, are the possibilities ?unbreakable? of? crowded? of means of mass transport, buses, trams, trains, subways, etc., this ?thank you? to the imperfect virucidal function offered by the masks used today. With this patent however, adding the use of chemical filters in the PPE and in the air treatment systems that all means of transport have, WE WOULD GET THE REAL PANACEA TO THIS PANDEMIC.

Claims (6)

1. USE OF Chlorhexidine (CAS number: 55-56-1) for the creation of virucidal chemical filters for the production of air purified from viruses for individual users and for the environment, against the contagion from COVID-19; with the use of said chlorhexidine will have to? be established the modalities? relating to the use of these filters and their effective duration. 2. USE of the chlorhexidine according to claim 1 wherein said chlorhexidine is powder or granular with the concentration from 0.0001% to 100% and can? be combined/mixed with pharmaceutically acceptable inerts and/or excipients to obtain the right combination of efficacy and duration of the virucidal chemical filter for the production of air purified from viruses. 3. USE of the chlorhexidine according to claim 1 wherein said chlorhexidine is in liquid solution, with the concentration from 0.0001% to 100% as digluconate with pharmaceutically acceptable excipients, but pu? be selected as dihydrochloride, diacetate or other and/or mixtures thereof, rendered in liquid form, with pharmaceutically acceptable excipients, for the production of air purified from viruses. 4. Virucidal chemical filters made with liquid chlorhexidine according to claims 1 and 3 also for imbibition of autonomous individual breathing devices, mouth-nose masks, made of cloth or other light imbibable material or imbibable filters dedicated to semi-facial masks, facial masks in material plastic, for the production of air purified from viruses. 5. Virucidal chemical filters made with granular chlorhexidine according to claims 1 and 2 are dedicated to individual self-contained breathing devices, masks or semi-facial masks and facial masks for the production of air purified from viruses. 6. Virucidal chemical filters dedicated to purification and air conditioning systems, made using chlorhexidine as per claims 1, 2 and 3 above, for the production of air purified from viruses.