This application is a national phase application under 35 U.S.C. 371 of International Application No. PCT/IB2021/053576 filed Apr. 29, 2021, entitled “BIDIRECTIONAL REUSABLE FILTERING FACE MASK,” which claims the benefit of and priority to Italian Patent Application No. 102020000009631 filed May 4, 2020, the contents of both of which being incorporated by reference in their entireties herein.
The present disclosure relates to the field of personal protective equipment (PPE), particularly respiratory masks used to filter the air breathed by people wearing such masks.
More precisely, it refers to a conveniently employable bidirectional filtration device to be worn profitably and advantageously, improving durability, production speed, safety and recyclability thereof.
The trade term “respiratory masks” usually refers to a family of masks intended to limit the transmission of infectious agents from staff to patients and vice versa, in certain situations during surgical procedures in operating theatres and other medical environments having similar requirements and/or intended for different types of working environments. This term therefore includes articles with different characteristics as regards materials and sometimes pattern, although the prevailing type is known to be disposable, made of a multilayer non-woven fabric with a rectangular or possibly gusseted shape.
Such respiratory masks are generally secured to the face by means of ties or elastic bands to be passed behind the ears or tied behind the nape of the neck; some models of such devices are further provided with a flexible wire for a better adherence to the nasal septum.
The masks approved for use as medical devices are also tested to ensure specific levels of protection against blood and other biological fluids penetrating through the mucous membranes of the nose and mouth.
Masks provide protection against the spread of influenza and other viruses that propagate by the so-called “droplet” mechanism, therefore they firstly block the droplets of respiratory secretions emitted by people wearing them; secondly, and only partially, they prevent the same droplets or sprays of secretions or other external biological fluids from reaching the mucous membranes of the nose and mouth of those wearing them. This is because the constituent material, or at least that of the outer layer in case of multiple layers, is impermeable to liquid droplets but allows air to pass through to let you breathe. As a result, these PPEs are not able to protect against fine aerosols that may contain very small infectious particles such as viruses.
Respiratory masks, to be safe, must be produced in compliance with the technical standards in force relating to the field of application in which they are to be used, such standards provide for characteristics and test methods, indicating the requirements of: liquid splashes resistance, breathability, bacterial filtration efficiency, being microbe-free.
Once used, disposable masks shall be disposed of immediately, as shall the filtering elements of reusable masks.
The present disclosure provides a conveniently employable device which allows to solve or at least considerably reduce the drawbacks of the related art. In said context, the Applicant has identified a system for reducing the bacteriological or viral proliferation by preserving one or more filters exposed with the external environment through the use of a pre-chamber provided with an anti-splash or anti-droplet filter allowing separating said pre-chamber from a traditional respiratory chamber. This mask that can be sterilised and reused with interchangeable filters, enables dramatically containing costs by reducing the production operations of the replaceable filtering components, ensuring a longer life and at the same time quality of results, both in terms of safety and in terms of adaptability, usability and ease of use.
Such results are achieved with the double-chamber protective mask according to the present disclosure, the essential features of which are defined in the claims appended to this description and the main objects of which are summarized below.
A device is described that allows to separate the filtering tissue in contact with the mouth and nose from the filtering device in contact with the external environment by a separation chamber, limiting the moistening of the filtering material in contact with the external environment and thus prolonging the duration and reliability of use.
A further object of the present disclosure is to provide a device that allows to optimally adhere to the face.
A further object of the present disclosure is to provide a device having removable disposable filters and that allows to possibly use glasses in an optimal manner.
A further object of the present disclosure is to provide a device that allows to replace filters easily and safely.
A further object of the present disclosure is to provide a device that can be used in a variety of conformations.
A further object of the present disclosure is to provide a device that allows to apply one or more check valves for optimal air escape with or without using an additional filter.
A further object of the present disclosure is to provide a device that allows to apply a battery-powered forced recirculation device with or without using an additional filter.
A further object of the present disclosure to provide a device that allows to connect the mask to a fixed forced ventilation device or system with or without using an additional, possibly remote, filter.
A further object of the present disclosure is to provide a product which, with respect to the above listed features, can be adapted to further commercial needs regardless of the environment of use.
Finally, a further object of the present disclosure is to make, following the same objects described in the previous points, a comfortable mask made of an anti-allergic plastic material which can be sterilised, easy to use, assemble and with low production costs.
The double-chamber protective mask according to the disclosure solves the highlighted problems and reaches the described objects by using a pre-chamber separating the filtering components in contact with the external environment and a filtering component that is in closer contact with the nose and mouth and intended to provide an anti-splash and anti-humidity protection, avoiding propagation thereof, through the same filter, to the filtering components in contact with the external environment.
The resolving principle underlying the disclosure is to use a pre-chamber with a disposable filter to prevent contamination and provide a degree of separation between the filter or filters in contact with the external environment and the portion of the mask in contact with the wearer's nose and mouth.
In order to further prolong the life of the filtering elements as well as to increase the comfort of the mask itself, the use of external or battery-powered forced ventilation systems of the chambers is possibly envisaged, so as to reduce the accumulation of humidity and CO2 inside the mask and ensure a longer life of the filtering components as well as a higher degree of protection, greater comfort and improved breathability under fatigue conditions.
The double-chamber protective mask according to the disclosure consists of various components (e.g., six components) comprising:
A plastic closure containing within its design two main quick-coupling clips and two or more secondary quick-coupling clips used for the connection with the anatomical base component, recesses for the peg seats and the other components necessary for holding in place and sealing a droplet filter. The closure element, within its design, further contains a recess for an extraction tab and other elements necessary for inserting and holding in place an intermediate element called pre-chamber dome;
Said pre-chamber dome is made of flexible plastic or silicone material and contains within its design a tab and other fasteners necessary for inserting and holding in place inside the aforementioned closure component, a central hole necessary for positioning a main filter and its main filter closure or, alternatively, other accessories described later adapted to perform the same function. The connection of said main filter closure with the corresponding pre-chamber dome may for example occur by quick coupling through a groove and a bead present on the two components, correctly positioned through at least one unique key within the recess. Said pre-chamber dome may optionally have one or more holes for the insertion of one or more check valves or fittings or both, with or without the relevant filter, or other accessories adapted to perform the same function described later;
An interchangeable main filter made of a multilayer non-woven fabric or other material having the same function, which is positioned correctly by means of one or more unique keys within the recess and locked by means of a main filter closure or other accessories described later;
A plastic main filter closure containing within its design a bead or quick-coupling groove necessary for the connection with the pre-chamber dome component, the recess for a unique mounting key and other components necessary for holding in place and sealing a main filter. Among the accessories available and replaceable with those previously listed we finally find:
A ventilated main filter closure that performs the same functions as the main filter closure component it replaces, adding to said component a forced ventilation provided by a battery-powered fan and optionally air monitoring sensors and a data transmission system; A forced main filter closure that performs the same functions as the main filter closure component it replaces, adding said component with a connection (possibly with a check valve positioned on the pre-chamber dome component) for forced ventilation provided by a duct connected to an external system or an additional remote filter.
A forced check valve that performs the same functions as the optional check valve component it replaces, by adding to the same component a connection for forced ventilation provided by a duct connected to an external system or an additional remote filter.
The use of the above mentioned accessories requires the use of the pre-chamber dome with at least one optional hole for the insertion of one or more check valves or one of the other accessories or equivalent fittings described later as well as a membrane to ensure proper air circulation.
This hole for the check valve can be made on one side only or on both sides, allowing a greater volume of air to be expelled depending on the use and need.
Furthermore, the same mask can also be used without inserting the pre-chamber dome and the main filtration system, using only the droplet filter, in less risky environments that allow use thereof.
Therefore, according to the Applicant's disclosure, the device plays an innovative role in preserving the main filter, which in the case of commercially available masks is exposed to moistening by saliva droplets at a short distance from the oral cavity by using a double barrier consisting in the droplet filter and the space inside the pre-chamber dome.
The filtering elements can also receive further advantages in terms of durability through the use of forced or battery-powered ventilation components which keep the filter elements drier, reducing the accumulation of CO2 inside the mask and producing as a secondary effect a greater comfort due to the increased air recirculation inside the respiratory chambers.
If a ventilated main filter closure is used, it is also possible to add a further degree of filtration through the insertion of a filtering element at the inlet of the fan of the same component as well as further safety elements through sensors for monitoring the quality of the air and filters.
Said disclosure therefore has:
The features and advantages of the double-chamber mask obtained according to the present disclosure will be more clearly shown by the following description of an embodiment thereof, given by way of an exemplary and non-limiting example in the 5 attached drawings, wherein:
As respiratory masks prevent the wearer from contaminating the surrounding environment, they should be used correctly and effectively to limit the transmission of infectious agents. This is all the more true in the case of medical, paramedical or similar staff in contact with patients during surgical procedures and other medical and health care activities and, in particular, to avoid pandemic phenomena from spreading in particularly high-risk environments such as clinics/hospitals/ambulatories. For a correct use, it is necessary to follow suitable precautions to properly wear, remove and dispose of a respiratory mask; otherwise said device, which is used to reduce the risk of contagion, can become a source of infection due to germs, bacteria and viruses that might settle on it. Regarding its use, it is necessary to replace the mask with a new one as soon as it is damp and do not reuse disposable ones; and replace it without touching the front portion.
Operators using disposable masks are thus required to replace them regularly as soon as they become damp. Unfortunately, this happens quite frequently because they are typically worn in adherence to the oral and nasal cavities, thus being subject to being easily moistened. In particular, they are subject to a latent but constant and significant moistening action due to the common and natural emissions of a person while talking and breathing normally; not only from acute phenomena such as sneezing. This reasonably reduces the life of most respiratory masks to a time span of a few hours.
The above-mentioned problems of limited life and frequent replacement may seem apparently negligible, since they are devices that are natively disposable and, above all, low cost, but they are of great importance in the hospital environment, especially in extraordinary circumstances such as pandemic events that put the healthcare system structures and staff under great stress. In fact, in these circumstances two serious problems can arise:
The above-mentioned problems, despite being prominent and crucial, are not the only ones afflicting this type of objects: important problems are reported about how these devices fit and in particular problems related to their proper positioning and stable adherence to the face. Although surgical masks are designed to prevent the wearer from contaminating the surrounding environment, it is obviously desirable that they also provide a reasonable, even if limited, barrier effect for the wearer in contaminated and hostile environments. Unfortunately, commercially available masks, being produced in a few formats and in standard sizes and being easily deformable, do not often perfectly adhere to the face and above all are poorly adaptable to the features and dimensions of the face and particularly of the nose, mouth and to the proportions between them. As a result, they can often allow viruses or harmful agents to pass through conspicuous and macroscopic side apertures that tend to form during use.
Finally, a further problem with commercially available respiratory masks, especially when using disposable devices, is the recyclability of the product itself. As described above, the aforesaid masks are made of at least 3 different materials, which are not separated for sanitary reasons.
With reference to the above mentioned figures, they are represented in the order:
As it can be seen from the two figures, the double-chamber mask comprises the following elements:
A pre-chamber dome (112) made of flexible plastic material or alternatively made of a silicone material comprising at least a tab necessary for the connection and positioning within the closure component (107), a central hole (113) necessary for positioning at least a main filter (114) with a unique key for fixing within the recess (113) and the subsequent insertion of a protective grid or main filter closure (115). Such pre-chamber dome (112) has the function of creating together with its own main filter (114) and the droplet filter (108) the so-called pre-chamber (101);
A main filter (114) made of a multilayer non-woven fabric or other material having the same function, interchangeable, which is positioned in a correct way through a unique key inside the hole (113) of the pre-chamber dome (112) and further locked through the main filter closure (115) such filter (114) has one or more tabs to facilitate the removal of the same in a safe way once contaminated or unusable; The main filter (114) can be safely removed from the pre-chamber dome (112), said dome (112) being made of flexible material, making it easy to remove the relative main filter closure (115);
A main filter closure (115) made of plastic material provided with a bead for quick coupling necessary to be connected with the pre-chamber dome component (112) used for holding in place and sealing the main filter (114), such main filter closure (115) may include fixing pegs necessary for pre-positioning the main filter (114);
A closure (107) made of plastic material in which they are visible the overlaps for hooking onto the anatomical base (104) necessary for a further degree of sealing against dirt and the realization of the secondary quick-coupling elements that interact with the beads arranged on the anatomical base component (104), and one of the two main quick-coupling clips with relative bead serving as main connection for engaging said part (107) to the anatomical base component (104) by means of eyelets present thereon, said closure (107) can include fixing pegs (110) necessary for pre-positioning the anti-splash or droplet filter (108) and, possibly, the seats corresponding to said pegs (116) will be obtained in the base (104).
With reference to the aforementioned figures and particularly to
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As it can be seen from the figure, such an alternative comprises the following elements:
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As it can be seen from the figures, such an alternative comprises, in addition to the main components, the following elements:
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As it can be seen from the figures, such an alternative comprises, in addition to the main components, the following elements:
At the end of this disclosure, it is worth repeating that the Double-Chamber Protective Mask of the present disclosure is particularly simple and easy to manufacture in the automatic or semi-automatic industrial production.
In terms of materials, the Double-Chamber Protective Mask may be made, for example (therefore by way of a non-limiting example), with EVA and HDPE mixtures, but also with different materials without departing from the object of the disclosure. It should be noted that in the previous descriptions, for ease of synthesis and brevity, all those components and common operations, known to a person skilled in the art, related to aesthetic and functional refining typical of this kind of device have been neglected, including by way of example:
Finally, as already mentioned several times, but it is worth repeating once again, the disclosure just described can be adapted to several variants which can offer further advantages with respect to those previously mentioned. Such further variants may reasonably be made by the person skilled in the art without thereby departing from the disclosure as it appears from the present description and appended claims. Furthermore, the disclosure may be realized partially, as well as all the various details described may be replaced by technically equivalent elements or solutions.
Number | Date | Country | Kind |
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102020000009631 | May 2020 | IT | national |
Filing Document | Filing Date | Country | Kind |
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PCT/IB2021/053576 | 4/29/2021 | WO |
Publishing Document | Publishing Date | Country | Kind |
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WO2021/224734 | 11/11/2021 | WO | A |
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Entry |
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International Search Report for International Application No. PCT/IB2021/053576 mailed Nov. 11, 2021. |
Written Opinion for International Application No. PCT/IB2021/053576 mailed Nov. 11, 2021. |
Number | Date | Country | |
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20230218931 A1 | Jul 2023 | US |