WO2021255629A1

WO2021255629A1 - Medical device for the protection of the respiratory tract

Info

Publication number: WO2021255629A1
Application number: PCT/IB2021/055248
Authority: WO
Inventors: Angela Maria Pia GUARNIERI
Original assignee: Silk Medical S.R.L.
Priority date: 2020-06-17
Filing date: 2021-06-15
Publication date: 2021-12-23
Also published as: EP4167788A1; IT202000014485A1

Abstract

The medical device (1) for the protection of the respiratory tract comprises: at least one surgical face mask (2); and joining means (3) to mount the surgical face mask (2) on the head of a user; wherein the face mask (2) is made at least partly of fibroin, the fibroin being present in a concentration by weight of more than 40%.

Description

MEDICAL DEVICE FOR THE PROTECTION OF THE RESPIRATORY TRACT

Technical Field

The present invention relates to a medical device for the protection of the respiratory tract.

Background Art

Medical devices are well known to be instruments used in medicine for diagnostic and/or therapeutic purposes and are often subject to specific regulatory frameworks, which may vary from country to country.

Medical devices for the protection of the respiratory tract include the so-called surgical face mask, also known as medical mask or facial mask for medical use, which is a device intended to be worn by health workers, for example, during surgery or other activities in the health sector, in order to prevent the dispersion of pathogens such as bacteria and viruses dispersed in liquid droplets and aerosols that can escape from the mouth and nose of the wearer.

Modern surgical face masks are made of paper or other non-woven material and should not be confused with other types of masks for the protection of the respiratory tract, such as e.g. dust masks that do not fall under the category of medical devices.

Surgical face masks are routinely attached to the operator’s face by special joining means which alternately consist of ear loops, wherein two cords are attached to the face mask and are placed behind the ears, the so-called tie-on, which consists of four non-woven straps that are tied behind the head or one, or two elastic straps, that are attached behind the head.

Traditional surgical face masks have some drawbacks related to the difficulty of using them for extended periods of time.

In this regard, it should be noted that the material of which surgical face masks are made is poorly breathable and is often the cause of skin irritation that, in severe cases, can cause pressure sores.

Additionally, wearing surgical masks for prolonged times causes breathing difficulties in users, thus leading to widespread discomfort such as headaches. In addition, the traditional joining means, which allow holding the surgical face mask on the face of the user, are not always practical, functional and comfortable to wear. For example, the contact of the joining means with the head of the user for prolonged periods of time is often the cause of skin irritation even of considerable entity that cause burning, erythema and pain in the user.

Other types of face masks are known from patent documents No. CN106136379, EP2484409 and US 2004/078860.

Description of the Invention

The main aim of the present invention is to devise a medical device for the protection of the respiratory tract which can be worn by users in an easy and functional manner for extended periods of time, while avoiding causing skin irritation, pressure sores or discomfort in the user.

A further object of the present invention is to devise a medical device for the protection of the respiratory tract which carries out a beneficial activity on the user’s skin.

Another object of the present invention is to devise a medical device for the protection of the respiratory tract which allows overcoming the aforementioned drawbacks of the prior art within a simple, rational, easy and effective to use as well as affordable solution.

The objects set out above are achieved by the present medical device for the protection of the respiratory tract having the characteristics of claim 1.

Brief Description of the Drawings

Other characteristics and advantages of the present invention will become more apparent from the description of a preferred, but not exclusive, embodiment of a medical device for the protection of the respiratory tract, illustrated by way of an indicative, yet non-limiting example in the accompanying tables of drawings wherein:

Figure 1 is an axonometric view of the medical device according to the invention;

Figure 2 is an axonometric view of the medical device according to the invention in an alternative embodiment;

Figure 3 is an axonometric view of the medical device according to the invention in a second embodiment;

Figure 4 is an axonometric view of the medical device in Figure 3 in an alternative embodiment;

Figure 5 is an internal axonometric view of the device in Figure 4.

Fmbodiments of the Invention

With particular reference to such figures, reference numeral 1 globally indicates a medical device for the protection of the respiratory tract.

The medical device 1 comprises: a surgical face mask 2; and joining means 3 to mount the surgical face mask 2 on the head of a user.

The surgical face mask 2 comprises a covering portion 4 made of quadrangular flexible foil which can be positioned to cover the nose and the mouth of the user.

Conveniently, the covering portion 4 is quadrangular in shape and comprises a first major side 5 and a second major side 6 opposite each other and two auxiliary sides 13 arranged at the ends of the major side 5 and extending transversely to the first major side 5.

Preferably, the covering portion 4 has a rectangular shape.

The first major side 5 is intended to be placed on the nose and on the cheekbones of the user’s face; the second major side 6, on the other hand, is intended to be placed on or under the chin of the user.

In this way, after the medical device 1 has been worn, the perimeter of the covering portion 4 completely surrounds both the nose and mouth of the user, providing full coverage of the respiratory tract.

Conveniently but not necessarily, the surgical face mask 2 may comprise a folding wire 7 associated with the covering portion 4 along the first major side 5, preferably incorporated inside the covering portion itself.

The folding wire 7 may be folded at the time when the medical device 1 is worn, so as to reproduce the features of the user’s face and make the first major side 5 better adhere to the user’s nose and cheekbones.

Alternative embodiments of the present invention cannot however be ruled out wherein the covering portion 4 has a different conformation, e.g. square, hexagonal, trapezoidal or oval.

According to the invention, the surgical face mask 2 is made at least partly of fibroin, the fibroin being present in a concentration by weight of more than 40%.

Advantageously, the surgical face mask 2 comprises fibroin in a concentration by weight greater than 45%, preferably greater than 50%.

More preferably, the surgical face mask comprises fibroin in a concentration by weight greater than 65%.

Advantageously, the surgical face mask 2 is made entirely of fibroin.

It is specified that the particular expedient of using fibroin in the manufacture of the medical device 1 allows the latter to be sterilized without the fibroin being degraded by the sterilization process itself.

In fact, fibroin as a biomaterial has the important characteristic, compared to other fibrous proteins such as, e.g. collagen, of being able to be sterilized without undergoing degradation. This characteristic is particularly important since each type of medical device 1 must be compulsorily sterile.

For example, the medical device 1 may be sterilized by means of saturated steam under pressure or by autoclaving.

In the latter case, it should be noted that the b-sheet content of fibroin is greater than 50%. This phenomenon can be explained by the following reasons: the high pressure applied increases the elastic modulus of polymers while increasing the crystallinity index; saturated steam, on the other hand, decreases the vitreous transition temperature (Tg) of fibroin, a condition that, when combined with the temperature increase, promotes the movement and rearrangement of chains (Lawrence BD et al, 2008).

In addition, the use of fibroin allows manufacturing a surgical face mask 2 permeable to vapor emanating from the user’s breath and to oxygen.

This ensures that the user’s skin is kept dry, thus preventing the spread of bacterial and/or fungal colonies thereon and promoting thermoregulation. Additionally, the joining means 3 are made of fibroin.

Furthermore, according to a second embodiment shown in Figures 3-5, the surgical face mask 2 comprises a filtering element 14 intended, in use, to be arranged at the nose and oral cavity of the user.

More specifically, the filtering element 14 is intended to be arranged, in use, at the nostrils and mouth of the user.

Advantageously, the filtering element 14 has a filtering power greater than 70%, preferably greater than 90%.

In this regard, it should be pointed out that the filtering element 14 is made at least partly of a biopolymer selected from the list comprising: polyolefins, polyamides, polylactic acid (PLA), polyhydroxyalkanoates (PHA), polyvinyl chloride (PVC), polyethylene terephthalate (PET), butylene adipate- coterephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polybutylene terephthalate (PBT), fibroin, or combinations thereof.

It is specified that, in the context of the present disclosure, the term “biopolymer” relates to materials directly derived from biological materials or microorganisms, or materials that can be obtained by classical chemical synthesis from renewable monomers.

In detail, biopolymers are selected from the list comprising: polymers directly extracted from natural materials, plants and animals. Examples of the type include polysaccharides such as cellulose, starch and starch mixtures, as well as proteins. Monomers, in turn, can be produced by fermentation of carbohydrates or sugars contained in foodstuffs; polymers produced by chemical synthesis, using biological and renewable monomers such as polylactic acid (e.g. PLA: bio-polyester polymerized from lactic acid monomers) or polyester; polymers produced by microorganisms isolated from natural or genetically modified environments such as e.g. polyhydroxyalkanoates (PHA).

Also, as visible in Figures 3-5, the filtering element 14 is associated with the covering portion 4. Advantageously, the filtering element 14 is arranged centrally to the covering portion 4.

Such an arrangement allows the covering portion 4 to be divided into three portions 15,16, a central portion 15 corresponding to the filtering element 14 and two side portions 16 with respect to the filtering element 14. Advantageously, the side portions 16 to the filtering element 14 are made entirely of fibroin.

This means that at the point where the side portions 16 are located, the covering portion 4 comprises fibroin present in a concentration by weight of 100%.

This expedient significantly increases the functional value of the device according to the present invention as it allows ensuring the well-being of the user’s skin in contact with the side portions 16.

In detail, the covering portion 4 comprises at least one housing pocket 17 of the filtering element 14.

The housing pocket 17 is configured to allow the filtering element 14 to be fitted to size.

As visible in Figure 5, the housing pocket 17 is made of foil and is associated with the covering portion 4.

The housing pocket 17 is associated with the covering portion 4 by stitching or, alternatively, by interposition of a layer of adhesive material.

It cannot, however, be ruled out from the scope of the present disclosure that the covering portion 4 comprises a first sheet and a second sheet associated with each other at the point where the first major side 5, the second major side 6 and the auxiliary sides 13 are located, and wherein the housing pocket 17 is made in the gap defined between the first sheet and the second sheet.

The first sheet and the second sheet are associated with each other by stitching or, alternatively, by interposition of a layer of adhesive material.

In other words, the filtering element 14 is tightened in a sandwich-like fashion between the first sheet and the second sheet.

In detail, the housing pocket 17 comprises an entry opening 18 through which the filtering element 14 is inserted. Preferably, the entry opening 18 is located in the proximity of the first major side 5.

It cannot, however, be ruled out from the scope of the present disclosure that the entry opening 18 is located in the proximity of the second major side 6 or, alternatively, of one of the auxiliary sides 13.

In addition, the housing pocket 17 comprises two side sections 11 arranged orthogonal to the first major side 5.

Preferably, the side sections 11 are obtained by sewing.

In actual facts, the housing pocket 17 has a substantially rectangular shape wherein the auxiliary sections 10 correspond to the major sides of the rectangle. In this way, the filtering element 14 is centered with respect to the flow of air inhaled and exhaled by the user.

Advantageously, the medical device 1 comprises one or more additional filtering elements 14 that are interchangeable with the filtering element 14.

This ensures that the user can remove the exhausted filtering element 14 and replace it with a new one.

Furthermore, according to two alternative embodiments shown in Figures 1 and 3, the device 1 comprises a protective portion 8 which can be positioned to cover the eyes of the user and associated with the surgical face mask 2.

In detail, the protective portion 8 is associated with the surgical face mask 2 at the point where the first major side 5 is located.

Preferably, the protective portion 8 is made at least partly of a biopolymer selected from the list comprising: polyolefins, polyamides, polylactic acid (PLA), polyhydroxyalkanoates (PHA), polyvinyl chloride (PVC), polyethylene terephthalate (PET), butylene adipate-coterephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polybutyleneterephthalate (PBT), cornstarch, fibroin, or combinations thereof.

Preferably, the biopolymer comprises fibroin.

Additionally, the aforementioned biopolymer is biocompatible.

It should be noted that the term “biocompatible” relates to the complex of interactions between the user and the medical device 1; the latter interacting with the tissues of the host organism does not cause adverse reactions that could interfere with its beneficial purpose.

Advantageously, the biopolymer comprises a combination of fibroin and cornstarch.

Advantageously, fibroin is present in a concentration by weight greater than 50%.

Preferably, fibroin is present in a concentration by weight of substantially 65%. In addition, cornstarch is present in a concentration by weight of less than 50%. Advantageously, cornstarch is present in a concentration by weight of substantially 35%.

In detail, the protective portion 8 is rectangular in shape and comprises a first main section 9 and two auxiliary sections 10 arranged at the ends of the first main section 9 and which extend transversely to the first main section itself. During use of the device 1, the first main section 9 is arranged at the user’s forehead, above the user’s eyes.

In addition, the protective portion 8 comprises an anti-fog film.

This allows the surgical face mask 2 to be worn even for prolonged periods, thus preventing the protective portion 8 from fogging up due to the user's breathing.

Additionally, the fact that the protective portion 8 is made of a biopolymer comprising fibroin allows for the promotion of hydro-lipidic balance.

In order to promote adherence of the device 1 to the skin of the user and isolation of the skin of the user from the outside, the device 1 comprises at least one adhesion edge 12 positioned at the point where at least one of either the first main section 9, the auxiliary sections 10, the first major side 5, the second major side 6 or the auxiliary sides 13 is located.

Preferably, the adhesion edge 12 has a convex circular profile.

As visible in Figure 1, the adhesion edge 12 is associated with the protective portion 8 at the point where the first main section 9, the two auxiliary sections 10 and the auxiliary sides 13 are located.

Nevertheless, according to an alternative embodiment shown in Figure 2, the adhesion edge 12 is associated with the first major side 5, the second major side 6 and the auxiliary sides 13.

Additionally, it cannot be ruled out from the scope of the present disclosure that the adhesion edge 12 is associated only with the first major side 5 and with the second major side 6.

Advantageously, the adhesion edge 12 is made of fibroin.

It has in practice been ascertained that the described invention achieves the intended objects.

In this regard, it should be noted that the particular expedient of providing for the use of fibroin allows the medical device to be worn even for prolonged periods, thus avoiding causing irritation to the user’s skin, together with burning, erythema and pain, but promoting skin regeneration and collagen production.

Furthermore, the use of fibroin allows the medical device to be sterilized, e.g. in an autoclave, without running the risk of the fibroin itself being degraded and losing its effectiveness on the user’s skin.

Additionally, the use of fibroin allows the medical device to be used on sensitive, allergic, hyperactive skin.

In addition, the use of fibroin prevents and treats bacterial infections through the inactivation of pathogens that, in contact with the surgical face mask, undergo the destruction of the cell membrane, so the formation of bacterial colonies is prevented, further preventing fungal infections.

Again, the use of fibroin in the manufacture of the medical device prevents rejection reactions by the immune system.

In addition, although the present invention is designed to be used in hospitals, it is also particularly suitable for applications outside the medical field, e.g. whenever it is necessary to avoid the dispersion of pathogens such as bacteria and viruses while carrying out normal daily work or leisure activities.

Claims

1) Medical device (1) for the protection of the respiratory tract comprising: at least one surgical face mask (2); and joining means (3) to mount the surgical face mask (2) on the head of a user; characterized by the fact that said face mask (2) is made at least partly of fibroin, said fibroin being present in a concentration by weight of more than 40%.

2) Medical device (1) according to claim 1, characterized by the fact that said surgical face mask (2) comprises a covering portion (4) made of a flexible foil which can be positioned to cover the nose and the mouth of said user.

3) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said surgical face mask (2) is made of fibroin, said fibroin being present in a concentration by weight greater than 45%, preferably greater than 50%.

4) Medical device (1) according to one or more of the preceding claims, characterized by the fact that it comprises at least one filtering element (14) intended, in use, to be arranged at the nose and oral cavity of said user.

5) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said filtering element (14) is associated inside said covering portion (4).

6) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said filtering element (14) is arranged centrally to said covering portion (4).

7) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said covering portion (4) comprises at least one housing pocket (17) of said filtering element (14).

8) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said housing pocket (17) is configured to allow said filtering element (14) to be fitted to size.

9) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said covering portion (4) comprises two side portions (16) with respect to said filtering element (14), made entirely of fibroin.

10) Medical device (1) according to one or more of the preceding claims, characterized by the fact that it comprises one or more additional filtering elements (14) that are interchangeable with said filtering element (14).

11) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said filtering element (14) is made at least partly of a biopolymer selected from the list comprising: polyolefins, polyamides, polylactic acid (PLA), polyhydroxyalkanoates (PHA), polyvinyl chloride (PVC), polyethylene terephthalate (PET), butylene adipate-coterephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polybutylene terephthalate (PBT), fibroin, or combinations thereof.

12) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said covering portion (4) is quadrangular in shape and comprises a first major side (5) and a second major side (6) opposite each other and two auxiliary sides (13) arranged at the ends of said first major side (5) and which extend transversely to said first major side (5).

13) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said housing pocket (17) is made of foil and is associated with said covering portion (4).

14) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said surgical face mask (2) comprises a folding wire (7) associated with said covering portion (4) along said first major side (5).

15) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said joining means (3) are made of fibroin.

16) Medical device (1) according to one or more of the preceding claims, characterized by the fact that it comprises at least one protective portion (8) which can be positioned to cover the eyes of said user and associated with said surgical face mask (2).

17) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said protective portion (8) is made at least partly of a biopolymer selected from the list comprising: polyolefins, polyamides, polylactic acid (PLA), polyhydroxyalkanoates (PHA), polyvinyl chloride (PVC), polyethylene terephthalate (PET), butylene adipate-coterephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polybutyleneterephthalate (PBT), cornstarch, fibroin, or combinations thereof.

18) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said biopolymer comprises a combination of fibroin and cornstarch.

19) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said fibroin is present in a concentration by weight greater than 50%.

20) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said cornstarch is present in a concentration by weight of less than 50%. 21) Medical device (1) according to one or more of the preceding claims, characterized by the fact that said protective portion (8) is rectangular in shape comprising a first main section (9) and two auxiliary sections (10) arranged at the ends of said first main section (9) and which extend transversely to said first main section (9). 22) Medical device (1) according to one or more of the preceding claims, characterized by the fact that it comprises at least one adhesion edge (12) positioned at the point where at least one of either said first main section (9), said auxiliary sections (10), said first major side (5), said second major side (6) or said auxiliary sides (13) is located, said adhesion edge (12) being made of fibroin.