EP1757196A2 - Face mask with tamper evident means - Google Patents

Abstract

The mask has a fastening element (3) integrated to a porous protection piece (2) to maintain the piece in unfolded position in front of the nose and mouth of a carrier. The piece has upper and lower elements (4, 5) with edges (8, 9) placed to form a slit. The piece, in unfolded position, opens the slit to bring in contact the edges with the face of the carrier and, in folded position, places the elements on one another to close the slit. A unit (10) e.g. adhesive tape (16), for inviolability of the closing of the slit is arranged to identify in an irreversible manner the opening of the slit.

Description

The invention relates to a respiratory protection mask.

The invention applies in particular, but not exclusively, to respiratory protection masks capable of filtering solid or liquid particles suspended in the air, and intended for a single use.

Respiratory protection masks are used in particular by medical personnel to avoid not only the contamination of a patient by the projection of aerosols emitted by medical personnel, but also to avoid contamination of medical personnel by inhalation of biological agents present in the air, such as viruses.

A particular type of respiratory protection mask is the foldable mask, such as that described in the document GB-A-1556679 .

In this document, when the mask is not worn, an upper face of the mask is superimposed on a lower face so as to form a flat structure, easily stackable. And when the mask is placed on the face of a wearer, the two faces form a cut whose opening covers the nose and the chin of the wearer.

These masks have a limited duration of use to maintain a certain filtration efficiency and comfort of breathing. In some cases and to avoid any contamination, once removed, the mask should not be put back on the face.

To verify that the mask has never been worn, the document EP-A1-884959 discloses a foldable type of mask whose holding elastic around the head is made of a material whose visual appearance is modified after extension, that is to say after positioning behind the head. This difference in appearance is proof of the use of the mask.

However, this inviolability system requires the use of particular material that can generate additional cost.
The invention therefore proposes a respiratory protection mask comprising a simple and inexpensive inviolability system making it possible to visually ascertain that the mask has not yet been worn, thereby reducing the risk of contamination due to the reuse of the mask.

For this purpose, the invention provides a foldable and disposable type of respiratory protection mask, comprising a porous filter protection piece and a fastening element secured to said piece so as to hold said piece in the unfolded position in front of the less the nose and the mouth of a carrier, the part comprising two parts each having at least one edge, the edges being arranged so as to form a slot between them, said part being shaped for, in unfolded position, to open the slot of so as to be able to bring the edges into contact with the wearer's face and, in the folded position, arrange the parts so as to close the slot, said mask comprising a means of tampering with the closing of the slot which is arranged to identify irreversible the first opening of the slot.

The invention will be understood from the following description with reference to the accompanying drawings, illustrating various embodiments.

Figures 1 and 2 schematically show a perspective view of a respiratory protection mask according to a first and a second embodiment of the invention.

Figures 3 to 5 show schematically a sectional view along the axis A-A of a respiratory protection mask according to different embodiments of the protective mask and tamper means.

Figures 6 and 7 respectively show schematically a top and bottom view of a respiratory protection mask according to a particular embodiment of the invention.

Figure 8 schematically shows a partial sectional view along the axis A-A of a respiratory protection mask comprising a malleable insert.

In the description which follows, the terms "upper", "lower", "inner", and "outer" are defined with respect to the normal direction of use of the mask, that is to say when it is placed on the face of a wearer.

The invention proposes a respiratory protection mask, in particular of the foldable and disposable type. The mask is for example intended to retain solid or liquid particles suspended in the air and in particular viruses or bacteria likely to cause diseases such as influenza.

According to FIG. 1, the respiratory protection mask 1 comprises a porous protection piece 2 by filtration and a fastening element 3 secured to said piece so as to hold said piece in an unfolded position in front of at least the nose and the mouth of a carrier.

The porous part 2 comprises two parts each having at least one edge 8, 9, the edges being arranged so as to form a slot between them, said part being shaped to, in unfolded position, open the slot so as to be able to put in contact the edges with the wearer's face and, in the folded position, arrange the parts so as to close the slot.

In particular, in the folded position, the porous piece is shaped to arrange the parts one on the other so as to close the slot by putting the edges 8,9 in contact. Alternatively, the folded porous piece is shaped to arrange the parts side by side so as to close the slot by putting the edges 8,9 in contact.

Such a mask is called foldable type, that is to say that when it is not worn, the mask is substantially flat and is easily stackable.

The porous protection piece is formed in particular of two elements 4,5, respectively upper and lower, whose edges are associated with each other, so that they can be applied respectively facing the nose and the chin of the wearer.

The combination of elements is made for example by welding such as ultrasonic welding, high frequency laser or heat, sewing, gluing or folding.

As illustrated in FIGS. 1 and 2, the upper 4 and lower 5 elements are trapezoidal in shape, three sides of each trapezium being associated two by two to form the protective part, the large base of each trapezium being free to form the slot .

When the mask is worn, the two trapezoidal elements form a section whose periphery comes into contact with the wearer's face.

In particular, the elements 4,5 have the same dimensions so as to be perfectly superimposable.

Alternatively, the elements are of different size and / or shape (s). For example, the height of the trapezoidal lower member 5 is greater than the height of the trapezoidal upper member 4, so that the mask covers a larger part of the chin.

In another example, the protective piece is formed of three elements associated with each other, two of the elements being foldable on a central element. Such a type of mask is described in the document EP-A-814871 .

The porous part 2 is provided with securing zones 6, 7 on which the fastening element 3 is secured. The securing zones 6, 7 are placed at the lateral ends of the upper and lower parts of the protective part 8 respectively. 2.

The securing zones are either outside or inside the mask for arranging the fastening element 3 respectively outside the mask, or, as in FIGS. 1 and 2, inside the mask. mask.

According to the invention, the mask 1 comprises a tamper-proof means 10 for closing the slot, which is arranged to irreversibly identify the first opening of the slot.

Therefore, at the time of opening of the slot, the inviolability means undergoes a permanent change which can be for example structural and / or visual.

The tamperproof means 10 is arranged, before the first use of the mask, to associate at least a portion of the edges 8, 9 forming the slot, and to allow the first opening of the slot by irreversible rupture of the association. It is no longer possible to close the slot with the tamper means 10.

Thus, the inviolability means 10 guarantees the integrity of the mask before use and avoids any contamination due to the reuse of the mask.

The tamper-proof means is in particular fixed to the porous piece between the edges 8, 9 or straddling the edges 8, 9 forming the slot.

According to a first variant of the invention and as illustrated in Figure 1, the tamperproof means 10 is provided between the edges 8,9 forming the slot.

In a particular embodiment, the tamper-proof means comprises an adhesive material, in particular an adhesive point. The adhesive material is for example an emulsion based on natural rubber, neoprene or acrylic.

The adhesive power is adapted to allow the opening of the slot without damaging the edges 8,9. Once peeled off, the adhesive material can not pick up again.

The adhesion is sufficient to hold the edges together 8,9.

In another embodiment, the tamper-proof means consists of a ribbon, for example of rectangular shape, with an adhesive material on at least one of the faces. For example, the tamper-proof means is an adhesive tape 16.

As shown in Figure 1, the adhesive tape 16 is fixed inside the porous part 2, at the upper edges 8 and lower 9, in particular equidistant from the securing zones 6,7.

The ribbon 16 is fixed to the porous piece 2 permanently or removably at the edges 8,9.

When the ribbon is fixed permanently, it is for example in the form of a ribbon 16 tearable manually or cut with a sharp tool.

In addition, the ribbon may comprise a primer that allows a simple and precise tearing of the ribbon 16.

To wear the mask, the user must tear the ribbon 16. The first use is therefore visually identifiable.

When the tape 16 is removably attached, it is for example in the form of a peelable tape. Once peeled, the ribbon 16 can not be glued. The mask used is identifiable by the absence of ribbon.

The tape, whether peelable or tearable, is especially made of vellum, polypropylene, polyethylene or polyvinyl chloride.

When the tape is permanently attached, the adhesive material is for example an emulsion based on acrylic.

When the tape is removably attached, the adhesive material is for example an emulsion based on natural rubber, neoprene or acrylic.

In another embodiment, the tamper means is comprised of a tape with an adhesive material on at least a portion of each of the faces of the tape. In this case, the ribbon is removably attached to the edges 8, 9 and it is then sufficient for the wearer of the mask to pull the ribbon to use the mask.

According to a second variant of the invention, the tamper-proof means 10 is provided astride the edges 8, 9 forming the slot, as illustrated in FIG.

The tamper-proof means 10 comprises an adhesive tape 16 which is fixed on at least a part of the outer surface of each of the edges 8, 9 forming the slot, in particular at an equal distance from the securing zones 6, 7.

In particular, the ribbon 16 is removably attached to the outer surface of at least one of the edges 8,9 forming the slot.

In a first example, the ribbon 16 is permanently fixed on the outer surface of the edges 8, 9 forming the slot. Thus the use of the mask is performed by breaking the ribbon at the slot to allow the separation of the two edges 8,9 to access the slot.

In a second example, the ribbon 16 is permanently attached to the outer surface of at least one edge 8 forming the slot and removably on the surface of the other edge 9 forming the slot. The visual tamper control will be effective by the peeling of the ribbon 16 at the edge 9.

In a third example, the ribbon 16 is removably attached to the outer surface of the edges 8, 9. Thus the mask is used by peeling the tape at the outer surface of the upper edge 8 and / or lower 9.

In this variant, in which the tamperproof means is straddling the slot, the adhesive tape 16 holds the fastening element 3 inside the mask as shown in FIGS. 1 or 2, or on the outside the mask as shown in Figure 3, before the first opening of the slot.

Consequently, when several masks are stacked one above the other, the fastening elements of the different masks retained by the ribbon do not intermingle. And when a mask has to be removed from the stack, he does not bring other masks with him.

In addition, to facilitate the use of the mask, inscriptions on the adhesive tape 16 make it possible to recognize the direction of wearing of the mask. The inscriptions are for example of the form "High" and "Low" or "Up" and "Down", as illustrated respectively in Figures 6 and 7.

In connection with FIGS. 4, 5 and 8 and according to a particular embodiment of the mask, the mask comprises a protective strip 11 which is provided along at least part of an edge 8, 9 of the protection part 2, the fastening element 3 being interposed between the protective part 2 and the protective strip 11 so that the band 11 covers the fastening element 3.

In particular, the band 11 is secured to the protection part 2 on the securing zones 6, 7 of the fastening element 3.

When the protective mask 1 is not worn, the protective strip 11 at least partially covers the fastening element 3 so as to protect it.

The adhesive tape 16, straddling the slot, at least partially covers the protective strip 11. In particular, it extends beyond the protective strip 11 and is fixed on the porous piece 2.

When the mask 1 is worn, the breaking or peeling of the adhesive tape 16, as the case may be, opens the slot and thus releases the fastening element 3.

If it is removable, the adhesive tape 16 is detached from the protective strip 11 and / or the porous part 2. The wearer then takes the fastening element 3 below the protective strip 11 and disposes it on the back of his head.

According to one embodiment of the protective strip and as illustrated in FIG. 4, the protective strip 11 is formed of an additional element associated in a continuous manner along the protective part 2 close to an edge 8 of said part .

The association of the protective strip 11 with the protective part 2 is carried out for example by welding such as ultrasonic welding, high frequency, laser or heat, sewing, gluing or folding.

Advantageously, the length of the protective strip 11 and / or the length of the fastening element 3 is substantially equal to that of an edge 8, 9 of the protective part 2.

When the protective strip 11 and the fastening element 3 have the same length, the strip 11 completely covers the fastening element 3, keeping it along the porous part 2.

Thus, when several masks are stacked one above the other, the fastening elements of the different masks arranged below the protective strips do not intermingle.

According to a second embodiment of the protective strip and as illustrated in FIG. 5, the protective strip 11 is movable between a folded position along said edge and an extended position where it extends beyond said edge so as to extend the protection piece 2.

As illustrated in Figures 4 or 5, the adhesive tape 16, which is attached to at least a portion of the outer surface of each of the edges 8,9, holds the protective strip 11 in the folded position before the first opening of the slot.

When the protective mask 1 is not worn, the protective strip 11 is in the folded position and at least partially covers the fastening element 3 so as to protect it.

When the mask 1 is worn, the protective strip 11 is in its extended position and is pressed against the wearer's face, ensuring a close contact between the mask and the wearer's face.

The presence of this protective strip thus makes it possible to reduce as much as possible the possibilities of face leakage. The respiratory protection mask is thus able to ensure a good seal on the face to avoid contamination of the wearer.

According to Figures 6 or 8 and to further increase the seal at the nose of the wearer, a malleable insert 12 is provided on the upper member 4 to fit around the nose of the wearer.

The insert 12 is in the form of a deformable metal strip, for example an aluminum strip.

The insert 12 is arranged, for example by gluing, directly on the protective part 2 facing the nose.

Alternatively, the insert 12 is inserted into the mask between two layers constituting the protective part, as shown in Figure 8. It is then maintained for example by welding spots.

In another variant, the insert 12 is disposed on the protective strip 11 of the mask.

The choice of the material constituting the protective part and its characteristics such as air permeability, porosity, density or thickness, depends on the final use of the mask.

According to a particular embodiment, the protective piece 2 is formed of at least one layer of fibrous polymer material.

In particular, the protective piece 2 is formed of a stack of several layers of meltblown and / or spunbond nonwoven polymer material, such as a spunbond / meltblown / spunbond (SMS) laminate. The nonwoven is especially chemically treated or electrostatically charged in order to increase its particle attraction capacity and improve the filtration efficiency.

For example and as illustrated in FIGS. 3 to 5 and 8, the protective part 2 comprises the superposition of at least three layers: at least one outer layer 13 comprising a spunbond-type nonwoven polymer material, at least one layer intermediate 14 comprising a meltblown nonwoven polymer material, and at least one inner layer 15 comprising spunbond-type nonwoven polymer material.

Examples of usable polymeric materials are polypropylene, polyester, expanded polytetrafluoroethylene (PTFE) or polyethylene.

As described above, the mask may comprise a protective strip, as illustrated in FIGS. 4 and 5.

In the first mode shown in Figure 4, the protective strip 11 is formed of an additional element which is secured to the protection piece.

In this case, the protective strip 11 is made of a material identical to that of the protective piece or in a different material.

For example, the protective strip 11 is formed of at least one layer of spunbond-type fibrous polymer material, in particular non-woven material.

In another example, the protective strip is made of a material impermeable to liquids and / or gases, such as polyethylene.

According to the second mode, illustrated in FIG. 5, the protective strip 11 is formed of a fold of at least one inner layer 15 of the protective part 2.

The fastening element 3 is advantageously flexible and elastic to be arranged around the head of the wearer. It is in particular in the form of a flange.

The length of the fastening element 3 in the unstretched state substantially corresponds to the distance between the two securing zones 6, 7.

According to one embodiment, when the mask 1 comprises a protective strip 11, the fastening element 3 is substantially of the same length as the protective strip 11 so that the strip completely covers the fastening element, when it is in the folded position.

The fastening element 3, whether inside or outside the mask 1, and whether or not it is protected by the protective strip 11, is advantageously blocked by the adhesive tape 16.

According to one embodiment, the fastening element 3 comprises a second flange.

For example, the ends of a first and second flanges 3 are secured respectively outside and inside the protective part 2, in particular, as illustrated in Figures 4, 5 and 8.

Claims (15)

Respiratory protection mask (1) of foldable and disposable type, comprising a porous piece (2) for protection by filtration and a fastening element (3) secured to said part so as to maintain said piece in unfolded position in front of the less the nose and the mouth of a carrier, the part comprising two parts each having at least one edge (8,9), the edges being arranged so as to form a slot between them, said part being shaped for, in unfolded position open the slot so that the edges (8, 9) can be brought into contact with the wearer's face and, in the folded position, arrange the parts so as to close the slot, said mask being characterized in that it comprises a tamper means (10) of the closing of the slot which is arranged to irreversibly identify the first opening of the slot. Respiratory protection mask (1) according to claim 1, characterized in that the tamperproof means (10) is arranged to associate, before the first use of the mask, at least a portion of the edges (8, 9) forming the slot , and to allow the first opening of the slot by irreversible rupture of the association. Respiratory protection mask (1) according to claim 1 or 2, characterized in that the porous piece (2) comprises two elements (4,5), respectively upper and lower, whose edges are associated with each other. Respiratory protection mask (1) according to claim 3, characterized in that the elements are trapezoidal in shape, three sides of each trapezium being associated in pairs to form the protective part (2), the large base of each trapezium being free to form the slot. Respiratory protection mask (1) according to any one of claims 1 to 4, characterized in that the tamperproof means (10) is provided between the edges (8,9) forming the slot. Respiratory protection mask (1) according to claim 5, characterized in that the tamper-evident means (10) comprises an adhesive material. Respiratory protection mask (1) according to any one of claims 1 to 4, characterized in that the tamperproof means (10) is provided straddling the edges (8,9) forming the slot. Respiratory protection mask (1) according to claim 7, characterized in that the tamper-evident means (10) comprises an adhesive tape (16) which is fixed on at least a part of the outer surface of each of the edges (8, 9). Respiratory protection mask (1) according to claim 8, characterized in that the tape (16) is removably attached to the outer surface of at least one of the edges (8, 9). Respiratory protection mask (1) according to claim 8 or 9, characterized in that the ribbon (16) is permanently attached to the outer surface of at least one of the edges (8, 9). Respiratory protection mask (1) according to any one of claims 8 to 10, characterized in that the tape (16) is tearable. Respiratory protection mask (1) according to any one of claims 1 to 11, characterized in that it comprises a protective strip (11) which is provided along at least part of an edge (8,9 ) forming the slot, said fastening element (3) being interposed between the protection member (2) and the protective strip (11) so that the strip (11) covers the fastening element (3) . Respiratory protection mask (1) according to claim 12, characterized in that the protective strip (11) is movable between a folded position along said edge (8,9) and an extended position where it extends beyond said edge (8,9) so as to extend the protection piece (2). Respiratory protection mask (1) according to claim 13 when dependent on claim 8, characterized in that the adhesive tape (16) holds the protective strip (11) in the folded position before the first opening of the slot. Respiratory protection mask (1) according to any one of claims 1 to 14 when dependent on claim 8, characterized in that the adhesive tape (16) holds the fastening element (3) on the outside of the mask before the first opening of the slot.

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