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1. (WO1991016936) DISPENSABLE BREATHING MASK
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Dispensable breathing mask

The invention relates to a dispensable breathing mask for use in practising the mouth-to-mouth method, comprising two flexible foils welded together within a central area, with a spout acting as check valve for insertion into the mouth of the patient, and with a through-going aperture extending laterally of the general plane of the foils.

As known, the mouth-to-mouth method has been put into practice for many years, training courses and a number of campaigns contributing positively for the propagation of the method and to the fact that it is well known by most people today.

However, in practising this method, particularly with life-saving but also during exercises, there exists an impending risk of infection. Bacteria and virus are readily
transferred through direct contact mouth to mouth, and there exists at all times a potential risk of e.g. HIV-infection .

Therefore, said risk of infection necessitates the use of infection-counteracting facilities in the practising of the mouth-to-mouth method.

For this purpose, different kinds of face masks or socalled breathing masks have been designed, and some of these designs are equipped with a check valve in order to prevent direct contact between the patient and the lifesaver. Often, infection-preventing equipment of this kind comprises complex and expensive devices and are, as a rule, merely used by the Red Cross, ambulance personal, hospital
personal, etc.

Dispensable breathing masks should be simple in construction and easy to use. Such a simple dispensable breathing mask comprises a plastic cloth having an electrostatic filter. In intact condition, such a filter is capable of retaining a substantial portion of the bacteria and virus present, but the user is, of course, not guaranteed a 100% protection against possible infection. An important problem linked to this dispensable breathing mask consists in the filter's lacking capability of taking care of blood and vomit from the patient. The filter sucks blood and liquids, thereby becoming more or less clogged and, ultimately, almost useless. An other disadvantage linked to such a dispensable filter is that it offers a far too great air resistance when used.

From German publication (Offenlegungsschrift ) 27 42 213 a dispensable breathing mask for use when practising the mouth-to-mouth method is known, comprising one single plastic foil having a check valve at a central reinforcement thereof. In this breathing mask, no measures whatsoever have been taken in order to facilitate the patient's breathing- out. Consequently, the mask has to be removed from the face of the patient after each blowing-in of air, in order to then give the patient the opportunity of breathing out. This has to result in a very uncomfortable form of life-saving.

From EP patent application 0 030 367, a revival device for use when carrying out of the mouth-to-moth method is known, comprising a flexible foil carrying a central mouthpiece or spout for insertion into the mouth of the patient and having a through-going aperture extending laterally of the general plane of the foil. The spout is rigid and, consequently, equipped with a separate check valve, which, of course, makes the construction more expensive. Nor in this known revival device, which hardly is intended to be used only once, measures have been taken in order to facilitate the breathing-out of the patient, the foil placing itself sealingly around nose and mouth of the patient, actually counteracting the patient's proper breathing-out between each blowing-in of air.

Thus, the present invention relates to a dispensable
breathing mask of the kind defined introductorily , the primary object of the invention being to form such a
breathing mask in such a way that disadvantages ,
deficiencies and application limitations linked to prior art technique are eliminated or reduced to a substantial extent. Thereby, one has aimed at making the use of a separate check valve superfluous and to arrange the conditions in order to not impeding the breathing-out of the patient.

In accordance with the invention, this is achieved through designing a breathing mask of the kind in question such that it exhibits the features defined in the following claims.

In contrast with the device according to the above-mentioned EP application, the mouthpiece or insertion spout to a dispensable breathing mask in accordance with the present invention is made from thin flexible material of such a nature and with such properties that it will be strongly deformed during the closing of the inner opening (positioned within the mouth of the patient ) through a flow of air ( from the patient) in a direction opposite the blowing-in direction. Thin flexible foil is a suitable material for the insertion spout. Because of the tendency of strong
deformation of the spout, no separate check valve is needed.

Around the insertion spout, the inner foil, i.e. the foil resting against the face of the patient, is formed with breathing-out holes (for the patient), so that he/she can breath out unimpededly between each blowing-in of air.

Thus, breathing-out air from the breathing-out holes
belonging to the patient and formed into the inner foil, passes laterally outward through the spaces defined between the two foils, the outer foil (at the lifesaver's side) preventing the lifesaver's immediate contact with the air coming from the patient.

An example of a preferred embodiment is diagrammatically shown in the accompanying drawings, wherein:

Figures 1 - 4 show the entire breathing mask separately, as seen in perspective from different angles, in that

Figures 1 and 2 show the breathing mask as seen from the lifesaver's side, the left half of the outer foil (at the lifesaver's side) in figure 1 being folded aside in order to show the design of the inner foil (at the patient's side) in a central area thereof;

Figures 3 and 4 show the same breathing mask as seen from the patient's side, figure 3 showing the mask in a somewhat folded together condition, while the mask in figure 4 takes a position approximately corresponding to figures 1 and 2 ;

Figures 5 and 6 show detail views of the mouthpiece or insertion spout of the mask in two different functional positions, as well as the immediate surrounding portion of the inner foil, figure 5 showing the spout during the blowing in of air into the mouth of the patient, while figure 6 shows the spout in the deformed position thereof when air is flowing in the opposite direction (during the breathing-out of the patient) wherein the inner spout orifice is closed due to said deformation, the spout then being closed to air passage. Consequently, the spout as such acts as a straightway or non-return valve;

Figures 7 and 8 show the breathing mask in use, figure 7 illustrating blowing-in of air into the mouth of the
patient, while figure 8 shows the situation whenever the patient is given the opportunity of breathing out.

In accordance with the embodiment shown, a breathing mask for use when practising the mouth-to-mouth method comprises two thin flexible foils 1 and 2, e.g. made of plastic, one foil 1 being intended to be placed over the face of the patient, i.e. being the foil at the patient's side - in the following description and in the claims designated the inner foil. Correspondingly, the other foil 2 which is intended to be situated at the lifesaver's side, is designated the outer foil.

Within a central area, the two foils 1,2 have corresponding openings, in figure 2 represented by an opening 3 in the outer foil 2 (the corresponding opening in the inner foil 1 not being visible).

In the area of the two corresponding openings 3, an annular welding seam 4 welds a mouthpiece or insertion spout 5 to the inner foil, the spout 5 being intended to be inserted into the mouth of the patient.

This mouthpiece/spout 5 is likewise made from thin flexible foil material, preferably plastic foil, and has at the free end thereof an orifice 5 ' . In non-actuated condition, the spout 5,5' has the form of a flattened sleeve, and due to its slight wall thickness and easy deformability, it will allow through-going flow of air in one direction only, namely in an direction toward the free end orifice 5' thereof, said direction of air flow corresponding to the blowing-in direction for air from the lifesaver into the mouth of the patient. In non-actuated condition, the spout 5 will take its extended position of readiness as shown in figures 3 and 4, wherein the end orifice 5' is closed.
During the blowing-in of air from the lifesaver, the spout 5 will be expanded, with full opening of the orifice 5', confer figure 5, wherein two arrows indicate the direction of flow.

When the force of expansion from the in-blown air ceases and, especially, upon opposite flow of air when the patient breaths out, the thinwalled, flexible spout 5 is immediately deformed, confer figure 6, wherein the orifice 5' is kept closed and all air passage through the spout excluded.

Figures 7 and 8 show how the lifesaver keeps the mask, with the inner foil pressed fairly tightly over the face of the patient (the spout 5 being inserted into the mouth of the patient ) .

Then, in order to give the patient the opportunity of breathing practically unimpededly out, i.e. contrary to conventional and other prior art technique, the inner foil 1, within an area surrounding the mouthpiece or insertion spout, is formed with breathing-out holes 6 . The breathing- out air escapes laterally through the spaces defined between the two foils 1,2. During the blowing-in of air into the mouth of the patient, the lifesaver's mouth/lips will urge the central area of the outer foil 2 against the perforated the blowing-in operation. As soon as a blowing-in step is terminated, figure 8, breathing-out air from the patient will, via the holes 6, flow unimpededly out between the two foils, confer the arrows in figure 8.

Over prior art masks , the breathing mask according to the invention primarily distinguishes itself in that it, due to design and choice of materials, does not offer a resistance against intentional air flow of such a magnitude as
otherwise encountered. This applies to the air resistance to be overcome by the lifesaver when blowing air into the mouth of the patient as well as to the air resistance to be overcome by the patient when breathing out.

Moreover, the breathing mask distinguishes itself through a very simple construction, also a result of appropriate design and choice of materials. Through the making of the mouthpiece or insertion spout of the mask in thin flexible material of such a nature in relation to the shape of the spout that the latter exhibits multipurpose-functions, namely as air transferring means and check valve, the use of a separate price-increasing straightway or non-return valve is made superfluous, and this is of significant importance with a dispensable product.