WO1998048878A2 - Breathing mask - Google Patents

Abstract

The present invention relates to a breathing mask used in a CPAP system, comprising one or several of the following devices: a) a fixing device enabling the breathing mask to be placed at less pressure on the wearer's face with a securing strap (32); b) a sound-proof air outlet (2); c) an air-feed connecting element (40); d) a mask seal which seals the mask to the wearer's face without damaging the skin.

Description

Name: breathing mask

The present invention relates to a breathing mask for breathing humans.

A large number of people, especially men, suffer from nightly breathing interruptions, which in extreme cases can even be life-threatening. A ventilator that can be worn at night can help with this so-called apnea.

The disease is caused by a slackening of the pharynx muscle tissue and, in addition to an undersupply of essential oxygen, often also leads to problems with the partner in question as a result of the resulting erectile dysfunction. The individual suspension phases of breathing last between about ten seconds and one minute.

One solution to this problem can be to use a respirator with a breathing mask. This is an apparatus that works according to the so-called CP AP method (Continous Positive Air Pressure) and supplies the patient with pressurized air by means of a slight overpressure via a hose feed and a face mask to be put on at night. Pressures of up to 16 millibars are used.

Such devices are available from Respironics Inc., 1001 Murry Ridge Drive, Murrysville, Pa. 15668-8550, United States.

Devices from Gottlieb Weinmann devices for medicine and occupational safety GmbH + Co., Hamburg, are also available on the market under the protected trademark SOMNOTRON ^® 2 nCPAP sleep apnea sets. The Winmann company uses the Somno Mask system in which a plastic filter cartridge is used in the fresh air hose leading to the mask instead of the previously known outlet slots. This filter cartridge consists of a ceramic filter and is very expensive to replace as a replacement part. In addition, the cartridge is arranged in a region of the supply air hose in such a way that the fresh air supplied or the exhaled breathing air can blow into the face of the user, which is detrimental to the comfort of the device.

However, all of these devices have problems which make their use considerably more difficult or even prevent them. So despite the use of silencers, the respective devices are still relatively loud and thus disturb both the patient himself and his life partner. So when leaving the bed at night, it is necessary to first put the entire device out of order to avoid disturbing air noise, which is extremely annoying for the user. In addition, many patients cannot tolerate the face masks due to their low wearing comfort. In more severe cases, they even lead to skin diseases and skin allergies.

A solution proposed by Respironics Inc., which has already been mentioned, addresses this problem in particular. They offer a silicone contour mask that is more skin-friendly than conventional masks with rubber seals due to the silicone material used. However, this proposed solution can still not be considered sufficient. In the edge area in particular, such silicone contour masks still have very sharp or at least abruptly shaped courses which can be disruptive to the patient.

All in all, it can be stated that no CP AP ventilators are known in the prior art which provide breathing masks with any accessories which allow sufficient attention to be paid to the wearing comfort and also to the noise development during their use.

It is therefore an object of the present invention to provide a breathing mask with such comfort properties. This object is achieved by a breathing mask, which is characterized by one or more of the following devices according to the invention, namely a fastening device of a fastening tape for pressure-reducing attachment of the breathing mask to the human face with fastening tape, a soundproofed air outlet, an air supply connection piece, and a mask seal for sealing but skin-friendly contact of the mask with the human face.

The fastening device of a fastening band for the pressure-reducing attachment of the breathing mask on the human face with fastening band is characterized in accordance with the invention in that it has a balance beam which is connected to the breathing mask approximately centrally via joints and on the other hand to the fastening band at the edge via attachment points . In the case of the breathing masks according to the prior art, rigid mounts are provided on the side of the actual mask, to which two lateral headbands are connected for fastening. This inevitably leads to the mask slipping if the head moves involuntarily while sleeping. This can only be countered by increasing the contact pressure, which in turn leads to skin problems.

According to the invention, the side headbands are now connected to the breathing mask in such a way that the force from the headbands is central to the area of the nose, i.e. about in the area of the bridge of the nose. This is achieved by the at least one balance beam, which is pivotally connected centrally to the mask, so that the mask is supported on the balance beam in an oscillating manner. Tilting of the mask against the face is therefore impossible, as is slipping sideways. The pressure forces can be low, which is accompanied by a reduction in skin problems.

In one embodiment according to the present invention, the balance beam can also be articulated on the respiratory mask via exactly one joint.

In the case of the joints, it is preferably universal or ball-and-socket joints which can be deflected in all directions, because the above-mentioned balance beam should be supported in such a way that not only horizontal pivoting, but also conditionally vertical pivoting of the balance beam with respect to the support point is possible.

The sound-damped air outlet according to the invention is characterized in that the air outlet has a silencer made of open-cell foam. This can be surrounded by a jacket, preferably made of plastic.

The muffler can be inserted or attached in the area of the breathing mask, or it can also surround the supply air hose at a perforated point in the hose. A separate housing for the muffler is preferably provided, in particular a pipe which is open on one side and is connected to the supply air area. Such a silencer, for example made of a plastic jacket, into which an inexpensive, fine-pored foam plug is inserted, can be replaced or cleaned if necessary. The air exhales further away from the face and is therefore less disruptive. It largely eliminates disturbing noises.

The air supply connector between the breathing mask and the air supply system according to the present invention is characterized in that it is slidably arranged on a mounting bracket in the region of the head.

In a preferred embodiment, it is designed to be detachable from the supply air hose going to the air supply system.

The device according to the present invention thus makes it possible, for example, to keep the breathing mask open during a shorter sleep interruption, only the supply air hose having to be loosened. This makes it much easier to use.

The supply air hose is guided via a whip holder on the bed to an adjustable, in particular displaceable, air supply connection piece attached to a mounting bracket, preferably on a head cover, to the mask. The air supply connector consists of a rotary adapter, a quick release, an automatic shut-off valve and fixes the mask position. If you want to get up at night, the supply air hose is disconnected at the push of a button and at the same time a flap closes the air flow. Back in bed, the supply air hose hanging on the whip holder becomes reconnected by simply plugging it in, the flap opens at the same time

According to the invention, the mask seal for the tight but skin-friendly contact of the mask with the human face is characterized in that the seal is designed as a silicone tube which is at least partially filled with a jelly-like compliant material.

The silicone tube is preferably filled to a maximum of 75%, ideally half with the jelly-like material.

In a further preferred embodiment of the present invention, the silicone tube jacket is made thicker towards the mask than towards the skin area to be sealed.

Respiratory masks according to the present invention therefore offer a novel, flexible and tension-compensating fastening technique. Even with a minimal adjustment pressure, the mask gets a firm hold. Skin injuries or pressure points on the nose, forehead and cheeks are eliminated.

The breathing mask does not twist or shift due to air hose strains, nor does it lift off on one side and therefore does not cause air leakage noises, which prevents eye and ear irritation due to secondary air leakage.

The breathing mask according to the invention has an all-round, uniform adjustment pressure, which remains constant even when the head is moved sideways. The mask body can be easily removed from the attachment in two easy steps. Quick cleaning is also not a problem, since the mask body including the sealing profile is smooth and seamless and has no room for "bacterial hatching".

The mask beads, which are generally used for sealing, and the sealing skins that interfere with the circulation of the skin, are replaced by a narrow, smooth, all-round silicone hollow profile, which is only partially filled with gel to exclude air. This flexible hollow profile adapts easily to the area around the nose. Even warts etc. in the sealing area are covered effortlessly. The exhaust air flows through cuts in the mask angle almost silently using a "piggyback silencer" with an exchangeable plug-like filter.

By using the breathing mask according to the invention, a large number of the previously known problems when using CPAP systems are reduced or even eliminated. The breathing masks according to the invention ensure a common, partner-friendly, trouble-free sleep.

In the following, non-restrictive exemplary embodiments are discussed with reference to the drawing. In this show:

1 is a schematic representation of a lying person, partially shown, wearing a breathing mask according to the invention in side view,

1A shows the mask corresponding to FIG. 1 on a larger scale with the head indicated,

1B, the mask in front view corresponding to the arrow 1B in Fig. 1A,

IC is a plan view of the mask as a section along the line IC-IC in Fig. 1A,

2 shows a schematic illustration of a breathing mask according to the present invention in longitudinal section,

2A is a view of a portion of the breathing mask in the direction ILA in Fig. 2,

3 is a plan view of an air supply connector as a section along the section line III-III in FIG. 1A,

4 shows a section along the section line IV-IV in FIG. 3,

4A shows the section according to FIG. 4A, but with the air supply connector disconnected, FIG.

5 shows a mask seal according to the present invention in cross section,

5A shows a further mask seal according to the present invention in cross section, 5B shows a mask seal according to the present invention in cross section and

5C shows a compensating cushion that can be inserted into the mask seal.

Fig. 1 shows a schematic representation of a person lying down, wearing a breathing mask according to the invention, which is shown even more clearly in Figures 1A to IC, in side view. The breathing mask is here provided with two fastening devices for the pressure-reducing attachment of the breathing mask to the human face, each in the manner of a balance beam 30, which is connected on the one hand to the breathing mask via universal joints 1 and on the other hand to the fastening strap 32 via attachment points 31. A sound-damped air outlet 2 sits on the supply air hose 33 in the area of the breathing mask. The two balance beams 30 can be mechanically connected to one another.

Fig. 2 shows a schematic representation of a breathing mask according to the present invention in longitudinal section. Here, too, the breathing mask is provided with two fastening devices for the pressure-reducing attachment of the breathing mask to the human face, each in the manner of a balance beam, which are connected to the breathing mask via joints 1. A sound-damped air outlet 2 sits on the supply air hose 33 in the area of the breathing mask. The slightly pressurized air flows in the direction of arrow 36 towards the actual breathing mask 34, where it supports inhalation. When exhaling, the air then flows out through the muffler 2 in the direction of the arrow 37. The actual breathing mask 34 lies tightly against the face via a silicone tube 20, so that no secondary air can flow out.

2A shows a schematic illustration of a fastening device of the breathing mask according to the present invention in the form of a balance beam in cross section. The breathing mask 34 is movably connected to the so-called balance beam 30 via a joint 1. The balance beam itself 30 is in turn connected to the elastic, flexible headband 32, which encloses the head 35, via attachment points 31.

Fig. 3 shows a schematic representation of an air supply connector 40 according to the present invention in longitudinal section and Figures 4 and 4A of this piece 40 in cross section. Both are discussed together below. A headband connecting plate 38 is provided for the support on the forehead and in particular above it, in the area of which a kind of angle or locking bracket 3 is arranged, on which the horizontal leg with the headband 4 in the direction of the arrows 5 in a different position, preferably by means of a bolt 6 can be fixed. The supply air hose 7 or 33 is coupled via a rotary adapter 8 with a removable intermediate piece 9, which, for. B. in a rail guide 10 of the angle bracket 3 in the direction of arrow 11 from the angle bracket 3 can be lifted or otherwise decoupled. For this purpose, an ejector spring 12 is arranged under the removable intermediate piece 9, which automatically pushes the intermediate piece 9 out of the angle bracket 3 when the snap locks 13 are actuated for this purpose.

In the removable intermediate piece 9, a butterfly valve 14 is provided, which is biased in the direction of rotation about the axial axis 15 by means of a spring 16. The pretensioning is carried out so that when the intermediate piece is inserted - i.e. As can be seen in Fig. 3, the butterfly valve 14 is aligned in the opening direction. This takes place automatically when the intermediate piece is inserted into the angle bracket 3 in that a control cam 18 arranged on the axle journal 17 in a manner fixed against relative rotation passes along the control curve 19 of the angle bracket 3. The butterfly valve 14 is thus automatically fixed in its position, it is open.

When lifting the intermediate piece 9, the spring 16 automatically moves the butterfly valve 14 into the closed position so that no air can escape from the supply air hose 7 or 33. It is therefore not necessary to shut down the air supply system.

5, 5A and 5B show mask seals according to the present invention, each in cross section. Here, a silicone tube 20 is used as the direct closure of the mask to the nose area, which is relatively thick-walled in the area designated by 21 and relatively thin-walled in the area designated by 22, which rests on the face. This silicone tube 20 is filled with a jelly-like material 39, preferably again silicone of a corresponding consistency, and then partially placed under vacuum, so that the film shown in FIG. 5B results. This shape arises due to the different wall thickness of the silicone tube 20 seen over the circumference of the circle. The mask seal has a holding profile with which it a tightly engages a groove or the like of the mask 34.

5C shows a compensating cushion 24 that can be inserted into the mask seal if required, for further improved adaptation of the silicone tube to the human facial physiognomy.

The breathing mask is provided with two fastening devices for pressure-reducing attachment of the breathing mask on the human face, each in the manner of a balance beam, which are connected to the breathing mask 34 via joints 1. A sound-damped air outlet 2 is located on the supply air hose 7, 33 in the area of the breathing mask. The slightly pressurized air flows in the direction of arrow 36 towards the actual breathing mask 34, where it supports inhalation. The air then flows out through the muffler 2 in the direction of the arrow 37 during the exhalation. The muffler has a tubular housing which is open towards the arrow 37 and is connected at the other end to the interior of the breathing mask via a channel. The muffler has a cylindrical foam filter that holds frictionally and can be easily removed. The actual breathing mask 34 lies tightly against the face via a silicone tube 20, so that no secondary air can flow out.

Claims

Godfather claims 1. breathing mask (34), characterized in that it has one or more of the following devices A fastening device according to claim 2 for the pressure-reducing attachment of the respiratory mask (34) on the human face with a fastening tape (32), a silenced air outlet (2) according to claim 5, an air supply connector (40) according to claim 7, a mask seal (20) for tight but skin-friendly contact of the mask with the face according to claim 8. 2. Fastening device for pressure-reducing attachment of the breathing mask (34) on the face with an elastic, flexible fastening band (32), characterized in that the fastening device has at least one balance beam (30), which on the one hand approximately in the center via at least one joint (1 ) is connected to the breathing mask (34) and, on the other hand, to the fastening band (32) at the edge via attachment points (31). 3. Fastening device according to claim 2, characterized in that the balance beam (30) is articulated via exactly one universal joint (1) on the breathing mask (34), preferably easily detachable. 4. Fastening device according to claim 2 or 3, characterized in that it is in the case of the joints (1) to ball joints which can be deflected in all directions. 5. Sound-damped air outlet, characterized in that the air outlet is a silencer (2) with an interchangeable filter made of fine-pored, air-permeable Material, preferably foam, in particular a cylindrical portion of a round rod made of foam with open pores. 6. Sound-damped air outlet according to claim 5, characterized in that the fine-pored air-permeable material is provided with a jacket, preferably made of plastic. 7. Air supply connector (40) between the breathing mask and air supply system, characterized in that the connector in the region of the head, in particular the forehead and preferably above the forehead there is slidably arranged on a mounting bracket (4, 38). 8. Air supply connector (40) according to claim 7, characterized in that the connecting piece of the supply air hose going towards the air supply system (7, 33) is detachable and in particular has a self-closing butterfly valve (14). 9. Mask seal for tight but skin-friendly contact of the mask to the face, characterized in that the seal is designed as a silicone tube (20) which is at least partially filled with a jelly-like flexible material (39). 10. Mask seal according to claim 9, characterized in that the silicone tube (20) is at least 30% and at most 75%, preferably half filled with the jelly-like material (39). 11. Mask seal according to claim 9 or 10, characterized in that the jacket of the silicone tube (22) in the area towards the mask and the holding profile (21) is thicker than in the area towards the skin area to be sealed (22).