DE102007057091B4 - Breathing mask with a filling body and manufacturing method - Google Patents

Abstract

A breathing mask with a mask upper part (3) made of an elastic material, wherein the mask upper part (3) is connected to a mask body (14) of the breathing mask (8) by a mask connection area (5), wherein a wall (6) of the mask upper part (3) at least partially delimits a cavity (4) which is at least partially filled with a filler (15) and which is formed at least partially along the circumference of the mask upper part (3), characterized in that the cavity (4) of the mask upper part (3) has a varying depth along its cross-section, wherein the cavity is inhomogeneously filled with filler (15a and 15b), wherein the filler has different properties, wherein the thickness of the wall (6) differs at least in two places along the circumference of the mask upper part (3), wherein the mask upper part (3) has an inwardly shaped, thin circumferential contact lip (1) on its side facing away from the mask body (14), and wherein the The amount of filler and/or a filler property differ at at least two locations of a cross-sectional area of the cavity (4), wherein the filler (15) has a hardness between approximately 10 Shore 00 and approximately 20 Shore 00 at least in some regions, wherein the filler has a softer hardness at least in some regions.

Description

The invention relates to a ventilation mask as described in the preamble of main claim 1.

In medical care, patients with various breathing disorders are treated with air or oxygen through ventilation systems, using devices that deliver air or an air mixture as a breathing gas to the nose and/or mouth. A key factor here is the contact interface between the tubes delivering the air mixture and the respiratory openings of the human or other living being, as animals can also be treated.

This interface is usually designed as a breathing mask that covers only the nose or mouth, or both the nose and mouth, preferably secured to the head with flexible straps and featuring one or two hose connections. The breathing mask must remain on a patient's face for hours, or even nights and days, placing high demands on comfort. Discomfort from pressure points on the face, particularly on the bridge of the nose, is stressful for the patient. In addition, there is the problem of adjusting the size of the masks to fit the different facial and nasal configurations of the patients.

To solve both the comfort and size issues, breathing masks were developed that include a face-adjusted airway cup, also referred to as a mask top or mask bead. This cup is made of a flexible material, preferably a skin-friendly silicone, a thermoplastic elastomer (TPE), or polyurethane, and is spring-loaded. It also features a circumferential lip contact rim on the inside. The mask top is intended to hold the ventilation mask against the patient's face, thus creating a tight seal between the ventilation mask and the face.

A state-of-the-art gel sphere is made of a gel encased in a protective PU film. An additional silicone sleeve lies between the patient's face and the PU gel body. The wall thicknesses of the PU film and the silicone sleeve are kept essentially constant.

The WO 2005/094928 A1 Describes a ventilation device with a breathing mask in whose upper part a gel bulge is inserted, which acts on the lips of the upper part of the mask, thus exerting more pressure on the facial areas. This also aims to achieve a better seal in order to operate the air supply more precisely and economically. The gel bulge is essentially of uniform thickness, also has a pressing part in the area of the bridge of the nose, and thus impairs the adaptability of the upper part of the mask to the shape of the patient's facial areas, or necessitates the production of parts individually shaped for the patient, which increases the effort and thus the costs.

DE 42 12 259 C1 describes an individual mask for ventilating a patient. The mask has a hollow body 3 provided with a filling 5. The filling 5 consists of a cured, resilient plastic that conforms to the contours of the patient's face and ensures a stable shape.

The DE 600 15 851 T2 describes a breathing mask having a sealing lip device with a cavity filled with a gel material, the gel having a hardness value of approximately 10 on the Shore OOO scale.

The DE 102 26 587 A1 describes a breathing mask with a sealing lip device with a cavity filled with a gel material, as well as a corresponding manufacturing method. The gel material has such different material properties that the Shore hardness of the mask cushion is higher in the edge area than in the core area or at least near the core.

The EP 1 900 388 A2 describes a breathing mask with a sealing lip device that has a bellows structure in the nasal bridge area.

WO 2005/118 040 A1 discloses a breathing mask with a structured sealing lip device having two sealing lips.

The EP 1 116 492 A2 relates to a method for providing information suitable for training or selecting a breathing mask for a mask user, wherein a spatial data set is generated by reading in the individual spatial facial contour of a mask user at least in the nose and/or mouth area of the mask user.

WO 2006/024 253 A relates to molded bodies for masks, for example, wherein the molded body is designed to repel germ settlements at least in sections.

The EP 1 099 452 A2 describes a breathing mask with a sealing lip device that provides gel layer, whereby the gel layer is covered by a thin skin.

WO 1997/009 090 A1 discloses a breathing mask with a sealing lip device comprising a gel-filled hollow body, wherein the gel has a Shore hardness on the 000 scale in the range 20 - 45.

The DE 10 2007 042 733 A1 Describes a ventilation mask with a hollow body. The hollow body is filled with a phase-change material that allows the mask to adapt to the user's physiognomy. The phase-change material is molded to the user's physiognomy and hardens there.

The DE 10 2005 033 650 A1 describes a breathing mask with a sealing lip device with a cavity filled with a gel material, as well as a corresponding manufacturing method.

WO 2007 / 068 044 A1 describes a breathing mask with a sealing lip device that has various air-filled chambers.

WO 2007 / 059 504 A1 describes a breathing mask with a sealing lip device which has a filled hollow body.

Such known solutions mean that the number of differently shaped mask tops to be offered must be large in order to cover different face shapes and sizes if one does not want to accept any compromises in terms of wearing comfort and achievable tightness.

Therefore, the present invention aims to solve the problems described above and to propose a mask upper part of a respiratory mask that allows for optimal adjustment of the contact pressure exerted on the facial areas, while allowing greater adaptability to patients' different sized and shaped facial areas, allowing for fewer different mask sizes, and requiring fewer individual parts. Furthermore, the invention aims to generally improve the wearing comfort of a respiratory mask and enable cost-effective production.

The stated object is essentially achieved with the characterizing features of the main claim 1, wherein the upper part of the mask is provided with a cavity which is filled with a filler of a certain consistency and elasticity.

The filler can have a wide variety of properties, ranging from the previously mentioned gel materials, such as polyurethane or silicone gel, or the natural gel agarose, to foams, gas mixtures, and liquids, such as the saline solution often used in medicine. Ultimately, it can also be the same material from which the upper part of the mask is made, especially if it is foamed. Thanks to the integrated construction according to the invention, the thickness of the walls of the upper part of the mask can be very precisely adapted to requirements, giving certain sections of the upper part of the mask more or less rigidity as needed.

The invention can be used for nasal and full-face masks, in emergency, home, and hospital ventilation. The mask upper part according to the invention is suitable, for example, for CPAP, APAP, bilevel, and home ventilation. The mask upper part according to the invention is suitable for a typical respiratory gas pressure range of 0 mbar to 50 mbar.

To produce the mask upper part according to the invention, it is proposed to produce the mask upper part using a molding process from an elastic plastic, preferably a silicone or polyurethane, with at least one cavity, and then to fill this cavity with the intended filler. Filling should preferably take place through at least one opening provided for this purpose, which is preferably not located in the areas of the mask upper part that come into contact with the facial skin.

Filling is particularly preferably carried out by injecting the filler material, with the shell preferably being pierced in the thicker areas of the mask upper part. The at least one opening is sealed tightly after filling, for example, with a plug, by welding, or by gluing, particularly when filling with liquid or gaseous fillers. Gaseous fillers, in particular, can be pressurized in this process, so that the pressure can influence and determine the properties of the mask upper part.

The shape, size, and spatial extent of the filled cavities are selected according to the invention to achieve the most favorable properties of the upper part of the mask. For example, the filled cavity is distributed in the form of a bead in the wall of the upper part of the mask in such a way that either almost the entire wall is covered or only specific parts of it. Preferably, the corner area of the upper part of the mask is provided with a to provide a locally filled bead to give this area a desired combination of elasticity and rigidity.

Furthermore, in further embodiments of the present invention, it is proposed to vary the properties of the filler depending on the filling location within the inventive cavity of the mask upper part. This allows, in addition to or as an alternative to the inventively varied thickness of the cavity, a location-dependent elasticity and viscosity of the filler to achieve an even better adaptation of the resulting, comfort-promoting properties of the mask upper part to the requirements of use on a patient's face. The combination of different fillers is also part of inventive embodiments of the present invention.

An alternative manufacturing process involves first producing a filler body formed from a specific filler material and then encasing it with a protective shell using a dipping process or overmolding it in a mold. When using gaseous or liquid fillers, the resulting bag can be a molded bag that is filled and coated with a protective layer.

According to the invention, it is further proposed to completely dispense with filling the areas of the mask's outer part near the nose, or to make the cavity to be filled very thin in order to avoid excessive pressure on the sensitive nose. Airtightness in the nose area is preferably achieved solely by means of the inwardly shaped contact lips, which, due to their high flexibility, also allow for greater adaptability to patients' noses of different sizes.

It is further proposed that a filler, such as gel or foam, not be introduced into a cavity in the mask upper part, but simply applied to the inside or outside of the walls of the mask upper part. This solution offers economic advantages, as the existing molds for mask uppers can continue to be used. To protect the fillers applied to the walls of the mask uppers in this way from contamination or skin contact, their open surfaces are subsequently provided with a protective layer. The protective layer is made either from the molten filler material or from a third material to be applied. The shape and the inventive varying thickness of the at least one bead-shaped filler applied in this way, preferably sprayed or foamed, is implemented by a process in which the filler, for example in pulverized form, is formed from a nozzle using different amounts or different dosages or different residence times.

The present invention enables improved adjustment of the pressure forces exerted on the facial parts by the upper part of the breathing mask and a one-piece design of the upper part of the mask which is advantageous for practical use.

It is pointed out that the scope of the present invention is not limited solely to the preferred embodiments presented and that further combinations and variants of the present invention can be derived by an average person skilled in the art from the main and subclaims without having to depart from the teaching of the present invention.

• 1 zeigt einen Teilausschnitt durch eine Ausführung des Maskenoberteils mit einem Hohlraum und einem Füllstoff darin,
• 2 zeigt eine Ausführung des Maskenoberteils mit einem begrenzt ausgedehnten Hohlraum,
• 3 zeigt eine Ausführung des Maskenoberteils mit einem begrenzt ausgedehnten Hohlraum im inneren Eckenbereich,
• 4 zeigt eine Ausführung des Maskenoberteils mit einem über die gesamte Innenseite des Maskenoberteils ausgedehnten Hohlraum,
• 5 zeigt eine Draufsicht auf ein Maskenoberteil,
• 6 zeigt eine Gesamtansicht einer Atemmaske,
• 7 zeigt mehrere Querschnitte durch den, mit Füllstoff (15) befüllten, Hohlraum,
• 8 zeigt einen schematischen Längsschnitt durch das Maskenoberteil (3) gemäß 6 und Querschnitte durch den gefüllten Hohlraum (15) an unterschiedlichen Stellen und
• 9 zeigt eine Ausführung des Maskenoberteils (3) mit bereichsweise unterschiedlichen Wandungsstärken.

Embodiments of the present invention will now be described by way of example only with reference to the accompanying drawings, in which functionally like parts are designated by corresponding reference numerals.

• 1 shows a partial section through a design of the mask upper part with a cavity and a filler therein,
• 2 shows a design of the upper part of the mask with a limited cavity,
• 3 shows a design of the upper part of the mask with a limited cavity in the inner corner area,
• 4 shows a design of the upper part of the mask with a cavity extending over the entire inside of the upper part of the mask,
• 5 shows a top view of a mask top,
• 6 shows an overall view of a breathing mask,
• 7 shows several cross sections through the cavity filled with filler (15),
• 8 shows a schematic longitudinal section through the upper part of the mask (3) according to 6 and cross sections through the filled cavity (15) at different locations and
• 9 shows a design of the upper part of the mask (3) with different wall thicknesses in some areas.

In 1 A partial section of a mask upper part (3) of a breathing mask (8) is shown, in the walls of which a cavity (4) with a filler (15) filled therein is designed such that the thickness or depth of the filler (15) varies over the cross-section of the mask upper part (3). Preferably, the patient contact area of the mask upper part (3) is designed to be softer.

The mask upper part (3) terminates on its contact side intended for contact with the patient's facial areas in a thinner contact lip (1), which encloses the edge of the mask upper part (3) and provides a soft and flexible contact zone. The walls of the mask upper part (3) are closed by a mask connection body (5), which is either made of the same material as the mask upper part (3) and is integrally formed or attached as a single piece by adhesive or welding.

The mask connector body (5) is mechanically connected to a mask base (not shown) by means of snap-in parts, or can alternatively be permanently connected to the mask base by adhesive or welding. The cavity (4) is defined by an outer skin (2).

According to the invention, the thickness or depth of the filler (15) can also be essentially constant over the course of the cross section of the upper mask part (3).

For filling the cavity (4) with a filler (15), the upper part of the mask (3) has at least one opening which is 1 not shown. This opening can be positioned anywhere in the wall of the upper mask part (3), except in the area of the outer surfaces of the contact lips (1) and their surroundings, so that it does not interfere with the facial skin to be contacted. The filling opening is preferably glued, welded, or closed with a plug.

2 shows a further preferred embodiment of the present invention, in which the upper mask part (3) has, at least in some regions, a cavity (4) limited to its inner corner area. This allows different properties to be specified for the upper mask part (3) and also saves costs. Specifically, the contact lips (1) are provided with a pressure-generating underlay made of a selected filler, while the wall area (6) remains free of any filler.

3 shows a preferred embodiment with a, as in 2 a cavity (4) limited to the corner area, the shape of which is specifically concavely curved outwards, whereby the transitions to the filler-free wall sections of the upper part of the mask (3) are designed more abruptly and thus other properties which are advantageous for some applications can be specified.

4 shows a further preferred embodiment of the present invention, which has an additional resilient buffer zone (16) and is provided with a cavity (4) that also extends over the additional resilient buffer zone (16). This makes it possible to specify other advantageous resilient properties of the upper part of the mask, which can be determined either experimentally or computationally.

A thin filling of the cavity (4), for example, creates a soft buffer zone. Filling the cavity (4) with a relatively inflexible material, such as gel with a hardness of over 15 Shore 00, gives the buffer zone (16) a supporting function. The resilient buffer zone (16) can also be designed such that the filling exhibits two different elastic properties, at least in certain areas.

5 shows a spatial representation of a mask upper part (3) which has contact lips (1) which are designed to enclose the edge and are shaped inwards into the mask upper part. The wall (6) of the mask upper part (3) serves to connect to the mask body (not shown) by means of mechanically locking elements, and it contains at least one cavity with a filler therein, which is not shown in the image. The hatched area (9) in the nasal bridge area (7) of the mask upper part is designed without a filler, for example without gel. In a further embodiment of the invention, no filler is provided in the entire nasal bridge area.

6 shows an embodiment of the breathing mask (8) with the upper mask part (3) according to the invention. The upper mask part (3) is connected with its mask connection area (5) to the mask body (14) by means of locking mechanical elements, and the breathing mask (8) otherwise has its known features, such as a rotating sleeve (10) for connecting an air-supplying hose, which is rotatably connected to the mask body (14) at an angle (11). A forehead cushion (13) is slidably attached to a holder (12) of the forehead support, with which the mask is additionally held on the patient's forehead. The mask is fastened to the patient's head with straps (not shown).

7 shows cross sections through cavities filled with filler (15). In 7a and 7b the cavity is homogeneously filled with a filler. In 7a the filler (15a) is of greater hardness and of lower elasticity than the filler in 7b . In 7b the filler (15b) is of lower hardness and of greater elasticity than the filler in 7a .

In 7c The cavity (4) is inhomogeneously filled with filler (15a and 15b). The area (17) closest to the face is filled with the softer filler (15b). The area (18) far from the face is filled with the harder filler (15b). Preferably, fillers with a hardness in the range of 5 Shore 000 to 15 Shore 00 are used as soft fillers, and fillers with a hardness > 15 Shore 00 are used as hard fillers.

7 also shows that the cavity filled with filler (15) can have different shapes.

The filler (15) according to the invention makes it possible, within a very wide design range, to provide the upper part of the mask (3) with a predeterminable increased stability precisely in those areas where this is required, and to leave other areas of the upper part of the mask (3) with a thin wall thickness and/or very soft material consistency.

The filling opening described several times above can be designed as an opening in the classic sense, which is closed again after the filler (15) has been applied. However, it is particularly conceivable to introduce the filler (15) in a flowable consistency by injecting it into the cavity (4). If this injection takes place in a thick-walled area within a casing of the cavity (4), the injection channel closes automatically after the injection agent is withdrawn due to the elastic material properties. This significantly simplifies production.

According to the above description, a preferred embodiment consists in designing the upper part of the mask (3) in the area of the nasal bridge (7) to be flexible and soft, in order to ensure pleasant wearing comfort for the user. The upper part of the mask (3) is therefore designed without additional filler (15) in the nasal bridge (7) area, or only with a very soft filler (15b), with a hardness of, for example, < 15 Shore 00.

8 shows a schematic longitudinal section through the essentially triangular shaped mask upper part (3) according to 6 and cross-sections through the filled cavity (4) at different locations. A cross-section through the filled cavity (4) in the nasal bridge region (7) shows that the filling (15b) is soft and elastic. The cavity is rounded in the shape of an ellipse in the nasal bridge region. A cross-section through the filled cavity (4) in the side region shows that the filling (15a) is harder. The shape of the filled cavity here (4) is angular, in particular trapezoidal.

According to the invention, the shape of the filled cavity (4) is designed differently over the circumference of the upper part of the mask, so that optimal sealing properties of the upper part of the mask can be achieved due to the respective locally different requirements for the upper part of the mask.

In a further embodiment, the material thickness of the walls (6) of the upper part of the mask can be selected differently, thus ensuring, on the one hand, the necessary rigidity and, on the other hand, the softest and tightest possible contact with the skin.

In particular, in the area of the walls (6) of the upper part of the mask that lie against the face, the wall has a lower material thickness than the areas of the walls of the upper part of the mask that do not lie against any part of the face.

Preferably, the material thicknesses are thin in the area of the walls of the upper mask part that rest against the bridge of the nose (7). Particularly preferably, the material thickness of the wall in the area that rests against the bridge of the nose is thinner than in those areas of the wall of the upper mask part that rest against other parts of the face. This achieves optimal sealing with minimal pressure in the area of the sensitive bridge of the nose.

Preferably, the cavity (4) is inhomogeneously filled with filler (15) such that the areas of the filler closest to the face are softer and more elastic than the areas of the filler far from the face. This achieves two things: on the one hand, a good support function due to the harder area far from the face, and on the other hand, a high sealing function or great flexibility in the area closest to the face.

9 shows a further preferred embodiment of the present invention as in 2 and 3 , in which the upper mask part (3) has a limited cavity (4) at least in some areas. The wall (6') remains free of filler. As a further development of the invention, the wall region is also formed with varying thicknesses. The wall area (6') that remains free of filler is thinner and more flexible than the remaining wall (6"). Preferably, the upper part of the mask is correspondingly 9 Due to the thin wall (6'), the upper part of the mask can adapt particularly well to the geometry of the face, especially in the area of the bridge of the nose. When the ventilation mask is in place and the ventilator is switched on, there is positive pressure in the mask. The filled cavity then forms a seal against the patient's face, while the soft wall (6') can be pushed outward depending on the pressure due to its flexibility, which supports optimal adaptation to the respective facial contour.

In a further embodiment of the invention, the filled cavity is only provided in certain regions. Preferably, there is no filled cavity in the region of the nasal bridge, or the cavity is not filled in the nasal bridge region. In this case, a good seal and high flexibility of the upper mask part (3) in the nasal bridge region are achieved by making the wall (6') thinner there. Preferably, the wall (6') in the nasal bridge region is designed to be as thin as possible.

Claims (30)

A breathing mask with a mask upper part (3) made of an elastic material, wherein the mask upper part (3) is connected to a mask body (14) of the breathing mask (8) by a mask connection area (5), wherein a wall (6) of the mask upper part (3) at least partially delimits a cavity (4) which is at least partially filled with a filler (15), which is formed at least partially along the circumference of the mask upper part (3), characterized in that the cavity (4) of the mask upper part (3) has a varying depth along its cross-section, wherein the cavity is inhomogeneously filled with filler (15a and 15b), wherein the filler has different properties, wherein the thickness of the wall (6) differs at least in two places along the circumference of the mask upper part (3), wherein the mask upper part (3) has an inwardly shaped, thin circumferential contact lip (1) on its side facing away from the mask body (14), and wherein the The amount of filler and/or a filler property differ at at least two locations of a cross-sectional area of the cavity (4), wherein the filler (15) has a hardness between approximately 10 Shore 00 and approximately 20 Shore 00 at least in some regions, wherein the filler has a softer hardness at least in some regions. Breathing mask after Claim 1 , characterized in that the amount of filler and/or a filler property differ at at least two locations along the circumference of the mask upper part (3). Breathing mask according to one of the Claims 1 or 2 , characterized in that the shape of the cavity and/or the size of the cavity differ at at least two locations along the circumference of the mask upper part (3). Breathing mask according to one of the Claims 1 until 3 , characterized in that the properties of the filler (15) are inhomogeneous at least in some areas over the circumference of the upper mask part (3). Breathing mask according to one of the Claims 1 until 4 , characterized in that the properties of the wall (6) in the course of a cross-section of the upper mask part (3) are at least partially inhomogeneous. Breathing mask according to one of the Claims 1 until 5 , characterized in that the properties of the filler (15) are inhomogeneous at least in some regions over the course of a cross section of the upper mask part (3). Breathing mask according to one of the Claims 1 until 6 , characterized in that the filler (15) has different degrees of viscosity or hardness in the course of a cross-section of the upper part of the mask (3). Breathing mask according to one of the Claims 1 until 7 , characterized in that the filler (15) is a gel. Breathing mask according to one of the Claims 1 until 7 , characterized in that the filler (15) is a foam. Breathing mask according to one of the Claims 1 until 7 , characterized in that the filler (15) is a liquid. Breathing mask according to one of the Claims 1 until 7 , characterized in that the filler (15) is a gas mixture. Breathing mask according to one of the Claims 1 until 7 , characterized in that the filler (15) is a natural gel agarose. Breathing mask after Claim 8 , characterized in that the gel is a silicone or polyurethane gel. Breathing mask according to one of the preceding claims, characterized in that the upper part of the mask (3) has no cavity for the filler in the nasal bridge region (7). Breathing mask according to one of the preceding claims, characterized in that the upper part of the mask (3) has a cavity (4) filled with a filler in the nasal bridge region (7) and that the cross section of the cavity (4) in the nasal bridge region (7) is minimal. Breathing mask according to one of the preceding claims, characterized in that the upper part of the mask (3) has a wall (6') of minimal thickness in the region of the bridge of the nose (7). Method for producing a mask upper part of a breathing mask according to Claim 1 , characterized in that the upper part of the mask (3) is formed at least in regions with a cavity (4) made of a flexible material and is provided with at least one opening for filling the filler (15), into which opening the filler (15) is filled. Procedure according to Claim 17 , characterized in that the viscosity or the degree of hardness of the filler to be filled is varied with the filling level of the cavity. Procedure according to Claim 17 or 18 , characterized in that a gel or a foam or a liquid or a gas mixture or a natural gel agarose is used as filler (15). Procedure according to one of the Claims 17 until 19 , characterized in that the filler is inserted into the cavity in the form of a closed body. Method for producing a mask upper part of a breathing mask according to Claim 1 , characterized in that first a shaped filling body (15) is produced, and this is then covered with a second protective material. Procedure according to Claim 21 , characterized in that the coating with the second protective substance is carried out by dipping. Procedure according to Claim 21 or 22 , characterized in that the filling body (15) is made of an elastic material, such as gel or foam. Procedure according to one of the Claims 21 until 23 , characterized in that the filling body (15) is produced as a hollow body and is filled with a gas mixture. Method for producing a mask upper part of a breathing mask according to Claim 1 , characterized in that a shaped bead is sprayed onto a wall (6) of the upper mask part (3) from a nozzle, the amount of filler applied being varied and a desired shape being achieved in this way. Procedure according to Claim 25 , characterized in that a gel or a foam is used as the applied filler (15). Procedure according to Claim 26 , characterized in that the bead sprayed onto the wall (6) is provided with a protective layer. Use of a filler (15) in a mask upper part (3) of a breathing mask (8) according to at least one of the preceding claims and in a method for producing the mask upper part (3), for predetermining an elasticity of the walls (6) of the mask upper part (3) which varies over the course of their cross-section. Mask upper part (3) with a filler (15) according to one of the preceding claims, characterized in that the thickness or depth of the filler (15) varies in the course of a cross-section of the mask upper part (3). Mask upper part (3) with a filler (15) according to one of the preceding claims, characterized in that in the area of the bridge of the nose, the areas of the mask upper part (3) close to the lips are not underlaid with a filler and/or the cavity to be filled is designed to be very thin.