EP1333874A2

EP1333874A2 - Breathing mask for feeding a breathing gas to a mask user and discharging device for discharging breathing gas

Info

Publication number: EP1333874A2
Application number: EP01987682A
Authority: EP
Inventors: Achim Biener; Bernd Lang
Original assignee: MAP Medizin Technologie GmbH
Current assignee: Resmed R&D Germany GmbH
Priority date: 2000-10-19
Filing date: 2001-10-16
Publication date: 2003-08-13
Also published as: WO2002032491A2; US10596342B2; US9662467B2; US20140230814A1; EP2347782A2; US20170224945A1; EP2347784A3; US20060260614A1; EP2347784A2; EP2347782A3; US20130199536A1; US7775209B2; US20100300447A1; US7100610B2; AU2002216967A1; EP2347784B1; US20030221691A1; DE20017940U1; ES2453467T3; EP2347783A2

Abstract

Die Erfindung betrifft eine Atemmaske zur Zufuhr eines Atemgases zu einem Maskenanwender sowie eine Ableitungseinrichtung zur Ableitung von Atemgas aus einem von einer Atemmaske definierten Maskeninnenbereich. Die erfindungsgemässe Atemmaske umfasst eine Dichtlippeneinrichtung zur Abdichtung einer Maskenauflagezone, einen Maskenbasiskörper zur Bildung des Maskeninnenraumes sowie eine Anschlusseinrichtung zum Anschluss wenigstens einer Atemgasleitung, wobei der Maskenbasiskörper und/oder die Anschlusseinrichtung mit wenigstens einer aus einem Elastomermaterial gebildeten Entkoppelungsstruktur versehen ist. Hierdurch wird auf vorteilhafte Weise eine Relativbewegung zwischen einem maskenbasiskörperseitigen Umfangsfussbereich der Dichtlippeneinrichtung und der Atemgasleitung in einem ausreichenden Bewegungsbereich erreicht.

Description

Breathing mask for supplying a breathing gas to a mask user and a derivation device for deriving breathing gas

The invention relates to a breathing mask for supplying a breathing gas to a mask user and to a derivation device for discharging breathing gas.

Such breathing masks are used in particular in the medical field, for example in the field of sleep medicine for the treatment of sleep-related breathing disorders.

These masks usually comprise a sealing lip device for sealing a mask support zone from the surroundings. In the case of nasal masks, the mask contact zone extends from the upper lip area into the face area adjacent to the nose wings of the mask user and from there into the area of the bridge of the nose. The sealing lip device is usually formed from an elastomeric material and is pressed against the mask contact zone by means of a headband arrangement under a predetermined pressing force.

In particular with the long-term use of such breathing masks, there is the problem that the required sealing effect can only be achieved under comparatively high mask contact forces. The wearing comfort is impaired by the high mask pressure required. In addition, there is a risk that pressure marks will occur in the area of the mask support zone.

The invention has for its object to provide a breathing mask for supplying a breathing gas, which is characterized by a high level of ease of use with sufficiently high tightness.

This object is achieved according to the invention by a breathing mask for supplying a breathing gas to a mask user with a sealing lip device for sealing off a mask support zone, a mask base body for forming a mask interior and a connecting device for connecting at least one breathing gas line, the mask base body and / or the connecting body are provided with at least one decoupling structure formed from an elastomeric material, which permits a relative movement between a circumferential foot region of the sealing lip device adjoining the mask base body and the breathing gas line in a tilt angle range of at least 5 °.

This advantageously makes it possible to achieve a sufficient sealing effect with a reduced mask holding force in a reliable manner, since in an advantageous manner no forces or moments can be transmitted to the sealing lip device via the breathing gas line even when the head of the mask user is moving. In a further advantageous manner, a relative movement between the sealing lip device seated on the face of the mask user and a breathing gas line which is preferably fixed on the face side (for example by a hose bracket formed on a stiffening frame) is also possible.

According to a particularly preferred embodiment of the invention, the decoupling structure is formed by a fold or bellows structure. This fold or roll bellows structure is preferably formed integrally with the sealing lip device using a core element.

According to a particularly preferred embodiment of the invention, the fold or bellows structure is formed on the connection device. This fold or bellows structure can be given a joint characteristic through zones with coordinated wall thicknesses, by means of which both turning and. Tilting moments and axial movements of the breathing gas line do not lead to the introduction of any forces into the sealing lip device.

Another particularly advantageous embodiment of the invention is given in that the decoupling structure is formed on the mask base body. This makes it possible to avoid the transmission of undesirable forces to the sealing lip device and at the same time to decouple any movements of the mask base body relative to the sealing lip device to a sufficient extent. An embodiment of the invention which is advantageous with regard to particularly low operating noises is provided in that at least one channel device is formed in the area of the decoupling structure in order to create a connection between the inner area of the mask and the surroundings.

The channel device is preferably formed by at least one through opening. The through opening preferably has a cross section on which is matched to a predetermined pressure / volume flow characteristic.

A particularly quiet derivation is achieved according to the invention in that the channel device tapers continuously or stepwise with respect to its cross section in the flow direction.

An embodiment of the invention which is also advantageous with regard to low noise emission is provided in that a sharp mouth edge is formed in an outlet mouth region of the channel device. A section of the narrowest cross-section is preferably defined in the channel device, the length of the section of the narrowest cross-section being less than 2 mm. It is advantageously possible to design the channel geometry in such a way that the narrowest cross section of the channel device is formed in a membrane element. This further reduces the coupling of any structure-borne noise events into the mask structure. The diameter of the membrane element is preferably at least 30% larger than the diameter of the throttle passage opening formed therein.

The movable coupling of the sealing lip device preferably takes place in that the decoupling structure extends in the mask base body in the circumferential direction of the sealing lip device along a transition region between a foot region of the sealing lip device and is formed by at least one circumferential fold or a bellows structure.

According to a further aspect of the present invention and preferably in combination with the measures described above, one is based on the created individual face architecture of the user tunable breathing mask, which has a forehead support device for supporting the mask in the forehead or nasal root area of the person, and comprises a stiffening element for stiffening the breathing mask with a first stiffening section assigned to the area of the sealing lip device and one associated with the forehead support device second stiffening section, the relative position of the two stiffening sections being mutually adjustable.

This advantageously makes it possible to achieve an optimal surface pressure distribution for the respective face structure of the mask user both in the area of the sealing lip contact zone and in the forehead area.

An embodiment of the invention which is advantageous in terms of ease of handling is provided in that the two stiffening sections are coupled to one another via a joint device. The hinge device can advantageously be formed by a film hinge device.

According to a particularly preferred embodiment of the invention, a fixing device is provided for fixing the two stiffening sections in a required relative position. The fixing device advantageously has a fixing mechanism, in particular a latching mechanism. A plurality of predetermined latching positions can preferably be selected. As an alternative to this - or in combination with this measure, it is also possible to design the fixing device using means for fixing by gluing, welding or chemical reaction.

An embodiment of the invention which is particularly advantageous from the point of view of production technology is given in that the two stiffening sections are integrally formed. Here, it is possible to form the two stiffening sections, for example from a thermoplastic material, in a mold that is only in two parts. The two stiffening sections can be injected in an orientation which is advantageous from the point of view of demolding technology. The stiffening element is preferably frame-like or at least bell-shaped in the area of the sealing lip device. In the case of a skeletal or frame-like configuration, the individual web sections preferably have essentially rectangular profile cross sections. Here a high rigidity is achieved with a low weight of the stiffening element.

The first stiffening or frame section preferably has a contour that essentially corresponds to the mask support zone. The second stiffening or frame section preferably extends into an area located in the application position of the mask above the eyebrows of the mask user.

An embodiment of the invention that is particularly advantageous when using an elastomeric mask base body is provided in that the stiffening element is provided with coupling sections for coupling a headband device. This makes it possible to introduce the mask holding forces without undue deformation of the mask.

The stiffening element is preferably formed from a plastic material. As an alternative to this, or in combination with it, it is possible to manufacture the stiffening element from a metal material, in particular a wire or profile material that can be bent. It is also possible to form the stiffening element from an at least locally thermoformable material, in particular a thermoplastic material with a rigid insert.

In particular, it is possible to provide a wire insert in the area of the bending-neutral zone of the profile material.

The profile material preferably has at least one stiff wire, for example made of a wire material. It is possible, at least locally, to allow the profile material to be deformed, for example by heating that a further adaptability of the stiffening or frame element to the facial structure is made possible.

A particularly advantageous adaptability of the breathing mask to the facial architecture of the mask user is achieved according to a particularly preferred embodiment of the invention in that the breathing mask has a mask base body formed from an elastomeric material. In this case, it becomes possible to influence the course of the sealing lip support zone and the surface pressure distribution in this zone by arbitrarily deforming the first stiffening section.

The end support device advantageously comprises a support element which is formed from an elastomeric material.

A particularly advantageous embodiment of the invention from a hygienic point of view is provided in that the sealing lip device is formed integrally with the mask base body. This integral configuration can be achieved by joint formation in a molding tool or also by gluing the sealing lip device to the mask base body, preferably including the stiffening device. It is also possible to form the mask base body and the sealing lip device and preferably also the cushion members of the forehead support device in the course of a vulcanization process.

According to a special aspect of the present invention, the cushion members of the forehead support device are preferably formed integrally with the sealing lip device and / or the mask base body. In the case of a multi-part configuration of the mask, it is possible to couple the sealing lip device to the mask base body via the stiffening element. The connection area between the mask base body and the forehead support device can be effective as an elastomeric joint structure.

According to a particularly preferred embodiment of the invention, the stiffening element is detachable with the sealing lip device and / or the mask mask. ice body coupled. This advantageously makes it possible to use the stiffening element several times. The stiffening element is preferably coupled to the base mask body via a locking or engagement profile structure.

The stiffening element is preferably designed in several parts. The mask base body is advantageously formed from a transparent or translucent elastomer material. A particularly advantageous embodiment of the invention in terms of high wearing comfort is given by the fact that the sealing lip device has a velvety matt surface. The realization of so-called lotus flower structures also achieves an improved cleaning possibility from a hygienic point of view.

The joint fixation can preferably also be reversible, for example using hot glue or chemically releasable adhesives. It is also possible, particularly in the area of the joint, to provide thermoformable structures which can be plastically deformed repeatedly and which, for example, allow the relative positions of the two stiffening or frame sections to be readjusted when heat is added.

It is also possible to form several joint or adjustment zones in the stiffening element or in its frame structure, so that, for example, adjustment options for adapting to the individual forehead curvature, the width of the nose root and the upper lip structure are also possible.

In particular in the configuration of the stiffening element as a locally deformable structure, sufficient strength can be achieved in a small installation space by the stiffening element being formed from a composite material. A wire / thermoplastic composite material is particularly suitable as the composite material.

According to the invention, the adjustability of the at least two stiffening or frame sections to one another can also be achieved in that the two stiffening or frame sections are in different coupling positions can be joined together, for example by means of joining points which can be coupled appropriately or selectable joining members.

Further details emerge from the following description in conjunction with the drawing. Show it:

1 shows a perspective view of a preferred embodiment of a breathing mask with an elastomeric mask base body and integral forehead support device, a stiffening element being provided via which the position of the forehead support device can be adjusted relative to an integral sealing lip device;

2 is a perspective view of the frame-like stiffening element as in the embodiment according to FIG. Fig. 1 is provided;

3 shows a further perspective view of the stiffening element mentioned here, with a view of a fixing element which can be locked in several fixing positions.

4 shows a simplified perspective view of a further embodiment of a breathing mask with an elastomer decoupling structure formed in the region of a breathing gas line device;

Fig. 5 is a perspective view of a third embodiment of a

Breathing mask with a mask base body formed from an elastomer material and a decoupling structure formed thereon and formed by fold indentations;

Fig. 6 is a perspective view of a fourth embodiment of a

Breathing mask, also with a mask base body formed from an elastomer material, but with a decoupling structure formed according to the rolling bellows principle; 7 shows a side view of a fifth embodiment of a breathing mask, likewise with a mask base body formed from an elastomer material and a connection device for a breathing gas line formed thereon, a decoupling structure being formed both between the connection device and the mask base body and in the area of the sealing lip device ;

8 shows a preferred embodiment of a connection section for a breathing gas line, here with integrated gas discharge openings;

Fig. 9 is a perspective view of another embodiment of a

Connection device for a breathing gas line, here with several circumferential bellows as well as molded discharge openings;

10 shows a simplified sectional view to explain a further embodiment of a channel device for discharging breathing gas;

11 a, 1 b schematic diagrams for explaining the structure of a deformable structure suitable as a force and / or pressure display device;

Fig. 12 is a detailed sketch for explaining a preferred arrangement of stiffening webs to prevent the passage openings from closing.

The representation acc. 1 shows a breathing mask as can be used in particular for carrying out CPAP therapy. The breathing mask comprises a mask base body 1 which, in the embodiment shown here, is formed from a fully transparent, elastomeric silicone material. The mask base body 1 defines a mask interior which is sufficiently dimensioned to accommodate the nose of a mask user. The mask interior is sealed off from the face of the mask user by means of a Sealing lip device 2, which is almost completely covered in this view. The sealing lip device 2 comprises a sealing lip formed from an elastomer material, which rests on the face surface of the mask user with elastic deformation and defines a nose receiving opening through which at least the nose tip area of the mask user can penetrate into the mask interior defined by the mask base body 1.

The breathing mask is provided with a forehead support device 3, which here comprises a forehead cushion device 4. In the embodiment shown here, the forehead cushion device 4 is likewise made of an elastomer material and is also formed integrally with the sealing lip device 2 and integrally with the mask base body 1. This integral formation of mask base body 1, sealing lip device 2 and forehead cushion device 4 is achieved with the formation of a connecting web section 5, which couples the forehead cushion device 4 to the mask base body 1 in a position-changeable manner. In the peripheral area of the mask body 1, a stiffening element 6 is provided, which is designed here as a frame-like structure. The stiffening element 6 comprises a first stiffening section 6a following the circumferential contour of the sealing lip device 2 and a second stiffening section 6b extending into the end support device 3. The two stiffening sections 6a, 6b are movably coupled to one another. The coupling of the two stiffening sections 6a, 6b takes place in the embodiment shown here via an articulation device 7, which is formed here by a film hinge section 8. The relative position of the forehead cushioning device 4 relative to the mask base body set by pivoting the two stiffening sections 6a, 6b relative to one another. 1 or to the sealing lip device 2 can be permanently fixed via a fixing device 9.

The fixing device 9 here comprises a fixing element 10 which can be brought into engagement with a holding element 11 in different fixing positions.

In the embodiment shown here, the holding element 11 is largely rigidly connected to the first connecting section 6a. The fixing element 10 is pivotally connected to the second stiffening section 6b. The Coupling of the fixing element 10 and the holding element 11 in selected coupling positions takes place here via plug bores 12 which are formed in the fixing element 10. These plug holes 12 can be brought into engagement with a fixing pin, which is not visible here. The fixing pin is formed on an end face of the holding element 11 facing the fixing element 10. As an alternative to this mechanism shown here, it is also possible to use different mechanisms for determining the relative position of the first stiffening section 6a with respect to the second stiffening section 6b.

The stiffening device 6 is coupled to the mask base body 1 in such a way that the mask base body 1 and with it also the sealing lip device 2 have a shape which is determined by the stiffening element 6. In the embodiment shown here, the stiffening element 6 is coupled to the mask base body 1 via a circumferential groove 14, into which the frame-like stiffening element 6 is inserted. For a better coupling of the stiffening element 6 with the mask base body 1, or with the sealing lip device 2, the circumferential groove is profiled in the area of its groove inner surfaces complementary to the stiffening element 6.

The stiffening element 6 is provided with a coupling device 15, via which a band element of a lower head band arrangement can be coupled to the breathing mask. In the embodiment shown here, the coupling device 15 is designed as a bow-like tab, which is made integrally with the stiffening element 6. As an alternative to this, it is also possible to use coupling devices of different construction, for example latching or snap-in devices, for coupling the headband to the stiffening element 6. Through the direct introduction of the tensile forces of the headgear into the stiffening element 6, an inadmissible deformation of the mask base body 1 and the sealing lip device 2 is avoided.

A coupling device 16 is also provided in the area of the end support device 3, the structure of which corresponds in the embodiment shown here essentially to the coupling device 15 provided in the area of the mask base body 1. The stiffening element 6 provided in the area of the end support device 3 or its second stiffening or frame section 6b is connected to the forehead cushioning device 4. In the embodiment shown here, the coupling of the forehead cushioning device 4 to the second stiffening section 6b takes place, similar to the coupling of the first stiffening section 6a to the mask base body 1, in that the second stiffening section 6b is inserted into a groove formed in the forehead cushioning device 4.

The forehead cushioning device 4 is formed from an elastomeric material and has a plurality of pocket sections 17, 18. The cushion properties of the forehead cushioning device 4 can be influenced in a defined manner by the pocket sections 17, 18.

A bellows structure 19 is provided on the mask base body 1, via which a breathing tube connection adapter 20 is pivotally coupled to the mask base body 1.

In the embodiment shown here, the bellows structure 19 is also formed integrally with the mask base body 1, whereby any gap formation is advantageously prevented from a hygienic point of view. A hose pin section 21 adjoins the bellows structure 19, the inner diameter of which is dimensioned such that the breathing hose connection adapter 20 can be firmly inserted therein. Instead of the breathing tube connection adapter 20, it is possible here to provide a CO ₂ washout adapter as described in the German patent specification 198 40 760.2 which goes back to the applicant.

In Fig. 2 this is according to the breathing mask. Fig. 1 provided stiffening element 6 shown as a single part. Both the first stiffening section 6a assigned to the mask base body 1 of the breathing mask and the second stiffening section 6b assigned to the forehead support device 3 (FIG. 1) are formed here by web-like elements which have an essentially polygonal, in particular rectangular cross section. Integral with these web-shaped elements elements are already formed in connection with FIG. 1 coupling ^devices 15, 16. The coupling point designed here as a film hinge 22 for coupling the two stiffening sections 6a, 6b is clearly recognizable in this illustration. The fixing element 10 is also mounted via a film hinge point 23 in such a way that, as indicated by the arrow P, it can be pivoted in a sufficient angular range. By appropriate pivoting of the fixing element 10 it is achieved that this releases a fixing pin 24, which is formed in the end region of the holding element 11. As long as the fixing element 10 is not coupled to the holding element 11, it is possible to pivot the second stiffening section 6b relative to the first stiffening section 6a into a desired position. By engaging the engagement structure provided on the fixing element 10 with a correspondingly complementary engagement structure of the holding element 11, it is possible to fix the two stiffening sections 6a, 6b in the desired relative position to one another. The fixing element 10, the holding element 11 and the section of the second stiffening section 6b extending between the film hinge 22 towards the film hinge 23 form a triangular framework in the embodiment shown here, by means of which the relative position of the second stiffening section 6b can be set in an adjustable manner relative to the first stiffening section 6a , As an alternative to this coupling structure, which can be produced particularly advantageously from the point of view of manufacturing technology, it is also possible to use structurally different coupling structures for coupling the two stiffening sections 6a, 6b.

In the embodiment shown here, the first stiffening section 6a has an essentially saddle-shaped outer contour. In a direction perpendicular to the mask support surface, the first stiffening section 6a is pulled upward in the area of the bridge of the nose such that it does not fall below a predetermined minimum distance from the face surface of the mask user.

FIG. 3 shows the mask frame according to FIG. 2 from a different perspective. The fixing element 10 here has four locking bores 26, 27, 28 and 29. The fixing element 10 is coupled to the holding element 11 in such a way that the locking bore 28 engages with the fixing pin 24 of the holding element 11. reached. When the fixing element 10 is coupled to the holding element 11 using the latching bore 29, the second stiffening section 6b is pivoted towards the forehead area of the mask user in such a way that the area of the first stiffening section 6a crossing the bridge of the nose is most raised. By selecting the locking bore 28, a configuration is selected in which the region of the first stiffening section 6a crossing the bridge of the nose is already approximated to the bridge of the patient's nose. Even flatter configurations are achieved through the locking bores 27 and 26.

I O It is possible to introduce an adhesive material between the two stiffening sections in the area of the coupling point formed here as a film hinge 22, as a result of which the relative position of the two stiffening sections 6a, 6b to one another is permanently fixed. The fixing element 10 and possibly also the holding element 11 can be removed after the adhesive material has hardened.

15 The breathing mask is advantageously adjusted using the fully assembled breathing mask. It is also possible to adapt the stiffening element to the face structure of the mask user in the disassembled state and only then to couple it to the mask base body. Advantageously, further setting options are provided, by means of which, for example, the position of the forehead cushioning device can be adjusted in the height and / or width direction. As an alternative to the design of the coupling area between the two stiffening sections as a hinge point, it is also possible to provide coupling options here, by means of which, for example with the addition of heat, the two stiffening sections 6a, 6b can be adjusted relative to one another.

The breathing mask shown in FIG. 4 comprises a connection device 32 for a breathing gas line (not shown) which is formed integrally with the mask base body 31. In a transition area between the connection device 32 and the mask base body 31, a decoupling structure 33 is provided, which in the embodiment shown here is formed by a bellows device. The bellows device comprises a first fold ring 34 and one second fold ring 35. In particular, the first fold ring 34 comprises two circumferential walls 36, 37 which extend in the radial direction. These two circumferential walls 36, 37 are designed as conical outer surfaces and have a wall thickness distribution selected with regard to a predetermined system rigidity. The decoupling structure is rotationally symmetrical here. A particularly large cross-section of breathing gas with comparatively little impairment of the visual field is advantageously achieved by the section of the breathing gas line having an elliptical or polygonal cross-section in the region of the nasal root. The decoupling structure here is rotationally symmetrical. As an alternative to this, however, it is also possible to design the flanks of the fold rings in such a way that they have different insertion depths in the circumferential direction and, if necessary, changing wall thicknesses.

In the embodiment shown here, in the peripheral wall 36 facing the forehead region of a mask user in the application position of the breathing mask, at least one breathing gas passage opening 38 is formed, via which an at least partially used breathing gas can flow into the surroundings. Also in the area of the second fold ring 35, a plurality of breathing gas through openings 39 are formed, through which breathing gas flow directed over the forehead area of the mask user can likewise take place. The respiratory gas through openings 38 and 39 are aligned such that the respiratory gas emerging therefrom does not collide directly with wall sections of the decoupling structure or also the connection device. The breathing gas passage openings 38, 39 are preferably arranged in such a way that the emerging air cannot impinge on the forehead area of the mask user.

It is possible to design the decoupling structure in such a way that a stop characteristic is achieved, so that decoupling is only permitted within a certain range of motion

In the breathing mask shown here, a forehead support device 40 is formed integrally with the mask base body 31. The sealing lip device 2 for sealing a face support zone is in the embodiment shown here also integrally formed with the mask base body 31 or integrally with the forehead support device 40. The position of the forehead support device 40 with respect to the mask base body 31 or also with respect to the sealing lip device 2 can be changed via an adjusting device.

In the embodiment of a breathing mask shown in FIG. 5, the mask base body 31 is likewise formed from an elastomer material, but in a departure from the embodiment described above, it is provided with a plurality of fold indentations, by means of which the connection device 32 is also largely mechanically decoupled from the Sealing lip device 2 is reached. In this embodiment too, the breathing mask has a forehead support device 40, which, similarly to the embodiment described above, can be formed integrally with the mask base body 31.

The fold indentations 41, 42, 43 are aligned here in such a way that they bridge the area of the bridge of the nose in the application position of the breathing mask. As an alternative to the embodiment shown here with three comparatively deep fold indentations, it is also possible to provide the mask base body 31 with a larger number of corresponding fold indentations, the elastic properties of the individual fold indentations preferably being matched in such a way that the connection means 32 and the sealing lip device 2 result in predetermined properties.

The breathing mask shown in FIG. 6, like the breathing mask described above, comprises a decoupling structure formed in the region of the mask base body 31. In the embodiment shown here, the decoupling structure is formed by a plurality of bellows zones 44, 45, 46. In addition to these rolling bellows zones 44, 45, 46, a further decoupling structure 33 is provided in the area of the connection device 32, which, similarly to the embodiment described in connection with FIG. 4, has two fold rings 34, 35. This breathing mask is also supported in the forehead region of a mask user here by a forehead support device 40, which here is formed integrally with the mask base body 31.

The connection device 32 is here formed integrally with the mask base body 31 and, accordingly, likewise made from an elastomer material. The connection device 32 has a circumferential bead 47, via which an improved coupling with a breathing gas line is achieved.

The breathing mask shown in FIG. 7 comprises a mask base body 31 made of an elastomer material with a connection device 32 also made of an elastomer material. The connection device 32 is here formed integrally with the mask base body, with the connection device 32 in the mask base body 31 in a transition region, here is provided by a single bellows, decoupling structure 33. In the area of the decoupling structure, a plurality of breathing gas passage openings 39 are formed for discharging breathing gas from the mask interior defined by the mask base body 31. The respiratory gas passage openings 39 have channel cross sections designed with respect to a predetermined outflow behavior. As illustrated here by way of example, the breathing gas passage openings 39 may not only have round cross sections, as explained in the previously described embodiments, but also polygonal, cross-shaped and other arbitrarily selected geometries. However, the breathing gas passage openings are preferably designed in such a way that the resulting air flow is not directed towards the forehead area of a mask user, but in particular in the hose direction, in particular along the side of the hose wall facing away from the mask user.

8 shows a discharge device 50 for discharging breathing gas. The discharge device 50 here forms a connection device 32 for connecting a breathing gas line and a decoupling structure 33 which here has a plurality of fold rings 34, 35. On a side facing away from the connection device 32, the derivation device 50 is provided with a fastening structure 51, via which the derivation device 50 also seals a mask base body of a breathing mask or a further breathing gas line section can be coupled. In the area of a circumferential section of the first pleated collar 34 which extends over an angle of approximately 120 °, breathing gas through openings 39 are formed similarly to the above-described embodiments, via which breathing gas is discharged from the interior defined by the derivation device 50 into the interior Environment can take place.

9 shows a further embodiment of a derivation device 50 for

I O line of at least partially used breathing gas shown. The derivation device 50 here comprises a connection device 32 provided for connecting a respiratory gas line and a connection structure 52 formed on a side facing away from the connection device 32, via which the derivation device with a mask base body 31 or another breathing device.

15 gas line section can be coupled. A decoupling structure 33 is provided between the connection structure 52 and the connection device 32, by means of which a relative movement between the connection device 32 and the connection structure 52 is permitted in a certain range of motion. In the embodiment shown here, axial movements of up to 10 mm and an angular range of approximately 30 ° allow tilting movements. Respiratory gas through openings 39 are formed in a peripheral section of a peripheral wall 36 of the first pleated collar 34, similarly to the embodiment described above. The breathing gas passage openings 39 are designed here as narrow, essentially radially aligned slots. The 5 wall thicknesses of the circumferential walls of the two fold rings 34 are chosen to be thinner in the area of the kinks than in the wall area extending between the kinks. The embodiment of a derivation device shown here has an inside diameter of 18 mm in the area of the connection device 32 and an outside diameter of 35 mm in the area of the decoupling structure 33. The axial length of the discharge device 50 is 54 mm in the unloaded state. The derivation device 50 is formed from an elastomer material - here fully transparent silicone rubber. The maximum wall thickness of the discharge device 50 is 4 mm. 10 shows a sketch of a preferred embodiment of a channel device for discharging breathing gas. The breathing gas path defined here runs through a passage opening 53 in a first intermediate space 54, which is connected to the environment via a gap area 55. In this gap area, a plurality of web sections 56 are formed, through which the throttle characteristic of the gap area is influenced. On the basis of the length of the gap area 55, the flow behavior of the respiratory gas path can be influenced in a defined manner, in particular in interaction with the webs 56. Such a breathing gas path for discharging breathing gas from an inner mask area into the surroundings can be formed directly on a mask base body 31 or preferably in the area of a connection device for connecting a breathing gas line. The structure shown here is preferably formed integrally from a fully elastomeric material. For cleaning purposes, it is possible to turn an upper cover wall 57 upward. A required minimum gap dimension in the gap area 55 can be achieved by web sections, not shown here, which extend in sections to the inner surface of the ceiling wall 57.

FIG. 11 shows an elastomer structure which, in conjunction with a breathing mask, is directly suitable for displaying the deformation that occurs when the breathing mask is applied. For example, it is possible to provide, for example, a color marking in the area of the inner wall of a fold or bellows structure 60, which is recognizable depending on the deformation of the fold or bellows structure. If, for example, the fold or bellows structure 60 is compressed as far as possible, as shown in FIG. 11, the color marking applied in the area of the inner wall of the fold or bellows structure is no longer visible from the outside. From this, it can be concluded, for example, that the surface pressure in the area of the faceplate and / or in the area of the sealing lip device of an appropriately designed breathing mask is inadmissibly high. It is also possible to use a fold or bellows structure 60 of this type to check whether a sufficient mask holding force has been applied to the breathing mask. In the case of such an embodiment, the colored marking can, for example, be arranged in such a way that it is visible in the case of insufficient mask holding forces and is covered with sufficient mask holding forces. FIG. 12 shows a section of a discharge device for discharging breathing gas, which is formed from an elastomer material. The derivation device comprises a peripheral wall 70, which is designed here as a fold ring 73. The peripheral wall is provided with a plurality of through openings 38 for discharging breathing gas. In the interior of the fold ring 73, webs 71 are formed, which are made integrally with the peripheral wall 70. The webs 71 act as kink protection and ensure that the through openings 38 are constantly open. A division of the gas flow is also achieved by means of the webs 71, which results in an even quieter discharge of the breathing gas into the environment (U). The through openings here have a circular cross section. A further fold ring 74 is connected to the fold ring 73 provided with the through openings 38. This fold ring 74 is coupled with the first fold ring 73 in a comparatively rigid manner and also has a lower height, so that it is not possible for the through opening 38 to be covered by the further fold ring 74. Adjoining the further fold ring 74 is an articulated fold ring 75, which defines a circumferential joint zone 76 in the region of its maximum diameter and an inner joint zone 77 in the inner region. In the area of the inner joint zone 77 and the circumferential joint zone 76, the wall thickness of the circumferential wall 70 is made so small that there is comparatively easy movement of the sections of the derivation device facing away from one another. The circumferential walls 78 of the fold ring 74 and the circumferential wall 79 of the joint fold ring 75 jointly limit the maximum swivel angle of the two fold rings to one another.

The operation of the breathing mask described above is explained in detail using the following application example:

To carry out CPAP therapy, the breathing mask is removed from a sterile packaging and the fixing element 10 is pivoted into a release position, so that the stiffening section 6b can be pivoted about the film hinge point 22 with respect to the first stiffening section 6a. Now a breathing gas hose is attached to the breathing mask using a rotary and quick-release adapter closed in that this is plugged into the quick-release adapter and this into the breathing tube connection adapter 20. Breathing gas is supplied via the breathing gas hose under a predetermined excess pressure of, for example, 8 mbar. The breathing mask is now applied to the nose area of the mask user. For this purpose, the respective section of a lower headband arrangement is passed through the lower coupling devices 15. The tensile stress in the lower headgear arrangement is adjusted in such a way until sufficient sealing of the sealing lip device 2 is ensured. Now the breathing mask is tilted away from the bridge of the nose or towards the bridge of the nose in the application position until an optimal contact of the sealing lip device 2 in the region of the bridge of the nose is achieved. Now the upper forehead cushion device 4 is pushed slightly against the forehead of the mask user. The relative positioning of the first stiffening section 6a relative to the second stiffening section 6b achieved in this way is fixed by bringing the fixing element 10 into engagement with the holding element 11.

As a result of the excess pressure prevailing in the breathing gas line, CO ₂ flows through the through openings formed in the fold ring. The through openings are dimensioned and designed in such a way that a predetermined pressure oil flow characteristic is achieved, so that a sufficient outflow of the breathing air exhaled into the breathing mask or into the breathing gas line into the surroundings is achieved.

The webs formed in the fold ring ensure a reliable manner. that the openings are not closed due to a compensating movement permitted by the decoupling structure.

The breathing mask is now ready to use. By coupling the coupling device 16 in the area of the forehead support device 3, the breathing mask is now also fixed in the forehead area of the mask user by the upper head strap arrangement on the mask user. It is possible to fix the relative positioning achieved here by means of additional measures, for example an element that locks in a snap-in manner (eg securing element). With a corresponding load-bearing capacity of these additional fixing means, it is possible to remove the fixing element 10 and possibly also the holding element 5 11.

It is also possible to select a stiffening element from a set of stiffening elements based on the ideal configuration of the breathing mask determined via the fixing device 9, which, without the fixing device 9, gives the IO sealing lip device and the forehead cushion device 4 the desired relative position - and such a stiffening element against the to replace the aforementioned stiffening element.

Claims

claims

1. A breathing mask for supplying a breathing gas to a mask user with: a sealing lip device for sealing off a mask support zone, a mask base body for forming a mask interior and a connection device for connecting at least one breathing gas line, the mask base body and / or the connection device having at least one decoupling structure formed from an elastomeric material is provided which permits a relative movement between a circumferential foot region of the sealing lip device on the side of the mask base body and the breathing gas line in a tilt angle range of at least 5 °.

2. Breathing mask according to claim 1, characterized in that the decoupling structure is formed by a fold or bellows structure.

3. Breathing mask according to claim 2, characterized in that the fold or roll bellows structure is formed on the connection device.

4. Breathing mask according to at least one of claims 1 to 3, characterized in that the decoupling structure is formed in the mask base body.

5. Respiratory mask according to at least one of claims 1 to 4, characterized in that at least one channel device is formed in the region of the decoupling structure, in order to create a connection between the inner region of the mask and the surroundings.

6. Breathing mask according to at least one of claims 1 to 5, characterized in that the channel device is formed by at least one through opening.

7. Breathing mask according to at least one of claims 1 to 6, characterized in that the through opening has a cross section which is matched to a predetermined pressure / volume flow characteristic.

8. Breathing mask according to at least one of claims 1 to 7, characterized in that the channel device tapers continuously or step-like in terms of its cross section in the flow direction.

9. Breathing mask according to at least one of claims 1 to 8, character- ized in that a sharp mouth edge is formed in an outlet mouth region of the channel device.

10. Breathing mask according to at least one of claims 1 to 9, characterized in that a section of the narrowest cross-section is defined in the channel device, and that the length of the section of the narrowest cross-section is less than 2 mm.

11. Breathing mask according to claim 10, characterized in that the narrowest cross section of the channel device is formed in a membrane element.

12. Respiratory mask according to claim 11, characterized in that the area of the membrane element is at least 30% larger than the cross section of the throttle passage opening formed therein.

13. Breathing mask according to at least one of claims 1 to 12, characterized in that the decoupling structure extends in the mask base body in the circumferential direction of the sealing lip device along a transition region between a foot region of the sealing lip device and has a circumferential fold or a bellows structure.

14. Respiratory mask for supplying a breathing gas to a person with: a sealing lip device for sealing a mask support zone and a forehead support device for supporting the mask in the forehead or nasal root region of the person, in particular according to at least one of claims 1 to 13, is characterized by a stiffening element, for stiffening the breathing mask with a first stiffening section assigned to the area of the sealing lip device and a second stiffening section assigned to the forehead support device, the relative position of the two stiffening sections being mutually adjustable.

15. Breathing mask according to claim 14, characterized in that the two stiffening sections are coupled to one another via a joint device.

16. Breathing mask according to claim 14 or 15, characterized in that a fixing device is provided for fixing the two stiffening sections in a required relative position.

17. Breathing mask according to at least one of claims 14 to 16, characterized in that the two stiffening sections are integrally formed.

18. Breathing mask according to at least one of claims 14 to 17, characterized in that the joint device is formed by a film hinge device.

19. Breathing mask according to at least one of claims 14 to 18, characterized in that the stiffening element is designed in a skeleton-bell or frame-like manner to match the locally acting forces.

20. Breathing mask according to at least one of claims 14 to 19, characterized in that the stiffening element has a substantially rectangular frame profile.

21. Breathing mask according to at least one of claims 14 to 20, characterized in that the fixing device has a fixing mechanism, in particular a latching mechanism.

22. Breathing mask according to at least one of claims 14 to 21, characterized in that the fixing device has means for fixing by gluing, welding or chemical reaction.

23. Breathing mask according to at least one of claims 14 to 22, characterized in that the first stiffening or frame section has a contour substantially corresponding to the mask support zone.

24. Breathing mask according to at least one of claims 14 to 23, characterized in that the second stiffening section extends into an area located in the application position of the mask above the eyebrows of the mask user.

25. Breathing mask according to at least one of claims 14 to 24, characterized in that the stiffening element is provided with coupling sections for coupling a headband device.

26. Breathing mask according to at least one of claims 14 to 25, characterized in that the stiffening element is formed from a plastic material and / or a preferably thermoformable material, in particular wire-plastic composite material.

27. Breathing mask according to at least one of claims 14 to 26, characterized in that the breathing mask has a mask base body formed from an elastomeric material.

28. Breathing mask according to at least one of claims 14 to 27, characterized in that the sealing lip device is formed integrally with the mask base body.

29. Breathing mask according to at least one of claims 14 to 28, characterized in that the sealing lip device is coupled to the mask base body via the stiffening element.

30. Breathing mask according to at least one of claims 14 to 29, characterized in that the forehead support device has a support element which is formed from an elastomeric material.

5 31 breathing mask according to at least one of claims 14 to 30, characterized in that the support element is integrally formed with the sealing lip device and / or the mask base body.

32. Respiratory mask according to at least one of claims 14 to 31, characterized in that it denotes that the stiffening element is detachably coupled to the sealing lip device and / or the mask base body.

33. Breathing mask according to at least one of claims 14 to 32, characterized in that the stiffening element via a locking or engagement profile

15 structure is coupled to the mask base body.

34. Breathing mask according to at least one of claims 14 to 33, characterized in that the stiffening element is formed in several parts.

20 35. Breathing mask according to at least one of claims 14 to 34, characterized in that the mask base body is formed from a transparent or translucent elastomer material.

36. Respiratory mask according to at least one of claims 14 to 35, characterized in that the sealing lip device and / or the elastomeric decoupling structure has a velvety matt surface.

37. derivation device for discharging breathing gas with a connection section for coupling a breathing gas line and a peripheral wall for

30 delimitation of a breathing gas passage, the peripheral wall being provided at least in sections with an elastomeric hinge structure, and at least one passage opening being provided in the area of the hinge structure, in order to create a connection between the breathing gas passage and the surroundings.

38. discharge device according to claim 37, characterized in that the passage opening is arranged such that an outflow of the breathing gas takes place in a region lying above the eyebrows.

5

39. derivation device according to claim 37 or 38, characterized in that a plurality of through openings are provided.

40. derivation device according to at least one of claims 37 to 39, o characterized in that the through-openings are formed in a wall of a pleated ring extending essentially in the radial direction.

41. Discharge device according to at least one of claims 37 to 40, 5 characterized in that the through openings each have a cross-sectional area in the range from 0.8 to 4 mm ² , and that the through openings are designed such that the outflow direction is substantially normal to the surrounding wall of the fold retraction.

0 42. Diverter device according to at least one of claims 37 to 41, characterized in that a web section is formed between adjacent through openings, to limit buckling or bending.

43. derivation device according to at least one of claims 37 to 42, 5 characterized in that a plurality of circumferential fold indentations are provided, and that the through openings are formed in the radial walls of two successive circumferential fold indentations.

44. derivation device according to at least one of claims 37 to 42, o characterized in that the passage openings are arranged such that the outflow takes place along the outer surfaces of a breathing gas tube.