Breathing mask for supplying breathing gas to a mask user

p0001The invention relates to a respiratory mask for supplying a respiratory gas to a mask user and a discharge means for discharging breathing gas.

p0002Such masks are used in particular in the medical field, for example in the field of sleep medicine for the treatment of sleep disordered breathing.

p0003Usually these masks include a sealing lip means for sealing a mask rest zone against the environment. When nasal masks, the mask bearing zone extends from the upper lip area in the nostrils of the mask wearer adjacent facial area and from here into the region of the nasal dorsum. The sealing lip device is usually formed from an elastomeric material and pushed through a Kopfbandanordung under a predetermined contact pressure against the mask rest zone.

p0004In particular with long-term use of such respirators there is a problem that the required sealing effect can be achieved only under comparatively high Maskenanpreßkräften. Due to the required high Maskenanpreßkräfte the wearing comfort is impaired. In addition, there is a risk that arise in the area of ​​the mask bearing zone bruises.

p0005<patcit id="pcit0001" dnum="DE19808105A1"><text>DE 19808105 A1</text></patcit> discloses a method for producing an Individual breathing mask and a mask produced by the method.

p0006<patcit id="pcit0002" dnum="US5243971A"><text>US 5,243,971 A</text></patcit> discloses a nasal mask for use in a CPAP system.

p0007The invention has for its object to provide a breathing mask for supplying a respiratory gas, which is characterized at a sufficiently high tightness by a high ease of use.

p0008The invention is defined by the subject matter of the independent claim. Preferred embodiments are given in the dependent claims.

p0009A breathing mask for supplying a respiratory gas to a mask user with a sealing lip device for sealing a mask rest zone, a mask base body to form a mask interior and a connection means for connecting at least one breathing gas line, the mask base body and / or the connecting device provided with at least one coupling structure formed from an elastomeric material are, which permits a relative movement between one adjoining the mask base body Umfangsfußbereich the sealing lip means and the breathing gas line in a tilt angle of at least 5 °, will be discussed.

p0010This makes it possible advantageously to achieve a sufficient sealing effect with reduced mask holding power in a reliable manner, since advantageously even with movement of the head of the mask wearer no forces or moments on the breathing gas line to the sealing lip device can be transferred. In a further advantageous manner, a relative movement between the resting on the face of the mask wearer sealing lip means and a preferably, (eg by a formed on a reinforcing frame tube headband) frontally fixed breathing gas line is possible.

p0011The coupling structure is formed according to an embodiment discussed by a pleat or roller bellows. This pleat or roller bellows structure is preferably integrally formed using a core member with the sealing lip means.

p0012According to one embodiment, discuss the pleat or roller bellows structure is formed on the connecting device. This pleat or roller bellows can hereby be imparted by zones with matching wall thicknesses a hinge characteristic not lead through which both rotary or tilting moments and axial movements of the breathing gas line to the commencement of any forces in the sealing lip means.

p0013One also discussed embodiment is provided in that the coupling structure is formed on the mask base body. This makes it possible to prevent the transmission of undesirable forces on the sealing lip means and at the same time any movements of the mask base body relative to the sealing lip means sufficiently to decouple.

p0014An advantageous with regard to particularly low operating noise embodiment is provided in that at least one passage means is formed in the coupling structure, establishing a connection between the mask interior and the surroundings.

p0015Preferably, the channel device is formed by at least one through hole. The through hole preferably has a cross-section on to a predetermined pressure / current characteristic vote is tuned.

p0016A particularly low-noise dissipation can be achieved in that the channel means tapers in terms of their cross-section in the flow direction continuously or in stages.

p0017A likewise advantageous in terms of low noise emissions embodiment is provided in that in a discharge mouth of the channel means a sharp mouth edge is formed. Preferably, in the channel means a portion of narrowest cross-section is defined, wherein the length of the portion of narrowest cross-section is smaller than 2 mm. It is possible in an advantageous manner to make the channel geometry such that the smallest cross-section of the channel means is formed in a membrane element. This incoupling any structure-borne sound events will be reduced even further in the mask pattern. The diameter of the membrane element is preferably at least 30% greater than the diameter of the throttle passage opening formed therein.

p0018The movable coupling of the sealing lip means is preferably carried out by using the de-coupling in the mask base body extends circumferentially of the sealing lip device along a transitional area between a base region of the sealing lip means and is formed by at least one circumferential fold or a roller bellows.

p0019According to one aspect of the present invention, preferably in combination with the previously described measures a tunable to the individual face structure of the user breathing mask is provided which has a forehead rest means, comprising for supporting the mask in the forehead or nose area of ​​the person, and a stiffening element for stiffening of the breathing mask having a region of the sealing lip means associated first stiffening portion and a forehead support means associated second stiffening portion, whereby the relative position of the two reinforcement sections to each other is adjustably variable.

p0020This makes it possible in an advantageous manner to achieve optimum for the respective face structure of the mask wearer surface pressure distribution both in the area of ​​the sealing lip zone, as well as the forehead.

p0021An advantageous in view of easy handleability embodiment of the invention is given by the fact that the two reinforcement sections are coupled to one another via a joint device. The hinge means may in this case be formed in an advantageous manner by a film-hinge device.

p0022According to a particularly preferred embodiment of the invention, a fixing device is provided for fixing of the two stiffening sections in a required relative position. The fixture has a Fixiermechanik particular a latching mechanism advantageously. Preferably several predetermined locking positions are selectable. Alternatively - 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.

p0023An under manufacturing aspects particularly advantageous embodiment of the invention is given by the fact that the two reinforcement sections are integrally formed. Here, it is possible to form the two reinforcement sections, for example made of a thermoplastic plastics material in one only two-part mold. The two reinforcement sections can be injected into an advantageous under entformungstechnischen viewpoints orientation.

p0024The stiffening member is preferably skeleton-frame or at least in the region of the sealing lip device like a bell. In the case of a skeleton or frame-like configuration, the individual web sections are preferably of substantially rectangular profile cross-sections. A high degree of rigidity is achieved at a low weight of the stiffening element.

p0025The first stiffening or Rahmenabschhnitt preferably has a corresponding substantially to the mask rest zone contour. The second stiffening or frame portion preferably extends well into one, in the application position of the mask above the eyebrows of the mask wearer located region of.

p0026An advantageous particularly when using an elastomeric mask base body embodiment of the invention is provided in that the stiffening element is provided with coupling portions for coupling a headband device. It is possible to introduce the mask holding forces without undue deformation of the mask.

p0027The stiffening member is preferably formed from a plastic material. Alternatively - or in combination with it - it is possible to manufacture the stiffening element consists of a metal material in particular a flexibly deformable wire or profile material. It is also possible to form the stiffening element consists of a thermoformable material, at least locally, in particular a thermoplastic material with zugsteifer insert.

p0028In particular, it is possible to provide a wire insert in the region of the flexurally neutral zone of the profile material.

p0029The profile material preferably has at least one zugsteife vein, for example, a wire material on. It is possible, at least locally, to enable a deformation of the profile material, for example by heating, so that a further stiffening or adaptability of the frame member is provided to the face.

p0030A particularly advantageous adaptability of the breathing mask to the face of the mask wearer is in a particularly preferred embodiment of the invention achieved by the fact that the breathing mask comprises a mask base body formed from an elastomeric material. In this case, it is possible to influence by random deformation of the first reinforcement section the contour of the sealing lip zone and the Fläachenpressungsverteilung in this zone.

p0031Advantageously, the forehead rest means comprises a support element which is formed from an elastomeric material.

p0032A hygienic point particularly advantageous embodiment of the invention is provided in that the sealing lip means is formed integrally with the mask base body. This integral design can be achieved through joint training in a mold or by gluing the sealing lip means to the mask base body preferably including the reinforcement. It is also possible to form the mask base body and the sealing lip means and preferably also the cushioning bodies forehead rest means in the context of a vulcanization process.

p0033In a particular aspect of the present invention, the cushion bodies forehead rest means are preferably formed integrally with the sealing lip means and / or the mask base body. In case of multi-part design of the mask, it is possible to couple the sealing lip means on the stiffening element with the mask base body. The connection region between the mask base body and the end support means can be effective as an elastomeric hinge structure.

p0034The stiffening element is detachably coupled in a particularly preferred embodiment of the invention with the sealing lip means and / or the mask base body. This makes it possible in an advantageous way to use the stiffening element multiple times. The stiffening element is preferably coupled via a locking or engagement profile structure with the mask base body.

p0035The stiffening member is preferably formed of several parts. Advantageously, the mask base body made of a transparent or translucent elastomer material is formed. A particularly advantageous in view of a comfortable fit embodiment of the invention is provided in that the sealing lip means comprises a velvety matte finish. Through the realization of so-called. Lotuses structures this also improved the hygienic point of cleaning are achieved.

p0036The joint fixation can preferably also reversible, for example by hot glue or chemically releasable adhesive carried. It is also possible to specially provide thermoformable structures in the joint body that are repeatedly plastically deformable and allow a readjustment of the relative positions of the two stiffening or frame sections, for example, by supplying heat.

p0037It is also possible to form in the stiffening member, or in whose framework several joint or Justierzonen, so that for example, adjustment to adapt to the individual curvature of the forehead, the nose width and Oberlippentektur are possible.

p0038In particular, in the embodiment of the stiffening element to be locally deformable structure can be achieved in that the stiffening element is formed from a composite material with small installation space sufficient strength. As composite material is particularly suitable for a wire / thermoplastic composite material.

p0039The adjustability of the at least two stiffening or frame sections to each other can also be achieved according to the invention that the two stiffening or frame sections can be joined in different coupling positions, for example by corresponding permutable be coupled joints or selectable joining members.

p0040The following points will be discussed:<ol><li>1. respiratory mask for supplying a respiratory gas to a mask user, comprising: a sealing lip means for sealing a mask rest zone, a mask base body to form a mask interior and a connection means for connecting at least one breathing gas line with the mask base body and / or the connecting device with at least one coupling structure formed from an elastomeric material is provided which permits a relative movement between a mask base body side Umfangsfußbereich the sealing lip means and the breathing gas line in a tilt angle of at least 5 °.</li><li>2. A breathing mask according to item 1, characterized in that the coupling structure is formed by a pleat or roller bellows.</li><li>3. A breathing mask according to item 2, characterized in that the pleat or roller bellows is formed on the connection means.</li><li>4. A breathing mask according to at least one of items 1 to 3, characterized in that the coupling structure is formed in the mask base body.</li><li>5. A breathing mask according to at least one of items 1 to 4, characterized in that at least one passage means is formed in the coupling structure, establishing a connection between the mask interior and the surroundings.</li><li>6. A breathing mask according to at least one of items 1 to 5, characterized in that said channel means is formed by at least one passage opening. </li><li>7. A breathing mask according to at least one of items 1 to 6, characterized in that the passage opening has a cross section which is matched to a predetermined pressure / flow characteristic.</li><li>8. A breathing mask according to at least one of items 1 to 7, characterized in that the channel means tapers continuously or stepwise with respect to their cross-section in the flow direction.</li><li>9. A breathing mask according to at least one of items 1 to 8, characterized in that in an exit mouth of the channel means a sharp orifice edge is formed.</li><li>10. A breathing mask according to at least one of items 1 to 9, characterized in that <b>that</b> in the channel means a portion of narrowest cross-section is defined, and that the length of the portion of narrowest cross-section is smaller than 2mm.</li><li>11. A breathing mask according to item 10, characterized in that the narrowest cross-section of the channel means is formed in a membrane element.</li><li>12. A breathing mask according to item 11, characterized in that the FIaeche of the membrane element is at least 30% larger than the cross section of the throttle through-hole formed therein.</li><li>13. A breathing mask according to at least one of items 1 to 12, characterized in that the de-coupling structure extends in the mask base body in the circumferential direction of the sealing lip device along a transitional area between a base region of the sealing lip means and having a peripheral fold or a roller bellows.</li><li>14. A breathing mask for supplying a respiratory gas to a person: a sealing lip device for sealing a mask rest zone and an end support means for supporting the mask in the forehead or nose area of ​​the person, in particular according to at least one of items 1 to 13, characterized by a stiffening element for stiffening the respiratory mask having a region of the sealing lip means associated first stiffening portion and a forehead support means associated second stiffening portion, whereby the relative position of the two reinforcement sections to each other is adjustably variable.</li><li>15. A breathing mask according to item 14, characterized in that the two reinforcement sections are coupled together via a Geienkeinrichtung.</li><li>16. A breathing mask according to points 14 or 15, characterized in that a fixing device is provided for fixing of the two stiffening sections in a required relative position.</li><li>17. A breathing mask according to at least one of items 14 to 16, characterized in that the two reinforcement sections are integrally formed.</li><li>18. A breathing mask according to at least one of items 14-37, characterized in that the hinge means is formed by a film hinge means is formed.</li><li>19. The breathing mask according to at least one of Points 14 to 38, characterized in that the stiffening element adapted to the local forces of skeletal bell-shaped or formed like a frame is.</li><li>20. A breathing mask according to at least one of items 14 to 14, characterized in that the stiffening element has by a substantially rectangular frame section.</li><li>21. A breathing mask according to at least one of items 14 to 20, characterized in that the fixing device comprises a Fixiermechanik in particular a latching mechanism. </li><li>22. A breathing mask according to at least one of items 14 to 21, characterized in that the fixing device comprises means for fixing by adhesive bonding, welding or chemical reaction.</li><li>23. A breathing mask according to at least one of items 14 to 22, characterized in that comprising the first stiffening or frame section corresponding substantially to the mask rest zone contour.</li><li>24. A breathing mask according to at least one of items 14 to 23, characterized in that the second stiffening portion extends into a, in the application position of the mask above the eyebrows of the mask wearer located region of into it.</li><li>25. A breathing mask according to at least one of items 14 to 24, characterized in that the stiffening element is provided with coupling portions for coupling a headband device.</li><li>26. A breathing mask according to at least one of items 14 to 25, characterized in that the stiffening element consists of a plastic material and / or a preferably thermoformable material particular wire-plastic composite material is formed.</li><li>27. A breathing mask according to at least one of items 14 to 26, characterized in that the mask comprises a mask base body formed from an elastomeric material.</li><li>28. A breathing mask according to at least one of items 14 to 27, characterized in that the sealing lip means is integrally formed with the mask base body.</li><li>29. A breathing mask according to at least one of items 14 to 28, characterized in that the sealing lip means is coupled to the stiffening element with the mask base body. </li><li>30. A breathing mask according to at least one of items 14 to 29, characterized in that the forehead support means comprises a support element which is formed from an elastomeric material.</li><li>31. A breathing mask according to at least one of items 14 to 30, characterized in that the support element is formed integrally with the sealing lip means and / or the mask base body.</li><li>32. A breathing mask according to at least one of items 14 to 31, characterized in that the stiffening element is releasably coupled to the sealing lip means and / or the mask base body.</li><li>33. A breathing mask according to at least one of items 14 to 32, characterized in that the stiffening element is coupled via a latching or engagement profile structure with the mask base body.</li><li>34. A breathing mask according to at least one of items 14 to 33, characterized in that the stiffening element is designed in several parts.</li><li>35. A breathing mask according to at least one of items 14 to 34, characterized in that the mask base body is formed of a transparent or translucent elastomeric material.</li><li>36. A breathing mask according to at least one of items 14 to 35, characterized in that the Dichtiippeneinrichtung and / or the elastomeric coupling structure has a velvety matt surface.</li><li>37. deriving means for discharging breathing gas with a connection portion for coupling a breathing gas line and a circumferential wall for defining a breathing gas passageway wherein the peripheral wall is at least partially provided with an elastomeric hinge structure, and is provided at least in the region of the articulated structure has a through-opening, establishing a connection between the breathing gas passageway and around. </li><li>38. deriving means according to item 37, characterized in that the passage opening is arranged such that an outflow of the breathing gas is in a lying above the eyebrows area.</li><li>39. deriving means according to item 37 or 38, characterized in that several passage openings are provided.</li><li>40. deriving means according to at least one of items 37 to 39, characterized in that the passage openings are formed in a substantially radially extending wall of a folding rim.</li><li>41. deriving means according to at least one of items 37 to 40, characterized in that the through-openings each have a cross-sectional area in the range of 0.8 to 4 mm² , and in that the passage openings are formed such that the outflow takes place substantially normal to the surrounding wall of the fold feeder.</li><li>42. deriving means according to at least one of items 37 to 41, characterized in that between adjacent through-holes a ridge portion is formed for bending or bending limit.</li><li>43. deriving means according to at least one of items 37 to 42, characterized in that a plurality Umfangsfalteneinzüge are provided, and in that the passage openings are formed in the radial walls of two abfoigender Umfangsfalteneinzüge.</li><li>44. Abieitungseinrichtung according to at least one of items 37 to 42, characterized in that the penetration openings are arranged aligned such that the flow-off takes place along the outer surfaces of a respiratory gas tube.</li></ol>

p0041More details will emerge from the following description in conjunction with the drawing. Show it:<dl id="dl0001"><dt><b>Fig. 1</b></dt><dd>a perspective view of a preferred embodiment of a breathing mask with an elastomeric mask base body and integral end support device, wherein a stiffening element is provided, the position of Stirnaufiageeinrichtung into an integral with this Dichtiippeneinrichtung is adjustably variable relative on which;</dd><dt><b>FIG. 2</b></dt><dd>a perspective view of the frame-like stiffening element as provided in the embodiment according to Fig.</dd><dt><b>Fig. 3</b></dt><dd>another perspective view of said stiffening element here overlooking a latchable in several fixing positions fixing member.</dd><dt><b>Fig. 4</b></dt><dd>a simplified perspective view of another embodiment of a breathing mask with a formed in the region of a respiratory gas conduit means Eiastomer-Entkoppeiungsstruktur:</dd><dt><b>Fig. 5</b></dt><dd>a perspective view of a third embodiment of a breathing mask with a formed from an elastomeric material and a mask base body formed on this formed by Falteneinzüge de-coupling;</dd><dt><b>Fig. 6</b></dt><dd>a perspective view of a fourth embodiment of a breathing mask, also with a formed from an elastomeric material mask base body, but with a trained after the bellows principle de-coupling; </dd><dt><b>Fig. 7</b></dt><dd>is a side view of a fifth embodiment of a breathing mask, also formed a formed from an elastomeric material mask base body and a molded-on connecting device for a breathing gas line, both between the Anschiußeinrichtung and the mask base body, and in the area of ​​the sealing lip means each have a coupling structure;</dd><dt><b>Fig. 8</b></dt><dd>a preferred embodiment of a terminal portion of a breathing gas line, here with integrated Gasableitungsäffnungen;</dd><dt><b>Fig. 9</b></dt><dd>a perspective view of another embodiment of a connection device for a breathing gas line, here with several umflaufenden bellows and molded Ableitun gsöffnungen;</dd><dt><b>Fig. 10</b></dt><dd>a simplified sectional view for explaining another embodiment of a channel means for discharging breathing gas;</dd><dt><b>FIG. 11a, FIG. 11b</b></dt><dd>Schematic diagrams for explaining the structure of a suitable as fuel and / or pressure indicator deformable structure;</dd><dt><b>Fig. 12</b></dt><dd>a detailed sketch illustrating a preferred arrangement of reinforcing webs for closure preventing the passage openings.</dd></dl>

p0042The presentation gem. <figref idrefs="f0001">Fig. 1</figref> shows a breathing mask, as they can be applied in particular for the implementation of CPAP therapy. The respiratory mask includes a mask base body 1, which is formed in the embodiment of a fully transparent, elastomeric silicone material shown here. The mask base body 1 defines a sufficiently dimensioned to receive the nose of the mask wearer mask interior. The sealing of the mask interior to the surface of the face mask wearer out via a sealing lip device 2, which is almost completely obscured in this view. The sealing lip device 2 comprises a layer formed from an elastomeric material lip that wraps under elastic deformation on the facial surface of the mask wearer and a nose receiving opening defined by which at least the tip of the nose portion of the mask wearer can penetrate into the interior of the mask defined by the mask base body. 1

p0043The breathing mask is provided with a forehead rest means 3, which here includes a forehead padding means. 4 The forehead padding means 4 is formed in the embodiment shown here is also made of an elastomer material and also integral with the sealing lip device 2 and integrally with the mask base body. 1 This integral formation of mask base body 1, the sealing lip means 2 and forehead padding means 4 is achieved forming a connecting web portion 5, which position changeable couples the forehead padding means 4 with the mask base body. 1 In the peripheral region of the mask body 1, a stiffening element 6 is provided, which is designed here as a framework-like structure. The stiffening element 6 comprises a 6b of the circumferential contour of the sealing lip means 2 following first reinforcement section 6a and a extending into the forehead rest means 3 second reinforcement section. The two reinforcement sections 6a, 6b are mutually coupled movable. The coupling of the two stiffening sections 6a, 6b is carried out in the embodiment illustrated here, via a hinge means 7, which is here formed by a film hinge portion eighth The another by pivoting the two reinforcement sections 6a, 6b set relative position of the forehead padding means 4 relative to the mask base body. 1 or to the sealing lip means 2 can be permanently fixed on a fixing device. 9

p0044The fixing device 9 comprises a fixing element 10 here, which can be brought into different fixing positions in engagement with a holding element eleventh

p0045In the embodiment shown here, the support member 11 is substantially rigidly connected to the first connection portion 6a. The fixing element 10 is connected to the second schwenkbewegbar stiffening portion 6b. The coupling of the fixing element 10 and the holding member 11 in selected positions coupling takes place via plug-in holes 12 formed in the fixing 10th This plug holes 12 engageable with a non-visible location pin here engaged. The fixing pin is formed on a fixing element 10 facing end surface of the retainer eleventh As an alternative to this mechanism shown here it is also possible to use different mechanisms for determining the relative position of the first reinforcement section 6a with respect to the second reinforcement section 6b.

p0046The stiffening device 6 is coupled to the mask base body 1 such that the mask base body 1 and with this also the sealing lip device 2 may have a co-determined by the stiffening element 6 shape. In the embodiment illustrated here, the coupling of Versteifungsefementes 6 is carried out with the mask base body 1 via a circumferential groove 14, in which the frame-like design stiffening element 6 is inserted. To better reflect the stiffening element 6 with the mask base body 1, and with the sealing lip device 2, the circumferential groove is profiled in the region of Nutinnenflächen complementary to the stiffener. 6

p0047The stiffening element 6 is provided with a coupling device 15, on which a band member of a lower headgear assembly to the mask can be coupled. In the embodiment shown here, the coupling device 15 is designed as a bracket-like tab which is integrally manufactured with the stiffening element. 6 Alternatively, it is also possible to constructively differently constructed coupling devices, such as locating or snap means for coupling the headgear zoom pull with the stiffener. 6 The immediate introduction of the tensile forces of the headband in the stiffening element 6 an impermissible deformation of the mask base body 1 and the sealing lip device 2 is avoided.

p0048In the area of ​​the forehead rest means 3 a coupling device 16 is also provided which corresponds to the embodiment shown here in its construction substantially provided in the area of ​​the mask base body 1 coupling device 15th

p0049That provided in the area of ​​the forehead rest means 3 stiffening element 6 and whose second stiffening or frame section 6b is connected to the forehead padding means. 4 In the embodiment shown here, the coupling of the forehead cushion unit 4 with the second stiffening portion 6b as the coupling of the first reinforcing portion 6a with the mask base body 1 is performed, similar, characterized in that the second stiffening portion 6b is inserted into a, formed in the end cushioning device 4 groove.

p0050The forehead padding means 4 is formed of an elastomeric material and has a plurality of pocket portions 17, 18. Through the pocket portions 17, 18, the cushioning properties of the forehead padding means 4 can be influenced defined.

p0051At the mask base body 1 a bellows structure 19 is provided, through which a breathing hose connection adapter 20 schwenkbewegbar coupled with the mask base body. 1

p0052The bellows structure 19 is in the embodiment shown here also formed integrally with the mask base body 1, which is prevented in the hygienic point advantageously possible clefts. a hose spigot portion adjoins the bellows structure 19 at 21, which is dimensioned in terms of its inside diameter, that the breathing hose connection adapter 20 in this is tightly inserted. Instead of breathing hose connection adapter 20, it is possible here a CO₂provide -Auswaschadapter as in going back to the applicant German Patent <patcit id="pcit0003" dnum="DE19840760"><text>198 40 760.2</text></patcit> is described.

p0053In <figref idrefs="f0002">FIG. 2</figref> is the gem in the breathing mask. <figref idrefs="f0001">Fig. 1</figref> provided reinforcement element 6 shown as an individual part. Both of the mask base body 1 of the breathing mask assigned first reinforcement section 6a and the forehead rest means 3 (<figref idrefs="f0001">Fig. 1</figref>) Associated with the second stiffening portion 6b are here formed by web-like elements having a substantially polygonal, in particular rectangular cross-section. Integral with this web-like elements are provided with already connected<figref idrefs="f0001">Fig. 1</figref> mentioned coupling devices 15, 16 is formed. Is clearly evident in this illustration, here designed as a film hinge 22 coupling point for coupling the two reinforcement sections 6a, 6b. The fixing element 10 is also mounted via a hinge point 23 such that this, as indicated by the arrow P, in a sufficient angular range is pivotable. By appropriately pivoting the fixing element 10 is achieved that this a stabilizing edge 24 formed in the end region of the retaining element 11 releases. As long as the fixing element 10 is not coupled to the holding member 11, it is possible, the second reinforcement section 6b to pivot relative to the first reinforcing portion 6a in a desired position. By engaging the fixing member 10 provided on the engagement structure with an appropriately complementary engagement structure of the holding element 11 it is possible for the two stiffening portions 6a, 6b to be fixed in the desired relative position to each other. The fixing element 10, the holding element 11 and which extends between the film hinge 22 to the film hinge 23 toward extending section of the second reinforcement section 6b form in the embodiment shown here, a triangular truss, through which the relative position of the second stiffening portion 6b to the first reinforcing portion 6a is adjustable relative fixable , As an alternative to this production under technical aspects particularly advantageous producible coupling structure, it is also possible to use structurally different coupling structures for coupling the two reinforcement sections 6a, 6b.

p0054The first stiffening portion 6a has in the embodiment shown here on a substantially saddle-shaped outer contour. In one respect. The mask bearing surface perpendicular direction of the first reinforcement section 6a is so pulled in nose back up, that this does not fall below a predetermined minimum distance from the surface of the face mask wearer.

p0055In <figref idrefs="f0002">Fig. 3</figref> the mask frame by <figref idrefs="f0002">FIG. 2</figref> shown from a different perspective. The fixing element 10 here has four locking holes 26, 27, 28 and 29th The fixing element 10 is gekoppeit with the holding member 11 such that the locking hole 28 engages with the fixing pin 24 of the strut 11 into engagement. For coupling of the fuser 10 with the holding member 11 using the locking hole 29 of the second reinforcement section 6b is such hinge pivots to the forehead area of ​​the mask wearer, that the bridge of the nose on traversing region of the first reinforcement section 6a furthest lifted. By selecting the corresponding detent hole 28, a configuration is selected in which the bridge of his nose on traversing region of the first reinforcement section 6a is the nose of the patient already approximated. By locking holes 27 and 26 respectively even flatter configurations are achieved.

p0056It is possible to introduce an adhesive material in the case designed as a film hinge 22 coupling point between the two stiffening sections, whereby the relative position of the two reinforcement sections 6a, 6b each other permanently fixed. The fixing element 10 and possibly also the holding element 11 can be removed after curing of the adhesive material. The adjustment of the breathing mask is performed advantageously using the fully assembled mounted breathing mask. It is also possible to adjust the stiffening element disassembled to the face of the mask wearer, and only then to be coupled with the mask base body. Advantageously, more Einstelimöglichkeiten are provided through which, for example, the position of the forehead padding means in the height and / or width direction is adjustable. As an alternative to the formation of the coupling area between the two stiffening portions as a hinge point, it is also possible here to provide coupling possibilities, by soft, for example, while heat is an adjustment of the two stiffening sections 6a, 6b to each other is provided.

p0057In the <figref idrefs="f0003">Fig. 4</figref> Breathing mask illustrated comprises an integrally formed with the mask base body 31 connecting means 32 for a breathing gas line (not shown). In a transition region between the connection means 32 and the mask base body 31 a coupling structure 33 is provided, which is formed in the embodiment shown here by a bellows. The Faktenbafgeinrichtung comprises a first fold collar 34 and a second fold collar 35. Specifically, the first fold collar 34 includes two radially extending circumferential walls 36, 37. These two circumferential walls 36, 37 are formed as Kegeimantelflächen and have a selected with respect to a predetermined system stiffness wall thickness distribution. The coupling structure is formed here rotationally symmetrical. An especially large breathing gas passage cross-section with a comparatively low or very little disturbance of the visual field is achieved in an advantageous manner by the Atemgasleitungsabschnit has an elliptical or polygonal cross-section in the area of ​​the nose. The coupling structure is formed here rotationally symmetrical. Alternatively, it is also possible to form the flanks of the fold collars such that they have circumferentially different catchment depths and possibly changing wall thicknesses.

p0058In the embodiment shown here a breathing gas passage opening 38 is, in the application position of the breathing mask on the face portion of a mask user facing peripheral 36 least formed through which an outflow of at least partially consumed respiratory gas can be carried out in the surrounding area. Also in the area of ​​the second fold collar 35 more breathing gas passage openings 39 are formed, through which can likewise be directed through the end region of the mask wearer away Atemgasabströmung. The breathing gas passage openings 38 and 39 are aligned such that the emerging therefrom breathing gas does not collide directly with the wall sections or de-coupling of the connecting device. Preferably, the breathing gas passage openings 38, 39 arranged such that the exiting air can not impinge on the end area of ​​the mask wearer.

p0059It is possible to form the coupling structure such that a stop characteristic is achieved, so that a decoupling is supplied read only undertaken within a certain range of motion

p0060In the breathing mask shown here is formed integrally with the mask base body 31 a forehead rest means 40th The sealing lip device 2 for sealing a face bearing zone is also integrally formed in the embodiment shown here with the mask base body 31, integrally with the forehead rest means 40th The position of the forehead rest means 40 relative to the mask base body 31 or also to the sealing lip device 2 is variable over a Einstelieinrichtung.

p0061When in <figref idrefs="f0004">Fig. 5</figref> Embodiment of a breathing mask shown is also formed from an elastomeric material, but differently provided by the above-described embodiment with a plurality of fold indentations through which an extensive mechanical decoupling of the connecting device is also 32 achieved by the sealing lip means 2 of the mask base body 31st Also in this embodiment, the breathing mask to a forehead support means 40, which may be integrally formed similarly as in the embodiment described above with the mask base body 31st

p0062The Falteneinzüge 41, 42, 43 are here oriented such that they bridge the arcuate nose area 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 form the mask base body 31 is provided with a larger number of corresponding Falteneinzüge, wherein the elastic properties of the individual folds trains are preferably tuned such that with regard to the coupling of the connection means 32 and the sealing lip means 2 predetermined properties result.

p0063In the <figref idrefs="f0005">Fig. 6</figref> Breathing mask illustrated comprises similar to the breathing mask foregoing a trained in the area of ​​the mask base body 31 de-coupling. In the embodiment shown here, the coupling structure is formed by several Rollbalgzonen 44, 45, 46th In addition to these Rollbalgzonen 44, 45, 46 a further coupling structure 33 is in the region of the connection means 32 is provided which similarly as in the in conjunction with<figref idrefs="f0003">Fig. 4</figref> Described embodiment comprises two fold collars 34, 35th

p0064The support of this breathing mask in the forehead area of ​​a mask user is done here by a forehead rest means 40 formed integrally with the mask base body here 31st

p0065The connection means 32 is here formed integrally with the mask base body 31 and also manufactured correspondingly from an elastomeric material. The connection means 32 comprises a circumferential bead 47, through which an improved coupling with a breathing gas conduit is achieved.

p0066In the <figref idrefs="f0006">Fig. 7</figref> Breathing mask illustrated includes a made of an elastomer material mask base body 31 with a likewise made of an elastomeric material connecting device 32. The connecting device 32 is here formed integrally with the mask base body, wherein in a transition region, the connection means 32 in the mask base body 31 a, here by only a single bellows formed, de-coupling structure 33 is provided. In the field of de-coupling several respiratory gas through holes 39 are formed for discharging breathing gas from the, by the mask base body 31 defined mask interior. The breathing gas passage openings 39 have respect to a predetermined Abströmverhaltens on trained channel cross sections. The breathing gas passage openings 39 can, as shown here by way of example, discussed not only as in the embodiments described above, round cross sections, but also have polygonal, cruciform and other randomly selected geometries. Preferably, however, the breathing gas passage openings are formed so that the success in this way air flow is directed to the front area of ​​a mask user, but especially in the hose direction in particular along the mask user side facing away from the hose occurs.

p0067In <figref idrefs="f0007">Fig. 8</figref> 50 for discharging breathing gas, a Abteitungseinnchtung. The discharge means 50 here forms a connection means 32 for connecting a breathing gas line and a coupling structure 33 having a plurality of fold collars 34, 35 here. On one of the terminal device 32 side facing away from the discharge device 50 is provided with an attachment structure 51 through which the discharge means 50 is coupled to a mask base body of a respiratory mask or a further breathing gas line section in a sealing manner. In the region of which extends over an angle of approximately 120 ° circumferential portion of the first fold collar 34 breathing gas passage openings 39 are similar to those in the embodiments described above is formed, over which a discharging breathing gas can take place from the interior space defined by the discharge means 50 into the environment ,

p0068In <figref idrefs="f0008">Fig. 9</figref> is dargesteilt another embodiment of a discharge means 50 for discharging at least partially consumed respiratory gas. The discharge means 50 comprises here a for connection of a breathing gas line provided connection means 32, as well as one on one, the terminal device 32 side facing away from formed connection structure 52 through which the derivation means with a mask base body 31 or another Atemgasleitungsabschnit be coupled. Between the connecting structure 52 and the connection means 32 a coupling structure 33 is provided, through which a relative movement between the connection means 32 and connection structure 52 is permitted in a certain range of motion. In the embodiment shown here are in a range of motion of up to 10 mm axial movements and approved in an angular range of about 30 ° tilting movements in a peripheral portion of a circumferential wall 36 of the first fold collar 34 are, similarly to the embodiment described above breathing gas passage openings 39 are formed. The breathing gas passage openings 39 are designed as narrow substantially radially oriented slots. The wall thickness of the peripheral walls of the two fold collars 34 are made thinner in the area of ​​kinks, as in the extending between the kinks wall area. The embodiment shown here of a deriving means has in the region of the connection means 32 has an inner diameter of 18 mm and in the area of ​​coupling structure 33 has an outer diameter of 35 mm. The axial length of the discharge means 50 is in the unloaded state 54 mm. The discharge means 50 is of an elastomeric material - formed - fully transparent silicone rubber here. The maximum wall thickness of the discharge means 50 is 4 mm.

p0069In <figref idrefs="f0009">Fig. 10</figref> illustrated sketch of a preferred embodiment of a channel means for discharging breathing gas. The defined here Atemgasweg passes through a through hole 53 in a first intermediate space 54, which communicates with the environment in connection through a gap region 55th In this gap area several web sections 56 are formed, through which the throttle characteristic of the gap region is influenced. Based on the length of the gap region 55 can in particular be influenced defined in conjunction with the webs 56, the flow behavior of the respiratory gas path. Such Atemgasweg for discharging breathing gas from a mask interior to the environment may be formed directly on a mask base body 31 or preferably in the range of a connection means for connecting a breathing gas line. The structure shown here is preferably formed integrally from a fully elastomeric material. For the purpose of cleaning, it is possible 57 aufzustülpen an upper cover wall upwards. A required Mindestspaltmaß in the gap portion 55 can be achieved by web sections not shown here, the sections extend up to the inner surface of the top wall 57th

p0070In <figref idrefs="f0010">Fig. 11</figref> is shown, an elastomeric structure which is suitable in conjunction with a breathing mask directly to the display of the application taking place at the breathing mask deformation. So it is for example possible to provide for example a color marking in the inner wall of a pleat or bellows structure 60, which is seen as a function of the deformation of the pleat or bellows structure. For example, the pleat or bellows structure 60 as shown in<figref idrefs="f0010">Fig. 11</figref> shown, compressed to the maximum, the attached in the area of ​​the inner wall of the pleat or bellows structure color marking from the outside is no longer visible. From this example, can be closed at an impermissibly high surface pressure in the area of ​​the forehead support and / or in the region of the sealing lip means an appropriately designed mask. It is also possible to check on the basis of such a pleat or bellows structure 60, whether a sufficient mask holding force is applied to the breathing mask. In such an embodiment, for example, the color coding can be arranged such that these in case of insufficient mask holding forces is visible and is covered first with sufficient mask holding forces:

p0071In <figref idrefs="f0011">Fig. 12</figref> is a portion of a discharging device for discharging breathing gas shown, which is formed from an elastomeric material. The deriving means comprises a peripheral wall 70, which is embodied here as a fold collar 73rd The circumferential wall is provided with a plurality of through holes 38 for discharging breathing gas. Inside the fold collar 73 lands 71 ​​are formed, which are produced integrally with the peripheral wall 70th The webs 71 act as buckling security, making sure that the through holes 38 are open at all times. The webs 71 a division of the gas flow is also achieved, resulting in an even quieter derivative of the respiratory gas into the environment (U). The through-openings have here a circular cross-section. Following the provided with the through holes 38 fold collar 73, a further fold collar 74 connects. This fold collar 74 is relatively rigid coupled to the first fold collar 73 and also has a lower height, so that a Abdekken the through hole 38 is not possible by the further fold collar 74th At the further fold collar 74 to a hinge fold collar 75 joins defining a circumferential hinge zone 76 and inside an inner hinge zone 77 in the region of its maximum diameter. In the inner joint zone 77 and the peripheral joint zone 76 the wall thickness of the peripheral wall 70 is formed so low that a comparatively smooth movability of the opposite portions of the deriving means is added to each other. The peripheral walls 78 of the fold collar 74 and the peripheral wall 79 of the hinge fold collar 75 together define each other the maximum swivel angle of the two fold collars.

p0072The operation of the breathing mask described above is explained in detail with reference to the following application example:<ul><li>To carry out a CPAP therapy, the breathing mask of a Sterilverpakkung is removed and the fixing element 10 is pivoted into a release position, so that the reinforcing portion 6b relative to the first reinforcing portion 6a is schwenkbewegbar around the hinge point the 22nd Now, a breathing gas hose is connected to the breathing mask via a rotary and Schnellverschlußadanter in which this and this is inserted into the breathing hose connection adapter 20 on the quick release adapter. Through the respiratory gas tube breathing gas is supplied under a predetermined pressure of, for example, 8 mbar. Now the mask is applied to the nose portion of the mask wearer. To this end is passed through the lower coupling means 15 of the respective portion of a lower headgear assembly. The tensile stress in the lower headgear assembly is adjusted to a sufficient tightness of the sealing lip device 2 is ensured. Now, the breathing mask in the application position is so tilted from the bridge of his nose off, or bridge of the nose down until an optimal contact of the sealing lip device 2 is achieved in the area of ​​the nasal dorsum. Now the upper forehead padding means 4 is slightly pushed against the front of the mask wearer. The hereby achieved relative positioning of the first stiffening portion 6a relative to the second stiffening portion 6b is fixed by the fixing member 10 is brought into engagement with the holding element eleventh</li></ul>

p0073As a result of the pressure prevailing in the breathing gas line overpressure flows CO₂ through the rim folds formed in the through holes. The through-holes are dimensioned and configured so that a predetermined pressure / flow characteristic is achieved, so that a sufficient effluent of the respiratory mask, or in the breathing gas line in exhaled breathing air is reached in the environment in such a way.

p0074By formed in the fold collar webs is reliably ensured that the openings are not closed due to a body authorized by the de-coupling compensation movement.

p0075The breathing mask is adjusted now ready for use. By coupling the coupling device 16 in the area of ​​the forehead rest means 3 now the mask is fixed by the upper headgear assembly to the mask user in the end region of the mask wearer.

p0076It is possible to fix the reached here relative positioning by additional measures such as a ratcheting manner in blocking element (eg fuse element). With appropriate load-bearing capacity of this additional fixing means, it is possible to remove the fixing element 10 and possibly also the holding element eleventh

p0077It is also possible to select on the basis of the above, the fixing device 9 computed ideal configuration of the breathing mask, a stiffening element of a stiffening elements set which imparts the desired relative position waiving the fixing 9 the sealing lip means and the forehead padding means 4 - and such a stiffening element to the above exchange said stiffener.