Patent Grant
11883597
The present application claims priority under 35 U.S.C. § 119 of German Patent Application No. 10 2018 005 517.6, filed on Jul. 12, 2018, the entire disclosure of which is expressly incorporated by reference herein.
The present invention relates to a respiratory mask and to a process for producing such a respiratory mask. The respiratory mask comprises at least one mask unit and at least one emission device for discharging exhaled gas from the respiratory mask. The emission device comprises a multiplicity of flow channels, which are arranged in at least one part of the mask unit.
In respiratory masks for so-called single-tube systems, the exhaled air is generally discharged directly from the respiratory mask into the atmosphere, or into the surroundings. However, the emission of the exhaled gas, or of the exhaled air, from the respiratory mask often leads to unpleasant noises. When the air impinges on the face of the patient or the person in bed next to them, this is often perceived as very unpleasant. Noises and air flows are a particular problem when the respiratory mask is being used for sleep therapy.
DE102005041717A1, the entire disclosure of which is incorporated by reference herein, discloses a respiratory mask having a connection unit for a respiratory gas tube and, next to the connection unit in the respiratory mask, an emission device for discharging exhaled gas. The emission device comprises a multiplicity of flow channels, which are arranged in an annular gap in the mask body and are partially covered by a cover ring, so that an exhalation gap is formed. A disadvantage in this case is, in particular, the two-part construction.
EP2027880B1, the entire disclosure of which is incorporated by reference herein, discloses a respiratory mask having a connection unit for a respiratory gas tube and, in the connection unit, an emission device for discharging exhaled gas. The emission device comprises a multiplicity of flow channels, which are at least partially covered in one exemplary embodiment. A disadvantage in this case is the arrangement in the connection unit.
It would therefore be advantageous to be capable of reducing or avoiding undesired noises and air flows when discharging exhaled gas from a respiratory mask. In this case, the respiratory mask should preferably also be producible in a cost-optimized way, in order to be available for as many users or patients as possible.
The respiratory mask according to the invention is intended, in particular, for a respirator apparatus and/or for a sleep therapy apparatus. The respiratory mask comprises at least one mask unit and at least one emission device for discharging exhaled gas from the respiratory mask. The mask unit comprises at least one mask body and at least one connection unit which can be connected to the mask body for connection of a respiratory gas line.
The respiratory mask according to the invention comprises a mask unit having at least one emission device for discharging exhaled gas from inside the respiratory mask, the mask unit comprising at least one mask body and at least one mask bead connected to the mask body and a connection unit connected to the mask body for connection of a respiratory gas feed line, and the emission device comprising a multiplicity of separate flow channels, the emission device comprising a plurality of separate flow channels which respectively consist of at least two flow subchannels, the flow channels being arranged at a distance from one another and at least in sections circularly or semicircularly.
The emission device comprises a multiplicity of flow channels which are arranged in at least one part of the mask unit. The emission device in this case comprises, for example, at least nine flow channels.
In particular, two or preferably a multiplicity of flow channels are provided with flow subchannels. In this way, particularly advantageous flow properties can be achieved. In particular, all or at least a majority of the flow channels comprise at least two flow subchannels. The flow subchannels, which form a flow channel, are in this case for example configured geometrically differently. The flow channels therefore comprise geometrically different subsections.
At least one of the flow channels preferably has a varying channel cross section. Preferably, at least one flow channel has at least two different channel cross sections. Noises and undesired flows can therefore be particularly advantageously suppressed. It is also possible and preferred for the channel cross section to be configured unvaryingly.
It is preferred for at least one of the flow channels to be configured at least in sections conically and/or in the shape of a cone. In this way, particularly advantageous flow properties are achieved. In particular, at least one of the flow channels is configured at least in sections in the shape of a funnel.
Particularly preferably, at least one shoulder is arranged in at least one of the flow channels. Such a shoulder offers a straightforward and at the same time effective possibility for reducing noises and impinging flows. In particular, the shoulder provides at least one flow subchannel or is configured as such. The shoulder may comprise at least one elevation and/or depression and/or step or the like, or be configured as such.
The emission device is, for example, arranged in the mask body or in the connection unit.
The emission device is, for example, arranged at an interface between the mask body and the connection unit.
The emission device is, for example, formed integrally as part of the mask body or of the connection unit.
The emission device is, for example, manufactured as a separate component, which is integrated into the mask body or into the connection unit.
The emission device defines a plane E3 and the mask body or the connection unit defines a plane E4.
The planes E3 and E4 are at a distance from one another or coincide.
If the planes E3 and E4 are at a distance from one another and are materially connected to one another by a shoulder, the flow channels are arranged in the shoulder.
The planes E3 and E4 may extend inclined to one another or extend parallel to one another.
In one particularly advantageous configuration, at least one of the flow channels comprises at least one constriction section. In particular, the constriction section extends over at least one distance. In particular, an elongate constriction section is provided. By such a constriction section, the flow properties, and for example flow velocity and pressure, may be influenced particularly advantageously. In particular, the constriction section provides at least one flow subchannel or is configured as such.
In particular, the distance of the constriction section is equal to at least about one eighth of the total length of the flow channel. Preferably, the distance is at least about one sixth or at least about one fifth and particularly preferably at least about one fourth or at least about one third of the total length of the flow channel. It is also possible for the distance to be at least about half of the total length of the flow channel. The distance may also be at least about two thirds or about three fourths or also about nine tenths or more of the total length of the flow channel. The distance may also be configured to be shorter. A point-like constriction section is possible and preferred. The constriction section may comprise one or two or more constrictions. The flow channel may also be equipped with two or three or more constriction sections.
Particularly preferably, at least one of the flow channels comprises at least one inlet region narrowing in the shape of a funnel before the constriction section in the flow direction. It is also particularly preferred for at least one of the flow channels to comprise at least one outlet region widening in the shape of a funnel after the constriction section in the flow direction. Such configurations offer a particularly advantageous adaptation of pressure conditions and flow velocities. Thus, noises may be reduced significantly and undesired impinging flows may be substantially avoided. A funnel-like region is, in particular, intended to mean a successively or varyingly increasing or decreasing channel cross section. The inlet region and/or the outlet region are in particular configured in the shape of a funnel, or as a funnel.
The inlet region is in this case arranged in the inner region of the respiratory mask, facing toward the face of the patient, and the outlet region, arranged opposite the inlet, opens to the ambient air.
At least one flow channel has a length, starting with the inlet region, as far as the outlet region, of about 0.5 to 5 mm, preferably about 0.8-3 mm. The length of the flow channel in this case preferably spans the emission device, or the mask body, starting with the inlet region as far as the outlet region.
At least one flow channel has (in cross section) a diameter or an edge length of about 0.1 to 0.9 mm, preferably about 0.3-7 mm, particularly preferably about 0.4-0.6 mm.
At least one of the flow channels may comprise at least in sections a channel cross section with a quadrilateral cross-sectional profile. In particular, the quadrilateral cross-sectional profile has rounded corners. Preferably, the quadrilateral cross-sectional profile is configured rectangularly. Such a cross-sectional profile is particularly advantageous with a view both to production and to the flow behavior. It is also possible for the quadrilateral cross-sectional profile to be configured squarely. A triangular or polygonal cross-sectional profile may also be provided. A round or oval, and for example elliptical, cross-sectional profile is also possible. The channel cross section may also have a cross-sectional profile with a different geometry. For example, a cross-shaped cross-sectional profile may be provided.
Preferably, at least one of the flow channels extends obliquely in the mask unit. It is also preferred for at least two of the flow channels to extend obliquely with respect to one another. Such a configuration offers particularly many advantages. The oblique arrangement in the mask unit relates, in particular, to a main plane of the mask unit. The profile of a flow channel is, in particular, determined by its longitudinal axis.
In particular, the flow channel extends at an angle of between about 10° and 50°, and preferably between about 20° and 40°, in the mask unit. Larger or smaller angles are also possible. An angle of 0° is also possible. In particular, the flow channels are arranged with respect to one another at an angle of between about 20° and 100°, and preferably between about 40° and 80°. Larger or smaller angles are also possible. An angle of 0°, i.e. a parallel arrangement of at least two flow channels, is also possible. At least two of the flow channels in particular do not extend parallel to one another.
In all configurations, it is possible for at least one flow channel at least in sections to be bent and/or extend in the manner of a curve and/or at an angle. For example, the flow channel may be angled at about 90°+/−10°. Other angles are also possible. It is also possible for at least one of the flow channels to extend in a straight line at least in sections. For example, such a flow channel is cylindrical or cuboid or provided with a different geometry. In particular, the angled section provides at least one flow subchannel or is configured as such.
In one advantageous configuration, the flow channels are inclined at an angle of between about 10° and 50° with respect to a common symmetry axis, so that an emission direction toward an edge region of the mask unit is formed. It is also possible for there to be an emission direction in another direction. This offers particularly advantageous discharge of the exhaled air. In particular, the flow channels are inclined at an angle of between about 10° and 50°, and preferably at an angle of between about 20° and 40°, with respect to the common symmetry axis. Larger or smaller angles are also possible. An arrangement of the flow channels at an angle of 0°, i.e. without inclination, is also possible. The symmetry axis is, in particular, a rotational symmetry axis.
The flow channels are preferably arranged annularly on the mask unit. Preferably, the longitudinal axes of the flow channels intersect at a common point. In particular, the flow channels are in this case arranged in such a way that a screen-shaped distribution of the emission directions is formed, which is preferably directed toward an outer side of the mask unit. This offers many advantages in the discharge of the exhaled air. In particular, a common axis, and for example a symmetry axis with respect to which the flow channels are inclined at an angle, and preferably at the angle described above, extends through the common point. The flow channels may be spaced apart uniformly or nonuniformly from one another in the annular arrangement.
Preferably, the flow channels are arranged annularly around the connection unit in the mask body. Preferably, the flow channels are arranged circularly on the mask unit. In particular, the flow channels are arranged on a circular path. The flow channels may be arranged rotationally symmetrically. The annular arrangement may be configured in the manner of a rectangle or triangle or of an oval. A different arrangement of the flow channels on the mask unit is also possible.
It is preferred for the flow channels to be distributed uniformly over at least one subsection of the annular arrangement. Preferably, the flow channels are omitted, or closed, over at least one other subsection of the annular arrangement. Thus, an undesired flow impinging on facial regions may be influenced in a particularly controlled way. In particular, the other subsection is directed toward the eyes during intended use of the respiratory mask. Other orientations are also possible. In particular, the flow channels have emission directions which are directed away from the eyes.
In one preferred configuration, at least one of the flow channels comprises an outlet opening which is arranged transversely with respect to an inlet opening. In particular, a flow of the exhaled gas is thereby diverted before emerging from the respiratory mask. This configuration also offers many advantages. In particular, the outlet opening is arranged at an angle of between about 60° and 120°, and preferably between about 80° and 100°, with respect to the inlet opening. For example, the outlet opening is arranged at an angle of about 90° with respect to the inlet opening. In this and other configurations, provision may be made for the angles indicated, particularly the angle of about 90°, to deviate by up to 5° or more upward or downward.
In all configurations, it is particularly preferred for the flow subchannels to be produced by at least one casting process. In this way, the above-described flow subchannels, or the flow channels, may be produced particularly economically and at the same time reliably. Particularly preferably, the emission device is produced by at least one casting process. It is also preferred for the mask unit, and in particular the mask body and/or the connection unit, to be produced by at least one casting process. The emission device and the mask unit may be produced in a common casting process. Separate casting processes are also possible. An injection-molding process is preferably provided. In particular, the and/or other parts of the respiratory mask are produced by injection molding. Other casting processes are also possible.
Particularly preferably, the parts produced in the casting process are made of plastic, and preferably of at least one thermoplastic. At least one thermoset and/or at least one elastomer or the like may also be provided. Other plastics or materials are also possible.
In particular, the flow subchannel is produced by casting into at least two mutually complementary casting tools, each having at least one projection protruding at least partially into at least one common flow channel during the casting. The flow subchannel may be produced by casting into at least one casting tool having at least one retractable projection which protrudes at least partially into at least one flow channel during the casting. A flow subchannel produced in such a way may be provided economically and allows particularly advantageous configurations of the emission device. The projections of the mutually complementary casting tools in particular protrude into the same flow channel. In particular, the at least two projections complement one another to form a geometry of the flow channel. The projection may, for example, be configured in the shape of a cone or in the shape of a rod. Other geometries are also possible.
It is possible for the emission device to be provided by at least one cast part. Preferably, the cast part is connected to the mask unit by injection-overmolding and/or by over-casting. In particular, the cast part is connected to the mask body and/or to the connection unit in such a way. The cast part may be connected to the mask unit by another process. For example, the cast part may be welded and/or adhesively bonded to the mask unit. In particular, the cast part is connected integrally to the mask unit. Such stepwise production offers many advantages.
The emission device is, in particular, produced by at least one casting process and connected to the mask unit by at least one further casting process. The mask unit is, in particular, produced in the further casting process. It is, however, also possible and preferred for the mask unit, in particular the mask body and/or the connection unit, to be produced together with the emission device in one casting process.
In all configurations, it is preferred for the flow channels to be arranged in the mask body and/or in the connection unit. This offers particularly advantageous fitting of the flow channels. It is possible for all flow channels to be arranged in the mask body or in the connection unit. It is also possible for some of the flow channels to be arranged in the mask body and others to be arranged in the connection unit. In particular, a flow channel is in each case arranged either fully in the mask body or fully in the connection unit. In particular, a flow channel is in each case delimited either by the mask body or by the connection unit.
According to the invention, the flow channels are arranged in the emission device. The emission device may be a part (region) of the mask body and to this extent be integral (with the mask body). The emission device may be a separate component, which is connected to the mask body with a form, material or force fit.
As an alternative or in addition, the emission device may also be a part (region) of the connection unit and to this extent be integral (with the connection unit). The emission device may be a separate component, which is connected to the connection unit with a form, material or force fit.
It is, however, also possible for at least one of the flow channels to be arranged partially in the mask body and partially in the connection unit. Then, the flow channel is in particular bounded by the mask body and the connection unit.
The emission device may be manufactured as a separate part and then injection-molded onto the mask body (two-component process).
The emission device may be manufactured as a separate part which is then pressed into a corresponding undercut in the mask body. This has the advantage that the fine precision part is manufactured separately in an optimized process.
The aim of all embodiments is to achieve a flow direction which is directed in the form of a screen outward, for example at an angle of about 10°-50° away from the face. The outlet opening of all embodiments is therefore directed at an angle outward. The flow is directed forward away from the face. The exit angle is therefore, for example, to be oriented excessively radially. It is also conceivable to give the flow channels different emission directions and thus to spread the flow even further. In this way, the flow energy is distributed over a larger region, which leads to less sound emission.
The process according to the invention is used for producing a respiratory mask, in particular for a respirator apparatus, and preferably for a sleep therapy apparatus. The respiratory mask produced comprises at least one mask unit and at least one emission device for discharging exhaled gas from the respiratory mask. The mask unit comprises at least one mask body and at least one connection unit which can be connected to the mask body for connection of a respiratory gas feed line. The emission device is equipped with a multiplicity of flow channels. The flow channels are arranged in at least one part of the mask unit, and preferably in the mask body and/or in the connection unit. In this case, the emission device is produced by means of at least one casting process, in particular by means of injection molding, while being equipped with at least one flow subchannel.
The process according to the invention offers many advantages. For example, particularly economical production of the respiratory mask is possible, so that it can be provided to a large range of patients or users.
Preferably, the process is used for producing the respiratory mask according to the invention. In particular, the respiratory mask described above is produced by the process according to the invention. Particularly preferably, the flow channels are produced at least partially by means of the casting process while being equipped with at least one flow subchannel.
Preferably, the emission device is cast into at least two mutually complementary casting tools. Preferably, in this case at least one projection protrudes in each case from the casting tools at least partially into at least one common flow channel during the casting. It is also possible for the emission device to be cast into at least one casting tool. Preferably, in this case at least one projection protrudes at least partially into at least one flow channel during the casting. The projection is subsequently retracted and thereby removed at least partially from the flow channel.
The respiratory mask is in particular suitable and configured to be used for a sleep therapy apparatus. The respirator apparatus is, in particular, a sleep therapy apparatus. The connection unit is preferably equipped with a tube flange. In particular, the respiratory mask is intended for a single-tube system. The tube is in this case used for the supply with respiratory gas. In particular, no tube is provided for discharging the exhaled gas. In particular, the emission device is suitable and configured to discharge the exhaled gas directly from the respiratory mask into the surroundings. During intended use of the respiratory mask, the flow channels are, in particular, arranged in a region over the mouth and/or over the nose.
Preferably, the connection unit is releasably coupled to the mask body and, in particular, connected by means of at least one latching connection. In particular, the connection unit can be inserted into a connection opening of the mask body. The connection unit may be configured to be angled or straight. The connection unit may comprise at least one angle piece or be configured as such. The mask unit may comprise at least one forehead support and/or at least one mask plate. The forehead support is, in particular, fastened on the mask body or firmly connected thereto. The mask plate is, in particular, releasably connectable to the mask body.
In particular, at least one flow subchannel is suitable and configured to make it possible to take the emission device and/or at least a part of the mask unit from a casting mold with a form fit.
The above-described configurations of the at least one flow channel, or of the at least two flow channels, are preferably provided for all flow channels or for a majority of the flow channels.
Further advantages and features of the present invention may be found in the description of the exemplary embodiments, which will be explained below with reference to the appended figures.
In the figures:
The particulars shown herein are by way of example and for purposes of illustrative discussion of the embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the present invention. In this regard, no attempt is made to show details of the present invention in more detail than is necessary for the fundamental understanding of the present invention, the description in combination with the drawings making apparent to those of skill in the art how the several forms of the present invention may be embodied in practice.
The connection unit 5 is in this case inserted into a corresponding connection opening of the mask body 4 and, for example, latched. The connection unit 5 is in this case provided with an angle piece 15 and is used for the connection of a respiratory gas feed line 101, and for example of a respiratory tube, to the mask 1. The respiratory tube is in this case connected to the respirator apparatus 100.
In order to be able to discharge the exhaled air from the mask 1 an emission device 3 having a multiplicity of flow channels is provided. The exhaled air is released into the surroundings through the flow channels 6. The emission device 3 is in this case part of the mask body 4. To this end, the flow channels 6 flow through the mask body 4. In addition or as an alternative, the flow channels 6 may also be provided in the connection unit 5.
The flow channels 6 in this case have a rectangular cross-sectional profile with rounded corners, and are arranged annularly around the connection unit 5 on the mask body 4. In this case, the flow channels 6 are distributed uniformly. In one configuration (not shown here) a subsection of the annular arrangement may be configured with closed flow channels 6 or even without flow channels 6. Such a subsection is, for example, directed toward the eyes or is arranged below the forehead support 11.
The emission device 3 is produced in a casting process and, for example, by injection molding. During production, the emission device 3 is provided with a flow subchannel 7 (not visible in the representation shown here). In order to be able to remove the emission device 3 from a casting mold in spite of the flow subchannel 7, or in order to avoid form-fit blocking of the removal, the process according to the invention described in more detail with reference to
The flow channels are provided here with a constant, or steady, channel cross section. The flow channels 6 in this case extend obliquely in the mask body 4 and also obliquely with respect to one another. For example, the flow channels 6 are in this case inclined at an angle of between about 20° and 40° with respect to a common symmetry axis. The longitudinal axes of the flow channels 6 in this case intersect at a common point. The exhaled air is thus discharged toward an edge region of the respiratory mask 1.
The flow channels 6 are in this case provided in sections with a varying channel cross section. In the region of the varying channel cross section, the flow channels 6 are for example configured conically or in the shape of a cone.
A constriction section 16 is in this case respectively arranged in the flow channels 6. As can be seen particularly well in the enlarged detail representation, the constriction section 16 is in this case configured elongatedly. The flow channel 6 shown in this case extends between an inlet opening 260 and an outlet opening 360. Here, the inlet opening 260 is followed by an inlet region 26 which narrows in the shape of a funnel and extends as far as the constriction section 16. The constriction section 16 extends from there elongatedly as far as the outlet opening 360.
In a configuration shown by dashes here, the flow channel 6 may be equipped with an outlet region 36 which widens in the shape of a funnel and extends in the flow direction after the constriction section 16. In such a configuration, the exhaled air enters the inlet region 26 narrowing in the shape of a funnel and flows on from there through the distance of the constriction section 16 as far as the outlet region 36 widening in the shape of a funnel. There, the air enters the atmosphere through the outlet opening 360.
Arranged in the flow channel 6, there is in this case a shoulder which forms a constriction section 16 or is part of such. The inlet region 26 in this case narrows increasingly as far as the constriction section 16. After the constriction section 16, the flow channel 6 widens again.
Advantageous configurations of the emission device 3 of the respiratory mask 1 shown in
During the casting, a projection 19 of one casting tool 9 in each case extends respectively with a projection 19 of the other casting tool 9 into a common flow channel 6. By the casting tools 9 and projections 19 shown here, mold releases are manufactured in the region of the flow channels 6, with a profile which offers particularly favorable flow properties.
By the mold releases, removal of the emission device 3 is not blocked with a form fit despite the flow subchannel 7.
In this case, the emission device 3 may be manufactured in one casting process together with the mask unit 2 and, for example, with the mask body 4 or the connection unit 5. It is, however, also possible for the emission device 3 to be manufactured as an initially separate cast part 13 in its own casting process. Subsequently, the cast part 13 is placed in a further casting tool 9, where it is injection-overmolded. By the injection over-molding, the cast part 13 is connected to the mask unit 2 and, for example, to the mask body 4 or the connection unit 5.
In one configuration, one or more casting tools 9 may also be equipped with retractable projections 19. In this case, the projections 19 protrude into one or more flow channels 6 during the casting. After the casting, the projections 19 may then be retracted so that removal of the emission device 3 is not blocked with a form fit despite the flow subchannel 7.
The emission device 3 may be configured as part of the mask body 4 or of the connection unit 5, or manufactured as a separate component which, however, is integrated into the mask body/the connection unit. The emission device 3 forms a plane E3, and the mask body/the connection unit forms a plane E4. The planes E3 and E4 are, for example, perpendicular to one another. The planes E3 and E4 may be at a distance from one another or may coincide. The planes E3 and E4 may extend inclined to one another or parallel to one another. If the planes E3 and E4 are at a distance from one another, they are materially connected to one another by a shoulder or a connecting piece 28. The flow channels 6 may be arranged in the shoulder. The shoulder may have any desired inclinations and, for example, connect the planes E3 and E4 with a curvature or a straight line. The flow direction is also determined by the inclination of the shoulder.
The emission device 3 of
In an operating state, the respiratory mask 1 is placed with the mask plate 21 in a leak-tight fashion on the face of a patient 200 while essentially maintaining a positive pressure inside the respiratory mask on the side facing toward the patient, the emission device 3 discharging exhaled gas at a positive pressure by means of the flow channels 6 from inside 210 the respiratory mask 1 to the ambient air 310.
With the arrangement of the emission device, the respiratory mask 1 defines a plane E perpendicular to the axis y of the connection device, the axis y of the connection device for example pointing perpendicularly away from the face of the patient in a working state on the patient. Here, perpendicularly means in an angle range of 70-120° relative to a plane which spans the face. With their flow direction, the flow channels 6 respectively define a plane z, for example by the region of their smallest cross section, the planes E and z being arranged at an angle a of between about 20 and 100°, preferably between about 45 and 90°, with respect to one another.
The emission device 3 may be formed integrally as a part of the mask body 4 or of the connection unit. The emission device 3 may also be manufactured as a separate component 3 which, however, is integrated into the mask body or the connection unit. The emission device 3 would then be replaceable. Emission devices 3 having different characteristic curves could thus be used for a mask.
The emission device 3 forms a plane E3, and the mask body or the connection unit forms a plane E4. The planes E3 and E4 may be at a distance from one another (
Next to the flow channels 6 or the flow subchannel 7a, the surface of the mask body 4 comprises a flow guide surface 4, which is for example inclined in such a way that the respiratory gases flowing out are diverted optimally from the patient. In
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