Face mask for covering the nose and mouth of a user
The face mask with a polypropylene rigid component and thermoplastic elastomer elastic component achieves a reliable seal with minimal force, addressing sealing and comfort issues in conventional masks.
Patent Information
- Application Number
- DE202025101167
- Authority / Receiving Office
- DE · DE
- Patent Type
- Utility models
- Current Assignee / Owner
- Filing Date
- 2025-03-05
- Publication Date
- 2025-06-26
- Estimated Expiration
- 2035-03-31
AI Technical Summary
Conventional face masks, both single-piece silicone and two-component masks, suffer from issues such as poor sealing, discomfort, and high contact forces, leading to ineffective treatment outcomes and potential safety hazards due to leakage.
A face mask designed with a rigid component made of polypropylene and an elastic component made of thermoplastic elastomer, featuring a 3D contour with a C-shaped elastic seal and a circumferential connection, allowing for a reliable seal with minimal contact force.
The mask provides a comfortable and effective seal with low contact forces, reducing leakage and enhancing treatment success while maintaining safety by distributing force evenly across the face.
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Abstract
Description
Technical FieldThe present disclosure relates to a face mask for covering a user's nose and mouth, optionally formed by two-component injection molding from different materials.Prior ArtConventional types of face masks used in the medical field include inhalation masks and respiratory masks. Respirator masks are typically placed on the user to assist in breathing the user. This is accomplished by forcing air into the user's airways. To this end, the respirator mask is placed on the user's face to form a cavity on the user's face, the cavity covering, for example, the user's mouth and nose so that air can flow into the user's airways. This is generally achieved by an overpressure which is built up at least in the cavity. Accordingly, such respirator masks have only one opening in the direction of the user's face and a connection for connecting a respirator to the mask in order to form a closed cavity when the mask is placed on the user's face.Inhalation masks are commonly used to connect inhalation systems such as chambers, spacers, metered dose aerosol inhalers (MDIs) or inhalers such as jet or mesh inhalers to the faces of the users. Inhalation masks thereby enable, inter alia, an aerosol treatment, for example of the airways of the user with a medicament. Inhalation masks should provide a connection from an inhalation system to the airways of the user through which an aerosol can flow.Leaks between such inhalation masks and the user's face should be minimized and / or avoided because the aerosol, possibly containing a medicament and / or an active ingredient, could damage the user's eyes. The same is true for respirators because leakage would impair the ability to assist the user's breathing from the outside.To counteract such leakage, the user-facing interface of conventional masks is often formed of a flexible material that is lipped. Such an easily deformable structure with a soft material aims to achieve a flexible adaptation of the face mask to the face geometry and thus a high tightness during the application of the mask.However, conventional masks are only inefficiently usable. They often need to be pressed too firmly on the face of the user or are pressed too weakly on the face of the user in order to avoid damage to the face of the user, thus leading to inadequate sealing.Examples from the prior art have masks which are manufactured in one piece from silicone. These masks typically have a curved sealing surface in a plane when the mask is viewed in a side view. This shape and silicone material ensure that the mask is comfortable to wear. However, the main disadvantage of these silicone masks, besides their expensive manufacture, is their low inherent dimensional stability, so that these masks do not correctly and reliably seal with the face of the user during use. At the same time, the use of silicone makes it particularly difficult, making its use during inhalation therapy burdensome and inconvenient. This has a negative effect on the success of the treatment.To solve these problems, masks made of PVC have been developed. This type of mask has good inherent dimensional stability but low elasticity. Consequently, they are not very comfortable to wear and do not seal properly against the face at acceptable application pressures.Accordingly, masks of two components, in particular masks having two components of two different materials, which are tailored to the functions of the respective components, have come on the market. Such masks include a rigid base component and an elastic sealing component which interfaces with the face of the user.Conventional two-component face masks have good inherent dimensional stability, but are not elastic enough to correctly seal and / or seal off only at high pressing forces in the case of acceptable pressing forces. As a rule, such pressing forces must be above about 15 N in conventional masks when they are measured in the normal direction to the face of the user.Due to the flexibility and material properties of such conventional two-component face masks, very high pressing forces can also compress the lip so strongly that the rigid base of the two-component face mask comes into direct contact with the face of the user. In particular for infants and children who are exemplary users of such two-component face masks, such high pressing forces are unacceptable and lead to leaky masks and thus to poorer treatment success. Moreover, high pressing forces can lead to a deformation of such conventional masks, which makes a reliable sealing on the face of the user impossible.However, the tightness of the face mask during its application to the user is important for the efficiency of the treatment, as otherwise it is impossible for the aerosol to reach the user's airways, for example. At the same time, the tightness of the mask during the treatment also plays an important role for the safety of the user, since otherwise the aerosol (mentioned here by way of example) can escape in an undefined manner and lead to irritation of the eyes of the user.SUMMARY OF THE INVENTIONIn view of the foregoing, it is an object of the present disclosure to provide a face mask for covering a user's nose and mouth, which enables adhesion and comfort during treatment to be increased with a design that is easy to clean and / or sanitize while being inexpensive to manufacture.This object is achieved by a face mask according to independent claim 1. Various embodiments can be derived from the dependent claims.According to a first aspect of the present disclosure, a face mask for covering the nose and mouth of the user is provided. The term "face mask" can be abbreviated as "mask" in the following explanations. Optionally, the face mask (or mask) is formed from different materials by two-component injection molding.The face mask essentially comprises two components: a rigid component and an elastic component.The rigid component is formed from a first material and the elastic component is formed from a second material. Optionally, the elastic component is formed of a different material than the first material forming the rigid component. The rigid component and the elastic component can thus optionally be formed from different materials by two-component injection molding.The term "rigid component" is to be understood as meaning that this part of the face mask has a sufficiently high stability in order to not deform elastically or plastically in the case of a customary application of the face mask, for example in the case of a treatment of the user. Therefore, the rigid component can also be understood as a rigid, non-bendable base portion / component of the present face mask.The rigid component has a connection via which the face mask can be fluidically connected to an external system. Examples of such an external system may be an inhalation system and / or a system for breathing. The connection of the rigid component has a central axis.The central axis of the connection is to be understood as the axis which extends along the direction of inhalation / exhalation through the mask when this is used during therapy.As the name implies, the elastic component of the face mask is configured to be elastically deformable to cover the nose and mouth thereof during application of the face mask to the user's face. That is, the mask is configured to return to its original shape once the mask is no longer placed on the user's face. Therefore, the elastic component is subjected to purely elastic deformation to interface with the user's face and seal this interface between the mask and the user's face during therapy / application of the mask to the user's face. Thus, uncontrolled leakage, e.g. of aerosol during therapy, can be avoided by this configuration of the elastic component.For this purpose, the elastic component is formed circumferentially on the rigid component. The resilient component is configured to form a circumferential seal that covers the user's nose and mouth when placed on the user's face. This can also be understood to be pressed onto the user's face with a certain force.This force may be applied parallel to the central axis of the terminal.In order to form the circumferential seal covering the nose and mouth of the user when pressed onto the face of the user, the elastic component further has a convex end portion. The convex end portion has a free edge which faces radially inward. Preferably, the free edge points radially inward into the interior of the mask.This configuration can also be understood as an inwardly pointing edge of a flange which forms the seal. In other words, the convex end portion has the shape of a C halved along its axis of symmetry.Consequently, the seal not only lies in a straight line, but flat on the face, which means that the force is distributed over a large area instead of over a line. The large bearing surface and the flexible adaptation of the contact surface to the shape of the user's face create a reliable seal with low forces. At the same time, the introduction of force at the interface to the face of the user can be improved.Further, the seal has a non-linear contour when viewed in a cross-section defined by the central axis of the port and the craniocaudal axis of the user when the mask is placed on the face of the user.The craniocaudal axis may also be understood as the longitudinal axis through the human body extending between the feet and the head. In other words, the vertical axis when the user is standing upright.The contour is to be understood as the (outermost) contour of the mask on the side of the mask facing the face of the user when viewed in the above-mentioned cross section.Accordingly, the non-linear contour implies that when the mask is placed on the user's face, there are different distances from the rigid component to the seal.In contrast to conventional designs that have in-plane face contact, the face mask according to the present disclosure provides a 3D contour that is ideally matched to a user's face.The resulting 3D contour of the seal allows for smooth deformation of the elastic component and thus provides for nearly constant facial contact. Consequently, only a low contact pressure is required for tight sealing with the face.That is, the mask has a three-dimensional seal with a (semi-)C-shaped contour of the elastic component that fits well to the face.The given combination of a rigid component and an elastic component combines high inherent stiffness and a very elastic sealing portion in a device, resulting in a dense mask under low forces.Preferably, the convex end portion may form an undercut facing the interior of the mask.Therefore, when the face mask is placed on the face of the user, the free edge of the convex end portion may face the inside of the mask, and when the mask is pressed on the face of the user, the convex end portion of the elastic component bends toward the inside of the mask.As a result, the undercut can be designed to be particularly large, which leads to a softer spring characteristic and makes the present face mask comfortable to wear. At the same time, it is possible to obtain a reliable sealing of the mask during the treatment under low forces. This increases the adhesion during the treatment and thus the success of the treatment.Preferably, an inner surface of the convex end portion may have a higher surface roughness than the remaining part of the elastic component.The convex end section is to be understood as the section of the elastic component which forms the undercut. In other words, the portion of the elastic component that faces the user's face and in which the radial extension of the mask decreases.Preferably, the increased roughness is above VDI 3400 Ref. 24. for example, the average surface roughness Ra is above 1.6 μm (micrometers). This increased roughness is applied to the inside to facilitate the forced deformation of the elastic component.Preferably, the rigid component may comprise a circumferential connecting portion. The circumferential connecting portion may face the elastic component to connect the elastic component to the rigid component. Here, the circumferential connecting portion has a linear contour when viewed in the above-mentioned cross section defined by the central axis of the terminal and the craniocaudal axis of the user when the mask is placed on the face of the user.Preferably, in a plan view from the rigid component to the elastic component, the rigid component can have approximately the size of the projected contact curve on the face in order to achieve an optimum introduction of force.This ensures that the tilting moment on the seal is as low as possible and it lies flat on the surface, whereby the sealing effect is improved and the surface pressure is reduced.In other words, if the rigid component of the face mask alone, i.e. without the elastic component, were to be viewed in the above-mentioned cross section, its circumferential connecting portion would be linear. In other words, if the rigid component were to rest on a planar surface, its circumferential connecting portion would contact the surface circumferentially along its entire circumference.It is preferable that the circumferential connecting portion may have an L-shape in a cross section defined by the central axis of the terminal and the craniocaudal axis of the user when the mask is placed on the face of the user to connect the elastic component to the rigid component with partial overlap.The L-shape can have either a right angle of 90° or an acute angle of less than 90°.The adhesion surface that is dissolved by the L-shape is decisive for the bonding of the materials. The L-shape thereby enables the overlap of the two materials / components to be kept as small as possible for good autoclavability. Otherwise, thermal expansion of the two materials could lead to production problems.Moreover, the L-shaped connection prevents the introduction of forces which would cause shear stresses. This means that during demolding from the mold during the injection molding process, higher forces can be tolerated and a greater undercut can be achieved with the C-shaped end section of the elastic component.At the same time, a planar outer surface can be produced.Preferably, the shorter leg of the L-shape is oriented towards the interior of the mask.No step-like outer shape is produced which would have a negative influence on the overall shape of the mask.Preferably, the terminal is arranged to face the mouth of the user when the mask is placed on the face of the user, and / or in the plan view from the rigid component to the elastic component, the terminal is arranged such that the central axis of the terminal and the center of the circumferential connection portion are aligned with each other or have an offset from each other of 12 mm or less.A connection which is opposite the mouth of the user when applying the mask makes it possible to avoid negative influences of an aerosol flow in the direction of the airways of the user.At the same time, the slight offset makes it possible to achieve the lowest possible bending load of the punch in the tool during injection molding production. In this way, the high forces acting during the forced deformation can be uniformly transmitted to the mask and a slight deformation of the elastic component can be achieved. The geometry of the elastic component is thus reliably maintained.In this context, the center of the encircling connecting section is to be understood as the center of the encircling connecting section in the abovementioned plan view. In other words, the center of the circumferential connecting portion in the two-dimensional plan view of the connection of the mask, which is remote from the elastic component.Preferably, the connection has an oval shape when viewed in plan view from the rigid component to the elastic component.This makes the correct connection of the face mask to an external system, such as an inhalation system and / or a ventilation system, particularly simple.Alternatively, the terminal may have a circular shape when viewed from the rigid component toward the elastic component in plan view.Preferably, the second material is a thermoplastic elastomer. Thermoplastic elastomer is often abbreviated as TPE.TPE enables thinner wall thicknesses compared to silicone. This reduces the deformation force and thus achieves a seal with lower forces.The first material is preferably polypropylene (PP).Preferably, the rigid component is made of polypropylene (PP).This allows the mask to be autoclaved and provides good adhesion between PP and TPE, i.e. between the rigid component and the elastic component. The adhesion depends on the chosen material pairing and the overlapping surface.Preferably, the surfaces of the mask may have hydrophilic properties.Optionally, these surfaces may have a surface energy between 40 mN / m and 70 mN / m.The surface energy can also be understood as free surface energy (SFE). It relates to breaking intermolecular bonds when a new surface is created. It thus defines the work required to increase the surface area of a solid material. The typical unit for surface energy is therefore mN / m (millinewtons per meter).The range indicated covers polymer masks which comprise additives.This provides two functions. First, it reduces friction and thus improves haptics. Second, it forms a barrier layer against the nucleating agent. Without this surface treatment, the nucleating agent would diffuse out of the material during autoclaving and leave a haze on the mask.More precisely, a barrier layer, preferably a permeation layer, can thereby be built up. Permeation, diffusion, migration, friction, adhesion, and tackiness can be reduced. Adhesion, film formation, adhesiveness, and wettability can be enhanced. Better removal of liquids, more rapid drying, higher print quality, better cleanliness, since dirt particles do not adhere, and less mold formation, better assembly or a more visually appealing surface can be achieved.Preferably, the surface of the rigid component facing away from the elastic component may have protrusions or recesses.Preferably, the face mask may have a substantially oval shape in plan view from the rigid component toward the elastic component.Further, the rigid component may include a transparent portion having a larger dimension in the area covering the mouth of the user when the mask is placed on the face of the user in a plan view from the rigid component toward the elastic component than in the area covering the nose of the user when the mask is placed on the face of the user.Preferably, the transparent portion may be substantially in the form of an isosceles triangle having a shorter base than its two equal-length leg portions, the apex facing a portion of the mask that covers the nose of the user when the mask is placed on the face of the user.The transparent section can also be understood in this context as a light-transmissive region.The transparent portion, which is substantially in the form of a pear, makes it easier to ensure correct alignment of the mask during therapy. Moreover, the transparent portion allows, for example, the parent to control the respiration (pattern) of a child to be treated during inhalation therapy and to observe the correct positioning and application of the mask on the face.Preferably, the elastic component can be configured to form a circumferential seal with the user's face when the mask is placed on the user's face with a force of 2 to 16 N, preferably about 4 N (Newton). In the context of the present application, the term "about" covers deviations in a range of ± 1 Newton.This improves the wearing comfort and thus increases the adhesion, in particular when the face mask is applied to children or infants who can feel higher forces, i.e. forces above 16 N, acting on their face, as particularly disturbing and unpleasant.The term "circumferential seal" is understood to mean that the face mask makes it possible to provide a (circumferential) surrounding seal circle which makes it possible to attach the face mask to the user's face with a surface contact instead of a point or section line contact.Preferably, the non-linear contour is sized and shaped to substantially conform to a projected face shape.This makes it possible to obtain a uniform introduction of force onto the user's face when the mask is placed on the latter and accordingly has a positive effect on the adhesion, since a drastically lower amount of forces, in particular forces of less than 16 N, preferably about 4 N, are required in order to obtain a secure and reliable seal.Preferably, the elastic component may have a recess for the nose bridge of the user. More preferably, the resilient component may include a recess adapted to conform to the contour of the nose bridge of the user.This allows the nose bridge of the user to be at least partially surrounded by the elastic component. This prevents an accidental expulsion of aerosol in the nose area and thus increases the safety of the mask.Brief Description of the DrawingsHereinafter, non-limiting examples of the present disclosure will be explained with reference to the drawings: FIG. 1 shows an isometric view of a face mask for covering a user's nose and mouth, according to an embodiment of the present disclosure, as viewed from the side of their rigid component. FIG. 2A shows a side view of the face mask of FIG. 1, illustrating, among other things, the non-linear contour of the seal. FIG. 2B shows a side cross-sectional view of the face mask according to FIG. 1, showing, among other things, the convex end portion and its free edge facing radially inward. The cross-section shown corresponds to a plane defined by the central axis of the port and the craniocaudal axis of the user when the mask is placed on the face of the user. FIG. 3 shows another isometric view of the face mask of FIG. 1 as viewed from one side of its resilient component, showing, among other things, the interior of the face mask, the seal, and the convex end portion and its free edge facing radially inward toward the interior of the mask. FIG. 4 is a cross-sectional view of the face mask of FIG. 1, wherein the cross-sectional view of FIG. 4 focuses on the resulting overlap between the circumferential connection portion of the rigid component and the elastic component of the face mask. FIG. 5 shows a face mask for covering a user's nose and mouth according to another embodiment of the present disclosure as viewed from a side of its rigid component, the face mask of FIG. 5 having a transparent portion in its rigid component.DETAILED DESCRIPTION OF PREFERRED EMBODIMENTSPresently preferred embodiments of the present disclosure will now be described with reference to the accompanying drawings.The exemplary embodiments of Figs. 1-4 and 5 relate to various embodiments of a face mask 1 for covering a user's nose and mouth. The exemplary embodiments relate here to masks which are designed as inhalation masks which can have ventilation openings 13, as described with reference to the embodiment illustrated in FIG. 5. As shown in FIGS. 1 to 4, such ventilation openings 13 are not absolutely necessary for such inhalation masks. All embodiments of the face mask 1 are designed such that they can be fluidically connected to an inhalation system. However, it is also possible to connect such masks fluidically to a ventilation system.The illustrated preferred embodiments of the face mask 1 are formed by two-component injection molding into an integrally molded mask 1 of two components of different materials.The first component may be understood as a rigid component 2 formed from a first material, here polypropylene (PP).The second component, which together with the rigid component 2 substantially forms the face mask 1, is an elastic component 3, which is formed, for example, from thermoplastic elastomer (TPE).In a process for producing such a face mask 1 by two-component injection molding, the rigid component 2 can first be molded from polypropylene (PP) and, in a further step, the elastic component 3 can be molded circumferentially onto the rigid component 2. This can preferably be done using a single tool of an injection molding device. As soon as the two components are united in the injection molding device, the mask can be removed from the mold.The resulting product, i.e. the resulting face mask, is shown inter alia in FIG. 1.FIG. 1 is an isometric view of the face mask for covering the nose and mouth of the user according to a first embodiment of the present disclosure as viewed from a side of its rigid component 2. FIG. 2A is a side view of the face mask, and FIG. 2B is a cross-sectional view of the face mask of FIG. 1. the cross-section shown in FIG. 2B corresponds to a plane defined by the central axis C of the terminal 4 and the user's craniocaudal axis CC when the mask 1 is placed on the user's face.As for the above-mentioned connection of the rigid component 2 and the elastic component 3 of the face mask 1 by circumferentially molding the elastic component 3 to the rigid component, it can be seen from FIGS. 2A and 2B that the rigid component 2 has a circumferentially connecting portion 8 facing the elastic component 3.This encircling connecting section 8 of the rigid component 2 has a linear contour in the lateral cross-sectional view of FIG. 2B. In other words, in the cross-sectional view of FIG. 2B, the circumferential connection portion 8 that functions as the end surface of the rigid component 2 facing the elastic component has a contour in the form of a straight line that extends vertically along the mask.FIG. 2A further illustrates that the elastic component 3 is formed circumferentially on the planar, circumferential connecting portion 8. With this planar shape facing the elastic component 3, it is particularly simple and cost-effective to form the elastic component 3 onto the rigid component 2.In order to ensure a reliable connection between the elastic component 3 and the rigid component 2 during the manufacturing process, the demolding and the use of the mask 1, the circumferential connecting portion 8 has an L-shape for connecting the rigid component 2 and the elastic component 3 with a partial overlap 11.This is illustrated in more detail in FIG. 4, which illustrates a cross-sectional view of the face mask according to FIG. 1 (and FIGS. 2A, 2B and 3 ), wherein the cross-sectional view of FIG. 4 focuses on the resulting overlap 11 between the circumferential connecting portion 8 of the rigid component 2 and the elastic component 3 of the face mask 1.FIG. 4 shows that the circumferential connecting portion 8 of the rigid component 2 has an L-shape to connect the rigid component 2 and the elastic component 3 with a partial overlap 11. The overlap 11 is formed in that the elastic component is formed into the L-shape of the circumferential connecting section 8 during the injection molding / production of the face mask 1. This results in the overlap 11 along the axis extending from the rigid component to the resilient component (and vice versa). In other words, the overlap 11 is formed substantially parallel to the central axis of the terminal 4, which will be described in more detail below.The L-shape of the encircling connecting section 8 is formed by a long leg 9 and a short leg 10. In order to provide a uniform outer surface of the face mask 1, the short leg 10 extends into the interior of the mask 1, while the long leg 9 of the circumferential connecting portion 8 extends in the direction of the elastic component 3.As shown in the enlarged sectional view of FIG. 4, the angle between the long leg 9 and the short leg 10 of the L-shape is an acute angle of less than 90°. However, it is also possible to use angles of 90°. Further, FIG. 4 illustrates that the material thickness of the elastic component 3 is substantially identical to the extension of the short leg 10 facing toward the inside of the face mask 1.Referring to FIGS. 1, 2A, and 2B, it can be seen that the rigid component 2 includes a terminal 4. This connection 4 is designed to fluidically connect the mask 1 to an external system, here to the aforementioned inhalation system. The terminal 4 has a central axis C which extends substantially through the terminal.Viewed in a plan view from the rigid component 2 towards the elastic component 3, the terminal 4 according to the embodiment of Figures 1 to 4 has an oval shape.In the embodiments shown, the connection 4 is arranged in such a way that it is opposite the mouth of the user when the mask 1 is placed on the face of the user in order to avoid aerosol vortices during therapy.In the plan view, not shown, from the rigid component 2 to the elastic component 3, the center CP of the circumferential connecting portion 8 is flush with the center axis C of the terminal 4 in the plan view or has an offset OS thereto of 12 mm or less. This latter embodiment is transferred to the side view of Fig. 2A, which shows an offset OS of 5 mm.FIGS. 1 and 2A further show that the surface of the rigid component 2 facing away from the elastic component 3 has recesses 12. In a further embodiment, not shown, it is also possible to replace the recesses 12 by projections.Referring now to FIGS. 2A, 2B and 3, the shape and configuration of the elastic component 3 will be described in more detail. FIG. 2A shows the side view of the face mask 1 with focus on the non-linear contour CO of the seal SA, while FIG. 2B shows a cross-sectional view of the face mask 1 with focus on the convex end section 5 of the elastic component and its free edge 6, which points radially inward. FIG. 3 shows a further isometric view of the face mask 1 as seen from the side of its elastic component 3 in order to show a view of the interior of the mask.The elastic component 3 is configured to form a circumferential seal SA covering the nose and mouth of the user when pressed on the face of the user. That is, as shown in FIG. 3, a sealing surface SA may be formed on the user's face instead of a line contact or a point contact, the sealing surface SA extending over the entire circumference of the seal.This is achieved in that the elastic component 3 has a convex end portion 5 with a free edge 6 facing radially inward inside the mask 1, as shown in Fig. 2B, and the seal has a non-linear contour CO when the mask is viewed from the side, as shown in Figs. 2A and 3 among others.It can be seen from said FIG. 2A that the non-linear contour CO is shaped such that it forms at least one obtuse angle along the contour CO, i.e. an angle between 90° and 180° (with the exception of the end points of said range). In other words, the linear contour CO is shaped to have at least one obtuse angle that is between a right angle of 90° and a straight angle of 180°. This angle contributes to the formation of the nonlinear contour CO, which makes it possible to improve the tightness of the mask under particularly low forces, such as 4N.Focusing on FIG. 2B, it can be seen that the convex end section 5 of the elastic component 3 forms an undercut 7 pointing towards the interior of the mask 1, so that the elastically deformable convex end section 5 and in particular its free edge 6 bend towards the interior of the mask 1 when the face mask 1 is placed / pressed onto the face of the user. Thus, as shown in FIG. 3, the sealing surface SA is formed on the outer surface of the elastic component 3 instead of being formed at least partially directly on the free edge 6.This sealing surface SA formed by the elastically deformable convex end portion 5 and its free edge 6 (see FIG. 3 ), together with the non-linear interface contour facing the user's face and discussed with reference to FIGS. 2A and 2B, allows the force with which the face mask 1 is pressed onto the user's face to be applied evenly and be distributed well onto the user's face. Thus, a reliable seal can be established around the mouth and the nose of the user with particularly low forces. Low forces stand for forces below 15 N, wherein the illustrated embodiments and their described configuration even make possible a seal at about 4 N. The respective forces are applied here substantially parallel to the central axis C of the connection 4.In order to obtain a particularly tight seal with uniform introduction of force through the non-linear contour CO, it can be seen in Fig. 3 that the elastic component 3 has a recess 15 adapted to align with a contour of the nose bridge of the user and at the same time the non-linear contour CO is dimensioned and shaped so as to substantially conform to a projected face shape.Thus, substantially equal forces are uniformly applied to the user's face throughout the entire circumference of the sealing surface SA formed by the elastic component 3 when pressed to the user's face.In order to improve the deformability of the face mask 1, an inner surface of the convex end portion 5, as can be seen in the cross section according to FIG. 2B, has a higher surface roughness than the rest of the elastic component 3.In order to positively influence the properties of the face mask 1, all surfaces of the mask 1 may have hydrophilic properties with a surface energy between 40 and 72 mN per meter.FIG. 5 shows a face mask for covering the user's nose and mouth according to another second embodiment of the present disclosure, as viewed from a side of the rigid component thereof.Except for the embodiment of the rigid component 2 which will be described in more detail below, all elements and features of the embodiment according to FIG. 5 are identical to the first embodiment which has been described above with reference to FIGS. 1 to 4. It is therefore omitted to describe it once again in order to avoid repetitions.It can be seen from FIG. 5 that the face mask 1 mentioned is a mask 1, in particular for inhalation treatment, since the mask 1 has two ventilation openings 13 which enable fluid communication with the outer side of the mask 1.FIG. 5 further shows that the mask 1 has a substantially oval overall shape. Moreover, and in particular seen in a plan view from the rigid component 2 onto the elastic component 3, the rigid component 2 comprises a transparent portion 14.As shown in Fig. 5, the transparent portion 14 has a greater extent in the area covering the mouth of the user when the mask 1 is placed on the face of the user than in the area covering the nose of the user in such a scenario.That is, the transparent portion 14 has a kind of pear shape, which can also be understood as a triangular shape. This transparently shaped portion allows on the one hand a correct positioning of the face mask 1 on the user's face, even if it has a symmetrical overall mask shape, and on the other hand an observation of the breathing (pattern) of the user or of the person to be treated.LIST OF REFERENCE CHARACTERS1 (Face) mask 2 Rigid component 3 Elastic component 4 Connection 5 Convex end section 6 Free edge 7 Undercut 8 Circumferential connecting section 9 Long limb of the L-shape 10 Short limb of the L-shape 11 Overlap 12 Recess 13 Ventilation opening 14 Transparent section 15 Recess CO Nonlinear contour CP Center point OS Offset C Central axis CC Craniocaudal axis (of the user) LA Lateral axis (of the user) SA Seal (surface)
Claims
A face mask (1) for covering a user's nose and mouth, optionally formed by two-component injection molding from different materials, the face mask (1) comprising: a rigid component (2) formed from a first material, the rigid component (2) comprising a port (4) for fluidically connecting the face mask (1) to an external system, in particular to an inhalation system and / or a ventilation system, the port (4) comprising a central axis (C), and an elastic component (3) formed circumferentially from a second, preferably different material onto the rigid component (2), the elastic component (3) being configured to form a circumferential seal (SA) covering the user's nose and mouth when being placed, in particular pressed, onto the user's face, characterized in that the elastic component (3) has a convex end portion (5) with a free edge (6) facing radially inwards, preferably towards the inside of the mask (1), and the seal (SA) has a non-linear contour (CO) in a cross section defined by the central axis (C) of the terminal (4) and the craniocaudal axis (CC) of the user when the face mask (1) is placed on the face of the user.Face mask (1) according to claim 1, wherein the convex end portion (5) forms an undercut (7) facing the interior of the face mask (1).The face mask (1) according to any one of the preceding claims, wherein an inner surface of the convex end portion (5) has a higher surface roughness than the rest of the elastic component (3).Face mask (1) according to any one of the preceding claims, wherein the rigid component (2) comprises a circumferential connecting portion (8) facing the elastic component (3) for connecting the elastic component (3) to the rigid component (2), the circumferential connecting portion (8) having a linear contour in cross section defined by the central axis (C) of the connector (4) and the craniocaudal axis (CC) of the user when the face mask (1) is placed on the face of the user.The face mask (1) according to claim 4, wherein, in the cross section defined by the central axis (C) of the connector (4) and the craniocaudal axis (CC) of the user, when the face mask (1) is placed on the face of the user, the circumferential connection portion (8) has an L-shape to connect the elastic component (3) to the rigid component (2) with a partial overlap (11).The face mask (1) according to claim 5, wherein the L-shape has a right angle of 90° or an acute angle of less than 90°.The face mask (1) according to any one of the preceding claims 4 to 6, wherein the port (4) is arranged to be opposed to the mouth of the user when the face mask (1) is placed on the face of the user, and / or in the plan view from the rigid component (2) to the elastic component (3), the port (4) is arranged such that the central axis (C) of the port (4) and the central point (CP) of the circumferential connection portion (8) are aligned with each other or have an offset (OS) of 12 mm or less from each other.Face mask (1) according to any one of the preceding claims, wherein the connector (4) has an oval or circular shape in plan view from the rigid component (2) to the elastic component (3).Face mask (1) according to one of the preceding claims, wherein the second material is a thermoplastic elastomer (TPE) and / or wherein the first material is a polypropylene.The face mask (1) according to any of the preceding claims, wherein the surfaces of the face mask (1) have hydrophilic properties, optionally with a surface energy between 40 and 72 mN / m.Face mask (1) according to any of the preceding claims, wherein the surface of the rigid component (2) facing away from the elastic component (3) comprises protrusions or recesses (12).The face mask (1) according to any one of the preceding claims, wherein in the plan view from the rigid component (2) to the elastic component (3), the face mask (1) has a substantially oval shape and the rigid component (2) has a transparent portion (14) having a greater extension in the area covering the mouth of the user than in the area covering the nose of the user when the face mask (1) is placed on the face of the user.The face mask (1) according to any one of the preceding claims, wherein the elastic component (3) is configured to form a circumferential sealing surface (SA) with the face of the user when the face mask (1) is applied to the face of the user with a force of 2 to 16 N, preferably about 4 N.A face mask (1) according to any preceding claim, wherein the non-linear contour (CO) is sized and shaped to substantially align with a projected face shape.A face mask (1) according to any one of the preceding claims, wherein the elastic component comprises a recess (15) for the nose bridge of the user, preferably a recess (15) adapted to be aligned with a contour of the nose bridge of the user.