Abstract
A breathing mask device, a sealing lip device for a breathing mask device, a molding tool and a method for producing a corresponding breathing mask device and sealing lip device are described. Also disclosed are ways that make it possible to create a breathing mask device that, with sufficiently strong tightness is distinguished by particular wearing comfort and which moreover can be produced advantageously in times of industrial production standpoints. A breathing mask device for administering a breathable gas is provided and includes a body structure that is sealed against a contact surface of a user's face, a sealing lip device that in combination with the body structure in part defines a breathing mask interior, a gel structure for at least intermittent and partial transmission of the retention forces, acting on the body structure, to the user's face area, and a gel material defining the gel structure is received in a gel receiving chamber defined at least in part by an elastically deformable receiving wall.
Claims
1. A breathing mask device for administering a breathable gas, having: a body structure structured to seal against a contact surface of a user's face in use, a sealing lip device that in combination with the body structure in part defines a breathing mask interior, a gel structure for at least intermittent and/or partial transmission of the retention forces, acting on the body structure, to the user's face area, and a gel material defining the gel structure is received in a gel receiving chamber defined at least in part by an elastically deformable receiving wall, wherein elastomer material intended for forming the receiving wall is integrally formed onto a wall portion of the breathing mask device, said receiving wall being separable from the wall portion to form the gel receiving chamber.
2. The breathing mask device of claim 1, wherein the gel receiving chamber comprises a bracing bead portion.
3. The breathing mask device of claim 2, wherein the bracing bead portion extends between the body structure and a user's face sealing lip.
4. The breathing mask device of claim 3, wherein the user's face sealing lip and the receiving wall of the gel structure are integrally formed.
5. The breathing mask device of claim 1, wherein the body structure comprises a hard mask shell or frame element.
6. The breathing mask device of claim 1, wherein the sealing lip device is injection-molded onto the hard mask shell or the frame element.
7. The breathing mask device of claim 1, wherein before the injection molding of the sealing lip device, locally defined reactive zones are generated on the element that forms the body structure.
8. The breathing mask device of claim 1, wherein the reactive zones are generated by corona or plasma treatment.
9. The breathing mask device of claim 1, wherein the reactive zones are generated by adhesion promotion.
10. The breathing mask device of claim 1, wherein the zones intended for detachment of the gel material are locally shielded.
11. The breathing mask device of claim 1, further comprising a filling conduit structure provided on the body.
12. A sealing lip device for a breathing mask having a body structure, comprising a gel structure having a gel body and an elastomer jacket surrounding at least a portion of the gel body, wherein the jacket is formed in the context of an injection-molding operation by injection molding onto an opposite wall of the body structure and is separable from the opposite wall to form a gel material receiving chamber.
13. A method for producing a breathing mask device having a body structure and a sealing lip device, wherein the method comprises: forming at least one adhesion zone on the body structure; injection-molding the sealing lip device with an elastomer material onto the body structure in a suitable mold chamber; forming an adhesive bond between the body structure and the sealing lip device in each adhesion zone; and creating detachment zones in which the injected elastomer material of one or more portions of the sealing lip device is detachable from the body structure.
14. The method of claim 13, wherein the adhesion zones are generated by corona or plasma treatment.
15. The method of claim 13, wherein the adhesion zones are generated by the application of adhesion promoters.
16. The method of claim 13, wherein the detachment zones are caused by or result from the basic properties of the material comprising the body structure.
17. The method of claim 13, wherein the detachment zones are generated by the application of parting means.
18. The method of claim 13, wherein a receiving chamber for receiving a cushioning filling is formed by lifting the elastomer material in the region of the detachment zone.
19. The method of claim 13, wherein the cushioning filling is formed by a gas or air.
20. The method of claim 13, wherein the cushioning filling is formed by a viscous medium.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] Further details and characteristics of the invention will become apparent from the ensuing description in conjunction with the drawings. Shown are:
[0023] FIG. 1, a sectional sketch explaining the makeup of a breathing mask device according to an embodiment of the invention, in the region of the sealing lip device thereof;
[0024] FIG. 2A, a sketch for explaining a hard shell component of the breathing mask device of FIG. 1;
[0025] FIGS. 2B-1 to 2B-3, a perspective sketch illustrating the portions, used as adhesion zones, of the hard shell element of FIG. 2A;
[0026] FIG. 3, a cross-sectional sketch illustrating the production of the breathing mask device of an embodiment of the invention, in a state immediately after the injection-molding of the elastomer material, intended to form the sealing lip device, onto the hard shell element;
[0027] FIG. 4, a sketch illustrating a filling portion for filling the hard mask shell with the gel material according to an embodiment of the present invention;
[0028] FIG. 5, a cross-sectional sketch explaining a preferred makeup of a hard shell element for furnishing large enough injection-molded wall portions according to an embodiment of the present invention;
[0029] FIG. 6, a further cross-sectional sketch explaining details of the generation according to an embodiment of the invention of the gel structure;
[0030] FIG. 7A, a basic sketch explaining the employment of the concept of an embodiment of the invention in the pairing of hard and elastomer materials;
[0031] FIG. 7B, a sketch explaining the concept of an embodiment of the invention in pairing of elastomer/elastomer materials;
[0032] FIG. 8, a perspective sketch illustrating a breathing mask device according to an embodiment of the invention that includes a body structure, e.g., a hard shell element, and an elastomer sealing lip device injection-molded onto it, in which the sealing lip device in cooperation with the body structure forms two finger-like receiving chamber portions, into which a gel material is introduced, forming gel bead portions;
[0033] FIG. 9A, a basic sketch illustrating relatively large-area detachment zones according to an embodiment of the present invention;
[0034] FIG. 9B, a basic sketch illustrating a breathing mask sealing lip according to an embodiment of the present invention;
[0035] FIG. 9C, a basic sketch illustrating a frame element that can be placed in a sealed fashion against a further mask structure according to an embodiment of the present invention.
DETAILED DESCRIPTION OF EMBODIMENTS
[0036] A portion of a simplified breathing mask device is shown in FIG. 1 and includes a body structure or mask frame 1 and a sealing lip device 2 coupled with the body structure. By means of the body structure 1 and the sealing lip device 2, a breathing mask interior I is sealed off from the environment U, in cooperation with a user's face area G, shown here only schematically and not exactly to scale.
[0037] The breathing mask device shown here is distinguished by the fact that a gel structure 3 is provided, and the gel material 4 that forms this gel structure is received in an elastically deformable receiving wall 5 or jacket. This receiving wall 5 is made by integrally forming the elastomer material, provided for forming the receiving wall 5, onto a wall portion 1a, and this material is lifted or separated from the wall portion 1a for forming the gel receiving chamber GA that receives the gel material 4.
[0038] The gel receiving chamber GA forms a bracing bead portion that braces the breathing mask device on the area G of the user's face on which it rests. The bracing bead portion extends between the body structure 1 and a highly elastic, preferably relatively thin-walled user's face sealing lip 2b of the sealing lip device 2, and in the application position of the mask can be seated on the inside of the user's face sealing lip 2b, or optionally on the area of the user's face it is intended to rest on.
[0039] The user's face sealing lip 2b and the receiving wall portion 5 that in portions defines the gel receiving chamber GA are thus embodied integrally to this extent.
[0040] The body structure 1 is preferably embodied as a hard mask shell made of a fully transparent thermoplastic plastic material. It includes connection structures, not shown further here, for connecting breathing gas lines or valve devices.
[0041] The sealing lip device 2 is injection-molded onto this hard mask shell, as will be described in further detail hereinafter. In the state shown here in FIG. 1, the sealing lip device 2 is seated on adhesion zones 7, 8, 9, thus making a heavy-duty adhesive bond, which are formed by corona or plasma treatment of the hard mask shell. The wall portion 1a of the hard mask shell forms a detachment zone from which the material intended for forming the receiving wall 5 is lifted or separated from the wall portion 1a.
[0042] The production of the breathing mask device shown here can be done as described hereinafter.
[0043] In FIG. 2A, a multi-piece molding tool is furnished, which in a first mold closing state furnishes a mold chamber intended to form the body structure 1 or the hard mask shell. This multi-part molding tool is shown here broken down merely as an example into mold segments A, B, C. Once the preferably thermoplastic plastic material intended for forming the hard shell has been injected into the mold chamber of the molding tool, and the plastic material has hardened sufficiently, the molding tool is opened by removing the core segment C. Next, preferably using a covering mask, adhesion zones 10, 11, 12 are embodied on the body structure 1 by corona or plasma treatment or some other kind of reactive treatment of the hard mask shell that otherwise still remains in the molding tool. In FIGS. 2B-1 to 2B-3, these adhesion zones 10, 11, 12 are shown in further detail.
[0044] Next, instead of the mold segment C, a core segment C and/or C, which is preferably again in multiple parts, is inserted into the molding tool as shown in FIG. 3. By means of this mold segment, a mold chamber intended for forming the sealing lip device 2 is furnished. An elastomer material, preferably liquid silicone rubber (LSR), is now injected into this mold chamber. This silicone material now enters into a firmly adhesive bond with the material of the hard mask shell, in the zones 10, 11, 12 sketched in FIGS. 2A and 2B-1 to 2B-3. In the wall portion 1a of the hard shell 1 adjacent to the wall 5, the silicone material is merely adjacent to or in contact with the wall portion 1a, but the silicone material is not bonded or is only slightly bonded to the wall portion 1a. The breathing mask device thus formed and including the body structure 1 or hard shell element and the sealing lip device 2 injection-molded onto it can be removed from the molding tool by suitable opening of the molding tool. By forcing a viscous medium, especially of silicone gel, into the boundary region defined between the receiving wall 5 and the hard shell 1, it becomes possible to lift the receiving wall 5 gradually from the body structure 1 and in the process gradually to form the gel structure 3 (see FIG. 1).
[0045] As can be seen from FIG. 4, it is possible to provide a filling stub structure 13 on the hard shell 1, through which the gel material can advantageously be introduced. Introducing the gel material and the detachability of the elastomer material injection-molded onto the hard shell in the region of the wall portion 1a can be reinforced by special surface properties in the region of the wall portion 1a and in particular also by means of flat preferential conduit geometries. The filling stub structure 13 can be embodied in such a way that it is advantageously closable, in particular in automated fashion. The closing can be done in particular by means of a screw, plug or peg structure.
[0046] FIG. 5 sketches a concept by which an enlarged wall portion 1a is created on the hard shell 1 or body structure, specifically by designing the cross section of the body structure 1 such that it has a strutlike or wavy form. The wall initially injection-molded onto the wall portion 1a here can then be lifted from this wall portion 1a, and in the corresponding cross section has essentially the same developed area, or length/width, as the length/width of the supporting wall 1a.
[0047] FIG. 6 shows a cross-sectional sketch in which the wall 5 injection-molded onto the wall portion 1a has different wall thicknesses. Adapting these wall thicknesses makes it possible to exert influence on the mechanical properties of the gel structure that is finally to be formed in cooperation with the wall 5. The mechanical properties of the sealing lip device 2a resting on the area G of a user's face can also be defined by special designing of the course of the wall thickness and of the profiling of the sealing lip device.
[0048] As shown in sketchlike form in FIG. 7A, an embodiment of the invention for forming a gel receiving chamber GA can be realized especially advantageously by making a rigid/elastomer pairing of materials. Reactive zones 10, 11 are embodied on the rigid structure 1. The elastomer material is initially injection-molded over the full area of the rigid structure 1 and in the process forms the wall 5 contacting the wall portion 1a. By introduction into the boundary region between the wall 5 and the supporting portion 1a, it becomes possible to inflate the wall 5 into the state represented here by dashed lines and as a result to create a gel-reinforced bead.
[0049] In FIG. 7B, a variant is shown in sketchlike form in which an embodiment of the invention is realized with a pairing of soft/soft or elastomer/elastomer materials. A second elastomer layer 5 is injection-molded onto the structure 1, here embodied of an elastomer material. Before the second injection step, intended for forming the wall 5, is performed, the structure 1 is pretreated in such a way that it includes reactive zones 10, 11. By introducing a viscous medium, in particular silicone gel, into the gap region formed between the wall portions 1, 5, it becomes possible to create the inflated cushioning structure represented here by dashed lines.
[0050] FIG. 8 in sketchlike form shows a breathing mask device according to another variant. This breathing mask device includes the body structure 1, which is embodied here as a completely transparent hard shell. The body structure 1 forms a connection opening 100 for connecting a line device serving to deliver breathing gas.
[0051] A sealing lip device 2 is injection-molded onto the body structure 1. The sealing lip device 2 is embodied such that it includes a bridge portion 2e, crossing the bridge of a user's nose, side portions 2f, 2g, and a lower bridge portion 2h crossing the upper lip or the chin region of the user. In the regions 2f, 2g, the sealing lip device 2 has a cross section that is approximately equivalent to the makeup shown in FIG. 1. In the region of the bridge portion 2e, the breathing mask device shown here has no gel structure. In the regions 2f and 2g, two beadlike gel cushions GP are provided, extending in beadlike form and, in the application position, along the side surface of the nose. These gel cushions GP are bounded partly by the body structure 1 and partly by the wall 5 that points toward the sealing lip 2b (see FIG. 1) and have a three-dimensionally greatly curved, finger-like course.
[0052] In FIG. 9A, a variant is illustrated by which it becomes possible to furnish an enlarged injection-molding surface 1a for the embodiment of the wall 5. This is achieved by embodying a strut 111 on the structural component 1. This strut, after the detachment of the wall 5 from the strut 111, dips into the gel receiving chamber GA. The strut 111 can damp the shifting of gel material in the gel receiving chamber and can thus influence the mechanical properties of the gel cushion. The strut 111 may be embodied to function as an end stop and prevents excessive deformation of the gel cushion. The definition of the region of the elastomer material, which serves as a gel chamber wall, is attained in this variant as well by embodying reactive zones 10, 11, on the injection-molding contact face toward the structure 1, which zones assure a sufficiently strong adhesion of the gel material to the structural part 1.
[0053] FIG. 9B shows a gel cushion of a breathing mask according to an embodiment of the present invention. This gel cushion may extend all the way around the entire circumference of the sealing lip, or it may be provided as gel segments in only some portions. Such gel segments preferably extend within the portion of the sealing lip device that is provided for resting on the cheek region. The gel material may be viscous, or in other words fluid, or partly crosslinked, or in other words may be very resilient. Other kinds of filling materials can also be introduced into the receiving chamber GA. These materials are preferably colored such that they lend the mask an aesthetically appealing external appearance.
[0054] FIG. 9C shows an embodiment of the invention that can be realized in combination with a frame element 11. By using the elastomer material, sealing structures, e.g., saw tooth region 11, can also be made, which serve to seal off and optionally secure the thus-created sealing structure to a mask body or other kind of carrier system.
[0055] While the invention has been described in connection with what are presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the invention. Also, the various embodiments described above may be implemented in conjunction with other embodiments, e.g., aspects of one embodiment may be combined with aspects of another embodiment to realize yet other embodiments. Alternatively, further embodiments may include a single component or subportion thereof of any given embodiment. In addition, while the invention has particular application to patients who suffer from OSA, it is to be appreciated that patients who suffer from other illnesses (e.g., congestive heart failure, diabetes, morbid obesity, stroke, barriatric surgery, etc.) can derive benefit from the above teachings. Moreover, the above teachings have applicability with patients and non-patients alike in non-medical applications.
