Devices for introducing respiratory gases into the airways, respiratory masks or breathing devices to facilitate breathing, multi-airway arrangements, inhalers or devices for administering gases for inhalation, CPAP breathing mask for sleep apnea patients, and others.

Abstract

Breathing mask for use with CPAP or ventilators, including: • an integrated nasal applicator with two conically shaped pads that can be inserted into the nostrils, • a central connecting element made of flexible, biocompatible material, • wherein the nasal cushions are connected to each other by a bridge to prevent complete penetration into the nose, • and wherein the mask has a front port for a breathing tube and a rear port for a mouthpiece.

Description

Technical field:

[0001] The invention relates to a medical respiratory aid, in particular for use in CPAP (Continuous Positive Airway Pressure) therapy, ventilation, or for supporting sleep-related breathing disorders. Specifically, it relates to a one-piece mask system with an integrated nasal applicator, a connection module for the mouthpiece and tubing, and innovative functional elements to improve wearing comfort, hygiene, and therapy efficiency. State of the art:

[0002] Conventional CPAP masks typically consist of several components such as nasal cushions, forehead supports, hose connectors, straps, etc. These designs often lead to pressure points, an uncomfortable fit, noise, increased friction, and complicated handling. Particularly problematic are facial imprints, slippage when lying on one's side, and limited suitability for those with beards. Purpose of the invention:

[0003] The aim is to provide a compact, comfortable, and hygienic face mask that requires no bothersome straps, adapts anatomically, ensures a secure seal, and is easy to clean. It should also be modular and usable as both a nose and mouth mask.

[0004] Solution: The invention relates to a breathing mask system made entirely of a flexible, biocompatible material (e.g., medical-grade silicone or TPE). It integrates the following components: 1. Nasal application:

[0005] Two tapered, gently shaped nose pads (similar to nose plugs) made of soft silicone.

[0006] The cushions have an integrated hole guide for airflow and simultaneous attachment to a connecting tube.

[0007] The inner rim (blocker) prevents insertion too deeply and ensures a secure fit without pressure.

[0008] Both cushions are connected by a flexible arc, so they cannot fully penetrate the nose.

[0009] Optionally, a membrane valve for exhaled air is integrated into each nasal cushion, especially if the path to the central exhalation opening is too long. 2. Central connection unit:

[0010] Massive body area directly below the nose application with the following openings: Rear: Receptacle for a separately insertable mouthpiece (e.g. snorkel mouthpiece), airtight and flexibly adjustable. Front: Connection for breathing tube, standardized with 22 mm cone. Side: Integrated mechanical one-way diaphragm valve for controlled exhalation without backflow. Alternatively, the exhalation valve can also be placed on the hose side of the connection module. 3. Connection to the nasal cushions:

[0011] The connection area to the nasal mask is approximately 5 cm long and has so-called predetermined breaking points every 0.3 cm.

[0012] These allow the end user to individually shorten the length for an optimal fit.

[0013] The predetermined breaking points are designed so that they only break when deliberately acted upon, not during use. 4. Mouthpiece: Variant 1: Snorkel

[0014] Can be used separately, airtight and adaptable.

[0015] Available in various sizes for an optimal fit for different users.

[0016] Alternatively, it can also be used as a standalone breathing mask if no nasal applicator is used.

[0017] The mouthpiece is held in the mouth by the natural closure of the jaw, without any fixing straps. Construction:

[0018] The mouthpiece is ergonomically shaped and made of a flexible, biocompatible material (e.g., medical-grade silicone or TPE). It is a snorkel-like mouthpiece that is placed between the lips and stays in place through the natural closure of the jaw – without a strap or other fixation.

[0019] The outer edges are softly rounded and optionally feature fine lamellae or lips that conform to the teeth and gums, ensuring a seal and comfort. Connection:

[0020] On the back of the mouthpiece is a conical connecting pin that is inserted into the central connecting unit of the mask system.

[0021] The connection is airtight, flexibly mounted (e.g. by a soft bellows or ball joint) and allows a certain degree of freedom of movement when lying on its side. Function:

[0022] The mouthpiece is used to supply air through the mouth, e.g. in combined nasal and mouth ventilation or in case of a blocked nose.

[0023] It can also be used on its own if the nasal applicator is removed or not needed.

[0024] The integrated connection to the breathing tube ensures a direct, low-loss airflow. Hygiene and care:

[0025] The mouthpiece is removable and reusable, but can also be designed as a disposable component.

[0026] It is easy to clean (e.g. dishwasher safe or sterilizable at 121 °C). Optional extensions:

[0027] Integrated bite protection for sensitive teeth or patients with bruxism (teeth grinding).

[0028] Optional check valve, if used in combination with a nose valve, to prevent air loss. Option 2: intraoral mouthpiece

[0029] Technical description - Intraoral mouthpiece with air channels (CPAP hybrid solution) 1. General form and application:

[0030] The mouthpiece is designed as an intraoral component and resembles a custom-fitted bite splint in shape and manner of wear.

[0031] It is worn entirely inside the mouth and rests on the upper and lower rows of teeth.

[0032] Breathing takes place via internal air channels that lead from the front connection opening to the rear mouth openings. 2. Material and design:

[0033] The mouthpiece is made of medically safe, biocompatible material (e.g. TPU, silicone or PA12).

[0034] The outer shape is anatomically adapted to lie comfortably between the teeth and cheeks.

[0035] Wall thickness: 1.5-2 mm, depending on the material.

[0036] Smooth surfaces to avoid friction. 3. Air ducts and flow guidance:

[0037] Two symmetrically arranged air channels run from the front connection opening (between the upper incisors) to the rear, approximately at the level of the molars.

[0038] The channels are oval or round, with an inner diameter of approximately 4-6 mm.

[0039] Optionally, exhaust openings can be equipped with a diffuser structure to allow for controlled removal of exhaled air. 4. Front connection:

[0040] The connection to the connector or hose is located centrally on the front, between the upper cutting teeth.

[0041] Connection diameter: approx. 8-10 mm (can be connected to a hose or connector).

[0042] The connection can be conical or cylindrical in shape, possibly with a locking groove or circumferential lip for mechanical securing. 5. Additional features:

[0043] Optional sealing lips in the area of ​​the cheeks or palate can contribute to an improved seal.

[0044] Optionally, an integrated bite guard or reinforcing ribs can be provided for dimensional stability. Size adjustment and customization of the intraoral mouthpiece

[0045] Two proven methods are available to ensure an optimal fit and secure placement of the intraoral mouthpiece within the oral cavity: 1. Individual customization via dental impression (high-precision manufacturing)

[0046] In this variant, a precise dental impression is first taken by a dental practice or a specialized dental technician. Based on this impression, the mouthpiece is individually manufactured so that it is exactly adapted to the patient's teeth. Advantages:

[0047] Maximum fit and high wearing comfort Good hold, even with stronger movements of the lower jaw. Low risk of pressure sores or mucous membrane irritation Very good long-term tolerability with regular use Disadvantages:

[0048] Increased time and financial expenditure

[0049] Requires at least one appointment with a dentist or dental technician. Adjustments for changes in tooth position are only possible to a limited extent. 2. Thermoplastic self-adaptation through moldable plastic (e.g., boil-and-bite technology)

[0050] Alternatively, the mouthpiece can be made from a thermoplastic material that can be shaped when heated in hot water (approx. 70-80 °C). After heating, the mouthpiece is placed in the mouth and shaped by gently biting down. After cooling, it retains the shape of the individual teeth. Advantages:

[0051] Fast and cost-effective customization for in-house use No dental visits required Can be reshaped at any time (adjustable multiple times) Ideal for home use and first aid Disadvantages:

[0052] Lower accuracy of fit compared to the dentally manufactured version Higher risk of fit problems or pressure points if the fit is inaccurate. Material can wear out or deform with frequent reheating. Functional reliability of the integrated air ducts in both variants Regardless of the chosen adaptation method, the air channels are designed to maintain their position and function unaffected. The channels are fully integrated into the main body and run outside of thermally or mechanically deformable contact areas. This ensures that the ventilation properties are reliably maintained in both variants and that no narrowing or deformation of the airways occurs. 5. Fixation system:

[0053] Optional elastic headband via side tabs on the central module. No external fixation is required when using the mouthpiece. Technical description - Hose connection module for hybrid breathing mask

[0054] The hose connector is integrated as an independent, functional component into the central connecting element of the hybrid breathing mask. It ensures a secure connection to an external breathing tube and efficient air drainage. The connector meets common compatibility standards while also taking into account ergonomic and functional requirements during sleep. Design features: Standardized geometry:

[0055] The connection is conical (22 mm) and conforms to the internationally accepted standard for CPAP and ventilator tubing. This ensures compatibility with existing systems and devices from all leading manufacturers. Secure fastening mechanism:

[0056] An optional locking or non-rotating locking ring ensures a secure yet flexible connection with the hybrid mask, preventing the hose from unintentionally coming loose. Exhaust air drainage:

[0057] The connection module may include an integrated diaphragm valve that selectively removes the exhaled air and prevents backflow into the system.

[0058] Alternatively, an open version without a valve mechanism can be manufactured to allow connection to external valve or filter systems. Angled hose routing:

[0059] The hose connection is positioned at a 90-degree angle to the mask, so the hose points downwards or to the side rather than forwards. This reduces mechanical stress on the face and prevents the hose from obstructing the field of vision or sleeping area. Integrated 360° joint:

[0060] A rotatable ball or ring joint at the end allows the hose to rotate freely 360 degrees, thus ensuring maximum freedom of movement for the wearer during sleep - regardless of lying position or posture. Advantages at a glance: 1. Universal compatibility through standardized 22 mm conical connection. 2. Stable connection with a secure, rotation-resistant fit - no unintentional loosening. 3. Targeted exhalation air drainage thanks to an optional one-way diaphragm valve. 4. Optimal hose routing thanks to the angled 90° connection - increases wearing comfort. 5. Unrestricted freedom of movement thanks to the integrated 360° joint - ideal for active sleepers. 6. Compact design that leaves facial areas free and avoids pressure points. 7. Flexibility in system integration, as versions without a valve are also available. 6. Advantages:

[0061] Seamless construction: High hygiene, easy cleaning.

[0062] Less skin contact: Ideal for sensitive skin and beard wearers.

[0063] High wearing comfort in all sleeping positions.

[0064] No pressure points or bothersome straps needed.

[0065] Modular system for individual application (nasal mask only, mouthpiece only or combination). Differentiation and degree of innovation compared to existing products

[0066] This breathing mask system represents a novel combination of a nasal applicator and a functional mouthpiece that is actively involved in the airflow during ventilation. It differs significantly in several respects from known products such as the "Somnipax CPAP pro," which merely function as passive aids for mouth closure control: 1. Functional mouthpiece with active airflow:

[0067] The integrated mouthpiece in the connecting unit is not solely for sealing purposes, but is part of the airflow system. It allows for optional breathing through the mouth (e.g., in case of nasal congestion) or acts as an alternative airway when needed – particularly in CPAP and BiPAP applications. 2. Dual ventilation channels:

[0068] The system allows for both nasal and oral ventilation. This differs fundamentally from passive mouthpieces, which have no air passage and merely prevent the mouth from opening unintentionally. 3. Combined valve technology:

[0069] The optionally integrated membrane valves on the nasal pads and in the connection module ensure effective control of the exhalation path - especially in the case of extended airways or variable hose routing. 4. Seamless connection unit:

[0070] Unlike conventional solutions that consist of multiple components, the breathing mask system is designed as a one-piece, flexible module - with a clear separation between nasal application, mouthpiece and connection for breathing tubes. 5. User comfort without pressure points:

[0071] The mask is completely free of a forehead strap, straps, or hard components. Only the nose pad and mouthpiece have direct skin contact – this significantly increases wearing comfort and makes the system particularly attractive for people with sensitive skin or facial hair. The state of the art includes various types of breathing masks for non-invasive ventilation, especially CPAP therapy. These include, in particular: - Full face masks that completely cover the nose and mouth, - Nasal masks or nasal pillow masks that allow only nasal breathing, - as well as mouthpieces for passive sealing, which merely force the mouth to close, but do not themselves act as air guides.

[0072] However, these known systems have various disadvantages, which are specifically avoided by the present invention: 1. Full-face masks, due to their large surface area, cause pressure points on the cheeks, forehead, and bridge of the nose. They are often uncomfortable, especially for those with facial hair, and tend to leak. Furthermore, they restrict freedom of movement while sleeping and create a feeling of confinement. 2. Nasal masks or nasal pillow masks do not allow mouth breathing. With an open mouth (e.g., in snorers or with a blocked nose), the effectiveness of the ventilation is reduced, necessitating additional aids (chin straps, forehead supports) and significantly reducing comfort. 3. Passive mouthpieces (e.g., silicone pieces for sealing the oral cavity) serve solely to seal the mouth and are not active ventilation components. Breathing through the mouth is not possible with these. Technical Design and Advantages of the Invention: The present invention relates to a one-piece breathing mask system with an integrated nasal applicator and a central connection unit for receiving a mouthpiece and for connecting an external breathing tube. Air is delivered via the nose, mouth, or both airways simultaneously, as required.

[0073] Key features and benefits: Modular system: The mask consists of a single, flexible, and biocompatible component that includes both the nasal applicator and the connecting unit. The mouthpiece can be used optionally or separately – for example, for mouth breathing only. Compact design: The mask touches the face only minimally – exclusively at the nose and lips. No forehead supports, cheek rests, or strap systems are required. Ergonomic fit: The nosepiece is conically shaped, anatomically angled, and features soft sealing lips. The mouthpiece is held securely in place by the natural jaw closure, without external fixation. Integrated valve technology: The connecting unit contains a mechanical one-way exhalation valve that enables safe, backflow-free exhalation. The system remains stable even with fluctuating breathing patterns. Suitable for all sleeping positions: Thanks to the flexible material and low profile, the mask is particularly suitable for side and stomach sleeping positions. Excellent hygiene: The one-piece, smooth design without joints, straps or textile elements allows for easy cleaning and prevents germ accumulation.

[0074] Particularly suitable for sensitive skin types and those with facial hair, as no sealing is required on wide areas of the face.

[0075] In summary, the invention represents a significant advancement over known breathing mask systems. It combines comfort, modularity, and functionality to an unprecedented degree. The mask is equally suitable for professional sleep apnea therapy as well as for clinical or home use in other non-invasive ventilation applications.

[0076] Application example and testing: The applicant uses CPAP therapy himself and tested a functional prototype over four weeks. This resulted in significantly improved sleep quality, no pressure sores, and increased wearing comfort, even when sleeping on his side.

[0077] Additional information regarding priority and filing: This utility model application serves to secure rights at an early stage. A subsequent patent application within 12 months, claiming priority, is planned.

[0078] Drawings and sketches: Sketches illustrating the construction, the nose pads, the combination unit, and variants of use as a pure mouth mask are enclosed or can be provided upon request. Patent Claims Abstract (Summary):

[0079] The invention relates to a breathing mask system for CPAP or ventilation therapies, consisting of an integrated nasal applicator with tapered nasal cushions and a connecting unit for the mouthpiece and breathing tube. Alternatively or additionally, a separate mouthpiece can be used, with the mask unit having a flexible and individually adjustable design. A clever combination of nasal cushions, mouthpiece, connecting elements, and exhalation valves creates an ergonomic, minimally invasive, and airtight connection to the airways without conventional fixation straps. The system allows for a variety of configurations for different application profiles. Technical description:

[0080] The breathing mask system includes: - Two flexible, conically shaped silicone nose pads connected by a flexible bridge to prevent unintentional slippage. The nose pads feature a central hole with an internal fixing rim. - A flexible connecting unit that receives the inhaled air from the nasal cushions. This unit is equipped with: or a connection for a mouthpiece (at the back) or a connection for a breathing tube (front, 22 mm standard cone) or one or more integrated membrane valves for controlled exhalation - A mouthpiece, ergonomically shaped, available in various sizes, for an airtight connection between the mouth and the connecting unit.

[0081] Optionally, exhalation valves can be provided on both the nasal pads and the hose connection to safely relieve excessively long airways.

[0082] The system can be used modularly: - Nose application only - Nose applicator + connecting unit + mouthpiece - Mouthpiece + connecting unit + breathing tube only

[0083] All components are made from biocompatible materials and primarily intended for medical use (e.g., CPAP therapy, sleep apnea, ventilation). The flexible design allows for adaptation to different facial and airway anatomies without extensive adjustments. Explanations for the drawings: Image 1: Mouthpiece variant 1 (snorkel): Image 2: Mouthpiece variant 2 (intraoral) Image 3: Nose pad Figure 4: Central connection unit without loops for securing straps Figure 5: Central connection unit with loops for securing straps Figure 6: Central connection unit, side view Figure 7: Front view of connection unit Figure 8: Rear view of connection unit Figure 9: Angle connection Image 10: Mouthpiece Figures 11-13: Operating principle Explanation of reference symbols:

[0084] Image 4 1 Nose pad 2 Connections for breathing tube (22mm) 3 Diaphragm valve Figure 5 1 Nose pad 2 Connections for breathing tubes (22mm) 3 Diaphragm valve 4 tabs for attaching the optional elastic headbands (Figure 6) 1 nose pad (interchangeable in different sizes) 2 Connection of breathing tube 3 Connecting part with connection for breathing tube and connection for mouthpiece 4 mouthpieces (interchangeable in different sizes) 5 Diaphragm valve for the discharge of exhaled air (Figure 7) 1 interchangeable nose pads in different sizes 2 Connecting part of all components with diaphragm valve for the discharge of exhaled air 3 Connection for breathing tube 22mm cone (Figure 8) 1 nose pad (interchangeable in different sizes) 2 Connection for the mouthpiece

[0085] Image 10 1.) The present invention is characterized in particular by the fact that a mouthpiece is provided which is integrated into the mask system or can be used separately and which is held in the oral cavity by the natural closure of the jaw, thereby completely eliminating the need for additional fixation by straps or bands - a concept previously unknown in CPAP mask systems, which represents a novel, low-contact and comfortable approach to mask stabilization.

Claims

[1] Breathing mask for use with CPAP or ventilators, comprising: • an integrated nasal applicator with two conically shaped pads that can be inserted into the nostrils, • a central connecting element made of flexible, biocompatible material, • wherein the nasal cushions are connected to each other by a bridge to prevent complete penetration into the nose, • and wherein the mask has a front port for a breathing tube and a rear port for a mouthpiece. [2] Mask according to claim 1, characterized by that at least one membrane valve is integrated in the nasal application area, which allows the exhaled air to be discharged in a controlled manner. [3] Mask according to claim 1 or 2, wherein the front connection is designed as a 22 mm conical connection and is provided with a diaphragm valve for the discharge of exhaled air. [4] Mask according to any of the preceding claims, characterized by , that the front connection has an integrated swivel joint which allows 360° rotation of the breathing tube. [5] Mask according to one of the preceding claims, wherein the central connecting unit is compact and has no direct contact with the face. [6] Mask according to one of the preceding claims, wherein the rear connector serves to receive a mouthpiece which actively participates in CPAP or ventilation therapy. [7] Mask according to claim 6, wherein the mouthpiece is designed in such a way that it can be fixed by means of jaw closure and provides an airtight access for ventilation in the oral cavity. [8] Mask according to one of the preceding claims, wherein the system can be operated with or without a nose cushion, in particular also exclusively with the mouthpiece. [9] Mask according to any of the preceding claims, wherein the system can be worn without a headband or other external supports. [10] CPAP breathing mask system, characterized by that the mouthpiece is designed as a snorkel mouthpiece with soft bite wings and is airtightly connected to the connecting part. [11] CPAP breathing mask system according to any of the preceding claims, characterized by that the mouthpiece is equipped with a separate air guide that can be used independently of the nasal mask. [12] CPAP breathing mask system according to any of the preceding claims, characterized by that the system can be used both as a pure mouth mask and as a hybrid mask with nose application and mouthpiece. [13] Use of the mask according to any one of claims 1 to 9 in a CPAP system or a ventilator. [14] Protection claims for an intraoral mouthpiece • Breathing guidance device for a CPAP ventilation system, characterized by that the air supply is exclusively via a mouthpiece positioned in the oral cavity, which is fixed by the natural jaw closure without external retaining straps or mask components. • Breathing guidance device according to claim 1, characterized by that the mouthpiece is made of a soft, biocompatible plastic and has at least one internal air channel coupled to an external connecting part. • Breathing guidance device according to one of the preceding claims, characterized by that the mouthpiece is ergonomically shaped so that it is positioned between the tongue and the roof of the mouth without displacing the tongue or completely blocking oral breathing. • Breathing guidance device according to one of the preceding claims, characterized bythat the mouthpiece has a mechanical locking mechanism or retention contour which prevents it from unintentionally sliding out of the mouth. • Breathing guidance device according to one of the preceding claims, characterized by , that the external connecting part is designed as a rounded, face-adapted transition unit, with one connection each for hose module, mouthpiece and optionally for nasal tube connections. • Breathing guidance device according to one of the preceding claims, characterized by that the system is designed as a completely intraoral CPAP solution without external mask parts or head support. • Breathing guidance device according to one of the preceding claims, characterized by that the mouthpiece is optionally equipped with an exhalation valve, moisture filter or bite protection. [15] According to the invention, the breathing mask system also includes the configuration in which a mouthpiece for ventilation is provided instead of or in addition to the nasal application. The mouthpiece is designed so that it is inserted directly into the user's mouth or held between the lips, creating an airtight connection to the breathing system. It can be used with or without a head or neck strap holder. The mouthpiece is preferably designed to be flexible and can be made in different shapes (e.g. oval, round, ergonomically adapted) and sizes. [16] all variants of breathing mask systems in which: • only a mouthpiece is used instead of a nasal mask, • a mouthpiece is provided in addition to the nasal application (hybrid mask), • the mouthpiece is combined with a connecting part that allows connection to a breathing tube, • one or more exhalation valves are integrated into the mouthpiece, the connecting part or the breathing tube. • The protection extends to all CPAP, BiPAP and other ventilation systems where a mouthpiece is used as part of the respiratory gas supply, regardless of whether it is designed as a separate element, permanently integrated or modular.

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