Air leakage prevention device for magnetic mask

Abstract

The invention belongs to the technical field of medical equipment, and discloses a magnetic type mask air leakage prevention device which comprises a patch, a magnetic sheet and a cavity. Strong magnetic sheets are installed on the pair of patches respectively, one of the patches is attached to the face or the nostril opening, and the other patch is attached to the mask. When a patient uses the breathing machine, the two patches attract each other through magnetic force, it is guaranteed that the mask is fixed to the face all the time, and mask displacement and air leakage caused by turning over at night are prevented. Strong magnetic sheets are installed on a pair of patches respectively, one patch is attached to the face or the nostril opening, and the other patch is attached to a mask. When a patient uses the breathing machine, the two patches attract each other through magnetic force, it is guaranteed that the mask is fixed to the face all the time, and mask displacement and air leakage caused by turning over at night are prevented.

Description

Technical Field

[0001] The present invention belongs to but is not limited to the technical field of medical equipment, and in particular relates to a magnetic mask anti-leakage device. Background Art

[0002] Obstructive sleep apnea (OSA) is a condition characterized by repetitive nocturnal upper airway collapse, affecting 170 million people in my country. Maintaining upper airway patency by applying positive pressure is one treatment option. Masks (including nasal pillows, nasal masks, and oronasal masks) are essential for the human-machine interface, but they can be prone to air leaks and mask displacement, leading to ventilator discontinuation.

[0003] The existing technology is that the mask is directly buckled on the face and fixed by a strap around the head, which is easy to move. There is no relative fixing device between the mask and the face. Summary of the Invention

[0004] In view of the problems existing in the prior art, the present invention provides a magnetic mask anti-leakage device.

[0005] The present invention is achieved by providing a magnetic mask air leakage prevention device, the device comprising a patch, a magnetic sheet, and a cavity;

[0006] Strong magnetic sheets are installed on a pair of patches, one of which is attached to the face or nostril opening, and the other is attached to the mask; when the patient uses the ventilator, the two patches are attracted to each other through magnetic force to ensure that the mask is always fixed on the face, preventing the mask from shifting and leaking due to turning over at night.

[0007] Furthermore, the cavity is consistent with the air outlet portion of the mask.

[0008] Furthermore, the patches are all made of medical silicone material.

[0009] Furthermore, the strong magnetic sheet is made of neodymium iron boron magnetic sheet.

[0010] Furthermore, the shape and size of the cavity are designed according to the facial structure and breathing needs of the human body. When the patch is attached to the face or mask, the cavity can avoid the patient's nostrils or mouth, etc., to ensure that the patient can breathe smoothly.

[0011] In combination with the above technical solutions and the technical problems solved, the advantages and positive effects of the technical solutions to be protected by the present invention are as follows:

[0012] Existing ventilators, the first-line treatment for OSA, suffer from mask leakage, resulting in poor treatment effectiveness. Existing masks on the market are secured solely by straps. The present invention allows for a better fit and minimizes leakage.

[0013] The invention features a pair of patches with strong magnetic sheets attached to each. One patch is attached to the face or nostril opening, and the other to the mask. When the patient uses the ventilator, the two patches are magnetically attracted to each other, ensuring the mask remains securely in place, preventing movement and leakage caused by turning over at night.

[0014] In existing ventilator treatment devices, masks mostly achieve facial fit through a headband-type elastic tensioning device, which essentially relies on a linear tension transmission mechanism for passive fixation. However, this method has problems such as uneven fitting stress, poor sealing at the edges, and local facial compression, which can easily lead to air leakage, thereby causing fluctuations in treatment airway pressure, reduced ventilation efficiency, and even the risk of patients falling off at night. The present invention adopts the principle of uniform distribution of magnetic attraction to construct a multi-point magnetic field coupling closed structure between the mask and the face, which significantly improves the sealing fit and wearing stability, avoids the "single point instability" problem of traditional structures in dynamic environments, and improves the reliability of clinical use.

[0015] In the prior art, due to the morphological deviation between the mask and the facial structure, it is impossible to achieve precise fitting according to the facial contours of different users, and side effects such as compressive discomfort, edema indentations, or skin friction damage often occur. The present invention integrates a medical-grade flexible silicone patch with a magnetic structure, and forms a flexible fitting coupling surface through the flexible interface material and the automatic magnetic adsorption behavior. It can adaptively fit the changes in facial curvature without strong tensioning. This structure solves the problem of uneven stress concentration on the skin caused by rigid masks under high-load sealing conditions, complies with the biomechanical pressure-dispersion principle, and significantly enhances the comfort and compliance of patients wearing it for a long time.

[0016] Traditional mask structures lack the ability to self-stabilize and adjust when faced with disturbances such as turning over at night and changing body positions. The mask is prone to micro-displacement, which can lead to the formation of peripheral leak paths. The present invention uses high-coercivity NdFeB magnetic patches to form a stable magnetic coupling closed-loop system, constructing a dynamic positioning system with self-resetting capabilities. The magnetic linkage between the patches can generate an automatic attractive correction torque after a slight offset, inducing the bonding surface to return to its initial bonding state. This allows for passive deviation correction and positioning closed-loop control without relying on an electronic control system, significantly improving the system's sealing continuity and functional reliability under dynamic disturbances.

[0017] Existing respiratory medical products generally have engineering problems such as low design standardization, large adaptation differences, and complex maintenance, which limit large-scale production and multi-scenario adaptation capabilities. The magnetic mask anti-leakage device proposed in this invention has modular structural characteristics. The patch and magnetic sheet can be replaced, cleaned or disinfected as needed. It supports both integrated design and independent component packaging, which is in line with the trend of module decoupling of medical devices. Its size, cavity morphology and adsorption strength can be parametrically modeled and industrially customized (parametric adaptive manufacturing) according to the physiological parameters of different populations, providing path support for large-scale personalized production and significantly improving the structural compatibility and engineering promotion efficiency of mask systems in the medical industry. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 1 is a structural diagram of a magnetic mask air leakage prevention device provided by an embodiment of the present invention;

[0019] In the figure: 1. Patch; 2. Magnetic sheet; 3. Cavity. DETAILED DESCRIPTION

[0020] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0021] like Figure 1 As shown, an embodiment of the present invention provides a magnetic mask anti-leakage device, which includes a patch 1, a magnetic sheet 2, and a cavity 3;

[0022] Strong magnetic sheets 2 are installed on a pair of patches 1, one of which is attached to the face or nostril opening, and the other is attached to the mask; when the patient uses the ventilator, the two patches 1 are attracted to each other through magnetic force to ensure that the mask is always fixed on the face, preventing the mask from shifting and leaking due to turning over at night.

[0023] Furthermore, the cavity 3 is consistent with the air outlet portion of the mask.

[0024] Furthermore, the patches 1 are all made of medical silicone material.

[0025] Furthermore, the strong magnetic sheet 2 is made of neodymium iron boron magnetic sheet.

[0026] Furthermore, the shape and size of the cavity 3 are designed according to the facial structure and breathing needs of the human body. When the patch is attached to the face or mask, the cavity can avoid the patient's nostrils or mouth, etc., to ensure that the patient can breathe smoothly.

[0027] The core working principle of this device is based on the principle of magnetic coupling positioning. A pair of patches are fixed to key areas of the patient's face (such as the sides of the nose or the periphery of the mouth) and the corresponding positions of the respiratory mask. The neodymium iron boron strong magnetic sheet built into the patch has high remanence and coercive force (generally between N35 and N52), forming a stable magnetic flux density distribution field. The patches are quickly closed and positioned through the vertical magnetic flux adsorption force, forming a pair of reusable magnetic fixing components. The magnetic attraction generates a stable adhesion field per unit area, ensuring that the mask can maintain a stable fit even if the patient turns over at night or has slight facial movements, significantly reducing the leakage rate.

[0028] The present invention uses medical-grade silicone material as the patch body, which has excellent biocompatibility and skin contact safety, avoiding skin irritation or allergic reactions caused by long-term wear. The patch surface undergoes microflex finishing to adapt to the anatomical differences of different users' faces (such as the height of the nose bridge and the curvature of the facial contour), enhancing local fit stability. The patch softly wraps around the magnetic sheet and forms a flexible pressure-bearing interface, effectively buffering the impact load during the magnetic attraction transmission process, improving user comfort and long-term stability.

[0029] The patch's center area is designed with an aperture structure (aperture zone). Its geometry and dimensions are based on optimized modeling of facial fluid dynamics and gas exchange efficiency, ensuring that the structure avoids the respiratory opening, nostrils, or air outlet areas after positioning. Once the mask is secured, the aperture aligns with the respiratory pathway or has minimal misalignment. This maintains unobstructed airflow through the mask-face interface, preventing airflow turbulence, increased respiratory resistance, or carbon dioxide backflow caused by obstruction or compression by the patch, thereby minimizing flow resistance and maintaining airway patency during gas exchange.

[0030] This magnetic fixation system creates a passive dynamic repositioning closure mechanism: if there is slight relative displacement between the mask and the face (such as when turning over or changing body position during sleep), the adhesive force between the magnetic patches automatically adjusts the position of the patches and achieves self-resetting adsorption, thereby preventing mask leakage caused by uneven force or contact surface deviation. This design replaces the traditional headband elastic traction fixation method, avoiding local indentation or blood flow obstruction caused by excessive tension, and improving long-term compliance of the wearing experience.

[0031] The selected NdFeB magnets feature high magnetic field strength, excellent temperature stability, and a compact size. Furthermore, shielding measures are implemented to minimize magnetic interference with peripheral devices. The magnets are encapsulated with a low-permeability, medical-grade biopolymer coating to isolate the risk of magnetic particle leakage, ensuring no interference with magnetically sensitive devices such as pacemakers and hearing aids. Furthermore, the magnets' polarity is arranged in an oriented manner to effectively minimize transverse magnetic field leakage, improve magnetic coupling accuracy, and enhance spatial magnetic stability, meeting the electromagnetic compatibility requirements of clinical environments.

[0032] This device features a simple structure, easy operation, and high reusability, making it suitable for a variety of respiratory support scenarios, including noninvasive ventilation (NIV), continuous positive airway pressure (CPAP), and postoperative assisted ventilation. For children, the elderly, or patients with special facial structures, the device can be customized in a variety of sizes and shapes to meet the personalized facial conformity needs of different populations. In conjunction with digital modeling tools, the patch shape can be pre-generated based on 3D facial scan data and optimized to match the magnetic field adsorption force, improving the overall ergonomic adaptability of the system.

[0033] This device relies primarily on a facial positioning patch system and a magnetic coupling mechanism to achieve a secure connection between the mask and the face. The system consists of a pair of patches (patch 1), both made of biocompatible medical silicone material. These patches offer excellent skin compatibility and flexible fit, allowing them to adhere to complex facial contours. Embedded within the patches are high-magnetic Neodymium Iron Boron (NdFeB)2 magnets, which possess high remanence and coercivity, enabling highly reliable non-contact magnetic attachment of the mask to the face. This bidirectional magnetic coupling structure ensures that the mask maintains an airtight connection even if the patient's position changes during sleep, significantly reducing unintentional leakage caused by mask movement.

[0034] To prevent the magnetic structure from compressing or obstructing the patient's airway, a cavity 3 is specifically designed within the patch structure, precisely aligning the mask's air outlet with the body's respiratory opening (such as the nostrils or mouth). The cavity is designed using fluid dynamics modeling and facial anatomical parameter fitting. Its shape and size are customized based on facial 3D reconstruction data and respiratory flow requirements to ensure unobstructed gas exchange pathways, thereby maintaining airway patency. The structure features a streamlined boundary design that effectively minimizes disturbances between the mask's airflow and the patch's edges, avoiding localized turbulence and further stabilizing the airflow pathway.

[0035] Traditional masks are prone to local interface detachment due to uneven stress or unbalanced facial pressure distribution when patients turn over or change sleeping positions, which can lead to leakage. This device significantly improves the uniformity of the mask's fitting pressure distribution on the skin through the normal holding force (normal holding force) created by the magnetic plate's suction, avoiding the formation of leakage channels caused by pressure gradients at the contact edge. At the same time, the magnetic field distribution design of the NdFeB magnet takes into account the flexible deformation compensation mechanism of the mask wearing area, maintaining adsorption stability under dynamic loads and effectively suppressing small displacements caused by facial muscle movement or skin rebound.

[0036] To ensure the device's comfort and physiological compatibility during prolonged nighttime wear, the patch is made of medical-grade silicone, which offers excellent breathability, anti-allergy, and antibacterial properties. It is compatible with a variety of skin types and reduces mechanical stress and the risk of contact dermatitis. The neodymium iron boron magnets used in the magnetic disc are a rare earth alloy coated with a medical epoxy resin to isolate metal ions from direct contact with the skin, preventing electrochemical corrosion and biological rejection. Furthermore, the device is designed with minimal invasiveness and ergonomically contoured fit, ensuring functionality while minimizing interference with the user's natural sleep and breathing rhythms.

[0037] The invention uses a pair of patches 1, each with a strong magnetic sheet 2. One patch is attached to the face or nostril opening, and the other is attached to the mask. When the patient uses the ventilator, the two patches are attracted to each other by magnetic force, ensuring that the mask is always fixed on the face, preventing the mask from shifting and leaking due to turning over at night.

[0038] In the description of the present invention, unless otherwise specified, "plurality" means two or more; terms such as "upper," "lower," "left," "right," "inner," "outer," "front end," "rear end," "head," and "tail" indicate positions or relationships based on those shown in the accompanying drawings. These terms are intended solely to facilitate the description of the present invention and simplify the description. They do not indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting the present invention. Furthermore, terms such as "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0039] The above description is only a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any modifications, equivalent substitutions and improvements made by any technician familiar with this technical field within the technical scope disclosed by the present invention and within the spirit and principles of the present invention should be covered by the scope of protection of the present invention.

Claims

1. A magnetic mask anti-leakage device, characterized in that: The device includes a patch, a magnetic sheet, and a cavity; A pair of patches, each made of a flexible substrate; strong magnetic sheets respectively arranged in the patches, with one strong magnetic sheet embedded in each patch, and each strong magnetic sheet being a neodymium iron boron magnet; At least one patch is provided with a through hole, which penetrates the patch body structure.

2. The magnetic mask air leakage prevention device according to claim 1, characterized in that: The flexible substrate is medical grade silicone material.

3. The magnetic mask air leakage prevention device according to claim 1, characterized in that: The distance between the position of the cavity and the outer edge of the patch is less than 50% of the width of the patch.

4. The magnetic mask air leakage prevention device according to claim 1, characterized in that: The plane outline of the cavity is an ellipse or an irregular curve shape.

5. The magnetic mask air leakage prevention device according to claim 1, characterized in that: The surface of the strong magnetic sheet is coated with an epoxy resin coating.

6. The magnetic mask air leakage prevention device according to claim 1, characterized in that: One of the pair of patches is disposed on the mask shell, and the other patch can be attached to the wearer's face.

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