Respiratory mask assembly for use with a continuous positive airway pressure (CPAP) device

The breathing assembly with a conduit coupler and gasket allows simultaneous use of CPAP and respiratory masks, effectively blocking airborne particles and preventing disease spread.

JP2026032078APending Publication Date: 2026-02-25SNAP CPAP LLC
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Patent Information

Application Number
JP2025199229
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2020-03-23
Filing Date
2025-11-19
Publication Date
2026-02-25

AI Technical Summary

Technical Problem

Patients connected to CPAP devices cannot simultaneously wear respiratory masks like N95 respirators due to feasibility issues, which hinders protection from airborne particles and prevents the spread of contagious diseases.

Method used

A breathing assembly with a conduit coupler and disposable respiratory mask that includes a gasket and airtight seals to allow simultaneous use with CPAP devices, blocking particles larger than 0.3 microns.

Benefits of technology

Enables patients to wear both CPAP masks and respiratory masks, reducing the spread of contagious diseases by blocking airborne particles effectively.

✦ Generated by Eureka AI based on patent content.

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Abstract

To provide a respiratory assembly for use with a continuous positive airway pressure (CPAP) device.SOLUTION: The respiratory assembly 10 includes a conduit coupler 100 comprising a male member and a female member. The respiratory assembly also includes a disposable respiratory mask 1 defining a central opening therethrough sized to receive the male member. A gasket is positioned between the male member and the respiratory mask, the gasket surrounding the central opening to provide sealing at the central opening. The channel opening of one of the male and female members connects to a continuous positive airway pressure (CPAP) mask that couples to one or more of the patient's nares and mouth.SELECTED DRAWING: Figure 1B
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Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 62 / 993,220, filed March 23, 2020, and U.S. Provisional Patent Application No. 62 / 992,966, filed March 21, 2020, the contents of which are incorporated herein by reference in their entireties.

[0002] The subject matter of this disclosure relates to respiratory assemblies, and more particularly to respiratory mask assemblies for use in conjunction with continuous positive airway pressure (CPAP) devices. [Background technology]

[0003] Face masks and nasal cannulae are typically used to treat individuals who have difficulty breathing or who otherwise require a positive respiratory air supply. High-flow delivery of respiratory gas can be delivered using nasal cannulae and / or face masks. Continuous positive airway pressure (CPAP) masks can deliver therapeutic fluids, such as ambient air, oxygen-enriched air, gases, gas mixtures, or gases with medications, to a patient at a predetermined or desired pressure setting. Alternatively, maskless breathing assemblies can be used to deliver such fluids. Summary of the Invention [Problem to be solved by the invention]

[0004] It may be beneficial for a patient connected to a CPAP device to wear a respiratory mask, such as an N95 respirator, surgical mask, or other similar face mask (hereinafter generally referred to as a "respiratory mask"), to protect the wearer from airborne particles such as microorganisms (e.g., bacteria and viruses). Alternatively, if the patient is suffering from a contagious disease, a respiratory mask worn by the patient can reduce or eliminate the spread of the contagious disease to medical professionals, caregivers, the patient's relatives, and other patients who may be in the patient's vicinity. However, it is not feasible or possible for a person / patient connected to a continuous positive airway pressure (CPAP) device to simultaneously wear a respiratory mask.

[0005] It would therefore be beneficial to provide an improvement that addresses the above-mentioned inconveniences. [Means for solving the problem]

[0006] This Summary is provided to introduce concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor should it be construed as limiting the scope of the claimed subject matter.

[0007] Provided herein is a breathing assembly for use with a continuous positive airway pressure (CPAP) device. According to various embodiments, the breathing assembly includes a conduit coupler including a male member and a female member. The assembly also includes a disposable respiratory mask defining a through central opening sized to receive the male member. A gasket is positioned between the male member and the respiratory mask. The gasket surrounds and seals the central opening. A channel opening in one of the male and female members connects to a continuous positive airway pressure (CPAP) mask that connects to one or more of a patient's nares and oral cavity.

[0008] According to one or more embodiments, the respirator is configured to block at least 95 percent of particles 0.3 microns or larger in size.

[0009] According to one or more embodiments, the respiratory mask is a surgical mask.

[0010] According to one or more embodiments, the gasket comprises an adhesive foam material.

[0011] According to one or more embodiments, the gasket is formed from a stretchable elastomeric material.

[0012] According to one or more embodiments, at least one major surface of the gasket comprises a peelable adhesive film.

[0013] According to one or more embodiments, at least one major surface of the gasket comprises an adhesive material.

[0014] 10. The respiratory assembly of claim 1, wherein the respiratory assembly comprises two gaskets, one gasket surrounding the central opening on each side of the respiratory mask wall, according to one or more embodiments.

[0015] According to one or more embodiments, the gasket forms an interference fit with the male member.

[0016] 10. The breathing assembly of claim 1, wherein, according to one or more embodiments, the female member selectively engages the male member.

[0017] According to one or more embodiments, the female member threadably engages threads formed on the male member.

[0018] According to one or more embodiments, the female member includes one or more release devices that can be pivoted to selectively engage the male member.

[0019] According to one or more embodiments, the female member selectively engages the male member with a quick disconnect mechanism.

[0020] According to one or more embodiments, the channel opening in the other of the male and female members receives a flexible tube connected to a fluid source.

[0021] According to one or more embodiments, the fluid source is selected from a high flow generator, a continuous positive airway pressure (CPAP) machine, a fluid reservoir, a medicated fluid source, or a humidifier.

[0022] According to one or more embodiments, the fluid source fluid is selected from a gas, a mixture of gases, or a gas with a drug.

[0023] According to one or more embodiments, both sides of the gasket include one or more of a peelable adhesive film and an adhesive material.

[0024] According to one or more embodiments, the central opening comprises a snap-on lid.

[0025] According to one or more embodiments, the snap lid had a circular profile.

[0026] Provided herein is a respiratory assembly for use with a continuous positive airway pressure (CPAP) device. According to one or more embodiments, the respiratory assembly includes a respiratory mask defining an opening. The assembly further includes a conduit coupler forming a substantially airtight seal around the opening of the respiratory mask. The conduit coupler includes a male member and a female member, each defining an opening through which a conduit fits. A sleeve of the male member passes through the opening of the respiratory mask and selectively engages with the female member. A gasket is provided between the female member and the respiratory mask such that a substantially airtight seal is formed between the sleeve of the male member and the opening when the male member selectively engages with the female member. A connector end of the female member is in fluid communication with a channel opening of a fluid source, and a connector end of the male member is in fluid communication with a CPAP mask assembly, which couples to one or more of a patient's nares and oral cavity.

[0027] Provided herein is a nasal breathing assembly. The nasal breathing assembly includes a pair of seats, each seat defining an opening sized and shaped to fit a patient's nostril, a ferromagnetic ring positioned on an underside of the seat and aligned around the opening, and an upper side of the seat configured to sealably engage the nostril. The nasal breathing assembly also includes a pair of posts, each post including a magnetic ring positioned at a first end thereof and a ball-shaped receiver positioned at a second end thereof, a passageway extending from the first end to the second end thereof, the magnetic ring comprising an array of magnets, and the magnetic ring removably attachable to the ferromagnetic ring. The nasal breathing assembly also includes a connector having a pair of socket openings at a post end, each socket opening sized and shaped to receive the ball-shaped receiver in a ball-and-socket configuration and form a substantially airtight connection therewith, and an inlet at a vent end in fluid communication with a flexible tube connected to a fluid source.

[0028] According to one or more embodiments, the array of magnets comprises magnets concentrically arranged at, near, or around the first ends of the posts.

[0029] According to one or more embodiments, the array of magnets comprises a plurality of magnetic pellets embedded at, near, or around the first ends of the posts.

[0030] According to one or more embodiments, the struts are 3D printed.

[0031] A nasal breathing assembly is provided herein. The nasal breathing assembly includes a pair of sheets, each sheet defining an opening sized and shaped to fit a patient's nostril, a ferromagnetic ring positioned on the underside of the sheet and aligned around the opening, and an upper side of the sheet configured to sealably engage the nostril. The nasal breathing assembly further includes a connector. The connector includes a pair of slip rings at the ends of the sheets, each containing a magnetic ring. Each slip ring defines a channel opening. The magnetic ring includes an array of magnets. The magnetic ring is configured to pivotally tilt around the slip ring. The magnetic ring is sized and shaped to be removably attachable to the ferromagnetic ring to form a substantially airtight connection with the ferromagnetic ring. An inlet at the vent end is in fluid communication with a flexible tube connected to a fluid source. The channel opening has a circular, rectangular, oval, or teardrop shape.

[0032] According to one or more embodiments, the opening in the ferromagnetic ring has a circular, rectangular, oval, or teardrop shape, and the shape of the opening in the ferromagnetic ring matches the shape of the channel opening in the magnetic ring.

[0033] According to one or more embodiments, the array of magnets comprises magnets concentrically arranged at, near, or around the seat end of the slip ring.

[0034] According to one or more embodiments, the slip ring is 3D printed. [Brief explanation of the drawings]

[0035] The foregoing and the following detailed description of the preferred embodiments will be better understood when read in conjunction with the accompanying drawings, in which: For the purposes of illustration, there are shown in the drawings exemplary embodiments; however, the subject matter of the disclosure is not limited to the specific methods and instrumentalities disclosed.

[0036] The embodiments illustrated, described, and discussed herein are exemplary of the present invention. Because these embodiments of the present invention are described with reference to examples, various modifications or adaptations of the methods and / or specific structures described may become apparent to those skilled in the art. Naturally, modifications and variations are encompassed by the above teachings and are within the scope of the appended claims without departing from the spirit and intended scope thereof. All such modifications, adaptations, or variations that rely on the teachings of the present invention and that have advanced the art are considered to be within the spirit and scope of the present invention. Therefore, these descriptions and drawings should not be considered in a limiting sense, as it is understood that the present invention is in no way limited to only the illustrated embodiments. [Figure 1A] FIG. 1 shows a perspective view of a respiratory mask assembly in an assembled configuration according to some embodiments of the presently disclosed subject matter. [Figure 1B] 1 illustrates the breathing assembly applied to a human face according to some embodiments of the presently disclosed subject matter. [Figure 2] FIG. 1 shows a perspective view of the inside of a respiratory mask assembly in an assembled configuration, according to some embodiments of the presently disclosed subject matter. [Figure 3]1 shows a perspective view of the exterior of a respiratory mask assembly in an exploded configuration, along with exploded portions of a coupler forming part of the respiratory mask assembly, according to some embodiments of the presently disclosed subject matter. [Figure 4] 1 shows a perspective view of the exterior of a respiratory mask assembly with a male member inserted through a central opening of the respiratory mask assembly, according to some embodiments of the presently disclosed subject matter. [Figure 5] 1 illustrates a side perspective view of the exterior of a respiratory mask assembly with a male member inserted through a central opening of the respiratory mask assembly, according to some embodiments of the presently disclosed subject matter. [Figure 6] 1 shows a perspective view of a portion of the interior of a respiratory mask assembly with a male member inserted through a central opening, according to some embodiments of the presently disclosed subject matter. [Figure 7] 1 shows a perspective view of a portion of the interior of a respiratory mask assembly with a flexible tube inserted through a male member, according to some embodiments of the presently disclosed subject matter. [Figure 8] FIG. 1 illustrates a perspective view of the exterior of a respiratory mask assembly with a gasket positioned on top of a male member inserted through a central opening of the respiratory mask assembly, according to some embodiments of the presently disclosed subject matter. [Figure 9] FIG. 1 shows, for illustrative purposes, a perspective view of the exterior of a respiratory mask assembly with a female member removably coupled to a male member and no tube inserted, according to some embodiments of the presently disclosed subject matter. [Figure 10] FIG. 1 shows a side perspective view of the exterior of a respiratory mask assembly with a female member about to be removably coupled to a male member and a CPAP tube inserted through both the male and female members, according to some embodiments of the presently disclosed subject matter. [Figure 11] FIG. 1 shows a side perspective view of the exterior of a respiratory mask assembly with a female member about to be removably coupled to a male member and a CPAP tube inserted through both the male and female members, according to some embodiments of the presently disclosed subject matter. [Figure 12]1 shows a side perspective view of the exterior of a respiratory mask assembly with a CPAP tube inserted through both the male and female members, according to some embodiments of the presently disclosed subject matter. [Figure 13] 1 illustrates a respiratory mask assembly in which the respiratory mask forming a part of the respiratory mask assembly is a typical surgical mask, according to some embodiments of the presently disclosed subject matter. [Figure 14] 1 illustrates a CPAP nasal breathing assembly configured to engage the nares of a patient, according to some embodiments of the presently disclosed subject matter. [Figure 15] FIG. 10 is a side perspective view of a socket magnet post that may be used with the disclosed nasal breathing assembly in some embodiments. [Figure 16] FIG. 10 is a side perspective view of a port magnet post that may be used with the disclosed ferromagnetic rings in some embodiments. [Figure 17] FIG. 1 is a perspective view of a nasal breathing assembly according to some embodiments of the presently disclosed subject matter. [Figure 18] 1 includes a schematic diagram of components of a nasal breathing assembly according to some embodiments. [Figure 19] 10A-10D include schematic diagrams of various embodiments of a sheet including a ferromagnetic ring that can form part of a nasal breathing assembly, according to some embodiments. [Figure 20] 4 illustrates another CPAP breathing assembly that may be used in conjunction with the breathing mask assembly shown in FIG. 3, according to some embodiments of the presently disclosed subject matter. [Figure 21] 4 illustrates a further CPAP breathing assembly that may be used in conjunction with the breathing mask assembly shown in FIG. 3, according to some embodiments of the presently disclosed subject matter. [Figure 22A] 4A-4D illustrate additional embodiments and aspects of conduit couplers that may be used in conjunction with the respiratory mask shown in FIG. 3 according to some embodiments of the presently disclosed subject matter. [Figure 22B] 4A-4D illustrate additional embodiments and aspects of conduit couplers that may be used in conjunction with the respiratory mask shown in FIG. 3 according to some embodiments of the presently disclosed subject matter. [Figure 22C] 4A-4D illustrate additional embodiments and aspects of conduit couplers that may be used in conjunction with the respiratory mask shown in FIG. 3 according to some embodiments of the presently disclosed subject matter. [Figure 23A] 4A-4D illustrate additional embodiments and aspects of conduit couplers that may be used in conjunction with the respiratory mask shown in FIG. 3 according to some embodiments of the presently disclosed subject matter. [Figure 23B] 4A-4D illustrate additional embodiments and aspects of conduit couplers that may be used in conjunction with the respiratory mask shown in FIG. 3 according to some embodiments of the presently disclosed subject matter. [Figure 23C] 4A-4D illustrate additional embodiments and aspects of conduit couplers that may be used in conjunction with the respiratory mask shown in FIG. 3 according to some embodiments of the presently disclosed subject matter. [Figure 24A] 4A-4D illustrate additional embodiments and aspects of conduit couplers that may be used in conjunction with the respiratory mask shown in FIG. 3 according to some embodiments of the presently disclosed subject matter. [Figure 24B] 4A-4D illustrate additional embodiments and aspects of conduit couplers that may be used in conjunction with the respiratory mask shown in FIG. 3 according to some embodiments of the presently disclosed subject matter. [Figure 24C] 4A-4D illustrate additional embodiments and aspects of conduit couplers that may be used in conjunction with the respiratory mask shown in FIG. 3 according to some embodiments of the presently disclosed subject matter. [Figure 24D] 4A-4D illustrate additional embodiments and aspects of conduit couplers that may be used in conjunction with the respiratory mask shown in FIG. 3 according to some embodiments of the presently disclosed subject matter. [Figure 25] 4A-4D illustrate additional embodiments and aspects of conduit couplers that may be used in conjunction with the respiratory mask shown in FIG. 3 according to some embodiments of the presently disclosed subject matter. [Figure 26] 4 shows a schematic perspective view of a snap-on lid that may be incorporated into the respiratory mask assembly shown in FIG. 3 to control access to the central opening of the respiratory mask, according to some embodiments of the presently disclosed subject matter. [Figure 27]1A-1C illustrate additional embodiments of snap-on lids that can be incorporated into respiratory masks, such as N95 respirators or other common CPAP masks, CPAP assemblies, and other positive airway pressure masks and breathing aids, according to some embodiments of the subject matter of the present disclosure. [Figure 28A] 1A-1C illustrate various aspects of a polymagnet forming part of a CPAP nasal breathing assembly configured to engage the nares of a patient, according to some embodiments of the presently disclosed subject matter. [Figure 28B] 1A-1C illustrate various aspects of a polymagnet forming part of a CPAP nasal breathing assembly configured to engage the nares of a patient, according to some embodiments of the presently disclosed subject matter. [Figure 28C] 1A-1C illustrate various aspects of a polymagnet forming part of a CPAP nasal breathing assembly configured to engage the nares of a patient, according to some embodiments of the presently disclosed subject matter. [Figure 28D] 1A-1C illustrate various aspects of a polymagnet forming part of a CPAP nasal breathing assembly configured to engage the nares of a patient, according to some embodiments of the presently disclosed subject matter. [Figure 29A] 10A-10C illustrate various aspects of a customized polymagnet forming part of a CPAP nasal breathing assembly configured to engage a patient's nares, according to some embodiments of the presently disclosed subject matter. [Figure 29B] 10A-10C illustrate various aspects of a customized polymagnet forming part of a CPAP nasal breathing assembly configured to engage a patient's nares, according to some embodiments of the presently disclosed subject matter. [Figure 29C] 10A-10C illustrate various aspects of a customized polymagnet forming part of a CPAP nasal breathing assembly configured to engage a patient's nares, according to some embodiments of the presently disclosed subject matter. [Figure 29D] 10A-10C illustrate various aspects of a customized polymagnet forming part of a CPAP nasal breathing assembly configured to engage a patient's nares, according to some embodiments of the presently disclosed subject matter. [Figure 30A]10A-10C illustrate various aspects of an aligned poly-magnet forming part of a CPAP nasal breathing assembly configured to engage the nares of a patient, according to some embodiments of the presently disclosed subject matter. [Figure 30B] 10A-10C illustrate various aspects of an aligned poly-magnet forming part of a CPAP nasal breathing assembly configured to engage the nares of a patient, according to some embodiments of the presently disclosed subject matter. [Figure 31A] 10A-10C illustrate various patterns programmed onto a polymagnet forming part of a CPAP nasal breathing assembly configured to engage a patient's nares, according to some embodiments of the presently disclosed subject matter. [Figure 31B] 10A-10C illustrate various patterns programmed onto a polymagnet forming part of a CPAP nasal breathing assembly configured to engage a patient's nares, according to some embodiments of the presently disclosed subject matter. [Figure 31C] 10A-10C illustrate various patterns programmed onto a polymagnet forming part of a CPAP nasal breathing assembly configured to engage a patient's nares, according to some embodiments of the presently disclosed subject matter. [Figure 31D] 10A-10C illustrate various patterns programmed onto a polymagnet forming part of a CPAP nasal breathing assembly configured to engage a patient's nares, according to some embodiments of the presently disclosed subject matter. [Figure 31E] 10A-10C illustrate various patterns programmed onto a polymagnet forming part of a CPAP nasal breathing assembly configured to engage a patient's nares, according to some embodiments of the presently disclosed subject matter. [Figure 31F] 10A-10C illustrate various patterns programmed onto a polymagnet forming part of a CPAP nasal breathing assembly configured to engage a patient's nares, according to some embodiments of the presently disclosed subject matter. DETAILED DESCRIPTION OF THE INVENTION

[0037] Below, technical solutions in the embodiments of the present invention are clearly and comprehensively presented in conjunction with the figures according to the embodiments of the present invention. Obviously, the embodiments presented herein are only some embodiments, not all embodiments of the present invention. Generally, the components of the embodiments of the present invention illustrated herein can be arranged and designed according to various configurations. Therefore, the detailed description of the embodiments of the present invention provided in the following figures is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments that can be obtained by those skilled in the art without using inventive efforts fall within the scope of protection of the present invention.

[0038] The description of various embodiments of the present invention has been presented for illustrative purposes, but is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terms used herein have been selected to best explain the principles of the embodiments, practical applications or technical improvements to technology found in the market, or to enable others skilled in the art to understand the embodiments disclosed herein.

[0039] The corresponding structure, material, acts, and equivalents of all means or functional element addition steps in the following claims are intended to include any structure, material, or act for performing a function in combination with other claimed elements as specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the invention. The embodiments were chosen and described to best explain the principles and practical application of the invention and to enable others skilled in the art to understand the invention in various embodiments with various modifications suitable for the particular uses contemplated.

[0040] These and other changes can be made to the present disclosure in light of the Detailed Description. While the above description describes particular embodiments of the present disclosure and sets forth the best mode contemplated, no matter how detailed the above appears in the text, the present teachings can be implemented in many ways. Details of the system may vary considerably in its implementation details while being encompassed by the subject matter disclosed herein. As noted above, a particular term used when describing a particular feature or aspect of the present disclosure should not be construed as implying that the term is redefined herein to be limited to any particular feature, feature, or aspect of the present disclosure to which it pertains. In general, the terms used in the following claims should not be construed to limit the disclosure to the specific embodiments disclosed herein unless the Detailed Description section above explicitly defines such terms. Thus, the actual scope of the present disclosure encompasses not only the disclosed embodiments but also all equivalent ways of practicing or implementing the disclosure under the scope of the claims.

[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the subject matter of this disclosure belongs. Although any methods, devices, and materials similar or equivalent to those described herein can be used in the practice or testing of the subject matter disclosed herein, representative methods, devices, and materials are now described.

[0042] Following long-standing patent law practice, the terms "a," "an," and "the" when used herein, including the claims, refer to "one or more." Thus, for example, reference to "a device" can include a plurality of such devices, and so forth.

[0043] Unless otherwise indicated, all numbers expressing quantities of ingredients, conditions, and the like used in the specification and claims are to be understood as being modified in all instances by the word "about." Accordingly, unless otherwise indicated, the numerical parameters set forth in the specification and appended claims are approximations that may vary depending upon the desired properties sought to be obtained by the subject matter disclosed herein.

[0044] As used herein, the term "about," when referring to values ​​or amounts of mass, weight, time, volume, concentration, and / or percentage, can include variations of + / -20%, in some embodiments + / -10%, in some embodiments + / -5%, in some embodiments + / -1%, in some embodiments + / -0.5%, and in some embodiments + / -0.1% from the specified amount, as appropriate in the disclosed packages and methods.

[0045] Various embodiments of the presently disclosed subject matter are directed to a respiratory mask assembly 10. Some embodiments of the presently disclosed subject matter are directed to a conduit coupler 100 (alternatively referred to as a "coupler 100" or simply a "coupler") for use with the respiratory mask assembly 10. In various examples, the respiratory mask assembly 10 comprises the conduit coupler 100 and a respiratory mask 1, and in some embodiments, the respiratory mask assembly 10 further comprises a nasal breathing assembly 5 and a tube 12 (e.g., a flexible conduit) for supplying fluid to the nasal breathing assembly 5. FIG. 1A illustrates the respiratory mask assembly 10 in an assembled configuration with the conduit coupler 100 assembled thereon, and FIG. 1B illustrates the respiratory mask assembly 10 in an assembled configuration applied to a person with the respiratory assembly with the conduit coupler 100 assembled thereon. According to at least one example, the respiratory mask assembly 10 may be used in conjunction with various commercially available continuous positive airway pressure (CPAP) devices, including, for example, the embodiments illustrated in FIGS. 14, 17, 18, 20, and 21.

[0046] In various embodiments, respiratory mask assembly 10 includes conduit coupler 100 having male member 24 and female member 22. Respiratory mask assembly 10 further includes respiratory mask 1 defining a central opening therethrough, the central opening sized to receive the male member therethrough. In one example, respiratory mask 1 may be disposable. In various embodiments, respiratory mask 1 can be made from any suitable material, including cloth, woven and nonwoven fabrics, paper, gauze, and polymers such as polypropylene, polyurethane, polyacrylonitrile, polystyrene, polycarbonate, polyethylene, and polyester. Respiratory mask assembly 10 also includes a gasket positioned between the male member and the respiratory mask, gasket 25 including central opening 36 to provide sealing. One channel opening of male member 24 and female member 22 connects to a continuous positive airway pressure (CPAP) mask, such as nasal breathing assembly 5, which connects to one or more of the patient's nares and oral cavity.

[0047] In various embodiments, the nasal breathing assembly 5 may be substituted or replaced with any other similar CPAP mask (configured to deliver fluid / gas to the patient's oral cavity or nostrils or both) that is a respiratory mask, such as respiratory mask 1 (as shown in FIG. 1 ) that can be used in conjunction with the nasal breathing assembly 5 to create a physical barrier between the wearer's mouth and nose on one side and potential contamination of the surrounding environment on the other side, or to prevent potential contamination emanating from the wearer's mouth and nose on one side from spreading to the surrounding environment on the other side.

[0048] The conduit coupler 100 can include a gasket 25, a female member 22, and a male member 24. In at least one embodiment, the gasket 25 can be in the form of a membrane having an orifice formed therethrough. One or both sides of the gasket 25 can include an adhesive for forming a sealing engagement with one or more of the male member 24, the female member 22, the inner surface 32 of the respirator 1, and the outer surface 34 of the respirator 1. In various embodiments, the gasket 25 can take any suitable shape. In some embodiments, the gasket 25 can effectively act as a washer to help maintain a substantial sealing engagement with one or more of the male member 24, the female member 22, the inner surface 32 of the respirator 1, and the outer surface 34 of the respirator 1. In various embodiments, the conduit coupler 100 acts to form a substantially airtight seal around the central opening 36 formed in the respirator 1. Both the male member 24 and the female member 22 define openings therethrough for fluid flow or for insertion of a tube or conduit, such as tubing 12, therethrough. In one embodiment, the female member 22 selectively engages with the male member 24 to form a substantially airtight connection therebetween. The coupler 100 further includes one or two gaskets 25 disposed between the male and female members. A side of at least one gasket is configured to sealably engage with a wall of the respiratory mask when the male member is inserted through a central opening 36 formed in the respiratory mask 1 and selectively engaged with the female member 22. The connector end of the female member 22 cooperates with a channel opening of a fluid source (e.g., a tube or conduit). In some implementations, the connector end of the female member can form a substantially airtight connection with the tube 12. The connector end of the male member 24 is in fluid communication with one or more of the patient's nares and oral cavity.

[0049] In some embodiments, the gasket 25 may engage or otherwise include one or more flexible adhesive sheets (not shown) to provide a sealable engagement with one or more of the male member, the female member, the respirator's inner surface 32, and the respirator's outer surface 34. The gasket 25 may be constructed from any known material, including, but not limited to, cloth, plastic, and / or latex. For example, in some embodiments, the gasket 25 may be composed of polyvinyl chloride, polyethylene, polyurethane, latex, or a combination thereof. In some embodiments, the gasket 25 may be foam medical tape, surgical tape, and / or hypoallergenic tape. One or both surfaces of the gasket 25 may include an adhesive. In one embodiment, the adhesive may be any medically safe adhesive known or used in the art. For example, the adhesive may be selected from one or more acrylates (e.g., methacrylates, alkyl acrylates, or epoxy diacrylates), acrylic acid, polyvinyl chloride, alkyl esters, or a combination thereof. In some embodiments, the adhesive may be a pressure-sensitive adhesive so that the gasket can be attached and removed as desired. The adhesive may be selected to cause mild or no irritation to the patient's skin. In some embodiments, the adhesive tape may be configured as a hydrocolloid tape and / or may include a polyurethane reactive layer. In some embodiments, the gasket 25 may include a peelable adhesive film.

[0050] In one embodiment, tubing 12 passes through male member 24, central opening 36, one or more gaskets 25, and female member 22 to supply fluid to inlet 38 of a nasal breathing assembly, such as nasal breathing assembly 5 shown in FIG. 14 , and tubing 12 may further form a substantially airtight connection with inlet 38, with the other end of tubing 12 fluidly communicating with a fluid source, for example, forming part of a CPAP machine. When male member 24 is coupled with female member 22, coupler 100 acts to form a substantially airtight seal around central opening 36, preventing or restricting the movement of any particles 0.3 microns or larger, e.g., particulates such as viruses, bacteria, fungi, and other similar microorganisms, across (or around the edges of) central opening 36 in any direction. In one embodiment, any particles 0.1 microns or larger in size are prevented or restricted from moving across (or around the edges of) central opening 36 in any direction. In one embodiment, any particle sized 0.01 microns or larger is prevented or limited from moving in any direction across (or around the edges of) the central opening 36. In one embodiment, any particle sized 1.0 microns or larger is prevented or limited from moving in any direction across (or around the edges of) the central opening 36. In one embodiment, any particle sized 10.0 microns or larger is prevented or limited from moving in any direction across (or around the edges of) the central opening 36.

[0051] Embodiments of the presently disclosed subject matter may advantageously allow a person to simultaneously wear both a continuous positive airway pressure (CPAP) mask and a respirator (e.g., an N95 respirator, etc.). Embodiments of the presently disclosed subject matter may serve to reduce or eliminate the spread of contagious diseases from a person wearing the respiratory mask assembly 10 to medical professionals and caregivers who may spend time in close proximity to the patient. Embodiments of the presently disclosed subject matter may further serve to reduce or eliminate the spread of contagious diseases from airborne microorganisms present in the vicinity of the person wearing the respiratory mask assembly 10 to the person wearing the respiratory mask assembly 10. Thus, embodiments of the presently disclosed subject matter may allow a person / patient to simultaneously wear both a continuous positive airway pressure (CPAP) assembly and a respirator, thereby preventing or limiting the movement of 0.01 micron-sized, 0.1 micron-sized, 0.3 micron-sized, 1.0 micron-sized, or 10.0 micron-sized airborne particles across the central opening 36 in either direction (inward or outward).

[0052] In at least one embodiment, the connector 100 includes two gaskets 25, a first gasket 25 that contacts the exterior surface 34 of the respirator 1 to form a substantially airtight seal, and a second gasket that contacts the interior surface 32 of the respirator to form a substantially airtight seal. In the same embodiment, the other side of the first gasket 25 contacts the female member 22 to form a substantially airtight seal, and the other side of the second gasket 25 contacts the male member 24 to form a substantially airtight seal. In this embodiment, the connector 100 operates to form a substantially airtight seal around the central opening 36 formed in the respirator 1 through the use of two gaskets 25. Both sides of each gasket 25 include an adhesive or adhesive tape.

[0053] In at least one embodiment, the respirator is configured to block at least 95 percent of particles 0.3 microns or larger in size (i.e., an N95 respirator or N95 respirator). In one embodiment, the respirator is a surgical mask. In one embodiment, gasket 25 is in the form of a membrane having an orifice formed therethrough for a portion of male member 24 to be inserted therethrough to form a substantially airtight seal.

[0054] N95 respirators and surgical masks (face masks) are examples of personal protective equipment used to protect the wearer from airborne particles and from liquids that contaminate the face. The Centers for Disease Control and Prevention (CDC), the National Institute for Occupational Safety and Health (NIOSH), and the Occupational Safety and Health Administration (OSHA) regulate N95 respirators. N95 respirators are respiratory protective devices designed to achieve a very close face fit and highly efficient filtration of airborne particles. The edges of the respirator are designed to form a seal around the nose and mouth. Surgical N95 respirators are commonly used in healthcare settings and are a subset of N95 Filtering Facepiece Respirators (FFRs), often referred to as N95s.

[0055] A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the wearer's mouth and nose and potential contamination in the surrounding environment. Surgical masks are regulated under 21 CFR 878.4040. Surgical masks should not be shared and may be labeled as surgical masks, isolation masks, dental masks, or medical procedure masks. They may or may not include a face shield. While they are often referred to as face masks, not all face masks are regulated as surgical masks. Surgical masks are manufactured with various thicknesses and performance characteristics to protect the wearer from contact with liquids and fluids. These characteristics can also affect how easily the wearer can breathe through the face mask and how well the surgical mask protects the wearer. When worn properly, surgical masks are intended to help block large particle droplets, droplets, mists, or spatter, which may contain pathogens (viruses and bacteria), preventing them from reaching the mouth and nose. Surgical masks may also help reduce exposure of saliva and respiratory secretions to others. While surgical masks can be effective at blocking droplets and large particles, face masks, by design, do not filter or block very small airborne particles that can be transmitted by coughing, sneezing, or certain medical procedures. Surgical masks also do not provide complete protection from pathogens and other contaminants due to the loose fit between the face mask surface and the face. Surgical masks are not intended to be used more than once. If the mask becomes damaged or soiled, or if breathing through it becomes difficult, remove the face mask, safely dispose of it, and replace it with a new one. To safely dispose of a mask, place it in a plastic bag and place it in a trash can. Hands should be washed after handling a used mask. When worn properly, surgical masks are intended to help block large droplets, sprays, mists, or spatter that may contain pathogens (viruses and bacteria) and prevent them from reaching the mouth and nose. Surgical masks can also help reduce exposure of the wearer's saliva and respiratory secretions to others.

[0056] People with chronic respiratory, cardiac, or other medical conditions that make breathing difficult should exercise caution when using N95 respirators, as the N95 respirator may make breathing more difficult for the wearer. Embodiments of the presently disclosed subject matter can help overcome this drawback, allowing the N95 respirator to operate in conjunction with a CPAP or other similar positive air pressure device. Specifically, a respirator mask 1 in the form of an N95 respirator can be attached to a breathing assembly, such as a nasal breathing assembly 5 (as shown in FIG. 1 ), to create a physical barrier between the wearer's nose and mouth and potential hot springs in the surrounding environment (or to prevent potential contamination from the wearer's nose and mouth from spreading to the surrounding environment).

[0057] In various embodiments, the gasket is formed from an adhesive foam material. In at least one embodiment, the gasket is formed from a stretchable elastomeric material. The elastomeric material can further include an adhesive material for forming a sealable engagement with a surface of the male component, a surface of the female component, and the inner and / or outer surface of a respiratory mask, such as an N95 respirator. In one embodiment, one or more sides of the gasket include a releasable adhesive film. In one embodiment, one or more sides of at least one gasket include an adhesive material. In one embodiment, the gasket forms an interference fit with the male component. In one embodiment, both sides of the gasket include a releasable adhesive film. In one embodiment, both sides of the gasket include an adhesive material.

[0058] In one embodiment, the female member removably couples with the male member. In one embodiment, the female member threads onto threads formed on the male member. In one embodiment, the female member includes one or more release devices that can be pivoted to selectively engage the male member. In one embodiment, the female member selectively engages the male member with a quick disconnect mechanism.

[0059] In one embodiment, the channel opening of the fluid source comprises a flexible tube connected to the fluid source. In one embodiment, the fluid source comprises a continuous positive airway pressure (CPAP) source. In one embodiment, the fluid source is selected from a high flow generator, a continuous positive airway pressure (CPAP) machine, a fluid tank, a medicated fluid source, or a humidifier. In one embodiment, the fluid is selected from a gas, a mixture of gases, or a gas with a medication.

[0060] A nasal breathing assembly 5 (see FIG. 14 ) can be attached to a patient in accordance with one or more embodiments of the presently disclosed subject matter. In one embodiment, the nasal breathing assembly 5 is as described in U.S. Provisional Application No. 62 / 855,193, filed May 31, 2019, the entire contents of which are incorporated herein by reference. In one embodiment, the nasal breathing assembly 5 can be replaced with a breathing assembly, such as a respiratory mask assembly 10, as described in International Patent Application No. PCT US / 2018 / 019109, filed August 31, 2018, the entire contents of which are incorporated herein by reference.

[0061] In some embodiments, the fluid source can be a high-flow generator, a continuous positive airway pressure (CPAP) machine, a fluid tank, a humidifier, or any other fluid source known or used in the art. As used herein, the term "fluid" refers to any gas, mixture of gases, or gas with a medication (such as an aerosol medication) suitable for delivery to a human airway. Flexible tubing, such as tubing 12 shown in FIG. 1 , can be coupled to an inlet to deliver fluid from a fluid source, and the tubing can include any known flexible tubing. As used herein, the term "tubing" refers to any conduit, delivery conduit, tube, pipe, passage, or channel through which a fluid flows. As used herein, the term "flexible" refers to any tubing that can bend or bend, flexes, and easily conforms to the general shape and contours of the human body. In some embodiments, tubing 12 can be constructed from medical-grade materials such as, but not limited to, polyurethane, polyvinyl chloride, polyamide, polyester, polyolefin, silicone resin, fluoropolymer, and combinations or copolymers thereof. The tubing is flexible, resilient, and hollow. In some embodiments, the tube can have an inner diameter of about 2-4 mm, although tubes with larger or smaller diameters can be used. For example, the inner diameter of the tube can be increased or decreased to tailor to a particular wearer's preferences and / or needs. In some embodiments, the tube can be hooked over the patient's ear during use and can be elevated under the chin during use.

[0062] According to one or more embodiments, a method for forming a substantially airtight seal around an opening formed in a respiratory mask is provided. In at least one embodiment, the method includes providing a respiratory assembly conduit coupler. The coupler includes a male member and a female member defining an opening therethrough for fluid flow, the female member being selectively engageable with the male member to form a substantially airtight connection therebetween, and at least one gasket disposed between the male member and the female member. A side of the at least one gasket is configured to sealably engage with a wall of the respiratory mask when the male member is inserted through the opening formed in the respiratory mask and selectively engaged with the female member. A connector end of the female member cooperates with a channel opening of a continuous positive airway pressure (CPAP) machine to form the substantially airtight connection. The connector end of the male member is in fluid communication with one or more of the patient's nares and oral cavity. The method further includes forming an opening in the respirator, inserting a male member through the opening formed in the respirator, and selectively engaging the male member with the female member such that the at least one gasket forms a substantially airtight, sealable engagement with a wall of the respirator.

[0063] According to various embodiments, a respiratory assembly conduit coupler for forming a substantially airtight seal around an opening formed in a respiratory mask is provided. In various embodiments, the coupler includes a male member and a female member defining an opening through which fluid can flow, the female member being selectively engageable with the male member to form a substantially airtight connection therebetween, and at least one gasket is provided between the male member and the female member. A side of the at least one gasket is configured to sealably engage with a wall of the respiratory mask when the male member is inserted through the opening formed in the respiratory mask and selectively engaged with the female member. A connector end of the male member cooperates with a channel opening of a fluid source to form a substantially airtight connection. The connector end of the female member is in fluid communication with one or more of the patient's nares and oral cavity. Thus, the position of the male member can be interchanged with the position of the female member.

[0064] The respiratory assemblies disclosed herein have a wide variety of uses. For example, in some embodiments, the assemblies can be used for high-flow delivery of respiratory mask gases through the nasal assembly. In some embodiments, the ambient air can be heated to near body temperature (e.g., about 37°C) and / or humidified (e.g., about 100% relative humidity) to reduce airway moisture loss, airway cooling, nasal irritation, etc. In high-flow therapy, an oxygen source is typically mixed with compressed air, allowing for the delivery of air, a mixture of about 22% to about 99% air and oxygen, or 100% oxygen through the use of an oxygen blender. Advantageously, the disclosed assemblies include tubing large enough to deliver a flow rate of respiratory gases of up to about 50 liters per minute for an adult. The nasal assembly and its components are also small enough to prevent sealing of the nares, allowing flow during exhalation and allowing excess gas to escape during inhalation. Advantageously, the delivered flow rate can meet the inhalation flow rate, so the delivered gas is not diluted by room air.

[0065] Alternatively, or additionally, the disclosed breathing assembly can be used in conjunction with a continuous positive airway pressure (CPAP) machine. CPAP machines typically apply a gentle continuous air pressure to keep a patient's airway continuously open. As a result, a CPAP machine used in conjunction with a patient's stent advantageously opens the alveoli in the lungs, thus recruiting more of the lung's surface area for ventilation. CPAP machines are commonly used for people with breathing problems, such as sleep apnea. Alternatively, CPAP machines can be used to treat premature infants whose lungs are not yet fully developed. In some embodiments, the disclosed assembly can be used as a replacement for a traditional CPAP mask.

[0066] The disclosed respiratory assembly can further be used for pressure recording applications in clinical settings, such as for diagnosing sleep apnea or other disorders. In particular, sleep apnea can be diagnosed based on characteristic clinical features associated with episodes of hypopnea and breathing cessation that define apneic events. The disclosed device can be used to measure nasal pressure by measuring nasal pressure using nasal prongs connected to a pressure transducer.

[0067] The disclosed assemblies can also be used with fluid tanks, humidifiers, or any other fluid source known or used in the art. Advantageously, the disclosed assemblies can eliminate the ear and lip pain commonly associated with conventional respiratory masks and cannulas. Additionally, the disclosed assemblies can allow for better control of gas (e.g., oxygen) during fluid delivery applications. In some embodiments, the disclosed assemblies are strapless and maskless, thereby increasing comfort of use. As a result, patients are more likely to use the assembly as directed by their physician. Additionally, unsightly mask and strap skin indentations are eliminated. The disclosed assemblies are less likely to be inadvertently removed by patients, such as during exercise or when pressed against a pillow.

[0068] In some embodiments, the disclosed respiratory assembly includes a disinfection enclosure that can be used to disinfect reusable portions of a CPAP assembly. As used herein, the term "disinfection" refers to the elimination of all or nearly all forms of microorganisms. The disinfection enclosure can include an active oxygen and / or UV light generator used to clean and / or disinfect reusable CPAP components. For example, in some embodiments, the generator can generate active oxygen to disinfect the interior contents of the enclosure and the reusable APAP system. Active oxygen (also known as O3 or ozone) is a safe, naturally occurring gas that has been shown to kill virtually all known forms of viruses in water and air. In particular, active oxygen has been shown to disrupt the metabolism of bacterial cells, likely by inhibiting and blocking the operation of enzyme control systems. Sufficient amounts of active oxygen can penetrate cell membranes, resulting in the destruction of bacteria. Active oxygen destroys viruses by diffusing through their protein coats into their nucleic acid cores, causing damage to the viral RNA. At higher concentrations, active oxygen can destroy viral capsids through oxidation, affecting their DNA or RNA structure. Reactive oxygen species have been shown to be effective in destroying dozens of harmful pathogens, including E. coli, influenza viruses, staphylococci, streptococci, stomatitis viruses, and many more.

[0069] In some embodiments, the generator can generate active oxygen concentrations of approximately 10-500 ppm (parts per million) within the disclosed system and / or enclosure. In some embodiments, the generator can generate UV light to disinfect the interior of the enclosure and the contents of an associated CPAP device. To this end, the generator can include one or more ultraviolet lights that can be activated for a preset period of time. UV light is highly effective at inactivating microorganisms, including bacteria, viruses, yeast, and mold. In some embodiments, the UV light is in the range of approximately 100-280 nanometers, which is known to damage DNA molecules in bacteria, viruses, mold, yeast, and other microorganisms, preventing them from replicating and causing harm.

[0070] The disinfection enclosure can kill approximately 99% of mold, bacteria, and viruses in a CPAP user's socket (or mask), tubing, humidifier, and CPAP chamber. In addition to being highly effective, the disinfection enclosure is designed for ease of use. The user simply places the socket or mask in the disinfection enclosure, closes the lid, and walks away. Importantly, no disassembly of the CPAP device is required before the disinfection process begins. Advantageously, the disinfection enclosure can be used daily. In one embodiment, the disinfection enclosure is configured to support several disinfection cycles performed per day. The enclosure can be configured in any desired shape, such as round, oval, square, triangular, elliptical, hexagonal, pentagonal, star-shaped, or solid. The enclosure can be configured in any desired size. In some embodiments, the enclosure can have a relatively small size compared to the size of the CPAP assembly. For example, the enclosure may have a height, width, and depth of less than about 5 inches, about 5.0, 4.75, 4.5, 4.25, 4.0, 3.75, 3.5, 3.25, 3.0, 2.75, 2.5, 2.25, 2.0, 1.75, 1.5, 1.25, etc. However, the enclosure may have any desired size to accommodate a particular CPAP element therein.

[0071] 13 illustrates a respiratory assembly 110 in which the respiratory mask 101 is a surgical mask, as is well understood in the art. The respiratory assembly may otherwise share the same or similar features as the respiratory mask assembly 10.

[0072] 14 illustrates a nasal breathing assembly 5 that can be attached to a patient along with a respiratory mask assembly 10, according to one or more embodiments of the presently disclosed subject matter. As illustrated, the nasal breathing assembly 5 includes a seat 27 configured to engage the patient's nares (i.e., nostrils). The nasal breathing assembly also includes socket magnet posts 20. One end of each socket magnet post 20 is configured to be removably attached to a ferromagnetic dome ring on the seat 27 in the presence of a magnetic field, and the other end of each socket magnet post 20 is configured to engage an opening in the nasal connector 90. Thus, the nasal breathing assembly 5 includes a pair of seats 27, each defining an opening 17 sized and shaped to fit over a patient's nostril, with a ferromagnetic dome-shaped ring disposed on an underside of the seat and circumferentially aligned with the opening, and an upper side of the seat configured to sealably engage a nostril. The nasal breathing assembly 5 includes a pair of socket magnet posts 20, each including a magnetic ring 50 (e.g., in the form of a magnetic ring as shown in FIG. 1 ) disposed at a first end and a post receptacle 35 disposed at a second end having a passageway extending from the first end to the second end. The magnetic ring 50 removably attaches to the dome-shaped ring at the outlet end 16. In one embodiment, the magnetic ring 50 is configured to pivotally move or rotate around the surface of the dome-shaped ring in a ball-and-socket configuration while maintaining a substantially airtight connection at the interface between the magnetic ring 50 and the dome-shaped ring. The nasal connector 90 of the nasal breathing assembly 5 includes a pair of channel openings, each sized and shaped to cooperate with one of the post receptacles 35 to form a substantially airtight connection, such that the channel 37 of the socket magnet post 20 aligns with the channel opening of the nasal connector 90, and includes an inlet, such as a vent fitting, at the vent end configured to fluidly communicate with tubing 12 connected to a fluid source. In one embodiment, a vent, such as vent 70 , is located between the vent fitting and the pipe 12 .Vent 70 includes a vent receptacle sized and shaped to cooperate with a fitting to form a substantially airtight connection, and inlet 38 is sized and shaped to cooperate with a tube, such as tube 12 shown in FIG. 1, to form a substantially airtight connection.

[0073] In some embodiments, each magnetic ring 50 may be in the form of a plurality of magnets 250 arranged in an array around the sheet-facing side of a magnet socket 52 disposed around the first end of the socket magnet post 20. In other embodiments, each magnetic ring 50 may be in the form of a single ring magnet disposed around the sheet-facing side of a magnet socket 52 disposed around the first end of the socket magnet post 20.

[0074] Thus, in at least one embodiment, each socket magnet post 20 may include a magnetic ring 50 including a plurality of magnets 250 forming an array as shown in FIG. 15 , instead of a magnetic ring 50 including a single ring magnet as shown in FIG. 14 . In one embodiment, the plurality of magnets 250 may take the form of magnetic pellets embedded within the magnetic ring 50 of the socket magnet post 20, for example, using 3D printing techniques commonly known in the art. Thus, the magnetic ring 50 may include a plurality of magnets 250 arranged in an array around the sheet-facing side of the magnetic ring 50. In various embodiments, the polarity of the magnets 250 may be arranged such that each magnet 250 has an opposite polarity to adjacent magnets 250. In other words, polarity may alternate among the plurality of magnets 250 arranged in an array on the magnetic ring 50. Thus, the plurality of magnets 250 of alternating polarities may be attached to the ring 262 (which may be a ferromagnetic ring or a magnetic ring in various embodiments) by magnetic attraction. In one embodiment, the socket magnet post 20 may be formed by 3D printing techniques. In various embodiments, the array of magnets 250 may be substantially planar. In various embodiments, the plane of the array of magnets 250 may be substantially planar with respect to a transverse plane passing through the center of the magnetic ring 50. In various embodiments, the array of magnets 250 may be arranged concentrically.

[0075] As commonly known in the art, 3D printing or additive manufacturing is the construction of three-dimensional objects from CAD models or digital 3D models. The term "3D printing" can refer to various processes in which materials are deposited, joined, or solidified under computer control to create three-dimensional objects; materials (e.g., plastic, liquid, or powder particles fused together) are typically added layer by layer. The precision, repeatability, and material range of 3D printing have increased to the point where some 3D printing processes are considered viable as industrial production techniques, thereby allowing the term additive manufacturing to be used synonymously with 3D printing. One of the key advantages of 3D printing is its ability to produce highly complex shapes or geometries that would otherwise be impossible to construct by hand, including hollow parts or parts with internal truss structures, thereby reducing weight. Fused deposition modeling, or FDM, is a common 3D printing process currently in use in 2020.

[0076] According to one embodiment, the nasal breathing assembly 5 includes a pair of seats, each seat defining an opening sized and shaped to fit over a patient's nostril, a ferromagnetic ring disposed on an underside of the seat in circumferential alignment with the opening, and an upper side of the seat configured to sealably engage the nostril. The nasal breathing assembly 5 includes a pair of socket-magnet posts 20. Each socket-magnet post 20 includes a magnetic ring 50 disposed on a first end of the post and a ball-shaped receptacle disposed on a second end of the post, the magnetic ring 50 including an array of magnets 250. The magnetic rings 50 are removably attachable to the ferromagnetic rings. The nasal breathing assembly further includes a connector having a pair of socket openings at the post ends, each sized and shaped to receive and form a substantially airtight connection with the ball-shaped receptacle within the ball-and-socket arrangement, and an inlet at the vent end for fluid communication with a flexible tube connected to a fluid source. The array of magnets can include a magnet concentrically disposed on the first end of the post. The array of magnets can include a plurality of magnetic pellets embedded in the first end of the post. The post 20 can be 3D printed.

[0077] The nasal breathing assembly 5 includes at least one vent 70 for receiving therapeutic gas into the patient's nasal passages. One end of the vent 70 has an inlet 38 configured to connect to a fluid source (not shown) via fluid tubing, such as the tube 12 that supplies respiratory gas, and a vent receptacle located at the other end of the vent 70 engages a vent coupling of the nasal connector 90. Thus, the nasal breathing assembly 5 can include one or more vents 70 positioned proximal to where fluid flow occurs. It should be understood that the vent 70 can be positioned in any desired location and is not limited to the locations shown herein. In some embodiments, the vent 70 can include a socket containing an adapter. The adapter can be constructed in any desired shape to enable connection with the tube 12 (the tube 12 is shown in FIG. 1). In such embodiments, the outer diameter of the adapter is larger than the inner diameter of the tube 12. In this manner, the adapter can be retained within the tube for a desired period of time and will not be accidentally removed by the patient, such as during sleep. However, the adapter may be releasably connected to the tube 12 using any known mechanism.

[0078] In some embodiments, the fluid source may be a high-flow generator, a continuous positive airway pressure (CPAP) machine, a fluid tank, a humidifier, or any other fluid source known or used in the art. As used herein, the term "fluid" refers to any gas, mixture of gases, or gas with medication (such as an aerosol medication) suitable for delivery to a human airway. A flexible tube, such as the tube shown in FIG. 1 , can be coupled to inlet 38 to supply fluid from a fluid source, and the tube can include any known flexible tube. As used herein, the term "tube" refers to any conduit, delivery conduit, tube, pipe, passage, or channel through which a fluid flows. The term "flexible" as used herein refers to any tube that can flex or bend, is compliant, and easily conforms to the general shape and contours of the human body. In some embodiments, tube 12 can be constructed from medical-grade materials such as, but not limited to, polyurethane, polyvinyl chloride, polyamide, polyester, polyolefin, silicone resin, fluoropolymer, and combinations or copolymers thereof. The tube is flexible, elastic, and hollow. In some embodiments, the tube can have an inner diameter of about 2-4 mm, although tubes with larger or smaller diameters can be used. For example, the inner diameter of the tube can be increased or decreased to tailor it to the preferences and / or needs of a particular wearer. In some embodiments, the tube can be hooked over the patient's ear and elevated under the chin during use.

[0079] Socket magnet posts 20 extend through magnetic ring 50 toward ring 262 (shown in FIG. 17 ) of sheet 27, which is configured as contact nasal prongs. Sheet 27 is configured to attach to the wearer's nares such that fluid received at inlets 38 is delivered into the wearer's nares through respective openings 17 in sheet 27. Ring 262 (which may be dome-shaped in some embodiments) is fabricated as an integral component of sheet 27 such that the openings in ring 262 are aligned with respective openings 17 in sheet 27.

[0080] In some embodiments, as shown in FIG. 15 , for example, each socket magnet post 20 is configured to be removably attached to a respective ring 262 of the sheet 225 via a plurality of magnets 250 arranged in an array around the sheet-facing side of the magnet socket 52, and disposed around a first end of the socket magnet post 20. Thus, in one embodiment, each socket magnet post 20 can include a plurality of magnets 250 (as shown in FIG. 15 ) instead of a single ring as shown in FIG. 14 . In one embodiment, the plurality of magnets 250 can take the form of magnet pellets embedded within the magnet socket 52 of the socket magnet post 20, for example, using 3D printing techniques commonly known in the art. Thus, the magnet socket 52 of the embodiment of FIG. 15 is configured to accommodate a plurality of magnets 250 arranged in an array around the sheet-facing side of the magnet socket 52. In various embodiments, the polarity of the magnets 250 can be arranged such that each magnet 250 has an opposite polarity to adjacent magnets 250. In other words, polarity may alternate among the plurality of magnets 250 arranged in an array on the magnet socket 52. For example, in the embodiment of FIG. 15 , the exposed sides of magnets 250a and 250c (i.e., the sides exposed on FIG. 15 ) may have a north polarity, while the exposed sides of magnets 250b and 250d may have a south polarity. Thus, the plurality of magnets 250 of alternating polarity may be attached to the ring 262 by magnetic attraction. In one embodiment, the socket magnet post 20 may be formed by 3D printing techniques. In various embodiments, the array of magnets 250 may be substantially planar. In various embodiments, the plane of the array of magnets 250 may be substantially planar with respect to a cross-section passing through the center of the magnet socket 52. In various embodiments, the array of magnets 250 may be arranged concentrically.

[0081] In some embodiments, the magnet socket 52 (i.e., the top surface of the socket magnet post 20) may be angled relative to the post body 30 to allow for enhanced attachment to the ring 262 of the seat 27 for better positioning over the patient's nares. The seat 27 may be configured to attach to the wearer's nares such that fluid received at the inlets 38 is delivered into the wearer's nares through the respective openings 17 of the seat 27. The ring 262 (which may be dome-shaped in some embodiments) is fabricated as an integral component of the seat 27 such that the openings in the ring 262 are aligned with the respective openings 17 of the seat 27. As shown in FIG. 15 , the top end of each socket magnet post 20 includes a magnet socket 52 that houses a plurality of magnets 250 arranged in an array. The socket magnet post 20 further includes a post body 30, a post receptacle 35, and a central opening 36. In some embodiments, the socket magnet posts 20 are parallel or nearly parallel to one another. While each magnet 250 can be cylindrical or pellet-shaped, other shapes are possible without departing from the spirit of the subject matter of this disclosure, and similarly, ring 262 may take other shapes such that any shape taken by ring 262 complements or matches the configuration / arrangement of magnet 250. In various embodiments, ring 62 is made of a ferromagnetic material so as to be attracted by the magnetic field of magnet 250 to form a substantially airtight connection or attachment. In some embodiments including an HFO source and / or HFNC, the top end of each socket magnet post 20 can include a magnet socket 52 configured to receive a magnet, such as magnet 250.

[0082] According to one embodiment, the nasal breathing assembly 5 includes a pair of seats, each seat defining an opening sized and shaped to fit over a patient's nostril, a ferromagnetic ring disposed on an underside of the seat in circumferential alignment with the opening, and an upper side of the seat configured to sealably engage the nostril. The nasal breathing assembly 5 includes a pair of socket-magnet posts 20. Each socket-magnet post 20 includes a magnetic ring in the form of a magnet socket 52 disposed at a first end of the post and a ball-shaped receptacle disposed at a second end of the post, a passageway extending from the first end to the second end, and the magnet socket 52 includes an array of magnets 250. The magnet socket 52 is removably attachable to the ferromagnetic ring. The nasal breathing assembly further includes a connector having a pair of socket openings at the post ends, each socket opening sized and shaped to receive and form a substantially airtight connection with the ball-shaped receptacle within the ball-and-socket arrangement, and an inlet at the vent end for fluid communication with a flexible tube connected to a fluid source. The array of magnets can include magnets concentrically disposed on the first end of the post. The array of magnets can include a plurality of magnetic pellets embedded in the first end of the post. The post 20 can be 3D printed.

[0083] 16 shows a port magnet post 120 that can be used in place of the socket magnet post 20 in the nasal breathing assembly 5. The port magnet post 120 can replace the socket magnet post in the nasal breathing assembly 5. The port magnet post 120 includes a ball-shaped receptacle 135 that cooperates with the socket opening of the nasal connector 90 in a ball-and-socket configuration. The ball-shaped receptacle is configured to pivotally move or rotate around the inner surface of the socket opening while maintaining a substantially airtight connection with the socket opening.

[0084] In some embodiments, as shown in FIG. 16 , for example, each port magnet post 120 is configured to be removably attached to a respective ring 262 of the seat 227 via a plurality of magnets 250 disposed around the seat-facing side of a magnet socket 152 disposed around a first end of the port magnet post 120. Each ring 262 includes an opening 217. Thus, in one embodiment, each port magnet post 120 can include a plurality of magnets 250 (as shown in FIG. 16 ) instead of a single ring magnet as shown in FIG. 14 . In one embodiment, the plurality of magnets 250 can take the form of magnet pellets embedded within the magnet socket 152 of the port magnet post 120, for example, using 3D printing techniques commonly known in the art. Thus, the magnet socket 152 of the embodiment of FIG. 16 is configured to accommodate a plurality of magnets 250 disposed around the seat-facing side of the magnet socket 152. In various embodiments, the polarity of the magnets 250 can be arranged such that each magnet 250 has an opposite polarity to adjacent magnets 250. In other words, the polarity may be alternated among the multiple magnets 250 disposed on the magnet socket 152. Thus, the multiple magnets 250 of alternating polarity may be attached to the ring 262 by magnetic attraction. In one embodiment, the port magnet post 120 may be formed by any commonly known 3D printing technique.

[0085] The magnet 250 disposed on the magnet socket 152 is removably attached or coupled to a ring 262 (which is a ferromagnetic ring) at the port magnet post outlet end. In one embodiment, the magnet socket 152 is configured to move or rotate around the surface of the ring 262 while maintaining a substantially airtight connection at the interface between the magnet 250 and the ring 262. Thus, the ring 262 can advantageously prevent or reduce the possibility of inadvertent disengagement of the nasal connector 90 when a wearer of the nasal breathing assembly 5 moves their head, either while awake or asleep, thereby enabling a continuous supply of therapeutic gas to the patient's (or wearer's) nares under ideal pressure. In at least one embodiment, the ring 262 can allow the magnet socket 152 to move or rotate around the surface of the ring 262 while maintaining a substantially airtight connection when the face of a patient wearing the nasal breathing assembly 5 is moved in sudden, jerky movements. In at least one embodiment, the ring 262 allows the magnetic socket 152 to move or rotate around the surface of the ring 262 when the wearer's pillow contacts or applies a shear force to the nasal breathing assembly 5 or a portion of the tube supplying fluid to the nasal breathing assembly 5, while still maintaining a substantially airtight connection with the wearer's pillow.

[0086] FIG. 17 illustrates a nasal breathing assembly 205 including a port magnet post 220 that can be used in place of the socket magnet post 20. The port magnet post 220 of the nasal breathing assembly 205 includes a receptacle that cooperates with an opening of the nasal connector 290 in a substantially airtight configuration. In one embodiment, a vent, such as vent 270, is disposed between a vent fitting and a tube, such as tube 12 shown in FIG. 1, to form a substantially airtight connection. The vent 270 can have features similar to the vent 70. In some embodiments, as shown in FIG. 17, for example, each port magnet post 220 is configured to be removably attached to a respective ring 262 of the seat 227 via multiple magnets 250 disposed around the seat-facing side of the magnet socket 152, with the magnet socket 152 disposed around the first end of the port magnet post 220. Thus, in one embodiment, each port magnet post 220 can include multiple magnets 250 (as shown in FIG. 17) instead of a single ring magnet as shown in FIG. 14. In one embodiment, the plurality of magnets 250 can take the form of magnet pellets embedded within the magnet socket 252 of the port magnet post 220, for example, using 3D printing techniques commonly known in the art. Thus, the magnet socket 152 of the embodiment of FIG. 16 is configured to accommodate the plurality of magnets 250 arranged around the seat-facing side of the magnet socket 252. In various embodiments, the polarity of the magnets 250 can be arranged such that each magnet 250 has an opposite polarity to adjacent magnets 250. In other words, the polarity of the plurality of magnets 250 arranged on the magnet socket 252 can alternate. Thus, the plurality of magnets 250 of alternating polarity can be attached to the ring 262 by magnetic attraction. In one embodiment, the port magnet post 220 can be formed by any commonly known 3D printing technique.

[0087] The ring 262 may or may not have a dome shape. The top surface of the port magnet post 220 may be angled, for example, as shown in FIG. 17 . A magnet socket 252 is disposed around a first end of the port magnet post. In some embodiments, the magnet socket 252 (e.g., the port magnet post top surface) may be angled relative to the body of the port magnet post 220 to allow for enhanced attachment of the seat 227 to the ring 262 for better positioning over the patient's nares.

[0088] The remaining components of nasal breathing assembly 205 have substantially similar or identical features to the respective components of nasal breathing assembly 5, and are components of nasal breathing assembly 205 designated by a numerical designation including a 100th prefix of "2" used to label each parallel component of nasal breathing assembly 5. For example, sheet 227 of nasal breathing assembly 205 may be substantially similar or identical to sheet 27 of nasal breathing assembly 5.

[0089] 18 and 19 illustrate components of nasal breathing assemblies 405A and 405B according to one or more embodiments of the presently disclosed subject matter. As illustrated in FIG. 18 , nasal breathing assembly 405A includes a telescoping tube 410 in fluid communication with a hollow elbow 480A, with a swivel connection 454 operative to provide a substantially tight connection between the telescoping tube 410 and elbow 480A. Swivel connection 454 allows for convenient pivotal movement of one of elbow 480A and telescoping tube 410 relative to the other. The end of elbow 480A facing nasal connector 490 is sized and shaped to cooperate with and form a substantially tight fit with the vent end of nasal connector 490. Thus, through a hollow opening through elbow 480A, the vent end of nasal connector 490 facing elbow 480A is configured for fluid communication with flexible tubing 410 connected to a fluid source. Thus, in one embodiment, a hollow elbow, such as elbow 480A, is located between nasal connector 490 and telescoping tube 410.

[0090] Elbow 480A includes a CO2 exhaust 491A sized and shaped to facilitate the exhaustion of CO2 exhaled by a patient wearing nasal breathing assembly 405A. Similarly, elbow 480B includes a CO2 exhaust 491B sized and shaped to facilitate the exhaustion of CO2 exhaled by a patient wearing nasal breathing assembly 405B. Each of nasal breathing assemblies 405A and 405B can further include a diffuser cap 492 that can be attached to elbow 480A via corresponding recessed notches 493 (see FIG. 18 ) on both sides of elbow 480A and elbow 480B and a protrusion on the diffuser cap with recessed notch sections positioned diagonally from each other. CO2 exhaust 491A operates to ensure that the patient's inspiratory force is not obstructed and to ensure the exit of excess fluid. CO2 exhaust 491A can be sized and shaped in any desired manner and can be positioned near any area where fluid flow occurs. The CO2 exhaust 491A can be varied in size and location so that the manipulation of the total inhalation fluid (e.g., for carbon dioxide) can be controlled and the flow rate can be varied to a desired setting. In some embodiments, the CO2 exhaust 491A can comprise extremely thin polymer fibers, membranes, and / or coatings (e.g., nanoscale to microscale).

[0091] Nasal connector 490 can be constructed of silicone or other similar flexible materials in accordance with one or more embodiments of the presently disclosed subject matter. The side of nose connector 490 facing the vent end (i.e., the end opposite the end facing elbow 480A) includes a flange, such as flange 470A, as shown in FIG. 18 . Flange 470A at the seat end of nose connector 490 can include silicone or other similar flexible materials in accordance with one or more embodiments of the presently disclosed subject matter. As shown in FIG. 18 , flange 470A secures two slip rings, such as slip rings 460A, 460B, 460C, or 460D, within flange 470A, which includes a silicone sheet or other similar material. Each slip ring 460A, 460B, 460C, or 460D securely holds a respective magnet array 450A, 450B, 450C, or 450D within. As shown in FIG. 18, magnet array 550 includes ridges 402 that circumferentially surround magnet array 550, and magnet array 650 includes grooves 404 that circumferentially surround magnet array 650.

[0092] In various embodiments, each magnet array 450A, 450B, 450C, or 450D can include either a groove 404 or a ridge 402 surrounding the magnet array. The magnet ring 404 or ridge 402 in the form of magnet array 450A, 450B, 450C, or 450D operates to provide a secure connection between the magnet ring in the form of magnet array 450A, 450B, 450C, or 450D and the magnet ring in the form of a respective slip ring 460A, 460B, 460C, or 460D. Each slip ring is made of a flexible material. In some embodiments, each slip ring can include a material, such as LDPE (low-density polyethylene), at or near its inner edge to hold magnet array 450A, and a material, such as styrene butadiene copolymer (SBC) sold under the trade name K-resin®, at or near its outer edge. The combination of materials forming part of the slip ring can advantageously allow the circular magnet array 450A to swivel within and near the respective slip ring 460A, for example, while being fixed thereto. In various embodiments, the magnet array 450A, 450B, 450C, or 450D can have any suitable shape, such as circular, oval, oval, or teardrop-shaped, and the shape of the opening in the respective ferromagnetic ring 462A, 426B, 426C, or 426D complements or matches the shape of the channel opening in the magnet ring. The materials used in the construction of the slip ring 460A, 460B, 460C, or 460D can conveniently provide the magnet array 450A, 450B, 450C, or 450D for pivotal movement relative to the respective slip ring 460A, 460B, 460C, or 460D. In some embodiments, the slip rings may further include a soft, renewable membrane that surrounds the magnet array and fills the remaining air gap within each slip ring between its outer and inner edges to help increase the comfort of a patient wearing the nasal breathing assembly by reducing or eliminating the torque felt by the patient's nose on the assembly during use of the assembly by the patient.In some embodiments, the soft renewable membrane may comprise a silicone resin or other similar material that can advantageously reduce or eliminate torque that may be felt at a patient's nose on the assembly during use of the assembly by the patient. In some embodiments, the entire slip ring may consist solely of the magnet array 450A, 450B, 450C, or 450D and the soft renewable membrane that surrounds the magnet array and fills all air gaps within the slip ring.

[0093] In some embodiments, as shown by way of example in the upper right portion of FIG. 18 , each magnet array 450A can comprise a plurality of magnets 250 arranged in a circular array, e.g., instead of the single ring magnet illustrated in FIG. 14 . Thus, in one embodiment, each magnet array 450A can comprise a plurality of magnets 250 (as shown in the magnet array 450A depicted in the upper right corner of FIG. 18 ) instead of the single ring magnet illustrated in FIG. 14 . In one embodiment, the plurality of magnets 250 can take the form of, for example, magnetic pellets embedded within the magnet array 450A using 3D printing techniques commonly known in the art. The magnet array 450A of the embodiment of FIG. 18 is configured to comprise a plurality of magnets 250 arranged around the periphery of the sheet surface of the magnetic array 450A. In various embodiments, the polarity of the magnets 250 can be arranged such that each magnet 250 has an opposite polarity to adjacent magnets 250. In other words, polarity can alternate among the plurality of magnets 250 arranged on each magnet array 450A. Thus, multiple magnets 250 of alternating polarity can be attached to the ferromagnetic ring 462A by magnetic attraction. In one embodiment, the port magnet post 220 can be formed by any commonly known 3D printing technique.

[0094] It should be noted that while Figure 18 illustrates only magnet array 450A, which includes an array of magnets 250, each of the other magnet arrays 450B, 450C, or 450D includes a magnet array similar to magnet array 450A, and such magnets 250 of magnet arrays 450B, 450C, or 450D are not shown in Figure 18 due to space limitations. Each of magnet arrays 450A, 450B, 450C, or 450D can be magnetically secured to and substantially intimately connected to ferromagnetic rings 462A, 462B, 462C, or 462D (see Figure 19), respectively, of sheets 425A, 425B, 425C, or 425D (see Figure 19), respectively, through magnetic attractive forces. In various embodiments, each magnet array 450A, 450B, 450C, or 450D is attached to a respective ferromagnetic ring 462A, 462B, 462C, or 462D via a plurality of magnets 250 disposed on each magnet facing side of each magnet array 450A, 450B, 450C, or 450D, accordingly. Providing ferromagnetic rings 462A-462D with various peripheral shapes affixed to sheets 425A-425D can enable an improved patient experience when integrated into nasal breathing assembly 405A or nasal breathing assembly 405B that can be attached to a patient.

[0095] In some further embodiments, the inner portion of the space between the outer periphery of the magnet array and the outer contour of the slip ring (i.e., the portion adjacent the outer periphery of the magnet array) includes a thin, slender, loose, highly flexible, and forgiving silicone resin layer configured to bounce against the slip ring or against the magnet array, which helps accommodate movements initiated by the patient during use of the nasal breathing assembly to reduce torque. In the same embodiments, the outer portion of the space between the outer periphery of the magnet array and the outer contour of the slip ring (i.e., the portion adjacent the outer periphery of the slip ring) can include a thinner, less flexible, and thicker silicone layer relative to the portion adjacent the outer periphery of the magnet array. Furthermore, the material of the flange 470A adjacent and surrounding the slip ring can include a less slender, less flexible, and thicker silicone layer than the portion that interfaces with the outer edge of the magnet array. Such a configuration can help further increase the comfort level of a patient wearing a nasal breathing assembly by reducing or eliminating the torque felt by the patient's nose on the assembly during use by the patient.

[0096] In various embodiments, the outer edges of slip rings 460A, 460B, and 460C may be of standard dimensions, but the dimensions of the slip ring's inner openings may vary depending on the size and shape of the internal openings configured and adapted for each received magnet array. In other words, the slip ring's inner openings are sized and shaped to securely hold the received magnet array. Thus, the dimensions of the internal openings are different for each of circular magnet array 450A, elliptical magnet array 450B, egg-shaped magnet array 450C, and teardrop-shaped magnet array 450D.

[0097] For example, the circular magnet array 450A, carried by the slip ring 460A, is magnetically secured to the ferromagnetic ring 462A (see FIG. 19 ) of the sheet 425A, forming a substantially intimate relationship therewith. During use of the nasal breathing assembly 405A by a patient, when the circular magnet array 450A is removably attached to the ferromagnetic ring 462A (see FIG. 19 ) of the sheet 425A, the upper ends of the channel openings 415 on the circular magnet array 450A of the nose connector 490 are in fluid communication with the interiors of the wearer's nares, while the lower ends of the channel openings 415 are in fluid communication with the interior of the nose connector 90 such that breathing fluid flows from the flexible tube 410, through the elbow 480A, through each channel opening 415 in the flange 470A, through the openings 417A in each sheet 425A, and into the interiors of the wearer's nares. Thus, each channel opening 415 provides a unique pathway for conveying fluid from a fluid source to the patient's nares.

[0098] The nasal breathing assembly 405A can further include a pair of sheets, such as sheets 425A, 425B, 425C, or 425D, each sized and shaped to fit over a patient's nostril, with a respective ferromagnetic ring 462A, 462B, 462C, or 462D located on an underside of the sheet and positioned around the periphery of the opening, with an upper side of the sheet configured for sealable engagement with the nostril. The channel opening 415 of the circular magnet array 450A has a circular cross-section that complements / matches the circular cross-section of the opening 417A in the sheet 425A. The channel opening 415 of the circular magnet array 450B has an oval cross-section that complements / matches the oval cross-section of the opening 417B in the sheet 425B. The channel opening 415 of the circular magnet array 450C has an oval intersection that complements / matches the oval cross-section of the opening 417C in the sheet 425C. The channel opening 415 of the circular magnet array 450D has a teardrop cross-section that complements / matches the teardrop cross-section of the opening 417D of the sheet 425D. Thus, each of the magnet arrays 450A, 450B, 450C, or 450D is configured to engage with a respective ferromagnetic ring 462A, 462B, 462C, or 462D (see FIG. 19 ) of a sheet 425A, 425B, 425C, or 425D (see FIG. 19 ). Each sheet 425A, 425B, 425C, or 425D is configured to engage a patient's nostril. Each sheet 425A, 425B, 425C, or 425D directly contacts the patient's nostril or the outside of the patient's skin surrounding the nostril. The sheets can be configured to provide a flush, sealable engagement with the patient's nostril.

[0099] In various embodiments, each sheet 425A, 425B, 425C, or 425D engages or includes one or more stretchable adhesive sheets (not shown) to provide a sealable engagement with the patient's nares. Sheets 425A, 425B, 425C, or 425D can be constructed from any known material, including, but not limited to, woven fabric, plastic, and / or latex. For example, in some embodiments, the sheets can be constructed from PVC, polyethylene, polyurethane, latex, or combinations thereof. In some embodiments, sheets 425A, 425B, 425C, or 425D can be foam medical tape, surgical tape, and / or hypoallergenic tape. The patient-contacting surface of sheets 425A, 425B, 425C, or 425D can include an adhesive. The adhesive can be any medically safe adhesive known or used in the art. For example, the adhesive can be selected from one or more acrylates (e.g., methacrylates, alkyl acrylates, or epoxy diacrylates), acrylic acid, polyvinyl chloride, alkyl esters, or combinations thereof. In some embodiments, the adhesive is a pressure-sensitive adhesive such that the sheet can be adhered to and removed from a patient's skin as desired. The adhesive can be selected to exhibit mild or no irritation to the skin with daily use. In some embodiments, the adhesive tape can be configured as a hydrocolloid tape and / or include a polyurethane reaction layer that adheres better to the nostrils as the patient's body temperature warms the adhesive. Alternatively, in some embodiments, the adhesive can be applied directly to the patient's nostrils or nose-engaging portions (e.g., no sheet is used) to provide a removable connection. In various embodiments, each sheet 425A, 425B, 425C, or 425D, or the adhesive body therein, is configured to conform to the shape of a respective magnet array 450A, 450B, 450C, or 450D (shown in FIG. 18 ).

[0100] In various embodiments, providing the magnet array 450A, 450B, 450C, or 450D to rest directly or closely against the surface of the discontinuity can significantly reduce torque. Moreover, the ability of the magnet array 450A, 450B, 450C, or 450D to shift and spin helps to significantly reduce torque. In other words, the ability of the magnet array 450A, 450B, 450C, or 450D to pivot on the slip ring 460A, 460B, 460C, 460D, or 460D that securely holds the magnet array 450A, 450B, 450C, or 450D while maintaining an airtight connection with the respective ferromagnetic ring 462A, 462B, 462C, or 462D can help increase the comfort of a patient wearing the nasal breathing assembly by reducing or eliminating the torque that may be felt at the patient's nose on the assembly during use by the patient.

[0101] Thus, in various embodiments, the nasal breathing assembly 405A can include a pair of seats 425C, each sized and shaped to fit over a patient's nostril, a ferromagnetic ring 462C positioned on the underside of the seat in circumferential alignment with the opening, and an upper side of the seat 425C configured to sealably engage the nostril. The nasal breathing assembly 405A further includes a nasal connector 490 including a pair of slip rings 460C at the ends of the seats, each slip ring 460C including a magnet array 450C defining a channel opening 415, the magnet array 450C configured to pivotally tilt about the slip ring 460C, and each magnet array 450C sized and shaped to be removably attached to and form a substantially airtight connection with one of the ferromagnetic rings 462C. In various embodiments, the channel openings can also have a circular, elliptical, oval, teardrop, or other similar shapes. The opening in the ferromagnetic ring can have a shape that complements / matches the shape of the channel opening in the magnetic ring. For example, opening 417C in ferromagnetic ring 462C can have a circular shape that complements / matches the circular shape of the channel opening in the magnetic ring.

[0102] In at least one embodiment, each magnet array 450A, 450B, 450C, or 450D is detachable to a ring 227 of a respective sheet 262 (see FIG. 17) via a plurality of magnets 250 disposed on the periphery of each magnet array 450A, 450B, 450C, or 450D.

[0103] The nasal breathing assembly 405A can further include a hollow elbow 480A that connects the inlet of the outlet end of the coupler to a flexible tube 410 that is connected to a fluid source. In some embodiments, a swivel connection 454 can connect the hollow elbow 480A to the flexible tube 410.

[0104] The lower right side of FIG. 18 further illustrates a nasal breathing assembly 405B according to one or more embodiments of the subject matter of the present disclosure. The nasal breathing assembly 405B can have the same or similar components as the nasal breathing assembly 405A, except as otherwise described herein. The nasal breathing assembly 405B can omit a nasal coupler, such as the nasal coupler 490; in other words, in the nasal breathing assembly 405B, the flange 470B can be attached directly to the seat end of the elbow 480B, opposite the side of the elbow 480B that includes the swivel joint 454. The swivel joint 454 connects to the flexible tube 410 in a manner that allows the flexible tube 410 to swivel relative to the elbow 480B. The CO2 exhaust 491B can be configured similarly or equivalently to the CO2 exhaust 491A. In some embodiments, nasal breathing assembly 405B can include a pair of flexible tubes 410, one for each nostril, an elbow 480B, and a flange 470B. In some embodiments, flange 470B can include two slip rings on the same single flange, for example, with respect to flange 470A in FIG. 18. Nasal breathing assembly 405B can be similar or identical to, and operate similarly to, nasal breathing assembly 405A in all other respects.

[0105] The remaining components of nasal breathing assembly 405A and nasal breathing assembly 405B have substantially similar or identical features to the respective components of nasal breathing assembly 5, and the components of nasal breathing assembly 405A / 405B are labeled with numbers including the 100th prefix of "4" used to label each of the parallel components of nasal breathing assembly 5. For example, sheet 427 of nasal breathing assembly 405A / 405B may be substantially similar or identical to sheet 27 of nasal breathing assembly 5. In some embodiments, the remaining components of nasal breathing assembly 405A and nasal breathing assembly 405B may have substantially similar or identical features to the respective components of nasal breathing assembly 105, that is, the components of nasal breathing assembly 405A / 405B labeled with numbers including the 100th prefix of "4" instead of the "1" used to label each of the parallel components of nasal breathing assembly 105. For example, the magnetic array 450 of the nasal breathing assembly 405A / 405B may be substantially similar to or identical to the magnet 250 of the nasal breathing assembly 205. As a further example, the sheet 425 of the nasal breathing assembly 405A / 405B may be substantially similar to or identical to the sheet 125 of the nasal breathing assembly 205.

[0106] According to at least one embodiment, the nasal breathing assembly 405A / 405B includes a pair of seats 425A, 425B, 425C, or 425D, each seat 425A, 425B, 425C, or 425D sized and shaped to fit over a patient's nostril, a ferromagnetic ring 462A, 462B, 462C, or 462D disposed on an underside of the seat in circumferential alignment with the opening, and an upper side of the seat 425A, 425B, 425C, or 425D configured for sealable engagement with the nostril. The nasal breathing assembly 405A / 405B further includes a nasal connector 490. The nose connector 490 includes a pair of slip rings 460A, 460B, 460C, or 460D at its seat end, each of which houses a magnetic ring in the form of a magnet array 450A, 450B, 450C, or 450D. Each slip ring 460A, 460B, 460C, or 460D defines a channel opening, and the magnetic rings form a series of magnetic. The magnetic rings in the form of magnet array 450A, 450B, 450C, or 450D are configured to pivot relative to the slip ring. The magnetic rings in the form of magnet array 450A, 450B, 450C, or 450D are sized to be attached to and substantially closely connected to any of the ferromagnetic rings 462A, 462B, 462C, or 462D. The nasal breathing assembly 405A / 405B further includes an inlet at the outlet end that fluidly communicates with a telescoping tube connected to a fluid source. The channel opening has a circular, elliptical, oval, or teardrop shape. The opening of the ferromagnetic ring has a circular (e.g., ferromagnetic ring 462A), oval (e.g., ferromagnetic ring 462B), oval (e.g., ferromagnetic ring 462C), or teardrop shape (e.g., ferromagnetic ring 462D), and the shape of the opening of the ferromagnetic ring matches the shape of the channel opening of the magnetic ring in the form of a magnet array 450A, 450B, 450C, or 450D. The magnet array can include magnets 250 arranged centrally at the sheet edge of the slip ring 460A, 460B, 460C, or 460D. The slip ring can be 3D printed.

[0107] 20 illustrates a nasal breathing assembly 105 that can be attached to a patient in conjunction with the respiratory mask assembly 10, according to one or more embodiments of the presently disclosed subject matter. Thus, the nasal breathing assembly 105 can replace the nasal breathing assembly 5 of the respiratory mask assembly 10 in at least one embodiment. Thus, the nasal breathing assembly 105 can be used in conjunction with the coupler 100 and the respiratory mask 1.

[0108] 21 illustrates a nasal breathing assembly 605 that can be attached to a patient along with the respiratory mask assembly 10, according to one or more embodiments of the presently disclosed subject matter. Thus, the nasal breathing assembly 605 can replace the nasal breathing assembly 5 of the respiratory mask assembly 10 in at least one embodiment.

[0109] 22-25 illustrate additional embodiments of a coupler 100 that may form part of a respiratory mask assembly 10 according to one or more embodiments of the presently disclosed subject matter. In various embodiments, the gasket may take on a variety of sizes and shapes without departing from the spirit of the present invention.

[0110] The respirator 1 described herein and the connector 100 described herein can be used in conjunction with any common CPAP mask, CPAP assembly, and other positive airway pressure masks and respiratory aids. The respirator 1 described herein and the connector 100 described herein can further be used in conjunction with any common respirator, including N95 respirators, surgical masks, and any other respirator capable of filtering particulate matter or microorganisms currently or in the future available on the market.

[0111] FIG. 26 shows a schematic perspective view of a snap lid 200 provided on a respirator 1 to provide access to a central opening 36 formed on the respirator 1. In various embodiments, access to the central opening 36 (shown in FIG. 3) can be achieved by opening an exterior cover provided on the snap lid 200. The snap lid 200 can have a substantially flat top in the closed position. Thus, in some embodiments, the snap lid 200 is provided on the respirator 1 to cover the central opening 36 of the respirator 1, whereby an exterior cover 212 of the snap lid 200 can be opened to provide access to the central opening 36. The exterior cover 212 is folded over a frame 214 provided around the central opening 36. When the exterior cover 212 is folded over and snapped onto the frame 214 to close the snap lid 200, a substantially airtight seal is formed between the exterior cover 212 of the snap lid 200 and the frame 214 of the snap lid 200. Tabs 221 are provided on the snap lid 200 to snap open the outer cover 212 and snap the outer cover 212 closed.

[0112] The outer cover 212 may be folded onto the frame 214 and snapped to close the snap lid 200 by folding a hinge 216 connecting the outer cover 212 and the frame 214. The frame 214 may include an outer lip 218 that seals the frame 214 around the edge or circumference of a central opening 36 formed on a respiratory mask, such as the respiratory mask 1. In various embodiments, the snap lid 200 may include the outer cover 212 hingedly connected to the frame 214 located on the edge or circumference of the central opening 36 formed on the respiratory mask 1. In various embodiments, the frame 214 is molded, adhered, or otherwise integrated into the fabric from which the respiratory mask 1 is formed. The upper surface of the raised portion 222 of the outer cover 212 is substantially flat. In various embodiments, the central opening 36 is configured to accommodate any tubing 12 connected to a fluid supply that supplies fluid from a device, such as a CPAP fluid supply, a high-flow technology device, or any other non-invasive ventilation option.

[0113] 27 illustrates several additional embodiments of snap lids 200 that can be incorporated into a respiratory mask 1, such as an N95 respirator. The snap lids described herein can be used in conjunction with any common CPAP mask, CPAP assembly, and other positive airway pressure masks and respiratory aids. The snap lids described herein can further be used in conjunction with any common respirator, including N95 respirators, surgical masks, and any other respirator capable of filtering particulate matter or microorganisms available on the market today or in the future.

[0114] In some embodiments, the connector 100 may be inserted through the frame 214 after the outer cover 212 is opened to expose the central opening 36, after which the gasket 25 forming part of the connector 100 operates to engage with or include one or more flexible adhesive sheets (not shown) to provide a sealable engagement with one or more of the male member, the female member, the frame 214, the inner wall or inner surface 32 of the respirator, and the outer surface 34 of the respirator.

[0115] In some embodiments, frame 214 can include a sealing mechanism that provides a substantially airtight seal around tube 12 inserted therethrough, such that coupler 100 may not be required. In various embodiments, the sealing mechanism can be an adhesive layer, a peel-back adhesive, or other similar sealing mechanism. In at least one embodiment, the sealing mechanism can be in the form of an elastomeric membrane or gasket (similar to gasket 25 described above) extending from or otherwise coupled to frame 214 that is configured to form a substantially airtight seal between tube 12 and frame 214.

[0116] 28-31 illustrate various aspects of a poly-magnet forming part of a continuous positive airway pressure (CPAP) mask, such as a nasal breathing assembly 5, that couples to one or more of a patient's nostrils and oral cavity, according to some embodiments of the presently disclosed subject matter. In some embodiments, each magnetic ring 50 can be in the form of one or more programmed magnets or poly-magnets 350, as shown, for example, in FIGS. 28-31 . In some embodiments, ring 262 can replace or otherwise include poly-magnets 350. Similarly, in some embodiments, magnet 250, as referred to herein, can also represent poly-magnets 350. In some embodiments, each magnetic ring 50 can be in the form of a plurality of poly-magnets 350 arranged in an array around the seat-facing side of magnet socket 52, which is disposed around the first end of socket magnet post 20. In another embodiment, each magnetic ring 50 can be in the form of a single-ring poly-magnet disposed around the seat-facing side of magnet socket 52, which is disposed around the first end of socket magnet post 20. Thus, in at least one embodiment, each socket magnet post 20 can include a magnetic ring 50 including one or more poly magnets 350 forming an array as shown in FIG. 15, instead of a magnetic ring 50 including a single ring poly magnet 350 as shown in FIG. 14.

[0117] In one embodiment, the one or more poly magnets 350 may further take the form of poly magnet pellets embedded within the magnetic ring 50 of the socket magnet post 20, for example, using 3D printing techniques commonly known in the art. Thus, the magnetic ring 50 may include one or more poly magnets 350 arranged in an array around the sheet-facing side of the magnetic ring 50. In various embodiments, the polarity within and between each poly magnet 350 may be arranged to maximize the intended effect of maintaining a substantially airtight connection between the magnetic ring 50 and the ring 262, which may otherwise be inadvertently detached while the CPAP device wearer is asleep. For example, in one embodiment, both the magnetic ring 50 and the ring 262 may be latching poly magnets, as described herein.

[0118] Thus, in at least one embodiment, one or more polymagnetic materials 350 of the magnetic ring 50 can have alternating polarities, and the magnetic ring 50 is attached to the ring 262 by magnetic attraction. In one embodiment, the socket magnet post 20 including one or more polymagnets 350 can be formed by 3D printing techniques. In one embodiment, the ring 262 including one or more polymagnets 350 can be formed by 3D printing techniques. In at least one embodiment, the one or more polymagnets 350 can be substantially planar. In various embodiments, the plane of the one or more polymagnetic materials 350 can be substantially planar with respect to a cross section passing through the center of the magnetic ring 50. In various embodiments, the one or more polymagnetic materials 350 can be arranged concentrically.

[0119] Polymagnets 350, such as those shown in Figures 28A-31F, can represent magnetic structures incorporating correlated patterns of magnets with alternating polarities designed to achieve desired behavior and deliver stronger localized forces. By varying the magnetic field and strength, different mechanical behaviors can be controlled. Polymagnets 350 can be programmed or encoded by varying the polarity and / or magnetic field strength of each source in the array of magnetic sources that make up each structure. The resulting magnetic structures, when fabricated using electromagnetic arrays, can be one-, two-, three-, or even four-dimensional. In one embodiment, encoding theory used to design radio frequency signals in communications and radar can be applied to form the magnetic domains of correlated magnets. A 3D magnetization printer, such as the "MagPrinter" developed by the American company Collated Magnetics Research (CMR), Huntsville, AL, can be used to fabricate polymagnets 350. This printer consists of magnetization coils in a cabinet with a motion control system. In various embodiments, polymagnet printers can be used to create multi-pole encoded magnets containing small magnetic elements called maxcels. This technology can be used to produce better attachment forces, safer magnets, precision alignment, shear and torque stiffness, and complex multi-stage / multi-force control on scales not easily achieved with conventional magnets. Poly magnet printers use engineered encoding of polar patterns into magnets that can be tailored to meet specific application requirements, enabling magnets with unique features, multiple forces per magnetic face, stronger forces especially at the magnet face, control over the "extent" and "shape" of the magnetic field, and enhanced breakaway and shear forces that can be several times stronger than those seen with conventionally magnetized materials.

[0120] Thus, polymagnets 350 can be fabricated by reprogramming conventional magnetic materials in minutes. With polymagnets, magnetic couplings can have a softer "feel" or snappier or crisper closure or opening behavior, and can be given a spring or latch feel. In conventional magnets, there is a north pole on one surface and a south pole (S pole) on the opposite surface (see Figures 28Ai, 28Bii, 28Ci, and 28Di), and magnetic field lines flow from pole to pole. In contrast, in polymagnets, numerous small polarized (N or S) magnetic pixels ("maxells") are fabricated by printing them in the desired pattern on the same surface (see Figures 28Aii, 28Aiii, 28Bi, 28Cii, and 28Dii), and magnetic field lines are completed between the maxells on that surface, resulting in a very compact and powerful magnetic field. This basic concept is illustrated in Figures 28Aii, 28Aiii, 28Bi, 28Cii, and 28Dii. Therefore, the mechanical 3D behavior of a PolyMagnet, such as the PolyMagnet 350, can be determined by the pattern and strength of Maxell embedded into the magnet's surface. Customizable behaviors include spring, latch, shear, align, snap, torque, hold, twist, soften, and release. Compact magnetic field configurations reduce magnetic interference with other equipment.

[0121] Most prefabricated magnets have a simple nature: one side is north and the other is south. Instead of a simple north-south arrangement, Polymagnets allow customizable patterns to be designed in software and programmed into the magnet in minutes. Polymagnets can be manufactured in any quantity, from prototypes to production quantities. Because the patterns are created in software, they can be changed and new prototypes can be delivered in days. While traditional magnets do not necessarily align when attached to each other, Polymagnets can be programmed to achieve various types of alignment. Polymagnets can be configured to be extremely powerful because their magnetic energy is concentrated near the surface. Polymagnets can be up to five times stronger than traditional magnets.

[0122] Polymagnets, when used in pairs, can utilize magnetic attraction and repulsion, as well as the idea of ​​controlled cancellation or interaction of these forces in space. Arrangements or patterns of magnetic regions (called maxels) can create unique magnetic circuits that define the function of a magnetic device and its interaction with other magnets or ferrous metals. Correlated magnet pairs (e.g., magnetic ring 50 in the form of one or more polymagnets and ring 262 in the form of one or more polymagnets) can be programmed to attract or repel with a predetermined force and engagement distance, or to attract or repel with a specific spatial orientation. Correlated magnets can be programmed to interact only with other magnetic structures coded to respond to them. Correlated magnets can also be programmed to attract and repel simultaneously.

[0123] Compared to conventional magnets, correlated magnets provide much stronger coercive forces and stronger shear resistance to targets. Programmable behavior can be achieved by creating multipole structures containing multiple magnetic elements (maxells) of various sizes, positions, orientations, and saturations. Maxell sizes range from 1 mm to 4 mm. By stacking these maxells, highly complex magnetic fields can be generated. Correlated magnetic materials can be developed from ferrites, rare earths (e.g., neodymium magnets, samarium-cobalt magnets), ceramics, electromagnets, etc., and the correlation effect is scalable from very large permanent magnets to nanometer-scale elements. Multipole magnetic devices can be constructed from individual permanent magnets or by exposing heated magnetizable materials to coded magnetic fields. Polymagnets can be designed to align with a wide variety of alignment functions. There are four main functions that correlated magnets can achieve:

[0124] Attach Poly Magnet (see Figure 29A): The magnetic field of the Attach Poly Magnet is designed to be close to the surface of the magnet. This feature provides increased safety from a distance and concentrates the field to be stronger. For best results, traction tape can be used.

[0125] Latch Poly Magnets (see Figure 29D): Latch poly magnets are configured so that the magnet pair repels until a defined transition point is passed, after which the polarity reverses and they attract. They can be used in sliding and rotary latches.

[0126] Spring poly magnets (see Figures 29B and 29C) can be configured to attract until they pass a defined transition point, at which point they repel and come to rest at an equilibrium distance.

[0127] Alignment Poly Magnets (see Figures 30A and 30B): Conventional magnets do not necessarily align when attached to one another, whereas poly magnets can be designed to align with a wide variety of alignment features. Alignment poly magnets can provide rotational alignment, twist release, and axial centering. Rotational alignment poly magnets (see Figure 30B) are designed to be attached together and have rotational detents or alignment positions. Twist release poly magnets attract in one position and repel when rotated. Centering alignment poly magnets (see Figure 30A) are designed to be attached together with high shear / sliding forces.

[0128] Figure 28Ai shows the magnetic field lines of a conventional magnet with magnetic field lines flowing from a single north pole to a single south pole. Figure 28Bii illustrates a conventional magnet including a single north pole and a single south pole.

[0129] Figures 28Aii and 28iii show the magnetic field lines of a polymagnet containing many small polarized (N or S) magnetic pixels ("maxels") fabricated by printing in a desired pattern on the same surface, with the magnetic field lines completing between the maxels on that surface, resulting in a very compact and strong magnetic field.

[0130] Figure 28Ci shows the magnetic field lines of a rod-shaped conventional magnet with field lines running from a single north pole to a single south pole. Figure 28Di shows the conventional magnet of Figure 28Ci attached to a ferromagnetic bar.

[0131] Figure 28Ci shows the magnetic field lines of a bar-shaped polymagnet containing many small polarized (N or S) magnetic pixels, with the magnetic field lines completed between each pair of N-S pole combinations, resulting in a very compact and strong magnetic field. Figure 28Dii shows the polymagnet of Figure 28Cii attached to a ferromagnetic bar.

[0132] Figure 29A shows two mounted poly magnets, designed so that the magnetic field is close to the surface of the magnet. This feature provides increased safety from a distance and concentrates the field to be stronger.

[0133] FIG. 29B illustrates two spring polymagnets that can be configured to attract until they pass a defined transition point, repel beyond the transition point, and rest at an equilibrium distance.

[0134] FIG. 29C shows another set of two spring magnets that can be configured to attract until they pass a defined transition point, repel beyond the transition point, and rest at an equilibrium distance that is set to be greater than the equilibrium distance set for the embodiment of FIG. 29B.

[0135] FIG. 29D shows two latching polymagnets configured to repel until the magnet pair passes a defined transition point, after which they reverse polarity and become attracted.

[0136] Figure 30A shows two mounted poly magnets designed so that the magnetic field is close to the surface of the magnet. This feature provides increased safety from a distance and concentrates the field to be stronger.

[0137] Although the embodiments have been described in connection with the preferred embodiment of the various figures, it should be understood that other similar embodiments may be used, or modifications and additions may be made to the described embodiments to perform the same function without departing from there. Therefore, the disclosed embodiments should not be limited to any single embodiment, but rather should be construed in breadth and scope in accordance with the appended claims.

[0138] Any dimensions expressed or implied in the drawings and these descriptions are provided for illustrative purposes. Accordingly, all embodiments within the drawings and these descriptions are not made to such illustrative dimensions. The drawings are not necessarily drawn to scale. Accordingly, all embodiments within the drawings and these descriptions are not made to the drawings' apparent scale with respect to the drawings' relative dimensions. However, for each drawing, at least one embodiment is made to the drawings' apparent relative scale.

[0139] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the subject matter of this disclosure belongs. Although any methods, devices, and materials similar or equivalent to those described herein can be used in the practice or testing of the subject matter disclosed herein, representative methods, devices, and materials are now described.

[0140] Following long-standing patent law practice, the terms "a," "an," and "the" when used herein, including the claims, refer to "one or more." Thus, for example, reference to "a device" can include a plurality of such devices, and so forth.

[0141] The description of various embodiments of the present invention has been presented for illustrative purposes, but is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terms used herein have been selected to best explain the principles of the embodiments, practical applications or technical improvements to technology found in the market, or to enable others skilled in the art to understand the embodiments disclosed herein. [Different aspects of the present invention] (Item 1) 1. A breathing assembly for use in conjunction with a continuous positive airway pressure (CPAP) device, comprising: a conduit coupler comprising a male member and a female member; a cloth-based disposable respiratory mask defining a central opening therethrough sized to receive said male member; a gasket positioned between the male member and the respiratory mask, the gasket surrounding the central opening to provide a seal for the central opening; A breathing assembly in which a channel opening in one of the male and female members connects to a continuous positive airway pressure (CPAP) mask that connects to one or more of the patient's nostrils and oral cavity. (Item 2) Item 10. The respiratory assembly of item 1, wherein the respiratory mask is configured to block at least 95 percent of particles 0.3 microns or larger in size. (Item 3) 10. The respiratory assembly of claim 1, wherein the respiratory mask is a surgical mask. (Item 4) 10. The breathing assembly of claim 1, wherein the gasket comprises an adhesive foam material. (Item 5) 10. The breathing assembly of claim 1, wherein the gasket is formed from a stretchable elastomeric material. (Item 6) 10. The breathing assembly of claim 1, wherein at least one major surface of the gasket comprises a peelable adhesive film. (Item 7) 10. The breathing assembly of claim 1, wherein at least one major surface of the gasket comprises an adhesive material. (Item 8) 10. The respirator assembly of claim 1, wherein the respirator assembly comprises two gaskets, one gasket surrounding the central opening on each side of the respirator wall. (Item 9) Item 1. A breathing assembly as described in item 1, wherein a female member selectively engages with the male member. (Item 10) Item 10. The breathing assembly of item 1, wherein both sides of the gasket comprise one or more of a peelable adhesive film and an adhesive material. (Item 11) Item 14. The breathing assembly of item 1, wherein the central opening comprises a snap-on lid. (Item 12) 1. A breathing assembly for use in conjunction with a continuous positive airway pressure (CPAP) device, comprising: a respiratory mask defining an opening; a conduit coupler that forms a substantially airtight seal around the opening in the respiratory mask; the conduit coupler includes male and female members each defining a bore therethrough into which a conduit fits; a sleeve of the male member passes through the opening in the respiratory mask and selectively engages with the female member; a gasket disposed between the female member and the respirator to form a substantially airtight seal between the sleeve and the opening of the male member when the male member selectively engages the female member; a connector end of the female member in fluid communication with a channel opening of a fluid source; The connector end of the male member is in fluid communication with a CPAP mask assembly, which in turn is a breathing assembly that couples to one or more of the patient's nostrils and oral cavity. (Item 13) a pair of sheets, each sheet defining an opening sized and shaped to fit a nostril of the patient, a ferromagnetic ring positioned on an underside of the sheet and aligned around the opening, an upper side of the sheet configured to sealably engage the nostril; a pair of posts, each post including a magnetic ring positioned at a first end thereof and a ball-shaped receiver positioned at a second end thereof, a passageway extending from the first end to the second end thereof, the magnetic ring including an array of magnets, the magnetic ring being removably attachable to the ferromagnetic ring; a connector having a pair of socket openings at a post end, each sized and shaped to receive a ball-shaped receptacle in a ball-and-socket configuration and form a substantially airtight connection therewith, and having an inlet at a vent end in fluid communication with a flexible tube connected to a fluid source. (Item 14) Item 14. The nasal breathing assembly of item 13, wherein the array of magnets comprises magnets arranged concentrically at the first end of the post. (Item 15) Item 14. The nasal breathing assembly of item 13, wherein the array of magnets comprises a plurality of magnetic pellets embedded in the first end of the post. (Item 16) Item 14. The nasal breathing assembly of item 13, wherein the struts are 3D printed. (Item 17) a pair of sheets, each sheet defining an opening sized and shaped to fit a nostril of the patient, a ferromagnetic ring positioned on an underside of the sheet and aligned around the opening, an upper side of the sheet configured to sealably engage the nostril; a connector including a pair of slip rings at the seat ends, each slip ring housing a magnetic ring; Each slip ring defines a channel opening; the magnetic ring comprises an array of magnets; the magnetic ring is configured to be tiltable pivotally about the slip ring; the magnetic ring is sized and shaped to be removably attachable to the ferromagnetic ring so as to form a substantially gas-tight connection therewith; an inlet at the vent end in fluid communication with a flexible tube connected to a fluid source; A nasal breathing assembly, wherein the channel opening has a circular, rectangular, oval, or teardrop shape. (Item 18) Item 18. The nasal breathing assembly of item 17, wherein the opening of the ferromagnetic ring has a circular, rectangular, oval, or teardrop shape, and the shape of the opening of the ferromagnetic ring matches the shape of the channel opening of the magnetic ring. (Item 19) Item 18. The nasal breathing assembly of item 17, wherein the array of magnets comprises magnets arranged concentrically at the seat end of the slip ring. (Item 20) Item 18. The nasal breathing assembly of item 17, wherein the slip ring is 3D printed. [Other aspects of the present invention] (Other item 1) 1. A breathing assembly for use in conjunction with a continuous positive airway pressure (CPAP) device, comprising: a respiratory mask defining an opening; a conduit coupler that forms a substantially airtight seal around the opening in the respiratory mask; the conduit coupler includes male and female members each defining a bore therethrough into which a conduit fits; a sleeve of the male member passes through the opening in the respiratory mask and selectively engages with the female member; a gasket disposed between the female member and the respirator to form a substantially airtight seal between the sleeve and the opening of the male member when the male member selectively engages the female member; a connector end of the female member in fluid communication with a channel opening of a fluid source; The connector end of the male member is in fluid communication with a CPAP mask assembly, which in turn is a breathing assembly that couples to one or more of the patient's nostrils and oral cavity. (Other items 2) a pair of sheets, each sheet defining an opening sized and shaped to fit a nostril of the patient, a ferromagnetic ring positioned on an underside of the sheet and aligned around the opening, an upper side of the sheet configured to sealably engage the nostril; a pair of posts, each post including a magnetic ring positioned at a first end thereof and a ball-shaped receiver positioned at a second end thereof, a passageway extending from the first end to the second end thereof, the magnetic ring including an array of magnets, the magnetic ring being removably attachable to the ferromagnetic ring; a connector having a pair of socket openings at a post end, each sized and shaped to receive a ball-shaped receptacle in a ball-and-socket configuration and form a substantially airtight connection therewith, and having an inlet at a vent end in fluid communication with a flexible tube connected to a fluid source. (Other items 3) 3. The nasal breathing assembly of claim 2, wherein the array of magnets comprises magnets arranged concentrically at the first end of the post. (4 other items) 3. The nasal breathing assembly of claim 2, wherein the array of magnets comprises a plurality of magnetic pellets embedded in the first end of the post. (5 other items) 3. The nasal breathing assembly of claim 2, wherein the support struts are 3D printed. (6 other items) a pair of sheets, each sheet defining an opening sized and shaped to fit a nostril of the patient, a ferromagnetic ring positioned on an underside of the sheet and aligned around the opening, an upper side of the sheet configured to sealably engage the nostril; a connector including a pair of slip rings at the seat ends, each slip ring housing a magnetic ring; Each slip ring defines a channel opening; the magnetic ring comprises an array of magnets; the magnetic ring is configured to be tiltable pivotally about the slip ring; the magnetic ring is sized and shaped to be removably attachable to the ferromagnetic ring so as to form a substantially gas-tight connection therewith; an inlet at the vent end in fluid communication with a flexible tube connected to a fluid source; A nasal breathing assembly, wherein the channel opening has a circular, rectangular, oval, or teardrop shape. (7 other items) Item 7. The nasal breathing assembly of item 6, wherein the opening of the ferromagnetic ring has a circular, rectangular, oval, or teardrop shape, and the shape of the opening of the ferromagnetic ring matches the shape of the channel opening of the magnetic ring. (8 other items) 7. The nasal breathing assembly of claim 6, wherein the array of magnets comprises magnets arranged concentrically at the seat end of the slip ring. (9 other items) 7. The nasal breathing assembly of claim 6, wherein the slip ring is 3D printed.

Claims

1. a pair of sheets, each sheet defining an opening sized and shaped to fit a nostril of the patient, a ferromagnetic ring positioned on an underside of the sheet and aligned around the opening, an upper side of the sheet configured to sealably engage the nostril; a pair of posts, each post including a magnetic ring positioned at a first end thereof and a ball-shaped receiver positioned at a second end thereof, a passageway extending from the first end to the second end thereof, the magnetic ring including an array of magnets, the magnetic ring being removably attachable to the ferromagnetic ring; a connector having a pair of socket openings at a post end, each sized and shaped to receive a ball-shaped receptacle in a ball-and-socket configuration and form a substantially airtight connection therewith, and having an inlet at a vent end in fluid communication with a flexible tube connected to a fluid source.

2. 10. The nasal breathing assembly of claim 1, wherein the array of magnets comprises a plurality of magnets arranged concentrically on the first end of the post.

3. 3. The nasal breathing assembly of claim 2, wherein the plurality of concentrically arranged magnets have alternating polarities.

4. 10. The nasal breathing assembly of claim 1, wherein the array of magnets comprises a plurality of magnetic pellets embedded within a magnet socket provided at the first end of the post.

5. 5. The nasal breathing assembly of claim 4, wherein the array of magnets lies in the same plane as a plane that intersects the center of the magnet socket.

6. 2. The nasal breathing assembly of claim 1, wherein the array of magnets is arranged around a periphery of a magnet socket provided at the first end of the post.

7. The nasal breathing assembly of claim 1 , wherein the ferromagnetic ring is dome-shaped.

8. The nasal breathing assembly of claim 1 , wherein the struts are 3D printed.

9. a pair of sheets, each sheet defining an opening sized and shaped to fit a nostril of the patient, a ferromagnetic ring positioned on an underside of the sheet and aligned around the opening, an upper side of the sheet configured to sealably engage the nostril; a connector including a pair of slip rings at the seat ends, each slip ring housing a magnetic ring; Each slip ring defines a channel opening; the magnetic ring comprises an array of magnets; the magnetic ring is configured to be tiltable pivotally about the slip ring; the magnetic ring is sized and shaped to be removably attachable to the ferromagnetic ring so as to form a substantially gas-tight connection therewith; an inlet at the vent end in fluid communication with a flexible tube connected to a fluid source; A nasal breathing assembly, wherein the channel opening has a circular, rectangular, oval, or teardrop shape.

10. 10. The nasal breathing assembly of claim 9, wherein the opening in the ferromagnetic ring has a circular, rectangular, oval, or teardrop shape, and the shape of the opening in the ferromagnetic ring matches the shape of the channel opening in the magnetic ring.

11. 10. The nasal breathing assembly of claim 9, wherein the array of magnets comprises magnets arranged concentrically at the seat end of the slip ring.

12. 10. The nasal breathing assembly of claim 9, wherein the slip ring is 3D printed.