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

Abstract

A respiratory assembly for use with a continuous positive airway pressure (CPAP) device is provided. The respiratory assembly includes a conduit coupler having a male member and a female member. The respiratory 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 surrounding the central opening and providing a seal for 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.

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 by reference in their entireties herein.

[0002] The subject matter of the present 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 cannulas are typically used to treat individuals who are in respiratory distress or otherwise require a positive respiratory air supply. High flow delivery of respiratory gases can be delivered using nasal cannulas and / or face masks. Continuous positive airway pressure (CPAP) masks can deliver therapeutic fluids, such as ambient air, oxygen-enriched air, gases, mixtures of gases, or gases with medication, to a patient under 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, a 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, the 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 wear a respiratory mask at the same time.

[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 breathing mask defining a central opening therethrough sized to receive the male member. A gasket is positioned between the male member and the breathing mask. The gasket surrounds the central opening to provide a seal to the central opening. A channel opening of 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 includes a peelable adhesive film.

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

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

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

[0016] 13. A breathing assembly as described in claim 1, wherein, in accordance with 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 into selective engagement with 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 tank, 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 in conjunction 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 aperture therethrough 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 including a pair of sheets, each sheet defining an opening sized and shaped to fit a patient's nostril, a ferromagnetic ring positioned on an underside of the sheet and aligned around the opening, and an upper side of the sheet configured to sealably engage the nasal opening. The nasal breathing assembly also includes a pair of posts, each post including a magnetic ring positioned at a first end of the post and a ball-shaped receiver positioned at a second end of the post, a passageway extending from the first end to the second end, the magnetic ring comprising an array of magnets, the magnetic ring being 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 and form a substantially airtight connection with the ball-shaped receiver in a ball and socket configuration, 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 disposed 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] Provided herein is a nasal breathing assembly, the nasal breathing assembly including a pair of sheets, each sheet defining an opening sized and shaped to fit a patient's nostril, a ferromagnetic ring positioned on an 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 sheet 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 pivotally tilt about 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 ends of the slip ring.

[0034] According to one or more embodiments, the slip ring is 3D printed. [Brief description 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 purposes of illustration, there are shown in the drawings exemplary embodiments, but 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 illustrative of the present invention. Since these embodiments of the present invention are described in connection with examples, various modifications or adaptations of the described methods and / or specific structures may become apparent to those skilled in the art. It is to be understood that modifications and variations are covered 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 to be understood that the present invention is in no way limited to only the illustrated embodiments. [Figure 1A] FIG. 1 illustrates 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 respiratory assembly applied to a human face according to some embodiments of the presently disclosed subject matter. [Diagram 2] FIG. 2 illustrates an inner perspective view of a respiratory mask assembly in an assembled configuration according to some embodiments of the presently disclosed subject matter. [Diagram 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. [Diagram 5] 1 illustrates an exterior side perspective view 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 an inner portion 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 an inner portion 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 an exterior side perspective view of a respiratory mask assembly according to some embodiments of the presently disclosed subject matter, with the female member being removably coupled to the male member and with a CPAP tube inserted through both the male and female members. [Figure 11] FIG. 1 shows an exterior side perspective view of a respiratory mask assembly according to some embodiments of the presently disclosed subject matter, with the female member being removably coupled to the male member and with a CPAP tube inserted through both the male and female members. [Figure 12]1 illustrates an exterior side perspective view 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, according to some embodiments of the presently disclosed subject matter, in which the respiratory mask forming a part of the respiratory mask assembly is a typical surgical mask. [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. 13 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. 13 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] 1A-1D 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 respiratory assembly that may be used in conjunction with the respiratory mask assembly shown in FIG. 3 according to some embodiments of the presently disclosed subject matter. [Figure 22A] 4 illustrates additional embodiments and aspects of a conduit coupler 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] 4 illustrates additional embodiments and aspects of a conduit coupler 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] 4 illustrates additional embodiments and aspects of a conduit coupler 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] 4 illustrates additional embodiments and aspects of a conduit coupler 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] 4 illustrates additional embodiments and aspects of a conduit coupler 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] 4 illustrates additional embodiments and aspects of a conduit coupler 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] 4 illustrates additional embodiments and aspects of a conduit coupler 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] 4 illustrates additional embodiments and aspects of a conduit coupler 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] 4 illustrates additional embodiments and aspects of a conduit coupler 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] 4 illustrates additional embodiments and aspects of a conduit coupler that may be used in conjunction with the respiratory mask shown in FIG. 3 according to some embodiments of the presently disclosed subject matter. [Diagram 25] 4 illustrates additional embodiments and aspects of a conduit coupler 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] FIG. 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 a central opening of the respiratory mask, according to some embodiments of the presently disclosed subject matter. [Figure 27]1A-1C show 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 respiratory aids, according to some embodiments of the subject matter of the present disclosure. [Figure 28A] 1 illustrates 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 disclosed subject matter. [Figure 28B] 1 illustrates 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 disclosed subject matter. [Figure 28C] 1 illustrates 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 disclosed subject matter. [Figure 28D] 1 illustrates 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 disclosed subject matter. [Figure 29A] 1A-1D 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] 1A-1D 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] 1A-1D 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] 1A-1D 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]1 illustrates 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] 1 illustrates 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] 1 illustrates 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] 1 illustrates 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] 1 illustrates 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] 1 illustrates 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] 1 illustrates 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. [Fig. 31F] 1 illustrates 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 PREFERRED EMBODIMENTS

[0037] In the following, technical solutions in the embodiments of the present invention are clearly and comprehensively illustrated in conjunction with the figures according to the embodiments of the present invention. Obviously, the embodiments illustrated 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 a person skilled in the art can obtain without using the inventive efforts fall within the scope of protection of the present invention.

[0038] The description of various embodiments of the present invention is 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 in this specification are selected to best explain the principles of the embodiments, practical applications or technical improvements to technologies found in the market, or to enable other skilled in the art to understand the embodiments disclosed herein.

[0039] The corresponding structures, materials, acts, and equivalents of any means or functional element adding 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 disclosed form. 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 have been selected and described in order 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 use contemplated.

[0040] These and other changes can be made to the present disclosure in light of the Detailed Description. Although the above description describes certain embodiments of the present disclosure and describes the best mode contemplated, no matter how detailed the above appears in the text, the present teachings can be implemented in many ways. The details of the system may vary considerably in the details of its implementation while being encompassed by the subject matter disclosed herein. As stated 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 the term 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 carrying out or implementing the present 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 described here.

[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, a 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 indicated to the contrary, 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 from the specified amount 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%, 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 attached 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, the respiratory mask assembly 10 includes a conduit connector 100 including a male member 24 and a female member 22. The respiratory mask assembly 10 further includes a respiratory mask 1 defining a central opening therethrough, the central opening being sized to receive the male member therethrough. In one example, the respiratory mask 1 may be disposable. In various embodiments, the respiratory mask 1 may 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. The respiratory mask assembly 10 also includes a gasket positioned between the male member and the respiratory mask, the gasket 25 including a central opening 36 to provide sealing. One channel opening of the male member 24 and the female member 22 connects to a continuous positive airway pressure (CPAP) mask such as a nasal breathing assembly 5 that connects to one or more of the patient's nares and oral cavity.

[0047] In various embodiments, the nasal breathing assembly 5 may be replaced or replaced with any other similar CPAP mask (configured to deliver fluid / gas to the patient's oral cavity or nostrils or both) that can be used in conjunction with respiratory mask 1 (as shown in FIG. 1 ) to create a physical barrier between the wearer's mouth / 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 / 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, and the outer surface 34 of the respirator. 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 a central opening 36 formed in the respirator 1. Both the male member 24 and the female member 22 define an opening therethrough for fluid flow or for insertion of a tube or conduit, such as the tube 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 members, the female members, the inner surface 32 of the respirator, and the outer surface 34 of the respirator. The gasket 25 may be constructed from any known material, including, but not limited to, fabric, plastic, and / or latex. For example, in some embodiments, the gasket 25 may be constructed from polyvinyl chloride, polyethylene, polyurethane, latex, or combinations 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 acids, polyvinyl chlorides, alkyl esters, or combinations thereof. In some embodiments, the adhesive may be a pressure sensitive adhesive so that the gasket may be attached and removed as desired. The adhesive may be selected to exhibit 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, the tube 12 passes through the male member 24, the central opening 36, the one or more gaskets 25, and the female member 22 to supply fluid to an inlet 38 of a nasal breathing assembly, such as the nasal breathing assembly 5 shown in FIG. 14, and the tube 12 may further form a substantially airtight connection with the inlet 38, with the other end of the tube 12 in fluid communication with a fluid source forming part of a CPAP machine, for example. The coupler 100, when the male member 24 is coupled with the female member 22, serves to form a substantially airtight seal around the central opening 36, such that any particles 0.3 microns or larger, such as particulates such as viruses, bacteria, fungi, and other similar microorganisms, are prevented or restricted from moving across (or around the edges of) the 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) the central opening 36 in any direction. In one embodiment, any particle sized 0.01 microns or greater 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 greater 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 greater 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 wear both a continuous positive airway pressure (CPAP) mask and a respirator (e.g., an N95 respirator, etc.) simultaneously. Embodiments of the presently disclosed subject matter may serve to reduce or eliminate the spread of infectious 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 infectious 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 wear both a continuous positive airway pressure (CPAP) assembly and a respirator simultaneously, thereby preventing or limiting the movement of 0.01 micron size or 0.1 micron size or 0.3 micron size or 1.0 micron size or 10.0 micron size airborne particles across the central opening 36 in either direction (inwardly or outwardly).

[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, the gasket 25 is in the form of a membrane having an orifice formed therethrough for a portion of the 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 of 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 be accompanied by a face shield. Although they are often referred to as face masks, not all face masks are regulated as surgical masks. Surgical masks are made in different thicknesses and with different performances to protect the wearer from contact with liquids and fluids. These characteristics may 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, splashes, mists, or splashes that may contain pathogens (viruses and bacteria) and keep 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 of droplets and large particles, face masks, by design, do not filter or block very small particles in the air 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 the mask becomes difficult, remove the face mask, dispose of it safely, and replace it with a new mask. To safely dispose of a mask, it should be placed in a plastic bag and placed in a trash can. Hands should be washed after handling a used mask. When worn properly, surgical masks are intended to help block large particle droplets, splashes, mist, or spray 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 be careful when using an N95 respirator, as the N95 respirator may make it more difficult for the wearer to breathe. An embodiment of the subject matter of the present disclosure can help overcome this drawback, allowing the N95 respirator to work in conjunction with a CPAP or other similar positive air pressure device. In particular, a respirator mask 1 in the form of an N95 respirator can be attached over a breathing assembly, such as a nasal breathing assembly 5 (as shown in FIG. 1), to provide a physical barrier between the wearer's mouth-nose and potential hot springs in the surrounding environment (or prevent potential contamination from the wearer's mouth-nose 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 may further include an adhesive material for forming a sealable engagement with a surface of the male member, a surface of the female member, and an 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 peelable 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 member. In one embodiment, both sides of the gasket include a peelable 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 subject matter of the present disclosure. 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 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. The term "fluid" as used herein refers to any gas, mixture of gases, or gas with medication (such as aerosol medication) suitable for delivery to the human airway. A flexible tube, such as tube 12 shown in FIG. 1, may be coupled with an inlet to deliver fluid from a fluid source, for example, and the tube may include any known flexible tube. The term "tube" as used herein 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 bend or flex, bend as desired, and easily conform to the general shape and contours of the human body. In some embodiments, the tube 12 may 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 having 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 of 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 is provided between the male member and the female member. A side of the at least one gasket is configured to sealably engage 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 air-tight, sealable engagement with a wall of the respirator.

[0063] According to various embodiments, a respiratory assembly conduit coupler is provided for forming a substantially airtight seal around an opening formed in a respiratory mask. In various embodiments, the coupler comprises a male member and a female member defining an opening through which fluid flows, 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, and the like. In high flow therapy, an oxygen source is typically mixed with compressed air, allowing 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 expiration and allowing excess gas to escape during inspiration. Beneficially, the delivered flow rate can meet the inhalation flow rate so that the delivered gas is not diluted by room air.

[0065] Alternatively or additionally, the disclosed breathing assembly may be used with a continuous positive airway pressure (CPAP) machine. CPAP machines typically apply a gentle air pressure continuously to keep the patient's airway open continuously. As a result, a CPAP machine used in conjunction with a patient's stent advantageously opens the alveoli of 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 may be used to treat premature infants whose lungs are not yet fully developed. In some embodiments, the disclosed assembly may 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 cessation of breathing that define apneic events. The disclosed device can be used to measure nasal pressure by measuring the nasal pressure with nasal prongs connected to a pressure transducer.

[0067] The disclosed assembly may further be used with a fluid tank, a humidifier, or any other fluid source known or used in the art. Advantageously, the disclosed assembly may eliminate soreness over the ears and sore lips commonly found with conventional respiratory masks and cannulas. In addition, the disclosed assembly may allow for better control of gas (e.g., oxygen) during fluid delivery applications. In some embodiments, the disclosed assembly is strapless and maskless, thereby increasing comfort of use. As a result, patients are more likely to follow physician instructions and use the assembly. In addition, unsightly mask and strap skin indentations are eliminated. The disclosed assembly is less likely to be inadvertently removed by the patient, 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 the reusable portion of the CPAP assembly. As used herein, the term "disinfection" refers to the elimination of all or nearly all microbial modalities. The disinfection enclosure can include an active oxygen and / or UV light generator that is used to clean and / or disinfect the reusable CPAP elements. 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, possibly by inhibiting and blocking the action of enzyme control systems. A sufficient amount of active oxygen breaks through the cell membrane, resulting in the destruction of the bacteria. Active oxygen destroys viruses by diffusing through the protein coat into the nucleic acid core, resulting in damage to the viral RNA. At higher concentrations, active oxygen destroys the viral capsid by oxidation, affecting the 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 at a concentration of about 10-500 ppm (parts per million) within and / or within the disclosed system. In some embodiments, the generator can generate UV light to sanitize the interior of the enclosure and the contents of the associated CPAP device. To this end, the generator can include one or more ultraviolet lights that can be activated for a pre-set 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 about 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 the CPAP user's socket (or mask), tubing, humidifier, and CPAP chamber. In addition to being highly effective, the disinfection enclosure is designed to be easy to 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, shapeless, etc. 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 the particular CPAP elements 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] FIG. 14 illustrates a nasal breathing assembly 5 that can be attached to a patient along with a respiratory mask assembly 10, in accordance with one or more embodiments of the presently disclosed subject matter. As illustrated, the nasal breathing assembly 5 includes a sheet 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 sheet 27 by 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 sheets 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 sheet and circumferentially aligned with the opening, and an upper side of the sheet 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 about a surface of the dome-shaped ring in a ball and socket arrangement while still 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 is aligned 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 a tube 12 connected to a fluid source. In one embodiment, a vent, such as vent 70 , is disposed between the vent fitting and the tube 12 .The vent 70 includes a vent receptacle sized and shaped to cooperate with a fitting to form a substantially gas-tight connection, and the inlet 38 is sized and shaped to cooperate with a tube, such as the tube 12 shown in FIG. 1, to form a substantially gas-tight 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 a 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 a first end of the socket magnet post 20.

[0074] Thus, in at least one embodiment, each socket magnet post 20 can 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 can 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 can 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 can be arranged such that each magnet 250 has an opposite polarity to the adjacent magnets 250. In other words, the polarity can be alternated among the plurality of magnets 250 arranged in an array on the magnetic ring 50. Thus, the plurality of magnets 250 of alternating polarity can be attached to the ring 262 (which can be a ferromagnetic ring or a magnetic ring in various embodiments) by magnetic attraction. In one embodiment, the socket magnet post 20 can 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 a variety of processes in which material is deposited, joined, or solidified under computer control to create a three-dimensional object, where the material (e.g., plastic, liquid, or powder particles fused together) is typically added layer by layer. The precision, repeatability, and material range of 3D printing have increased to the point that some 3D printing processes are considered viable as industrial production techniques, whereby the term additive manufacturing can be used synonymously with 3D printing. One of the key advantages of 3D printing is the ability to generate highly complex shapes or geometries that would otherwise be impossible to build by hand, including hollow parts or parts with internal truss structures, to reduce weight. Fused Deposition Modeling, or FDM, is a common 3D printing process in use as of 2020.

[0076] According to one embodiment, the nasal breathing assembly 5 comprises 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 and circumferentially aligned with the opening, and an upper side of the seat configured to sealably engage the nasal opening. The nasal breathing assembly 5 comprises 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, with a passageway extending from the first end to the second end, the magnetic ring 50 comprising an array of magnets 250. The magnetic ring 50 is removably attachable to the ferromagnetic ring. The nasal breathing assembly further comprises a connector having a pair of socket openings at the post end, 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, with an inlet at the vent end in 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.

[0077] The nasal breathing assembly 5 includes at least one vent 70 for receiving therapeutic gas into the patient's nasal cavity. One end of the vent 70 has an inlet 38 configured to connect to a fluid source (not shown) via fluid tubing such as tube 12 that supplies respiratory gas, and a vent receptacle located at the other end of the vent 70 engages with a vent coupling of the nasal connector 90. Thus, the nasal breathing assembly 5 can include one or more vents 70 located proximal to where fluid flow occurs. It should be understood that the vent 70 can be located at any desired location and is not limited to the locations shown herein. In some embodiments, the vent 70 can include a socket that includes an adapter. The adapter can be constructed in any desired shape to allow connection with the tube 12 (tube 12 is shown in FIG. 1). In such an embodiment, the outer diameter of the adapter is larger than the inner diameter of the tube 12. In this manner, the adapter is retained within the tube for a desired period of time and is not 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. The term "fluid" as used herein refers to any gas, mixture of gases, or gas with medication (such as aerosol medication) suitable for delivery to the human airway. A flexible tube, such as the tube shown in FIG. 1, may be coupled to the inlet 38 to deliver fluid from the fluid source, for example, and the tube may 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, the tube 12 may 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 having larger or smaller diameters can be used. For example, the inner diameter of the tube can be increased or decreased to adjust to the preferences and / or needs of a particular wearer. In some embodiments, the tube can be hooked over the patient's ear during use and can be elevated under the chin during use.

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

[0080] In some embodiments, as shown, for example, in FIG. 15, 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, the polarity may alternate among the 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 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 transverse plane 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 sheet 27 for better positioning over the patient's nares. The sheet 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 sheet 27. The rings 262 (which may be dome-shaped in some embodiments) are fabricated as an integral component of the sheet 27 such that the openings of the rings 262 are aligned with the respective openings 17 of the sheet 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 as 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 may 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 is complementary or consistent with the configuration / arrangement of magnet 250. In various embodiments, ring 62 is made of a ferromagnetic material such that it is 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 may include a magnet socket 52 configured to receive a magnet, such as magnet 250.

[0082] According to one embodiment, the nasal breathing assembly 5 comprises 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 and circumferentially aligned with the opening, and an upper side of the seat configured to sealably engage the nasal opening. The nasal breathing assembly 5 comprises 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 comprises a connector having a pair of socket openings at the post end, 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 in 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 illustrates a port magnet post 120 that may be used in place of the socket magnet post 20 in the nasal breathing assembly 5. The port magnet post 120 may 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 an inner surface of the socket opening while maintaining a substantially airtight connection with the socket opening.

[0084] In some embodiments, as shown, for example, in FIG. 16, each port magnet post 120 is configured to be removably attached to a respective ring 262 of the sheet 227 via a plurality of magnets 250 disposed around the sheet-facing side of a magnet socket 152 disposed around a first end of the port magnet post 120. Each ring 262 includes an aperture 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 sheet-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, 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 about a surface of the ring 262 while continuing to maintain 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 the nasal connector 90 being inadvertently dislodged when the wearer of the nasal breathing assembly 5 moves his / her head either while awake or asleep, thereby allowing for 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 about a surface of the ring 262 while continuing to maintain a substantially airtight connection when the face of a patient wearing the nasal breathing assembly 5 is moved in a sudden, jerk motion. In at least one embodiment, the ring 262 allows the magnet socket 152 to move or rotate about a 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 may 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 the vent 270, is disposed between the vent fitting and a tube, such as the tube 12 shown in FIG. 1, to form a substantially airtight connection. The vent 270 may have similar features to the vent 70. In some embodiments, as shown, for example, in FIG. 17, each port magnet post 220 is configured to be removably attached to a respective ring 262 of the sheet 227 via a plurality of magnets 250 disposed around the sheet-facing side of the magnet socket 152, the magnet socket 152 being disposed around a first end of the port magnet post 220. Thus, in one embodiment, each port magnet post 220 may include a plurality of 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 may 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 sheet-facing side of the magnet socket 252. In various embodiments, the polarity of the magnets 250 may be arranged such that each magnet 250 has an opposite polarity to the adjacent magnets 250. In other words, the polarity may alternate between the plurality of magnets 250 arranged on the magnet socket 252. Thus, the plurality of magnets 250 of alternating polarity may be attached to the ring 262 by magnetic attraction. In one embodiment, the port magnet post 220 may 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. The magnet socket 252 is disposed about 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 sheet 227 to the ring 262 for better positioning over the patient's nares.

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

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

[0090] The elbow 480A includes a CO2 exhaust 491A sized and shaped to facilitate the exhaust of CO2 exhaled by a patient wearing the nasal breathing assembly 405A. Similarly, the elbow 480B includes a CO2 exhaust 491B sized and shaped to facilitate the exhaust of CO2 exhaled by a patient wearing the nasal breathing assembly 405B. Each of the nasal breathing assemblies 405A and 405B can further include a diffuser cap 492 that can be attached to the elbow 480A via corresponding recessed cutouts 493 (see FIG. 18) on both sides of the elbow 480A and elbow 480B and a protrusion on the diffuser cap with recessed cutout sections located diagonally from each other. The CO2 exhaust 491A operates to ensure that the patient's inhalation is not impeded and to ensure the exit of excess fluid. The CO2 exhaust 491A can be sized and shaped in any desired manner and can be positioned in any vicinity of the 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 include extremely thin polymer fibers, membranes, and / or skins (e.g., nano- to micro-scale).

[0091] The nose connector 490 can be constructed of silicone or other similar flexible material according to one or more embodiments of the presently disclosed subject matter. The one piece of nose connector 490 located on the side of the nose connector 490 facing the vent end (i.e., the end opposite the end facing the elbow 480A) includes a flange, such as flange 470A, as shown in FIG. 18. The flange 470A at the sheet end of the nose connector 490 can include silicone or other similar elastic material according to one or more embodiments of the presently disclosed subject matter. As shown in FIG. 18, the flange 470A has two slip rings secured therein, such as slip rings 460A, 460B, 460C, or 460D, and the flange 470A 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. As shown in FIG. 18, magnet array 550 includes ridge portion 402 that circumferentially surrounds magnet array 550, and magnet array 650 includes groove portion 404 that circumferentially surrounds magnet array 650.

[0092] In various embodiments, each magnet array 450A, 450B, 450C, or 450D may include either a groove 404 or a ridge 402 surrounding the magnet array. The magnet ring 404 or ridge 402 in the form of the magnet array 450A, 450B, 450C, or 450D operates to provide a secure connection between the magnet ring in the form of the magnet array 450A, 450B, 450C, or 450D and the magnet ring in the form of the respective slip ring 460A, 460B, 460C, or 460D. Each slip ring is made of a flexible material. In some embodiments, each slip ring may include a material at or near its inner edge, such as LDPE (low density polyethylene), which holds the magnet array 450A, and a material at or near its outer edge, such as Styrene Butadiene Copolymer (SBC) sold under the trade name K-resin®. The combination of materials forming part of the slip rings can advantageously permit the circular magnet array 450A to swivel within and around the respective slip ring 460A, for example while being fixed thereto. In various embodiments, the magnet array 450A, 450B, 450C, or 450D can take any suitable shape, such as circular, oval, oval, or teardrop shaped, with the shape of the opening of the respective ferromagnetic ring 462A, 426B, 426C, or 426D complementing or matching the shape of the channel opening of the magnet ring. The materials used in the construction of the slip rings 460A, 460B, 460C, or 460D can conveniently provide the magnet array 450A, 450B, 450C, or 450D to pivot 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 gap within each slip ring between its outer and inner edges to help increase comfort for a patient wearing the nasal breathing assembly by reducing or eliminating the torque felt at the patient's nose of 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 of only the magnet array 450A, 450B, 450C or 450D and the soft renewable membrane surrounding the magnet array and filling all voids within the slip ring.

[0093] In some embodiments, as shown in the upper right corner of FIG. 18 by way of example, each magnet array 450A may 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 may comprise a plurality of magnets 250 (as shown in the magnet array 450A illustrated 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 may take the form of magnet pellets embedded in the magnet array 450A, e.g., 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 may be arranged such that each magnet 250 has an opposite polarity to the adjacent magnets 250. In other words, the polarity may 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 Fig. 18 illustrates only magnet array 450A including an array of magnets 250, while 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 illustrated in Fig. 18 due to space limitations. Each of magnet arrays 450A, 450B, 450C or 450D can be magnetically secured to and substantially intimately connected to each of ferromagnetic rings 462A, 462B, 462C or 462D (see Fig. 19) of each of sheets 425A, 425B, 425C or 425D (see Fig. 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 of 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 embodiment, 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 to further increase the comfort level of the patient wearing the nasal breathing assembly by reducing or eliminating the torque felt by the patient's nose of the assembly during use of the assembly by the patient.

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

[0097] For example, the circular magnet array 450A, located by the slip ring 460A, is magnetically secured to the ferromagnetic ring 462A (see FIG. 19) of the sheet 425A to form 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 interior 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 of each sheet 425A, and into the interior 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 may further comprise a pair of sheets, such as sheets 425A, 425B, 425C or 425D, each sheet sized and shaped to fit over a patient's nares, with a respective ferromagnetic ring 462A, 462B, 462C or 462D located on an underside of the sheet and located at the periphery of the opening with an upper side of the sheet configured for sealable engagement with the nares. 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 of 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 of the sheet 425B. The channel opening 415 of the circular magnet array 450C has an oval intersection that complements / matches the oval intersection of the opening 417C of the sheet 425C. The channel opening 415 of the circular magnet array 450D has a teardrop cross section, which 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 the sheet 425A, 425B, 425C or 425D (see FIG. 19). Each sheet 425A, 425B, 425C or 425D is configured to engage a patient's nares. Each sheet 425A, 425B, 425C or 425D directly contacts the patient's nares or the outside of the skin surrounding the patient's nares. The sheets can be configured to provide a flush and sealable engagement with the patient's nares.

[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 acids, polyvinyl chlorides, 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 the patient's skin as desired. The adhesive can be selected to exhibit mild or no irritation to the skin when used daily. In some embodiments, the adhesive tape can be configured as a hydrocolloid tape and / or include a polyurethane reactive layer that adheres more to the nares as the patient's body heat warms the adhesive. Alternatively, in some embodiments, the adhesive can be applied directly to the patient's nostrils or nose engagement 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 the respective magnet array 450A, 450B, 450C, or 450D (shown in FIG. 18).

[0100] In various embodiments, the torque can be significantly reduced by providing the magnet array 450A, 450B, 450C, or 450D to rest directly or adjacent to the surface of the discontinuity. Moreover, the ability of the magnet array 450A, 450B, 450C, or 450D to shift and spin helps to significantly reduce the torque. In other words, the ability of the magnet array 450A, 450B, 450C, or 450D to pivot on the slip ring 460A, 460B, 460C, 460C, or 460D that holds the magnet array 450A, 450B, 450C, or 450D securely while maintaining an airtight connection with the respective ferromagnetic ring 462A, 462B, 462C, or 462D can help to 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 of the assembly during use of the assembly by the patient.

[0101] Thus, in various embodiments, the nasal breathing assembly 405A can include a pair of seats 425C, each seat 425C sized and shaped to fit over a patient's nostril, a ferromagnetic ring 462C positioned on the underside of the seat and circumferentially aligned with the opening, and an upper side of the seat 425C configured to sealably engage with 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, or teardrop shape, or other similar shapes. The opening of the ferromagnetic ring can have a shape that complements / matches the shape of the channel opening of the magnetic ring. For example, the opening 417C of the ferromagnetic ring 462C can have a circular shape that complements / matches the circular shape of the channel opening of 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 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 connector 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 described herein. The nasal breathing assembly 405B can omit a nasal connector, such as the nasal connector 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 that is positioned opposite the side of the elbow 480B that includes the swivel joint 454. The swivel joint 454 connects to the flexible tube 410 such that the swivel joint 454 can allow 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 of FIG. 18. Nasal breathing assembly 405B can be similar or identical to nasal breathing assembly 405A in all other respects and can operate similarly.

[0105] The remaining components of the nasal breathing assembly 405A and nasal breathing assembly 405B have substantially similar or identical features to the respective components of the nasal breathing assembly 5, and the components of the nasal breathing assembly 405A / 405B are labeled with numbers including a 100th prefix of "4" used to label each of the parallel components of the nasal breathing assembly 5. For example, the sheet 427 of the nasal breathing assembly 405A / 405B may be substantially similar or identical to the sheet 27 of the nasal breathing assembly 5. In some embodiments, the remaining components of the nasal breathing assembly 405A and nasal breathing assembly 405B may have substantially similar or identical features to the respective components of the nasal breathing assembly 105, and the components of the nasal breathing assembly 405A / 405B are labeled with numbers including a 100th prefix of "4" instead of the "1" used to label each of the parallel components of the 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] In accordance with 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 nares, a ferromagnetic ring 462A, 462B, 462C, or 462D disposed on an underside of the seat and circumferentially aligned with the opening, and an upper side of the seat 425A, 425B, 425C, or 425D configured for sealable engagement with the nares. 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 the seat end, each slip ring 460A, 460B, 460C or 460D housing 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 constitute a series of magnetic. The magnetic rings in the form of magnet arrays 450A, 450B, 450C or 450D are configured to pivot on the slip rings. The magnetic rings in the form of magnet arrays 450A, 450B, 450C or 450D are sized to be attached to and substantially intimately 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 in fluid communication with a telescopic 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), elliptical (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 array of magnets can include magnets 250 arranged centrally at the sheet end 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 may be attached to a patient along with the respiratory mask assembly 10, in accordance with one or more embodiments of the presently disclosed subject matter. The nasal breathing assembly 105 may thus replace the nasal breathing assembly 5 of the respiratory mask assembly 10 in at least one embodiment. The nasal breathing assembly 105 may thus be used in conjunction with the connector 100 and the respiratory mask 1.

[0108] 21 illustrates a nasal breathing assembly 605 that may be attached to a patient along with the respiratory mask assembly 10, in accordance with one or more embodiments of the presently disclosed subject matter. Thus, the nasal breathing assembly 605 may 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 in accordance with 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 may 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 may further be used in conjunction with any common respirator, including N95 respirator, surgical mask, and any other respirator capable of filtering particulate matter or microorganisms currently and in the future available on the market.

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

[0112] The outer cover 212 may be folded over the frame 214 and snapped to close the snap lid 200 by folding over the 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 an 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 hinged to the frame 214 located on an edge or circumference of a central opening 36 formed on the respiratory mask 1. In various embodiments, the frame 214 is molded, bonded, or otherwise integrated into the fabric from which the respiratory mask 1 is formed. The top surface of the raised portion 222 of the outer cover 212 is substantially planar. In various embodiments, the central opening 36 is configured to accommodate any tubing 12 connected to a fluid supply that provides fluid from a device, such as a CPAP fluid supply, a high flow technology device, and any other non-invasive ventilation option.

[0113] 27 shows several additional embodiments of a snap-on lid 200 that can be incorporated into a respiratory mask 1, such as an N95 respirator. The snap-on 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-on lids described herein can further be used in conjunction with any common respiratory mask, including N95 respirators, surgical masks, and any other respirators capable of filtering particulate matter or microorganisms available on the market today and 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 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, the frame 214 can include a sealing mechanism that provides a substantially airtight seal around the tube 12 inserted therethrough, such that the 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 the frame 214 that is configured to form a substantially airtight seal between the tube 12 and the frame 214.

[0116] 28-31 show 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 nares and oral cavity, according to some embodiments of the subject matter of the present disclosure. In some embodiments, each magnetic ring 50 may 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, the ring 262 may be substituted for or otherwise include a poly-magnet 350. Similarly, in some embodiments, the magnet 250 as referred to herein may also represent a poly-magnet 350. In some embodiments, each magnetic ring 50 may be in the form of a plurality of poly-magnets 350 arranged in an array around the sheet-facing side of a magnet socket 52 arranged around a first end of the socket magnet post 20. In another embodiment, each magnetic ring 50 may be in the form of a single ring poly-magnet arranged around the sheet-facing side of a magnet socket 52 arranged around a first end of the 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 that is not otherwise inadvertently removed during sleep of the wearer of the CPAP device. 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, the one or more polymagnetic bodies 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 with the one or more polymagnets 350 can be formed by 3D printing techniques. In one embodiment, the ring 262 with the 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 planar surface of the one or more polymagnetic bodies 350 can be substantially planar with respect to a transverse plane passing through the center of the magnetic ring 50. In various embodiments, the one or more polymagnetic bodies 350 can be arranged concentrically.

[0119] Polymagnet 350 as shown in Figures 28A-31F may represent a magnetic structure 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. By varying the polarity and / or magnetic field strength of each source in the array of magnetic sources that make up each structure, polymagnet 350 can be programmed or encoded. The resulting magnetic structure can be one-dimensional, two-dimensional, three-dimensional, or even four-dimensional when fabricated using electromagnetic arrays. 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. For example, a 3D magnetization printer such as the "MagPrinter" developed by the US company Collated Magnetics Research (CMR), Huntsville, AL, can be used to fabricate polymagnet 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 that contain small magnetic elements called maxels. 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 a scale 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, allowing for 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, as well as enhanced breakaway and shear forces that can be several times stronger than seen with conventional magnetized materials.

[0120] Thus, polymagnets 350 can be made by reprogramming conventional magnetic materials in a matter of minutes. With polymagnets, magnetic couplings can have a softer "feel" or snap-pier or crisper closing or opening behavior, and can be given a spring or latch feeling. 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 run from pole to pole. In contrast, in polymagnets, many small polarized (N or S) magnetic pixels ("maxells") are fabricated by printing in a 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. Thus, 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 configuration reduces magnetic interference with other equipment.

[0121] Most pre-made magnets have a simple nature, one side is the north side and the other is the south side. In Polymagnets, instead of a simple north-south arrangement, customizable patterns can 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 a matter of days. Conventional magnets do not necessarily align when attached to each other, but Polymagnets can be programmed to achieve various types of alignment. Polymagnets can be constructed as very powerful magnets because their magnetic energy is concentrated near the surface. Polymagnets can be up to five times stronger than conventional magnets.

[0122] Polymagnets, when used in pairs, can utilize magnetic attraction, magnetic repulsion, and the idea of ​​controlled cancellation or interaction of these forces in space. An array or pattern of magnetic regions (called maxels) can create a unique magnetic circuit that defines the function of the magnetic device and its interaction with other magnets or ferrous metals. A correlated magnet pair (e.g., a magnetic ring 50 in the form of one or more polymagnets and a 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 that are coded to respond to them. Correlated magnets can also be programmed to attract and repel simultaneously.

[0123] Compared to conventional magnets, correlated magnets provide a much stronger holding force and stronger shear resistance to the target. Programmable behavior can be achieved by creating multipole structures containing multiple magnetic elements (maxells) of various sizes, positions, orientations, and saturations. The size of the maxells ranges from 1mm to 4mm. By overlapping 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 an encoded magnetic field. 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 may be used.

[0125] Latch Poly Magnets (see Figure 29D): Latch poly magnets are configured so that the magnet pairs repel each other until they pass a defined transition point, after which they reverse polarity and attract. They can be used in sliding and rotating latches.

[0126] Spring poly magnets (see Figures 29B and 29C): Spring poly magnets can be configured to attract until they pass a defined transition point, then repel once the transition point is crossed, 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 running from a single north pole to a single south pole. Figure 28Bii illustrates a conventional magnet that includes a single north pole and a single south pole.

[0129] Figures 28Aii and 28iii show the magnetic field lines of a polymagnet that contains many small polarized (N or S) magnetic pixels ("maxels") produced 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 magnetic 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, where the magnetic field lines are completed between each pair of N-S magnetic 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 a two spring polymagnet that can be configured to attract until it passes a defined transition point, repel beyond the transition point, and come to 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 come to rest at an equilibrium distance, where the equilibrium distance 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. Thus, 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. Thus, all embodiments within the drawings and these descriptions are not made according to such illustrative dimensions. The drawings are not necessarily drawn to scale. Thus, all embodiments within the drawings and these descriptions are not made according to the drawings' apparent scale with respect to the drawings' relative dimensions. However, for each drawing, at least one embodiment is made according 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 described here.

[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, a reference to "a device" can include a plurality of such devices, and so forth.

[0141] The description of various embodiments of the present invention is 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 in this specification are selected to best explain the principles of the embodiments, practical applications or technical improvements to technologies found in the market, or to enable other skilled in the art to understand the embodiments disclosed herein.

Claims

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, a female member, and a channel, the conduit coupler including an opening defined in the male member and the female member; a cloth-based disposable respiratory mask defining a central opening therethrough sized and shaped to receive said male member over both the oral cavity and the nostrils of a patient; a first gasket positioned between the male member and the respiratory mask and surrounding the central opening to provide a seal for the central opening; a nasal breathing assembly that couples directly to the patient's nares and that connects directly to the conduit coupler or one of the tubes disposed through the conduit coupler.

2. 10. The respirator assembly of claim 1, wherein the respiratory mask is an N95 respirator.

3. 10. The respiratory assembly of claim 1, wherein the respiratory mask is a surgical mask.

4. 10. The breathing assembly of claim 1, wherein the first gasket comprises an adhesive foam material.

5. 10. The breathing assembly of claim 1, wherein the first gasket is formed from a stretchable elastomeric material.

6. 10. The respirator assembly of claim 1, wherein at least one major surface of the first gasket comprises an adhesive.

7. 10. The respirator assembly of claim 1, wherein at least one major surface of the first gasket comprises an adhesive material.

8. 10. The respirator assembly of claim 1, further comprising a second gasket disposed between the male member and the respirator mask and surrounding the central opening.

9. 10. The breathing assembly of claim 1, wherein a female member selectively engages said male member.

10. 10. The respirator assembly of claim 1, wherein both sides of the first gasket are provided with an adhesive.

11. 10. The breathing assembly of claim 1, wherein the central opening comprises a snap-on lid.

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