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

Abstract

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

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 62 / 993,220, filed Mar. 23, 2020, and U.S. Provisional Patent Application No. 62 / 992,966, filed Mar. 21, 2020, the contents of which are hereby incorporated by reference in their entirety.

[0002] The subject matter of the present disclosure relates to a respiratory assembly, and more particularly to a respiratory mask assembly for use in conjunction with a continuous positive airway pressure (CPAP) device.

Background Art

[0003] Face masks and nasal cannulas are typically used to treat individuals who require a positive respiratory air supply due to breathing difficulties or other reasons. Respiratory gas at high flow rates can be delivered using nasal cannulas and / or face masks. A continuous positive airway pressure (CPAP) mask can deliver a treatment fluid, such as ambient air, oxygen - enriched air, gas, a mixture of gases, or a gas with a drug, to a patient under a predetermined or desired pressure setting. Alternatively, a maskless respiratory assembly can be used to deliver such a fluid.

Summary of the Invention

Problems to be Solved by the Invention

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

[0005] Therefore, it would be beneficial to provide an improvement to address the above inconvenience.

Means for Solving the Problem

[0006] This summary is provided to introduce, in a simplified form, concepts that will be further described in the detailed description below. This summary is not intended to identify the 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 in conjunction with a continuous positive airway pressure (CPAP) device. According to various embodiments, the breathing assembly includes a conduit coupler having a male member and a female member. The assembly also includes a disposable breathing mask that defines a central opening sized to receive the male member. A gasket is positioned between the male member and the breathing mask. The gasket surrounds the central opening and provides a seal to the central opening. One of the channel openings of the male member and the female member is connected to a continuous positive airway pressure (CPAP) mask that connects to one or more of the patient's nostrils and mouth.

[0008] According to one or more embodiments, the breathing mask is configured to block at least 95 percent of particles having a size of 0.3 microns or greater.

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

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

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

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

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

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

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

[0016] According to one or more embodiments, the female member selectively engages with the male member, the breathing assembly according to claim 1.

[0017] According to one or more embodiments, the female member threads into a thread formed on the male member.

[0018] According to one or more embodiments, the female member includes one or more release devices that can be rotated to form a selective engagement with the male member.

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

[0020] According to one or more embodiments, the other channel opening of the male member and the female member 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 medicinal fluid source, or a humidifier.

[0022] According to one or more embodiments, the fluid of the fluid source 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 comprise 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-on lid has a circular outer shape.

[0026] A respiratory assembly for use in conjunction with a continuous positive airway pressure (CPAP) device is provided. According to one or more embodiments, the respiratory assembly includes a respiratory mask that defines an opening. The assembly further includes a conduit coupler that forms a substantially airtight seal around the opening of the respiratory mask. The conduit coupler includes a male member and a female member that each define a through hole for a conduit to fit through. 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 so as to form a substantially airtight seal 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 that connects to one or more of a patient's nostrils and mouth.

[0027] A nasal respiratory assembly is provided herein. The nasal respiratory assembly includes a pair of sheets, each sheet defining an opening sized and shaped to fit over a patient's nostril, with a ferromagnetic ring positioned on a lower side of the sheet and aligned around the opening, and an upper side of the sheet configured to sealingly engage with the nostril. The nasal respiratory assembly also includes a pair of struts, each strut including a magnetic ring positioned at a first end of the strut and a ball-shaped receiver positioned at a second end of the strut, with a passage extending from the first end to the second end, the magnetic ring comprising an array of magnets, and the magnetic ring removably attachable to the ferromagnetic ring. The nasal respiratory assembly also includes a connector having a pair of socket openings at a post end, each socket opening sized and shaped to receive the ball-shaped receiver in a ball-and-socket configuration and form a substantially airtight connection therewith, and having an inlet at a vent end in fluid communication with a flexible tube connected to a fluid source.

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

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

[0030] According to one or more embodiments, the strut is 3D printed.

[0031] Provided herein is a nasal breathing assembly. The nasal breathing assembly is a pair of sheets, each sheet defining an opening sized and shaped to fit into a patient's nostril, with a ferromagnetic ring positioned under the sheet and aligned around the opening, and the upper side of the sheet configured to sealingly engage with 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 tilt rotatably about the slip ring. The magnetic ring is sized and shaped to be removably attachable to the ferromagnetic ring so as to form a substantially airtight connection with the ferromagnetic ring. The inlet at the ventilation end is in fluid communication with a flexible tube connected to a fluid source. The channel opening has a circular, rectangular, elliptical, or teardrop shape.

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

[0033] According to one or more embodiments, the array of magnets comprises magnets arranged concentrically at, near, or around the sheet end 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 are better understood when read in conjunction with the accompanying drawings. For purposes of illustration, exemplary embodiments are shown in the drawings, but the subject matter of the present disclosure is not limited to the specific methods and means disclosed.

[0036] The embodiments illustrated, described, and discussed herein are examples of the present invention. Since these embodiments of the present invention are described in relation to the examples, various modifications or adaptations of the described methods and / or specific structures may become apparent to those skilled in the art. Of course, the modifications and changes are covered by the above teachings and are within the scope of the appended claims without departing from the spirit and intended scope. All such modifications, adaptations, or variations that rely on the teachings of the present invention and advance the art are considered to be within the spirit and scope of the present invention. Therefore, these descriptions and drawings should not be considered in a limiting sense, as it is understood that the present invention is in no way limited to the illustrated embodiments.

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DETAILED DESCRIPTION

[0037] The following presents the technical solutions in the embodiments of the present invention clearly and comprehensively in relation to the figures according to the embodiments of the present invention. Obviously, the embodiments shown in this specification are only some embodiments and not all embodiments of the present invention. Generally, the components of the embodiments of the present invention shown and presented in this specification 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 those skilled in the art can obtain without using the inventive approach fall within the scope of protection of the present invention.

[0038] The descriptions of various embodiments of the present invention are presented for illustrative purposes and are 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, the practical application to technologies found in the market, or technological improvements, or to enable other skilled artisans to understand the embodiments disclosed in this specification.

[0039] The corresponding structures, materials, actions, and equivalents of all steps adding means or functional elements in the following claims are intended to include any structures, materials, or actions for performing functions in combination with other specifically claimed elements for which claims are made. The description of the present invention is presented for illustrative and explanatory purposes and is not intended to be exhaustive or limited to the disclosed form of the invention. 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 are selected and described to best explain the principles and practical applications of the present invention and to enable other skilled artisans to understand the present invention with respect to various embodiments with various modifications suitable for the specific uses contemplated.

[0040] These and other modifications can be made to the present disclosure in light of the [Mode for Carrying Out the Invention]. The above description explains specific embodiments of the present disclosure and describes the contemplated best mode, but even if the above appears in the text in as much detail as possible, the present teachings can be implemented in many ways. The details of the system, while included in the subject matter disclosed herein, can vary considerably in its implementation details. As noted above, specific terms used when describing a particular characteristic 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, characteristic, or aspect of the present disclosure to which the term relates. Generally, the terms used in the following claims should not be construed as limiting the present disclosure to the specific embodiments disclosed herein unless the above [Mode for Carrying Out the Invention] column explicitly defines such terms. Thus, the actual scope of the present disclosure includes not only the disclosed embodiments but also all equivalent ways of carrying out or practicing the present disclosure under 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 technical field to which the subject matter of the present disclosure belongs. 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, but representative methods, devices, and materials are described herein.

[0042] In accordance with long-standing patent law convention, the terms "a," "an," and "the," as used in this application, including in the claims, refer to "one or more." Thus, for example, a reference to "a device" can include a plurality of such devices, and so on.

[0043] Unless otherwise indicated, all numbers expressing quantities of ingredients, properties, and so forth used in the specification and claims are to be understood as being modified in all instances by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in this specification and the 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 a value or amount of mass, weight, time, volume, concentration, and / or percentage, may include in some embodiments a variation of + / -20%, in some embodiments + / -10%, in some embodiments + / -5%, in some embodiments + / -1%, in some embodiments + / -0.5%, and in some embodiments + / -0.1% from the specified amount, as appropriate for the disclosed package and method.

[0045] Various embodiments of the subject matter of the present disclosure are directed to a respiratory mask assembly 10. Some embodiments of the subject matter of the present disclosure are directed to a conduit coupler 100 (alternatively referred to as "coupler 100" or simply "coupler") for use with the respiratory mask assembly 10. In various examples, the respiratory mask assembly 10 includes the conduit coupler 100 and a respiratory mask 1, and in some embodiments, the respiratory mask assembly 10 further includes 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 shows the respiratory mask assembly 10 in an assembled configuration with the conduit coupler 100 assembled thereon, and FIG. 1B shows the respiratory mask assembly 10 in an assembled configuration attached to a person with the respiratory assembly assembled on the conduit coupler 100. 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 shown in FIGS. 14, 17, 18, 20, and 21.

[0046] In various embodiments, the respiratory mask assembly 10 includes a conduit coupler 100 having 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 a male member therethrough. In one example, the respiratory mask 1 may be disposable. In various embodiments, the respiratory mask 1 can be made of any suitable material including cloth, woven and non-woven 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 a seal. One of the channel openings of the male member 24 and the female member 22 is connected 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 nostrils and mouth.

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

[0048] The conduit connector 100 can include a gasket 25, a female member 22, and a male member 24. In at least one embodiment, the gasket 25 may 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 breathing mask, and the outer surface 34 of the breathing mask. 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 breathing mask 1, and the outer surface 34 of the breathing mask 1. In various examples, the conduit connector 100 acts to form a substantial airtight seal around a central opening 36 formed in the breathing mask 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 therein. In one embodiment, the female member 22 selectively engages the male member 24 to form a substantial airtight connection therebetween. The connector 100 further includes one or two gaskets 25 provided between the male member and the female member. The side surface of at least one gasket is configured to sealingly engage with the wall of the breathing mask when the male member is inserted through the central opening 36 formed in the breathing mask 1 and selectively engaged with the female member 22. The connector end of the female member 22 cooperates with the channel opening of a fluid supply source (e.g., a tube or conduit). In some implementations, the connector end of the female member can form a substantial 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 nostrils and oral cavity.

[0049] In some embodiments, gasket 25 can engage or otherwise include one or more flexible adhesive sheets (not shown) to provide a sealable engagement with one or more of the male member, female member, inner surface 32 of the breathing mask, and outer surface 34 of the breathing mask. Gasket 25 can be constructed from any known material including, but not limited to, cloth, plastic, and / or latex. For example, in some embodiments, gasket 25 can be composed of polyvinyl chloride, polyethylene, polyurethane, latex, or combinations thereof. In some embodiments, gasket 25 can be a foam medical tape, surgical tape, and / or a low-allergenic tape. One or both surfaces of gasket 25 can include an adhesive. In one embodiment, 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., methacrylate, alkyl acrylate, or epoxy diacrylate), acrylic acid, polyvinyl chloride, alkyl ester, or combinations thereof. In some embodiments, the adhesive can be a pressure-sensitive adhesive such that the gasket can be adhered and removed as desired. The adhesive can be selected to show little or no irritation to the patient's skin. In some embodiments, the adhesive tape can be configured as a hydrocolloid tape and / or can include a polyurethane reaction layer. In some embodiments, gasket 25 can include a peelable adhesive film.

[0050] In one embodiment, the tube 12 passes through the male member 24, the central opening 36, one or more gaskets 25, and the female member 22 to supply fluid to the inlet 38 of a nasal breathing assembly, such as the nasal breathing assembly 5 shown in FIG. 14. The tube 12 may further form a substantially airtight connection with the other end of the tube 12 that is in fluid communication with a fluid source that forms part of, for example, a CPAP machine, and the inlet 38. The coupler 100 serves to form a substantially airtight seal around the central opening 36 when the male member 24 is connected to the female member 22, preventing or restricting any particle of 0.3 microns or greater, such as fine particles like viruses, bacteria, fungi, and other similar microorganisms, from moving across (or around the edge of) the central opening 36 in any direction. In one embodiment, any particle of size 0.1 microns or greater is prevented or restricted from moving across (or around the edge of) the central opening 36 in any direction. In one embodiment, any particle of size 0.01 microns or greater is prevented or restricted from moving across (or around the edge of) the central opening 36 in any direction. In one embodiment, any particle of size 1.0 microns or greater is prevented or restricted from moving across (or around the edge of) the central opening 36 in any direction. In one embodiment, any particle of size 10.0 microns or greater is prevented or restricted from moving across (or around the edge of) the central opening 36 in any direction.

[0051] Embodiments of the subject matter of the present disclosure can advantageously enable a person to wear both a continuous positive airway pressure (CPAP) mask and a respiratory mask (e.g., an N95 respiratory mask, etc.) simultaneously. Embodiments of the subject matter of the present disclosure can serve to reduce or eliminate the spread of infectious diseases to medical professionals and caregivers who may spend time in the vicinity of a patient while a person is wearing the respiratory mask assembly 10. Embodiments of the subject matter of the present disclosure can further serve to reduce or eliminate the spread of infectious diseases from airborne microorganisms present in the vicinity of a person wearing the respiratory mask assembly 10 to the person wearing the respiratory mask assembly 10. Thus, embodiments of the subject matter of the present disclosure can enable a person / patient to wear both a continuous positive airway pressure (CPAP) assembly and a respiratory mask simultaneously, thereby preventing or restricting the movement of airborne particles 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 across the central opening 36 in either direction (inward or outward).

[0052] In at least one embodiment, the coupler 100 includes two gaskets 25, a first gasket 25 contacts the outer surface 34 of the respiratory mask 1 to form a substantial airtight seal, and a second gasket contacts the inner surface 32 of the respiratory mask to form a substantial airtight seal. In the same embodiment, the other side of the first gasket 25 contacts the female member 22 to form a substantial airtight seal, and the other side of the second gasket 25 contacts the male member 24 to form a substantial airtight seal. In this embodiment, the coupler 100 serves to form a substantially airtight seal around the central opening 36 formed in the respiratory mask 1 by the use of two gaskets 25. An adhesive or adhesive tape is included on both sides of each gasket 25.

[0053] In at least one embodiment, the breathing mask is configured to block at least 95 percent of particles of a size of 0.3 microns or greater (i.e., an N95 breathing mask or an N95 respirator). In one embodiment, the breathing mask is a surgical mask. In one embodiment, gasket 25 is in the form of a membrane having an orifice formed therethrough for a portion of male member 24 to be inserted therein 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. An N95 respirator is a respiratory protective device designed to achieve a very close face fit and very 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 medical environments and are a subset of N95 Filtering Facepiece Respirators (FFRs), often referred to as N95s.

[0055] A surgical mask is a device that creates a physical barrier between the wearer's nose and mouth and potential contamination of the surrounding environment. It is a disposable, loosely fitting device. Surgical masks are regulated by 21 CFR 878.4040. Surgical masks should not be shared and may be labeled as surgical masks, isolation masks, dental masks, or masks for medical procedures. They may or may not be accompanied by a face shield. These are often referred to as face masks, but not all face masks are regulated as surgical masks. Surgical masks are made in various thicknesses and with various performance characteristics to protect the wearer from contact with liquids and fluids. These characteristics can also affect how easily the wearer can breathe through the face mask and how well the surgical mask protects the wearer. When worn properly, a surgical mask serves to block large particle droplets, splashes, sprays, or aerosols that may contain pathogenic agents (viruses and bacteria) so that they do not reach the mouth and nose. Surgical masks may also help reduce the wearer's exposure of saliva and respiratory secretions to others. Surgical masks can be effective in blocking droplets and large particle aerosols, but depending on the design, face masks do not filter or block very small particles in the air that can be transmitted by coughing, sneezing, or certain medical procedures. Also, due to the loose fit between the surface of the face mask and the face, surgical masks do not provide complete protection from pathogenic agents and other contaminants. Surgical masks are not intended to be used more than once. Remove the face mask and safely discard it and replace it with a new one if the mask is damaged or soiled or if breathing through the mask becomes difficult. To safely discard the mask, it should be placed in a plastic bag and put in the trash. Hands should be washed after handling a used mask. When worn properly, a surgical mask serves to block large particle droplets, splashes, sprays, or aerosols that may contain pathogenic agents (viruses and bacteria) so that they do not reach the mouth and nose. Surgical masks may also help reduce the wearer's exposure of saliva and respiratory secretions to others.

[0056] People with chronic respiratory, heart, or other medical conditions that make breathing difficult need to be cautious when using an N95 respirator, as the N95 respirator can make it more difficult for the wearer to breathe. Embodiments of the subject matter of the present disclosure can help overcome this drawback, thereby enabling the N95 respirator to operate in conjunction with a CPAP or other similar positive airway pressure device. Specifically, a respiratory mask 1 in the form of an N95 respirator can be mounted (as shown in FIG. 1) on a respiratory assembly such as a nasal breathing assembly 5, calming the physical barrier between the wearer's mouth and nose and the potential plume of the surrounding environment (or preventing potential contamination exiting the wearer's mouth and 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. This elastomeric material can further include an adhesive material for forming a sealable engagement with the surface of the male member, the surface of the female member, and the inner and / or outer surfaces 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 is removably coupled to the male member. In one embodiment, the female member is threaded onto a screw thread formed on the male member. In one embodiment, the female member includes one or more release devices that can be rotated to form a selective engagement with 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 includes 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 medicinal fluid source, or a humidifier. In one embodiment, the fluid is selected from a gas, a mixture of gases, or a gas with a drug.

[0060] The nasal breathing assembly 5 (see FIG. 14) can be attached to a patient according to 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 the breathing mask assembly 10 as described in International Patent Application No. PCT US / 2018 / 019109, filed Aug. 31, 2018, the entire contents of which are incorporated herein by reference.

[0061] In some embodiments, the fluid source can be a high flow generator, a continuous positive airway pressure (CPAP) machine, a fluid tank, a humidifier, or any other fluid source known or used in the art. As used herein, the term "fluid" refers to any gas, mixture of gases, or gas with an agent (such as an aerosol agent) suitable for delivery to a human airway. A flexible tube, such as tube 12 shown in FIG. 1, can be connected to an inlet, for example, to supply fluid from the fluid source, and the tube can include any known flexible tube. As used herein, the term "tube" refers to any conduit, delivery conduit, tube, pipe, passageway, or channel through which fluid flows. As used herein, the term "flexible" refers to any tube that can be bent or flexed, conforms, and easily adapts to the general shape and contour of the human body. In some embodiments, tube 12 can be constructed from medical grade materials such as polyurethane, polyvinyl chloride, polyamide, polyester, polyolefin, silicone resin, fluoropolymer, and combinations or copolymers thereof (but not limited to these). The tube is flexible, elastic, and hollow. In some embodiments, the tube can have an inner diameter of about 2-4 mm, but tubes with 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, during use, the tube can be hooked over the patient's ear and lifted under the chin during use.

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

[0063] According to various embodiments, a breathing assembly conduit coupler is provided for forming a substantially airtight seal around an opening formed in a breathing mask. In various embodiments, the coupler includes a male member and a female member that define 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 being provided between the male member and the female member. The side surface of at least one gasket is configured to sealingly engage the wall of the breathing mask when the male member is inserted through the opening formed in the breathing mask and selectively engaged with the female member. The connector end of the male member cooperates with the 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 nostrils and oral cavity. Thus, the positions of the male member and the female member can be exchanged.

[0064] The respiratory assemblies disclosed herein have a wide variety of uses. For example, in some embodiments, the assembly can be used for high-flow delivery of breathing mask gas via a nasal assembly. In some embodiments, the atmosphere can be heated to near body temperature (e.g., about 37°C) and / or humidified (e.g., about 100% relative humidity) to reduce airway water loss, airway cooling, nasal irritation, etc. In high-flow therapy, an oxygen source is typically mixed with compressed air to enable delivery of air, a mixture of air and oxygen from about 22% to about 99%, or 100% oxygen using an oxygen blender. Advantageously, the disclosed assembly includes a tube large enough to deliver a respiratory gas flow rate of up to about 50 liters per minute for an adult. The nasal assembly and its components are also small enough to prevent a seal of the nostrils, allow flow during exhalation, and allow leakage of excess gas during inhalation. Beneficially, the delivered flow rate can meet the inspiratory flow rate so that the delivered gas is not diluted by room air.

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

[0066] The disclosed breathing 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 apnea that define hypopnea and apnea events. The disclosed device can be used to measure nasal pressure by measuring nasal pressure using a nasal prong connected to a pressure transducer.

[0067] The disclosed assembly can further be used with a fluid tank, a humidifier, or any other fluid source known or used in the art. Advantageously, the disclosed assembly can eliminate the ear pain and lip pain commonly seen with conventional breathing masks and cannulas. In addition, the disclosed assembly can allow for better control of gases (e.g., oxygen) during fluid delivery applications. In some embodiments, the disclosed assembly is strap - less and mask - less, thereby increasing the comfort of use. As a result, patients are more likely to use the assembly as directed by a physician. In addition, skin indentations from unsightly masks and straps are eliminated. The disclosed assembly is less likely to be accidentally removed by a patient, such as during exercise or when pressed against a pillow.

[0068] In some embodiments, the disclosed breathing assembly includes a disinfection enclosure that can be used to disinfect reusable parts of a CPAP assembly. As used herein, the term "disinfection" refers to the elimination of all or substantially all microbial forms. The disinfection enclosure can include an active oxygen and / or UV light generator used to clean and / or disinfect reusable CPAP elements. For example, in some embodiments the generator can generate active oxygen to disinfect the contents inside the enclosure and the reusable APAP system. Active oxygen (also known as O3 or ozone) is a safe and 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 interfere with the metabolism of bacterial cells, perhaps by inhibiting and blocking the function of enzyme control systems. A sufficient amount of active oxygen penetrates 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, causing damage to the viral RNA. At higher concentrations, active oxygen destroys the viral capsid by oxidation, affecting the DNA or RNA structure. Active oxygen has been shown to be effective in destroying dozens of harmful pathogens, including E. coli, influenza virus, staphylococcus, streptococcus, herpes simplex virus, and many more.

[0069] In some embodiments, the generator can generate reactive oxygen species at a concentration of about 10 to 500 ppm (parts per million) within the internal and / or disclosed system. In some embodiments, the generator can generate UV light to disinfect the interior of the enclosure and the contents of the associated CPAP device. For this purpose, the generator can include one or more ultraviolet lights that can be operated for a preset time period. UV light is very effective in inactivating microorganisms including bacteria, viruses, yeasts, and molds. In some embodiments, the UV light is in the range of about 100 to 280 nanometers, which is known to damage DNA molecules in bacteria, viruses, molds, yeasts, and other microorganisms, preventing them from replicating and causing harm.

[0070] The disinfection enclosure can kill approximately 99% of the mold, bacteria, and viruses in the CPAP user's socket (or mask), tube, humidifier, and CPAP chamber. In addition to being highly effective, the disinfection enclosure is designed to be user-friendly. The user simply places the socket or mask inside the disinfection enclosure, closes the lid, and walks away. Importantly, disassembly of the CPAP device is not 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 that are performed daily. The enclosure can be configured in any desired shape, such as circular, oval, square, triangular, elliptical, hexagonal, pentagonal, star-shaped, amorphous, 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 can 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 can have any desired size for accommodating specific CPAP elements inside it.

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

[0072] FIG. 14 shows a nasal breathing assembly 5 that can be attached to a patient along with a respiratory mask assembly 10. As shown, the nasal breathing assembly 5 includes a sheet 27 configured to engage the patient's nostrils (i.e., nares). 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 of a nasal connector 90. Accordingly, the nasal breathing assembly 5 includes a pair of sheets 27, each sheet defining an opening 17 sized and shaped to fit over the patient's nostrils, having a ferromagnetic dome-shaped ring disposed on the underside of the sheet and circumferentially aligned with the opening, and the upper side of the sheet being configured to sealingly engage the nostrils. The nasal breathing assembly 5 includes a pair of socket magnet posts 20, each socket magnet post 20 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 passage extending from the first end to the second end. The magnetic ring 50 is removably attached to the dome-shaped ring at the outlet end 16. In one embodiment, the magnetic ring 50 is configured to pivotally move or rotate around the surface of the dome-shaped ring in a ball and socket configuration while maintaining a substantially airtight connection at the interface between the magnetic ring 50 and the dome-shaped ring. The nasal connector 90 of the nasal breathing assembly 5 includes a pair of channel openings, each channel opening sized and shaped to cooperate with one of the post receptacles 35, such that the channel 37 of the socket magnet post 20 is aligned with the channel opening of the nasal connector 90, to form a substantially airtight connection, and includes an inlet such as a ventilation fitting at a ventilation end configured to be in fluid communication with a tube 12 connected to a fluid source. In one embodiment, a ventilation port such as ventilation port 70 is disposed between the ventilation fitting and the tube 12.The vent 70 includes a vent receptacle sized and shaped to cooperate with the joint to form a substantially airtight connection, and the inlet 38 is sized and shaped to cooperate with a tube, such as tube 12 shown in FIG. 1, to form a substantially airtight connection.

[0073] In some embodiments, each magnetic ring 50 can be in the form of a plurality of magnets 250 arranged as an array around the periphery of the side facing the sheet of magnet sockets 52 disposed around the first end of the socket magnet post 20. In another embodiment, each magnetic ring 50 can be in the form of a single ring magnet provided around the periphery of the side facing the sheet of magnet sockets 52 disposed around the first end of the socket magnet post 20.

[0074] Accordingly, in at least one embodiment, each socket magnet post 20 can include a magnetic ring 50 that includes a plurality of magnets 250 forming an array as shown in FIG. 15, 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 magnetic ring 50 of the socket magnet post 20, using, for example, 3D printing techniques generally known in the art. Accordingly, the magnetic ring 50 can include a plurality of magnets 250 arranged as an array around the side of the magnetic ring 50 facing the sheet. In various embodiments, the polarities of the magnets 250 may be arranged such that each magnet 250 has an opposite polarity to an adjacent magnet 250. In other words, the polarities may be alternated among the plurality of magnets 250 arranged as an array on the magnetic ring 50. Accordingly, the plurality of magnets 250 with alternating polarities can be attached to a 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 cross-section passing through the center of the magnetic ring 50. In various embodiments, the array of magnets 250 may be arranged concentrically.

[0075] As is generally 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 materials are deposited, joined, or solidified under computer control to create three-dimensional objects, and the materials (e.g., plastics, liquids, or powder particles are fused together) are typically added layer by layer. The accuracy, reproducibility, and material range of 3D printing have increased to the point where some 3D printing processes are considered viable as industrial production technologies, whereby the term additive manufacturing can be used synonymously with 3D printing. One of the important advantages of 3D printing is the ability to generate very complex shapes or geometries that would otherwise be impossible to construct by hand, including hollow parts or parts with internal truss structures, thereby reducing weight. Fused deposition modeling, or FDM, is a common 3D printing process currently in use as of 2020.

[0076] According to one embodiment, the nasal breathing assembly 5 comprises a pair of sheets, each sheet defining an opening sized and shaped to fit over a patient's nostril, a ferromagnetic ring being disposed on the underside of the sheet and circumferentially aligned with the opening, and the upper side of the sheet being configured to sealingly engage the nostril. The nasal breathing assembly 5 comprises a pair of socket magnet posts 20. Each socket magnet post 20 includes a magnetic ring 50 disposed at a first end of the post and a ball-shaped receptacle disposed at a second end of the post, and has a passage 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 ends, each socket opening being sized and shaped to receive the ball-shaped receptacle within a ball and socket configuration and form a substantially airtight connection therewith, and having an inlet at a venting end in fluid communication with a flexible tube connected to a fluid source. The array of magnets can include magnets concentrically disposed at the first end of the post. The array of magnets can include a plurality of magnetic pellets embedded at 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 treatment gas in a patient's nasal cavity. One end of the vent 70 has an inlet 38 configured to connect to a fluid source (not shown) via a fluid conduit such as a tube 12 that supplies breathing 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 disposed proximal to where fluid flow occurs. It should be understood that the vents 70 can be disposed at any desired location and are 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 enable connection with the tube 12 (the tube 12 is shown in FIG. 1). In such embodiments, the outer diameter of the adapter is larger than the inner diameter of the tube 12. In this way, the adapter is held within the tube for a desired period of time and is not accidentally removed by the patient, such as during sleep. However, the adapter can be releasably connected to the tube 12 using any known mechanism.

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

[0079] The socket magnet post 20 extends toward the ring 262 (shown in FIG. 17) of the sheet 27 via the magnetic ring 50 and is configured as a contact nose prong. The sheet 27 is configured to be attached to the wearer's nostrils such that the fluid received at the inlet 38 is delivered into the wearer's nostrils through the respective openings 17 of the sheet 27. The ring 262 (which may be dome-shaped in some embodiments) is fabricated as an integral component of the sheet 27 such that the openings of the ring 262 are aligned with the respective openings 17 of 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 each ring 262 of the sheet 225 via a plurality of magnets 250 arranged as an array around the periphery of the side facing the sheet of the magnet socket 52, and is disposed around the 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 using, for example, 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 as an array around the periphery of the side facing the sheet of the magnet socket 52. In various embodiments, the polarities of the magnets 250 may be arranged such that each magnet 250 has a polarity opposite to that of an adjacent magnet 250. In other words, the polarities may be alternated among the plurality of magnets 250 arranged as 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 an N polarity, while the exposed sides of magnets 250b and 250d may have an S polarity. Thus, the plurality of magnets 250 with alternating polarities can be attached to the ring 262 by magnetic attraction force. 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 cross-section passing through the center of the magnet socket 52. In various embodiments, the array of magnets 250 may be arranged concentrically.

[0081] In some embodiments, the magnet socket 52 (i.e., the upper surface of the socket magnet post 20) can be angled with respect 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 nostrils. The sheet 27 may be configured to attach to the wearer's nostrils such that fluid received at the inlet 38 is delivered into the wearer's nostrils through respective openings 17 of the sheet 27. The ring 262 (which may be dome-shaped in some embodiments) is fabricated as an integral component of the sheet 27 such that the openings of the ring 262 are aligned with the respective openings 17 of the sheet 27. As shown in FIG. 15, the upper 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 substantially parallel to each other. While each magnet 250 can be cylindrical or pellet-shaped, other shapes are possible without departing from the spirit of the subject matter of the present disclosure. Similarly, the ring 262 may take other shapes such that any shape taken by the ring 262 is complementary or conforms to the configuration / arrangement of the magnets 250. In various embodiments, the ring 62 is made of a ferromagnetic material so as to be attracted by the magnetic field of the magnets 250 to form a substantially airtight connection or attachment. In some embodiments that include an HFO source and / or HFNC, the upper end of each socket magnet post 20 can include a magnet socket 52 configured to house a magnet, such as magnet 250.

[0082] According to one embodiment, the nasal breathing assembly 5 comprises a pair of sheets, each sheet defining an opening sized and shaped to fit over a patient's nostril, the ferromagnetic ring being disposed on the underside of the sheet and circumferentially aligned with the opening, and the upper side of the sheet being configured to sealingly engage with the nostril. 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 passage 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 ends, each socket opening being sized and shaped to receive the ball-shaped receptacle within a ball and socket configuration and form a substantially airtight connection therewith, and an inlet at a ventilation end in fluid communication with a flexible tube connected to a fluid source. The array of magnets can include magnets concentrically disposed at the first end of the post. The array of magnets can include a plurality of magnetic pellets embedded at the first end of the post. The post 20 can be 3D printed.

[0083] FIG. 16 shows a port magnet post 120 that can be used in place of the socket magnet post 20 within the nasal breathing assembly 5. The port magnet post 120 can replace the socket magnet post within the nasal breathing assembly 5. The port magnet post 120 includes a ball-shaped receptacle 135 that cooperates with the socket opening of the nose connector 90 in a ball and socket configuration. The ball-shaped receptacle is configured to move or rotate pivotally around the 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 each ring 262 of the sheet 227 via a plurality of magnets 250 disposed around the side of the port magnet post 120 facing the sheet of magnet sockets 152 disposed around the first end of the port magnet post 120. Each ring 262 includes an opening 217. Thus, in one embodiment, each port magnet post 120 can include a plurality of magnets 250 (as shown in FIG. 16) instead of a single ring magnet as shown in FIG. 14. In one embodiment, the plurality of magnets 250 can take the form of magnet pellets embedded within the magnet sockets 152 of the port magnet post 120 using, for example, 3D printing techniques commonly known in the art. Accordingly, the magnet sockets 152 of the embodiment of FIG. 16 are configured to accommodate a plurality of magnets 250 disposed around the side of the magnet socket 152 facing the sheet. In various embodiments, the polarities of the magnets 250 may be arranged such that each magnet 250 has an opposite polarity to an adjacent magnet 250. In other words, the polarities may be alternated among the plurality of magnets 250 disposed on the magnet socket 152. Thus, the plurality of magnets 250 of alternating polarities can be attached to the ring 262 by magnetic attraction. In one embodiment, the port magnet post 120 can be formed by any generally known 3D printing technique.

[0085] The magnet 250 disposed on the magnet socket 152 is removably attached or connected to a ring 262 (a ferromagnetic ring) at the port magnet post exit end. In one embodiment, the magnet socket 152 is configured to move or rotate around the surface of the ring 262 while maintaining a substantially airtight connection at the interface between the magnet 250 and the ring 262. Accordingly, the ring 262 advantageously prevents or reduces the possibility that the nose connector 90 may inadvertently become detached when the wearer of the nasal breathing assembly 5 moves their head either while awake or asleep, thereby enabling the continuous supply of therapeutic gas to the nostrils of the patient (or wearer) under ideal pressure. In at least one embodiment, the ring 262 enables the magnet socket 152 to move or rotate around the surface of the ring 262 when the face of a patient wearing the nasal breathing assembly 5 is moved by a sudden, sharp movement, while being able to maintain a substantially airtight connection. In at least one embodiment, the ring 262 enables the magnet socket 152 to move or rotate around the surface of the ring 262 when the wearer's pillow contacts or applies a shearing force to the nasal breathing assembly 5 or a portion of the tube supplying fluid to the nasal breathing assembly 5, while being able to continue to maintain a substantially airtight connection with the wearer's pillow.

[0086] Figure 17 shows a nasal breathing assembly 205 that includes a port magnet post 220 that can be used in place of the socket magnet post 20. The port magnet post 220 of the nasal breathing assembly 205 includes a receptacle that cooperates with the opening of the nasal connector 290 in a substantially airtight configuration. In one embodiment, a vent such as vent 270 is disposed between a vent fitting and a tube such as tube 12 shown in FIG. 1 to form a substantially airtight connection. The vent 270 can have similar characteristics to the vent 70. In some embodiments, for example, as shown 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 periphery of the side facing the sheet of the magnet socket 152, and the magnet socket 152 is disposed around the first end of the port magnet post 220. Thus, in one embodiment, each port magnet post 220 can 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 can take the form of magnet pellets embedded within the magnet socket 252 of the port magnet post 220 using, for example, 3D printing techniques generally 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 periphery of the side facing the sheet of the magnet socket 252. In various embodiments, the polarities of the magnets 250 may be arranged such that each magnet 250 has an opposite polarity to an adjacent magnet 250. In other words, the polarities may be alternated among the plurality of magnets 250 disposed on the magnet socket 252. Thus, the plurality of magnets 250 with alternating polarities can be attached to the ring 262 by magnetic attraction. In one embodiment, the port magnet post 220 can be formed by any generally known 3D printing technique.

[0087] The ring 262 may or may not have a dome shape. The upper surface of the port magnet post 220 may be angled, for example, as shown in FIG. 17. The magnet socket 252 is disposed around the first end of the port magnet post. In some embodiments, the magnet socket 252 (e.g., the port magnet post upper surface) may be angled with respect to the body of the port magnet post 220 to enable better positioning over the patient's nostril and to enhance the attachment of the sheet 227 to the ring 262.

[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 numerically represented with a "2" hundredth prefix used to label each parallel component of the nasal breathing assembly 5. For example, the sheet 227 of the nasal breathing assembly 205 may be substantially similar or identical to the sheet 27 of the nasal breathing assembly 5.

[0089] Figures 18 and 19 illustrate components of nasal breathing assemblies 405A and 405B according to one or more embodiments of the presently disclosed subject matter. As illustrated in FIG. 18, nasal breathing assembly 405A includes an extensible tube 410 in fluid connection with a hollow elbow 480A, and a swivel connection 454 operates to provide a substantially tight connection between the extensible tube 410 and the elbow 480A. The swivel connection 454 enables one of the elbow 480A and the extensible tube 410 to pivotally move advantageously 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 engagement with the vent end of the nasal connector 490. Thus, through the 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 fluid source. Thus, in one embodiment, a hollow elbow, such as elbow 480A, is positioned between the nasal connector 490 and the extensible tube 410.

[0090] Elbow 480A includes a CO 2 exhaust portion 491A sized and shaped to facilitate the exhaust of CO 2 exhaled by a patient wearing nasal breathing assembly 405A. Similarly, elbow 480B includes a CO 2 exhaust portion 491B sized and shaped to facilitate the exhaust of CO 2 exhaled by a patient wearing nasal breathing assembly 405B. Each of nasal breathing assemblies 405A and 405B can further include a diffuser cap 492 that can be attached to elbow 480A via corresponding recessed cuts 493 (see FIG. 18) provided on both sides of elbows 480A and 480B, and protrusions provided on a diffuser cap having recessed cut sections positioned diagonally to each other. The CO 2 exhaust portion 491A operates to ensure that the patient's inspiratory force is not impeded and to ensure that excess fluid exits. The CO 2The exhaust portion 491A can have any desired size and shape and can be positioned in the vicinity of any region where fluid flow occurs. CO 2 The exhaust portion 491A can vary in size and position such that the operation of the total inhaled fluid (e.g., for carbon dioxide) is controlled and the flow rate can be changed to a desired setting. In some embodiments, CO 2 The exhaust portion 491A can include extremely thin polymer fibers, membranes, and / or coatings (e.g., from the nanoscale to the microscale).

[0091] The nasal connector 490 can be constructed of silicone or other similar flexible materials according to one or more embodiments of the subject matter of the present disclosure. A single nasal connector 490 located on the side surface of the nasal connector 490 opposite the end facing the elbow 480A (i.e., the vent end) includes a flange such as the flange 470A as shown in FIG. 18. The flange 470A at the sheet end of the nasal connector 490 can include silicone or other similar stretchable materials according to one or more embodiments of the subject matter of the present disclosure. As shown in FIG. 18, the flange 470A secures two slip rings such as the slip rings 460A, 460B, 460C, or 460D therein, and the flange 470A comprises a silicone sheet or other similar material. Each slip ring 460A, 460B, 460C, or 460D is securely held within its respective magnet array 450A, 450B, 450C, or 450D. As shown in FIG. 18, the magnet array 550 includes a ridge 402 that circumferentially surrounds the magnet array 550, and the magnet array 650 includes a groove 404 that circumferentially surrounds the magnet array 650.

[0092] In various embodiments, each magnet array 450A, 450B, 450C, or 450D can comprise 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 each slip ring 460A, 460B, 460C, or 460D. Each slip ring is made of a flexible material. In some embodiments, each slip ring can include materials such as LDPE (low-density polyethylene) that holds the magnet array 450A at or near its inner edge, and a styrene-butadiene copolymer (SBC) sold under the trade name K-resin at or near its outer edge. The combination of materials forming a part of this slip ring preferably allows the circular magnet array 450A to pivot, for example while being fixed thereto, inside and near each slip ring 460A. In various embodiments, the magnet arrays 450A, 450B, 450C, or 450D can take any suitable shape such as circular, oval, egg-shaped, or teardrop-shaped, and the shape of the opening of each ferromagnetic ring 462A, 426B, 426C, or 426D complements or matches 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 for the magnet arrays 450A, 450B, 450C, or 450D to pivot relative to each of the slip rings 460A, 460B, 460C, or 460D. In some embodiments, the slip ring can further include a soft, renewable membrane that surrounds the magnet array and fills the remaining void inside each slip ring between its outer and inner edges, helping to increase the comfort of a patient wearing the nasal breathing assembly by reducing or eliminating the torque felt by the patient's nose on the assembly during use of the assembly.In some embodiments, the soft, renewable membrane may comprise a silicone resin or other similar material that can conveniently reduce or eliminate the torque felt by the patient's nose of the assembly during use of the assembly by the patient. In some embodiments, the entire slip ring can consist solely of a soft, renewable membrane that surrounds the magnet arrays 450A, 450B, 450C, or 450D and fills all the voids inside the slip ring.

[0093] In some embodiments, as shown in the upper right of FIG. 18 by way of example, each magnet array 450A can comprise a plurality of magnets 250 arranged as a circular array, for example, instead of a single ring magnet illustrated in FIG. 14. Thus, in one embodiment, each magnet array 450A can comprise a plurality of magnets 250 (as shown in the magnet array 450A 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 can take the form of magnet pellets embedded, for example, within the magnet array 450A using 3D printing techniques generally 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 perimeter of the sheet surface of the magnetic array 450A. In various embodiments, the polarities of the magnets 250 may be arranged such that each magnet 250 has a polarity opposite to that of an adjacent magnet 250. In other words, the polarities can be alternated among the plurality of magnets 250 arranged on each magnet array 450A. Thus, the plurality of magnets 250 with alternating polarities can be attached to the ferromagnetic ring 462A by magnetic attraction. In one embodiment, the port magnet post 220 can be formed by any generally known 3D printing technique.

[0094] FIG. 18 shows only the magnet array 450A including the array of magnets 250, but it should be noted that each of the other magnet arrays 450B, 450C, or 450D includes a magnet array similar to the magnet array 450A, and such magnets 250 of the magnet arrays 450B, 450C, or 450D are not shown in FIG. 18 due to space limitations. Each of the magnet arrays 450A, 450B, 450C, or 450D can magnetically fix each of the ferromagnetic rings 462A, 462B, 462C, or 462D (see FIG. 19) of the sheets 425A, 425B, 425C, or 425D (see FIG. 19) through magnetic attraction force and be substantially closely connected thereto. In various embodiments, each of the magnet arrays 450A, 450B, 450C, or 450D is attached so as to be attached to each of the ferromagnetic rings 462A, 462B, 462C, or 462D through a plurality of magnets 250 disposed on the magnet-facing surfaces of each of the magnet arrays 450A, 450B, 450C, or 450D, respectively. By providing the ferromagnetic rings 462A to 462D with various peripheral shapes attached to the sheets 425A - 425D, an improved patient experience can be enabled when integrated into the nasal breathing assembly 405A or the nasal breathing assembly 405B that can be attached to the 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 to the outer periphery of the magnet array) includes an elongate, loose, very flexible, and forgiving thin layer of silicone resin configured to bounce back against the slip ring or against the magnet array, which helps to accommodate movements initiated by the patient during use of the nasal respiration 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 to the outer periphery of the slip ring) can include a thinner, less flexible, and thicker silicone layer relative to the portion adjacent to the outer periphery of the magnet array. Further, the material of the flange 470A that surrounds and is adjacent to the slip ring can include a thinner, less flexible, and thicker silicone layer compared to the portion that joins with the outer edge of the magnet array. Such a configuration can serve to further enhance the comfort level of a patient wearing the nasal respiration 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 can vary depending on the size and shape of the internal openings configured and adapted for each respective magnet array received, in other words, the inner openings of the slip rings are sized and shaped to securely hold the magnet arrays received. Thus, the dimensions of the internal openings differ for each of the circular magnet array 450A, oval magnet array 450B, egg-shaped magnet array 450C, and teardrop-shaped magnet array 450D.

[0097] For example, the circular magnet array 450A located by the slip ring 460A is magnetically fixed to the ferromagnetic ring 462A (see FIG. 19) of the sheet 425A to form a substantially close relationship therewith. During use of the nasal breathing assembly 405A by the patient, when the circular magnet array 450A is detachably attached to the ferromagnetic ring 462A (see FIG. 19) of the sheet 425A, the upper end of the channel opening 415 on the circular magnet array 450A of the nasal connector 490 is in fluid communication with the inside of the wearer's nostril, while the lower end of the channel opening 415 is such that the breathing fluid flows from the flexible tube 410, through the elbow 480A, through each channel opening 415 of the flange 470A, through the opening 417A of each sheet 425A, and into the inside of the wearer's nostril, and is in fluid communication with the inside of the nasal connector 90. Accordingly, each channel opening 415 provides a unique path for carrying fluid from a fluid source to the patient's nostril.

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

[0099] In various embodiments, each of the sheets 425A, 425B, 425C, or 425D engages with, or includes an engagement with, one or more stretchable adhesive sheets (not shown) to provide a sealable engagement with the patient's nostrils. The 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 sheet can be constructed from PVC, polyethylene, polyurethane, latex, or combinations thereof. In some embodiments, the sheets 425A, 425B, 425C, or 425D can be foam medical tape, surgical tape, and / or low allergen tape. The patient contact surface of the 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., methacrylate, alkyl acrylate, or epoxy diacrylate), acrylic acid, polyvinyl chloride, alkyl esters, or combinations thereof. In some embodiments, the adhesive is a pressure sensitive adhesive such that the sheet can be adhered to and removed from the patient's skin as desired. The adhesive can be selected to exhibit mild irritation to the skin, or no irritation, when used daily. In some embodiments, the adhesive tape can be configured as a hydrophilic colloid tape and / or can include a polyurethane reactive layer that adheres more to the nostrils as the patient's body temperature warms the adhesive. Alternatively, in some embodiments, the adhesive can be applied directly to the patient's nostrils or nasal engagement portion to provide a removable connection (e.g., the sheet is not used). In various embodiments, each of the sheets 425A, 425B, 425C, or 425D, or the adhesive body therein, is configured to conform to the shape of the respective magnet arrays 450A, 450B, 450C, or 450D (shown in FIG. 18).

[0100] In various embodiments, by providing the magnetic arrays 450A, 450B, 450C, or 450D to come to rest directly on or in proximity to the cut surface, torque can be significantly reduced. Moreover, the shifting and spinning capabilities of the magnetic arrays 450A, 450B, 450C, or 450D serve to significantly reduce torque. In other words, the ability of the magnetic arrays 450A, 450B, 450C, or 450D to pivot to slip rings 460A, 460B, 460C, 460C, or 460D that firmly hold the magnetic arrays 450A, 450B, 450C, or 450D can reduce or eliminate the torque felt by the patient's nose of the assembly during use of the assembly by the patient while maintaining an airtight connection with their respective ferromagnetic rings 462A, 462B, 462C, or 462D, which can help increase the comfort of a patient wearing the nasal breathing assembly.

[0101] Accordingly, in various embodiments, the nasal breathing assembly 405A can comprise a pair of sheets 425C, each sheet 425C sized and shaped to conform above a patient's nostrils, with the ferromagnetic ring 462C positioned under the sheet and circumferentially aligned with the opening, and the upper side of the sheet 425C configured to sealingly engage the nostrils. The nasal breathing assembly 405A further comprises a nasal connector 490 including a pair of slip rings 460C at the sheet ends, 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 removably attach to one of the ferromagnetic rings 462C to form a substantially airtight connection therewith. In various embodiments, the channel opening can also have a circular, oval, ovoid, or teardrop shape, or other similar shape. 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 removable from the ring 227 of each 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 connect a hollow elbow 480A, which connects the inlet of the outlet end of the connector, to a flexible tube 410 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 shows 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 in the specification. 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 directly attached to the seat end of the elbow 480B located on the opposite side of the side of the elbow 480B including the swivel joint 454. The swivel joint 454 is connected to the flexible tube 410 such that the swivel joint 454 can allow the flexible tube 410 to pivot with respect to the elbow 480B. CO 2 The exhaust portion 491B is CO 2 configured in the same or equivalent manner as the exhaust portion 491A. In some embodiments, the nasal breathing assembly 405B can include a pair of flexible tubes 410, elbows 480B, and flanges 470B, one for each nostril. In some embodiments, the flange 470B can include two slip rings on the same single flange, for example, with respect to the flange 470A of FIG. 18. The nasal breathing assembly 405B is similar or identical to the nasal breathing assembly 405A in all other respects and can operate in a similar manner.

[0105] The remaining components of nasal breathing assemblies 405A and 405B have features that are substantially similar or identical to each component of nasal breathing assembly 5, and the components of nasal breathing assemblies 405A / 405B are designated by numerical values that include a hundreds prefix of "4" for labeling each of the parallel components of nasal breathing assembly 5. For example, sheet 427 of nasal breathing assemblies 405A / 405B may be substantially similar or identical to sheet 27 of nasal breathing assembly 5. In some embodiments, the remaining components of nasal breathing assembly 405A and nasal breathing assembly 405B may have features that are substantially similar or identical to each respective component of nasal breathing assembly 105. These components are the components of nasal breathing assemblies 405A / 405B that are labeled with numerical values that include a hundreds prefix of "4" instead of "1" used for labeling each of the parallel components of nasal breathing assembly 105. For example, magnetic array 450 of nasal breathing assemblies 405A / 405B may be substantially similar or identical to magnet 250 of nasal breathing assembly 205. As a further example, sheet 425 of nasal breathing assemblies 405A / 405B may be substantially similar or identical to sheet 125 of nasal breathing assembly 205.

[0106] According to at least one embodiment, the nasal breathing assembly 405A / 405B includes a pair of sheets 425A, 425B, 425C or 425D, each sheet 425A, 425B, 425C or 425D being sized and shaped to conform to a patient's nostrils, and ferromagnetic rings 462A, 462B, 462C or 462D being disposed on the underside of the sheet, aligned circumferentially with the openings, and the upper side of the sheets 425A, 425B, 425C or 425D being configured to sealably engage the nostrils. The nasal breathing assembly 405A / 405B further includes a nasal connector 490. The nasal connector 490 includes a pair of slip rings 460A, 460B, 460C or 460D at the sheet ends, each slip ring 460A, 460B, 460C or 460D accommodating 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 magnetisms. The magnetic rings in the form of the magnet arrays 450A, 450B, 450C or 450D are configured to pivot and incline to the slip rings. The magnetic rings in the form of the magnet arrays 450A, 450B, 450C or 450D are sized to be attachable to and substantially closely connected to any of the ferromagnetic rings 462A, 462B, 462C or 462D. The nasal breathing assembly 405A / 405B further includes an inlet at the outlet end in fluid communication with a flexible tube connected to a fluid source. The channel openings have a circular, elliptical, oval, or teardrop shape. The openings of the ferromagnetic rings have 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 openings of the ferromagnetic rings matches the shape of the channel openings of the magnetic rings in the form of the magnet arrays 450A, 450B, 450C or 450D. The magnet array can include magnets 250 intensively arranged at the sheet ends of the slip rings 460A, 460B, 460C or 460D. The slip rings may be 3D printed.

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

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

[0109] Figures 22 - 25 show additional embodiments and additional embodiments of a coupler 100 that can form part of a breathing mask assembly 10 according to one or more embodiments of the subject matter of the present disclosure. In various embodiments, the gasket can take on various sizes and shapes without departing from the spirit of the present invention.

[0110] The breathing mask 1 described herein and the coupler 100 described herein can be used in conjunction with any general CPAP mask, CPAP assembly, and other positive airway pressure masks and breathing aids. The breathing mask 1 described herein and the coupler 100 described herein can be further used in conjunction with any general breathing mask, including N95 breathing masks, surgical masks, and any other breathing masks capable of filtering particulate matter or microorganisms available on the current and future markets.

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

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

[0113] FIG. 27 shows some additional embodiments of a snap-on lid 200 that can be incorporated into a breathing mask 1 such as an N95 respiratory protector. The snap-on lids described herein can be used in conjunction with any general CPAP mask, CPAP assembly, and other positive airway pressure masks and respiratory aids. The snap-on lids described herein can be further used in conjunction with any general breathing mask including an N95 breathing mask, a surgical mask, and any other breathing mask capable of filtering particulate matter or microorganisms available in current and future markets.

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

[0115] In some embodiments, the frame 214 can comprise a sealing mechanism that provides a substantially gas-tight seal around the tube 12 inserted therethrough, whereby 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 mechanisms. In at least one embodiment, the sealing mechanism can be in the form of an elastomeric membrane or gasket (similar to the aforementioned gasket 25) that extends from or is otherwise connected to the frame 214 and is configured to form a substantially gas-tight seal between the tube 12 and the frame 214.

[0116] Figures 28 - 31 show various aspects of a polymer magnet forming part of a nasal respiration assembly 5 that couples to one or more of a patient's nostrils and within the oral cavity, such as a continuous positive airway pressure (CPAP) mask, according to some embodiments of the subject matter of the present disclosure. In some embodiments, each magnetic ring 50 can be in the form of one or more programmed magnets or polymer magnets 350, as shown, for example, in Figures 28 - 31. In some embodiments, the ring 262 may be replaced by, or otherwise include, the polymer magnet 350. Similarly, in some embodiments, the magnet 250, as referred to herein, can also represent the polymer magnet 350. In some embodiments, each magnetic ring 50 may be in the form of an array of a plurality of polymer magnets 350 disposed around the perimeter of the side facing a sheet of magnetic socket 52 disposed around the first end of the socket magnet post 20. In another embodiment, each magnetic ring 50 may be in the form of a single ring polymer magnet provided around the perimeter of the side facing a sheet of magnetic socket 52 disposed around the 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 that includes one or more polymer magnets 350 forming an arrangement as shown in Figure 15, instead of a magnetic ring 50 that includes a single ring polymer magnet 350 as shown in Figure 14.

[0117] In one embodiment, one or more polymer magnets 350 can further take the form of polymer magnet pellets embedded within the magnetic ring 50 of the socket magnet post 20, for example, using 3D printing techniques generally known in the art. Thus, the magnetic ring 50 can include one or more polymer magnets 350 arranged as an array around the side of the magnetic ring 50 facing the sheet. In various embodiments, the polarities within and between each polymer magnet 350 can be arranged to maximize the intended effect of maintaining a substantially airtight connection between the magnetic ring 50 and the ring 262, or else be 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 can be latch polymer magnets as described herein.

[0118] Accordingly, in at least one embodiment, one or more multi-magnets 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 comprising one or more polymer magnets 350 can be formed by 3D printing techniques. In one embodiment, the ring 262 comprising one or more polymer magnets 350 can be formed by 3D printing techniques. In at least one embodiment, one or more polymer magnets 350 can be substantially planar. In various embodiments, the plane of one or more polymagnets 350 can be substantially planar with respect to a cross-section passing through the center of the magnetic ring 50. In various embodiments, one or more polymagnets 350 can be arranged concentrically.

[0119] As shown in FIGS. 28A to 31F, the polymer magnet 350 can represent a magnetic structure incorporating a correlation pattern of magnets with alternating polarities, designed to achieve a desired behavior and deliver stronger local forces. By varying the magnetic field and intensity, different mechanical behaviors can be controlled. By varying the polarity and / or magnetic field intensity of each source of the array of magnetic sources constituting each structure, the polymer magnet 350 can be programmed or encoded. The resulting magnetic structure can be one-dimensional, two-dimensional, three-dimensional, and even four-dimensional when manufactured using an electromagnetic array. In one embodiment, an encoding theory used to design radio frequency signals in communication and radar can be applied to form the magnetic regions of the correlated magnets. For example, a 3D magnetization printer such as the "MagPrinter" developed by Collated Magnetics Research (CMR), Huntsville, AL, USA, can be used to manufacture the polymer magnet 350. This printer consists of magnetization coils within a cabinet equipped with a motion control system. In various embodiments, a polymer magnet printer can be used to create a multi-pole encoded magnet containing small magnetic elements called macels. This technology can be used to generate better attachment forces, safer magnets, precise alignment, shear and torque rigidity, and complex multi-step / multi-force control on scales that are not easily achieved with conventional magnets. The polymer magnet printer can use a magnet with a designed encoding of the polarity pattern and can be adjusted to meet specific application requirements, enabling magnets with unique functions, multiple forces per magnetic surface, particularly stronger forces on the magnet surface, controlling the "range" and "shape" of the magnetic field, and enabling enhanced detachment and shear forces that can be several times stronger than those found in conventional magnetization materials.

[0120] Accordingly, the polymer magnet 350 can be fabricated by reprogramming conventional magnetic materials in a matter of minutes. Using polymer magnets, magnetic linkages can have a softer “feel” or snap-to or crisper closing or opening behavior, and can impart a spring or latch-like sensation. In conventional magnets, there is an N pole on one surface and an S pole (S pole) on the opposite surface (see FIGS. 28Ai, 28Bii, 28Ci, and 28Di), and magnetic field lines flow from pole to pole. In contrast, in polymer magnets, a number of small polarized (N or S) magnetic pixels (“macels”) are fabricated by printing in a desired pattern on the same surface (see FIGS. 28Aii, 28Aiii, 28Bi, 28Cii, and 28Dii), and magnetic field lines are completed between the macels on that surface, resulting in a very compact and powerful magnetic field. This basic concept is shown in FIGS. 28Aii, 28Aiii, 28Bi, 28Cii, and 28Dii. Accordingly, the mechanical 3D behavior of a polymer magnet, such as the polymer magnet 350, can be determined by the pattern and strength of the macels embedded in the surface of the magnet. Customizable behaviors include spring, latch, shear, alignment, snap, torque, hold, torsion, softening, and release. Compact magnetic field settings reduce magnetic interference with other devices.

[0121] Most off-the-shelf magnets have simple properties, one side being the north and the other being the south. In the case of polymagnets, instead of a simple north-south arrangement, a customizable pattern can be designed in software and programmed into the magnet in a few minutes. Polymagnets can be manufactured in any quantity from prototypes to production volumes. Since the pattern is created in software, the pattern can be changed and new prototypes can be delivered in a few 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 configured 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] When used in pairs, polymagnets can utilize the magnetic attraction, repel the magnetic force, and utilize the idea of controlled cancellation or interaction of these forces in space. The arrangement or pattern of magnetic regions (referred to as a maccell) can create a unique magnetic circuit that defines the function of the magnetic device and its interaction with other magnets or ferromagnetic metals. Correlated magnet pairs (e.g., magnetic ring 50 in the form of one or more polymagnets and ring 262 in the form of one or more polymagnets) can be programmed to attract or repel at a predetermined force and engagement distance, or to attract or repel in a specific spatial orientation. Correlated magnets can be programmed to interact only with other magnetic structures that are encoded to respond. Correlated magnets can also be programmed to attract and repel simultaneously.

[0123] Compared with conventional magnets, the correlated magnet provides a much stronger holding force and stronger shear resistance as a target. Programmable behavior can be achieved by creating a multipole structure that includes multiple magnetic elements (macels) of various sizes, positions, orientations, and saturations. The size of the macel ranges from 1 mm to 4 mm. By stacking these macels, a very complex magnetic field can be generated. Correlated magnetic materials can be developed from ferrite, rare earths (e.g., neodymium magnets, samarium-cobalt magnets), ceramics, electromagnets, etc., and the correlated effect can be extended from very large permanent magnets to nanometer-scale elements. Multipolar magnetic devices can be constructed from individual permanent magnets or by exposing a heated magnetizable material to a coded magnetic field. The polymagnet can be designed to align using a wide variety of alignment functions. There are four main functions that the correlated magnet can achieve.

[0124] Attach polymagnet (see Fig. 29A). The magnetic field of the attach polymagnet is designed to be close to the surface of the magnet. This function provides an improved safety from distance and concentrates the field to make it stronger. To obtain the best results, a traction tape can be used.

[0125] Latch polymagnet (see Fig. 29D). The latch polymagnet is configured to repel until the magnet pair passes a defined transition point and then reverse polarity to attract after the transition point. These can be used for slide latches and rotary latches.

[0126] Spring polymagnet (see Figs. 29B and 29C). The spring polymagnet is configured to attract until it passes a defined transition point, repel after passing the transition point, and can be configured to rest at an equilibrium distance.

[0127] Alignment polymer magnets (see FIGS. 30A and 30B), conventional magnets are not necessarily aligned when attached to each other, while polymer magnets can be designed to be aligned with a variety of alignment functions. Alignment polymer magnets can provide rotational alignment, twist release, and axial centering. Rotational alignment polymer magnets (see FIG. 30B) are designed to be attached together and have a rotational detent or alignment position. Twist release polymer magnets attract at one position and repel when rotated. Centering alignment polymer magnets (see FIG. 30A) are designed to be attached together with high shear / slide forces.

[0128] FIG. 28Ai shows the magnetic field lines of a conventional magnet having magnetic field lines flowing from a single N pole to a single S pole. FIG. 28Bii illustrates a conventional magnet including a single N pole and a single S pole.

[0129] FIGS. 28Aii and 28iii show the magnetic field lines of a polymer magnet including many small polarized (N or S) magnetic pixels ("maxels") manufactured by printing in a desired pattern on the same surface, and the magnetic field lines are completed between the maxels on its surface, resulting in a very compact and strong magnetic field.

[0130] FIG. 28Ci shows the magnetic field lines of a bar-shaped conventional magnet having magnetic field lines flowing from a single N pole to a single S pole. FIG. 28Di shows the conventional magnet of FIG. 28Ci attached to a ferromagnetic bar.

[0131] FIG. 28Ci shows the magnetic field lines of a bar-shaped polymer magnet including many small split-pole (N or S) magnetic pixels, and the magnetic field lines are completed between each pair of N pole S pole combinations, resulting in a very compact and strong magnetic field. FIG. 28Dii shows the polymer magnet of FIG. 28Cii attached to a ferromagnetic bar.

[0132] Figure 29A shows two mounting polymer magnets designed such that the magnetic field is close to the surface of the magnet. This function provides improved safety from distance and concentrates the field to be stronger.

[0133] Figure 29B illustrates two spring polymer magnets configured to attract until passing a defined transition point, repel beyond the transition point, and be able to rest at an equilibrium distance.

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

[0135] Figure 29D shows two latch polymer magnets configured such that the magnet pair repels until passing a defined transition point, and after the transition point, they reverse polarity and are attracted.

[0136] Figure 30A shows two mounting polymer magnets designed such that the magnetic field is close to the surface of the magnet. This function provides improved safety from distance and concentrates the field to be stronger.

[0137] Although embodiments have been described in relation to preferred embodiments 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 without departing therefrom to perform the same function. Accordingly, 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 only. Accordingly, all embodiments within the scope of the drawings and these descriptions are not made in accordance with such illustrative dimensions. The drawings are not necessarily drawn to scale. Accordingly, all embodiments within the scope of the drawings and these descriptions are not made in accordance with the apparent scale of the drawings with respect to the relative dimensions of the drawings. However, for each drawing, at least one embodiment is created in accordance with the apparent relative scale of the drawing.

[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. Any methods, devices, and materials similar or equivalent to those described herein may be used in the practice or testing of the subject matter disclosed herein, but representative methods, devices, and materials are described herein.

[0140] In accordance with longstanding patent law convention, the terms "a", "an", and "the", as used in this application 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 on.

[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 of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terms used herein are chosen to best explain the principles of the embodiments, the practical application to technologies found in the marketplace, or the technical improvements thereof, or to enable other ordinary skill in the art to understand the embodiments disclosed herein. [Different aspects of the present invention] (Item 1) A breathing assembly for use in conjunction with a continuous positive airway pressure (CPAP) device, A conduit coupler comprising a male member and a female member, A cloth-based disposable breathing mask defining a central opening large enough to receive the male member, and A gasket positioned between the male member and the breathing mask, the gasket surrounding the central opening and providing a seal thereto, One of the channel openings of the male member and the female member is a breathing assembly connected to a continuous positive airway pressure (CPAP) mask that connects to one or more of a patient's nostrils and mouth. (Item 2) The breathing mask is configured to block at least 95 percent of particles sized 0.3 microns or greater, the breathing assembly of item 1. (Item 3) The breathing mask is a surgical mask, the breathing assembly of claim 1. (Item 4) The gasket comprises an adhesive foam material, the breathing assembly of claim 1. (Item 5) The gasket is formed from a stretchable elastomeric material, the breathing assembly of claim 1. (Item 6) At least one major surface of the gasket comprises a peelable adhesive film, the breathing assembly of claim 1. (Item 7) At least one major surface of the gasket comprises an adhesive material, the breathing assembly of claim 1. (Item 8) The breathing assembly comprises two gaskets, each gasket surrounding the central opening on each side of the breathing mask wall, the breathing assembly of claim 1. (Item 9) The female member selectively engages the male member, the breathing assembly of item 1. (Item 10) Both sides of the gasket comprise one or more of a peelable adhesive film and an adhesive material, the breathing assembly of item 1. (Item 11) The respiratory assembly according to item 1, wherein the central opening is provided with a snap-on lid. (Item 12) A respiratory assembly for use in conjunction with a continuous positive airway pressure (CPAP) device, a respiratory mask defining an opening, and a conduit coupler forming a substantially airtight seal around the opening of the respiratory mask, comprising: the conduit coupler includes a male member and a female member each defining a through hole for a conduit to fit therein, 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 so as to form a substantially airtight seal 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, a connector end of the male member is in fluid communication with a CPAP mask assembly, the CPAP mask assembly being a respiratory assembly connected to one or more of a patient's nostrils and mouth. (Item 13) A pair of sheets, each sheet defining an opening sized and shaped to fit over a patient's nostril, a ferromagnetic ring being positioned under the sheet and aligned around the opening, and an upper side of the sheet being configured to engage the nostril in a sealable manner, the pair of sheets; A pair of struts, each strut including a magnetic ring positioned at a first end of the strut and a ball-shaped receiving portion positioned at a second end of the strut, a passage 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 pair of struts; A connector having a pair of socket openings at a post end, each socket opening being sized and shaped to receive the ball-shaped receiving portion in a ball and socket configuration and form a substantially airtight connection therewith, and a connector having an inlet at a ventilation end in fluid communication with a flexible tube connected to a fluid source, a nasal respiration assembly comprising: (Item 14) The array of magnets of claim 13, wherein the array of magnets comprises magnets concentrically arranged at the first end of the post. (Item 15) The array of magnets of claim 13, wherein the array of magnets comprises a plurality of magnetic pellets embedded in the first end of the post. (Item 16) The nasal respiration assembly of claim 13, wherein the strut is 3D printed. (Item 17) A pair of sheets, each sheet defining an opening sized and shaped to fit into a patient's nostril, a ferromagnetic ring being positioned under the sheet and aligned around the opening, the upper side of the sheet being configured to engage the nostril in a sealable manner, a pair of sheets; A connector including a pair of slip rings at a sheet end for receiving a magnetic ring in each slip ring, Each slip ring defines a channel opening, The magnetic ring comprises an array of magnets, The magnetic ring is configured to tilt rotatably about the slip ring, The magnetic ring is sized and shaped to be removably attachable to the ferromagnetic ring so as to form a substantially airtight connection with the ferromagnetic ring, The inlet at the ventilation end is in fluid communication with a flexible tube connected to a fluid source, The nasal respiration assembly, wherein the channel opening has a circular, rectangular, elliptical, or teardrop shape. (Item 18) The nasal respiration assembly according to item 17, wherein the opening of the ferromagnetic ring has a circular, rectangular, elliptical, or teardrop shape, and the shape of the opening of the ferromagnetic ring matches the shape of the channel opening of the magnetic ring. (Item 19) The nasal respiration assembly according to item 17, wherein the magnet array includes magnets concentrically arranged at the sheet end of the slip ring. (Item 20) The nasal respiration assembly according to item 17, wherein the slip ring is 3D printed.

Claims

1. 1. A breathing assembly for use in conjunction with a continuous positive airway pressure (CPAP) device, comprising: a respiratory mask defining an opening; a conduit coupler that forms a substantially airtight seal around the opening in the respiratory mask; the conduit coupler includes male and female members each defining a bore therethrough into which a conduit fits; a sleeve of the male member passes through the opening in the respiratory mask and selectively engages the female member; a gasket is disposed between the female member and the respirator to form a substantially airtight seal between the sleeve and the opening of the male member when the male member selectively engages the female member; a connector end of the female member in fluid communication with a channel opening of a fluid source; The connector end of the male member is in fluid communication with a CPAP mask assembly, which in turn is a respiratory assembly that couples to one or more of the patient's nostrils and oral cavity.

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

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

4. The nasal breathing assembly of claim 2 , wherein the array of magnets comprises a plurality of magnetic pellets embedded in the first end of the post.

5. The nasal breathing assembly of claim 2 , wherein the struts are 3D printed.

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

7. 7. The nasal breathing assembly of claim 6, wherein the opening in the ferromagnetic ring has a circular, rectangular, oval, or teardrop shape, and the shape of the opening in the ferromagnetic ring matches the shape of the channel opening in the magnetic ring.

8. 7. The nasal breathing assembly of claim 6, wherein the array of magnets comprises magnets arranged concentrically at the seat end of the slip ring.

9. The nasal breathing assembly of claim 6 , wherein the slip ring is 3D printed.

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