CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application No. 63/025,172 filed on May 14, 2020, which is incorporated by reference herein in its entirety.

FIELD OF INVENTION

The disclosure relates to a self-contained respiratory device and to systems comprising the same and methods of making and using the same.

BACKGROUND

Respiratory masks are generally used by professionals for the single purpose of protecting themselves in specific situations, mostly in medical and industrial settings. Due to industrialization and de-forestation, air pollution has become an increasing threat to humans, resulting in increasing cases of human respiratory illnesses, pollution related complications of cardiovascular conditions and conditions related to the organs. Wearing a respiratory mask in daily life for consumer protection in polluted environments is becoming a norm in many places around the world. The recent, ongoing COVID-19 pandemic, also known as the coronavirus pandemic, caused by highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has led to wearing a respiratory mask or face covering a new norm globally.

Such respiratory masks or face coverings typically include an interior chamber surrounding the mouth and nose of a user, sealing against the surrounding skin. Ambient air is drawn through the mask or face covering, which removes pollutants, into the interior chamber, and thereafter inhaled. When exhaled, the exhaled air is released from the interior chamber through the same mask or face covering. Such a bi-directional mask or face covering presents a serious problem for patients with respiratory infection caused by infectious pathogens because their exhaled air contains the infectious pathogens, which, if not effectively filtered, will become airborne and then inhaled by the patient again or by others standing close by. The infectious pathogens will also be collected inside the mask or face covering, and then inhaled again by the patient. This way, patients remain infected and contagious for an extended period of time while the infectious contagions are transmitted to others and the process repeats perpetually until patients gradually recover or eventually die.

SUMMARY OF EMBODIMENTS

The present disclosure relates to a device which prevents expelled pathogens in breath from re-entry to the patient in order to reduce the rate of viral replication. In some embodiments, the disclosure relates to a device comprising: a first and a second one-way valve; at least a first and a second air channel; a mouthpiece; and at least a first nasal adapter; wherein the first one-way valve is attached to and in fluid communication with the first air channel; wherein the mouthpiece is attached to and in fluid communication with the first air channel distal from the first one-way valve; wherein the second one-way valve is in fluid communication with at least one second air channel; and wherein the first nasal adapter is attached to the second air channel at a position distal from the second one-way valve. In some embodiments, the second air channel comprises a bifurcated end capped with the first nasal adapter and a second nasal adapter.

In some embodiments, the disclosed device further comprises at least one air filter in fluid communication with the first one-way valve. In some embodiments, the disclosed device further comprises at least a first air filter in fluid communication with the first one-way valve and at least a second air filter in fluid communication with the second one-way valve. In some embodiments, the first air filter, first one-way valve, the first air channel and the mouthpiece are connected in a first fluid circuit; and wherein the second filter, second one-way valve, the second air channel and the first and/or second nasal adapter are connected in a second fluid circuit. In some embodiments, the first air filter is in fluid communication to the first air channel by the first one-way valve positioned therebetween; and the second air filter is in fluid communication to the second air channel by the second one-way valve positioned therebetween.

In some embodiments, the disclosed device further comprises a head band comprising at least one strap configured to wrap around the head of a user of the device and attached to a region of the device proximate to or on the mouthpiece by at least one connecting element. In some embodiments, the second air channel comprises two bifurcated tubes which on one end are attached to the second one-way valve and at the other end are each capped with one nasal adapter, the nasal adapter configured to be placed in the nostrils of a user. In some embodiments, the disclosed device further comprises a first operating condition; wherein, in the first operating condition, the first one-way valve is set to allow airflow from the end of the one-way valve distal from the mouthpiece through the first air channel and into the mouthpiece, and the second one-way valve is set to allow airflow from the nasal adapter through the second air channel and toward the second one-way valve. In some embodiments, the disclosed device further comprises a second operating condition; wherein, in the second operating condition, the first one-way valve is set to allow airflow from the mouth piece to through the first air channel and through the first one-way valve; and the second one-way valve is set to allow airflow from one end of the second one-way valve through the second air channel and into the nose. In some embodiments, the second air channel is attached to the mouthpiece by a connecting element. In some embodiments, the connecting element is a region of the mouthpiece positioned along a side region of the mouthpiece, contiguous with its outer surface and protruding from the outer surface such that the surface of the region forms a concave or substantially concave shape creating a cavity into which the second air channel is fixed.

In some embodiments, the disclosed device further comprises an air channel connection in fluid communication with the first or second one-way valve and attached to a disinfectant chamber. In some embodiments, the disinfectant chamber is chosen from one or a plurality of: a heating element, a fluid element comprising a disinfectant solution, or an energizing element.

In some embodiments, the disclosed device further comprises a head band unit, the head band unit comprising a head band sheath, a first band and a second band; wherein the head band sheath comprises a centered hole portion through which the first air channel or the mouthpiece pass and two opposite positioned strap regions, each strap region comprising an eyelit configured for receiving another strapped region of a band; wherein the first band is attached to both ends of the head band sheath by threading the ends through the eyelits and configured for transversing around the side portion of a user’s head; and wherein the second band is attached to sides of the portions of the band sheath by a connecting element and configured for transversing around the crown portion of a user’s head.

The disclosure further relates to a system comprising a fluid circuit, the fluid circuit comprising any of the devices disclosed herein and an air source. In some embodiments, the air source is an air pump. In some embodiments, the air source is in fluid communication with the first one-way valve by a third air channel. In some embodiments, the third air channel is a length of tubing. In some embodiments, the second one-way valve is in fluid communication with a disinfectant chamber by a fourth air channel. In some embodiments, the fourth air channel is a length of tubing. In some embodiments, the disinfectant chamber comprises one or a plurality of a: heating element, an energizing element, and disinfectant solution. In some embodiments, the disinfectant solution comprises at least a 60% alcohol solution. In some embodiments, the disinfectant chamber comprises a heating element adjacently positioned in sequence and in fluid communication to a heat sink. In some embodiments, the heat sink is a ceramic ring. In some embodiments, the disclosed system further comprises an air filter in fluid communication with the disinfectant chamber.

The disclosure also relates to a method of making any of the devices disclosed herein comprising: (a) attaching the first air channel to the first one-way valve and the mouthpiece by sealing one end of the first air channel to the first one-way valve and/or sealing one end of the first air channel to the mouthpiece. In some embodiments, the method further comprises the step of: (b) attaching the second air channel to the second one-way valve and at least one nasal adapter by sealing one end of the second air channel to the second one-way valve and/or by sealing one end of the second air channel to the nasal adapter.

BRIEF DESCRIPTION OF DRAWINGS

The invention will now be described by way of example only, with reference to the accompanying drawings, in which:

FIG. 1 A and FIG. IB depict a front view (FIG. 1 A) and a back view (FIG. IB) of a device in accordance with one embodiment of the disclosure.

FIG. 2A and FIG. 2B depict a front view (FIG. 2A) and a back view (FIG. 2B) of a device in accordance with one embodiment of the disclosure.

FIG. 3 depicts a front view of a device being worn by a person in combination with an air source (113, 114) and a disinfectant chamber (116) in accordance with one embodiment.

FIG. 4 depicts a front view of a device being worn by a person in combination with an air source and a disinfectant chamber without attaching to a filter in accordance with one embodiment.

DETAILED DESCRIPTION OF EMBODIMENTS In the following description, reference is made to the accompanying drawings, which form a part hereof, and which show, by way of illustration, specific embodiments or processes in which the disclosure may be practiced. Where possible, the same reference numbers are used throughout the drawings to refer to the same or like components. In some instances, numerous specific details are set forth in order to provide a thorough understanding of the present disclosure. The present disclosure, however, may be practiced without the specific details or with certain alternative equivalent devices, components, and methods to those described herein. In other instances, well- known devices, components, and methods have not been described in detail so as not to unnecessarily obscure aspects of the present disclosure.

Definitions

Unless defined otherwise, 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 invention pertains.

As used in the specification and the appended claims, the singular forms “a,” “an” and “the” can include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a compound” includes mixtures of compounds; reference to “a pharmaceutical carrier” includes mixtures of two or more such carriers, and the like.

The term “about” is used herein to mean within the typical ranges of tolerances in the art. For example, “about” can be understood as about 2 standard deviations from the mean. According to certain embodiments, when referring to a measurable value such as an amount and the like, “about” is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, ±0.9%, ±0.8%, ±0.7%, ±0.6%, ±0.5%, ±0.4%, ±0.3%, ±0.2% or ±0.1% from the specified value as such variations are appropriate to perform the disclosed methods. When “about” is present before a series of numbers or a range, it is understood that “about” can modify each of the numbers in the series or range.

The term "comprises" or "comprising" means its definition as is standard in patent terminology, being an open-ended term that is generally synonymous with "includes", "having", or "containing". Although "comprises", "includes", "having", and "containing" and variations thereof are commonly-used, open-ended terms, this invention also may be suitably described using narrower terms such as "consists essentially of, which is semi open-ended term in that it excludes only those things or elements that would have a deleterious effect on the performance of the inventive respirator in serving its intended function.

The term "clean air" means a volume of atmospheric ambient air that has been filtered to remove contaminants.

The term "contaminants" means particles (including dusts, mists, and fumes) and/or other substances such as pathogens that generally may not be considered to be particles (e.g., organic vapors, etc.) but which may be suspended in air.

Device

The one-way device of the disclosure consists of two air passages. The first air passage contains a first one-way valve that only allows air to travel into one or more of the airways of the person - whether it is the mouth, nostrils, nose, ear(s), eyes, a passage in their throat, or a passage straight to one or both of their lungs, or any other orifice. The second air passage contains a second one-way valve that only allows air to travel out of one or more of the airways of the person as described above.

One-Way Valve

Typical one-way valves can be oriented to allow air to be inhaled, but not exhaled in the inhale passage. Whereas the exhale passage would orient the one-way valve to allow air to be exhaled, but not inhaled.

In an example, a valvular conduit described in U.S. Patent No. 1,329,559 (incorporated by reference) could be placed in any passage closest to the patient to mitigate sneezing or coughing from pushing through some one-way valve designs. Normally, continuous pressure is possible in both directions of the valvular conduit, but sudden pressures can be stopped in one direction, but not the other direction. In such an example, the valvular conduit would act as the one-way valve during such sudden high pressure scenarios to alleviate the sinuses and lungs from such high pressures (mitigating forcing infectious excretions back through the linings of the airways and mucus membranes) and re-route the air through a relatively high pressure bypass passage, which is not normally open during regular breathing.

Filters The filters act as traps for mucus, saliva, blood, and other excretions. In an example, excretions may be as a result from the person’s coughs, sneezes, spit, drool, bloody nose, etc.

In some embodiments, there are up to three connections per filter. Two of the connections are the main ducts for passage on either side of the filter. The third port is only on one side of the filter. It is typically called a monitoring port, and can be used for different purposes.

In some embodiments, the monitoring port of the exhale filter can have a negative pressure applied to aid in breathing through the static pressure of longer passages.

In some embodiments, the monitoring port of the inhale filter can have a positive pressure applied to aid in breathing through the static pressure of longer passages.

In some embodiments, the monitoring port can be used as a drain for any excretions. A negative pressure can be applied to the port to aid the draining.

In some embodiments, the system and device comprises a first and second fluid circuits, the first fluid circuit providing airflow from a point external to the one-way valve, or the device, to the user’s mouth via the first air channel and, upon use, the operator or subject providing airflow from the nose through the first and/or second nasal adapter and into the second one-way filter. In some embodiments, the first fluid circuit is under positive pressure.

Diagnostic Examples

In some embodiments, the system or device of the disclosure comprises a filter with a monitoring port. Monitoring ports can provide access to the device for monitoring the pressure, frequency of breaths, and airflow of inhaled and exhaled breaths without any vacuum applied.

In an example, the filter’s monitoring port can be hooked up to, or in fluid communication with, a vacuum and gas analysis machine to sample the gases being inhaled and exhaled. In such an example, the gas mixture can be analyzed for oxygen, carbon dioxide, or other gas concentrations in the exhaled breath relative to the inhaled breath. In a further example, if the oxygen level of the exhaled breath is higher than normal relative to the inhaled breath, then it may indicate that the lungs are not absorbing as much oxygen, resulting in the blood oxygen level to be lower than normal. The gas analyzer would then alert the person’s care provider when their correlated blood oxygen level was declining and eventually became too low, so that they could be hospitalized and treated. In some embodiments, the disclosure relates to a system comprising any device disclosed herein in fluid communication with a gas analysis device capable of measuring the gaseous content of an exhaled breath of a user. In some cases the user or subject is a human. In some embodiments, the system is free of a vacuum.

The disclosure relates to a method of monitoring the pressure, frequency of breaths, and/or airflow of inhaled and exhaled breaths of a subject.

Disinfectant Chamber

One type of disinfectant chamber comprises a heating element. In some embodiments, the heating element heats air to about 100, about 200, about 300, about 400 or more degree Fahrenheit (above boiling point is ideal). In some embodiments, the disinfectant chamber comprises an energizing element. In some embodiments, the energizing element is an ultraviolet and/or infrared light source capable of emitting wavelengths that are sufficiently capable of destroying pathogens such as bacteria or viruses. In some embodiments, the energizing element is a light source capable of emitting UV, IR, or other wavelengths of light and/or energy of intensities that are sufficient in magnitude to destroy pathogens.

In some embodiments, the disinfectant chamber comprises a disinfectant solution. Any disinfectant solution known in the art can be used in the disinfectant chamber of the disclosed device. In some embodiments, the disinfectant solution is an alcohol solution. In some embodiments, the disinfectant solution contained in the disinfectant chamber of the disclosed device comprises about 60% alcohol solution. In some embodiments, the disinfectant solution contained in the disinfectant chamber comprises about 65% alcohol solution. In some embodiments, the disinfectant solution contained in the disinfectant chamber comprises about 70% alcohol solution. In some embodiments, the disinfectant solution contained in the disinfectant chamber comprises about 75% alcohol solution.

The purpose of the disinfectant is to eliminate the need for filters or reduce the number of filters in the system or device.

In some embodiments, the disclosure relates to methods of removing contaminants from air comprising wearing or operating the device or system for respiration, aerosolizing one or a plurality of pathogens or contaminants exhaled from the user and allowing a time period sufficient for the aerosolized 9, 10 or more seconds. pathogens or contaminants to become exposed to the disinfectant chamber and dissolve. In some embodiments, the time period is about 2, 3, 4, 5, 6, 7, 8, 9, 10 or more seconds. In some embodiments the time period is less than about one minute.

Compatible with other equipment

Normally CPAP (Continuous Positive Airway Pressure), BiPAP (or BPAP; Bilevel Positive Airway Pressure), and other positive pressure machines are discouraged, because they aerosolize a contaminant or pathogen, and do not contain or isolate it, so it aerosolizes into the room. If such positive pressure equipment was physically attached and in fluid communication with the device or system disclosed herein with the ventilator filters that are effective at removing 99.99% of all viruses and bacteria, then, not only could they be used, but the recovery times may be better than if only the one-way mask was used alone, because the higher flow rate would aerosolize the pathogen more in the body and get flushed out faster. This reduces the pathogen replication rate faster. The disclosure relates to a method of flushing a pathogen from the airway of a subject comprising breathing into the device disclosed herein thereby creating a positive pressure in the closed system of the airway. In some embodiments, the method further comprises

To further understand the present disclosure, reference is made to the accompanied drawings.

FIG. 1 A and FIG. IB depict a front view (FIG. 1 A) and a back view (FIG. IB) of a device in accordance with one embodiment of the disclosure. The device according to this embodiment includes a mouthpiece 101 configured to attach to and in fluid communication with a first air channel 102, which is attached to and in fluid communication with a first one-way valve 103 at a position distal from the mouthpiece 101, and a nasal adapter 105 configured to attach to and in fluid communication with a second air channel 106, which is attached to and in fluid communication with a second one-way valve 104 at a position distal from the nasal adapter 105 configured to be placed in the nostrils of a user. The device further includes a connecting element

100 attaching the second air channel 106 to the mouthpiece 101. The second air channel 106 has a bifurcated end, each end is capped with the nasal adapter 105. This bifurcated air channel is converted into a single air channel by an air channel adapter 109. The first one-way valve 103 is configured to allow airflow from the end of the first one-way valve 103 distal from the mouthpiece

101 through the first air channel 102 and into the mouthpiece 101, and the second one-way valve 104 is configured to allow airflow from the nasal adapter 105 through the second air channel 106 and toward the second one-way valve 104.

In further embodiments depicted in FIG. 2A and FIG. 2B, the device of the disclosure may further include an filters 108 in fluid communication with the first one-way valve 103 and/or an filters 108 in fluid communication with the second one-way valve 104. In some embodiments, the device of the disclosure include filters 108 in fluid communication with each of the first one-way valve 103 and the second one-way valve 104.

In further embodiments depicted in FIG. 2A and FIG. 2B, the device of the disclosure may also include a head band 121 comprising at least one strap 107 configured to wrap around the head of a user of the device and attached to a region 122 of the device proximate to or on the mouthpiece 101. Optionally, the device may further include an eye-protecting device 110, such as goggles.

In other embodiments, the device of the disclosure may be used in conjunction with an air source, such as an air pump, and/or a disinfectant chamber. Such embodiments are exemplified in FIG. 3 and FIG. 4. As depicted in FIG. 3, the first one-way valve 103 is attached to and in fluid communication with a third air channel 112 configured to be attached to a pump unit at a position distal from the first one-way valve 103, the pump unit may include a pump unit 113 and a base 114 for the pump unit 113, inside the pump unit 113 includes a humidity tank (not shown). In other embodiments, the second one-way valve 104 is attached to and in fluid communication with a fourth air channel 115 configured to be attached to a disinfectant chamber 116 at a position distal from the second one-way valve 104. The disinfectant chamber 116 may be mounted on a surface, such as a wall, via a mount 117. The disinfectant chamber 116 may be a device configured to heat air to a temperature sufficiently high enough to destroy any pathogens that may be present in the airflow, such as at boiling point. If this type of disinfectant chamber is used, a heat insulation 119 may be used to connect the third air channel 115 and the disinfectant chamber 116 to prevent the third air channel 115 from melting due to the heat. In addition, a heat sink 118, such as a ceramic ring, may also be used and attached to the disinfectant chamber 116 at a position distal from the heat insulation 119 to cool down the air. Other types of pathogen disinfectant may also be used, such as those applying ultraviolet (UV) light or infrared (IR) light or one containing a disinfectant solution, such as a 60% alcohol solution. If those types of disinfectant chamber are used, the heat insulation 119 may not be necessary. In some embodiments, it may be desired to further filter the airflow coming out of the disinfectant chamber 116. In such embodiments, a filter 123 may be attached to the disinfectant chamber 116 at a position distal from the third air channel 115, or the heat insulation 119 if one is used. Again, if a heat-type pathogen disinfectant is used, a second heat insulation 120 may be used in between the heat sink 118 and the filter 123 to protect the filter 123.

While the present disclosure has been illustrated by the description of the embodiments thereof, and while the embodiments have been described in detail, it is not the intention to restrict or in any way limit the scope of the appended claims to such detail. Further, the above embodiments may be implemented individually, or may be combined where compatible. Additional advantages and modifications, including combinations of the above embodiments, will readily appear to those skilled in the art. Therefore, the disclosure in its broader aspects is not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described. Accordingly, departures may be made from such details without departure from the spirit or scope of the general concept disclosed herein.