AEROSOL CONTAINMENT MASK AND METHODS OF USE THEREOF

Abstract

Among the various aspects of the present disclosure is the provision of an aerosol containment mask and methods of use thereof. An aerosol containment mask is described that minimizes aerosol release during insertion or removal of an airway management device or gastric tube. Methods of insertion and removal of an airway management device or gastric tube are also described wherein the aerosol containment mask is employed.

Description

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

MATERIAL INCORPORATED-BY-REFERENCE

Not applicable.

FIELD OF THE INVENTION

The present disclosure generally relates to an aerosol containment mask and methods of using the aerosol containment mask to contain the release of aerosols from the subject during the insertion or removal of an airway management device or gastric tube.

BACKGROUND OF THE INVENTION

Significant aerosols are produced by subjects during the process of inserting and/or removing endotracheal, oropharyngeal, and/or nasogastric tubes into/from individuals as part of medical treatment. Aerosol production is more common with removal (extubation) than insertion (intubation). During extubation, the individual often coughs leading to further aerosolization. Currently, there are minimal direct protective barriers used to help safeguard healthcare professionals (e.g., anesthesiologists, nurses, and other personnel in a procedure room) from these aerosols and bodily fluids.

SUMMARY OF THE INVENTION

Among the various aspects of the present disclosure is the provision of an aerosol containment mask and methods of use thereof.

Briefly, therefore, the present disclosure is directed to an aerosol containment mask configured to contain aerosols released from a subject during insertion or removal of an airway management device or gastric tube. The mask includes a mask frame sized to fit over a face of the subject; a central valve formed within a mask frame, the central valve configured to reversibly receive a portion of the airway management device or gastric tube; and a cushion affixed to a contact surface of the mask frame, the cushion configured to seal against the face of the subject when the aerosol containment mask is secured to the face of the subject. In some aspects, the airway management device is selected from an endotracheal tube, a laryngeal mask, an oropharyngeal airway, and a nasopharyngeal airway. In some aspects, the gastric tube is selected from a nasogastric tube or an orogastric tube. In some aspects, the central valve is a rotary seal configured to seal around the airway management device or the gastric tube. In some aspects, the mask further comprises at least one port to supply oxygen to the subject or vent exhaled air from the subject. In some aspects, at least one port comprises a sensor to monitor gas levels. In some aspects, the sensor monitors gas levels comprising oxygen, carbon dioxide levels, and any combination thereof. In some aspects, the mask further comprises at least two mounts affixed around a perimeter of the mask frame, wherein the mounts are configured to provide an attachment point for at least one strap to the mask. In some aspects, the at least one strap is configured to secure the mask to the subject's face. In some aspects, the dimensions of the mask frame are custom-designed to fit the subject's face. In some aspects, the mask further comprises a hinge and latch system comprising a hinge, a first latch component, and a second latch component, wherein the mask frame further comprises the first and second frame portions attached at adjoining ends by the hinge; the first and second frame portions end in the first and second latch components, respectively; and the first and second latch components are configured to mechanically link and unlink to reversibly separate the first and second frame portions between an opened and closed configuration. In some aspects, the hinge and latch system is configured to facilitate opening and reclosing the mask without disturbing the airway management device or gastric tube positioned in the trachea or esophagus of the subject.

In another aspect, a method of inserting an airway management device into a trachea of a subject is described. The method includes placing an aerosol containment mask of any previous claim over the subject's nose and mouth. The mask includes a mask frame sized to fit over the face of the subject; a central valve formed within a mask frame, the central valve configured to reversibly receive a portion of the airway management device or gastric tube; at least two mounts attached around a perimeter of the mask; at least two straps anchored to the at least two mounts; and a cushion affixed to a contact surface of the mask frame, the cushion configured to seal against the face of the subject when the aerosol containment mask is secured to the face of the subject. The method further includes securing and sealing the mask to the subject's face with straps anchored to the mounts; and inserting the airway management device through the central valve and into the trachea of the subject, wherein the central valve maintains a seal around the airway management device. In some aspects, the central valve is a rotary seal configured to seal around the airway management device.

The present teachings further include methods for inserting an airway management device into a trachea of a subject. The method includes placing the disclosed aerosol containment mask over the subject's nose and mouth. The mask includes a central valve, at least one port to supply a gas, at least one port to monitor gas levels, mounts to secure the mask to the subject's face, and a cushion at the rear of the mask configured to seal against the face of the subject. The method further includes securing and sealing the mask to the subject's face with straps secured by the mounts. The method further includes inserting the airway management device through the central valve and into the trachea of the subject, wherein the central valve maintains a seal around the airway management device. In some aspects, the central valve of the mask used in the method is a rotary seal that seals around the airway management device. In some aspects, the mask used in the method further includes a hinge and latch system that includes at least one hinge and at least one latch configured to reversibly join and release at least two portions of the mask. In some aspects, the hinge and latch system is configured to facilitate opening and reclosing the mask without disturbing the airway management device positioned in the trachea of the subject.

The present teachings also include methods for removing an airway management device from a trachea of a subject. In one aspect, the method includes inserting a proximal end of an endotracheal tube protruding from an airway of a subject through a rear side of an aerosol containment mask at a central valve such that the proximal end of the endotracheal tube protrudes from the front side of the mask through the central valve. The method further includes securing the rear face of the mask over the nose and mouth of the subject to seal the mask over the subject's nose and mouth. The method further includes withdrawing the endotracheal tube from the trachea through the central valve of the mask. In another aspect, the mask includes at least one port to supply gas. In another aspect, the mask includes at least one port to monitor gas levels. In another aspect, the mask includes mounts to secure the mask to a subject's face. In yet another aspect, the mask includes a cushion at the rear of the mask configured to form a seal against the face of the subject when the mask is secured over the mouth and nose of the subject. In some embodiments, the central valve of the mask used in the method is a rotary seal that seals around the endotracheal tube as it is withdrawn from the airway of the subject. In some embodiments, the mask used in the method includes a hinge and latch system. In some embodiments, the hinge and latch system allows a healthcare provider to open the mask without disturbing the intubation material. In some embodiments, the subject has a virulent respiratory illness.

Other objects and features will be in part apparent and in part pointed out hereinafter.

DESCRIPTION OF THE DRAWINGS

Those of skill in the art will understand that the drawings, described below, are for illustrative purposes only. The drawings are not intended to limit the scope of the present teachings in any way.

FIG. 1 is a front view drawing showing the outer surface of the aerosol containment mask showing a port where supplementary oxygen can be supplied, a port where carbon dioxide levels can be vented and monitored, and a dynamic rotary seal for insertion or removal of airway management device including endotracheal tubes or laryngeal masks (not shown).

FIG. 2 is a rear view drawing showing the inner surface of the aerosol containment mask of FIG. 1, including a cushion that contacts and seals against the subject's face and mounts used to affix anchor straps (not shown) to the mask. The anchor straps are used to secure the mask over the nose and mouth of a subject.

FIG. 3A is a front-view drawing of the aerosol containment mask of FIG. 1 shown secured on the face of a subject; an intubated endotracheal tube is shown protruding from the central valve of the mask.

FIG. 3B is a front-view line drawing similar to FIG. 3A with the mask represented transparently to visualize the mask's placement over the subject's mouth and nose.

FIG. 4 is a side-view drawing showing the aerosol containment mask of FIG. 1 and a subject's head prior to placement on the subject's face with the aerosol containment mask represented transparently.

FIG. 5 contains front and side view line drawings of the aerosol containment mask of FIG. 1 showing exemplary dimensions of various elements of the mask in one aspect.

FIG. 6 is a front view drawing showing an aerosol containment mask in one aspect that incorporates a hinge and latch system to provide access to the face of a subject for a healthcare provider by opening the mask without disturbing any intubation materials protruding from the subject's airway; the mask is shown in an opened configuration.

FIG. 7A is a front view drawing showing the aerosol containment mask of FIG. 6 with the hinge and latch system in the open position and placed on the face of a subject; an intubated endotracheal tube is shown protruding from the airway of the subject and from the central valve of the mask.

FIG. 7B is a front-view line drawing showing the aerosol containment mask of FIG. 6 with the hinge and latch system in the open position and placed on the face of a subject with the mask represented transparently to visualize the mask's position relative to the subject's face.

FIG. 8A is a front view drawing showing the aerosol containment mask of FIG. 6 with the hinge and latch system in the closed position and placed on the face of a subject; an intubated endotracheal tube is shown protruding from the airway of the subject and from the central valve of the mask.

FIG. 8B is a front-view line drawing showing the aerosol containment mask of FIG. 6 with the hinge and latch system in the closed position and placed on the face of a subject with the mask represented transparently to visualize the mask's position relative to the subject's face.

FIG. 9 is a schematic illustration of an apparatus used to test leak rates of the aerosol containment masks described herein.

FIG. 10 is a schematic illustration of a CO2 development kit used to quantify CO2 exhaled from an aerosol containment mask as tested using the apparatus of FIG. 9.

DETAILED DESCRIPTION OF THE INVENTION

The present disclosure is based, at least in part, on the discovery that an aerosol containment mask can improve outcomes during an insertion or removal process by providing a protective barrier to contain any aerosols released during the insertion or removal of an airway management device such as an endotracheal tube or laryngeal mask.

Briefly, therefore, by way of non-limiting example, as illustrated in FIGS. 1 and 2, the present disclosure is directed to an aerosol containment mask 100 configured to contain aerosol release during insertion or removal of an airway management device 200 such as an endotracheal tube, an oropharyngeal tube, or a gastric tube such as an orogastric or nasogastric tube.

In various aspects, the aerosol containment mask 100 is illustrated in FIGS. 1 and 2. The mask 100 maintains a seal around a portion of an airway management device 200 including, but not limited to, an endotracheal tube, an oropharyngeal tube, or a gastric tube such as an orogastric or nasogastric tube, and any combination thereof during placement and removal of the device. In various other aspects, an aerosol containment mask 100 is disclosed that provides for a seal to be maintained over the face and respiratory tract of a subject using a large central valve 102 configured to receive and seal against the outer walls of the endotracheal tube 200 during insertion or removal.

In various aspects, the aerosol containment mask 100 is illustrated in FIGS. 1 and 2. In some aspects, the disclosed mask 100 includes a frame 113, a central valve 102, at least one of a supply port 104 and an exhaust port 110 to supply gas, a plurality of mounts 106 configured to provide attachment points to hold and adjust straps or other means of attachment used to secure the mask 100 to a subject's face. The mask further includes a cushion 108 at the rear of the mask 100 configured to form a seal against the face of the subject when the mask 100 is attached to the face of the subject. In another aspect, the central valve 102 of the mask 100 can be a dynamic rotary seal configured to seal around one or more airway management devices 200 during their placement and removal. The dynamic seal at the front of the mask 100 is intended to be large enough to more readily allow for oropharyngeal inspection and maintenance by the healthcare provider. In some aspects, the mask 100 includes at least one port including, but not limited to, a supply port 104 configured to supply oxygen to the subject and/or one vent port 110 configured to vent exhaled air from the subject. [0027] In some aspects, as illustrated in FIGS. 3A and 3B, the mounts 106 can include strap retention elements configured to reversibly retain and release at least one strap 112 used to secure the mask 100 to the face of the subject.

Referring to FIG. 5, in an exemplary embodiment, the diameter of the central valve 102 is about 50 mm, the diameter of the mask 100 is about 75 mm, the height of the mask 100 is about 45 mm, and the diameters of the supply/vent ports 104/110 are about 13 mm. In other embodiments, the dimensions of the mask 100 can be custom-designed to fit an individual subject's face. The dimensions of the final product are not restricted to these depicted, and can be adjusted to pediatric subjects as well as a variety of child, young adult, and large adult facial anatomies, or to any other suitable dimension without limitation. This disclosure is intended to illustrate the relative dimensional ratios that may be present.

In various other aspects, as illustrated in FIGS. 6-8B, the disclosed aerosol containment mask 100a further includes at least two portions of mask frame 113a/113b coupled by a latch system 114 which includes a first and second latch elements 114a/114b configured to mechanically attach and release to reversibly open and close the two portions of the mask frame 113a/113b together in a locked position and to reversibly unlock to separate the two portions of the mask frame 113a/113b by rotating at the at least one hinge 116 in the unlocked position to provide access to the face of the subject without disturbing an airway management device 200 positioned within the trachea of the subject and/or inserted gastric tube. In another aspect, should intubation material 200 be inserted through the mask 100a and sealed using the dynamic seal, it is possible to incorporate a hinge 116 and latch system 114 to provide access by a healthcare provider to the face of the subject by opening the mask 100a at the hinge 116 without disturbing the intubation material 200. This may be necessary to more closely inspect the oropharyngeal and nasal cavity, and apply suction or supplemental treatment as needed.

In some aspects, as illustrated in FIGS. 3B, 4, 5, 7B, and 8B, the mask 100 may include integrated supply/vent ports 104/110 for the placement of at least one sensor 111, including, but not limited to carbon dioxide sensors and oxygen sensors.

In some aspects, as illustrated in FIGS. 3B, 4, 5, 7B, and 8B, the at least one supply/vent ports 104/110 include at least one sensor 111 positioned within at least one of the ports 104/110. In some aspects, the at least one sensor 111 is configured to monitor the levels and/or flow rates of gases associated with the ventilation of the subject including, but not limited to, oxygen and carbon dioxide. In some embodiments, the at least one sensor 111 monitors oxygen levels, carbon dioxide levels, and any combination thereof. The supply/vent ports 104/110 are not limited to the two shown, and are sealed when not connected to a sensor.

Referring to FIGS. 1, 3A, 7A, and 8A, in various aspects, methods for inserting an airway management device 200 such as an endotracheal tube or oropharyngeal tube are disclosed. In some aspects, the method includes placing the disclosed aerosol containment mask 100/100a over a subject's nose and mouth and securing the mask 100/100a to a subject's face using the mounts 106 and attached straps 112 to secure and seal the mask 100/100a over a subject's nose and mouth. The method further includes inserting the airway management device 200 through the central valve 102 and into the trachea of the subject and sealing the endotracheal tube in the central valve 102.

In various additional aspects, methods for removing an airway management device 200 such as an endotracheal tube or oropharyngeal tube from a subject are disclosed. In one aspect, the method includes inserting a proximal end of the airway management device 200 protruding from an airway of a subject through the rear side of the aerosol containment mask 100/100a at the central valve 102 such that the proximal end of the endotracheal tube protrudes from the front side of the mask 100/100a through the central valve 102. The method further includes securing the rear face of the mask 100/100a over the nose and mouth of the subject to seal the mask 100/100a over the subject's nose and mouth. The method further includes withdrawing the airway management device 200 from the trachea through the central valve 102 of the mask 100/100a.

The present teachings include methods for performing a placement of an oropharyngeal tube such as a laryngeal mask airway (LMA) tube 200 into a subject. In some aspects, the method includes securing and sealing the disclosed aerosol containment mask 100/100a over the oropharyngeal tube 200 through a central valve 102 of the mask 100/100a and advancing the oropharyngeal tube 200 into the oropharynx of the subject. In yet another aspect, the method includes sealing the oropharyngeal tube 200 in the central valve 102. In some aspects, as illustrated in FIGS. 7A and 8A, in some embodiments, the mask 100a used in the method includes a hinge 116 and latch system 114 configured to reversibly open and close the mask 100a without disturbing the placement of the oropharyngeal tube 200 and also provide a healthcare provider access to the face of the subject. In some aspects, as illustrated in FIGS. 7A and 8A, the latch system 114 includes a first and second latch elements 114a/114b configured to mechanically attach and release to reversibly open and close the mask 100a.

Referring to FIGS. 1, 3A, 7A, and 8A, the present teachings also include methods for performing the removal of an oropharyngeal tube 200 such as a laryngeal mask airway (LMA) tube. In one aspect, the method includes inserting a proximal end of an oropharyngeal tube 200 protruding from the oropharynx of a subject through a rear side of an aerosol containment mask 100/100a at a central valve 102 such that the proximal end of the oropharyngeal tube 200 protrudes from the front side of the mask 100/100a through the central valve 102. The method further includes securing the rear face of the mask 100/100a over the nose and mouth of the subject to seal the mask 100/100a over the subject's nose and mouth. The method further includes withdrawing the oropharyngeal tube 200 from the oropharynx through the central valve 102 of the mask 100/100a.

The present teachings also include methods for performing a placement of an orogastric or nasogastric tube 200 for either enteric feeding or gastric decompression. In some aspects, the method includes securing and sealing the disclosed aerosol containment mask 100/100a over the orogastric tube 200 or nasogastric tube 200 through a central valve 102 and into the nasopharynx or oropharynx of the subject. In yet another aspect, the method includes sealing the orogastric or nasogastric tube 200 in the central valve 102 of the mask 100/100a. In some embodiments, the central valve 102 of the mask 100/100a used in the method can be a rotary seal that seals around the orogastric or nasogastric tube 200. Referring to FIGS. 7A and 8A, in some embodiments, the mask 100a used in the method includes a hinge 116 and latch 114 system configured to reversibly open and close the mask 100 without disturbing the placement of the orogastric or nasogastric tube 200 and also provide a healthcare provider access to the face of the subject. In some aspects, as illustrated in FIGS. 7A and 8A, the latch system 114 includes a first and second latch elements 114a/114b configured to mechanically attach and release to reversibly open and close the mask 100a.

Referring to FIGS. 1, 3A, 7A, and 8A, the present teachings also include methods for performing the removal of an orogastric or nasogastric tube 200. In one aspect, the method includes inserting a proximal end of an orogastric or nasogastric tube 200 protruding from the nasopharynx or oropharynx of a subject through a rear side of an aerosol containment mask 100/100a at a central valve 102 such that the proximal end of the orogastric or nasogastric tube 200 protrudes from the front side of the mask 100/100a through the central valve 102. The method further includes securing the rear face of the mask 100/100a over the nose and mouth of the subject to seal the mask 100/100a over the subject's nose and mouth. The method further includes withdrawing the orogastric or nasogastric tube 200 from the oropharynx or nasopharynx through the central valve 102 of the mask 100/100a.

Referring to FIGS. 1, 3A, 7A, and 8A, in some aspects the aerosol containment mask 100/100a includes a central valve 102 in the form of a rotary seal to provide for the insertion or removal of at least a portion of an airway management device 200 from a subject through an emplaced mask 100/100a and more readily facilitate inspection and suction of the oropharyngeal cavity if necessary. This may be beneficial in cases of subjects infected with a virulent respiratory illness, as a means of supplemental protection in existing isolation procedures, or as a possible means of supplemental protection in emergent situations, since the majority of respiratory aerosols occur during the extubation process while removing an endotracheal tube 200 and when the subject is coughing following extubation.

Referring to FIGS. 1, 3A, FIG. 7A, and FIG. 8A, in various aspects, the disclosed aerosol containment mask 100/100a may be used to contain the release of aerosols during the insertion and/or removal of airway management devices and/or gastric tubes 200 from a subject. In some aspects, the airway management device includes infraglottic devices and supraglottic devices. As used herein, infraglottic devices refer to airway management devices configured to create a conduit between the mouth, passing through the glottis, and into the trachea of the subject. Non-limiting examples of infraglottic devices include endotracheal tubes. By way of non-limiting example, endotracheal tubes are inserted using a tracheal intubation procedure, also referred to herein as intubation, that includes the placement of a flexible plastic or rubber tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs. A typical intubation route is orotracheal, in which an endotracheal tube is passed through the mouth and vocal apparatus into the trachea of the subject.

As used herein, supraglottic airway management devices 200 are configured to have a distal tip resting above the level of the glottis in its final seated position to ensure patency of the upper respiratory tract without entry into the trachea by bridging the oral and pharyngeal spaces. Non-limiting examples of supraglottic devices include laryngeal masks, oropharyngeal airways, and nasopharyngeal airways.

As used herein, gastric tubes 200 refer to flexible plastic tubes providing a pathway between the stomach and the exterior surroundings of the subject. Non-limiting examples of gastric tubes include nasogastric tubes and orogastric tubes. By way of non-limiting example, nasogastric intubation includes the insertion of a plastic tube (nasogastric tube or NG tube) through the nose, down the esophagus, and down into the stomach. By way of another non-limiting example, orogastric intubation is a similar process involving the insertion of a plastic tube (orogastric tube) through the mouth down the esophagus, and down into the stomach of the subject.

Definitions and methods described herein are provided to better define the present disclosure and to guide those of ordinary skill in the art in the practice of the present disclosure. Unless otherwise noted, terms are to be understood according to conventional usage by those of ordinary skill in the relevant art.

The terms “distal” and “proximal” are used herein as would be understood by a person having ordinary skill in the art. Such relational terms are to be interpreted from the health care provider's reference point.

In some embodiments, numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth, used to describe and claim certain embodiments of the present disclosure are to be understood as being modified in some instances by the term “about.” In some embodiments, the term “about” is used to indicate that a value includes the standard deviation of the mean for the device or method being employed to determine the value. In some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the present disclosure are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the present disclosure may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements. The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. The recitation of discrete values is understood to include ranges between each value.

In some embodiments, the terms “a” and “an” and “the” and similar references used in the context of describing a particular embodiment (especially in the context of certain of the following claims) can be construed to cover both the singular and the plural, unless specifically noted otherwise. In some embodiments, the term “or” as used herein, including the claims, is used to mean “and/or” unless explicitly indicated to refer to alternatives only or the alternatives are mutually exclusive.

The terms “comprise,” “have” and “include” are open-ended linking verbs. Any forms or tenses of one or more of these verbs, such as “comprises,” “comprising,” “has,” “having,” “includes” and “including,” are also open-ended. For example, any method that “comprises,” “has” or “includes” one or more steps is not limited to possessing only those one or more steps and can also cover other unlisted steps. Similarly, any composition or device that “comprises,” “has” or “includes” one or more features is not limited to possessing only those one or more features and can cover other unlisted features.

All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the present disclosure and does not pose a limitation on the scope of the present disclosure otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the present disclosure.

Groupings of alternative elements or embodiments of the present disclosure disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

All publications, patents, patent applications, and other references cited in this application are incorporated herein by reference in their entirety for all purposes to the same extent as if each individual publication, patent, patent application, or other reference was specifically and individually indicated to be incorporated by reference in its entirety for all purposes. Citation of a reference herein shall not be construed as an admission that such is prior art to the present disclosure.

Having described the present disclosure in detail, it will be apparent that modifications, variations, and equivalent embodiments are possible without departing from the scope of the present disclosure defined in the appended claims. Furthermore, it should be appreciated that all examples in the present disclosure are provided as non-limiting examples.

EXAMPLES

The following example is provided to illustrate at least one aspect of the disclosure described herein.

Example 1: Leak Rate Assessment of Extubation Mask

To quantify the leak rate through the face seal portion of an extubation mask described herein, the following experiments were conducted. Carbon dioxide was used as a tracer to measure the total extubation mask leak rate.

A schematic illustration of the testing circuit is provided at FIG. 9. The testing circuit 900 uses CO₂ tracing as a method for measuring leak rates and is designed to only allow leaks through the face seal of the mask 100b, i.e. the cushion mask-to-skin interface. The testing circuit 900 created two divided reservoirs of air so that the concentration of CO₂ in exhaled air 902 and the air around the mask 904 can be compared. From these concentrations (recorded in parts per million) the leak rate through the face seal was back-calculated.

To measure the concentrations of CO₂ two sensors were used. The first sensor 906, calibrated for low concentrations of CO₂ (<1%), measured the environment 904 within the helmet 908 (i.e. any leaks that escaped the face seal). The second sensor 910 measured higher CO₂ concentrations (˜4%) that were exhaled. This measure of exhaled CO₂ was used as a baseline since exhaled CO₂ varied person-to-person depending on metabolism and activity. Capturing the exhaled air also allowed for the possibility of measuring total exhaled air volume. If leaks were high through the face seal, the volumetric measurement would help increase the sensitivity of the experiment.

In the circuit shown in FIG. 9, the subject inhaled pure O₂ 912 as shown on the left. The O₂ 912 is delivered to the two way non rebreathing valve 914 and into the mask 100b. The nonrebreathing valve 914 ensures that as the subject exhales, the exhaled air travels towards the outlet 902 and not back into the inlet valve 912. This guarantees that exhaled CO₂ only leaves the system from the mask/face interface or the outlet channel 902.

A Development Kit 918 allows the data to be collected and imported to GasLab (via a Data Acquisition Manager). Also included in this schematic is a filtration unit and pump (not illustrated). The filtration ensures that the second sensor 910 is not damaged. The pump guarantees airflow over the sensor 910, yielding consistent data. The air finally exits on the other side of the pump.

The exhaled air then travels through the outlet channel and into a tee joint. This joint splits into an exhaust and the CO2 Development Kit 918. The CO2 Development Kit is shown illustrated schematically in additional detail in FIG. 10.

Examples are provided herein to further illustrate the present disclosure. It should be appreciated by those of skill in the art that the techniques disclosed in the examples that follow represent approaches the inventors have found function well in the practice of the present disclosure, and thus can be considered to constitute examples of modes for its practice. However, those of skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific embodiments that are disclosed and still obtain a like or similar result without departing from the spirit and scope of the present disclosure.

Claims

1. An aerosol containment mask configured to contain aerosols released from a subject during insertion or removal of an airway management device or gastric tube, the mask comprising: a mask frame sized to fit over a face of the subject,a central valve formed within a mask frame, the central valve configured to reversibly receive a portion of the airway management device or gastric tube; anda cushion affixed to a contact surface of the mask frame, the cushion configured to seal against the face of the subject when the aerosol containment mask is secured to the face of the subject.

2. The mask of claim 1, wherein the airway management device is selected from an endotracheal tube, a laryngeal mask, an oropharyngeal airway, and a nasopharyngeal airway.

3. The mask of claim 1, wherein the gastric tube is selected from a nasogastric tube or an orogastric tube.

4. The mask of claim 1 wherein the central valve is a rotary seal configured to seal around the airway management device or the gastric tube.

5. The mask of claim 1, wherein the mask further comprises at least one port to supply oxygen to the subject or vent exhaled air from the subject.

6. The mask of claim 5, wherein at least one port comprises a sensor to monitor gas levels.

7. The mask of claim 6, wherein the sensor monitors gas levels comprising oxygen, carbon dioxide levels, and any combination thereof.

8. The mask of claim 1, further comprising at least two mounts affixed around a perimeter of the mask frame, wherein the mounts are configured to provide an attachment point for at least one strap to the mask.

9. The mask of claim 8, wherein the at least one strap is configured to secure the mask to the subject's face.

10. The mask of claim 9, wherein the dimensions of the mask frame are custom-designed to fit the subject's face.

11. The mask of claim 1, further comprising a hinge and latch system comprising a hinge, a first latch component, and a second latch component, wherein: a. the mask frame further comprises the first and second frame portions attached at adjoining ends by the hinge;b. the first and second frame portions end in the first and second latch components, respectively; andc. the first and second latch components are configured to mechanically link and unlink to reversibly separate the first and second frame portions between an opened and closed configuration.

12. The mask of claim 1, wherein the hinge and latch system is configured to facilitate opening and reclosing the mask without disturbing the airway management device or gastric tube positioned in the trachea or esophagus of the subject.

13. A method of inserting an airway management device into a trachea of a subject, the method comprising: placing an aerosol containment mask of any previous claim over the subject's nose and mouth, the mask comprising: a mask frame sized to fit over the face of the subject;a central valve formed within a mask frame, the central valve configured to reversibly receive a portion of the airway management device or gastric tube;at least two mounts attached around a perimeter of the mask;at least two straps anchored to the at least two mounts; anda cushion affixed to a contact surface of the mask frame, the cushion configured to seal against the face of the subject when the aerosol containment mask is secured to the face of the subject;securing and sealing the mask to the subject's face with straps anchored to the mounts; andinserting the airway management device through the central valve and into the trachea of the subject, wherein the central valve maintains a seal around the airway management device.

14. The method of claim 13 wherein the central valve is a rotary seal configured to seal around the airway management device.