The present invention generally relates to medical devices for preventing transmission of infectious diseases.
Current standard of care does not give enough attention to protecting healthcare environments and workers from accidental exposure to aerosolized pathogens, like COVID-19. To provide safer healthcare environments, there is a need for technologies that do a better job at preventing environmental contamination and healthcare worker infection from asymptomatic or otherwise unknown infectious patients.
An infectious aerosol capture mask (IACM) is disclosed. In embodiments, the IACM includes a face tent coupled to a suction tube adapter. The face tent includes a proximal opening configured to be disposed over the mouth and nose of a patient. The face tent further includes a distal opening with a smaller diameter than the proximal opening. A coupler is configured to secure the suction tube adapter to the distal opening of the face tent. The suction tube adapter includes a suction port configured to be coupled to a suction tube for active capture of infectious aerosol and left unconnected for passive capture of infectious aerosol. A viral filter is disposed between the suction port and the face tent to capture infectious aerosol being expelled by the patient (e.g., as a result of exhaled breath, coughing, sneezing, etc.). The IACM further includes one or more one-way valves that are configured to permit airflow into the face tent when the patient is not being provided oxygen through breathing tubes or a nebulizer, or as a redundant measure so that the patient may continue to breath if a medical oxygen supply is somehow cutoff. The one or more one-way valves may also prevent excessive negative pressure from forming within the face tent when suction is being applied through the suction port of the suction tube adapter.
In some embodiments, the one or more one-way valves permit airflow into the face tent indirectly through valve apertures in the suction tube adapter. For example, the suction tube adapter may include a base with a raised central portion extending from the base, where the suction port and the one or more one-way valves are both disposed within the raised central portion of the suction tube adapter. Alternatively, the one or more one-way valves may permit airflow into the face tent directly through valve apertures in the face tent itself. For example, the one or more one-way valves may be disposed within side portions (e.g., left and right sides) of the face tent instead of being disposed within the central portion of the suction tube adapter. In further embodiments, the suction tube adapter and the face tent may each include one or more one-way valves.
This Summary is provided solely as an introduction to subject matter that is fully described in the Detailed Description and Drawings. The Summary should not be considered to describe essential features nor be used to determine the scope of the Claims. Moreover, it is to be understood that both the foregoing Summary and the following Detailed Description are example and explanatory only and are not necessarily restrictive of the subject matter claimed.
The detailed description is described with reference to the accompanying figures. The use of the same reference numbers in different instances in the description and the figures may indicate similar or identical items. Various embodiments or examples (“examples”) of the present disclosure are disclosed in the following detailed description and the accompanying drawings. The drawings are not necessarily to scale. In general, operations of disclosed processes may be performed in an arbitrary order, unless otherwise provided in the claims.
The present disclosure is directed to an infectious aerosol capture mask (IACM) that prevents potential environmental contamination, and therefore potential healthcare worker infection, by effectively capturing aerosolized particles directly from hospital patients. The IACM can be used both actively (with applied suction) and passively (without applied suction) to contain and prevent the spread of infectious aerosol being expelled by a patient (e.g., as a result of exhaled breath, coughing, sneezing, etc.).
As an active system, the IACM incorporates both filtration and vacuum and, as such, can capture the majority if not all exhaled aerosols even if they are being generated at high flow rates. Currently available masks are typically not form, which would be necessary in a passive system to drive all aerosols generated by a nebulizer and/or exhaled by a patient through filters. Thus, with currently available technology, the expiratory gases typically follow the path of least resistance, around the face mask (i.e., the perimeter of the mask where it abuts the patient’s face). This results in leakage of infectious aerosol about the mask perimeter. Consequently, most if not all currently available masks are only effective at low flow rates and cannot support concurrent delivery of high flow oxygen to the patient due to the amount of infectious aerosol leakage that occurs at high flow rates.
The IACM does not suffer from the above-mentioned limitations. Because of its structure and configuration, which are discussed below, the IACM can handle high flow rates when being used actively (i.e., with applied suction). The IACM also gives caregivers the option of using it passively (i.e., without applied suction), further preventing the spread of infectious aerosol by alleviating the need to remove a patient’s mask when the patient is not being connected to oxygen or given a nebulizer treatment. For example, the IACM may be used passively (without applied suction) when a patient is being transported, given emergency medical attention, or during standard procedures that may necessitate the removal of a vacuum or pump.
The suction tube adapter 106 includes a suction port 108 configured to be connected to a suction tube 110 for active capture of infectious aerosol and left unconnected for passive capture of infectious aerosol. In embodiments, the suction tube 110 may be coupled to a vacuum source or pump that creates a negative pressure in the suction tube 110 so that fluid (gas and/or liquid) is removed from the IACM 100 through the suction port 108 at a controlled rate. The applied suction force drives aerosols generated by a nebulizer and/or exhaled by a patient through a viral filter 116 (see
As shown in
In embodiments, the suction tube adapter 106 includes the suction port 108 at or near the center of the suction tube adapter 106. The suction tube adapter 106 may further include one or more one-way valves 112 adjacent to the suction port 108. For example, in the embodiment illustrated in
The one or more one-way valves 112 may be configured to permit airflow through the suction tube adapter 106 and into the face tent 102 when the patient is not being provided oxygen through breathing tubes or a nebulizer, or as a redundant measure so that the patient may continue to breath if a medical oxygen supply is somehow cutoff. The one or more one-way valves 112 may also prevent excessive negative pressure from forming within the face tent 102 when suction is being applied through the suction port 108 of the suction tube adapter 106, thereby preventing any harm to the patient as a result of the applied suction.
As shown in
The viral filter 116 is disposed between the suction port 108 and the face tent 102 to capture infectious aerosol expelled by the patient (e.g., as a result of exhaled breath, coughing, sneezing, etc.), infectious aerosol circulated within the IACM 100 by a nebulizer, or any infectious aerosols that are otherwise present within the face tent 102. As previously noted herein, the suction port 108 may be connected to a suction tube 110 for active capture of infectious aerosol and left unconnected for passive capture of infectious aerosol. In an active use configuration, the suction tube 110 may be coupled to a vacuum source or pump that creates a negative pressure in the suction tube 110 so that fluid (gas and/or liquid) is removed from the IACM 100 through the suction port 108 at a controlled rate. The applied suction force drives aerosols generated by a nebulizer and/or exhaled by the patient through the viral filter 116 so that infectious particles and/or droplets are captured by the viral filter 116 and are therefore prevented from being released into the ambient air.
In embodiments, the coupler 118 is configured to hold the viral filter 116 within the suction tube adapter 106 with the viral filter 116 being pressed firmly against the suction port 108 so that aerosols being drawn out of the IACM 100 through the suction port 108 are not able to circumvent the viral filter 116. In order to firmly secure the viral filter 116 within the suction tube adapter 106 so that it is held against the suction port 108, the coupler 118 may include a plurality of protrusions 122 (e.g., fin-like or tooth-like structures, rods, or alternatively shaped projections) that extend from the annular frame 121 at least part of the way toward a center of the annular frame 121. The protrusions 122 are configured to stabilize the viral filter 116 within the suction tube adapter 106 in between the suction port 108 and the coupler 118 and/or inner rim 120 of the distal opening of the face tent 102. The protrusions 122 can hold the viral filter 116 in place and may also serve to prevent the viral filter 116 from deforming or vibrating when suction is applied as this could undesirably increase the chances of aerosol circumventing the viral filter 116 (e.g., through an air leak from about the perimeter of the viral filter 116).
In some embodiments, the coupler 118 may further include one or more rings 124 extending from the annular frame 121 part of the way toward the center of the annular frame 121. Each of the rings 124 may be configured to be aligned with a corresponding one-way valve 112 in the suction tube adapter 106, so that a portion of the viral filter 116 is disposed between each ring 124 and the one-way valve 112 with which it is aligned. Having a portion of the viral filter 116 disposed over each of the one-way valves 112 helps ensure that, even if some backflow occurs through a one-way valve 112, the viral filter 116 will still be able to prevent the one-way valve 112 from releasing any infectious aerosol out of the IACM 100. The one or more rings 124 also provide an additional safety measure by isolating portions of the viral filter 116 that are used to capture infectious particles/droplets in the aerosols forced through the suction port 108 from the portions of the viral filter 116 that are used to filter the air flow through the one or more one-way valves 112.
As shown in
When the suction port 108 is connected to the suction tube 110 and suction is applied (i.e., in an active use configuration), the suction force produces one or more flow paths (much like air currents) in the IACM 100 (i.e., within the face tent 102 and suction tube adapter 106) that are directed toward the suction port 108. This drives all fluids (gases, liquids, and/or aerosols) expelled by the patient or circulated within the IACM 100 through the suction port 108, and hence through the viral filter 116. As a result, there is much less chance of any aerosol leakage from about the permitter of the face tent 102 even if the face tent 102 does not fully conform to the patient’s face. Furthermore, when the suction port 108 is connected to the suction tube 110, air can only enter the IACM 100 through the one or more one-way valves 112. As a result, the portions of the viral filter 116 that are disposed over the suction port 108 only experience fluid flow in a single direction (out of the IACM 100), so there is very low chance that any infectious particles/droplets previously have been captured by the viral filter 116 will be subsequently dislodged because incoming air must flow through the one or more one-way valves 112, which may share the viral filter 116 with the suction port 108 in some embodiments but have means (e.g., rings 124) for isolating the respective filter portions used for the one or more one-way valves from the filter portions used for the suction port 108. Without applied suction (active use), the performance of the IACM 100 is much less dependent upon the conformance of the face tent 102 to the patient’s face, and it is contemplated that the IACM 100 may capture at least 80-90% of infectious particles/droplets in aerosols exiting the IACM 100.
As shown in
In embodiments, the suction port 108 and the one or more one-way valves 112 are both disposed within the raised central portion 111 of the suction tube adapter 106. For example, in the embodiment illustrated in
As shown in
In some embodiments, the suction port 108 may include a cross-bar 107 disposed over or within the opening of the suction port 108 to regulate flow through the suction port 108. For example, the cross-bar 107 may prevent air pockets from forming and causing the suction tube 110 to experience a sudden jerk or an otherwise irregular flow rate.
In embodiments, the face tent 102 and/or the suction tube adapter 106 may be formed medical grade plastics. Furthermore, the suction tube adapter 106 may be formed by a common (integrated) injection molded or 3D printed structure that includes the base 109 and the raised central portion 111 with a plurality of openings formed within the raised central portion 111 for the suction port 108 and the one or more one-way valves 112. The face tent 102 may be formed from a flexible plastic (or other substantially nonpermeable material) to enable the face tent 102 to better conform to the patient’s face (e.g., form fitting and conforming to the patient’s cheeks and chin), whereas the suction tube adapter 106 may be formed from a more rigid and/or thicker plastic (or other substantially nonpermeable material).
In further embodiments, the suction tube adapter 106 and the face tent 102 may each include one or more one-way valves 112. For example, the suction tube adapter 106 as illustrated in
The IACM 100, in any of the configurations described above, may further include an opening or port in the face tent 102 for a nebulizer, breathing tube, or any other medical fluid (gas and/or liquid) supply line to be provided for the patient. For example, a nebulizer, breathing tube, or any other medical fluid (gas and/or liquid) supply line may be fed through an opening or coupled to a port above or below the suction tube adapter 106. In some embodiments, the face tent 102 itself may include a portion of nebulizer integrated within the structure of the face tent 102. For example, the face tent 102 may include a nebulizer mouthpiece extending into the face tent 102 as part of its overall structure (e.g., formed from the same injection mold or 3D print). Alternatively, the suction tube adapter 106 may include an opening or port for a nebulizer, breathing tube, or any other medical fluid (gas and/or liquid) supply line to be provided for the patient. For example, a nebulizer, breathing tube, or any other medical fluid (gas and/or liquid) supply line may be fed through an opening or coupled to a port in the suction tube adapter 106. In some embodiments, the suction tube adapter 106 itself may include a portion of nebulizer integrated within the structure of the suction tube adapter 106. For example, the suction tube adapter 106 may include a nebulizer mouthpiece extending into the suction tube adapter 106 as part of its overall structure (e.g., formed from the same injection mold or 3D print). It is further contemplated that, in some embodiments, one or more one-way valves 112 in the face tent 102 or the suction tube adapter 106 may be reconfigured to connect a nebulizer, breathing tube, or any other medical fluid (gas and/or liquid) supply line through the IACM 100.
In embodiments, the IACM 100 may further include a suction indicator (e.g., a light-emitting diode (LED) or other visual indicator, audible indicator, or signal transmitter) that is configured to indicate when suction is applied based on a flow switch embedded within or coupled to the suction port 108. For example, the suction port 108 may include or may be coupled to an electromechanical or electromagnetic flow switch that is configured to activate the suction indicator when active suction (e.g., fluid flow above a predefined threshold) is detected within the suction port 108 or alternatively within the suction tube 110.
Although the technology has been described with reference to the embodiments illustrated in the attached drawing figures, equivalents may be employed, and substitutions may be made herein without departing from the scope of the technology as recited in the claims. Components illustrated and described herein are examples of devices and components that may be used to implement the embodiments of the present invention and may be replaced with other devices and components without departing from the scope of the invention. Furthermore, any dimensions, degrees, and/or numerical ranges provided herein are to be understood as non-limiting examples unless otherwise specified in the claims.
The present application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application Serial No. 63/038,409, filed Jun. 12, 2020, and titled “Infectious Aerosol Capture Mask (IACM),” which is incorporated herein by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/US2021/037179 | 6/14/2021 | WO |
Number | Date | Country | |
---|---|---|---|
63038409 | Jun 2020 | US |