WO2021202306A1 - Respiration apparatus and methods of use thereof - Google Patents
Respiration apparatus and methods of use thereof Download PDFInfo
- Publication number
- WO2021202306A1 WO2021202306A1 PCT/US2021/024466 US2021024466W WO2021202306A1 WO 2021202306 A1 WO2021202306 A1 WO 2021202306A1 US 2021024466 W US2021024466 W US 2021024466W WO 2021202306 A1 WO2021202306 A1 WO 2021202306A1
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- WO
- WIPO (PCT)
- Prior art keywords
- mask
- filter
- droplet capturing
- capturing filter
- droplet
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A62—LIFE-SAVING; FIRE-FIGHTING
- A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
- A62B7/00—Respiratory apparatus
- A62B7/10—Respiratory apparatus with filter elements
-
- A—HUMAN NECESSITIES
- A41—WEARING APPAREL
- A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
- A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
- A41D13/05—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
- A41D13/11—Protective face masks, e.g. for surgical use, or for use in foul atmospheres
- A41D13/1107—Protective face masks, e.g. for surgical use, or for use in foul atmospheres characterised by their shape
- A41D13/1138—Protective face masks, e.g. for surgical use, or for use in foul atmospheres characterised by their shape with a cup configuration
-
- A—HUMAN NECESSITIES
- A41—WEARING APPAREL
- A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
- A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
- A41D13/05—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
- A41D13/11—Protective face masks, e.g. for surgical use, or for use in foul atmospheres
- A41D13/1161—Means for fastening to the user's head
-
- A—HUMAN NECESSITIES
- A62—LIFE-SAVING; FIRE-FIGHTING
- A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
- A62B18/00—Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
- A62B18/02—Masks
-
- A—HUMAN NECESSITIES
- A62—LIFE-SAVING; FIRE-FIGHTING
- A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
- A62B18/00—Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
- A62B18/08—Component parts for gas-masks or gas-helmets, e.g. windows, straps, speech transmitters, signal-devices
- A62B18/084—Means for fastening gas-masks to heads or helmets
-
- A—HUMAN NECESSITIES
- A62—LIFE-SAVING; FIRE-FIGHTING
- A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
- A62B23/00—Filters for breathing-protection purposes
- A62B23/02—Filters for breathing-protection purposes for respirators
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D39/00—Filtering material for liquid or gaseous fluids
- B01D39/14—Other self-supporting filtering material ; Other filtering material
- B01D39/16—Other self-supporting filtering material ; Other filtering material of organic material, e.g. synthetic fibres
- B01D39/1692—Other shaped material, e.g. perforated or porous sheets
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/04—Additives and treatments of the filtering material
- B01D2239/0435—Electret
Definitions
- Numerous respiratory pathogens including viruses (e.g., severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), measles virus, varicella-zoster virus, adenovirus, influenza virus (e.g., H1N1), rhinovirus), and bacteria (e.g., Mycobacterium tuberculosis, Bordetella pertussis) are transmitted from an infected subject to an uninfected subject in particle droplets. These particle droplets containing respiratory pathogens are generated when an infected person, for example, coughs or sneezes.
- viruses e.g., severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), measles virus, varicella-zoster virus, adenovirus, influenza virus (e.g., H1N1), rhinovirus), and bacteria (e.g., Mycobacterium tuberculosis, Bordetella pertussis) are transmitted from an infected subject to an uninfected subject
- the particle droplets can range in size with large particles (e.g., greater than 10 microns in diameter) generally remaining airborne for shorter periods of time than small droplets (e.g., less than 10 microns in diameter).
- the particle droplets assist in the transmission of the pathogen to another subject by, e.g., inhalation through the nose or mouth, or through the conjunctiva or nasal mucosa.
- Current standard protocols require or suggest that special respirators be worn by health care providers and infected subjects to avoid this airborne transmission.
- Current respirators include fine particle/vapor filter respirators, such as negative air respirators and N95 respirators. However, these respirators greatly increase breathing resistance (both oral and nasal) making them unsuitable to be worn by numerous populations. For example, many individuals infected with a respiratory pathogen (the very individuals for which the respirators are indicated for use) may be unable to wear these respirators, as the infection commonly causes respiratory difficulty.
- respirators that do not create undue airflow resistance that would make it more difficult for the subject to breath.
- masks with modular design that allows use of filters of different sizes and/or shapes for different purposes.
- head harnesses that are easier to adjust and more comfortable to wear for a prolonged time. This disclosure provides respirators that meet these needs.
- a mask for use in preventing the spread of microorganisms through airborne transmission comprising: a) a respirator body comprising at least two ports capable of accepting a droplet capturing filter and providing a flexibly sealed interface around a subject’s nostrils and mouth; and b) a droplet capturing filter that exhibits an airflow resistance of less than about 1.5 cm FbO/L/sec at flow rates of at least about 14 L/sec.
- the droplet capturing filter exhibits an airflow resistance of less than about 1.0, less than about 0.9, less than about 0.8, less than about 0.7, less than about 0.6, less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, or less than about 0.1 cm FbO/L/sec at flow rates of 14 L/sec.
- the droplet capturing filter comprises a filter standard in the use of pulmonary function testing.
- the droplet capturing filter comprises a non-woven synthetic fiber.
- the droplet capturing filter comprises polypropylene.
- the droplet capturing filter comprises electrostatically-charged polypropylene.
- the droplet capturing filter comprises polyester. In some embodiments, the droplet capturing filter comprises electrostatically-charged polyester. In some embodiments, the droplet capturing filter comprises nylon. In some embodiments, the droplet capturing filter comprises electrostatically-charged nylon. In some embodiments, the droplet capturing filter is hydrophobic.
- the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
- the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
- the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- the droplet capturing filter is disposable.
- the mask further comprises a droplet capturing filter cap.
- the droplet capturing filter cap is reusable.
- the droplet capturing filter cap is locking.
- the droplet capturing filter cap secures the droplet capturing filter and seals the droplet capturing filter to the respirator body.
- the mask further comprises a seal energizer. In some embodiments, the mask further comprises a seal energizer positioned between the droplet capturing filter and the droplet capturing filter cap. In some embodiments, the seal energizer is reusable. In some embodiments, the respirator body comprises at least two ports capable of accepting a droplet capturing filter. In some embodiments, the mask comprises at least two droplet capturing filters. In some embodiments, the two droplet capturing filters are the same. In some embodiments, the two droplet capturing filters are different. In some embodiments, the respirator body is configured to receive a droplet capturing filter without a droplet capturing filter cap to secure the droplet capturing filter to the respirator body.
- the respirator body is configured to receive at least one cartridge that comprises the droplet capturing filter.
- the at least one cartridge is disposable.
- the at least one cartridge is releasably coupled to the respirator body.
- the respirator body is fabricated such that it has a size, shape, or both a size and shape that conforms to at least one defined headform.
- the respirator body is fabricated using an additive manufacturing technique.
- the additive manufacturing technique is vat photopolymerization, powder bed fusion, material extrusion, material jetting, binder jetting, and/or direct energy deposition.
- the additive manufacturing technique is a 3D printing technique.
- the 3D printing technique is direct light processing (DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
- DLP direct light processing
- CDLP continuous direct light processing
- SLA stereolithography
- FDM fused deposition modeling
- FFF fused filament fabrication
- SLS selective laser sintering
- MJ material jetting
- NPJ nanoparticle jetting
- DOD drop on demand
- binder jetting direct metal laser sintering
- DMLS selective laser melting
- EBM electron beam melting
- MJF multi jet fusion
- DED direct energy deposition
- a mask for use in preventing the spread of microorganisms through airborne transmission comprising: a respirator body comprising at least one port capable of accepting a droplet capturing filter and providing a flexibly sealed interface around a subject’s nostrils and mouth; and a droplet capturing filter that exhibits an airflow resistance of less than an N95 respirator, wherein the droplet capturing filter exhibits at least about 85% of the microbial filtration efficiency of the N95 respirator.
- the droplet capturing filter exhibits at least about 90%, at least about 91%, at least about 92%, at least about 93%, at least about 94%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 100%, at least about 105%, or at least about 110% of the microbial filtration efficiency of the N95 respirator.
- the droplet capturing filter comprises a filter standard in the use of pulmonary function testing.
- the droplet capturing filter comprises a non-woven synthetic fiber.
- the droplet capturing filter comprises polypropylene.
- the droplet capturing filter comprises electrostatically-charged polypropylene.
- the droplet capturing filter comprises polyester. In some embodiments, the droplet capturing filter comprises electrostatically-charged polyester. In some embodiments, the droplet capturing filter comprises nylon. In some embodiments, the droplet capturing filter comprises electrostatically-charged nylon. In some embodiments, the droplet capturing filter is hydrophobic.
- the droplet capturing filter exhibits an airflow resistance of at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, or at least about 90% less than an N95 respirator.
- the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
- the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
- the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- the droplet capturing filter is disposable.
- the mask further comprises a droplet capturing filter cap.
- the droplet capturing filter cap is reusable.
- the droplet capturing filter cap is locking.
- the droplet capturing filter cap secures the droplet capturing filter and seals the droplet capturing filter to the respirator body.
- the mask further comprises a seal energizer. In some embodiments, the mask further comprises a seal energizer positioned between the droplet capturing filter and the droplet capturing filter cap. In some embodiments, the seal energizer is reusable. In some embodiments, the respirator body comprises at least two ports each capable of accepting a droplet capturing filter. In some embodiments, the mask comprises at least two droplet capturing filters. In some embodiments, the two droplet capturing filters are the same. In some embodiments, the two droplet capturing filters are different. In some embodiments, the respirator body is configured to receive a droplet capturing filter without a droplet capturing filter cap to secure the droplet capturing filter to the respirator body.
- the respirator body is configured to receive at least one cartridge that comprises the droplet capturing filter.
- the at least one cartridge is disposable.
- the at least one cartridge is releasably coupled to the respirator body.
- the respirator body is fabricated such that it has a size, shape, or both a size and shape that conforms to at least one defined headform.
- the respirator body is fabricated using an additive manufacturing technique.
- the additive manufacturing technique is vat photopolymerization, powder bed fusion, material extrusion, material jetting, binder jetting, and/or direct energy deposition.
- the additive manufacturing technique is a 3D printing technique.
- the 3D printing technique is direct light processing (DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
- DLP direct light processing
- CDLP continuous direct light processing
- SLA stereolithography
- FDM fused deposition modeling
- FFF fused filament fabrication
- SLS selective laser sintering
- MJ material jetting
- NPJ nanoparticle jetting
- DOD drop on demand
- binder jetting direct metal laser sintering
- DMLS selective laser melting
- EBM electron beam melting
- MJF multi jet fusion
- DED direct energy deposition
- a mask for use in preventing the spread of microorganisms through airborne transmission comprising: a) a respirator body comprising at least two ports capable of accepting a droplet capturing filter; and b) a droplet capturing filter that comprises, consists of, or consists essentially of a non-woven synthetic fiber.
- the droplet capturing filter comprises a filter standard in the use of pulmonary function testing.
- the droplet capturing filter comprises polypropylene.
- the droplet capturing filter comprises electrostatically-charged polypropylene.
- the droplet capturing filter comprises polyester.
- the droplet capturing filter comprises electrostatically-charged polyester.
- the droplet capturing filter comprises nylon. In some embodiments, the droplet capturing filter comprises electrostatically-charged nylon. In some embodiments, the droplet capturing filter is hydrophobic. In some embodiments, the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
- the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
- the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- the droplet capturing filter exhibits an airflow resistance of less than about 1.5, less than about 1.0, less than about 0.9, less than about 0.8, less than about 0.7, less than about 0.6, less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, or less than about 0.1 cm fhO/L/sec at flow rates of 14 L/sec.
- the droplet capturing filter is disposable. In some embodiments, the mask further comprises a droplet capturing filter cap. In some embodiments, the droplet capturing filter cap is reusable. In some embodiments, the droplet capturing filter cap is locking. In some embodiments, the droplet capturing filter cap secures the droplet capturing filter and seals the droplet capturing filter to the respirator body. In some embodiments, the mask further comprises a seal energizer. In some embodiments, the mask further comprises a seal energizer positioned between the droplet capturing filter and the droplet capturing filter cap. In some embodiments, the seal energizer is reusable. In some embodiments, the respirator body comprises at least two ports each capable of accepting a droplet capturing filter.
- the mask comprises at least two droplet capturing filters. In some embodiments, the two droplet capturing filters are the same. In some embodiments, the two droplet capturing filters are different. In some embodiments, the respirator body is configured to receive a droplet capturing filter without a droplet capturing filter cap to secure the droplet capturing filter to the respirator body. In some embodiments, the respirator body is configured to receive at least one cartridge that comprises the droplet capturing filter. In some embodiments, the at least one cartridge is disposable. In some embodiments, the at least one cartridge is releasably coupled to the respirator body.
- the respirator body is fabricated such that it has a size, shape, or both a size and shape that conforms to at least one defined headform.
- the respirator body is fabricated using an additive manufacturing technique.
- the additive manufacturing technique is vat photopolymerization, powder bed fusion, material extrusion, material jetting, binder jetting, and/or direct energy deposition.
- the additive manufacturing technique is a 3D printing technique.
- the 3D printing technique is direct light processing (DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
- DLP direct light processing
- CDLP continuous direct light processing
- SLA stereolithography
- FDM fused deposition modeling
- FFF fused filament fabrication
- SLS selective laser sintering
- MJ material jetting
- NPJ nanoparticle jetting
- DOD drop on demand
- binder jetting direct metal laser sintering
- DMLS selective laser melting
- EBM electron beam melting
- MJF multi jet fusion
- DED direct energy deposition
- a mask for use in preventing the spread of microorganisms through airborne transmission comprising (a) a facepiece body comprising at least one opening capable of accepting a cover plate; (b) the cover plate configured to accept at least one droplet capturing filter of various sizes; and (c) the at least one droplet capturing filter.
- the cover plate is releasably coupled with the facepiece body.
- the cover plate comprises at least one plate opening that allows air passage.
- the mask further comprises a filter cap.
- the filter cap is releasably coupled with the facepiece body.
- the filter cap comprises at least one cap opening that allows air passage.
- the filter cap and the cover plate can be releasably assembled to form a confined space.
- the at least one droplet capturing filter is positioned in the confined space between the cover plate and the filter cap.
- the at least one droplet capturing filter is fixed on at least one filter cartridge.
- the at least one filter cartridge is releasably coupled with the facepiece body by a screw on mechanism.
- the facepiece body comprises a rigid body surrounding the at least one opening of the facepiece body.
- the facepiece body comprises a flexible body that is molded to fit and seal upon a face of a user. In some embodiments, the flexible body is over-molded onto the rigid body.
- the flexible body comprises silicone.
- the cover plate is capable of snapping into and sealing the facepiece body.
- the filter cap comprises a hinge and the facepiece body comprises a matching base for the hinge, wherein the hinge and the matching base allow the filter cap to be releasably coupled with the facepiece body.
- the hinge is a snap-in hinge.
- the filter cap comprises an inner surface, wherein the inner surface comprises at least one smooth surface.
- the filter cap comprises an edge seal positioned on at least one portion of the inner surface, wherein the edge seal secures and seals the droplet capturing filter with the cover plate or the facepiece body.
- the facepiece body comprises at least two the openings capable of accepting the cover plate.
- the at least one opening of the facepiece body has a size of from about 8 to about 14 square inches.
- the at least one opening of the facepiece body has a size of from about 10 to about 12 square inches.
- the at least one opening of the facepiece body has a size of about 11 square inches.
- the at least one opening of the facepiece body has a shape of circular, oval, oblong, square, or rectangle.
- the cover plate has a size of from about 100% to about 120% of the size of said at least one opening of said facepiece body.
- the cover plate has a size of from about 105% to about 115% of the size of said at least one opening of said facepiece body. In some embodiments, the cover plate has a size of about 110% of the size of said at least one opening of said facepiece body. In some embodiments, the plate opening has a size of about 95%, about 90%, about 80%, about 70%, about 60%, about 50%, about 40%, about 30%, about 20%, about 10%, or about 5% of the size of the cover plate. In some embodiments, the filter cap has a size of from about 100% to about 120% of the size of said at least one opening of said facepiece body.
- the filter cap has a size of from about 105% to about 115% of the size of said at least one opening of said facepiece body. In some embodiments, the filter cap has a size of about 110% of the size of said at least one opening of said facepiece body. In some embodiments, the cap opening has a size of about 95%, about 90%, about 80%, about 70%, about 60%, about 50%, about 40%, about 30%, about 20%, about 10%, or about 5% of the size of the filter cap. In some embodiments, at least one side of the filter cap is attached to a harness.
- the filter cap comprises at least two prongs, wherein each of the at least two prongs is extended from the at least one side of the filter cap, wherein the at least two prongs are capable of receiving a harness.
- the at least one side comprises two nonadjacent sides.
- the mask further comprises an exhalation valve.
- the at least one droplet capturing filter exhibits an airflow resistance of less than about 1.5 cm FbO/L/sec at flow rates of at least about 14 L/sec.
- the droplet capturing filter exhibits an airflow resistance of less than about 1.0, less than about 0.9, less than about 0.8, less than about 0.7, less than about 0.6, less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, or less than about 0.1 cm HiO/L/sec at flow rates of 14 L/sec.
- the droplet capturing filter comprises a filter standard in the use of pulmonary function testing.
- the droplet capturing filter comprises a non-woven synthetic fiber.
- the droplet capturing filter comprises polypropylene.
- the droplet capturing filter comprises electrostatically-charged polypropylene.
- the droplet capturing filter comprises polyester. In some embodiments, the droplet capturing filter comprises electrostatically-charged polyester. In some embodiments, the droplet capturing filter comprises nylon. In some embodiments, the droplet capturing filter comprises electrostatically-charged nylon. In some embodiments, the droplet capturing filter is hydrophobic.
- the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
- the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
- the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- the droplet capturing filter is disposable.
- the droplet capturing filter comprises pre-printed pattern or color.
- a harness for securing a mask to a head of a user comprising (a) a head strap capable of positioning and securing the mask to the head of the user; (b) a first adjustable mechanism that is capable to adjust the position and length of the head strap; (c) at least one second strap that is connected to the head strap; and (d) at least one second adjustable mechanism connecting the second strap to the head strap; wherein the at least one second adjustable mechanism is located on at least one end of the head strap.
- the first adjustable mechanism comprises a ladder-type buckle.
- the at least one second adjustable mechanism is a latching mechanism.
- the harness comprises two the second straps.
- the harness comprises two the second adjustable mechanisms, wherein each of the second adjustable mechanism is located on each end of the head strap.
- the head strap comprises a flexible material.
- the flexible material comprises silicone.
- the flexible material comprises a low durometer, injection moldable, thermoplastic elastomer.
- the at least one second strap comprises an elastic material.
- the elastic material is rubber.
- the at least one second strap is made from a bungee cord.
- FIG. 1A shows a non-limiting example of a front view of an exemplary mask according to various embodiments described herein.
- there are two disposable droplet capturing filters e.g., one on the left and one on the right
- each droplet capturing filter is secured in place with a reusable filter cap.
- FIG. IB shows a non-limiting example of a front angled view of an exemplary mask according to various embodiments described herein.
- there are two disposable droplet capturing filters e.g., one on the left and one on the right
- each droplet capturing filter is secured in place with a reusable filter cap.
- FIG. 1C shows a non-limiting example of a back view of an exemplary mask according to various embodiments described herein.
- there are two disposable droplet capturing filters e.g., one on the left and one on the right
- each droplet capturing filter is secured in place with a reusable filter cap.
- FIG. ID shows a non-limiting example of a front exploded view of an exemplary mask according to various embodiments as described herein.
- there are two disposable droplet capturing filters e.g., one on the left and one on the right
- each droplet capturing filter is secured in place with a reusable filter cap
- the respirator body comprises two filter ports, each capable of receiving a filter and securing a filter cap.
- FIG. IE shows a non-limiting example of a front angled exploded view of an exemplary mask according to various embodiments as described herein.
- there are two disposable droplet capturing filters e.g., one on the left and one on the right
- each droplet capturing filter is secured in place with a reusable filter cap
- the respirator body comprises two filter ports, each capable of receiving a filter and securing a filter cap.
- FIG. IF shows a non-limiting example of a back exploded view of an exemplary mask according to various embodiments as described herein.
- there are two disposable droplet capturing filters e.g., one on the left and one on the right
- each droplet capturing filter is secured in place with a reusable filter cap
- the respirator body comprises two filter ports, each capable of receiving a filter and securing a filter cap.
- FIG. 2A shows a non-limiting example of a front view of an exemplary mask according to various embodiments as described herein.
- the mask comprises a respirator body, two disposable filter elements (e.g., one on the left and one on the right), an optional cap- to-filter seal energizer element (e.g., one on the left and one on the right), and a reusable locking filter cap element (e.g., one on the left one on the right) that secure the filter and seal it to the respirator body.
- FIG. 2B shows a non-limiting example of a front exploded view of an exemplary mask according to various embodiments as described herein.
- the image shows the filter elements separated from the respirator body.
- the image shows the respirator body, disposable filter element (e.g., two - one on the left and one on the right), an optional cap-to-filter seal energizer element (e.g., two - one on the left and one on the right), and a reusable locking filter cap element (e.g., one on the left one on the right) that secure the filter and seal it to the respirator body.
- disposable filter element e.g., two - one on the left and one on the right
- an optional cap-to-filter seal energizer element e.g., two - one on the left and one on the right
- a reusable locking filter cap element e.g., one on the left one on the right
- FIG. 2C shows a non-limiting example of a front angled exploded view of an exemplary mask according to various embodiments as described herein.
- the image shows the filter elements separated from the respirator body.
- the image shows the respirator body, disposable filter element (e.g., two - one on the left and one on the right), an optional cap-to-filter seal energizer element (e.g., two - one on the left and one on the right), and a reusable locking filter cap element (e.g., one on the left one on the right) that secure the filter and seal it to the respirator body.
- disposable filter element e.g., two - one on the left and one on the right
- an optional cap-to-filter seal energizer element e.g., two - one on the left and one on the right
- a reusable locking filter cap element e.g., one on the left one on the right
- FIG. 3A shows a non-limiting example of a front angled exploded view of an exemplary mask according to various embodiments as described herein.
- the image shows the facepiece body, the cover plate, the droplet capturing filter(s), and the filter cap.
- FIG. 3B shows a non-limiting example of a front view of an exemplary mask according to various embodiments as described herein.
- the image shows the facepiece body, the cover plate, the droplet capturing filter, and the filter cap.
- the image shows the filter cap that is releasably coupled with the facepiece body by a hinge.
- FIG. 3C shows a non-limiting example of a front angled exploded view of an exemplary mask according to various embodiments as described herein.
- the image shows the facepiece body, the cover plate, and the filter cartridge(s). In this example, the filter cap is not needed.
- FIG. 4A shows a non-limiting example of components of an exemplary mask with an exemplary harness.
- the image shows a facepiece body, a droplet capturing filter, and a filter cap connected to the harness.
- FIG. 4B shows a non-limiting example of the assembled front view of the exemplary mask with the exemplary harness in FIG. 4A.
- FIG. 4C shows a non-limiting example of the assembled side view of the exemplary mask with the exemplary harness in FIG. 4A.
- FIG. 5 shows a non-limiting example of the front view of the exemplary mask with the exemplary droplet-capturing filter with pre-printed color and/or pattern.
- Numerous respiratory pathogens including viruses (e.g., severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), measles virus, varicella-zoster virus, adenovirus, influenza virus (e.g., H1N1), rhinovirus, and bacteria (e.g., Mycobacterium tuberculosis, Bordetella pertussis) are transmitted from an infected subject to an uninfected subject in particle droplets. These particle droplets containing respiratory pathogens are generated when an infected person, for example, coughs or sneezes.
- viruses e.g., severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), measles virus, varicella-zoster virus, adenovirus, influenza virus (e.g., H1N1), rhinovirus, and bacteria (e.g., Mycobacterium tuberculosis, Bordetella pertussis) are transmitted from an infected subject to an uninfected subject
- the particle droplets can range in size with large particles (e.g., greater than 10 microns in diameter) generally remaining airborne for shorter periods of time than small droplets (e.g., less than 10 microns in diameter).
- the particle droplets assist in the transmission of the pathogen to another subject by, e.g., inhalation through the nose or mouth, or through the conjunctiva or nasal mucosa.
- Current standard protocols require or suggest that special respirators be worn by health care providers and infected subjects to avoid this airborne transmission.
- Current respirators include fine particle/vapor filter respirators, such as negative air respirators and N95 respirators. However, these respirators greatly increase breathing resistance (both oral and nasal) making them unsuitable to be worn by numerous populations.
- the present disclosure relates to a respirator that provides a high-level of protection for individuals from respiratory-based pathogen transmission by continuously and effectively capturing the exhaled/expelled droplets from an individual’s breath, without making it more difficult for the individual to breathe.
- the capture mechanism provides protection when transmittable respiratory pathogens (e.g., viruses (e.g., severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), measles virus, varicella-zoster virus, adenovirus, influenza virus (e.g., H1N1), rhinovirus), and bacteria (e.g., Mycobacterium tuberculosis, Bordetella pertussis) are enveloped in these droplets (e.g., capturing the droplets effectively captures the pathogen).
- viruses e.g., severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), measles virus, varicella-zoster virus, adenovirus, influenza virus (e.g., H1N1), rhinovirus)
- bacteria e.g., Mycobacterium tuberculosis, Bordetella pertussis
- the respirators described herein contain high efficiency, disposable filter cartridges/media that are designed to continuously capture exhaled droplets contained in the airstream of a human breath without creating undue airflow resistance that would make it more difficult for a person to breathe.
- This may be particularly important because individuals suffering from respiratory issues, such as those caused by respiratory pathogens (e.g., SARS-CoV-2) most often already have difficulty breathing, and a high resistance filter would only exacerbate that issue or make it impossible for the individual to breathe at all with the respirator, thus defeating the purpose of the respirator altogether.
- the respirators described herein can be manufactured at large scale within days, as is normally needed during outbreaks of respiratory pathogens.
- the present disclosure also relates to a mask having a modular design which enhances comfort, safety, convenience of use and efficiency.
- the modular design allows the use of filters of different sizes and/or shapes for different purposes.
- the mask can be assembled and disassembled by a user. It is easy for the user to replace filters and to clean the components of the mask.
- the present disclosure further relates to a head harness that is easier to adjust and more comfortable to wear for a prolonged time.
- respirator body generally refers to an element that provides a flexibly sealed interface around an individual’s nostrils and mouth.
- resistance generally refers to the amount of effort that is required to make an inspiratory or an expiratory breath.
- efficiency generally refers to the level of filtration protection or function that a droplet capturing filter can deliver.
- the efficiency of the filter is normally expressed as a reflection of the number of microorganisms that pass through the filter media when it is challenged. This filter is then described as being X% efficient.
- the X% is an expression of the number of microorganisms penetrating the filter when challenged by an aerosol containing 1,000,000 microorganisms.
- N95 Respirator generally refers to a respiratory protective device with a filtration efficiency of at least 95% against non-oily, air-based particles when tested using the National Institute for Occupational Safety and Health (NIOSH) criteria.
- NIOSH National Institute for Occupational Safety and Health
- airflow resistance and “resistance to airflow” are used interchangeably herein, and generally refer to the resistance to airflow through a filter (e.g., a droplet-capturing filter as described herein).
- over-molded means that one component is molded over or onto another already formed part or component.
- peripheral means the peripheral portion of an object.
- plain refers to a filter comprising filter media without outer sheath or scrim.
- the subject is a human.
- the mask is intended for use by a human subject having or suspected of having a respiratory infection (e.g., an infection caused by a respiratory pathogen).
- the mask is intended for use by a human subject who is in contact with or who may come into contact with another individual who has or is suspected of having a respiratory infection (e.g., to protect the mask wearer from infection with a respiratory pathogen).
- the respiratory pathogen is a bacterium.
- Non limiting examples of bacteria that can cause respiratory infections include: a Group A beta- hemolytic streptococci (e.g., Streptococcus pyogenes ), Corynebacterium diphtheriae , Neisseria gonorrhoeae , Mycoplasma pneumoniae , Mycoplasma hominis (Type I), mixed anaerobes, Haemophilus influenzae , Streptococcus pneumoniae , Staphylococcus aureus , Klebsiella pneumoniae , Escherichia coli , Pseudomonas aeruginosa , Legionella spp ., Mycobacterium tuberculosis , Coxiella burnetii , Chlamydia psittaci , Chlamydia trachomatis , Chlamydia pneumoniae, and Bordetella pertussis.
- the respiratory pathogen is a virus.
- viruses that can cause respiratory infections include: coronaviruses (e.g., severe acute respiratory syndrome coronavirus (SARS-CoV), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), human coronavirus 299E (HCoV-299E), human coronavirus NL63 (HCoV-NL63), human coronavirus OC43 (HCoV-OC43), human coronavirus HKEG1 (HCoV-HKEil), and Middle East respiratory syndrome coronavirus (MERS-CoV)), rhinoviruses (e.g., rhinovirus A, rhinovirus B, rhinovirus C), parainfluenza viruses (e.g., human parainfluenza virus type 1, human parainfluenza virus type 2, human parainfluenza virus type 3, human parainfluenza virus type 4), adenoviruses (e.g., human adenovirus B, human adenovirus C), respiratory infections (SARS-CoV
- the respiratory pathogen is a fungus.
- fungi that can cause respiratory infections include: Candida albicans , Histoplasma capsulatum , Blastomyces dermatitidis , Paracoccidioides brasiliensis , Coccidioides immitis , Filobasidiella neoformans , and Aspergillus fumigatus.
- the mask described herein may be used by a healthcare worker, a frontline worker, a first responder, etc. (or another individual) who is or is likely to be in contact (e.g., close contact) with an individual having or suspected of having a respiratory infection (e.g., as described herein).
- the mask may reduce the risk of, or may prevent, the healthcare worker, the frontline worker, or the first responder (or other individual in contact with an infected individual) from being exposed to and/or becoming infected with the respiratory pathogen.
- a mask described herein comprises a respirator body (e.g., as described herein). In some embodiments, a mask described herein comprises a droplet-capturing filter (e.g., as described herein). In some embodiments, a mask described herein comprises a respirator body (e.g., as described herein) and a droplet-capturing filter (e.g., as described herein). [0043] In some embodiments, the mask is a quarter mask that covers the nose and mouth of an individual (e.g., a human), wherein the lower sealing surface rests between the chin and the mouth.
- the mask is a half mask that covers the nose and mouth of an individual (e.g., a human) and fits under the chin.
- the mask is a full facepiece that covers the entire face of an individual (e.g., a human) from below the chin to the hairline.
- the mask has a modular design that allows the use of filters of different sizes and/or shapes for different purposes.
- the mask comprises a facepiece body comprising at least one opening capable of accepting a cover plate; the cover plate configured to accept at least one droplet capturing filter of various sizes and/or shapes; and the at least one droplet capturing filter.
- the cover plate comprises at least one plate opening that allows air passage. By adjusting the size of the cover plate and the size of the plate opening, the cover plate can accommodate differently types of filters with different sizes and/or shapes.
- the filter is positioned in a filter cartridge.
- the mask further comprises a filter cap.
- the filter cap comprises at least one cap opening that allows air passage.
- the filter cap and the cover plate can be releasably assembled to form a confined space where the filter can be positioned. By adjusting the size of the confined space, the mask can accommodate different types of filters with different sizes and/or shapes.
- the components of the mask having the modular design, including facepiece body, cover plate, and filter cap, will be discussed in detail below.
- respirator bodies In some aspects, described herein are respirator bodies. In some aspects, described herein are masks comprising a respirator body. As outlined above, the term “respirator body” as used herein generally refers to an element that provides a flexibly sealed interface around an individual’s nostrils and mouth.
- any respiratory body capable of being equipped with one or more ports (e.g., at least two ports) to accept a droplet-capturing filter (e.g., as described herein) and capable of creating a seal against the face (e.g., around the nose and mouth) may be used in the masks described herein.
- the respiratory body may be made out of any material commonly used in the art.
- the respirator body comprises at least one strap that goes around the head of the subject in order to keep the respirator body on the subject. The respirator can provide a high-level of protection from pathogen transmission by continuously and effectively capturing the exhaled/expelled droplets from an individual’s breath.
- the respirator may be configured to receive one or more droplet-capturing filters to filter out transmittable respiratory pathogens that are enveloped in the exhaled/expelled droplets. In some cases, capturing the droplets effectively captures the pathogen.
- the respirator may be compatible with high efficiency, disposable filter cartridges/media that are designed to continuously capture exhaled droplets contained in the airstream of a human breath without creating undue airflow resistance that would make it more difficult for an individual to breathe.
- FIGS. 1A-1F An exemplary respiratory body 102 is shown in FIGS. 1A-1F.
- the respiratory body 102 comprises two ports 108 capable of accepting a droplet capturing filter 104.
- the respiratory body 102 may be made from a flexible material that can provide a flexibly sealed interface around a subject’s nostrils and mouth.
- the flexible material may be silicone or other soft thermoplastic elastomer that is comfortable against human facial skin (e.g., such as any known in the art).
- FIGS. 2A-2C Another exemplary respirator respiratory body 102 is shown in FIGS. 2A-2C.
- the respiratory body 102 comprises two ports 108 capable of accepting a droplet capturing filter 104.
- At least one (e.g., at least two, three, four) straps are added to the respirator body (e.g., as shown in FIGS. 1A-2C) to secure the respirator body to the face of a subject wearing a mask comprising the respirator body.
- the respirator body is equipped with at least one port to accept a droplet-capturing filter (e.g., as described herein). In some embodiments, the respirator body is equipped with at least two or three ports to accept a droplet capturing filter (e.g., as described herein).
- the respirator body comprises at least one port capable of accepting a droplet capturing filter. In some embodiments, the respirator body comprises at least two ports, each capable of accepting a droplet capturing filter. In some embodiments, the respirator body comprises at least three ports, each capable of accepting a droplet capturing filter. In some embodiments, the respirator body comprises at least four ports, each capable of accepting a droplet capturing filter. In some embodiments, the respirator body comprises at least five ports, each capable of accepting a droplet capturing filter.
- the respirator body is manufactured using a 3D printer. Any suitable 3D printer can be utilized.
- An exemplary 3D printer material is HP 3D HR PA12, which is a polyamide powder that is approved by the FDA for intact skin surface devices.
- Other materials and processes can be utilized to manufacture the respirator body, e.g., vacuum thermoforming or injection molding using appropriate biocompatible materials such as polypropylene.
- the facepiece body 202 comprises at least one opening 212 capable of accepting a cover plate 208.
- the facepiece body comprises at least two openings 212 capable of accepting the cover plate(s).
- the at least one opening 212 of the facepiece body 202 has a size of from about 6 to about 16 square inches. In some embodiments, the at least one opening 212 of the facepiece body 202 has a size of from about 8 to about 14 square inches.
- the at least one opening 212 of the facepiece body 202 has a size of from about 9 to about 13 square inches. In some embodiments, the at least one opening 212 of the facepiece body 202 has a size of from about 10 to about 12 square inches. In some embodiments, the at least one opening 212 of the facepiece body 202 has a size of about 11 square inches. In some embodiments, the at least one opening 202 is in the shape of an oval, a circle, an oblong, a square, a rectangle or any other shape. In some embodiments, the shape of the at least one opening 212 is oval. In some embodiments, the shape of the at least one opening 212 is circular. In some embodiments, the shape of the at least one opening 212 is square.
- the shape of the at least one opening 212 is rectangular.
- the facepiece body 202 comprises at least two openings 212 and each of the openings 212 has the same size.
- each of the openings 212 has different sizes.
- each of the openings 212 has the same shape.
- each of the openings 212 has different shapes.
- the facepiece body 202 comprises a rigid body 206 surrounding the at least one opening 212.
- the rigid body 206 comprises a rigid material.
- the rigid material is polypropylene, polycarbonate, thermoplastic elastomer, or other suitable plastic resin.
- the polypropylene is injection- molded polypropylene.
- the thermoplastic elastomer is a thermoplastic elastomer of high durometer rating for rigidity.
- the facepiece body 202 comprises a flexible body 204 that is molded to fit and seal upon a face of a user.
- the flexible body 204 comprises soft, cushiony, elastomeric material.
- the soft, cushiony, elastomeric material may be rubber-like material.
- the rubber-like material is a thermoplastic rubber.
- the thermoplastic rubber comprises polypropylene.
- the soft, cushiony, elastomeric material may be silicone.
- the soft, cushiony, elastomeric material may be gel.
- the soft, cushiony, elastomeric material may be thermoplastic elastomer or other suitable plastic resin.
- the thermoplastic elastomer is injection-molded thermoplastic elastomer.
- the thermoplastic elastomer is a thermoplastic elastomer of low durometer rating for softness.
- the soft, cushiony, elastomeric material is in a unitary piece.
- the flexibility of the soft, cushiony, elastomeric material allows the facepiece body 202 to conform to the user’s facial contours in a passive manner and form a seal with the user’s face.
- the flexible body is over-molded onto the rigid body.
- cover plates In some aspects, described herein are cover plates. In some aspects, described herein are masks comprising a cover plate. [0054] In some embodiments, the cover plate 208 is releasably coupled with the facepiece body 202. In some embodiments, the cover plate 208 is coupled with the facepiece body 202 by a snap- fit engagement mechanism. The cover plate 208 may be instantaneously snapped into engagement to the facepiece body 202 without rotational movement. In some embodiments, the cover plate 208 is pressed against the corresponding receiving structure on the facepiece body 202.
- the snap- fit engagement mechanism provides an extraordinarily easy and hygienic way for attaching a cover plate to the facepiece body. An audible noise may be provided to indicate a secure attachment.
- the cover plate 208 is capable of being removed quickly from the facepiece body 202 by pulling the cover plate in a direction opposite to which it was pressed onto the facepiece body 202 without rotational movement. In some embodiments, the cover plate 208 is capable of sealing the opening 212 of the facepiece body 202.
- the cover plate has a size of from about 100% to about 120% of the size of the at least one opening 212 of the facepiece body 202. In some embodiments, the cover plate has a size of from about 105% to about 115% of the size of the at least one opening 212 of the facepiece body 202. In some embodiments, the cover plate has a size of about 110% of the size of the at least one opening 212 of the facepiece body 202. In some embodiments, the cover plate may have a shape, such as, circular, oval, oblong, square, or rectangular. In some embodiments, the cover plate 208 has the same shape as the opening 212 of the facepiece body 202. In some embodiments, the cover plate 208 has the same size as the opening 212 of the facepiece body 202.
- the cover plate 208 comprises a plate opening 214 that allows air passage.
- the cover plate 208 comprises at least two plate openings 214.
- the plate opening 214 has a size that is about 95%, about 90%, about 80%, about 70%, about 60%, about 50%, about 40%, about 30%, about 20%, about 10%, or about 5% of the cover plate 208.
- the plate opening 214 may be in any shape known in the art.
- described herein are filter caps. In some aspects, described herein are masks comprising a filter cap.
- the filter cap 210 is releasably coupled with the facepiece body 202.
- the cover plate 208 and the filter cap 210 can be releasably assembled to form a confined space where the droplet capturing filter 104 can be positioned.
- the filter cap 210 has a size of from about 100% to about 120% of the size of the at least one opening 212 of said facepiece body 202.
- the filter cap 210 has a shape, such as, circular, oval, oblong, square, or rectangle. In some embodiments, the filter cap 210 has the same shape as the cover plate 208.
- the filter cap 210 has the same shape as the opening 212 of the facepiece body 202. In some embodiments, the filter cap 210 has the same size as the cover plate 208. In some embodiments, the filter cap 210 has the same size as the opening 212 of the facepiece body 202.
- the filter cap 210 is coupled with the facepiece body 202 by a snap-fit engagement mechanism.
- the filter cap 210 may be instantaneously snapped into engagement to the facepiece body 202 without rotational movement.
- the filter cap 210 is pressed against the corresponding receiving structure on the facepiece body 202.
- the snap-fit engagement mechanism provides an extraordinarily easy and hygienic way for attaching a filter cap 210 to the facepiece body. An audible noise may be provided to indicate a secure attachment.
- the filter cap 210 comprises a hinge 218 and the facepiece body 202 comprises a matching base 219 for the hinge 218, wherein the hinge 218 and the matching base 219 allow the filter cap 210 to be releasably coupled with the facepiece body 202.
- the hinge 218 is a snap-in hinge. The snap-in hinge provides an easy way for alignment, filter replacement, and decontamination.
- the filter cap 210 is capable of being removed quickly from the facepiece body 202 by pulling the filter cap 210 in a direction opposite to which it was pressed onto the facepiece body 202 without rotational movement.
- the cover plate 208 is capable of sealing the opening 212 of the facepiece body 202 and/or the plate opening 214 of the cover plate 208.
- the filter cap 210 comprises an inner surface, wherein the inner surface comprises at least one smooth surface 222.
- the smooth surface eliminates crevices and thus minimizes bacterial growth potential on the mask.
- the smooth surface also provides an easy way for decontamination.
- the filter cap 210 comprises an edge seal (not shown) positioned on at least one portion of the inner surface, wherein the edge seal secures and seals the droplet capturing filter 104 with the cover plate 210 and/or the facepiece body 202.
- the at least one portion of the inner surface is the perimeter of the filter cap 210.
- the at least one portion of the inner surface is at least one portion of the perimeter of the filter cap 210.
- the edge seal is able to provide a secure and leak-free seal over the droplet capturing filter 104.
- the edge seal latches to the periphery of the opening 212 of the facepiece body 202.
- the filter cap 210 comprises a cap opening 216 that allows air passage.
- the filter cap 210 comprises at least two cap openings 216.
- the cap opening 216 has a size that is about 95%, about 90%, about 80%, about 70%, about 60%, about 50%, about 40%, about 30%, about 20%, about 10%, or about 5% of the size of the filter cap 210.
- the cap opening 216 may be in any shape known in the art.
- the cover plate 208 or filter cap 210 is reusable.
- the filter cap 210 comprises at least one prong 220, wherein the prong 220 is extended from at least one side of the filter cap 210.
- the filter cap 210 comprises at least two prongs 220, wherein each of the two prongs 220 is extended from at least one side of the filter cap 210, wherein the at least two prongs 220 are capable of receiving a harness 302.
- the two prongs 220 are the same.
- the two prongs 220 are extended from the same side of the filter cap 210.
- the two prongs 220 are extended from two sides of the filter cap 210. In some embodiments, the two sides of the filter cap 210 are nonadjacent.
- the filter cap 210 is attached to a harness 302 that may be used to secure and position the mask to a head of a user.
- the filter cap 210 is attached to the harness 302 through connecting the two prongs 220 of the filter cap 210 to both ends of the harness 302.
- both ends of the harness 302 are connected to at least one side of the filter cap 210.
- harnesses used to secure the mask to the head of the user.
- masks comprising a harness.
- the harness 302 comprises a head strap 304 capable of positioning and securing the mask to the head of the user; a first adjustable mechanism 306 that is configured to adjust the position and length of the head strap 304; at least one second strap 308 that is connected to the head strap 304; and at least one second adjustable mechanism 310 connecting the second strap 308 to the head strap 304; wherein the at least one second adjustable mechanism 310 is located on at least one end of the head strap 304.
- the head strap 304 is made of flexible material.
- the flexible material comprises silicone.
- the flexible material comprises flexible strapping material.
- the flexible strapping material comprises cotton, nylon, polypropylene, or other fabrics.
- the first adjustable mechanism 306 is located on the head strap 304.
- the first adjustable mechanism 306 comprises a ladder-type buckle, a multiple ladder, or D-shaped buckle.
- at least one end of the head strap 304 is attached to at least one prong 220 of the filter cap 210.
- each of the two ends of the head strap 304 is attached to each of the two prongs 220 of the filter cap 210.
- the at least one end of the head strap 304 is attached to at least one prong 220 of the filter cap 210 by a snap- fit mechanism.
- each of the two ends of the head strap 304 has a part of the snap-fit mechanism and each of the two prongs 220 of the filter cap 210 has a mating part of the snap-fit mechanism, wherein the end of the head strap 304 is capable of snapping into the prong 220 of the filter cap 210.
- the harness 302 comprises at least one second strap 308 connected to the head strap 304.
- the harness 302 comprises two second straps 308 and each of the two second straps 308 is connected to the head strap 304.
- the second strap 308 is connected to the head strap 304 by a second adjustable mechanism 310.
- the second adjustable mechanism 310 is a latching mechanism.
- the second adjustable mechanism 310 is located on the end of the head strap 304.
- both ends of each of the two second straps 308 are connected to the filter cap 210.
- each end of the head strap 304 is connected to one of the two second straps 308 by the second adjustable mechanism(s) 310.
- the ends of the two second straps 308 are connected to the filter cap 210.
- the ends of the two second straps 308 are connected to the filter cap 210 by a snap-fit mechanism.
- the two second straps 308 are connected to the filter cap 210 by connecting a first component that is located at the end of the second strap 308 with a matching component that is located on at least one side of the filter cap 210, wherein the first component matches and secures the matching component.
- the first component is a knot and the matching component is a keyhole shaped opening.
- the end of the second strap 308 is directly molded into the filter cap 210.
- the second strap 308 comprises an elastic material.
- the elastic material is rubber.
- the second strap 308 is made from bungee cords.
- droplet capturing filters 104 In some aspects, described herein are masks comprising droplet capturing filters. In some embodiments, the droplet capturing filter is disposable. In some embodiments, as shown in FIG. 5, the droplet capturing filter comprises pre-printed pattern or color.
- the pre-printed pattern may be logos, cartoon drawings, or other pictures.
- the pre-printed color may be any color. The pre-printed pattern or color may make the mask look friendly or pleasant (e.g., to a child).
- a droplet capturing filter is any filter that is standardly used in pulmonary function testing (e.g., spirometry, plethysmography, etc.).
- the droplet capturing filter is plain. In some embodiments, the droplet capturing filter comprises a filter media that is backed by at least one scrim layer. In some embodiments, the droplet capturing filter comprises the filter media that is sandwiched by at least two scrim layers. In some embodiments, the droplet capturing filter is a flat filter media (with accompanying support/security elements). In some embodiments, the droplet capturing filter is in a shape of an oval, a circle, an oblong, a rectangle, a square, or other suitable shapes. In some embodiments, the droplet capturing filter has a size of from about 8 to about 14 square inches.
- the droplet capturing filter has a size of from about 9 to about 13 square inches. In some embodiments, the droplet capturing filter has a size of from about 10 to about 12 square inches. In some embodiments, the droplet capturing filter has a size of about 11 square inches. In some embodiments, the droplet capturing filter has a size of from about 4 to about 7 square inches. In some embodiments, the droplet capturing filter has a size of from about 5 to about 6 square inches. In some embodiments, the droplet capturing filter has a size of from about 3 to about 6 square inches. In some embodiments, the droplet capturing filter has a size of from about 4 to about 5 square inches.
- the droplet capturing filter comprises polypropylene. In some embodiments, the droplet capturing filter consists of polypropylene. In some embodiments, the droplet capturing filter consists essentially of polypropylene. In some embodiments, the droplet capturing filter comprises electrically-charged polypropylene. In some embodiments, the droplet capturing filter consists of electrically-charged polypropylene. In some embodiments, the droplet capturing filter consists essentially of electrically-charged polypropylene. In some embodiments, the droplet capturing filter consists essentially of polystyrene. In some embodiments, the droplet capturing filter comprises electrically-charged polystyrene.
- the droplet capturing filter consists essentially of nylon. In some embodiments, the droplet capturing filter comprises electrically-charged nylon. In some embodiments, the droplet capturing filter is hydrophobic. In some embodiments, the droplet capturing filter is an electrostatic filter (e.g., 50% of fibers positively charged and 50% of fibers negatively charged). Exemplary filter cartridges include, e.g., the PulmoGuardTM series from SDI Diagnostics, the VBMaxTM series from A-M Systems, and the Spiroguard series from GVS. In some embodiments, the droplet capturing filter is contained in a housing. In some embodiments, the mask further comprises a droplet capturing filter cap (also referred to herein as a “droplet capturing filter cap”).
- a droplet capturing filter cap also referred to herein as a “droplet capturing filter cap”.
- the droplet capturing filter cap is reusable. In some embodiments, the droplet capturing filter cap is disposable. In some embodiments the droplet capturing filter cap secures the droplet capturing filter and seals the droplet capturing filter to the respirator body. In some embodiments, the droplet capturing filter cap is locking. In some embodiments, the mask further comprises a seal energizer. In some embodiments, the seal energizer is positioned between the droplet capturing filter and the droplet capturing filter cap. In some embodiments, the seal energizer is reusable. In some embodiments, the seal energizer is disposable. In some embodiments, the seal energizer is a cantilever “V” spring, a helical wound spring, or a canted coil seal. In some embodiments, the seal energizer is a cantilever “V” spring. In some embodiments, the seal energizer is a helical wound spring. In some embodiments, the seal energizer is a canted coil seal.
- the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
- the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral and bacterial filtration efficiency.
- the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral and bacterial filtration efficiency.
- Viral and bacterial filtration efficiency can be assessed using any standard method known in the art.
- a challenge particle may be chosen to simulate the size of the commonly occurring pathogens (e.g., bacteria and viruses).
- Challenge particles can be chosen based on specific needs of the end user (e.g., to ensure filtration efficiency of certain pathogens).
- Common exemplary bacterial test protocols use Staphylococcus aureus as a challenge organism which has an approximate size of 0.6 mm, and common exemplary viral test protocols use an XI 74 Bacteriophage which has a size of 0.027 mm.
- Viral and bacterial filtration efficiency can be assessed against any standard known in the art.
- viral and bacterial filtration efficiency of a droplet capturing filter can be assessed against the ASTM F2101 standard for bacterial and viral filtration efficiency.
- viral and bacterial filtration efficiency of a droplet capturing filter is assessed against the ASTM F2101 standard for bacterial and viral filtration efficiency.
- a standardBS EN 13328 -1 2002 (Breathing System Filters for Anesthetic and Respiratory use. Part 1 Salt Test method to assess filtration performance) may be performed.
- the test provides, inter alia , a method of benchmarking the performance of one filter against another.
- the test requires the filter to be challenged by a 0.3 mm Sodium Chloride particle at a flow rate of 30 Liters per minute. The level of penetration is measured and the resulting efficiency reported as a percentage (e.g., if a filter has a penetration rate of 0.5%, the filter’s performance will be recorded as 99.5% efficient).
- This test allows a direct comparison of how individual filters perform. Under this system, a filter must be more than 99.97% efficient to classified as a HEPA filter. All of the Air Safety pleated filters are individually tested during manufacture to confirm that they are HEPA performance. Airflow Resistance
- the droplet capturing filter exhibits an airflow resistance of less than about 1.5 cm bbO/L/sec at flow rates of at least about 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 1.0, less than about 0.9, less than about 0.8, less than about 0.7, less than about 0.6, less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, less than about 0.1 cm LLO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 1.0 cm bbO/L/sec at flow rates of 14 L/sec.
- the droplet capturing filter exhibits an airflow resistance of less than about 0.9 cm FbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.8 cm FbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.7 cm FbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.6 cm LbO/L/sec at flow rates of 14 L/sec.
- the droplet capturing filter exhibits an airflow resistance of less than about 0.5 cm bbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.4 cm LbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.3 cm bbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.2 cm bbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.1 cm bbO/L/sec at flow rates of 14 L/sec.
- the droplet capturing filter exhibits an airflow resistance of at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, or at least about 90% less than an N95 respirator.
- the droplet capturing filter exhibits an airflow resistance of at least about 10% less than an N95 respirator.
- the droplet capturing filter exhibits an airflow resistance of at least about 15% less than an N95 respirator.
- the droplet capturing filter exhibits an airflow resistance of at least about 20% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 25% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 30% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 40% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 45% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 50% less than an N95 respirator.
- the droplet capturing filter exhibits an airflow resistance of at least about 55% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 60% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 65% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 70% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 80% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 85% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 90% less than an N95 respirator.
- airflow resistance is standard practice in the art, and can be measured by any common technique known to a person of ordinary skill in the art.
- airflow resistance may be measured by connecting a negative pressure source to a mask or respirator body comprising the droplet capturing filter and inducing a flow of air through the droplet capturing filter.
- the negative pressure source may comprise a vacuum source or a breathing simulator.
- the mask and/or the respirator body may be configured to receive a filter without using a cap to secure the filter 104 to the mask, respirator body 102, or cover plate 208.
- the droplet capturing filters 104 described herein may be secured and/or affixed to the mask, respirator body 102, or cover plate 208 without using a cap or lid as described above.
- the droplet capturing filters 104 described herein may be releasably coupled to the mask, respirator body 102, or cover plate 208 using one or more cartridges 224.
- the one or more cartridges may be configured to receive one or more filters and to releasably couple to the mask, respirator body, or cover plate.
- the one or more cartridges may be configured to permit airflow through a filter provided within the one or more cartridges.
- the one or more cartridges may permit a subject to breathe filtered or sanitized ambient air that passes one or more droplet capturing filters provided within the one or more cartridges.
- the cartridges 224 may be releasably coupled to the mask, respirator body, or cover plate using a coupling mechanism.
- the coupling mechanism may comprise, for example, one or more hooks, clamps, clips, straps, spring-loaded tabs, elastic bands, magnets, bracket, or holders.
- the coupling mechanisms may comprise, for example, snap-fits, fasteners, cradles, frames, interlocking elements, mating elements, ropes, suction cups, and the like.
- the mating elements may comprise a male and a female threaded portion that may be coupled together using a twisting motion.
- the coupling mechanism may comprise a quick release coupling mechanism.
- the quick release coupling mechanism may enable a user to rapidly mechanically couple and/or decouple a plurality of components with a short sequence of simple motions (e.g., rotating or twisting motions; sliding motions; pulling a lever; depressing a button, switch, or plunger; squeezing a tab, etc.).
- a quick release coupling mechanism may require no more than one, two, three, or four motions to perform a coupling and/or decoupling action.
- a quick release coupling mechanism can be coupled and/or decoupled manually by a user without the use of tools.
- the quick release coupling mechanism may enable a user to couple and/or decouple the cartridges to the mask, respirator body, or cover plate within a predetermined period of time.
- the predetermined period of time may be at most about 1 minute, 55 seconds, 50 seconds, 45 seconds, 40 seconds, 35 seconds, 30 seconds, 25 seconds, 20 seconds, 15 seconds, 10 seconds, 5 seconds, 4 seconds, 3 seconds, 2 seconds, 1 second, or less.
- the cartridge is releasably coupled with the facepiece body by a screw on mechanism.
- the filter disc may be placed within and encapsulated by a body of the cartridge.
- the cartridge may be attached directly to the face piece and may not or need not require a cap or lid to secure the filter to the face piece.
- the filter may be replaced with another filter. In such cases, the cartridge may be reusable with the newly replaced filter.
- the cartridge can be a single component, and the filter is not removable from the cartridge.
- the cartridge may be a disposable product.
- the cartridge may be decontaminated or sanitized after use and before re-use.
- the cartridges can provide several benefits.
- the cartridges can provide a common interface geometry between the filter and the face piece (e.g., respirator body). Filters of different sizes, shapes, and/or specifications can be used in a compatible manner with the face piece or respirator body without having to use different types of cartridges and without having to change the geometry (e.g., size and/or shape) of the cartridges.
- the respirator body or any other component of the masks described herein may be fabricated using one or more additive manufacturing techniques, such as one or more three- dimensional (3D) printing techniques.
- Additive manufacturing techniques may include vat photopolymerization, powder bed fusion, material extrusion, material jetting, binder jetting, and/or direct energy deposition.
- Additive manufacturing techniques may include one or more three-dimensional (3D) printing techniques.
- a 3D printing technique may include direct light processing (DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
- DLP direct light processing
- CDLP continuous direct light processing
- SLA stereolithography
- FDM fused deposition modeling
- FFF fused filament fabrication
- SLS selective laser sintering
- MJ material jetting
- NPJ nanoparticle jetting
- DOD drop on demand
- binder jetting direct metal laser sintering
- DMLS selective laser melting
- EBM electron beam melting
- MJF multi jet fusion
- DED direct energy de
- the respiratory body may be fabricated to have a size and/or a shape that is compatible with and that conforms with one or more headforms defined by the NIOSH (National Institute for Occupational Safety and Health).
- the one or more headforms defined by the NIOSH may correspond to headforms generated based on anthropometric modeling and surface scans of the heads of current U.S. respirator users.
- the respirator body may be sized and/or shaped to accommodate the head and face measurements associated with the NIOSH headforms.
- the NIOSH headforms may comprise at least five distinct types of headforms (e.g., small, medium, large, long/narrow, and short/wide).
- the NIOSH headforms are symmetric and represent the facial size and shape distribution of current U.S.
- the mask and the respirator body can be shaped to accommodate a range of face sizes, face shapes, face contours, and face feature dimensions to provide improved face-fitting characteristics.
- the masks and respirator bodies of the present disclosure may be sized and/or shaped in accordance with the NIOSH headforms described above.
- the masks and respirator bodies of the present disclosure may be sized and/or shaped based on manual measurements or 3D scans of a user’s head or face.
- the mask and respirator body may be sized and/or shaped to accommodate a variety of head sizes and shapes.
- the mask and respiratory body may be configured to accommodate a bigonial breadth between about 90 mm and about 160 mm, a bitragi on chin arc between about 271 mm and about 393 mm, a bitragi on coronal arc between about 310 mm and about 405 mm, a bitragion frontal arc between about 263 mm and about 349 mm, a bitragion subnasale arc between about 253 mm and about 345 mm, a bizygomatic breadth between about 120 mm and about 170 mm, a head breadth between about 135 mm and about 129 mm, a head circumference between about 520 mm and about 639 mm, a head length between about 174 mm and about 225 mm, an interpupillary distance between about 53 mm and about 79 mm, a lip length between
- the mask and respirator body may be sized and/or shaped to accommodate a variety of head sizes and shapes.
- the mask and respiratory body may be configured to accommodate a bigonial breadth between about 88 mm and about 150 mm, a bitragi on chin arc between about 248 mm and about 375 mm, a bitragi on coronal arc between about 290 mm and about 425 mm, a bitragion frontal arc between about 250 mm and about 330 mm, a bitragion subnasale arc between about 238 mm and about 335 mm, a bizygomatic breadth between about 115 mm and about 157 mm, a head breadth between about 129 mm and about 165 mm, a head circumference between about 475 mm and about 654 mm, a head length between about 152 mm and about 215 mm, an interpupillary distance between about 52 mm and about 78 mm, a lip length
- a mask for use in preventing the spread of microorganisms through airborne transmission comprising: a. a respirator body comprising at least two ports capable of accepting a droplet capturing filter and providing a flexibly sealed interface around a subject’s nostrils and mouth; and b. a droplet capturing filter that exhibits an airflow resistance of less than about 1.5 cm fhO/L/sec at flow rates of at least about 14 L/sec.
- said droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
- said droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- said droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- respirator body comprises at least two ports capable of accepting a droplet capturing filter.
- respirator body is fabricated such that it has a size, shape, or both a size and shape that conforms to at least one defined headform.
- said 3D printing technique is direct light processing (DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
- DLP direct light processing
- CDLP continuous direct light processing
- SLA stereolithography
- FDM fused deposition modeling
- FFF fused filament fabrication
- SLS selective laser sintering
- MJ material jetting
- NPJ nanoparticle jetting
- DOD drop on demand
- binder jetting direct metal laser sintering
- DMLS selective laser melting
- EBM electron beam melting
- MJF electron beam melting
- DED direct energy deposition
- a mask for use in preventing the spread of microorganisms through airborne transmission comprising: a respirator body comprising at least one port capable of accepting a droplet capturing filter and providing a flexibly sealed interface around a subject’s nostrils and mouth; and a droplet capturing filter that exhibits an airflow resistance of less than an N95 respirator, wherein said droplet capturing filter exhibits at least about 85% of the microbial filtration efficiency of said N95 respirator.
- any one of embodiments 37-47 wherein said droplet capturing filter exhibits an airflow resistance of at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, or at least about 90% less than an N95 respirator.
- any one of embodiments 37-48 wherein said droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
- any one of embodiments 37-49, wherein said droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
- any one of embodiments 37-50 wherein said droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- 3D printing technique is direct light processing (DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
- DLP direct light processing
- CDLP continuous direct light processing
- SLA stereolithography
- FDM fused deposition modeling
- FFF fused filament fabrication
- SLS selective laser sintering
- MJ material jetting
- NPJ nanoparticle jetting
- DOD drop on demand
- binder jetting direct metal laser sintering
- DMLS selective laser melting
- EBM electron beam melting
- MJF multi jet fusion
- DED direct energy deposition
- a mask for use in preventing the spread of microorganisms through airborne transmission comprising: a. a respirator body comprising at least two ports capable of accepting a droplet capturing filter; and b. a droplet capturing filter that comprises, consists of, or consists essentially of a non-woven synthetic fiber.
- any one of embodiments 74-84 wherein said droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
- respirator body is configured to receive at least one cartridge that comprises said droplet capturing filter.
- 3D printing technique is direct light processing (DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
- DLP direct light processing
- CDLP continuous direct light processing
- SLA stereolithography
- FDM fused deposition modeling
- FFF fused filament fabrication
- SLS selective laser sintering
- MJ material jetting
- NPJ nanoparticle jetting
- DOD drop on demand
- binder jetting direct metal laser sintering
- DMLS selective laser melting
- EBM electron beam melting
- MJF multi jet fusion
- DED direct energy deposition
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Abstract
The current disclosure provides, inter alia, respirators with decreased airflow resistance. Respirators described herein are particularly useful for use by subjects infected with respiratory pathogens (e.g., viruses) to both prevent the spread of the pathogen through respiratory droplets and also to not make it more difficult for the infected subject to breathe. Further provided herein are face masks having a modular design that allows the use of different types of filters of different sizes and/or shapes for different purposes. Further provided herein are head harnesses that are easier to adjust and more comfortable to wear for a prolonged time.
Description
RESPIRATION APPARATUS AND METHODS OF USE THEREOF
CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No. 63/001,303, filed
March 28, 2020, which is incorporated herein by reference in its entirety.
BACKGROUND
[0002] Numerous respiratory pathogens, including viruses (e.g., severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), measles virus, varicella-zoster virus, adenovirus, influenza virus (e.g., H1N1), rhinovirus), and bacteria (e.g., Mycobacterium tuberculosis, Bordetella pertussis) are transmitted from an infected subject to an uninfected subject in particle droplets. These particle droplets containing respiratory pathogens are generated when an infected person, for example, coughs or sneezes. The particle droplets can range in size with large particles (e.g., greater than 10 microns in diameter) generally remaining airborne for shorter periods of time than small droplets (e.g., less than 10 microns in diameter). The particle droplets assist in the transmission of the pathogen to another subject by, e.g., inhalation through the nose or mouth, or through the conjunctiva or nasal mucosa. Current standard protocols require or suggest that special respirators be worn by health care providers and infected subjects to avoid this airborne transmission. Current respirators include fine particle/vapor filter respirators, such as negative air respirators and N95 respirators. However, these respirators greatly increase breathing resistance (both oral and nasal) making them unsuitable to be worn by numerous populations. For example, many individuals infected with a respiratory pathogen (the very individuals for which the respirators are indicated for use) may be unable to wear these respirators, as the infection commonly causes respiratory difficulty.
SUMMARY
[0003] A great need exists for respirators that do not create undue airflow resistance that would make it more difficult for the subject to breath. There is also a great need for masks with modular design that allows use of filters of different sizes and/or shapes for different purposes. Another need exists for head harnesses that are easier to adjust and more comfortable to wear for a prolonged time. This disclosure provides respirators that meet these needs.
[0004] In one aspect, a mask for use in preventing the spread of microorganisms through airborne transmission is provided, comprising: a) a respirator body comprising at least two ports capable of accepting a droplet capturing filter and providing a flexibly sealed interface around a subject’s
nostrils and mouth; and b) a droplet capturing filter that exhibits an airflow resistance of less than about 1.5 cm FbO/L/sec at flow rates of at least about 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 1.0, less than about 0.9, less than about 0.8, less than about 0.7, less than about 0.6, less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, or less than about 0.1 cm FbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter comprises a filter standard in the use of pulmonary function testing. In some embodiments, the droplet capturing filter comprises a non-woven synthetic fiber. In some embodiments, the droplet capturing filter comprises polypropylene. In some embodiments, the droplet capturing filter comprises electrostatically-charged polypropylene. In some embodiments, the droplet capturing filter comprises polyester. In some embodiments, the droplet capturing filter comprises electrostatically-charged polyester. In some embodiments, the droplet capturing filter comprises nylon. In some embodiments, the droplet capturing filter comprises electrostatically-charged nylon. In some embodiments, the droplet capturing filter is hydrophobic. In some embodiments, the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency. In some embodiments, the droplet capturing filter is disposable. In some embodiments, the mask further comprises a droplet capturing filter cap. In some embodiments, the droplet capturing filter cap is reusable. In some embodiments, the droplet capturing filter cap is locking. In some embodiments, the droplet capturing filter cap secures the droplet capturing filter and seals the droplet capturing filter to the respirator body. In some embodiments, the mask further comprises a seal energizer. In some embodiments, the mask further comprises a seal energizer positioned between the droplet capturing filter and the droplet capturing
filter cap. In some embodiments, the seal energizer is reusable. In some embodiments, the respirator body comprises at least two ports capable of accepting a droplet capturing filter. In some embodiments, the mask comprises at least two droplet capturing filters. In some embodiments, the two droplet capturing filters are the same. In some embodiments, the two droplet capturing filters are different. In some embodiments, the respirator body is configured to receive a droplet capturing filter without a droplet capturing filter cap to secure the droplet capturing filter to the respirator body. In some embodiments, the respirator body is configured to receive at least one cartridge that comprises the droplet capturing filter. In some embodiments, the at least one cartridge is disposable. In some embodiments, the at least one cartridge is releasably coupled to the respirator body. In some embodiments, the respirator body is fabricated such that it has a size, shape, or both a size and shape that conforms to at least one defined headform. In some embodiments, the respirator body is fabricated using an additive manufacturing technique. In some embodiments, the additive manufacturing technique is vat photopolymerization, powder bed fusion, material extrusion, material jetting, binder jetting, and/or direct energy deposition. In some embodiments, the additive manufacturing technique is a 3D printing technique. In some embodiments, the 3D printing technique is direct light processing (DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
[0005] In another aspect, a mask for use in preventing the spread of microorganisms through airborne transmission is provided, comprising: a respirator body comprising at least one port capable of accepting a droplet capturing filter and providing a flexibly sealed interface around a subject’s nostrils and mouth; and a droplet capturing filter that exhibits an airflow resistance of less than an N95 respirator, wherein the droplet capturing filter exhibits at least about 85% of the microbial filtration efficiency of the N95 respirator. In some embodiments, the droplet capturing filter exhibits at least about 90%, at least about 91%, at least about 92%, at least about 93%, at least about 94%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 100%, at least about 105%, or at least about 110% of the microbial filtration efficiency of the N95 respirator. In some embodiments, the droplet capturing filter comprises a filter standard in the use of pulmonary function testing. In some embodiments, the droplet capturing filter comprises a non-woven synthetic fiber. In some embodiments, the droplet capturing filter comprises polypropylene. In some embodiments, the droplet capturing filter
comprises electrostatically-charged polypropylene. In some embodiments, the droplet capturing filter comprises polyester. In some embodiments, the droplet capturing filter comprises electrostatically-charged polyester. In some embodiments, the droplet capturing filter comprises nylon. In some embodiments, the droplet capturing filter comprises electrostatically-charged nylon. In some embodiments, the droplet capturing filter is hydrophobic. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, or at least about 90% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency. In some embodiments, the droplet capturing filter is disposable. In some embodiments, the mask further comprises a droplet capturing filter cap. In some embodiments, the droplet capturing filter cap is reusable. In some embodiments, the droplet capturing filter cap is locking. In some embodiments, the droplet capturing filter cap secures the droplet capturing filter and seals the droplet capturing filter to the respirator body. In some embodiments, the mask further comprises a seal energizer. In some embodiments, the mask further comprises a seal energizer positioned between the droplet capturing filter and the droplet capturing filter cap. In some embodiments, the seal energizer is reusable. In some embodiments, the respirator body comprises at least two ports each capable of accepting a droplet capturing filter. In some embodiments, the mask comprises at least two droplet capturing filters. In some embodiments, the two droplet capturing filters are the same. In some embodiments, the two
droplet capturing filters are different. In some embodiments, the respirator body is configured to receive a droplet capturing filter without a droplet capturing filter cap to secure the droplet capturing filter to the respirator body. In some embodiments, the respirator body is configured to receive at least one cartridge that comprises the droplet capturing filter. In some embodiments, the at least one cartridge is disposable. In some embodiments, the at least one cartridge is releasably coupled to the respirator body. In some embodiments, the respirator body is fabricated such that it has a size, shape, or both a size and shape that conforms to at least one defined headform. In some embodiments, the respirator body is fabricated using an additive manufacturing technique. In some embodiments, the additive manufacturing technique is vat photopolymerization, powder bed fusion, material extrusion, material jetting, binder jetting, and/or direct energy deposition. In some embodiments, the additive manufacturing technique is a 3D printing technique. In some embodiments, the 3D printing technique is direct light processing (DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
[0006] In another aspect, a mask for use in preventing the spread of microorganisms through airborne transmission is provided, comprising: a) a respirator body comprising at least two ports capable of accepting a droplet capturing filter; and b) a droplet capturing filter that comprises, consists of, or consists essentially of a non-woven synthetic fiber. In some embodiments, the droplet capturing filter comprises a filter standard in the use of pulmonary function testing. In some embodiments, the droplet capturing filter comprises polypropylene. In some embodiments, the droplet capturing filter comprises electrostatically-charged polypropylene. In some embodiments, the droplet capturing filter comprises polyester. In some embodiments, the droplet capturing filter comprises electrostatically-charged polyester. In some embodiments, the droplet capturing filter comprises nylon. In some embodiments, the droplet capturing filter comprises electrostatically-charged nylon. In some embodiments, the droplet capturing filter is hydrophobic. In some embodiments, the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least
about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 1.5, less than about 1.0, less than about 0.9, less than about 0.8, less than about 0.7, less than about 0.6, less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, or less than about 0.1 cm fhO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter is disposable. In some embodiments, the mask further comprises a droplet capturing filter cap. In some embodiments, the droplet capturing filter cap is reusable. In some embodiments, the droplet capturing filter cap is locking. In some embodiments, the droplet capturing filter cap secures the droplet capturing filter and seals the droplet capturing filter to the respirator body. In some embodiments, the mask further comprises a seal energizer. In some embodiments, the mask further comprises a seal energizer positioned between the droplet capturing filter and the droplet capturing filter cap. In some embodiments, the seal energizer is reusable. In some embodiments, the respirator body comprises at least two ports each capable of accepting a droplet capturing filter. In some embodiments, the mask comprises at least two droplet capturing filters. In some embodiments, the two droplet capturing filters are the same. In some embodiments, the two droplet capturing filters are different. In some embodiments, the respirator body is configured to receive a droplet capturing filter without a droplet capturing filter cap to secure the droplet capturing filter to the respirator body. In some embodiments, the respirator body is configured to receive at least one cartridge that comprises the droplet capturing filter. In some embodiments, the at least one cartridge is disposable. In some embodiments, the at least one cartridge is releasably coupled to the respirator body. In some embodiments, the respirator body is fabricated such that it has a size, shape, or both a size and shape that conforms to at least one defined headform. In some embodiments, the respirator body is fabricated using an additive manufacturing technique. In some embodiments, the additive manufacturing technique is vat photopolymerization, powder bed fusion, material extrusion, material jetting, binder jetting, and/or direct energy deposition. In some embodiments, the additive manufacturing technique is a 3D printing technique. In some embodiments, the 3D printing technique is direct light processing
(DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
[0007] In another aspect, a mask for use in preventing the spread of microorganisms through airborne transmission is provided, comprising (a) a facepiece body comprising at least one opening capable of accepting a cover plate; (b) the cover plate configured to accept at least one droplet capturing filter of various sizes; and (c) the at least one droplet capturing filter. In some embodiments, the cover plate is releasably coupled with the facepiece body. In some embodiments, the cover plate comprises at least one plate opening that allows air passage. In some embodiments, the mask further comprises a filter cap. In some embodiments, the filter cap is releasably coupled with the facepiece body. In some embodiments, the filter cap comprises at least one cap opening that allows air passage. In some embodiments, the filter cap and the cover plate can be releasably assembled to form a confined space. In some embodiments, the at least one droplet capturing filter is positioned in the confined space between the cover plate and the filter cap. In some embodiments, the at least one droplet capturing filter is fixed on at least one filter cartridge. In some embodiments, the at least one filter cartridge is releasably coupled with the facepiece body by a screw on mechanism. In some embodiments, the facepiece body comprises a rigid body surrounding the at least one opening of the facepiece body. In some embodiments, the facepiece body comprises a flexible body that is molded to fit and seal upon a face of a user. In some embodiments, the flexible body is over-molded onto the rigid body. In some embodiments, the flexible body comprises silicone. In some embodiments, the cover plate is capable of snapping into and sealing the facepiece body. In some embodiments, the filter cap comprises a hinge and the facepiece body comprises a matching base for the hinge, wherein the hinge and the matching base allow the filter cap to be releasably coupled with the facepiece body. In some embodiments, the hinge is a snap-in hinge. In some embodiments, the filter cap comprises an inner surface, wherein the inner surface comprises at least one smooth surface. In some embodiments, the filter cap comprises an edge seal positioned on at least one portion of the inner surface, wherein the edge seal secures and seals the droplet capturing filter with the cover plate or the facepiece body. In some embodiments, the facepiece body comprises at least two the openings capable of accepting the cover plate. In some embodiments, the at least one opening of the facepiece body has a size of from about 8 to about 14 square inches. In some embodiments, the at least one
opening of the facepiece body has a size of from about 10 to about 12 square inches. In some embodiments, the at least one opening of the facepiece body has a size of about 11 square inches. In some embodiments, the at least one opening of the facepiece body has a shape of circular, oval, oblong, square, or rectangle. In some embodiments, the cover plate has a size of from about 100% to about 120% of the size of said at least one opening of said facepiece body. In some embodiments, the cover plate has a size of from about 105% to about 115% of the size of said at least one opening of said facepiece body. In some embodiments, the cover plate has a size of about 110% of the size of said at least one opening of said facepiece body. In some embodiments, the plate opening has a size of about 95%, about 90%, about 80%, about 70%, about 60%, about 50%, about 40%, about 30%, about 20%, about 10%, or about 5% of the size of the cover plate. In some embodiments, the filter cap has a size of from about 100% to about 120% of the size of said at least one opening of said facepiece body. In some embodiments, the filter cap has a size of from about 105% to about 115% of the size of said at least one opening of said facepiece body. In some embodiments, the filter cap has a size of about 110% of the size of said at least one opening of said facepiece body. In some embodiments, the cap opening has a size of about 95%, about 90%, about 80%, about 70%, about 60%, about 50%, about 40%, about 30%, about 20%, about 10%, or about 5% of the size of the filter cap. In some embodiments, at least one side of the filter cap is attached to a harness. In some embodiments, the filter cap comprises at least two prongs, wherein each of the at least two prongs is extended from the at least one side of the filter cap, wherein the at least two prongs are capable of receiving a harness. In some embodiments, the at least one side comprises two nonadjacent sides. In some embodiments, the mask further comprises an exhalation valve. In some embodiments, the at least one droplet capturing filter exhibits an airflow resistance of less than about 1.5 cm FbO/L/sec at flow rates of at least about 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 1.0, less than about 0.9, less than about 0.8, less than about 0.7, less than about 0.6, less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, or less than about 0.1 cm HiO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter comprises a filter standard in the use of pulmonary function testing. In some embodiments, the droplet capturing filter comprises a non-woven synthetic fiber. In some embodiments, the droplet capturing filter comprises polypropylene. In some embodiments, the droplet capturing filter comprises electrostatically-charged polypropylene. In some embodiments, the droplet capturing filter comprises polyester. In some embodiments, the droplet capturing filter comprises electrostatically-charged polyester. In some embodiments, the droplet capturing filter comprises nylon. In some embodiments, the droplet capturing filter comprises electrostatically-charged
nylon. In some embodiments, the droplet capturing filter is hydrophobic. In some embodiments, the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency. In some embodiments, the droplet capturing filter is disposable. In some embodiments, the droplet capturing filter comprises pre-printed pattern or color.
[0008] In other aspects, a harness for securing a mask to a head of a user is provided, comprising (a) a head strap capable of positioning and securing the mask to the head of the user; (b) a first adjustable mechanism that is capable to adjust the position and length of the head strap; (c) at least one second strap that is connected to the head strap; and (d) at least one second adjustable mechanism connecting the second strap to the head strap; wherein the at least one second adjustable mechanism is located on at least one end of the head strap. In some embodiments, the first adjustable mechanism comprises a ladder-type buckle. In some embodiments, the at least one second adjustable mechanism is a latching mechanism. In some embodiments, the harness comprises two the second straps. In some embodiments, the harness comprises two the second adjustable mechanisms, wherein each of the second adjustable mechanism is located on each end of the head strap. In some embodiments, the head strap comprises a flexible material. In some embodiments, the flexible material comprises silicone. In some embodiments, the flexible material comprises a low durometer, injection moldable, thermoplastic elastomer. In some embodiments, the at least one second strap comprises an elastic material. In some embodiments, the elastic material is rubber. In some embodiments, the at least one second strap is made from a bungee cord.
[0009] In other aspects, a mask for use in preventing the spread of microorganisms through airborne transmission, comprising the harness disclosed herein.
BRIEF DESCRIPTION OF THE DRAWINGS [0010] The novel features of the disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which.
[0011] FIG. 1A shows a non-limiting example of a front view of an exemplary mask according to various embodiments described herein. In this example, there are two disposable droplet capturing filters (e.g., one on the left and one on the right), and each droplet capturing filter is secured in place with a reusable filter cap.
[0012] FIG. IB shows a non-limiting example of a front angled view of an exemplary mask according to various embodiments described herein. In this example, there are two disposable droplet capturing filters (e.g., one on the left and one on the right), and each droplet capturing filter is secured in place with a reusable filter cap.
[0013] FIG. 1C shows a non-limiting example of a back view of an exemplary mask according to various embodiments described herein. In this example, there are two disposable droplet capturing filters (e.g., one on the left and one on the right) and each droplet capturing filter is secured in place with a reusable filter cap.
[0014] FIG. ID shows a non-limiting example of a front exploded view of an exemplary mask according to various embodiments as described herein. In this example, there are two disposable droplet capturing filters (e.g., one on the left and one on the right), each droplet capturing filter is secured in place with a reusable filter cap, and the respirator body comprises two filter ports, each capable of receiving a filter and securing a filter cap.
[0015] FIG. IE shows a non-limiting example of a front angled exploded view of an exemplary mask according to various embodiments as described herein. In this example, there are two disposable droplet capturing filters (e.g., one on the left and one on the right), each droplet capturing filter is secured in place with a reusable filter cap, and the respirator body comprises two filter ports, each capable of receiving a filter and securing a filter cap.
[0016] FIG. IF shows a non-limiting example of a back exploded view of an exemplary mask according to various embodiments as described herein. In this example, there are two disposable droplet capturing filters (e.g., one on the left and one on the right), each droplet capturing filter is
secured in place with a reusable filter cap, and the respirator body comprises two filter ports, each capable of receiving a filter and securing a filter cap.
[0017] FIG. 2A shows a non-limiting example of a front view of an exemplary mask according to various embodiments as described herein. In this example, the mask comprises a respirator body, two disposable filter elements (e.g., one on the left and one on the right), an optional cap- to-filter seal energizer element (e.g., one on the left and one on the right), and a reusable locking filter cap element (e.g., one on the left one on the right) that secure the filter and seal it to the respirator body.
[0018] FIG. 2B shows a non-limiting example of a front exploded view of an exemplary mask according to various embodiments as described herein. The image shows the filter elements separated from the respirator body. The image shows the respirator body, disposable filter element (e.g., two - one on the left and one on the right), an optional cap-to-filter seal energizer element (e.g., two - one on the left and one on the right), and a reusable locking filter cap element (e.g., one on the left one on the right) that secure the filter and seal it to the respirator body.
[0019] FIG. 2C shows a non-limiting example of a front angled exploded view of an exemplary mask according to various embodiments as described herein. The image shows the filter elements separated from the respirator body. The image shows the respirator body, disposable filter element (e.g., two - one on the left and one on the right), an optional cap-to-filter seal energizer element (e.g., two - one on the left and one on the right), and a reusable locking filter cap element (e.g., one on the left one on the right) that secure the filter and seal it to the respirator body.
[0020] FIG. 3A shows a non-limiting example of a front angled exploded view of an exemplary mask according to various embodiments as described herein. The image shows the facepiece body, the cover plate, the droplet capturing filter(s), and the filter cap.
[0021] FIG. 3B shows a non-limiting example of a front view of an exemplary mask according to various embodiments as described herein. The image shows the facepiece body, the cover plate, the droplet capturing filter, and the filter cap. The image shows the filter cap that is releasably coupled with the facepiece body by a hinge.
[0022] FIG. 3C shows a non-limiting example of a front angled exploded view of an exemplary mask according to various embodiments as described herein. The image shows the facepiece body, the cover plate, and the filter cartridge(s). In this example, the filter cap is not needed.
[0023] FIG. 4A shows a non-limiting example of components of an exemplary mask with an exemplary harness. The image shows a facepiece body, a droplet capturing filter, and a filter cap connected to the harness.
[0024] FIG. 4B shows a non-limiting example of the assembled front view of the exemplary mask with the exemplary harness in FIG. 4A.
[0025] FIG. 4C shows a non-limiting example of the assembled side view of the exemplary mask with the exemplary harness in FIG. 4A.
[0026] FIG. 5 shows a non-limiting example of the front view of the exemplary mask with the exemplary droplet-capturing filter with pre-printed color and/or pattern.
DETAILED DESCRIPTION
[0027] Numerous respiratory pathogens, including viruses (e.g., severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), measles virus, varicella-zoster virus, adenovirus, influenza virus (e.g., H1N1), rhinovirus, and bacteria (e.g., Mycobacterium tuberculosis, Bordetella pertussis) are transmitted from an infected subject to an uninfected subject in particle droplets. These particle droplets containing respiratory pathogens are generated when an infected person, for example, coughs or sneezes. The particle droplets can range in size with large particles (e.g., greater than 10 microns in diameter) generally remaining airborne for shorter periods of time than small droplets (e.g., less than 10 microns in diameter). The particle droplets assist in the transmission of the pathogen to another subject by, e.g., inhalation through the nose or mouth, or through the conjunctiva or nasal mucosa. Current standard protocols require or suggest that special respirators be worn by health care providers and infected subjects to avoid this airborne transmission. Current respirators include fine particle/vapor filter respirators, such as negative air respirators and N95 respirators. However, these respirators greatly increase breathing resistance (both oral and nasal) making them unsuitable to be worn by numerous populations. For example, many individuals infected with a respiratory pathogen (the very individuals for which the respirators are indicated for use) may be unable to wear these respirators, as the infection commonly causes respiratory difficulty. See e.g., Heow Pueh Lee, De Yun Wang, Objective Assessment of Increase in Breathing Resistance of N95 Respirators on Human Subjects, The Annals of Occupational Hygiene, Volume 55, Issue 8, October 2011, Pages 917-921, https://doi.org/10.1093/annhyg/mer065. Therefore, a great need exists for new respirators that do not create undue airflow resistance that would make it more difficult for the subject to breath. [0028] The present disclosure relates to a respirator that provides a high-level of protection for individuals from respiratory-based pathogen transmission by continuously and effectively capturing the exhaled/expelled droplets from an individual’s breath, without making it more difficult for the individual to breathe. The capture mechanism provides protection when transmittable respiratory pathogens (e.g., viruses (e.g., severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2), measles virus, varicella-zoster virus, adenovirus, influenza virus (e.g., H1N1), rhinovirus), and bacteria (e.g., Mycobacterium tuberculosis, Bordetella pertussis) are enveloped in these droplets (e.g., capturing the droplets effectively captures the pathogen). Importantly, the respirators described herein contain high efficiency, disposable filter cartridges/media that are designed to continuously capture exhaled droplets contained in the airstream of a human breath without creating undue airflow resistance that would make it more difficult for a person to breathe. This may be particularly important because individuals suffering from respiratory issues, such as those caused by respiratory pathogens (e.g., SARS-CoV-2) most often already have difficulty breathing, and a high resistance filter would only exacerbate that issue or make it impossible for the individual to breathe at all with the respirator, thus defeating the purpose of the respirator altogether. Furthermore, the respirators described herein can be manufactured at large scale within days, as is normally needed during outbreaks of respiratory pathogens. The present disclosure also relates to a mask having a modular design which enhances comfort, safety, convenience of use and efficiency. The modular design allows the use of filters of different sizes and/or shapes for different purposes. With the modular design, the mask can be assembled and disassembled by a user. It is easy for the user to replace filters and to clean the components of the mask. The present disclosure further relates to a head harness that is easier to adjust and more comfortable to wear for a prolonged time.
Definitions:
[0029] The term “respirator body” as used herein generally refers to an element that provides a flexibly sealed interface around an individual’s nostrils and mouth.
[0030] The term “resistance” as used herein generally refers to the amount of effort that is required to make an inspiratory or an expiratory breath.
[0031] The term “efficiency” as used herein generally refers to the level of filtration protection or function that a droplet capturing filter can deliver. The efficiency of the filter is normally expressed as a reflection of the number of microorganisms that pass through the filter media when it is challenged. This filter is then described as being X% efficient. The X% is an expression of the number of microorganisms penetrating the filter when challenged by an aerosol containing 1,000,000 microorganisms.
[0032] As used herein, the term “N95 Respirator” generally refers to a respiratory protective device with a filtration efficiency of at least 95% against non-oily, air-based particles when tested using the National Institute for Occupational Safety and Health (NIOSH) criteria.
[0033] The terms “airflow resistance” and “resistance to airflow” are used interchangeably herein, and generally refer to the resistance to airflow through a filter (e.g., a droplet-capturing filter as described herein).
[0034] The terms “about” and “approximately” as used herein, generally refer to a range that is 15% greater than or less than a stated numerical value within the context of the particular usage. For example, “about 10” or “approximately 10” would include a range from 8.5 to 11.5.
[0035] As used herein, the term “or” is used nonexclusively to encompass “or” and “and.” For example, “A or B” includes “A but not B,” “B but not A,” and “A and B”, unless otherwise indicated.
[0036] “A”, “an”, and “the”, as used herein, can include plural referents unless expressly and unequivocally limited to one referent.
[0037] As used herein, the term “over-molded” means that one component is molded over or onto another already formed part or component.
[0038] As used herein, the term “perimeter” means the peripheral portion of an object.
[0039] As used herein, the term “plain” refers to a filter comprising filter media without outer sheath or scrim.
Masks
[0040] In some aspects, described herein are masks that are for use by a subject. In some embodiments, the subject is a human. In some embodiments, the mask is intended for use by a human subject having or suspected of having a respiratory infection (e.g., an infection caused by a respiratory pathogen). In some embodiments, the mask is intended for use by a human subject who is in contact with or who may come into contact with another individual who has or is suspected of having a respiratory infection (e.g., to protect the mask wearer from infection with a respiratory pathogen). In some embodiments, the respiratory pathogen is a bacterium. Non limiting examples of bacteria that can cause respiratory infections include: a Group A beta- hemolytic streptococci (e.g., Streptococcus pyogenes ), Corynebacterium diphtheriae , Neisseria gonorrhoeae , Mycoplasma pneumoniae , Mycoplasma hominis (Type I), mixed anaerobes, Haemophilus influenzae , Streptococcus pneumoniae , Staphylococcus aureus , Klebsiella pneumoniae , Escherichia coli , Pseudomonas aeruginosa , Legionella spp ., Mycobacterium tuberculosis , Coxiella burnetii , Chlamydia psittaci , Chlamydia trachomatis , Chlamydia pneumoniae, and Bordetella pertussis. In some embodiments, the respiratory pathogen is a virus. Non-limiting examples of viruses that can cause respiratory infections include: coronaviruses (e.g., severe acute respiratory syndrome coronavirus (SARS-CoV), severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2), human coronavirus 299E (HCoV-299E), human coronavirus NL63 (HCoV-NL63), human coronavirus OC43 (HCoV-OC43), human coronavirus HKEG1 (HCoV-HKEil), and Middle East respiratory syndrome coronavirus (MERS-CoV)), rhinoviruses (e.g., rhinovirus A, rhinovirus B, rhinovirus C), parainfluenza viruses (e.g., human parainfluenza virus type 1, human parainfluenza virus type 2, human parainfluenza virus type 3, human parainfluenza virus type 4), adenoviruses (e.g., human adenovirus B, human adenovirus C), respiratory syncytial viruses, influenza viruses (e.g., influenza virus A, influenza virus B), coxsackieviruses (e.g., coxsackie A virus, coxsackie B virus), Epstein-Barr virus, cytomegalovirus, herpes simplex virus, varicella zoster virus, measles virus, and Hanta virus. In some embodiments, the respiratory pathogen is a fungus. Non-limiting examples of fungi that can cause respiratory infections include: Candida albicans , Histoplasma capsulatum , Blastomyces dermatitidis , Paracoccidioides brasiliensis , Coccidioides immitis , Filobasidiella neoformans , and Aspergillus fumigatus.
[0041] In some embodiments, the mask described herein may be used by a healthcare worker, a frontline worker, a first responder, etc. (or another individual) who is or is likely to be in contact (e.g., close contact) with an individual having or suspected of having a respiratory infection (e.g., as described herein). In some embodiments, the mask may reduce the risk of, or may prevent, the healthcare worker, the frontline worker, or the first responder (or other individual in contact with an infected individual) from being exposed to and/or becoming infected with the respiratory pathogen.
[0042] In some embodiments, a mask described herein comprises a respirator body (e.g., as described herein). In some embodiments, a mask described herein comprises a droplet-capturing filter (e.g., as described herein). In some embodiments, a mask described herein comprises a respirator body (e.g., as described herein) and a droplet-capturing filter (e.g., as described herein). [0043] In some embodiments, the mask is a quarter mask that covers the nose and mouth of an individual (e.g., a human), wherein the lower sealing surface rests between the chin and the mouth. In some embodiments, the mask is a half mask that covers the nose and mouth of an individual (e.g., a human) and fits under the chin. In some embodiments, the mask is a full facepiece that covers the entire face of an individual (e.g., a human) from below the chin to the hairline.
[0044] In some embodiments, the mask has a modular design that allows the use of filters of different sizes and/or shapes for different purposes. In some embodiments, the mask comprises a facepiece body comprising at least one opening capable of accepting a cover plate; the cover plate configured to accept at least one droplet capturing filter of various sizes and/or shapes; and the at least one droplet capturing filter. In some embodiments, the cover plate comprises at least one
plate opening that allows air passage. By adjusting the size of the cover plate and the size of the plate opening, the cover plate can accommodate differently types of filters with different sizes and/or shapes. In some embodiments, the filter is positioned in a filter cartridge. In some embodiments, the mask further comprises a filter cap. In some embodiments, the filter cap comprises at least one cap opening that allows air passage. In some embodiments, the filter cap and the cover plate can be releasably assembled to form a confined space where the filter can be positioned. By adjusting the size of the confined space, the mask can accommodate different types of filters with different sizes and/or shapes. The components of the mask having the modular design, including facepiece body, cover plate, and filter cap, will be discussed in detail below.
Respirator Bodies
[0045] In some aspects, described herein are respirator bodies. In some aspects, described herein are masks comprising a respirator body. As outlined above, the term “respirator body” as used herein generally refers to an element that provides a flexibly sealed interface around an individual’s nostrils and mouth.
[0046] Any respiratory body capable of being equipped with one or more ports (e.g., at least two ports) to accept a droplet-capturing filter (e.g., as described herein) and capable of creating a seal against the face (e.g., around the nose and mouth) may be used in the masks described herein. For example, the respiratory body may be made out of any material commonly used in the art. In some embodiments, the respirator body comprises at least one strap that goes around the head of the subject in order to keep the respirator body on the subject. The respirator can provide a high-level of protection from pathogen transmission by continuously and effectively capturing the exhaled/expelled droplets from an individual’s breath. The respirator may be configured to receive one or more droplet-capturing filters to filter out transmittable respiratory pathogens that are enveloped in the exhaled/expelled droplets. In some cases, capturing the droplets effectively captures the pathogen. The respirator may be compatible with high efficiency, disposable filter cartridges/media that are designed to continuously capture exhaled droplets contained in the airstream of a human breath without creating undue airflow resistance that would make it more difficult for an individual to breathe.
[0047] An exemplary respiratory body 102 is shown in FIGS. 1A-1F. The respiratory body 102 comprises two ports 108 capable of accepting a droplet capturing filter 104. The respiratory body 102 may be made from a flexible material that can provide a flexibly sealed interface around a subject’s nostrils and mouth. In some embodiments, the flexible material may be silicone or other soft thermoplastic elastomer that is comfortable against human facial skin (e.g., such as any known
in the art). Another exemplary respirator respiratory body 102 is shown in FIGS. 2A-2C. The respiratory body 102 comprises two ports 108 capable of accepting a droplet capturing filter 104. In some embodiments, at least one (e.g., at least two, three, four) straps (not shown) are added to the respirator body (e.g., as shown in FIGS. 1A-2C) to secure the respirator body to the face of a subject wearing a mask comprising the respirator body.
[0048] In some embodiments, the respirator body is equipped with at least one port to accept a droplet-capturing filter (e.g., as described herein). In some embodiments, the respirator body is equipped with at least two or three ports to accept a droplet capturing filter (e.g., as described herein).
[0049] In some embodiments, the respirator body comprises at least one port capable of accepting a droplet capturing filter. In some embodiments, the respirator body comprises at least two ports, each capable of accepting a droplet capturing filter. In some embodiments, the respirator body comprises at least three ports, each capable of accepting a droplet capturing filter. In some embodiments, the respirator body comprises at least four ports, each capable of accepting a droplet capturing filter. In some embodiments, the respirator body comprises at least five ports, each capable of accepting a droplet capturing filter.
[0050] In some embodiments, the respirator body is manufactured using a 3D printer. Any suitable 3D printer can be utilized. An exemplary 3D printer material is HP 3D HR PA12, which is a polyamide powder that is approved by the FDA for intact skin surface devices. Other materials and processes can be utilized to manufacture the respirator body, e.g., vacuum thermoforming or injection molding using appropriate biocompatible materials such as polypropylene.
Facepiece Bodies
[0051] In some aspects, described herein are facepiece bodies. In some aspects, described herein are masks comprising a facepiece body. As shown in FIGS. 3A-3C, in some embodiments, the facepiece body 202 comprises at least one opening 212 capable of accepting a cover plate 208. In some embodiments, the facepiece body comprises at least two openings 212 capable of accepting the cover plate(s). In some embodiments, the at least one opening 212 of the facepiece body 202 has a size of from about 6 to about 16 square inches. In some embodiments, the at least one opening 212 of the facepiece body 202 has a size of from about 8 to about 14 square inches. In some embodiments, the at least one opening 212 of the facepiece body 202 has a size of from about 9 to about 13 square inches. In some embodiments, the at least one opening 212 of the facepiece body 202 has a size of from about 10 to about 12 square inches. In some embodiments, the at least one opening 212 of the facepiece body 202 has a size of about 11 square inches. In
some embodiments, the at least one opening 202 is in the shape of an oval, a circle, an oblong, a square, a rectangle or any other shape. In some embodiments, the shape of the at least one opening 212 is oval. In some embodiments, the shape of the at least one opening 212 is circular. In some embodiments, the shape of the at least one opening 212 is square. In some embodiments, the shape of the at least one opening 212 is rectangular. In some embodiments, the facepiece body 202 comprises at least two openings 212 and each of the openings 212 has the same size. In some embodiments, each of the openings 212 has different sizes. In some embodiments, each of the openings 212 has the same shape. In some embodiments, each of the openings 212 has different shapes.
[0052] In some embodiments, the facepiece body 202 comprises a rigid body 206 surrounding the at least one opening 212. In some embodiments, the rigid body 206 comprises a rigid material. In some embodiments, the rigid material is polypropylene, polycarbonate, thermoplastic elastomer, or other suitable plastic resin. In some embodiments, the polypropylene is injection- molded polypropylene. In some embodiments, the thermoplastic elastomer is a thermoplastic elastomer of high durometer rating for rigidity. In some embodiments, the facepiece body 202 comprises a flexible body 204 that is molded to fit and seal upon a face of a user. In some embodiments, the flexible body 204 comprises soft, cushiony, elastomeric material. In some embodiments, the soft, cushiony, elastomeric material may be rubber-like material. In some embodiments, the rubber-like material is a thermoplastic rubber. In some embodiments, the thermoplastic rubber comprises polypropylene. In some embodiments, the soft, cushiony, elastomeric material may be silicone. In some embodiments, the soft, cushiony, elastomeric material may be gel. In some embodiments, the soft, cushiony, elastomeric material may be thermoplastic elastomer or other suitable plastic resin. In some embodiments, the thermoplastic elastomer is injection-molded thermoplastic elastomer. In some embodiments, the thermoplastic elastomer is a thermoplastic elastomer of low durometer rating for softness. In some embodiments, the soft, cushiony, elastomeric material is in a unitary piece. The flexibility of the soft, cushiony, elastomeric material allows the facepiece body 202 to conform to the user’s facial contours in a passive manner and form a seal with the user’s face. In some embodiments, the flexible body is over-molded onto the rigid body.
Cover Plates
[0053] In some aspects, described herein are cover plates. In some aspects, described herein are masks comprising a cover plate.
[0054] In some embodiments, the cover plate 208 is releasably coupled with the facepiece body 202. In some embodiments, the cover plate 208 is coupled with the facepiece body 202 by a snap- fit engagement mechanism. The cover plate 208 may be instantaneously snapped into engagement to the facepiece body 202 without rotational movement. In some embodiments, the cover plate 208 is pressed against the corresponding receiving structure on the facepiece body 202. The snap- fit engagement mechanism provides an extraordinarily easy and hygienic way for attaching a cover plate to the facepiece body. An audible noise may be provided to indicate a secure attachment. The cover plate 208 is capable of being removed quickly from the facepiece body 202 by pulling the cover plate in a direction opposite to which it was pressed onto the facepiece body 202 without rotational movement. In some embodiments, the cover plate 208 is capable of sealing the opening 212 of the facepiece body 202.
[0055] In some embodiments, the cover plate has a size of from about 100% to about 120% of the size of the at least one opening 212 of the facepiece body 202. In some embodiments, the cover plate has a size of from about 105% to about 115% of the size of the at least one opening 212 of the facepiece body 202. In some embodiments, the cover plate has a size of about 110% of the size of the at least one opening 212 of the facepiece body 202. In some embodiments, the cover plate may have a shape, such as, circular, oval, oblong, square, or rectangular. In some embodiments, the cover plate 208 has the same shape as the opening 212 of the facepiece body 202. In some embodiments, the cover plate 208 has the same size as the opening 212 of the facepiece body 202.
[0056] In some embodiments, the cover plate 208 comprises a plate opening 214 that allows air passage. In some embodiments, the cover plate 208 comprises at least two plate openings 214. In some embodiments, the plate opening 214 has a size that is about 95%, about 90%, about 80%, about 70%, about 60%, about 50%, about 40%, about 30%, about 20%, about 10%, or about 5% of the cover plate 208. The plate opening 214 may be in any shape known in the art.
Filter Caps
[0057] In some aspects, described herein are filter caps. In some aspects, described herein are masks comprising a filter cap.
[0058] In some embodiments, the filter cap 210 is releasably coupled with the facepiece body 202. In some embodiments, the cover plate 208 and the filter cap 210 can be releasably assembled to form a confined space where the droplet capturing filter 104 can be positioned. In some embodiments, the filter cap 210 has a size of from about 100% to about 120% of the size of the at least one opening 212 of said facepiece body 202. In some embodiments, the filter cap 210 has a
shape, such as, circular, oval, oblong, square, or rectangle. In some embodiments, the filter cap 210 has the same shape as the cover plate 208. In some embodiments, the filter cap 210 has the same shape as the opening 212 of the facepiece body 202. In some embodiments, the filter cap 210 has the same size as the cover plate 208. In some embodiments, the filter cap 210 has the same size as the opening 212 of the facepiece body 202.
[0059] In some embodiments, the filter cap 210 is coupled with the facepiece body 202 by a snap-fit engagement mechanism. The filter cap 210 may be instantaneously snapped into engagement to the facepiece body 202 without rotational movement. In some embodiments, the filter cap 210 is pressed against the corresponding receiving structure on the facepiece body 202. The snap-fit engagement mechanism provides an extraordinarily easy and hygienic way for attaching a filter cap 210 to the facepiece body. An audible noise may be provided to indicate a secure attachment. In some embodiments, the filter cap 210 comprises a hinge 218 and the facepiece body 202 comprises a matching base 219 for the hinge 218, wherein the hinge 218 and the matching base 219 allow the filter cap 210 to be releasably coupled with the facepiece body 202. In some embodiments, the hinge 218 is a snap-in hinge. The snap-in hinge provides an easy way for alignment, filter replacement, and decontamination. The filter cap 210 is capable of being removed quickly from the facepiece body 202 by pulling the filter cap 210 in a direction opposite to which it was pressed onto the facepiece body 202 without rotational movement. In some embodiments, the cover plate 208 is capable of sealing the opening 212 of the facepiece body 202 and/or the plate opening 214 of the cover plate 208.
[0060] In some embodiments, the filter cap 210 comprises an inner surface, wherein the inner surface comprises at least one smooth surface 222. The smooth surface eliminates crevices and thus minimizes bacterial growth potential on the mask. The smooth surface also provides an easy way for decontamination.
[0061] In some embodiments, the filter cap 210 comprises an edge seal (not shown) positioned on at least one portion of the inner surface, wherein the edge seal secures and seals the droplet capturing filter 104 with the cover plate 210 and/or the facepiece body 202. In some embodiments, the at least one portion of the inner surface is the perimeter of the filter cap 210. In some embodiments, the at least one portion of the inner surface is at least one portion of the perimeter of the filter cap 210. The edge seal is able to provide a secure and leak-free seal over the droplet capturing filter 104. In some embodiments, the edge seal latches to the periphery of the opening 212 of the facepiece body 202.
[0062] In some embodiments, the filter cap 210 comprises a cap opening 216 that allows air passage. In some embodiments, the filter cap 210 comprises at least two cap openings 216. In
some embodiments, the cap opening 216 has a size that is about 95%, about 90%, about 80%, about 70%, about 60%, about 50%, about 40%, about 30%, about 20%, about 10%, or about 5% of the size of the filter cap 210. The cap opening 216 may be in any shape known in the art. In some embodiments, the cover plate 208 or filter cap 210 is reusable.
[0063] In some embodiments, the filter cap 210 comprises at least one prong 220, wherein the prong 220 is extended from at least one side of the filter cap 210. In some embodiments, the filter cap 210 comprises at least two prongs 220, wherein each of the two prongs 220 is extended from at least one side of the filter cap 210, wherein the at least two prongs 220 are capable of receiving a harness 302. In some embodiments, the two prongs 220 are the same. In some embodiments, the two prongs 220 are extended from the same side of the filter cap 210. In some embodiments, the two prongs 220 are extended from two sides of the filter cap 210. In some embodiments, the two sides of the filter cap 210 are nonadjacent.
[0064] In some embodiments, the filter cap 210 is attached to a harness 302 that may be used to secure and position the mask to a head of a user. In some embodiments, the filter cap 210 is attached to the harness 302 through connecting the two prongs 220 of the filter cap 210 to both ends of the harness 302. In some embodiments, both ends of the harness 302 are connected to at least one side of the filter cap 210.
Harness
[0065] In some aspects, described herein are harnesses used to secure the mask to the head of the user. In some aspects, described herein are masks comprising a harness.
[0066] As shown in FIGS. 4A-4C, in some embodiments, the harness 302 comprises a head strap 304 capable of positioning and securing the mask to the head of the user; a first adjustable mechanism 306 that is configured to adjust the position and length of the head strap 304; at least one second strap 308 that is connected to the head strap 304; and at least one second adjustable mechanism 310 connecting the second strap 308 to the head strap 304; wherein the at least one second adjustable mechanism 310 is located on at least one end of the head strap 304.
[0067] In some embodiments, the head strap 304 is made of flexible material. In some embodiments, the flexible material comprises silicone. In some embodiments, the flexible material comprises flexible strapping material. In some embodiments, the flexible strapping material comprises cotton, nylon, polypropylene, or other fabrics. In some embodiments, the first adjustable mechanism 306 is located on the head strap 304. In some embodiments, the first adjustable mechanism 306 comprises a ladder-type buckle, a multiple ladder, or D-shaped buckle.
[0068] In some embodiments, at least one end of the head strap 304 is attached to at least one prong 220 of the filter cap 210. In some embodiments, each of the two ends of the head strap 304 is attached to each of the two prongs 220 of the filter cap 210. In some embodiments, the at least one end of the head strap 304 is attached to at least one prong 220 of the filter cap 210 by a snap- fit mechanism. In some embodiments, each of the two ends of the head strap 304 has a part of the snap-fit mechanism and each of the two prongs 220 of the filter cap 210 has a mating part of the snap-fit mechanism, wherein the end of the head strap 304 is capable of snapping into the prong 220 of the filter cap 210.
[0069] In some embodiments, the harness 302 comprises at least one second strap 308 connected to the head strap 304. In some embodiments, the harness 302 comprises two second straps 308 and each of the two second straps 308 is connected to the head strap 304. In some embodiments, the second strap 308 is connected to the head strap 304 by a second adjustable mechanism 310. In some embodiments, the second adjustable mechanism 310 is a latching mechanism. In some embodiments, the second adjustable mechanism 310 is located on the end of the head strap 304. Traditional ear loop straps of a mask keep the mask in place by putting a lot of pressure on the ears and aggravate the skin of the user. When face mask straps rub against ears, friction is created and can cause inflammation in the outer skin layer and blistering. By using the disclosed harness with the two second straps that are connected to the head strap, it is easier for a user to adjust the tightness and/or position of the mask as compared to the traditional mask. For example, by adjusting the position of the second straps by the second adjustable mechanism (e.g., the latching mechanism), the user can avoid placing the straps next to the ears and meanwhile secure the position of the mask to the head, making it comfortable to wear for a prolonged time. Moreover, by freeing the ears of the user, the user may be able to wear an additional face apparatus or face shield that may require using the ears. In some embodiments, both ends of each of the two second straps 308 are connected to the filter cap 210. In some embodiments, each end of the head strap 304 is connected to one of the two second straps 308 by the second adjustable mechanism(s) 310. In some embodiments, the ends of the two second straps 308 are connected to the filter cap 210. In some embodiments, the ends of the two second straps 308 are connected to the filter cap 210 by a snap-fit mechanism. In some embodiments, the two second straps 308 are connected to the filter cap 210 by connecting a first component that is located at the end of the second strap 308 with a matching component that is located on at least one side of the filter cap 210, wherein the first component matches and secures the matching component. In some embodiments, the first component is a knot and the matching component is a keyhole shaped opening. In some embodiments, the end of the second strap 308 is directly molded into the filter cap 210. In some
embodiments, the second strap 308 comprises an elastic material. In some embodiments, the elastic material is rubber. In some embodiments, the second strap 308 is made from bungee cords.
Droplet Capturing Filter
[0070] In some aspects, described herein are droplet capturing filters 104. In some aspects, described herein are masks comprising droplet capturing filters. In some embodiments, the droplet capturing filter is disposable. In some embodiments, as shown in FIG. 5, the droplet capturing filter comprises pre-printed pattern or color. The pre-printed pattern may be logos, cartoon drawings, or other pictures. The pre-printed color may be any color. The pre-printed pattern or color may make the mask look friendly or pleasant (e.g., to a child).
[0071] In some embodiments, a droplet capturing filter is any filter that is standardly used in pulmonary function testing (e.g., spirometry, plethysmography, etc.).
[0072] In some embodiments, the droplet capturing filter is plain. In some embodiments, the droplet capturing filter comprises a filter media that is backed by at least one scrim layer. In some embodiments, the droplet capturing filter comprises the filter media that is sandwiched by at least two scrim layers. In some embodiments, the droplet capturing filter is a flat filter media (with accompanying support/security elements). In some embodiments, the droplet capturing filter is in a shape of an oval, a circle, an oblong, a rectangle, a square, or other suitable shapes. In some embodiments, the droplet capturing filter has a size of from about 8 to about 14 square inches. In some embodiments, the droplet capturing filter has a size of from about 9 to about 13 square inches. In some embodiments, the droplet capturing filter has a size of from about 10 to about 12 square inches. In some embodiments, the droplet capturing filter has a size of about 11 square inches. In some embodiments, the droplet capturing filter has a size of from about 4 to about 7 square inches. In some embodiments, the droplet capturing filter has a size of from about 5 to about 6 square inches. In some embodiments, the droplet capturing filter has a size of from about 3 to about 6 square inches. In some embodiments, the droplet capturing filter has a size of from about 4 to about 5 square inches.
[0073] In some embodiments, the droplet capturing filter comprises polypropylene. In some embodiments, the droplet capturing filter consists of polypropylene. In some embodiments, the droplet capturing filter consists essentially of polypropylene. In some embodiments, the droplet capturing filter comprises electrically-charged polypropylene. In some embodiments, the droplet capturing filter consists of electrically-charged polypropylene. In some embodiments, the droplet capturing filter consists essentially of electrically-charged polypropylene. In some embodiments, the droplet capturing filter consists essentially of polystyrene. In some embodiments, the droplet
capturing filter comprises electrically-charged polystyrene. In some embodiments, the droplet capturing filter consists essentially of nylon. In some embodiments, the droplet capturing filter comprises electrically-charged nylon. In some embodiments, the droplet capturing filter is hydrophobic. In some embodiments, the droplet capturing filter is an electrostatic filter (e.g., 50% of fibers positively charged and 50% of fibers negatively charged). Exemplary filter cartridges include, e.g., the PulmoGuard™ series from SDI Diagnostics, the VBMax™ series from A-M Systems, and the Spiroguard series from GVS. In some embodiments, the droplet capturing filter is contained in a housing. In some embodiments, the mask further comprises a droplet capturing filter cap (also referred to herein as a “droplet capturing filter cap”). In some embodiments, the droplet capturing filter cap is reusable. In some embodiments, the droplet capturing filter cap is disposable. In some embodiments the droplet capturing filter cap secures the droplet capturing filter and seals the droplet capturing filter to the respirator body. In some embodiments, the droplet capturing filter cap is locking. In some embodiments, the mask further comprises a seal energizer. In some embodiments, the seal energizer is positioned between the droplet capturing filter and the droplet capturing filter cap. In some embodiments, the seal energizer is reusable. In some embodiments, the seal energizer is disposable. In some embodiments, the seal energizer is a cantilever “V” spring, a helical wound spring, or a canted coil seal. In some embodiments, the seal energizer is a cantilever “V” spring. In some embodiments, the seal energizer is a helical wound spring. In some embodiments, the seal energizer is a canted coil seal.
Microorganism Filtration Efficiency
[0074] In some embodiments, the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral and bacterial filtration efficiency.
[0075] In some embodiments, the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency. In some embodiments, the droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral and bacterial filtration efficiency.
[0076] Viral and bacterial filtration efficiency can be assessed using any standard method known in the art. For example, a challenge particle may be chosen to simulate the size of the commonly occurring pathogens (e.g., bacteria and viruses). Challenge particles can be chosen based on specific needs of the end user (e.g., to ensure filtration efficiency of certain pathogens). Common exemplary bacterial test protocols use Staphylococcus aureus as a challenge organism which has an approximate size of 0.6 mm, and common exemplary viral test protocols use an XI 74 Bacteriophage which has a size of 0.027 mm.
[0077] Viral and bacterial filtration efficiency can be assessed against any standard known in the art. For example, viral and bacterial filtration efficiency of a droplet capturing filter can be assessed against the ASTM F2101 standard for bacterial and viral filtration efficiency. In some embodiments, viral and bacterial filtration efficiency of a droplet capturing filter is assessed against the ASTM F2101 standard for bacterial and viral filtration efficiency.
[0078] A standardBS EN 13328 -1 2002 (Breathing System Filters for Anesthetic and Respiratory use. Part 1 Salt Test method to assess filtration performance) may be performed. The test provides, inter alia , a method of benchmarking the performance of one filter against another. The test requires the filter to be challenged by a 0.3 mm Sodium Chloride particle at a flow rate of 30 Liters per minute. The level of penetration is measured and the resulting efficiency reported as a percentage (e.g., if a filter has a penetration rate of 0.5%, the filter’s performance will be recorded as 99.5% efficient). This test allows a direct comparison of how individual filters perform. Under this system, a filter must be more than 99.97% efficient to classified as a HEPA filter. All of the Air Safety pleated filters are individually tested during manufacture to confirm that they are HEPA performance.
Airflow Resistance
[0079] In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 1.5 cm bbO/L/sec at flow rates of at least about 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 1.0, less than about 0.9, less than about 0.8, less than about 0.7, less than about 0.6, less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, less than about 0.1 cm LLO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 1.0 cm bbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.9 cm FbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.8 cm FbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.7 cm FbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.6 cm LbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.5 cm bbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.4 cm LbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.3 cm bbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.2 cm bbO/L/sec at flow rates of 14 L/sec. In some embodiments, the droplet capturing filter exhibits an airflow resistance of less than about 0.1 cm bbO/L/sec at flow rates of 14 L/sec.
[0080] In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, or at least about 90% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 10% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 15% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 20% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 25% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 30% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 40% less than an N95 respirator. In some embodiments, the droplet
capturing filter exhibits an airflow resistance of at least about 45% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 50% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 55% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 60% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 65% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 70% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 80% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 85% less than an N95 respirator. In some embodiments, the droplet capturing filter exhibits an airflow resistance of at least about 90% less than an N95 respirator.
[0081] Measurement of airflow resistance is standard practice in the art, and can be measured by any common technique known to a person of ordinary skill in the art. In some cases, airflow resistance may be measured by connecting a negative pressure source to a mask or respirator body comprising the droplet capturing filter and inducing a flow of air through the droplet capturing filter. The negative pressure source may comprise a vacuum source or a breathing simulator.
Cartridges
[0082] In some embodiments, the mask and/or the respirator body may be configured to receive a filter without using a cap to secure the filter 104 to the mask, respirator body 102, or cover plate 208. The droplet capturing filters 104 described herein may be secured and/or affixed to the mask, respirator body 102, or cover plate 208 without using a cap or lid as described above. The droplet capturing filters 104 described herein may be releasably coupled to the mask, respirator body 102, or cover plate 208 using one or more cartridges 224. The one or more cartridges may be configured to receive one or more filters and to releasably couple to the mask, respirator body, or cover plate. The one or more cartridges may be configured to permit airflow through a filter provided within the one or more cartridges. The one or more cartridges may permit a subject to breathe filtered or sanitized ambient air that passes one or more droplet capturing filters provided within the one or more cartridges.
[0083] In some cases, the cartridges 224 may be releasably coupled to the mask, respirator body, or cover plate using a coupling mechanism. The coupling mechanism may comprise, for example, one or more hooks, clamps, clips, straps, spring-loaded tabs, elastic bands, magnets, bracket, or holders. The coupling mechanisms may comprise, for example, snap-fits, fasteners, cradles,
frames, interlocking elements, mating elements, ropes, suction cups, and the like. In some cases, the mating elements may comprise a male and a female threaded portion that may be coupled together using a twisting motion. In some cases, the coupling mechanism may comprise a quick release coupling mechanism. The quick release coupling mechanism may enable a user to rapidly mechanically couple and/or decouple a plurality of components with a short sequence of simple motions (e.g., rotating or twisting motions; sliding motions; pulling a lever; depressing a button, switch, or plunger; squeezing a tab, etc.). For example, a quick release coupling mechanism may require no more than one, two, three, or four motions to perform a coupling and/or decoupling action. In some instances, a quick release coupling mechanism can be coupled and/or decoupled manually by a user without the use of tools. The quick release coupling mechanism may enable a user to couple and/or decouple the cartridges to the mask, respirator body, or cover plate within a predetermined period of time. The predetermined period of time may be at most about 1 minute, 55 seconds, 50 seconds, 45 seconds, 40 seconds, 35 seconds, 30 seconds, 25 seconds, 20 seconds, 15 seconds, 10 seconds, 5 seconds, 4 seconds, 3 seconds, 2 seconds, 1 second, or less. In some embodiments, the cartridge is releasably coupled with the facepiece body by a screw on mechanism.
[0084] In some embodiments, the filter disc may be placed within and encapsulated by a body of the cartridge. The cartridge may be attached directly to the face piece and may not or need not require a cap or lid to secure the filter to the face piece. After use, the filter may be replaced with another filter. In such cases, the cartridge may be reusable with the newly replaced filter.
[0085] In some embodiments, the cartridge can be a single component, and the filter is not removable from the cartridge. In such cases, the cartridge may be a disposable product. In some cases, the cartridge may be decontaminated or sanitized after use and before re-use.
[0086] The use of the cartridge can provide several benefits. For example, the cartridges can provide a common interface geometry between the filter and the face piece (e.g., respirator body). Filters of different sizes, shapes, and/or specifications can be used in a compatible manner with the face piece or respirator body without having to use different types of cartridges and without having to change the geometry (e.g., size and/or shape) of the cartridges.
Headform Compatibility
[0087] The respirator body or any other component of the masks described herein may be fabricated using one or more additive manufacturing techniques, such as one or more three- dimensional (3D) printing techniques. Additive manufacturing techniques may include vat photopolymerization, powder bed fusion, material extrusion, material jetting, binder jetting,
and/or direct energy deposition. Additive manufacturing techniques may include one or more three-dimensional (3D) printing techniques. A 3D printing technique may include direct light processing (DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
[0088] The respiratory body may be fabricated to have a size and/or a shape that is compatible with and that conforms with one or more headforms defined by the NIOSH (National Institute for Occupational Safety and Health). The one or more headforms defined by the NIOSH may correspond to headforms generated based on anthropometric modeling and surface scans of the heads of current U.S. respirator users. The respirator body may be sized and/or shaped to accommodate the head and face measurements associated with the NIOSH headforms. The NIOSH headforms may comprise at least five distinct types of headforms (e.g., small, medium, large, long/narrow, and short/wide). The NIOSH headforms are symmetric and represent the facial size and shape distribution of current U.S. respirator users. In addition, the ears have been placed on the headforms to match the average position for the chosen heads of a given size. These headforms have been incorporated into a technical specification standard for ISO TC94 Personal Protective Equipment, SC 15 Respiratory Protective Devices, WG1 General, PG5 Human Factors, titled “ISO 16976-2 Respiratory Protective Devices — Human Factors — Part 2: Anthropometries”. The five digital headforms are available in stl, ply, and igs format.
[0089] The mask and the respirator body can be shaped to accommodate a range of face sizes, face shapes, face contours, and face feature dimensions to provide improved face-fitting characteristics. In some cases, the masks and respirator bodies of the present disclosure may be sized and/or shaped in accordance with the NIOSH headforms described above. Alternatively, the masks and respirator bodies of the present disclosure may be sized and/or shaped based on manual measurements or 3D scans of a user’s head or face.
[0090] The mask and respirator body may be sized and/or shaped to accommodate a variety of head sizes and shapes. For male users, the mask and respiratory body may be configured to accommodate a bigonial breadth between about 90 mm and about 160 mm, a bitragi on chin arc between about 271 mm and about 393 mm, a bitragi on coronal arc between about 310 mm and about 405 mm, a bitragion frontal arc between about 263 mm and about 349 mm, a bitragion subnasale arc between about 253 mm and about 345 mm, a bizygomatic breadth between about
120 mm and about 170 mm, a head breadth between about 135 mm and about 129 mm, a head circumference between about 520 mm and about 639 mm, a head length between about 174 mm and about 225 mm, an interpupillary distance between about 53 mm and about 79 mm, a lip length between about 40 mm and about 70 mm, a maximum frontal breadth between about 95 mm and about 131 mm, a Menton-Sellion length between about 100 mm and about 156 mm, a minimum frontal breadth between about 90 mm and about 127 mm, a nasal root breadth between about 10 mm and about 29 mm, a neck circumference between about 312 mm and about 570 mm, a nose breadth between about 26 mm and about 58 mm, a nose protrusion between about 13 mm and about 32 mm, and/or a Subnasale-Sellion length between about 40 mm and about 66 mm.
[0091] The mask and respirator body may be sized and/or shaped to accommodate a variety of head sizes and shapes. For female users, the mask and respiratory body may be configured to accommodate a bigonial breadth between about 88 mm and about 150 mm, a bitragi on chin arc between about 248 mm and about 375 mm, a bitragi on coronal arc between about 290 mm and about 425 mm, a bitragion frontal arc between about 250 mm and about 330 mm, a bitragion subnasale arc between about 238 mm and about 335 mm, a bizygomatic breadth between about 115 mm and about 157 mm, a head breadth between about 129 mm and about 165 mm, a head circumference between about 475 mm and about 654 mm, a head length between about 152 mm and about 215 mm, an interpupillary distance between about 52 mm and about 78 mm, a lip length between about 35 mm and about 63 mm, a maximum frontal breadth between about 92 mm and about 130 mm, a Menton-Sellion length between about 91 mm and about 135 mm, a minimum frontal breadth between about 84 mm and about 126 mm, a nasal root breadth between about 10 mm and about 25 mm, a neck circumference between about 260 mm and about 505 mm, a nose breadth between about 22 mm and about 54 mm, a nose protrusion between about 11 mm and about 29 mm, and/or a Subnasale-Sellion length between about 32 mm and about 59 mm. Non-limiting List of Exemplary Embodiments
[0092] In addition to the aspects and embodiments described and provided elsewhere in this disclosure, the following non-limiting list of particular embodiments are specifically contemplated.
1. A mask for use in preventing the spread of microorganisms through airborne transmission, comprising: a. a respirator body comprising at least two ports capable of accepting a droplet capturing filter and providing a flexibly sealed interface around a subject’s nostrils and mouth; and
b. a droplet capturing filter that exhibits an airflow resistance of less than about 1.5 cm fhO/L/sec at flow rates of at least about 14 L/sec.
2. The mask of embodiment 1, wherein said droplet capturing filter exhibits an airflow resistance of less than about 1.0, less than about 0.9, less than about 0.8, less than about 0.7, less than about 0.6, less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, or less than about 0.1 cm fbO/L/sec at flow rates of 14 L/sec.
3. The mask of embodiment 1 or 2, wherein said droplet capturing filter comprises a filter standard in the use of pulmonary function testing.
4. The mask of any one of embodiments 1-3, wherein said droplet capturing filter comprises a non-woven synthetic fiber.
5. The mask of any preceding embodiment, wherein said droplet capturing filter comprises polypropylene.
6. The mask of any preceding embodiment, wherein said droplet capturing filter comprises electrostatically-charged polypropylene.
7. The mask of any preceding embodiment, wherein said droplet capturing filter comprises polyester.
8. The mask of any preceding embodiment, wherein said droplet capturing filter comprises electrostatically-charged polyester.
9. The mask of any preceding embodiment, wherein said droplet capturing filter comprises nylon.
10. The mask of any preceding embodiment, wherein said droplet capturing filter comprises electrostatically-charged nylon.
11. The mask of any preceding embodiment, wherein said droplet capturing filter is hydrophobic.
12. The mask of any preceding embodiment, wherein said droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
13. The mask of any preceding embodiment, wherein said droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
14. The mask of any preceding embodiment, wherein said droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
15. The mask of any preceding embodiment, wherein said droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
16. The mask of any preceding embodiment, wherein said droplet capturing filter is disposable.
17. The mask of any preceding embodiment, further comprising a droplet capturing filter cap.
18. The mask of embodiment 17, wherein said droplet capturing filter cap is reusable.
19. The mask of embodiment 17 or 18, wherein said droplet capturing filter cap is locking.
20. The mask of any one of embodiments 17-19, wherein said droplet capturing filter cap secures said droplet capturing filter and seals said droplet capturing filter to said respirator body.
21. The mask of any preceding embodiment, wherein said mask further comprises a seal energizer.
22. The mask of any one of embodiments 17-20, wherein said mask further comprises a seal energizer positioned between said droplet capturing filter and said droplet capturing filter cap.
23. The mask of embodiment 21 or 22, wherein said seal energizer is reusable.
24. The mask of any preceding embodiment, wherein said respirator body comprises at least two ports capable of accepting a droplet capturing filter.
25. The mask of embodiment 24, wherein said mask comprises at least two droplet capturing filters.
26. The mask of embodiment 25, wherein said two droplet capturing filters are the same.
27. The mask of embodiment 25, wherein said two droplet capturing filters are the different.
28. The mask of any preceding embodiment, wherein said respirator body is configured to receive a droplet capturing filter without a droplet capturing filter cap to secure said droplet capturing filter to said respirator body.
29. The mask of any preceding embodiment, wherein said respirator body is configured to receive at least one cartridge that comprises said droplet capturing filter.
30. The mask of embodiment 29, wherein said cartridge is disposable.
31. The mask of embodiment 29 or 30, wherein said cartridge is releasably coupled to said respirator body.
32. The mask of any preceding embodiment, wherein said respirator body is fabricated such that it has a size, shape, or both a size and shape that conforms to at least one defined headform.
33. The mask of any preceding embodiment, wherein said respirator body is fabricated using an additive manufacturing technique.
34. The mask of embodiment 33, wherein said additive manufacturing technique is vat photopolymerization, powder bed fusion, material extrusion, material jetting, binder jetting, and/or direct energy deposition.
35. The mask of embodiment 33, wherein said additive manufacturing technique is a 3D printing technique.
36. The mask of embodiment 35, wherein said 3D printing technique is direct light processing (DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
37. A mask for use in preventing the spread of microorganisms through airborne transmission, comprising: a respirator body comprising at least one port capable of accepting a droplet capturing filter and providing a flexibly sealed interface around a subject’s nostrils and mouth; and a droplet capturing filter that exhibits an airflow resistance of less than an N95 respirator, wherein said droplet capturing filter exhibits at least about 85% of the microbial filtration efficiency of said N95 respirator.
38. The mask of embodiment 37, wherein said droplet capturing filter exhibits at least about 90%, at least about 91%, at least about 92%, at least about 93%, at least about 94%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 100%, at least about 105%, or at least about 110% of the microbial filtration efficiency of said N95 respirator.
39. The mask of embodiment 37 or 38, wherein said droplet capturing filter comprises a filter standard in the use of pulmonary function testing.
40. The mask of any one of embodiments 37-38, wherein said droplet capturing filter comprises a non-woven synthetic fiber.
41. The mask of any one of embodiments 37-39, wherein said droplet capturing filter comprises polypropylene.
42. The mask of any one of embodiments 37-41, wherein said droplet capturing filter comprises electrostatically-charged polypropylene.
43. The mask of any one of embodiments 37-42, wherein said droplet capturing filter comprises polyester.
44. The mask of any one of embodiments 37-43, wherein said droplet capturing filter comprises electrostatically-charged polyester.
45. The mask of any one of embodiments 37-44, wherein said droplet capturing filter comprises nylon.
46. The mask of any one of embodiments 37-45, wherein said droplet capturing filter comprises electrostatically-charged nylon.
47. The mask of any one of embodiments 37-46, wherein said droplet capturing filter is hydrophobic.
48. The mask of any one of embodiments 37-47, wherein said droplet capturing filter exhibits an airflow resistance of at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, or at least about 90% less than an N95 respirator.
49. The mask of any one of embodiments 37-48, wherein said droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
50. The mask of any one of embodiments 37-49, wherein said droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
51. The mask of any one of embodiments 37-50, wherein said droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about
99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
52. The mask of any one of embodiments 37-51, wherein said droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
53. The mask of any one of embodiments 37-52, wherein said droplet capturing filter is disposable.
54. The mask of any one of embodiments 37-53, further comprising a droplet capturing filter cap.
55. The mask of embodiments 54, wherein said droplet capturing filter cap is reusable.
56. The mask of embodiments 54 or 55, wherein said droplet capturing filter cap is locking.
57. The mask of any one of embodiments 54-56, wherein said droplet capturing filter cap secures said droplet capturing filter and seals said droplet capturing filter to said respirator body.
58. The mask of any one of embodiments 37-57, wherein said mask further comprises a seal energizer.
59. The mask of any one of embodiments 37-58, wherein said mask further comprises a seal energizer positioned between said droplet capturing filter and said droplet capturing filter cap.
60. The mask of embodiment 58 or 59, wherein said seal energizer is reusable.
61. The mask of any one of embodiments 37-60, wherein said respirator body comprises at least two ports each capable of accepting a droplet capturing filter.
62. The mask of embodiment 61, wherein said mask comprises at least two droplet capturing filters.
63. The mask of embodiment 62, wherein said two droplet capturing filters are the same.
64. The mask of embodiment 62, wherein said two droplet capturing filters are different.
65. The mask of any one of embodiments 37-64, wherein said respirator body is configured to receive a droplet capturing filter without a droplet capturing filter cap to secure said droplet capturing filter to said respirator body.
66. The mask of any one of embodiments 37-65, wherein said respirator body is configured to receive at least one cartridge that comprises said droplet capturing filter.
67. The mask of embodiment 66, wherein said at least one cartridge is disposable.
68. The mask of embodiment 66 or 67, wherein said at least one cartridge is releasably coupled to said respirator body.
69. The mask of any one of embodiments 37-68, wherein said respirator body is fabricated such that it has a size, shape, or both a size and shape that conforms to at least one defined headform.
70. The mask of any one of embodiments 37-69, wherein said respirator body is fabricated using an additive manufacturing technique.
71. The mask of embodiment 70, wherein said additive manufacturing technique is vat photopolymerization, powder bed fusion, material extrusion, material jetting, binder jetting, and/or direct energy deposition.
72. The mask of embodiment 70, wherein said additive manufacturing technique is a 3D printing technique.
73. The mask of embodiment 72, wherein said 3D printing technique is direct light processing (DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
74. A mask for use in preventing the spread of microorganisms through airborne transmission, comprising: a. a respirator body comprising at least two ports capable of accepting a droplet capturing filter; and b. a droplet capturing filter that comprises, consists of, or consists essentially of a non-woven synthetic fiber.
75. The mask of embodiment 74, wherein said droplet capturing filter comprises a filter standard in the use of pulmonary function testing.
76. The mask of embodiment 74 or 75, wherein said droplet capturing filter comprises polypropylene.
77. The mask of any one of embodiments 74-76, wherein said droplet capturing filter comprises electrostatically-charged polypropylene.
78. The mask of any one of embodiments 74-77, wherein said droplet capturing filter comprises polyester.
79. The mask of any one of embodiments 74-78, wherein said droplet capturing filter comprises electrostatically-charged polyester.
80. The mask of any one of embodiments 74-79, wherein said droplet capturing filter comprises nylon.
81. The mask of any one of embodiments 74-80, wherein said droplet capturing filter comprises electrostatically-charged nylon.
82. The mask of any one of embodiments 74-81, wherein said droplet capturing filter is hydrophobic.
83. The mask of any one of embodiments 74-82, wherein said droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
84. The mask of any one of embodiments 74-83, wherein said droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
85. The mask of any one of embodiments 74-84, wherein said droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
86. The mask of any one of embodiments 74-85, wherein said droplet capturing filter exhibits at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
87. The mask of any one of embodiments 74-86, wherein said droplet capturing filter exhibits an airflow resistance of less than about 1.5, less than about 1.0, less than about 0.9, less than about 0.8, less than about 0.7, less than about 0.6, less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, or less than about 0.1 cm FbO/L/sec at flow rates of 14 L/sec.
88. The mask of any one of embodiments 74-87, wherein said droplet capturing filter is disposable.
89. The mask of any one of embodiments 74-88, further comprising a droplet capturing filter cap.
90. The mask of embodiment 89, wherein said droplet capturing filter cap is reusable.
91. The mask of embodiment 89 or 90, wherein said droplet capturing filter cap is locking.
92. The mask of any one of embodiments 89-91, wherein said droplet capturing filter cap secures said droplet capturing filter and seals said droplet capturing filter to said respirator body.
93. The mask of any one of embodiments 74-92, wherein said mask further comprises a seal energizer.
94. The mask of any one of embodiments74-93, wherein said mask further comprises a seal energizer positioned between said droplet capturing filter and said droplet capturing filter cap.
95. The mask of embodiment 93 or 94, wherein said seal energizer is reusable.
96. The mask of any one of embodiments 74-94, wherein said respirator body comprises at least two ports each capable of accepting a droplet capturing filter.
97. The mask of embodiment 96, wherein said mask comprises at least two droplet capturing filters.
98. The mask of embodiment 97, wherein said two droplet capturing filters are the same.
99. The mask of embodiment 98, wherein said two droplet capturing filters are different.
100. The mask of any one of embodiments 74-99, wherein said respirator body is configured to receive a droplet capturing filter without a droplet capturing filter cap to secure said droplet capturing filter to said respirator body.
101. The mask of any one of embodiments 74-100, wherein said respirator body is configured to receive at least one cartridge that comprises said droplet capturing filter.
102. The mask of embodiment 101, wherein said at least one cartridge is disposable.
103. The mask of embodiment 101 or 102, wherein said at least one cartridge is releasably coupled to said respirator body.
104. The mask of any one of embodiments 74-103, wherein said respirator body is fabricated such that it has a size, shape, or both a size and shape that conforms to at least one defined headform.
105. The mask of any one of embodiments 74-104, wherein said respirator body is fabricated using an additive manufacturing technique.
106. The mask of embodiment 105, wherein said additive manufacturing technique is vat photopolymerization, powder bed fusion, material extrusion, material jetting, binder jetting, and/or direct energy deposition.
107. The mask of embodiment 105, wherein said additive manufacturing technique is a 3D printing technique.
108. The mask of embodiment 107, wherein said 3D printing technique is direct light processing (DLP), continuous direct light processing (CDLP), stereolithography (SLA), fused
deposition modeling (FDM), fused filament fabrication (FFF), selective laser sintering (SLS), material jetting (MJ), nanoparticle jetting (NPJ), drop on demand (DOD), binder jetting, direct metal laser sintering (DMLS), selective laser melting (SLM), electron beam melting (EBM), multi jet fusion (MJF), direct energy deposition (DED), laser engineered net shaping, and/or electron beam additive manufacturing.
Claims
1. A mask for use in preventing the spread of microorganisms through airborne transmission, comprising:
(a) a facepiece body comprising at least one opening capable of accepting a cover plate;
(b) said cover plate configured to accept at least one droplet capturing filter of various sizes and/or shapes; and
(c) said at least one droplet capturing filter.
2. The mask of claim 1, wherein said cover plate is releasably coupled with said facepiece body.
3. The mask of claim 1 or 2, wherein said cover plate comprises at least one plate opening that allows air passage.
4. The mask of any one of claims 1-3, wherein said mask further comprises a filter cap.
5. The mask of claim 4, wherein said filter cap is releasably coupled with said facepiece body.
6. The mask of claim 4 or 5, wherein said filter cap comprises at least one cap opening that allows air passage.
7. The mask of any one of claims 4-6, wherein said filter cap and said cover plate can be releasably assembled to form a confined space.
8. The mask of claim 7, wherein said at least one droplet capturing filter is positioned in said confined space between said cover plate and said filter cap.
9. The mask of any one of claims 1-8, wherein said at least one droplet capturing filter is fixed on at least one filter cartridge.
10. The mask of claim 9, wherein said at least one filter cartridge is releasably coupled with said facepiece body by a screw on mechanism.
11. The mask of any one of claims 1-10, wherein said facepiece body comprises a rigid body surrounding said at least one opening of said facepiece body.
12. The mask of any one of claims 1-11, wherein said facepiece body comprises a flexible body that is molded to fit and seal upon a face of a user.
13. The mask of claim 12, wherein said flexible body is over-molded onto said rigid body.
14. The mask of claim 12 or 13, wherein said flexible body comprises silicone.
15. The mask of any one of claims 1-14, wherein said cover plate is capable of snapping into and sealing said facepiece body.
16. The mask of any one of claims 1-15, wherein said filter cap comprises a hinge and said facepiece body comprises a matching base for said hinge, wherein said hinge and said matching base allow said filter cap to be releasably coupled with said facepiece body.
17. The mask of claim 16, wherein said hinge is a snap-in hinge.
18. The mask of any one of claims 1-17, wherein said filter cap comprises an inner surface, wherein said inner surface comprises at least one smooth surface.
19. The mask of claim 18, wherein said filter cap comprises an edge seal positioned on at least one portion of said inner surface, wherein said edge seal secures and seals said droplet capturing filter with said cover plate or said facepiece body.
20. The mask of any one of claims 1-19, wherein said facepiece body comprises at least two openings capable of accepting said cover plate.
21. The mask of claim 20, wherein said at least one opening of said facepiece body has a size of from about 10 to about 12 square inches.
22. The mask of claim 21, wherein said at least one opening of said facepiece body has a size of about 11 square inches.
23. The mask of any one of claims 1-22, wherein said at least one opening of said facepiece body has a shape of circular, oval, oblong, square, or rectangular.
24. The mask of any one of claims 1-23, wherein said cover plate has a size of from about 100% to about 120% of the size of said at least one opening of said facepiece body.
25. The mask of claim 24, wherein said cover plate has a size of about 110% of the size of said at least one opening of said facepiece body.
26. The mask of any one of claims 1-25, wherein said filter cap has a size of from about 100% to about 120% of the size of said at least one opening of said facepiece body.
27. The mask of claim 26, wherein said filter cap has a size of about 110% of the size of said at least one opening of said facepiece body.
28. The mask of any one of claims 1-27, wherein at least one side of said filter cap is attached to a harness.
29. The mask of claim 28, wherein said filter cap comprises at least two prongs, wherein each of said at least two prongs is extended from said at least one side of said filter cap, wherein said at least two prongs are capable of receiving a harness.
30. The mask of any one of claims 1-29, wherein said at least one droplet capturing filter exhibits an airflow resistance of less than about 1.5 cm FbO/L/sec at flow rates of at least about 14 L/sec.
31. The mask of claim 30, wherein said droplet capturing filter exhibits an airflow resistance of less than about 1.0, less than about 0.9, less than about 0.8, less than about 0.7, less than about 0.6, less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, or less than about 0.1 cm FbO/L/sec at flow rates of 14 L/sec.
32. The mask of any one of claims 1-31, wherein said droplet capturing filter comprises a filter standard in the use of pulmonary function testing.
33. The mask of any one of claims 1-32, wherein said droplet capturing filter comprises a non- woven synthetic fiber, polypropylene, polyester, or nylon.
34. The mask of any one of claims 1-33, wherein said droplet capturing filter is electrostatically-charged.
35. The mask of any one of claims 1-34, wherein said droplet capturing filter is hydrophobic.
36. The mask of any one of claims 1-35, wherein said droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% bacterial filtration efficiency.
37. The mask of any one of claims 1-36, wherein said droplet capturing filter exhibits at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, or at least about 99.9% viral filtration efficiency.
38. The mask of any one of claims 1-37, wherein said droplet capturing filter is disposable.
39. The mask of any one of claims 1-38, wherein said droplet capturing filter comprises pre printed pattern or color.
40. A harness for securing a mask to a head of a user, comprising
(a) a head strap capable of positioning and securing said mask to said head of said user;
(b) a first adjustable mechanism that is capable to adjust the position and/or length of said head strap;
(c) at least one second strap that is connected to said head strap; and
(d) at least one second adjustable mechanism connecting said second strap to said head strap; wherein said at least one second adjustable mechanism is located on at least one end of said head strap.
41. The harness of claim 40, wherein said first adjustable mechanism comprises a ladder-type buckle.
42. The harness of claim 40 or 41, wherein said at least one second adjustable mechanism is a latching mechanism.
43. The harness of any one of claims 40-42, wherein said harness comprises two said second adjustable mechanisms, wherein each of said second adjustable mechanism is located on each end of said head strap.
44. The harness of any one of claims 40-43, wherein said head strap comprises a flexible material.
45. The harness of claim 44, wherein said flexible material comprises a low durometer, injection moldable, thermoplastic elastomer or silicone.
46. The harness of any one of claims 40-45, wherein said at least one second strap comprises an elastic material.
47. A mask for use in preventing the spread of microorganisms through airborne transmission, comprising the harness of any one of claims 40-46.
48. A mask for use in preventing the spread of microorganisms through airborne transmission, comprising: a. a respirator body comprising at least two ports capable of accepting a droplet capturing filter and providing a flexibly sealed interface around a subject’s nostrils and mouth; and b. a droplet capturing filter that exhibits an airflow resistance of less than about 1.5 cm ThO/L/sec at flow rates of at least about 14 L/sec.
49. A mask for use in preventing the spread of microorganisms through airborne transmission, comprising: a respirator body comprising at least one port capable of accepting a droplet capturing filter and providing a flexibly sealed interface around a subject’s nostrils and mouth; and a droplet capturing filter that exhibits an airflow resistance of less than an N95 respirator, wherein said droplet capturing filter exhibits at least about 85% of the microbial filtration efficiency of said N95 respirator.
50. A mask for use in preventing the spread of microorganisms through airborne transmission, comprising:
(a) a respirator body comprising at least two ports capable of accepting a droplet capturing filter; and
(b) a droplet capturing filter that comprises, consists of, or consists essentially of a non- woven synthetic fiber.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US202063001303P | 2020-03-28 | 2020-03-28 | |
US63/001,303 | 2020-03-28 |
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WO2021202306A1 true WO2021202306A1 (en) | 2021-10-07 |
Family
ID=77929817
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Application Number | Title | Priority Date | Filing Date |
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PCT/US2021/024466 WO2021202306A1 (en) | 2020-03-28 | 2021-03-26 | Respiration apparatus and methods of use thereof |
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WO (1) | WO2021202306A1 (en) |
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