It is commonly known that pathogens such as viruses and bacteria are easily transmitted between people via direct and indirect contact. An example of direct transmission is when aerosolization of pathogens occur during exhalation, coughing, or sneezing, and is transferred to another individual. Indirect transmission occurs when pathogens contact and reside on an intervening surface such as doorknobs, countertops, tabletops, or on an individual's hand.
Techniques are provided for providing a barrier treated with pathogenicidal components positioned between a first region and a second region to kill or deactivate pathogens (e.g. virus particles) and thus prevent transmission of pathogens between the first and second regions.
The inventors recognized that various conventional methods are available (e.g. melt blowing) which can be used to form non-woven fabric from a polymer material, that can then be used as a barrier between a first region and a second region. However, the inventors recognized that such conventional methods do not add pathogenicidal components (e.g. salt crystals) to the non-woven fabric, which would enhance the prevention of transmission of pathogens between the first and second region. The inventors then considered that the melt blowing method could be used to form non-woven fabric, after which pathogenicidal components (e.g. salt crystals) could be added to the non-woven fabric using various means (e.g. soaking the non-woven fabric in a salt solution for 24-36 hours). However, the inventors recognized that such a method would be time consuming, as it would require about 24-36 hours (e.g. due to curing) to form the barrier with the pathogenicidal components. Thus, the inventors developed the improved method disclosed herein, where pathogenicidal components are incorporated into the melt blowing process, such that the non-woven fabric formed by the melt blowing process already has pathogenicidal components embedded therein. This eliminates the time consuming step of adding pathogenicidal components to the non-woven fabric after the melt blowing process (e.g. during a curing step that may extend for 24-36 hours). Consequently, as a result of the improved melt blowing process, the non-woven fabric with embedded pathogenicidal components can be formed in under one hour, as opposed to 24-36 hour with the conventional melt blowing process.
The inventors recognized that conventional masks are available which attempt to prevent the transmission of pathogens between two regions. In one example, conventional masks are available which provide an interior layer treated with pathogenicidal components (e.g. virucidal components) sandwiched between two exterior layers that are not treated with pathogenicidal components. Although the interior layer of these conventional masks is used to kill or deactivate pathogens, the untreated exterior layers of these masks become contaminated when pathogens contact these exterior layers. Consequently, when the user touches or removes the mask, they contaminate their hand and thus may subsequently contaminate themselves (e.g. touching their face) or other surfaces (e.g. by touching these surfaces). Additionally, the inventors of the present invention recognized that disposing this contaminated mask may cause further contamination of other surfaces that make contact with the exterior layer during disposal. To overcome this drawback of conventional masks, the inventors of the present invention developed the improved method disclosed herein, to form a barrier (e.g. single ply barrier or multiple layer barrier) that is treated with pathogenicidal components that can be worn over the face as a facial cover. This improved method is used to form the barrier that advantageously kills or deactivates incident pathogens and thus minimizes the risk of contamination of the barrier. Thus, the improved barrier formed by the method disclosed herein minimizes the risk of contamination of the user (e.g. when touching or disposing of the barrier) and other surfaces (e.g. when the barrier is discarded).
The inventors recognized other drawbacks of conventional masks. For example, since the conventional masks include multiple layers, the air permeability and thus the breathability of these masks is severely limited. This can pose health concerns for individuals who suffer from respiratory illnesses (e.g. asthma). Additionally, this can severely restrict the breathing of athletes who may be required to wear such conventional masks during sports activity (e.g. due to laws and/or regulations governing viral pandemics). To overcome this significant drawback of conventional masks, the inventors of the present invention developed the improved method disclosed herein, to form the barrier (e.g., single ply barrier or multiple layer barrier) that is treated with pathogenicidal components that can be worn over the face. In some embodiments, the improved barrier formed by the improved method disclosed herein only includes a single ply layer, and thus has significantly higher air permeability and breathability than conventional masks, while at the same time being at least as effective in killing or deactivating pathogens. However, the invention is not limited to barriers formed of a single-ply layer and in other embodiments includes barriers formed from multiple layers.
The inventors also recognized another drawback of conventional masks. For example, during viral pandemics there is a well-known shortage of certain masks (e.g. N95) used by medical professionals. This shortage is facilitated by the frequency by which these masks are discarded after a certain amount of use. Although there are certain methods that can be used to sterilize such masks after multiple uses, these sterilization methods can damage the mask material and thus affect the performance of these masks during reuse. To overcome this noted drawback of shortage of certain masks, the inventors of the present invention developed the improved method disclosed herein, to form a barrier that is treated with pathogenicidal components that can be used to enclose a conventional mask (e.g. N95) to minimize contamination of the mask. This advantageously extends the lifetime of the conventional mask and thus reduces the instance of shortage of the conventional masks. Additionally, the barrier formed by the improved method disclosed herein also improves upon other methods (e.g. sterilization) that may affect the performance of the conventional masks during reuse.
The inventors of the present invention noticed that attempts to reduce transmission include prior inventions of masks. However, the limitations of masks are that the external surface (facing away from the user, and the internal surface (facing the user) are inherently contaminated whether from the environment or from the user and thus present a risk for infection if an individual does not remove and dispose of the mask correctly. This represents a risk to the user, as well as others via indirect transmission. Also, in the situation of a pandemic, with the result of shortages of personal protective equipment, many individuals are forced to reuse protective masks, and often do not have a reliable means of sterilizing a mask for reuse. Furthermore, some methods of sterilization result in a breakdown of the fibers of the mask, thereby reducing its effectiveness in filtering out pathogens. When shortages occur, many individuals are forced to use simple cloth face covers, which are not reliable for preventing airborne transmission, and still pose a risk to enable indirect transmission when removed.
In one embodiment, the present invention provides an improved method to form a cover for a mask, which has embedded pathogenicidal components (e.g. virucidal and/or bactericidal components), providing protection for both the external and internal surfaces of a mask, preventing/reducing contamination of a mask, thereby improving safety if reuse is necessary, and by inactivating or destroying pathogens, reducing risk of indirect transmission when the cover is removed and disposed. If a mask was not available for use, the individual may also elect to use this invention to form a face cover and provide a measure a safety due to the embedded pathogenicidal and bactericidal components.
The inventors of the present invention also recognized other contexts than facial covers where barriers to prevent pathogens passing from the first region to the second region are either deficient or not provided. For example, air filters (e.g. for air-conditioning systems or ventilators, etc.), apparel (e.g. garments for medical professionals or any clothing items worn by everyday people) and food storage (e.g. to prevent pathogens in the air from contaminating and/or spoiling food). The inventors recognized that with conventional food packaging (e.g. shipping containers or storage containers) there is no effective barrier to prevent pathogens from making contact with the food, thereby resulting in contamination and/or spoilage of the food. Thus, in some embodiments the inventors of the present invention developed a barrier with pathogenicidal components that is effective to prevent contamination and/or spoilage of food by preventing pathogens from making contact with the food items enclosed by the barrier.
In a first set of embodiments, a method is provided to form a barrier configured to be placed between a first region and a second region, to prevent passage of pathogens between the first region and the second region. The method includes melt blowing a stream of polymer fibers onto a surface to form a non-woven fabric used to make the barrier. The melt blowing includes introducing pathogenicidal components into the stream of polymer fibers.
In a second set of embodiments, a device of a system is provided to form a barrier configured to be placed between a first region and a second region, to prevent passage of pathogens between the first region and the second region. The system includes an extruder configured to melt polymer pellets to form pressurized molten polymer. The system further comprising a metering pump configured to discharge a consistent flow of pressurized molten polymer received from the extruder. The system further includes a spinneret configured to extrude polymer filament strands from holes defined by the spinneret based on the pressurized molten polymer received from the metering pump. The system further includes an air manifold configured to attenuate the polymer filament strands into the stream of polymer fibers that are directed onto a collector that defines the surface to form the non-woven fabric. The device is configured to introduce pathogenicidal components into the stream of polymer fibers downstream of the extruder and upstream of the collector.
In a third set of embodiments, a barrier formed by the method according to the first set of embodiments is provided. The barrier includes a first side directed towards the first region and a second side directed towards the second region.
In a fourth set of embodiments, a facial cover configured to be worn by a user is provided. The facial cover includes one or more barriers formed by the method according to the first set of embodiments. The one or more barriers are configured to deactivate pathogens incident from the external surroundings of the user.
Still other aspects, features, and advantages are readily apparent from the following detailed description, simply by illustrating a number of particular embodiments and implementations, including the best mode contemplated for carrying out the invention. Other embodiments are also capable of other and different features and advantages, and its several details can be modified in various obvious respects, all without departing from the spirit and scope of the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.
Embodiments are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings in which like reference numerals refer to similar elements and in which:
A method and apparatus are described for providing a barrier (e.g. single ply layer barrier, multiple layer barrier, etc.) treated with pathogenicidal components between a first and second region to prevent passage of pathogens between the first and second regions. In the following description, for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be apparent, however, to one skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form in order to avoid unnecessarily obscuring the present invention.
Some embodiments of the invention are described below in the context of a method for forming a barrier positioned between a first region and a second region to prevent passage or transmission of pathogens between the first and second regions. In one embodiment, the invention is described in the context of a melt blowing method for forming a barrier positioned between the first region and the second region. However, the invention is not limited to this context and includes a barrier formed by the method including a single ply layer or a multiple layer barrier with pathogenicidal components that is positioned between the first and second regions to prevent passage or transmission of viral particles between the first and second regions.
For purposes of this description, “barrier” means one or more layer(s) of material treated with pathogenicidal (e.g. virucidal or bactericidal components) and positioned between a first and second region to prevent or reduce the instance of transmission of pathogens between the first and second regions. In one example, “barrier” means a single ply layer of the material treated with pathogenicidal components. In other examples, “barrier” means multiple layers of the material (e.g. multiple single-ply layers that are affixed together) treated with pathogenicidal components. In still other examples, “barrier” means multiple layers where one or more layers are treated with pathogenicidal components and one or more other layers are not treated with the pathogenicidal components. For purposes of this description, “single ply layer” means a single layer of material and excludes multiple layers of the material or additional layers of a different material. For purposes of this description, “pathogenicidal components” means any chemical or molecule having the capacity to or tending to destroy or inactivate pathogens and includes (but is not limited to) virucidal components and bactericidal components. For purposes of this description, “virucidal components” means any chemical or molecule having the capacity to or tending to destroy or inactivate viruses. For purposes of this description, “bactericidal components” means any chemical or molecule having the capacity to or tending to destroy or inactivate bacteria. For purposes of this description, “mask” means a conventional facial mask worn to reduce the instance of transmission of pathogens (e.g. N95 mask) and including multiple layers of material. For purposes of this description, “facial cover” means a cover worn over the face that includes the barrier disclosed herein.
In one embodiment, the present invention provides a cover for a mask, or cover for the face, suitable for wear, which inhibits the passage of viruses and bacteria, and is treated with a compound designed to destroy viruses and bacteria. This cover will allow the user to reuse the mask, whether it be a surgical mask, N95 mask, KN95 mask, P100 mask, or other masks that an individual may use, by reducing contamination of the mask. This invention will also reduce contamination of the user's environment upon disposal, due to the treatment with a compound designed to kill viruses and bacteria.
Although
In an embodiment, the barrier 100 includes a single ply layer 101 positioned between the first region 102 and the second region 104 and the barrier 100′ includes multiple layers 101a, 101b positioned between the first and second regions 102, 104. As shown in
In an embodiment, the barrier 100, 100′ includes pathogenicidal components 112 within each layer 101. In one embodiment, each layer 101 of the barrier 100, 100′ is treated with pathogenicidal components 112 using a method discussed hereinafter. In yet another embodiment, the pathogenicidal components are integrated or incorporated into the layer 101 of the barrier 100, 100′, during the manufacturing process of the barrier 100, 100′. In one embodiment, the layer 101 of the barrier 100, 100′ is treated with single or combinations of components that possess virucidal and/or bactericidal properties. In an example embodiment, these components include one or more of acids, salts, or esters. In one example embodiment, the components include citric acid, any carboxylic acid, or any mineral acid. In another example embodiment, the components include one or more of citrate esters, vitamin C esters, pyruvate, citrate, isocitrate, ketoglutarate, succinate, fumarate, malate, oxaloacetate or basic components (e.g., such as soaps, sodium lauryl sulfate, quaternary ammonium salts; cationic, anionic and nonionic surfactants, or tallow amines). In an example embodiment, the concentration of the acidic components may range from about 11% to about 100% of the acid, salt, or ester, and the concentration of the basic components may range from about 0.1% to about 10% of the surfactant, salt or ester. In yet another example embodiment, other pathogenicidal components (e.g., virucidal and/or bactericidal components) that may be utilized include NaCl, zinc disodium EDTA, copper, nickel, iodine, manganese, tin, boron, or silver; salts thereof; chelants thereof; chelactants thereof; surfactant-linked compositions thereof; or ions thereof. In an example embodiment, the metal virucidal composition may range from about 1% to about 100% solution, and also colloids and phycocolloids may be utilized.
In another embodiment, the barrier 100, 100′ is treated with the pathogenicidal components 112 across an entire thickness of the barrier 100, 100′ (e.g., entire thickness of the single ply layer 101 in the barrier 100 or an entire thickness of each layer 101a, 101b of the multiple-layer barrier 100′). Thickness is a dimension perpendicular to the interface between the regions 102, 104 and extending from the first region 102 to the second region 104. As shown in
In an example embodiment, salt is effective as a virucidal component to kill and/or deactivate a viral particle, since the viral particle is usually incident on the barrier 100, 100′ in a water droplet (e.g. aerosol). Once the water droplet containing the viral particle makes contact with the layer(s) 101 of the barrier 100, 100′, salt crystals within the layer(s) 101 dissolve in the water droplet. Over time, the water droplet evaporates, thus reducing the water volume containing the viral particle and consequently increasing the relative salt concentration. Once the salt concentration reaches a sufficient level, the salt deactivates and/or kills the viral particle.
In an embodiment, the first side 106 of the barrier 100, 100′ is directed toward the first region 102. In an example embodiment, the outer surface 108 of the first side 106 is coated with the pathogenicidal components 112 and is directed toward the first region 102 such that the pathogen 110 in the first region 102 is incident on the outer surface 108 of the first side 106. In another example embodiment, the outer surface 108 of the first side 106 is the first surface that is encountered by the pathogen 110 incident on the barrier 100, 100′ (e.g. no other layer or surface or component of the barrier 100 interacts with the pathogen 110 before the outer surface 108).
In an embodiment, the second side 116 of the barrier 100, 100′ is directed toward the second region 104. In an example embodiment, the outer surface 118 of the second side 108 is coated with the pathogenicidal components 112 and is directed toward the second region 102 such that the pathogen 111 in the second region 104 is incident on the outer surface 118 of the second side 116. In another example embodiment, the outer surface 118 of the second side 116 is the first surface that is encountered by the pathogen 111 incident on the second side 116 (e.g. no other layer or surface or component of the barrier 100 makes contact with the pathogen 111 before the outer surface 118). In an example embodiment, the pathogenicidal components 112 coated on the outer surfaces 108, 118 of the first side 106 and the second side 116 are configured to deactivate the pathogens 110, 111 (e.g. viral particles in aerosol) incident on the outer surfaces 108, 118 of the respective first side 106 and the second side 116.
In an embodiment, the pathogenicidal components 112 comprise salt with a level of crystallization of across a thickness of the layer(s) 101 of the barrier 100, 100′ from the outer surface 108 of the first side 106 to the outer surface 118 of the second side 116. In an embodiment the level of crystallization of the salt is measured based on X-ray Diffraction (XRD) Analysis as discussed hereafter with respect to
In an embodiment, the barrier 100, 100′ has an air permeability that is greater than a threshold value of air permeability. In one embodiment, the air permeability is based on a value of an air pressure difference across the barrier 100, 100′ (e.g. between the first side 106 and the second side 116) based on an airflow passed through the barrier 100, 100′ at a constant flowrate (e.g. about 8 L/min or in a range from about 4 L/min to about 12 L/min). In an example embodiment, the air permeability of the barrier 100, 100′ is such that the air pressure difference is less than about 0.2 mm H20/cm2. In another example embodiment, the air permeability is such that the air pressure difference is less than about 0.1 mm H20/cm2.
In an embodiment, the barrier 100, 100′ has a viral filtration efficiency between the first and second regions 102, 104 that is above a threshold filtration efficiency (e.g. 85%). In one embodiment, the viral filtration efficiency of the barrier 100, 100′ is at least 95% between the first region 102 and the second region 104.
In one embodiment, the barrier 100, 100′ is used as a facial cover.
In this embodiment, the first region is external surroundings 202 of a user 203 of the facial cover 200. Thus, in this embodiment, the outer surface 108 of the first side 106 is directed toward the external surroundings 202 (see
In one embodiment, the facial cover 200 is secured to the face of the user 203 using ear loops 206. However, the embodiments of the present invention are not limited to this design.
In yet another embodiment, the facial cover can be attached to the user 203 using a fastener (e.g. elastic) that secures around the head of the user 203.
In another embodiment, as shown in
Although the embodiments discussed with respect to
In one embodiment, the barrier 100, 100′ is used to over the outside of the conventional mask (e.g. the side of the mask facing the exterior surroundings of the user). In an example embodiment, the conventional mask 310 includes one or more untreated layers (e.g. that are not treated with pathogenicidal components) and thus are susceptible to surface contamination by pathogens.
In another embodiment, the barrier 100, 100′ is used to enclose the conventional mask (e.g. cover both sides of the mask facing the external surroundings 202 and facing the user 203 when worn on the face).
In still other embodiments, the barrier 100, 100′ encloses the conventional mask 310 (e.g. such that all surfaces of the conventional mask 310 are covered by the barrier 100, 100′). As shown in
In one embodiment, the barrier 100, 100′ is an integral barrier such that the outer surface 108′ and the outer surface 118′ are part of the same single piece of material. In other embodiments, the outer surface 108′ and the outer surface 118′ are from separate pieces of the barrier 100, 100′ and thus are not integral. In an example embodiment, where the outer surfaces 108′, 118′ are separate pieces of material, each of these outer surfaces 108′, 118′ are adhered to the conventional mask 310 (e.g. using an adhesive).
As discussed with respect to
Based on the previously disclosed embodiments, the barrier 100, 100′ allows users to reduce their exposure to infectious pathogens. In one embodiment, the barrier 100, 100′ is a pleated mask cover, with flexibility similar to a surgical mask, wraps around the user's mask 310, and provides a sealed environment with the aid of the adhesive 330, 340 to prevent contamination of the mask, and also has flexibility to fit to the user's face and allow a snug fit such as is required when using N95 and similar masks/respirators. The mask cover has slits 326a through 326d to allow the passage of straps when using a mask with that form factor, similar to a surgical mask. In another embodiment, the mask cover will also provide sealed protection if one is using a mask 310 with ear loops 306, or other methods used to fasten/secure to the user's head. In an example embodiment, the flaps for the adhesive seal are designed to peel away allowing the cover to be opened and remove the mask 310 without contaminating either the external or internal surfaces.
Although
In one embodiment, the air filter 404 includes the barrier 100, 100′ discussed with respect to
In an embodiment, although
In yet another embodiment, although
In one embodiment, another context where the barrier 100, 100′ can be used is in forming garments or clothing, particularly garments or clothing used in areas where pathogens are present (e.g. medical facility). In an example embodiment, the barrier 100, 100′ can be used to form garments worn by medical professionals (e.g. surgeons in a surgical room). In this example embodiment, the first region 102 is the external surroundings of the medical facility and the second region 104 is the body of the medical professional (e.g. covered by the garment).
In one embodiment, another context where the barrier 100, 100′ can be used is for air filters used in ventilators.
In one embodiment, another context where the barrier 100, 100′ can be used is protecting food items from being contaminated and/or spoiled by pathogens.
A method is now presented herein for forming the barrier 100, 100′.
In an embodiment, the method 700 is configured to form the material of the barrier 100, 100′ in order to optimize one or more design parameters of the barrier 100, 100′. In one embodiment, one of the design parameters is the efficiency of the pathogenicidal components 112 in killing or deactivating pathogens. The inventors recognized that this efficiency is based on the concentration of pathogenicidal components 112 used in forming the barrier 100, 100′. In an example embodiment, where salt is employed as the virucidal components 112, this efficiency is based on a level of crystallization (LOC) of the salt. Another design parameter is the air permeability of the barrier 100, 100′, which affects the comfort of the user (e.g. breathability) wearing the facial cover including the barrier 100, 100′. Thus, in an embodiment, the method 700 is configured to optimize these two parameters (e.g. killing or deactivation efficiency of pathogens and breathability) of the barrier 100, 100′. The inventors of the present invention understood that varying one of the parameters may affect the other parameter. In an example embodiment the inventors of the present invention understood that increasing the level of concentration of the pathogenicidal components 112 (or level of crystallization of the salt) may decrease the air permeability (and thus the breathability) of the facial cover employing the barrier 100, 100′. Thus, in an example embodiment, the method 700 is employed to optimize values of these parameters in order to design the barrier 100, 100′ with a sufficient concentration of pathogenicidal components 112 to efficiently kill or deactivate the pathogens while simultaneously ensuring an adequate air permeability (and thus breathability).
In an embodiment, one or more sheets of material are used to form the barrier 100, 100′ (e.g. with a width and length of about 40 cm by 40 cm and/or with a width and length in respective ranges from about 10 cm to about 50 cm). In one example embodiment, the sheet(s) of material is a thermo plastic material (e.g. polypropylene) and/or cotton blend (e.g. silk, wool, cotton, etc.).
In an embodiment, step 701 includes wetting material with a solution including pathogenicidal components with a concentration of a particular value. In one embodiment, the wetting of step 701 is performed over a first time period (e.g. about 20 hours). In an example embodiment, the solution has a salt concentration (e.g. in a range from about 0.02 ml/cm2 to about 0.06 ml/cm2 and/or in a range from about 0.01 ml/cm2 to about 0.1 ml/cm2 of salt).
In another embodiment, step 701 includes applying the pathogenicidal components (e.g. virucidal and/or bactericidal components) to the material and includes one or more of misting, spraying, sputtering, painting or soaking/submerging (e.g. for liquid components) and pelleting or powdering (e.g. for solid components) and applied in a dry coat, rolled, aerially dispersed, dry-sputtered, evaporated, pressured, and vacuum incorporated. In an example embodiment, dry powders may be ground into nanoparticles or suspended and emulsified in a liquid for applications to coat the mask cover. Gels and oils may be applied a liquid coating.
In an embodiment, step 701 includes submerging the material in a tank with the solution for the first time period such that the material is fully submerged and/or uniformly spraying the material with the solution and/or injecting, from an injectable platform, the solution into the material. In an example embodiment, step 701 includes submerging the material in a tank with a volume (e.g. about 34 mL) of solution for the first time period (e.g. about 12 hours) to transform hydrophobic properties and increase wetting/absorption, which is considered the pre-wetting process. In this example embodiment, a remaining volume (e.g. about 68 mL) is applied in the same manner prior to the drying step 703. In another example embodiment, the material is fully submerged in the tank of solution during the wetting step 701. It should be noted that the particular values of the parameters of the submerging discussed above (e.g. time period for the step 701, size of the material, volume of solution, etc.) can be adjusted based on the purpose of the material (e.g. facial cover, air filter, garment/apparel, food packaging, etc.).
In an embodiment, step 701 includes spraying the material placed in a petri dish or a plate of a necessary size (e.g. about 40 cm by 40 cm). In this embodiment, for all intents and purposes), the spraying step is performed using a jet or mist spray, and the solution is uniformly spread over the material. In an example embodiment, the first time period is about the same (e.g. about 12 hours) as for the submerging step. In an example embodiment, a volume of spray solution utilized in the spraying step is about 0.90 mL. In another example embodiment, a spray diameter used during the spraying step is about 15.5 cm when placed about 20 cm away from the material. It should be noted that the particular values of the parameters of the spraying discussed above (e.g. time period for the step 701, size of the material, volume of solution, volume of spray, etc.) can be adjusted based on the purpose of the material (e.g. facial cover, air filter, garment/apparel, food packaging, etc.). It should be noted that the particular values of the parameters of the spraying discussed above (e.g. time period for the step 701, size of the material, volume of spray, diameter of spray, etc.) can be adjusted based on the purpose of the material (e.g. facial cover, air filter, garment/apparel, food packaging, etc.).
In an embodiment, step 701 includes injecting the material with the solution. In this embodiment, the injecting is performed using an injectable platform and syringe needles with a gauge in a certain range (e.g. from about gauge 28 to about gauge 32 with an inner diameter ranging from about 0.18 mm to about 0.11 mm). In an example embodiment, the active wetting area is about 2.7 mm. In another embodiment, the needles are aligned on a platform of width equal (e.g. about 40 cm) to the sheet of material. In an example embodiment, the solution is equally divided to penetrate, inject, and impregnate material immediately with no prewetting time. In an example embodiment, step 701 involves about 22,500 syringes each delivering about 0.004 mL in one step, thus eliminating the need for a pre-wetting step. In another example embodiment, the volume is well above the dead volume of needles that size, allowing optimal priming of each syringe.
In an embodiment, step 703 including drying the wetted material from step 701 for a second time period (e.g. about 10 hours or in a range from about 8 hours to about 15 hours) after the first time period. In one embodiment, step 703 is performed in one of an oven or an airtight vessel, where the second time period for the drying step in the airtight vessel is less than the second time period for the drying step in the oven. In an example embodiment, in step 703 the drying may be undertaken at a temperature in a range from about 20 degrees C. to about 100 degrees C., and sterilization may be performed with either heat (e.g. from about 20 degrees C. to about 100 degrees C.) or with gas sterilization.
In an embodiment, the drying step 703 involves conventional drying, where the material is placed in a conventional oven of uniform temperature and throughout brought by a fan in the rear. In this embodiment, the drying step 703 is performed for about 24 hours. In another embodiment, the drying step 703 involves vacuum drying performed in an airtight vessel, where the relative humidity and pressure are drastically reduced. In this example embodiment, with the atmospheric pressure lowered, materials can dry much more rapidly. In an example embodiment, the boiling point of water significantly decreases (e.g., from about 100 degrees to about 35 degrees C.), as a result the rate of evaporation increases, allowing drying that would take 24 hours at atm to take place within hours, depending on the specific conditions set.
In an embodiment, step 705 includes measuring an air permeability of the material after step 703. In one embodiment, the measuring of the air permeability includes measuring an air pressure difference across the material after step 703 based on a constant flowrate across the material.
In an embodiment, step 707 includes comparing the value of the air permeability measured in step 705 with a threshold value of air permeability (e.g. corresponding to an air pressure difference equal to or less than 0.2 mm H20/cm2). If the measured value of the air permeability from step 705 is greater than the threshold value, the method 700 moves to block 709. If the measured value of the air permeability from step 705 is not greater than the threshold value, then the method 700 moves to block 711.
In an embodiment, step 709 includes increasing the concentration of the pathogenicidal components 112 in the solution (e.g. increasing the concentration of salt in the solution) and then repeating steps 701 through 707 for the increased concentration value of the solution.
In an embodiment, step 711 includes using the material from the previous iteration of step 703 as the barrier 100, 100′. In one embodiment, where a multiple layer 101a, 101b barrier 100′ is used in step 711, the method 700 (e.g. steps 701 through 709) are repeated to form each respective layer 101a, 101b of the multiple layer barrier 100′ which is then used in step 711. In one embodiment, steps 701 through 707 are repeated provided that the measured air permeability is greater than the threshold value of air permeability. Once step 707 indicates that the value of the air permeability is less than the threshold value of the air permeability, this indicates that the concentration of the pathogenicidal components 112 is too high and thus adversely affecting the air permeability. Thus, the concentration of the pathogenicidal components 112 in the previous iteration of steps 701 through 707 is utilized in step 711 to form the barrier 100, 100′. In an example embodiment, if the fourth iteration of steps 701 through 707 indicates that the measured air permeability is less than the threshold value, then the value of the concentration used in the third iteration of steps 701 through 707 is employed in step 711 to form the barrier 100, 100′. This concentration of pathogenicidal components 112 advantageously provides an effective balance between a high concentration of pathogenicidal components 112 (e.g. to maximize the killing or deactivation of the pathogens) while still ensuring an acceptable level of air permeability. The inventors of the present invention found a surprising result-despite four iterations of steps 701 through 709 and four consecutive increases in the salt concentration of the solution, the measured air permeability exceeded the threshold value in step 707 for each iteration. This is a surprising result since the inventors expected that an increase the salt concentration of the solution would cause reduced air permeability (e.g. since the increased concentration of salt crystals were expected to partially cover some of the pores). Thus, in one embodiment, the inventors performed the method 700 and utilized the highest concentration value among four consecutive increases (four iterations of steps 701 through 709). In one example embodiment, increasing values of the salt concentration used during the four iterations of steps 701 through 709. In an example embodiment, these increasing values of concentration for each iteration of steps 701 through 709 include 0.02122 ml/cm2, 0.03182 ml/cm2, 0.04244 ml/cm2 and 0.06367 ml/cm2. However, these example values of the salt concentration are just one example of values and the values of the salt concentration employed in the method herein are not limited to these particular values or these particular range of values.
The treated material with the virucidal components (from steps 701 and 703) has certain properties and characteristics. In an embodiment, due to the application of the solution to the polypropylene sheet (step 701), the material exhibits certain properties and characteristics that differ drastically from the bare sheet utilized in current conventional masks 310 (e.g. conventional surgical masks). Contact Angle (ΘC) is defined as a quantity measuring ability of a liquid to the wet the surface of a solid. In addition to the formation of salt crystals in the material (e.g. NaCl crystals) on the material (e.g. polypropylene fibers), the presence of surfactant altered the surface properties from hydrophobic (e.g. ΘC is about) 134±5° to hydrophilic (e.g. ΘC is about) 0°. As a result, the adhesion of viral aerosols to the fibers is greatly improved.
In one embodiment, during use of the barrier 100, 100′ formed by the method 700, once the outer surface 108, 118 is exposed to virus aerosols, the salt crystals at the point of contact dissolve and gradually increase the osmotic pressure in the viral cells. In this embodiment, evaporation takes place, causing the salt concentration to shift from the higher concentration of the barrier 100, 100′ into the virus eventually leading to the oversaturation of the cell. Once the solubility limit is reached, recrystallization of the salt commences. During drying, viruses and bacterial cells are exposed to even more osmotic pressure, eventually reaching hyperosmotic stress (e.g. about >541 mOsm). The combination of crystallization and intercellular stress, prompts irreversible deformation of the viral envelope and overall structural damage causing infectivity loss of the virus.
Unlike the first method 700 for forming the barrier 100, 100′ that is disclosed in
A system that is used to perform the second method is now discussed herein.
In an embodiment, the method disclosed herein involves melt blowing. Melt blowing is a conventional fabrication method of micro- and nanofibers where a polymer melt is extruded through small nozzles surrounded by high speed blowing gas. The randomly deposited fibers form a nonwoven sheet product applicable for filtration, sorbents, apparels and drug delivery systems. The substantial benefits of melt blowing are simplicity, high specific productivity and solvent-free operation. Some of the polymers used to produce melt blown fabric include, Polypropylene, Polystyrene, Polyesters, Polyurethane, Polyamides (nylons), Polyethylene, Polycarbonate, Polylactic Acid (PLA) to name a few. Nonwoven melt-blown fabrics are porous. As a result, they can filter liquids and gases. Their applications include water treatment, masks, and air-conditioning filters. Nonwoven materials can retain liquids several times their own weight. Melt-blown fabrics have three qualities that help make them useful for clothing, especially in harsh environments: thermal insulation, relative moisture resistance and breathability. The inventors of the present invention recognized that an improved melt blowing method could be used, with the additional step of introducing pathogenicidal components 112 (e.g. salt) into the polymer material (e.g. into an air stream utilized in the melt blowing process), so that it is incorporated into the fabric as it is produced, negating the need for a secondary process of adding a salt solution to the finished fabric and then drying the fabric to form a crystalline structure within the fabric. This formed fabric is used to form the one or more layers 101 of the barrier 100, 100′.
As shown in
In an embodiment, the system 1100 also includes a gear pump 1104 which receives the pressurized molten polymer 1122 from the extruder 1102. The gear pump 1104 subsequently discharges a consistent flow of pressurized molten polymer 1124.
In an embodiment, the system 1100 also includes a die assembly 1106 which receives the consistent flow of pressurized molten polymer 1124 from the gear pump 1104. In one embodiment, the die assembly 1106 extrudes polymer filament strands through holes in a spinneret (not shown) of the die assembly 1106 based on the pressurized molten polymer 1122 received from the gear pump 1104.
In an embodiment, the system 1100 also includes an air manifold 1108 (e.g. air compressor) to supply a flow of air to attenuate the polymer filament strands output from the die assembly 1106 into a stream of polymer fibers 1128. In one example embodiment, the flow of air is a primary air flow 1126 that is high velocity and is directed within the die assembly 1106 (e.g. within a slot defined by the die assembly 1106) after which the primary air flow 1126 attenuates the polymer filament strands into the stream of polymer fibers 1128. In another example embodiment, the flow of air is a secondary air flow 1127 that is low velocity (e.g. a velocity lower than the primary air flow 1126) and is directed downstream of the outlet of the die assembly 1106 where the secondary air flow 1128 attenuates the polymer filament strands into the stream of polymer fibers 1128. In some embodiments, both the primary air flow 1126 and the secondary air flow 1127 are employed to attenuate the polymer filament strands into the stream of polymer fibers 1128.
In an embodiment, the system 1100 also includes a collector 1110 (or conveyor) with a surface onto which the stream of polymer fibers 1128 are directed to form a non-woven fabric (not shown). In an embodiment, the non-woven fabric is used to form the layer 101 of the barrier 100 or the multiple layers 101a, 101b of the barrier 100′. In one embodiment, the stream of polymer fibers 1128 are directed over a width 1129 of the collector 1110 such that the non-woven fabric formed on the collector 1110 has the width 1129. In an example embodiment, the width 1129 varies based on the system 1100 and/or parameters of the system 1100 (e.g. a separation between the die assembly 1106 and the collector 1110).
In an embodiment, the system 1100 includes a device configured to introduce the pathogenicidal components 112 into the polymer material at one or more locations along the system 1100. In one embodiment, the device is a pathogenicidal component source 1105 and is configured to introduce the pathogenicidal components 112 into one or both of the primary air flow 1126 or secondary air flow 1127 such that the pathogenicidal components 112 are introduced into the stream of polymer fibers 1128 upstream of the collector 1110. In other embodiments, the pathogenicidal component source 1105 is configured to introduce the pathogenicidal components 112 at a location in the system 1100 more upstream, such as in the consistent flow of pressurized molten polymer 1124 (e.g. at or downstream of the gear pump 1104) or in the pressurized molten polymer 1122 (e.g. at or downstream of the extruder 1102). In these embodiments, the pathogenicidal component source 1105 is configured to introduce the pathogenicidal components 112 into the system such that the polymer material is sufficiently malleable that the pathogenicidal components 112 adhere to the polymer material. In an example embodiment, where the pathogenicidal component source 1105 is configured to introduce the pathogenicidal components 112 into the primary air flow 1126 or secondary air flow 1127, the stream of polymer fibers 1128 is sufficiently malleable that the pathogenicidal components 112 adhere to the stream of polymer fibers 1128. The inventors recognized that this feature of the method is advantageous as it ensures that the non-woven fabric formed on the collector 1110 features a non-woven fabric of the polymer fibers with embedded or integrated pathogenicidal components 112 therein (which can then be used to form the one or more layer 101 of the barrier 100, 100′). Hence, the inventors of the present invention recognized that this advantageous step obviates the need to first form the non-woven fabric followed by a separate time consuming step of coating the formed non-woven fabric with pathogenicidal components 112.
In an embodiment, the system 1100 includes a winder 1112 that is used to collect (e.g. wind up) the formed non-woven fabric on the collector 1110 with the integrated or embedded pathogenicidal components 112. In an example embodiment, the winder 1112 is rotatable such that it forms a spool of the non-woven fabric that can be then used to form various layers 101 of the barrier 100, 100′ previously disclosed (e.g. facial cover, air filter, PPE equipment, clothing or gown material for medical professionals, food packaging, etc.).
In an embodiment, the system 1200 includes the extruder 1102 with an inlet 1201 through which the polymer pellets 1120 are gravity fed into a heated barrel 1204 that houses a screw 1202. The screw 1202 rotates within the heated barrel 1204. The pellets 1120 are conveyed forward along hot walls of the barrel 1204 between the flights of the screw 1202, as shown in
In an embodiment, the system 1200 includes the gear pump (or metering pump) 1104 that is a positive-displacement and constant-volume device for uniform melt delivery to the die assembly 1106. In one embodiment, the gear pump 1104 ensures consistent flow of clean polymer mix under process variations in viscosity, pressure, and temperature. The gear pump 1104 also provides polymer metering and the required process pressure. As shown in
In an embodiment, the system 1200 includes the die assembly 1106 that has one or more distinct components. In one embodiment, these distinct components include a polymer feed distribution (not shown), a spinneret 1220 (
In an embodiment, the feed distribution (not shown) of the die assembly 1106 usually has no mechanical adjustments to compensate for variations in polymer flow across the die assembly 1106 width. In another embodiment, the system 1200 is often operated in a temperature range where thermal breakdown of polymers proceeds rapidly. Thus, in some embodiments, the feed distribution is usually designed in such a way that the polymer distribution is less dependent on the shear properties of the polymer. This feature allows the melt blowing of widely different polymeric materials with one distribution system. The feed distribution balances both the flow and the residence time across the width of the die assembly 1106. In an embodiment, there are two types of feed distribution that have been employed in the melt-blown die assembly 1106: a T-type (e.g., tapered and non-tapered) and a coat hanger type. In some embodiments, the coat hanger type feed distribution is widely used because it gives both even polymer flow and even residence time across the full width of the die assembly 1106.
As shown in
In some embodiments, in the spinneret 1220 smaller orifices are usually employed compared to those generally used in either fiber spinning or spun bond processes. In one embodiment, the spinneret 1220 has about 0.4-mm diameter orifices spaced at about 1 to 4 per millimeters (e.g., about 25 to 100 per inch). In an example embodiment, there are two types of spinnerets used: a capillary type spinneret 1220 (
In an embodiment, the air manifold 1108 supplies the high velocity primary air flow 1126 through the slot 1235a on the top and the slot 1235b on the bottom sides of the spinneret 1220, as shown in
As soon as the molten polymer is extruded from the spinneret 1220 holes, the high velocity primary air flow 1126 (exiting from the top and bottom sides of the spinneret 1220) attenuate the polymer streams to form the stream of polymer fibers 1128 (e.g. microfibers). In an embodiment, the pathogenicidal components 112 (e.g. salt crystals) are added to the primary air flow 1126 from the pathogenicidal component source 1105 (e.g. salt hopper 1205). Thus, by adding the pathogenicidal components 112 to the primary air flow 1126, the pathogenicidal components 112 adhere to the stream of polymer fibers 1128 which are heated and malleable based on the primary air flow 1126. The inventors of the present invention recognized that this advantageously adheres the pathogenicidal components 112 (e.g. salt crystals) to the stream of polymer fibers 1128 upstream of the collector 1110. In an example embodiment, in some embodiments a vacuum device 1240a, 1240b is provided to collect pathogenicidal components 112 that were added to the primary air flow 1126 but did not adhere to the stream of polymer fibers 1128. The vacuum device 1240a, 1240b advantageously returns these pathogenicidal components 112 back to the pathogenicidal component source 1105 (e.g. salt hopper 1205a, 1205b) to enhance the cost efficiency of the system 1100, 1200.
Although
In one embodiment, as the primary air flow 1126 containing the stream of polymer fibers 1128 (e.g. microfibers) progresses toward the collector 1110 screen, it draws in a large amount of surrounding air (e.g., the secondary air flow 1127) that cools and solidifies the fibers in the stream 1128, as shown in
In an embodiment, after being cooled and solidified by the secondary air flow 1127, the solidified stream of fibers 1128 subsequently get laid randomly onto the collector 1110 screen, forming a self-bonded nonwoven fabric 1130. In an embodiment, the nonwoven fabric 1130 is then used to form the layer(s) 101 of the barrier 100, 100′.
As further shown in
In an embodiment, the collector 1110 moves at a speed, in order to collect the non-woven fabric 1130. In one embodiment, the winder 1112 then collects the non-woven fabric 1130 on a reel. In an example embodiment, the collector 1110 speed and the collector 1110 distance from the spinneret 1220 can be varied to produce a variety of melt-blown webs and/or a variety of distributions of the pathogenicidal components 112 within the non-woven fabric 1130. In some embodiments, a vacuum is applied to the inside of the collector 1110 screen to withdraw the hot air and enhance the fiber laying process. In one example embodiment, the collector 1110 is a conveyor.
In an embodiment, the winder 1112 is provided to collect the non-woven fabric 1130 into a reel. In one embodiment, the melt-blown web is usually wound by the winder 1112 onto a cardboard core and processed further according to the end-use requirement. In an example embodiment, the combination of fiber entanglement and fiber-to-fiber bonding generally produce enough web cohesion so that the web can be readily used without further bonding. However, additional bonding and finishing processes may further be applied to these melt-blown webs. Additional bonding, over the fiber adhesion and fiber entanglement that occurs at lay down, is employed to alter web characteristics. In an example embodiment, thermal bonding is the most commonly used technique. The bonding can be either overall (area bonding) or spot (pattern bonding). Bonding is usually used to increase web strength and abrasion resistance. As the bonding level increases, the web becomes stiffer and less fabriclike.
In an embodiment, although most nonwovens are considered finished when they are rolled up at the end of the production line, many receive additional chemical or physical treatment such as calendering, embossing, and flame retardance. Some of these treatments can be applied during production, while others must be applied in separate finishing operations.
In an embodiment, in step 1401 polymer pellets are melted within an extruder to form pressurized molten polymer. In one embodiment, polymer pellets 1120 are added to the extruder 1102 (e.g. through the inlet 1201 shown in
In an embodiment, in step 1403 a consistent flow of pressurized molten polymer is discharged from the gear pump. In one embodiment, in step 1403 the consistent flow of pressurized molten polymer 1124 is discharged from the gear pump 1104 based on the pressurized molten polymer 1122 received by the gear pump 1104 from the extruder 1102.
In an embodiment, in step 1405 polymer filament strands are extruded from the die assembly. In one embodiment, in step 1405 polymer filament strands are extruded from holes in the spinneret 1220 based on the consistent flow of pressurized molten polymer 1124 received from the gear pump 1104.
In an embodiment, in step 1407 the polymer filament strands extruded in step 1405 are attenuated with air from an air manifold to form a stream of polymer fibers. In one embodiment, in step 1407 the polymer filament strands extruded in step 1405 are attenuated with air from the air manifold 1108 to form the stream of polymer fibers 1128. In this embodiment, the stream of polymer fibers 1128 are directed onto the collector 1110 (e.g. across the width 1129) to form non-woven fabric 1130. In some embodiments, in step 1407 the primary air flow 1126 from the air manifold 1108 is used to attenuate the polymer filament strands to form the stream of polymer fibers 1128. In other embodiments, in step 1407 the secondary air flow 1127 from the air manifold 1108 is used to attenuate the polymer filament strands to form the stream of polymer fibers 1128. In still other embodiments, in step 1407 both the primary air flow 1126 and the secondary air flow 1127 from the air manifold 1108 is used to attenuate the polymer filament strands to form the stream of polymer fibers 1128.
In an embodiment, in step 1409 pathogenicidal components 112 are introduced into the system 1100, 1200 upstream of the collector 1110. In some embodiments, in step 1409 the pathogenicidal components 112 (e.g., salt crystals 1304) are introduced from the pathogenicidal component source 1105 (e.g. salt hopper 1205) into the primary air flow 1126 and/or the secondary air flow 1127 during step 1407 such that they adhere to the stream of polymer fibers 1128 that are malleable due to step 1407. In other embodiments, in step 1409 the pathogenicidal components 112 are introduced into the gear pump 1104 and/or into the consistent flow of pressurized molten polymer 1124 downstream of the gear pump 1104. In still other embodiments, in step 1409 the pathogenicidal components 112 are introduced into the extruder 1102 and/or into the pressurized molten polymer 112 downstream of the extruder 1102. In some embodiments, the size of the pathogenicidal components 112 (e.g. salt crystals 1304) are larger than the size of the polymer fibers within various components of the system and thus in these embodiments the pathogenicidal components 112 are not added to components of the system which may feature a filter that permits the polymer fibers to pass through but would remove the pathogenicidal components 112 from the stream of polymer fibers (e.g. extruder 1102).
In an embodiment, after steps 1407 and 1409, a winder is used to collect the formed non-woven fabric from the collector. In one embodiment, after steps 1407 and 1409, the winder 1112 is used to wrap the formed non-woven fabric 1130 from the collector 1110 into a reel. In these embodiments, the reel of non-woven fabric 1130 can then be used to form one or more items or articles with the non-woven fabric 1130.
In an embodiment, in step 1411 the non-woven fabric formed by the method 1400 is used to form the barrier 100, 100′ positioned between the first region 102 and the second region 104 to prevent passage of pathogens 110 between the first and second regions 102, 104. In one embodiment, in step 1411 the non-woven fabric 1130 (e.g. formed on the reel due to the winder 1112) is used to form the one or layer(s) 101 of the barrier 100, 100′. In an example embodiment, in step 1411 the non-woven fabric 1130 is used to form a facial cover (e.g., facial cover 200, 200′, 200″, 300, 300′). In still other embodiments, in step 1411 the non-woven fabric 1130 is used to form an air filter (e.g., air filter 404, air filter 601, etc.). In still other embodiments, in step 1411 the non-woven fabric 1130 is used to form a garment (e.g. garment 500 for a medical professional, any article of clothing or apparel, etc.). In still other embodiments, in step 1411 the non-woven fabric 1130 is used to form packaging for food items (e.g. packaging 1500 of
In one embodiment, the level of crystallization (LOC) of the salt virucidal components used in the material is measured during X-ray diffraction. X-Ray diffraction analysis is a commonly used method for microstructural analysis, specifically to determine the crystallographic structure of the material. Results of this analysis are quantified by Miller indices, a set of three compound specific numbers indicating the orientation of planes of atoms in a crystal.
X-ray diffraction (XRD) is the experimental science determining the atomic and molecular structure of a crystal, in which the crystalline structure causes a beam of incident X-rays to diffract into many specific directions. By measuring the angles and intensities of these diffracted beams, a crystallographer can produce a three-dimensional picture of the density of electrons within the crystal. From this electron density, the mean positions of the atoms in the crystal can be determined, as well as their chemical bonds, their crystallographic disorder, and various other information.
Since many materials can form crystals—such as salts, metals, minerals, semiconductors, as well as various inorganic, organic, and biological molecules—XRD has been fundamental in the development of many scientific fields. In a single-crystal X-ray diffraction measurement, a sample (e.g. barrier 100, 100′ formed by the methods herein or a small portion thereof) is mounted on a goniometer. The goniometer is used to position the sample (e.g. barrier 100, 100′) at selected orientations. The sample (e.g., barrier 100, 100′) is illuminated with a finely focused monochromatic beam of X-rays, producing a diffraction pattern of regularly spaced spots known as reflections. The two-dimensional images taken at different orientations are converted into a three-dimensional model of the density of electrons within the sample (e.g. barrier 100, 100′) using the mathematical method of Fourier transforms, combined with chemical data known for the sample.
In an embodiment, XRD produces a diffraction pattern which provides insight on the atomic structure within the salt crystals and the intensity associated with it quantifies the electron density in the crystalline lattice planes (in arbitrary units, see vertical axis 804). The inventors of the present invention recognized that when lower concentration values of salt were used, the intensity of the XRD diffraction pattern would respectively decline, since less salt was used. In an example embodiment, the peaks 806a, through 806i are correlated to that of NaCl, since every crystal has a specific miller indices. In an example embodiment, the average intensity achieved with the salt concentration values used herein was about 3 au (arbitrary units), with crystal specific peaks having higher values.
In one embodiment, a filtration efficiency of the barrier 100, 100′ is another parameter that is measured and utilized in developing the barrier 100, 100′. The purpose of particulate filtration efficiency (PFE) is to display adequate filtration of monodispersed particles under a constant flow rate (e.g. using ASTM F2299 method). In an embodiment, to measure the PFE of the barrier 100, 100′, a predetermined amount of polystyrene latex particles (e.g., mean particle diameter of about 0.216±0.0009 μm; Agar Scientific) are passed through the material at a constant flowrate (e.g. about 10 cm/second). Light scattering is used to quantify the particle count downstream. An efficiency value is calculated using:
Where E is the value of the PFE; Ma is the particle count downstream of the barrier 100, 100′ and Mn is the particle count upstream of the barrier 100, 100′. In one embodiment, Md was held constant by using manufacturer particle concentration of about 1.80×1011 n/mL.
Table 1 below indicates values of the PFE for a conventional fleece mask; a conventional 3 ply surgical mask and for the barrier 100, 100′ (or “amp shield” in Table 1). As indicated by the values of PFE in Table 1, the filtration efficiency of the barrier 100, 100′ is about 98.7% and higher than the filtration efficiency of both conventional masks.
In one embodiment, a viral/bacterial filtration efficiency (VFE/BFE) of the barrier 100, 100′ is another parameter that is measured and utilized in developing the barrier 100, 100′. The purpose of VFE/BFE is to quantity performance of the barrier 100, 100′ in filtering out bacteria and viruses (e.g. using ASTM F2101 method). In one embodiment, the ASTM F2101 method that measures BFE is based on aerosolized liquid suspension of Staphylococcus aureus (e.g. mean particle size of 3.5±0.6 μm; Sigma Aldrich) passed through target material at a constant flow rate of 1 ft3/min in a six-stage Andersen sampler. Each of the tiers contain an agar plate acting as a medium for growth of any bacteria which passes through the material.
In one embodiment, the ASTM F2101 method that measures VFE is based on bacteriophage ΦX174 that is aerosolized (e.g., mean size of virus-containing water droplet 3.2±0.4 μm, not individual viruses), which only infects E. coli, and then targeted at sample. Rather than bare agar plates, they are inoculated with Escherichia coli.
For both BFE and VFE tests, results are compared to a control test in the absence of the barrier 100, 100′. The BFE and VFE are calculated using:
where C and F are the control and filter results. Tables 2 and 3 below indicates the values of BFE (Table 2) and VFE (Table 3) for the barrier 100, 100′ (AMP) and the control. As indicated by the values of BFE in Table 2 and VFE in Table 3, the BFE and VFE values of the single ply layer 101 is about 99.4-99.5%.
In one embodiment, a fluid resistance of the barrier 100, 100′ is another parameter that is measured and utilized in developing the barrier 100, 100′. The purpose of fluid resistance is to provide adequate resistance to the transfer of fluids from its out to its inner layers due to splashing or spraying. In an example embodiment, a particular method is employed to measure the fluid resistance (e.g. ASTM F1862). In an example embodiment, 2 mL of synthetic blood is targeted at the barrier 100, 100′ at varying velocities corresponding to the following blood pressures: 80 mmHg: Level 1, venous blood pressure; 120 mmHg: Level 2, arterial pressure; and 160 mmHg: Level 3, high pressures occurring during trauma. In one embodiment, the barrier 100, 100′ is an accessory to current masks, extending the lifetime of current masks while additionally reducing the number of possible fomites and as a result, reduction in cross contamination. Depending on the setting, the barrier 100, 100′ adapts, at all three levels improving barrier efficiency by adding an additional layer. ASTM defines passing as having at least 29 of 32 masks not showing fluid onto opposite side. Table 4 below indicates the amount of barrier 100, 100′ that passed and failed, at each level.
In one embodiment, air exchange (or air permeability) of the barrier 100, 100′ is another parameter that is measured and utilized in developing the barrier 100, 100′. The air exchange parameter, commonly referred to as AP, indicates sufficient breathability for the user wearing the facial cover (made from the single ply layer 101). That is, the ability of the barrier 100, 100′ to restrict airflow through it (e.g. using method EN 14683). In an embodiment the method for measuring air exchange (or air permeability) is employed in step 705 of the method 700 and measures the air pressure difference on both sides of the barrier 100, 100′ using a manometer, with airflow supplied at a constant flowrate. Table 5 below indicates the values of the air exchange (or air permeability) for the requirement of FDA approval (top row of Table 5), the conventional mask 310 (second row of Table 5) and the facial cover 300 including the conventional mask 310 and the barrier 100, 100′ (third row of Table 5). Thus, in one embodiment, the air exchange (or air permeability) is based on the difference between the third row and second row of Table 5 (e.g. in a range from about 0.05 to about 0.07 mmH20/cm2).
Table 6 below also indicates a summary of the measured performance parameters of the barrier 100, 100′ (far right column of Table 6) for various levels.
indicates data missing or illegible when filed
Filing Document | Filing Date | Country | Kind |
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PCT/US22/53364 | 12/19/2022 | WO |
Number | Date | Country | |
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63290751 | Dec 2021 | US |