The present invention relates to a polypropylene (PP) and polytetrafluoroethylene (PTFE), multilayered mask. One embodiment also relates to a polypropylene (PP) and polytetrafluoroethylene (PTFE), multilayered mask having a transparent window therein.
SARS-CoV-2 or COVID-19 is a rapidly transmissible and highly infectious virus that was first detected in China in December 2019. Since its discovery, it has spread all over the world infecting 266 million individuals and counting. Currently, as of Dec. 1, 2021, COVID-19 has killed 5.2 million people world-wide. To avoid a complete lockdown and to prevent increased transmission of the virus, various countries have instituted and/or reinstituted mask mandates requiring various degrees of compliance in public spaces, such as requiring masks in all indoor facilities, and in more populated areas, even when outside in public.
As of Dec. 3, 2021, COVID-19 has mutated into two new strains, the Delta variant which dominated 2021 and the Omicron variant that was newly discovered in late November 2021. Compared to the original strain of COVID-19, the Delta variant has been shown to have increased transmissibility, and preliminary information has also predicted that the Omicron variant also has increased transmissibility.
Personal protective equipment (PPE) has long included facial coverings within the art. PPE face masks have traditionally been worn in medical facilities to avoid transmitting diseases to high-risk patients. PPE face masks are considered best practice for surgical procedures to preserve a sterile environment while decreasing the risk of infection. Widespread and public use of face masks was first used in eastern-Asian countries and has now become commonplace worldwide in view of COVID-19. In view of the new variations of COVID-19 and their increased transmissibility, PPE has become a primary method of reducing transmission.
Meltblown polypropylene is used as the middle layer of many certified medical masks and in the manufacture of respirators such as N95s. These masks contain a layer of many layers of fine woven polypropylene which is electrostatic and greatly aids in trapping air particulates. However, polypropylene masks usually are only effective for about four hours as the built-up humidity from a user's respiration will nullify the electrostatic properties of polypropylene.
Previously designed surgical face masks include versions with a transparent section arranged over the user's mouth. These face masks are arranged to secure to a user via a head strap fixed to the outside surface of the face mask and additionally comprises a filtration portion that may or may not have anti-microbial materials integrated within the filtration portion. However, the efficacy of these facemasks that include transparent windows may not meet certain required standards for medical providers. Such standards include Health Canada and ASTM International, previous known as the American Society for Testing and Materials.
Thus, there is a long-felt need for a face mask that has superior blood and fluid resistance while still maintaining breathability and dryness after prolonged use that complies with the ASTM International standards and Health Canada standards. Further, there is also a long-felt need for a face masking having the above-mentioned properties and configured to have a transparent portion where a user's mouth is visible in compliance with ASTM International standards and Health Canada standards.
The present invention generally comprises a first polypropylene outer layer, a second polypropylene outer layer, a combination polytetrafluoroethylene and polypropylene inner layer arranged between the first and second polypropylene outer layers, and at least one strap fixed to an outside surface of one of the outer layers.
The present invention also generally comprises a first polypropylene outer layer having an aperture, a second polypropylene outer layer having an aperture, a combination polytetrafluoroethylene and polypropylene inner layer having an aperture arranged between the first and second polypropylene outer layers, a transparent window arranged to overlap the apertures of the outer layers and the inner layer, the transparent window fixedly secured to an external surface of the first polypropylene outer layer, and at least one strap fixed to an external surface of one of the outer layers.
A general object of the present invention is to provide a face mask that provides filtration when the mask has accumulated humidity from extended user respiration over four hours.
A further object of the present invention is to provide a face mask that includes a transparent portion to allow visibility of a user's mouth that increases audibility and aesthetically is more appealing in settings where a user communicates frequently.
Another object of the present invention is to provide a face mask that has specific folding or pleat geometry that increases the distance of the inside surface of the face mask and a window therein from the user's mouth, to improve audibility and general comfort.
A still further object of the present invention is to provide a face mask that is compliant with ASTM F2100-19 Level 2 and 3 compliance levels.
An even further objection of the present invention is to provide a face mask that is compliant with Health Canada standards.
These and other objects, features, and advantages of the present invention will become readily apparent upon a review of the following detailed description of the invention, in view of the drawings and appended claims.
Various embodiments are disclosed, by way of example only, with reference to the accompanying schematic drawings in which corresponding reference symbols indicate corresponding parts, in which:
At the outset, it should be appreciated that like drawing numbers on different drawing views identify identical, or functionally similar, structural elements. It is to be understood that the claims are not limited to the disclosed aspects.
Furthermore, it is understood that this disclosure is not limited to the particular methodology, materials and modifications described and as such may, of course, vary. It is also understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to limit the scope of the claims.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure pertains. It should be understood that any methods, devices or materials similar or equivalent to those described herein can be used in the practice or testing of the example embodiments.
It should be appreciated that the term “substantially” is synonymous with terms such as “nearly,” “very nearly,” “about,” “approximately,” “around,” “bordering on,” “close to,” “essentially,” “in the neighborhood of,” “in the vicinity of,” etc., and such terms may be used interchangeably as appearing in the specification and claims. It should be appreciated that the term “proximate” is synonymous with terms such as “nearby,” “close,” “adjacent,” “neighboring,” “immediate,” “adjoining,” etc., and such terms may be used interchangeably as appearing in the specification and claims.
It should also be appreciated that the directional terms, e.g., “upward”, “top”, “downward”, “bottom”, “rightward”, “leftward”, and similar variations thereof, pertain to the corresponding figures described herein as they are illustrated. For example, “component X being positioned rightwardly relative to component Y”, means that “component X” is located to the right of “component Y” with respect to the drawing to which it pertains.
It should also be further appreciated that polypropylene will be referenced as “PP” herein and after. Also, polytetrafluoroethylene will be referenced as “PTFE” herein and after.
Adverting now to the figures,
It should be appreciated that mask 200 includes all the components of mask 100 and is rotated in
Mask 200 allows the mouth of user 500 to be seen through window 60, making verbal communication easier, i.e., allowing lip-reading. Window 60 is preferably a plastic material having anti-fog attributes and, in a preferred embodiment, is made of polyethylene. This is helpful in decreasing social intimidation that can be experienced in young children's classrooms throughout COVID-19 masking procedures, where a teacher and students are able to see each others' mouths, or in other situations such as occupation therapy settings or mental disability settings. Window 60 may serve a security purpose to identify user 500 more easily behind mask 200 in a setting where user 500 may need to produce identification for entry and temporary removal of a mask may be prohibited, e.g., hazardous chemical or biologic labs, or where removal is unnecessarily risky, e.g., immunocompromised individuals.
The following description should be taken in view of
To fully secure all three layers of mask 100 together, first side ultrasonic weld 402 and second side ultrasonic weld 403 are applied to the sides of mask 100. First side ultrasonic weld 402 and second side ultrasonic weld 403 also function to pleat mask 100 by creating pleats P1-P6. Pleats P1-P6 are all folds on fold lines L1-L6. Fold lines L1, L3, and L5 create pleats P1, P3, and P5, respectively, and are all upward folds, that is, mask 100 is folded upwardly (weld 404 is folded in a direction towards weld 42) and into face surface 21. Fold lines L2, L4, and L6 create pleats P2, P4, and P6, respectively, and are all downward folds (weld 404 is folded in a direction away from weld 42), that is, mask 100 is folded downwardly and away from face surface 21. Pleats P1-P6 create pinch points at their respective ends via first side ultrasonic weld 402 and second side ultrasonic weld 403. When mask 100 is expanded and worn, as shown in
The following description should be taken in view of
To fully secure all three layers of mask 200 together, first side ultrasonic weld 402 and second side ultrasonic weld 403 are applied to the sides of mask 200. First side ultrasonic weld 402 and second side ultrasonic weld 403 also function to pleat mask 200 by creating pleats P1′-P6′. Pleats P1′-P6′ are all folds on fold lines L1′-L6′, respectively. Fold lines L1′, L3′, and L5′ create pleats P1′, P3′, and P5′, respectively. Fold line L1′ is an upward fold, that is, mask 200 is folded upwardly and away from face surface 21 and fold lines L3′ and L5′ are upward folds, that is, mask 200 is folded upwardly and into face surface 21. Fold lines L2′, L4′, and L6′ create pleats P2′, P4′, and P6′, respectively. Fold line L2′ is a downward fold, that is, mask 200 is folded downwardly and into face surface 21. Fold lines L4′ and L6′ are downward folds, that is, mask 200 is folded downwardly and away from face surface 21. Pleats P1′-P6′ create pinch points at their respective ends via first side ultrasonic weld 402 and second side ultrasonic weld 403. When mask 100 is expanded and worn, as shown in
Pleats P1′-P6′ create four (4) panels within mask 200: lower boundary panel 80, connecting panel 82, upper boundary panel 84, and window panel 86. Lower boundary panel 80 is defined by the edge of mask 200 proximate to lower ultrasonic weld 404 and pleat P6′, connecting panel 82 is defined by pleats P5′ and P4′, upper boundary panel 84 is defined by the edge of mask 200 proximate to weld 42 and pleat P1′, and window panel 86 is defined by pleats P2′ and P3′. Window panel 60 is contained within window panel 86 and is arranged to be located on the panel that is farthest from a user's mouth or face. Pleats P1′-P6′ create three (3) different depths of panels 80-86. Lower boundary panel 80 is arranged at a proximal depth PD. Connecting panel 82 and upper boundary panel 84 are arranged at intermediate depth ID. Window panel 86 is arranged at distal depth DD, where distal depth DD is arranged at the farthest distance away from a user's mouth and face—increasing comfort for extended periods of use.
In reference to both
It should be appreciated that PP layer 30a and PTFE layer 30b of inner layer 30 are shown as separate layers in
It should be understood that polypropylene (PP) is a thermoplastic polymer used in a wide variety of applications. It is produced via chain-growth polymerization from the monomer propylene. PP fabric is a non-woven fabric and may be electrostatically charged to improve filtration of air particulates that would pass through a PP sheet. As such, PP is a vital raw material for producing meltblown fabric, which is, in turn, the raw material for producing facial masks.
It should also be understood that polytetrafluoroethylene (PTFE) is a fluorocarbon solid, as it is a high molecular weight compound consisting wholly of carbon and fluorine. PTFE is hydrophobic: neither water nor water-containing substances wet PTFE, as fluorocarbons demonstrate mitigated London dispersion forces due to the high electronegativity of fluorine. PTFE has one of the lowest coefficients of friction of any solid. Since PTFE is hydrophobic, face mask 100 or mask 200 of the present invention will not lose efficiency after extended use, whereas purely PP-comprised face masks will lose their electrostatic charge when worn for over four hours. An advantage of the PP and PTFE combination mask is the microporous structure that is created when it is stretched that is small enough to prevent bacteria and even virus transmission through inner layer 30 of masks 100 and 200.
The ratings of the PTFE layer and PP layer of inner layer 30 are as follows:
The ultrasonic welds, described supra, should be understood to mean techniques well known and understood by one having ordinary skill in the art of “ultrasonic soldering”. The ultrasonic welds may be a laminating process or any other suitable attachment process for textile adhesion. Alternatively, the ultrasonic welds, described supra, may be achieved by ultrasonic slitting, that is, cleanly cutting and sealing the components of mask 100 and 200, thereby eliminating the disadvantages of hot wire or rotating knives, fraying, unraveling, or beading along the cut edge.
Efficacy Standards and Results
The ASTM International, formerly known as the American Society for Testing and Materials, provides a guide assessing the appropriate face mask level for various procedures:
ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks, provides for the requirements of medical face masks, which are subdivided into three categories. The threshold requirements are based on: Bacterial filtration efficiency (BFE) percentage; Particulate filtration efficiency (PFE) percentage; Splash Resistance (mmHg) pass/fail; Pressure differential (mmH2O/cm2) ΔP; and Flammability pass/fail, as follows:
The following charts show the testing data of mask 100. It should be appreciated that mask 100 may comprise two different levels of efficacy, ATSM F2100-19/Level 2 Compliant or ATSM F2100-19/Level 3 Compliant. The applicable testing data of mask 100 are shown in summation, below:
The following charts show the testing data representation mask 200. It should be appreciated that mask 200 may comprise two different levels of efficacy, ATSM F2100-19/Level 2 Compliant or ATSM F2100-19/Level 3 Compliant. The applicable testing data of mask 200 are shown in summation, below:
Canada no longer follows the ASTM International standards and instead follows new guidance from Health Canada, both mask 100 and mask 200 comply with Health Canada guidelines. Mask 200 also complies with the National Institute for Occupational Safety and Health for medical grade face masks with a transparent window. Mask 200 was also tested for bacterial cleanliness and cytotoxicity per the International Organization for Standardization, ISO 10993-5 and ISO 10993-10 for medical devices and mask 200 passed both tests. ISO 10993-5 tests relate to the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. 10993-10 tests relate to the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
It will be appreciated that various aspects of the disclosure above and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations, or improvements therein may be subsequently made by those skilled in the art which are also intended to be encompassed by the following claims.
Filing Document | Filing Date | Country | Kind |
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PCT/CA2021/051763 | 12/8/2021 | WO |
Number | Date | Country | |
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63122759 | Dec 2020 | US |