[0001] FACEMASKS AND METHODS TO PROTECT AGAINST AIRBORNE PATHOGENS AND PARTICULATES

CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims the benefit under 35 U.S.C. § 119(e) of United States Provisional Patent Application No. 63/155,293, Facemasks and Methods to Protect Against Airborne Pathogens and Particulates, filed on March 1, 2021, and United States Non-Provisional Patent Application No. 17/683,431, Facemasks and Methods to Protect Against Airborne Pathogens and Particulates, filed on March 1, 2022, which applications are incorporated herein by reference.

TECHNCIAL FIELD

[0003] The present invention relates to facemasks and methods, in particular a facemask and method that is designed to protect the wearer from airborne pathogens and particulates which includes a wearer-adjusted polymer strap to conform to both the nose and the entire upper cheek area. In some embodiments the facemask has a snap-together framework that expands the breathable surface of the filter material, facilitates assembly and cleaning, and enables a strap system that can be a single, adjustable continuous strap that goes above, or below, the ear or can be configured to create dual ear loops. Such an embodiment also enables the user to center the inward pressure against the face.

[0004] In addition, a clip is insertable to capture and hold the strap within the facemask structure or the snap-together structure is separatable and the front clip and strap inserted within the facemask.

BACKGROUND ART

[0005] Facemasks are typically worn to cover the mouth and nose of the wearer for respiratory protection in environments with airborne particulates of air pollution, pathogens or allergens and have become especially significant due to the Covid-19 pandemic.

[0006] Since the American Civil War (1861-1865) surgical facemasks (also called “medical masks”) have been in widespread use to supposedly prevent, or reduce, infection of surgical wounds from staff-generated nasal and oral bacteria.

[0007] Thus, such medical masks were designed to be merely “cough suppressors” and not to provide protection to the wearer. However, according to the National Institute for Occupational Safety and Health (NIOSH), three clinical studies found no difference in surgical infection rates whether the staff wore medical masks or not. NIOSH also published that to be effective in reducing a wearer’s exposure to airborne substances, a respiratory protection device needs to have sufficient fit as well as high filtration efficiency. NIOSH also stated that a recent laboratory study of five most-common surgical masks found that 80-100% of subjects failed an OSHA-accepted qualitative fit test. (See CDC - NIOSH Science Blog - N95 Respirators and Surgical Masks at http://blogs.cdc.gov/niosh-scienceblog/2009/10/n95/).

[0008] A more recent study found that “surgical masks barely worked. Masks with ties filtered about 70% of small particles. Those with ear loops filtered less than 40%. ”

[0009] Also “[what is] true for surgical masks appears to be doubly true for homemade cloth masks, which generally filter even fewer small particles and are even less effective. The overall evidence is clear: Standard cloth and surgical masks offer next to no protection against virus-sized particles or small aerosols” according to a recent Journal of American Medical Association (JAMA) study. (See at https://i amanetwork.com/article. aspx?doi=10.1001/iamainternmed.2020 4221)

[0010] Filtering Facepiece Respirators (FFP), with a NIOSH rating of N95-100, are more commonly used in environments where greater protection is required than that provided by medical masks and are designed to have edges to form a seal around the user’s nose and mouth. This tight facial fit is the one primary difference between respirators and medical masks which are not intended to provide respirator protection to the wearer.

[0011] Yet, these designs suffer from the inherent flaws:

(1) the nasal seal to be created by the wearer pinching in the usually aluminum strip in the hard nose bridge area rarely effects a proper seal but restricts the use of protective eye wear and most eyeglasses; and

(2) ties or elastic strap connections that connect along the sides of the facemask are near parallel to the upper nose seal area and thus, when sufficiently tied or tensioned to seal against the face, simultaneously pull the facemask away from the upper nose seal area, preventing a complete seal; and

(3) little or no upward lift is provided by either ties or elastic straps for a proper seal in the chin area. [0012] Accordingly, a facemask that secures snuggly and comfortably to the wearer’s face with an adjustable and conformable elastic facial seal design, and with a highly user-adaptive elastic strap/tubing construct, would more effectively protect both the wearer and those in their proximity.

SUMMARY OF THE INVENTION

[0013] Shortcomings of conventional facemasks are overcome by a facemask comprising:

[0014] A user adjustable facial seal involving flexing the top section, dual polymer strap with the filter material bonded in between. This polymer strap can consist of a composite material that combines an ultra-high strength thermoplastic fiber with a low temperature activated thermoplastic polymer matrix. This construct takes advantage of the characteristics of each of the individual components - the strength of the fiber and the low temperature formability of the matrix polymer. [0015] A two-part, snap-together frame construct that greatly expands the breathable filter surface area, facilitates assembly and enables a strap mounting variability of single strap - above or below the ear - or a dual ear loop system.

[0016] In another embodiment, a facemask comprises:

(a) A facial seal provided by an interior band of closed cell foam.

(b) A lower nose / upper cheeks adjustable seal created by user- adjustable polymer strap preferably configurable to provide a compression zone over the wearer’s lower nose, rather than the upper, nose bridge area.

(c) The same to enable a customized chin seal.

(d) A continuous strap that is user positioned to center the inward sealing pressure appropriate to their face.

[0017] The entire facemask system that can be washed in warm, or hot, water with a soap/detergent, or spray disinfected, and then reused similar to cloth masks.

[0018] When the facemask is not worn the loose strap can be stored inside the facemask by being inserted within a clip snapped into the facemask interior frame or, by unclipping the Front Clip - which then contains the strap - and inserting that within the interior of the facemask.

BRIEF DESCRIPTION OF THU DRAWINGS

[0019] FIG. 1 is a perspective exploded view of the facemask showing all of the facemask components minus the filter material and the mounting strap system. [0020] FIG. 2 is a perspective view taken from the front side of an embodiment of the facemask with the filter material shown.

[0021] FIG. 3 is a perspective view of the facemask illustrated in FIG. 1 on a head form showing the nose and chin area seal adjustments via flexing the polymer strap.

[0022] FIG. 4 is a perspective view of the facemask illustrated in FIGS. 2-3 taken from the back side of the facemask assembled from components illustrated in FIG. 1.

[0023] FIG. 5A is a side view of the Front Clip and Back Frame shown in FIG. 1 in a separated alignment.

[0024] FIG. 5B is a side view of the same but now snapped together.

[0025] FIG. 5C is a back view of the same.

[0026] FIG. 6A is a perspective front view of the Front Clip snapped over the Back Frame with the Filter in between and out the sides to form the facial seal area.

[0027] FIG. 6B is a perspective side view of the same.

[0028] FIG. 7 is a graphic showing the difference in breathable area between an embodiment of an invention described herein and competitor products.

[0029] FIG. 8 is a side view of the facemask with the single strap tubing configuration running either above or below the ear.

[0030] FIG. 9 is a perspective view showing how the Front Clip allows for the vertical adjustment of the strap.

[0031] FIG. 10 is a perspective view of the same strap now configured as a dual ear loop approach mounted on the head form.

[0032] FIG. 11 A is a perspective view of the Strap Clip.

[0033] FIG. 1 IB is a perspective view of the Strap Clip inserted within the Front Clip.

[0034] FIG. 12 is a front view of the Strap Clip inserted within the facemask.

[0035] FIG. 13 is back view of the facemask with the Front Clip unclipped from the Back Frame and retaining the strap.

DESCRIPTION OF EMBODIMENTS

[0036] When describing elements of FIGS. 1-13, the same number is used to identify elements that are the same or substantially similar to each other in the different views illustrated in FIGS. 1-13. [0037] Hereinafter the reference to the “strap” is meant to represent a wide varies of straps, cords, tubing, and/or O-rings. For purposes of the drawing depictions a hollow silicone tubing is shown. [0038] Not shown is the means of tensioning and securing such straps via, for example, mounting buckles, tri-glides, plastic strap adjusters, cord-locks and other adjustable elements and an open- ended strap can also simply be tied behind the ears or the head. Straps, tubings, tensioning and other similar, equivalent and/or functional securing materials known in the art and to be discovered may used as securing material to secure the facemasks to a donning user.

[0039] As shown in FIG. l is a perspective exploded view of the facemask components minus the filter material 105 and the mounting strap 106. The sequence of assembly is that the multi-layer Filter is pre-cut to a template, or laser cut, and inserted between the conformal straps 104A and 104B at the top whereinafter heat is applied to bond all three elements together. The Filter is then heat sealed at the edges and inwardly folded and heat sealed again to create an interior “wing” wherein the Back Frame 101 is inserted and the conformal strap top 102A and conformal strap bottom 102B - having already been heat bonded to the Back Frame 101 at their respective positions - are then heat bonded to both the conformal internal bottom strap 104A and Filter 105 (not shown) at the base. Thereafter the facial sealing Foam Strip 103 - with a strong, temperature-tolerant adhesive on one side - is inserted around the interior rim to complete the facemask A1 assembly. [0040] As shown in FIG. 2 a front view of the assembled Facemask 1 A components of FIG. 1 with conformable nose and upper cheek polymer straps 104A/B configured to provide a compression zone over the nose of the wearer and against the upper cheek area. The Front Clip 100 is shown in its snapped in position over the internal Back Frame 101 (not shown), atop the Filter 105.

[0041] FIG. 3 is a perspective view of the Facemask A1 of FIG. 2 mounted on to a Head Form Bl, minus the strap system, showing both the soft tissue area nasal seal being adjusted via the inward/outward flexing the conformal strap 102A and 102B as well as similarly adjusting the seal in the chin area. The dot-dash-dot line 105 A represents an inward adjustment of the conformal strap 102A and 102B to elongate the chin seal for larger faces. The dashed line 105B represents an outward adjustment of the same to provide a tighter chin seal for a smaller face. An advantage of facial seal being precisely adjustable to suit the facial physiology of the wearer is an increased likelihood that the facemask A1 is more comfortable and effective than conventional facemask assemblies. [0042] As shown in FIG. 4 is a back view of Facemask 1 A of FIG S 2 & 3 further comprising an interior foam strip facial seal 103. A preferred embodiment would have this rim consist of a closed cell foam that is designated as “Ultra Soft” (i.e: 25% compression with only 3~4 psi pressure). [0043] FIG. 5A is an exploded side view of internal Back Frame 101 and external Front Clip 100 without Filter 105 between. FIG. 5B is the side view but with the two elements snapped together. FIG. 5C is a back view of the same. The snap-in construct not only supports ease of assembly and spreads the filter material internally but also facilitates disassembly to improve the ability to more completely clean and reuse.

[0044] FIG. 6 shows Frames 100&101 covered with Filter material 105. FIG. 6A is a perspective front view of the Front Clip snapped over the Back Frame with the Filter in between and out the sides to form the facial seal area with the internal Facial Seal Foam Strip 103 (shown as dashed lines). FIG. 6B is a perspective side view of the same.

[0045] FIG. 7 is a graphic display of the comparative benefit of the present facemask assembly A1 with the greater breathable filter area created by the structure of the Front Clip 100 and the Back Frame 101 with the Filter 105 sandwiched in between. This significant increase in breathable area facilitates alternatively incorporating a wide variety of filter materials with different filtration levels (with possible biocidal elements) and the amount of possible layers not possible due to the comparatively limited breathable areas of competitor masks.

[0046] It is a benefit of the present invention that it currently incorporates a three-layer filter with the outermost layer being hydrophobic - to reject the droplet form of transmission of the Covid- 19 and/or Influenza and similar viruses - the internal layer is rated to an N95 level of particulate capture and the innermost layer is hydrophilic to not only help the capture of airborne particulates but also coughed-out - possibly infective - aerosol droplets.

[0047] FIG. 8 showing the Facemask A1 of FIGS. 2~4 with the single mounting strap 106 inserted behind the Front Clip 100 and then extended above 106A the ear of the head form B1 and below the ear 106B of the same. Once adjusted as described above, the Facemask assembly can be readily removed by the wearer, for example, by holding the facemask and lifting forward and then over the head without the need for slacking the strap. Thereafter the wearer can don the facemask assembly again, without further adjustment.

[0048] FIG. 9 is a perspective view of the single polymer strap being adjusted vertically to optimize the compression force specific to the wearer. While shown as the tubing strap mounted below the ear, a benefit of the present invention is that this adjustability applies whether the strap is above or below the ear. Front Clip 100 enables whatever strap/tubing to be inserted, removed and replaced between the Filter 105 and the Back Frame 101. The Front Clip 100 structure has a post 100A that enables the vertical adjustment of the single strap/tubing to center the inward pressure on the wearers’ face as opposed to most masks providing fixed-in-place straps. Front Clip 100 has a slot construct at its base 100B to enable the ear loop system to be created but this entire system is also configured to enable the insertion of a wide variety of straps, cords, tubing, and/or o-ring stock to enable a wearer to make emergency repairs to Facemask Al. For example, if the existing strap were to break the user could utilize a wide variety of suitable materials such as his or her own shoelace for an immediate field repair. This feature could be life-saving should such an immediate field repair be necessary in an infectious or hazardous air environment.

[0049] FIG. 10 is a perspective view of the Facemask Al mounted on to the Head Form B1 using a dual head loop approach. In the higher position the Strap 106 is inserted between the Front Clip 100 and the Filter 105 sandwiched between the internal Back Frame 101. The lower position Strap 106 is then inserted within the groove 100B within the lowest portion of the Front Clip thus creating the dual loops of the Strap shown extending behind the left ear of the Head Form Bl. In some embodiments, the strap/tubing can be slid back and forth to balance the position of any cord- locks, clips and/or buckles (not shown).

[0050] FIG. 11 A is a perspective view of the Strap Clip 107 showing the snap-in slots 108 for the Front Clip 100, the four compression slots 109 for the strap 106 (not shown) to be inserted and the Tabs 110 that the loose strap 106 is inserted behind and held therein. FIG. 1 IB is a perspective view of the Front Clip 100 inserted into the snap-in slots 108 of the Strap Clip 107.

[0051] FIG. 12 is a back view of the Facemask Al with the Strap Clip 107 inserted and the Front Clip 100 snapped into the two snap-in slots (not shown). The strap 106 is shown inserted into the four compression slots 109 and pressed below the Tabs 110 into the body of the Facemask Al and Back Frame 101.

[0052] FIG. 13 is a back view of the Facemask Al with the Front Clip 100 - having been unclipped from the Back Frame 101 but retaining the strap 106 - inserted within the back of the Facemask Al in following the strap being pushed up to the Back Frame and somewhat inserted within the Filter 105 folds. The interior lip created by the foam strip 103 aids in holding the Front Clip 100 and strap 106. [0053] It is a benefit of the present invention that the strap as illustrated in FIGS. 8—13 can be hollow medical-grade surgical tubing. Other suitable securing material can be used, for example O-ring cord or polymer flat strap.

[0054] It is a benefit of the present invention that it does not require a front vent - which is normally a hole in front of the mouth with an elastic diaphragm valve - and thus broadly distributes any exhalations to distribute their collective velocity. But furthermore, the preponderance of the filter material is directly in front of the mouth to facilitate the necessary increased airflow when required by the wearer due to exercise, for example, necessarily requiring mouth breathing.

[0055] It is also a benefit of the present invention that the Filter is in close proximity to the nose and mouth of the wearer, thereby providing less opportunity for back pressure, build-up of CO2 within the facemask, and/or re-inhalation of exhaled air by the wearer.

[0056] The expanded breathable surface area in the nose zone allows the escape of exhaled heat and CO2 loaded air which leads to improved nasal breathability. In addition, nasal breathing has been found to lower blood pressure and individuals’ heartrates. It has also been found to help improve the function of individual’s organs, including the brain, with optimal oxygenation.

[0057] As used herein “elastic” is intended to mean the state or quality of being elastic, flexible, resilient and/or adaptable.

[0058] While facemask assembly 1A as illustrated in FIGS. 8—10 has starting position on the left side of the assembly (when viewed from the back or from the perspective of the wearer), it will be understood that in other embodiments (such as for a left-handed wearer) the starting position can be on the right side of the assembly.

[0059] While particular elements, embodiments and applications of the present invention have been shown and described, it will be understood, that the invention is not limited thereto since modifications can be made by those skilled in the art without departing from the scope of the present disclosure, particularly in light of the foregoing teachings.

[0060] Furthermore, particular elements of the present invention as described in the embodiments above can be incorporated into facemask assemblies in other suitable combinations or arrangements, for example, to suit particular applications.

[0061] The examples used herein are only some embodiments of the invention. Thus, it is seen that the objects of the present invention are efficiently obtained, although modifications and changes to the invention should be readily apparent to those having ordinary skill in the art, which modifications are intended to be within the spirit and scope of the invention as claimed. It is also understood that the foregoing description is illustrative of the present invention and should not be considered as limiting. Therefore, other embodiments of the present invention are possible without departing from the spirit and scope of the present invention.

INDUSTRIAL APPLICABILITY

[0062] The invention is applicable for a facemask assembly and method of manufacturing a facemask assembly.