Patent Application Publication (10) Pub. No.: US 2016/0015098 A1
Patent Application Publication (10) Pub. No.: US 2016/0015098 A1
Patent Application Publication (10) Pub. No.: US 2016/0015098 A1
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Patent Application Publication Jan. 21, 2016 Sheet 1 of 9 US 2016/0015098 A1
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US 2016/00 15098 A1 Jan. 21, 2016
configured to contact an external environment, the facemask BRIEF DESCRIPTION OF THE DRAWINGS
having upper and lower edges and at least one pleat disposed
between at least the upper and lower edges and configured to 0018 FIG. 1 illustrates an embodiment of an outside sec
fit over a chin of the wearer when unfolded, the at least one tional view of the facemask in a folded configuration prior to
pleat configured for folding and unfolding the facemask Such the facemask being installed upon a wearer's face. The bend
that when folded the facemask is configured to assume a portion or crimp causes a projection, convex projection, or
generally flat storage configuration and when unfolded the peak visible from the outside of the mask and a recesses or
facemask is configured to cover at least the nose and mouth of trough visible from the inside of the mask that the wearer
the wearer. places against the face. In this embodiment, the rest of the
facemask is flat.
0014. In some embodiments, there is a method of making 0019 FIG. 2A illustrates an embodiment of a top view of
a facemask, the method comprising providing an inner layer the malleable stiffening member (e.g., metal Strip) having a
comprising nonwoven fiber material configured to contact a bend portion shown as a crimp, concave recess, or crease that
wearer's nose and mouth; disposing a middle layer on the causes a recess or trough or cavity visible from the inside of
inner side of an outer layer, the middle layer comprising a the mask in the nose section.
nanofiber material; disposing an outer layer on the middle 0020 FIG. 2B illustrates an embodiment of a top view of
layer, the outer layer comprising nonwoven fiber material, the the malleable stiffening member (e.g., metal Strip) having a
outer layer configured to contact an external environment; bend portion shown as it would bend further around the nose
and forming at least one pleat disposed between upper and if the facemask was unfolded and the user pinched the mal
lower edges of the facemask, the at least one pleat configured leable stiffening member.
to fit over a chin of the wearer when unfolded, the at least one 0021 FIG. 3 illustrates a cross-sectional exploded view of
pleat configured for folding and unfolding the facemask Such an embodiment of a facemask installed upon a wearer's face.
that when folded the facemask is configured to assume a 0022 FIG. 4 illustrates a perspective view of an embodi
generally flat storage configuration and when unfolded the
facemask is configured to cover at least the nose and mouth of ment of a facemask installed upon a wearer's face.
the wearer. 0023 FIG. 5 illustrates an embodiment of the inner sur
face of a facemask.
0.015. In some embodiments, there is a stack of facemasks, 0024 FIG. 6 illustrates an embodiment of the outer sur
each face mask comprising: an inner layer comprising non face of the facemask as the mask is installed upon a wearer's
woven fiber material configured to contact a wearer's nose face and having a visual indicator of temperature, moisture,
and mouth; a middle layer disposed on the inner side of an and/or if a pathogen contacts the mask.
outer layer and comprising a nanofiber material; an outer
layer disposed on the middle layer and comprising nonwoven 0025 FIG. 7 illustrates an embodiment of the indicator as
fiber material, the outer layer configured to contact an exter a strip.
nal environment, the facemask having upper and lower edges 0026 FIG. 8 is a graphic illustration showing different
and at least one pleat disposed between at least the upper and mask filtration. The nanofiber masks had greater filtration
lower edges and configured to fit over a chin of the wearer than other masks.
when unfolded, the at least one pleat configured for folding 0027 FIG. 9 is a graphic illustration showing different
and unfolding the facemask such that when folded the face pressure differentials with various masks. The pressure dif
mask is configured to assume a generally flat storage configu ferentials were lower with the nanofiber masks indicating
ration and when unfolded the facemask is configured to cover reduced deflection and better filtration.
at least the nose and mouth of the wearer. The mask allows 0028. It is to be understood that the figures are not drawn
bidirectional air flow. to scale. Further, the relation between objects in a figure may
0016. In some embodiments, there is a facemask, compris not be to Scale, and may in fact have a reverse relationship as
ing: an inner layer comprising nonwoven fiber material con to size. The figures are intended to bring understanding and
figured to contact a wearer's nose and mouth; a middle layer clarity to the structure of each object shown, and thus, some
disposed on the inner layer and comprising a nanofiber mate features may be exaggerated in order to illustrate a specific
rial; an outer layer disposed on the middle layer and compris feature of a structure.
ing nonwoven fiber material, the outer layer configured to
contact an external environment, the facemask having upper DETAILED DESCRIPTION
and lower edges and at least one pleat disposed between at 0029. For the purposes of this specification and appended
least the upper and lower edges and configured to fit over a claims, unless otherwise indicated, all numbers expressing
chin of the wearer when unfolded, the at least one pleat quantities of ingredients, percentages or proportions of mate
configured for folding and unfolding the facemask Such that rials, reaction conditions, and other numerical values used in
when folded the facemask is configured to assume a generally the specification and claims, are to be understood as being
flat storage configuration and when unfolded the facemask is modified in all instances by the term “about.” Accordingly,
configured to cover at least the nose and mouth of the wearer. unless indicated to the contrary, the numerical parameters set
0017 Additional features and advantages of various forth in the following specification and attached claims are
embodiments will be set forth in part in the description that approximations that may vary depending upon the desired
follows, and in part will be apparent from the description, or properties sought to be obtained by the present invention. At
may be learned by practice of various embodiments. The the very least, and not as an attempt to limit the application of
objectives and other advantages of various embodiments will the doctrine of equivalents to the scope of the claims, each
be realized and attained by means of the elements and com numerical parameter should at least be construed in light of
binations particularly pointed out in the description and the number of reported significant digits and by applying
appended claims. ordinary rounding techniques.
US 2016/00 15098 A1 Jan. 21, 2016
0030 Notwithstanding that the numerical ranges and ments, the face mask can be comfortably worn by the source
parameters setting forth the broad scope of the invention are of the airborne contaminants (e.g., patient).
approximations, the numerical values set forth in the specific 0036 Nanofiber filtration media will enable high filtration
examples are reported as precisely as possible. Any numerical and limit differential pressure within the mask allowing for
value, however, inherently contains certain errors necessarily greater comfort and perceived breathability. This discomfort
resulting from the standard deviation found in their respective level may also be measured by temperature readings within
testing measurements. Moreover, all ranges disclosed herein the worn mask. Nanofiber masks show low temperature read
are to be understood to encompass any and all Subranges ing within the space between the mask and the wearer, an
subsumed therein. For example, a range of “1 to 10” includes indication of greater comfort. Likewise, healthcare personnel
any and all Subranges between (and including) the minimum are required to wear masks inclinical settings to either protect
value of 1 and the maximum value of 10, that is, any and all themselves from large airborne droplets or to protect other
Subranges having a minimum value of equal to or greater than patients from their potentially infectious respiratory emis
1 and a maximum value of equal to or less than 10, e.g., 5.5 to sions. Nanofiber masks will contribute to higher mask-wear
10. ing compliance as well as the wearing of masks with more
0031. It is noted that, as used in this specification and the proper fit. In association with MOF (Metal Organic Frame
appended claims, the singular forms “a,” “an and “the works) chemistries, nanofiber masks may also serve to pro
include plural referents unless expressly and unequivocally tect the wearer from specific airborne gaseous chemical
limited to one referent. Thus, for example, reference to “a threats.
layer” includes one, two or more layer(s). 0037 Discrete integrated or detachable nanofiber strips
0032 Reference will now be made in detail to certain placed within the nanofiber masks may enable the capture of
embodiments of the invention, examples of which are illus exhaled particles for Subsequent analysis and detection of
trated in the accompanying drawings. While the invention wearer illness/infection. Including a discrete nanofiber layer
will be described in conjunction with the illustrated embodi between two discrete nonwoven fiber layers provides for
ments, it will be understood that they are not intended to limit enhanced filtration of airborne particles, such as, for example,
the invention to those embodiments. On the contrary, the pathogens, and reduced pressure drop.
invention is intended to cover all alternatives, modifications, 0038 FIG. 1 illustrates an embodiment of an outside sec
and equivalents, which may be included within the invention tional view of the face mask 10 in a folded configuration 11
as defined by the appended claims. prior to the facemask being installed upon a wearer's face. In
0033. The headings below are not meant to limit the dis the view shown, this side of the facemask 10 would face the
closure in any way; embodiments under any one heading may outside environment and not touch the wearer's nose, cheeks,
be used in conjunction with embodiments under any other jaw and/or chin. The facemask 10 may have application in
heading. healthcare, industrial, domestic, public, or other settings. The
embodiment shown is an N95 respirator, which is a light
Face Mask weight, nose-and-mouth respirator that provides protection
for the wearer from microorganisms (e.g., bacteria, fungi,
0034. The present disclosure includes a face mask con yeast, molds and viruses).
taining nanofiber material. By including one or more discrete 0039. The facemask 10 is generally configured so as to
nanofiber layers on or in place of the standard polypropylene provide a secure fit which reduces or prevents gaps and pas
filtration layer, the facemask provided allows for reduced sage of material between the nostrils and mouth and the
airflow resistance and thereby reduced deflection of inhaled Surrounding environment except through the filter material
or exhaled air and associated particles, which enhances fil 13. The makeup of the filter material 13, and the pleating 20
tration efficiency for airborne particles that pass through the used in connection with the facemask 10 will be explained in
mask. In some embodiments, the face mask provided allows detail shortly. The facemask 10 has the particular advantage
consistent pressure and comfortable and consistent tempera of allowing a secure fit to be created and to be maintained
tures within the mask for the user when the mask is worn. In upon installation of the facemask 10 on the face with the use
Some embodiments, the materials to make the mask comprise of two ear loops 28 and 30.
hydrophobic materials, e.g., hydrophobic polymers, hydro 0040. The facemask 10 may be constructed of a wide
phobic fluoropolymers, or polymers having a hydrophobic variety of materials and is preferably disposable. The inner,
surfactants, or the like. Suitable hydrophobic materials outer, and filtration materials 13 used to fabricate the face
include polyolefins (polyethylene, polypropylene and com mask 10 may vary according to the particular application of
binations thereof) or polyesters that are free of hydrophilic the facemask 10. For example, when the facemask 10 is to be
materials. In some embodiments, the hydrophobic polymer used in a medical application, such as on members of a
can comprise fluoro Surfactants. Examples of fluoro Surfac Surgical team, it is common to use a three layer filter material
tants are the perfluoroalkyl acrylic copolymers sold under the that will provide blood (or other) fluid resistance to prevent
tradename Zonyl 8300 or Zonyl 7040, supplied by Ciba penetration of fluids to the inner lining of the mask. However,
Geigy. appropriate inner, outer, and filtration materials may be of a
0035. In some embodiments, the face mask provided single or multiple layer design. Multi-layer material may be
allows for reduced pressure differential (internal to ambient readily purchased in a precollated form, that is with the three
air) and enhanced filtration of airborne particles. The face layers already arranged, or the materials may be obtained
mask provided improves filtration and/or reduces breathing separately and the filter material 13 formed in part of the
resistance (e.g., provides wearer comfort) while protecting process for forming the facemask 10.
the wearer from airborne particles as small as 0.05 microns 0041 Generally, a three or four layer filter medium might
(e.g., including viruses, bacteria, spores, mold, dust and dif include an outer layer of a relatively porous paper-like or
fuse airborne chemical pollutants, etc.). In some embodi spunbond polypropylene material which provides durability
US 2016/00 15098 A1 Jan. 21, 2016
and resistance against abrasion and/or fluid penetration. The of escape, all while providing a Superior fit on a wider range
outer layer may also be generally stiffer than the other layers. of facial sizes and shapes. The maintenance of such a secure
By using a stiffer outer layer, the effectiveness of the various fit greatly improves the overall efficiency of the face mask 10.
pleating arrangements is increased. The pleats 20 are dis 0044) The structure of the face mask 10 is generally pre
posed between the upper edge 12 and lower edge 25 and side pared as a rectangular piece offlat filter material 13. However,
edges 21 and 29 and may be incorporated in the body of the it will be understood by those of ordinary skill in the art that
filter material 13 to hold the facemask 10 in a cup-like shape other shapes of the face mask can be made in order to cover
when installed. The inner layer or layers of the filter material additionally both the eyes, hair, and throat of the user. As
generally contain polyethylene or polypropylene, or other Such, the present application includes face masks 10 that
material, which exhibits the proper filtration characteristics. cover areas above and beyond simply the nose and mouth of
In the embodiment shown, the middle layer comprises the user. The facemask may also incorporate any combination
nanofiber material that is coated onto either the outer side of of known face mask 10 features, such as visors or shields,
the inner layer or the inner side of the outer layer. Glass fiber sealing films, beard covers, etc. In some embodiments, the
based materials may also have applications as the middle face mask 10 may be from about 5.5 inches to 7 inches across
filtration layer. The innermost layer of the filter material is to in length to cover the user's nose and mouth. In FIG. 1, the
be worn next to or against the face and generally comprises a mask is shown as it would be packaged in its folded and flat
Soft material for providing a soft, non-irritating Surface configuration, except for the convex outside by the malleable
against which the facial skin will make contact. stiffening member 14, where the outside surface is viewed.
0042. In medical, dental and/or Surgical applications, it is 0045. The facemask 10 comprises a malleable stiffening
generally important that the combined mask materials 13 also member 14 attached to or imbedded in the mask material 13
provide bacterial filtration efficiency (BFE) in accord. The at the masks upper edge 12. The malleable stiffening member
BFE of a filter material is generally determined by the per 14 is configured to conform the filter material 13 to at least a
centage of bacteria, Such as Staphylococcus aureus or Bacil nose portion and a cheek portion of the face of the wearer. It
lus Stearothermophilus, that is able to migrate through the will cause a portion of the mask to be convex and have, in
filter material under normal conditions. The fewer bacteria Some embodiments a curved projection on the outer layer to
which are able to pass through the filter material 13, the higher indicate the nose and cheek area.
the BFE. Of course, a BFE of 100% is desirable; however, 0046. A second malleable stiffening member 24 is
efficiencies of as low as 25% are not uncommon among some attached to or within lower edge 25 of the filter material 13, as
types of prior art disposable facemasks. However, materials illustrated in FIG.1. The second malleable stiffening member
are available which provide BFE's of between 90 and 99%. is configured to conform the mask material to at least a chin
Thus, in a medical, dental and/or Surgical environment it is portion and a jaw portion of the face of the wearer. In some
generally desirable to utilize a filter material having as high a embodiments, the second malleable member does not include
BFE as possible so as to prevent release of nasopharyngeal a bend portion. In other embodiments, it can include a bend
organisms into the environment. In general, the consider portion that is different from the bend portion 15 in the nose
ations that provide for a high BFE are the same considerations and cheek portion of the mask provided that they can be
which provide that a filter material would be desirable in distinguished (e.g., the bend portion 15 at the nose section can
applications in industry and domestic use. For example, a be creased at a larger angle than the optional bend portion in
filter material which inhibits the migration of nearly all bac the chin piece). The portion of the mask that has the second
teria would generally also prevent inhalation of dust and dirt malleable stiffening member will also have, in some embodi
particles in industrial applications. Furthermore, it has gen ments, a convex projection on the outer layer.
erally been found that those materials providing a high BFE 0047. It should be understood that the use of the term
are often also those materials which provide the least resis “malleable stiffener” or “malleable stiffening member
tance to passage of gases through the filter material. herein is meant to include the use of both malleable and
0043. The easy passage of gases through the filter material flexible stiffeners. It is preferred that the malleable stiffeners
is important in maintaining the comfort of the wearer and 14 and 24 be placed adjacent to the upper 12 and lower edges
reduce or inhibit deflection of air and the particles it carries 25 of the mask material 13, respectively. Alternatively, the
out of any openings created by imperfect sealing of the face malleable stiffeners 14, and 24 may be placed somewhere
mask to the face, thereby by-passing the particle filtration along the upper 12 and lower edges 25 of the mask material
process intended. It should be realized by one of ordinary skill 13. The important property of the malleable stiffeners 14 and
in the art, however, that many applications might require 24 is that the material be pliant enough to be bent to a shape
greater or lesser standards of filtration than is commonly that conforms to the face of the wearer, and then retain that
required in the medical environment. Therefore, while filter shape. In this regard, it is important that the malleable stiff
materials having an efficiency suitable for use with the eners 14 and 24 not be too stiffso as to make it difficult for the
present application available in the art, the best filter material wearer to conform the face mask 10 upon installation. The
is of little use if the air inhaled and exhaled by the wearer is face mask 10 also has ear loop 30 attached to edges of the
allowed or facilitated to escape the face mask 10 without mask at attachment points 16 and 22 and ear loop 28 to edges
passing through the filter material 13. Indeed, the lack of a of the mask at attachment points 18 and 26 used in donning
secure fit acrossa wide variety of facial sizes and shapes in the the mask. In the embodiment shown in FIG. 1, the ear loops
face masks available in the prior artis important to the design are attached to the outside surface of the mask. However, it
and fabrication of face masks. Therefore, the present appli will be understood by those of ordinary skill in the art that the
cation provides a unique secure fit which reduces or prevents loops can be attached to the inside Surface of the mask.
inhaled and exhaled air from leaking around the edges 12, 25. 0048. In some embodiments, the mask can be a mask that
21, and 29 of the facemask 10 by finding the combination of is not folded, e.g., a cone shaped mask that has the nanofiber
airflow patterns caused by pressure differentials, and an route disposed on the inner layer or the inside of the outer layer.
US 2016/00 15098 A1 Jan. 21, 2016
0049. In some embodiments, the mask of the current appli recess, crease, or trough on the inside Surface of the mask and
cation is not an N95 mask, but other mask type like a cone as the malleable stiffening member 14 is further pinched, bent
shaped mask. or folded (as shown by the arrows in FIG. 2A), a cavity,
0050 Generally, as used herein, the upper portion of the indentation, recess, crease, or trough becomes larger to
facemask 10 will refer to that portion which contacts the nose accommodate the nose. In this way, the user will have a visual
and cheek areas of the wearer while the lower portion of the indication of where the top of the mask is, where the nose
facemask 10 will be that portion which is in proximity to the section of the mask is and/or where the center of the mask is
lower jaw and chin of the wearer. The malleable stiffeners 14 for those embodiments where the bend portion is disposed
and 24 can comprise any pliant material. Such as a malleable within the center or generally within the center of the mal
metal or alloy, plastic, or the like. In some embodiments, the leable stiffening member 14. In some embodiments, the bend
malleable stiffeners comprise aluminum or other binding portion 15 allows the user to identify the outside of the mask,
material which exhibits stiffening characteristics. the inside of the mask, top of the mask, and/or center of the
0051. The malleable stiffeners 14 and 24 can be attached mask. In some embodiments, the bend portion 15 is packaged
to orimbedded within the inside or outside surface of the filter (not shown) at least partially bent so that the cavity, indenta
material. In some embodiments, the malleable stiffening tion, recess, crease, or trough is visible on the interior of the
members can be attached to the facemask and then covered mask.
with the same or different material used to make the mask. For 0056. The bend portion 15 or crimp is typically formed
example, the malleable stiffening members can be attached to from the same material as the malleable stiffening member.
the mask by covering it with spunbonded polypropylene and However, the same or different material may be used as long
ultrasonically sealing it to the outer Surface of the mask. In as the bend portion will cause a crease or fold in the filter
Some embodiments, the malleable stiffening members can be material and allow the user to identify the top, center, inside
attached to the mask by adhesive or other means for holding and/or outside of the mask. The bend portion may be formed
the malleable stiffening members to the mask. from any Suitable material. Such as an elastic material (e.g., a
0.052. In some embodiments, first malleable stiffener 14 polymer), inelastic material, a nonwoven, knit, ribbon, cloth,
used for the nose portion of the mask may be from about 3 to wire, metal or the like.
6inches in length and from about 0.025 or 0.125 or 0.25 or 0.5 0057. In some embodiments, the bend portion may be bent
inches in height and from about 0.01 or 0.02 or 0.05 or 0.125 before use by the manufacturer by about 1 to about 5 degrees,
or 0.25 inches thick.
by about 1 to about 10 degrees, or by about 5 to about 20
0053. In some embodiments, second malleable stiffener degrees. In some embodiments, the bend portion may be bent
24 used for the chin portion of the mask may be from about before use by the manufacturer so that the bend portion
1.5 to 5 inches in length and from about 0.025 or 0.125 or 0.25 projects out of the inner or outer surface of the mask by about
or 0.5 inches in height and from about 0.01 or 0.02 or 0.05 or 0.25 mm to about 0.5 mm, or by about 1 mm to about 5 mm
0.125 or 0.25 inches thick. In some embodiments, the first or by about 1 mm to about 10 mm or by about 5 mm to about
malleable stiffener 14 used in the nose portion is a length that 20 mm, or by about 10 mm to about 30mm or by about 35 mm
is larger or the same size as the length of second malleable to about 60 mm. Therefore, the facemask will not be flat when
stiffener 24 that is used in the chin portion of the facemask. In stored or in the package as a stack before it is worn. In some
some embodiments, the second malleable stiffener 24 is embodiments, the bend portion is designed for easy bending
smaller than the first malleable stiffener 14.
around the ridge of the nose. In some embodiments, the bend
Bend Portion
portion, like the malleable stiffening member, may be sub
stantially deformable so that a wearer is able to bend, pinch or
0054 The malleable stiffening member 14 has a bend fold the bend portion and/or the malleable stiffening member
portion 15 indicating at least the inner Surface, outer Surface, between two or more fingers when gripping it as it is put
center and/or the nose portion of the facemask. The bend around the ridge of the nose.
portion or crimp includes an angular or rounded shape made 0058. The bend portion 15, since it provides space
by pinching, folding, punching or bending the malleable stiff between adjacent masks, allows the facemask 10 to be
ening member 14 to cause a cavity, indentation, recess, stacked for easy packaging and dispensing of a plurality of
crease, concave recess, or trough on the inside Surface of the masks. In one embodiment, there is a stack of facemasks,
mask (not shown) and a projection, convex projection, peak, each face mask comprising: an inner layer comprising non
protrusion, elevation or ridge on the outside Surface of the woven fiber material configured to contact a wearer's nose
mask (shown). At these portions of the facemask, it will not be and mouth; a middle layer disposed on the inner layer and
flat on storage. In some embodiments, the bend portion 15 comprising a nanofiber material; an outer layer disposed on
includes making a ridge or fold by pinching the malleable the middle layer and comprising nonwoven fiber material, the
stiffening member 14 by hand or machine. Although the bend outer layer configured to contact an external environment, the
portion 15 is shown generally in the center of the malleable facemask having upper and lower edges and at least one pleat
stiffening member 14, it will be understood that the bend disposed between at least the upper and lower edges and
portion 15 can be disposed to the left, or right of center. configured to fit over a chin of the wearer when unfolded, the
0055. The bend portion 15 or crimp may be located by the at least one pleat configured for folding and unfolding the
nose portion of the mask on the outer or inner Surface and be facemask Such that when folded the facemask is configured to
angled or crimped in the direction away from the nose so that assume a generally flat storage configuration and when
the user can bend it further for a custom fit around the nose unfolded the facemask is configured to cover at least the nose
and check area. In this way, the bend portion can be "pre and mouth of the wearer. The facemasks are positioned in a
bent' or “pre-crimped by the manufacturer. Accordingly, the nestled relation to one another (e.g., masks that are close or
bend portion will cause the inner surface of the mask that is to one on top of the other in the package), the inner Surface of at
be placed against the user's nose to have a cavity, indentation, least one mask being apposed to the outside Surface of an
US 2016/00 15098 A1 Jan. 21, 2016
adjacent mask, thereby forming a stack. Likewise, when the 0063. In some embodiments, the bend is in a vertical direc
facemask comprises bent malleable stiffening members, the tion relative to the one or more pleats. In some embodiments,
concave portions can be stacked one on top of the other and the bend portion 32 is crimped, bent, creased, folded, or
parallel to each other for ease of packaging. angled toward the inner surface or outer surface of the face
0059 FIG. 2A illustrates a top side view of the malleable mask by about 1 to 10 degrees or by 0.5 mm to about 50 mm.
stiffening member 31 (e.g., metal Strip) having a bend portion For example, the crimp can be from 1 mm, 10 mm, 15 mm, 20
shown as a crimp or crease. The bend portion has a projection, mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60mm,
or 65 mm.
peak, protrusion, elevation, convex surface or ridge 32A that
extends out and is visible on the outside surface of the mask
(not shown). The bend portion has a cavity, concave surface, Securing Means
indentation, recess, crease, or trough 32B on the inside of the 0064. The facemask may be attached to the user by a
mask that is visible on the inside surface of the mask. The
stiffening member 31 would have this configuration when securing means that can attach the mask to the user. For
attached to the mask. The mask would be in a flat and/or
example, the securing means may be a pair of manual tie
folded configuration, except for the bend portion(s). In the straps that are wrapped around the head of the user and are
connected to one another, or the securing means may be ear
embodiment shown, the bend portion, like the malleable stiff loops (28 and 30 in FIG. 1), elastic bands wrapped around the
ening member 31, may be substantially deformable so that a head of the user, a hook and loop type fastener arrangement
wearer is able to bend or fold the bend portion and/or the (e.g. VELCROR) fasteners), or a connection directly attach
malleable stiffening member in the direction of the arrows ing the face mask to a hair cap.
shown using two or more fingers when gripping it as it is put
around the ridge of the nose. 0065. In some embodiments, the ear loops (28 and 30 in
FIG. 1) can be attached to the inner or outer surface of the
0060. By employing a bend portion in the malleable stiff maskatupper edges 16 and 18 and lower edges 22 and 26. The
ening member 31, which is placed in the center of the face attachment points may be in from the edge by, for example,
mask, the wearer will see a projection, peak, protrusion, from about/s" of an inch to 1 inch. The closer together the ear
elevation, convex surface, or ridge or other marker visible on loops are, the tighter the fit and the mask will reduce gaps and
the outside surface of the mask, or a cavity, concave surface, leakage of inhaled and exhaled air. In some embodiments, the
indentation, recess, crease, or trough or other marker visible loop is positioned so as to be balanced in the wearer's hand,
on the inside surface of the mask and know where the top thereby stabilizing the mask for donning.
inside or outside, and/or center of the mask is and where the 0066. The loop may beformed from any suitable material,
nose portion of the mask is to be placed on the face. It will be Such as an elastic material (e.g. a polymer), inelastic material,
understood by those of ordinary skill in the art that the bend a nonwoven, knit, ribbon, cloth, wire, and so forth. As used
portion can be any shape (e.g., circular, Square, rectangular, herein, the term "elastic’ refers to the ability of a material to
regular, irregular, symmetrical or asymmetrical shape). recover its size and shape after deformation. As used herein,
0061. In some embodiments, the bend portion causes a the term “inelastic’ refers to the inability of a material to
projection, peak, protrusion, elevation, or ridge or other recover its size and shape after deformation. In some embodi
marker on the top front, outside and/or center portion of the ments, the loop is formed from the same material selected to
mask so that the wearer will know these portions of the mask form the outside surface of the mask. The loop may be bonded
and know the right side of the mask should be facing the or otherwise affixed to the outside surface or inside surface of
outside environment and not the wearer's nose or face. In this the mask. Examples of Suitable techniques include adhesive
way, the facemask of the present application reduces the risk bonding, thermal bonding, Stitching, and so forth. As used
that the wearer will wear the mask incorrectly. herein, the term “adhesive' refers to the property of any
0062 FIG. 2B illustrates a top view of the malleable stiff material that allows the material to bond together substrates
ening member 31 having a bend portion shown as it would by Surface attachment.
start to bend around the nose if the facemask (not shown) was 0067. The loop is generally sized and positioned to facili
unfolded. The bend portion has a projection, peak, protrusion, tate gripping by a wearer, both prior to, during, and after
elevation or ridge 32A that extends out and is visible on the donning. The loop 30 may be more or less than about 80 mm
outside Surface of the mask (not shown). The projection (0.08 m) in length as measured from the first end 16 to the
increases as the malleable stiffening member 31 is further second end 22 along the length of the loop. In other embodi
bent or pinched. The bend portion has a cavity, indentation, ments, the loop 30 may be less than about 60 mm (0.06 m) in
recess, crease, or trough 32B on the inside of the mask that is length. In yet other embodiments, the loop 30 may be less
visible on the inside Surface of the mask and gets bigger as the than about 40 mm (0.04 m) in length. Where, in some embodi
malleable stiffening member is further bent, pinched or ments, the loop is formed from an elastic material, the loop
folded. The stiffening member 31 would have this configura may have a fully extended length of 200 mm (0.200 m) or
tion when attached to or in the unfolded mask. In the embodi more. In some embodiments, the loop is from about 4 to 10
ment shown, the bend portion, like the malleable stiffening inches in length.
member 31 may be substantially deformable so that a wearer 0068. In some embodiments, the loop generally extends
is able to bend or fold the bend portion and/or the malleable inwardly from the outside surface or inside surface a suffi
stiffening member using two or more fingers when gripping it cient distance so that the wearer of the mask may grip the loop
as it is put around the ridge of the nose. It will be understood between two or more fingers of a single hand. In some
that the one or more malleable members once bent will cause embodiments, the loop may extend outwardly from the inside
the mask to be elevated where the bend is, while the other or outside surface at least 5 mm (0.005 m). In other embodi
portions of the mask that do not have a bend portion will ments, the loop may extend outwardly from the outside or
remain flat. inside surface at least about 8 mm (0.008 m). In yet other
US 2016/00 15098 A1 Jan. 21, 2016
embodiments, the loop may extend outwardly from the out binations thereof. In some embodiments, the nanofibers can
side or inside surface at least about 10 mm (0.01 m) from the be coated on or adhered to the inside of the outer layer, middle
outside Surface. layer inside or outside of it, or on or adhered to the inside or
outside of the inner layer of the mask.
Nanofibers (0071. As used herein, the term “nanofibers' refers to very
0069 Current medical masks incorporate filter materials Small diameter fibers having an average diameter not greater
that are made of non-woven cellulose and/or polypropylene than about 1500 nanometers (nm). Nanofibers are generally
materials. Fiber diameter and density is the main variable understood to have a fiber diameter range of about 10 to about
responsible for maintaining a balance between filtration effi 1500 nm, more specifically from about 10 to about 1000 nm,
ciency and pressure differentials (inside the mask on the face more specifically still from about 20 to about 500 nm, and
in relation to ambient pressures outside the mask). Greater most specifically from about 20 to about 400 nm. Other
diameter and density of fibers provide for less fiber surface exemplary ranges include from about 50 to about 500 nm,
area and thereby less space between fibers through which from about 100 to 500 nm, or about 40 to about 200 nm. In
gaseous particles may pass. When such a dense-fiber mask is instances where particulates are present and heterogeneously
sealed to the face through a tight fit, upon wearer exhalation distributed on nanofibers, the average diameter of a nanofiber
pressure within the mask is elevated creating a pressure dif can be measured using known techniques (e.g., image analy
ferential between the inside of the mask and the ambient air. sis tools coupled with electro microscopy), but excluding the
The pressurized gas will seek equivalence to ambient (lower) portions of a fiber that are substantially enlarged by the pres
air pressures through the pathway of least resistance, namely ence of added particles relative to the particle free portions of
the fiber.
any opening or unintended leak around the mask, rather than
through the dense filtration material. This creates a condition 0072 Nanofibers ranging from 10 nm to 1000 nm can be
whereby airflows are deflected off of the mask material (inner, used in filtration medium to capture Submicron particles
and filter layers) rather than passing through it. Likewise, below 1000 nm. The ability of nanofibers to capture particles
upon inhalation of a mask with high(er) density filtration is believed to be due to a combination of interception of
material and a tight seal, inhalation will produce a negative submicron particles by the fibers as well as the Brownian
pressure within the mask chamber. This pressure differential motion or “random walk” of submicron particles, both of
will resolve itself in the same fashion, namely, with higher which facilitate the particles to be captured by the large sur
ambient (external) air flows seeking entry into the mask via face/mass ratio of the nanofibers. Further increase of capture
the path of least resistance; through any mask leaks, rather capability may be obtained by increasing the nanofiber Sur
than through the filter material. In both exhalation and inha face area such as by reducing the fiber diameter and/or by
lation, greater effort is required to move air through the mask. increasing the packing density of the nanofibers, as measured
For example, the use of N95 respirators, which generally in terms of grams of nanofibers per square meter.
contain higher density filtration materials, require medical 0073. In some embodiments, the facemask configuration
clearance to ensure that the extra burden on the diaphragmatic of the present application may offer many advantages: the
muscles used for breathing don't cause adverse health con nanofibers may maintain a low solid Volume fraction (or
sequences to the wearer. The lower the resistance, or pressure equivalently a higher porosity) in each nanofiber layer, the
differential, created by the mask filtration material, therefore, total thickness of the nanofiber layers in the filter may well
the lower the likelihood for air escape and filter by-pass in exceed the single nanofiber layer having the same total poly
seeking pressure equilibrium within and external to the mask, mer packing density (i.e. same grams per square meter or
and the lower “work” required for the wearer to move the air, 'gSm'), a high particle capture efficiency may be attained
through his/her breathing cycle, through the filter material. with Submicron particles, a lower pressure drop may be
Mask fit, therefore, becomes less critical in achieving optimal achieved when compared to the single layer with the same
filtration. Replacement of conventional filtration materials by packing density (i.e. Samegsm), the Substrate layer may act as
nanofiber material with ~150x smaller diameter and far a Support providing mechanical stress (tensile) for the filtra
greater Surface area will result in significant improvements in tion medium, and the Substrate layer may serve as a filter
filtration efficiency, lower pressure differentials, and less medium.
mask leakage and filter bypass. Efficiency increases are 0074. In some embodiments, the nanofibers can be in a
attributed to the enormous specific surface of the nanofiber discrete layer(s) sandwiched between the outer and inner
filter media. Less inward to outward leakage, higher filtration layer. In some embodiments, the nanofibers can make up the
efficiency, and lower pressure differential will enhance the middle layer or can be disposed on the middle layer of the
respiratory source control (inward to outward filtration/cap facemask. In some embodiments, the nanofiber can be dis
ture of potentially infectious particles) efficacy of the mask. posed on the inner, middle and/or outer layer by electrospin
Additionally, the nanofiber layer, while chemically inert, can ning.
be modified to incorporate specific functional characteristics. 0075. As used herein, the term “electrospinning refers to
In some embodiments, the nanofiber can be modified with a technology which produces nano-sized fibers referred to as
silver, copper, or gold nanoparticles for antimicrobial func electrospun fibers from a solution using interactions between
tionality or application of Metal Organic Frameworks fluid dynamics and charged Surfaces. In general, formation of
(MOFs) that can be functionalized for capture of specific the electrospun fiber involves providing a solution to an ori
gaseous airborne threats. Additionally, these fibers can be fice in a body in electric communication with a Voltage
tailored to be hydrophobic or hydrophilic. Source, wherein electric forces assist in forming fine fibers
0070 The nanofibers can be any suitable type of nanofiber, that are deposited on a Surface that may be grounded or
including electrospun fibers, protein nanofibers, cellulose otherwise at a lower Voltage than the body. In electrospinning,
nanofibers, hollow nanofibers, bacterial nanofibers, inorganic a polymer Solution or melt provided from one or more
nanofibers, hybrid nanofibers, splittable nanofibers or com needles, slots or other orifices is charged to a high Voltage
US 2016/00 15098 A1 Jan. 21, 2016
relative to a collection grid. Electrical forces overcome sur nanofiber layers are not interwoven into the nonwoven fiber
face tension and cause a fine jet of the polymer Solution or layers nor are they composites of the nonwoven fiber layers.
melt to move towards the grounded or oppositely charged Discrete nanofiber layers can be coated on one or a plurality
collection grid. The jet can splay into even finer fiber streams of the surfaces of the first, second and third fiber layers 33,36.
before reaching the target and is collected as an intercon 39. In one embodiment, second layer 36 is replaced with a
nected web of small fibers. The dried or solidified fibers can first discrete nanofiber layer 42 coated on outer surface 35 of
have diameters of about 40 nm, or from about 10 to about 100 first layer 33 and a second nanofiber layer 43 coated onto
nm, although 100 to 500 nm fibers are commonly observed. inner surface 40 of third layer 39. In one embodiment, dis
Various forms of electrospun nanofibers include branched crete nanofiber layers are coated onto outer surface 35 of first
nanofibers, tubes, ribbons and split nanofibers, nanofiber layer 33, inner and outer surfaces 37, 38 of second layer 36,
yarns, Surface-coated nanofibers (e.g., with carbon, metals, and inner surface 40 of third layer 39 forming a facemask
etc.), nanofibers produced in a vacuum, and so forth. The having four discrete nanofiber layers for enhanced filtration
production of electrospun fibers is illustrated in many publi of airborne pathogens. In one embodiment, a discrete nanofi
cation and patents, including, for example, P. W. Gibson et al. ber layer is coated on inner surface 34 of first layer 33 and/or
“Electrospun Fiber Mats: Transport Properties. AIChE Jour inner surface 40 of third layer 39.
nal, 45(1): 190-195 (January 1999), which is hereby incorpo 0080. The nanofiber layer density and the combination of
rated by reference. non-woven/nanofiber layers will vary according to specific
0076. The nanofibers can be in the mask to create a gradi performance objectives for each mask version. For example,
ent in the mask. The gradient can be a multi-component one mask version may incorporate a more dense nanofiber
material in which nano-sized fibers of at least two different layer as a replacement for the non-woven filtration layer in
“types” which have been produced by electrospinning are order to achieve similar filtration efficacy while reducing
present and non-uniformly distributed to create one or more pressure differentials (increasing breathability). Another ver
gradients or heterogeneity in one or more directions. The sion may incorporate a less dense nanofiber layer onto an
gradient in a “gradient electrospun material provides dis existing layer to achieve greater filtration efficiency. Addi
crete areas having measurable differences in Surface chemis tionally, the hydrophilic or hydrophilic nature of the incorpo
try (e.g., wicking, contact angle, etc.) or other material prop rated nanofibers may vary. For example, a highly hydropho
erties, including, but not limited to, density, pore size, Surface bic outer layer would be used to improve the fluid bather
charge, Zeta potential, and so forth, resulting from the pres properties of the mask. Conversely, a highly hydrophilic
ence of fibers of different types, i.e., of substantially different nanofiber layer may be used to draw moisture in (wick)
material composition. towards a Subsequent layer in order to draw moisture away
0077. In some embodiments, the nanofibers can be coated from the wearer's face and/or to draw potentially infectious
on the mask in the inner, middle and/or outer layer. In some moisture droplets toward an anti-microbial layer where the
embodiments, the inner layer is the most porous, the middle pathogen would be neutralized. It is envisioned that the
layer is less porous than the middle layer and the outer layer nanofiber layers may incorporate antimicrobial nanopar
is the least porous. In some embodiments, the porosity of the ticles, metal organic frameworks, moisture sensors and/or an
inner and middle layer is the same and the outer layer is the integrated flu diagnostic nano-strip. In some embodiments,
least porous. the materials to make the mask comprise hydrophobic mate
0078. With reference to FIG.3, which shows an exploded rials, e.g., hydrophobic polymers, hydrophobic fluoropoly
cross-sectional view of the medical facemask of the present mers, or polymers having a hydrophobic Surfactants, or the
disclosure, the medical facemask has a first discrete non like.
woven fiber layer 33 (inner layer) disposed adjacent a wear I0081. It is further contemplated that the facemask is a
er's face. First layer 33 has an inner surface 34, which is at continuous loop of fabric that is stretched over the wearer's
least partially contacting the wearer's face. First layer also head covering the neck. Approximately half of the fabric will
has an outer surface 35. A second discrete nonwoven fiber comprise nano-filter material and the other half will comprise
layer 36 (middle layer) is disposed adjacent to outer surface fabric having elastic properties. The front filter portion will be
35 of first layer 33. Second layer 36 can be spaced apart from pulled over the bridge of the nose. It is contemplated that the
first layer 33 or can be disposed in contact with first layer 33. facemask has a tear-away perforation for removal and safety
Second layer 36 has an inner surface 37 facing direction A as purposes, and will not require any metal pieces or ties in order
shown in FIG. 3. Second layer 36 includes an outer surface 38 to secure the facemask to the wearer.
facing direction B as shown in FIG.3 opposite inner surface I0082 In one embodiment, discrete nanofiber layer 42 is
34. In one embodiment, a third discrete nonwoven fiber layer hydrophilic to draw moisture away from first layer 33. In a
39 is disposed adjacent second layer 36 such that second layer further embodiment, the discrete nanofiber layers increase in
36 is disposed between first and second layers 33, 36. Third hydrophilicity from inner surface 34 of first layer 33 to inner
layer 39 (outer layer) has an inner surface 40 facing direction surface 40 of third layer 39 such that a moisture concentration
A as shown in FIG. 3 disposed adjacent outer surface 38 of gradient is formed between first and third layers 33,39. First
second layer 36. Third layer 39 (outer layer) also includes an layer 33 has the lowest moisture content and third layer 39 has
outer Surface 41 exposed to the Surrounding environment the highest moisture content given that moisture will be con
opposite inner surface 40 of third layer 39. stantly drawn away from the wearer's face in direction Bas
0079 Nanofiber material is layered or coated onto sur shown in FIG.3. Once moisture originating from the wearer's
faces of first, second and/or third fiber layers 33 (inner layer), breath passes from inner surface 34 of first layer 33 to outer
36 (middle layer), 39 (outer layer). Alternatively, the nanofi surface 41 of third layer 39, the moisture will evaporate into
ber layer can replace the outer, middle, or inner layer. The the Surrounding environment. The moisture concentration
nanofiber layers are discrete layers, separate from and coated gradient reduces the amount of moisture in an interior cavity
on first, second and third fiber layers 33, 36, 39. The discrete 27 of facemask 10, thus enhancing comfort for the wearer. In
US 2016/00 15098 A1 Jan. 21, 2016
one embodiment, first, second and third layers 33, 36, 39 mask 44 still allows for normal speech without significant
comprise material increasing in hydrophilicity, respectively. difficulty while maintaining a secure fit.
0083 FIG. 4 illustrates a perspective view of an embodi 0088 FIG. 5 illustrates an embodiment of the inner sur
ment of a facemask 44 installed upon a wearer's face. The face 68 of a facemask that the wearer would place against
outer surface 58 of the facemask 44 is shown facing the his/her face. The mask is shown in the unfolded or partially
outside or external environment that the wearer 64 is exposed unfolded position. The upper malleable stiffener 67 imbed
to. The facemask 44 is shown in its unfolded position and ded or attached to the mask has been folded, crimped,
secured to the wearer's face to provide the secure and com pinched, bent, creased, and/or angled around the wearer's
fortable fit by securing the ear loops (one shown as 62) around nose and/or cheek area and causes a cavity 66 in the filter
the wearer's ears. The ear loops are preferably formed of material that conforms and pulls it closer to a portion of the
elastic such that they will secure the facemask 44 in the proper nose and/or cheek. The lower malleable stiffener 70 imbed
position on the wearer's face. Use of elastic ear loops allows ded or attached to the mask has been crimped, bent, creased,
the facemask 44 to be easily installed by the wearer and folded, pinched, and/or angled around or under the wearer's
avoids the difficulty of tying a string tie behind the head. chin and/or jaw area and causes a cavity 69 in the filter
Furthermore, since the ear loops are elastic, there is not the material that conforms and pulls it closer to a portion of the
risk of the ear loops becoming untied at an inopportune wearer's chin and/or jaw area. In some embodiments, the
moment which accompanies the use of ordinary tie Strings. cavity 69 will be located under the chin so that the user can
Furthermore, the elasticity of the ear loops may be chosen so rest it on it. The mask provides a secure and comfortable fit for
as to allow the facemask 44 to be easily repositioned on the the user by simply pinching the malleable stiffeners. It will be
face while only using one hand. understood by those of ordinary skill in the art that the cavities
0084. The facemask 44 comprises one or more pleats in the inside of the mask 66 and 69 can be aligned vertically
with each other or be substantially parallel to each other so
(shown in the unfolded position are three pleats that have been that projection 66 and 69 line up.
unfolded 48,50 and 52). The one or more pleats are disposed 0089 FIG. 6 illustrates an embodiment of the outer sur
between at least the upper, lower, and/or side edges of the face 73 of the facemask installed upon a wearer's face. The
mask. As used herein, the term “pleat” refers to a relatively mask is shown in the unfolded or partially unfolded position.
flat double-fold formed in the facemask 44 when the face
mask 20 is in the flat storage configuration (as illustrated in The upper malleable stiffener 71 imbedded or attached to the
mask has been folded, crimped, pinched, bent, creased, and/
FIG. 1). The pleats in the filter material can be any known in or angled around the wearer's nose and/or cheek area and
the art and include, for example, Z shaped pleats, standard causes a projection 72 in the filter material that conforms it to
pleats, omega pleats, secondary pleats, reverse pleats or the a portion of the nose and/or cheek. The lower malleable
like. stiffener 74 imbedded or attached to the mask has been
0085. The one or more pleats are disposed between the crimped, bent, creased, folded, pinched, and/or angled
upper, lower and side edges (60) of the mask. It will be around or under the wearer's chin and/or jaw area and causes
understood by those of ordinary skill in the art that the mask a projection 75 in the filter material that conforms to a portion
may have one, two, three, four, five, six, seven, eight or more of the wearer's chin and/or jaw area. In some embodiments,
pleats, each of which can be the same or different sizes and/or the projection 75 will be located under the chin so that the user
shapes. can rest it on it. The mask provides a secure and comfortable
I0086. The facemask 44 comprises in its upper section, an fit for the user by simply pinching the malleable stiffeners. In
upper malleable stiffener 46, which when pinched, folded or this way, the mask reduces leakage of material around the top,
twisted pulls the filter material including its top and side bottom and edges of the masks. It will be understood by those
edges against the nose and cheeks. The facemask also com of ordinary skill in the art that the projections in the outside of
prises lower malleable stiffener 54 in the lower section of the the mask 72 and 75 can be aligned vertically with each other
facemask, which when pinched, folded or twisted pulls the or be substantially parallel to each other so that projection 72
side and lower edges into the side of the face and lower jaw and 75 line up and the masks can be stacked one on top of the
area to provide a secure facial fit. Furthermore, it can also be other.
seen that the pleats 48, 50, and 52 allow the creation of a 0090. In some embodiments, individuals who wear eye
pocket-like shape by which the inner surface of the filter glasses also are plagued by the problem of fogging of their
material is held tightly against the lower jaw area of the glasses due to condensation of warm, vapor laden exhaled air
wearer. The upper and lower malleable stiffeners (46 and 54) on the colder Surface of their eyeglasses. Ensuring a secure fit
are attached to or imbedded in the mask material, typically on along the upper edge of the facemask helps to reduce fogging
or in the inside or outside of the mask. These malleable of eyeglasses due to the condensation of vapor laden air. The
stiffeners increase the secure fit formed around the nose and nanofibers can be combined with FogFree(R) face masks,
cheek area and the chin and jaw portion of the face of the some with fog free strips, available from CrossTex (Haup
Weare. pauge, N.Y.).
0087. By properly positioning the ear loops, the one or 0091. In some embodiments, for easy grasping, the face
more pleats, and pinching, bending, folding or twisting the mask may be thermally molded or heat set to increase stiff
malleable stiffeners against the nose, cheek, chin and/or jaw ness. In other embodiments, binder chemicals may be added
areas upon installation of the facemask, a secure fit is pro to the materials prior to formation of the mask. The facemask
vided not only along the upper and lower malleable stiffeners can be disposable and/or for single use.
46 and 54, but also along the side edges of the facemask 44 Indicator
which contact the cheeks. This is due to the effect of the
tension exerted because of the cooperation of the pleats, mal 0092. In FIG. 6, the outer surface 73 of the facemask
leable stiffener(s) and the ear loops. Furthermore, the face comprises a temperature, moisture, and/or pathogen indica
US 2016/00 15098 A1 Jan. 21, 2016
tor. Although shown on the outer surface, it will be under lose color when heated, so that they change from a color
stood by those of ordinary skill in the art that this indicator can towards clear. These dyes include 178002TC (black/clear)
be disposed on or in the outer, inner, and/or middle layer. which is active at 80 to 97 degrees C. and 128001 TC (orange/
0093. The indicator provides a visual indication when a clear), 1384175TC (rose/clear), 150015TC (green/clear),
certain temperature, and/or moisture is reached and/or when 148003TC (blue/clear), 17800TC (black/clear), 14001TCBR
a pathogen is detected. (blue/red), or 128001TCY (orange/yellow), or combinations
0094. The indicator can have for example, a thermochro thereof.
mic dye, such as for example, that disclosed in U.S. Pat. No. 0098. In some embodiments, for moisture detection, the
4,826,550, the entire disclosure is herein incorporated by indicator can comprise an agent that changes colors based on
reference, to provide the indication of a temperature change pH Such as, for example, bromophenol blue. For example, as
in the mask. When the temperature threshold is reached, it moisture from respiration or Sweat occurs in the mask, the pH
results in a visual indication. For example, at temperatures will decrease and the color will be indicated so the user can
above 60° F., above 70° F., above 85° F., above 87 F., or change the mask.
above 97° F., the indicator will change color. Desirably, the 0099 FIG. 7 illustrates an embodiment of the indicator
visual indication of a change in temperature threshold is a shown as a strip 77. The strip at one end has a section 81 that
change in color. This can signal the user to change the mask. can be held and used to pull the strip from the mask. This
0.095. In some embodiments, the indicator can be a label, embodiment is useful for example when the strip is going to
strip, film, and/or tape that can change between two colors, or be used to test a pathogen. The strip can be pulled from the
between a colored condition and colorless condition. A ther mask and the strip can be cultured to see what pathogen can
mochromic material can have an activation temperature, grow (bacteria, virus, mold, etc.). The Strip can be attached to
which is the temperature at which the material has reached its the mask by Velcro, adhesive, glue, or other attachment
final color (or clear) state. For example, a thermochromic means. In some embodiments, the strip comprises an indica
material can be provided in the form of microcapsules which tor region 83 disposed on the strip that gives a visual indica
contain crystal violet lactone, a weak acid, and a dissociable tion (certain color, color change, or turn colorless, etc.) when
salt dissolved in a non-polar or slightly polar solvent liquid a certain threshold temperature, moisture, and/or pathogen is
crystal solvent such as dodecanol or another Suitable liquid present so that the mask can be changed or used only for a
crystal solvent. When the temperature is room temperature, certain period of time. The strip can comprise a region 85 that
the dye exists in its lactone leuco form. However, when the does not contain any visual indication. In some embodiments,
temperature increases, the liquid crystal solvent melts, the the Strip can comprise the same material as the mask, for
salt dissociates, the pH inside the microcapsule lowers (mak example, nanofibers and non-nanofibers.
ing protons readily available), the dye becomes protonated, 0100. In some embodiments, the indicator comprises a
and the lactone ring opens causing its absorption spectrum to collector that can capture microbes and they can be sent to the
shift, absorbing in the visible spectrum, Such as a deeply laboratory for identification or in some embodiments, the
violet color for crystal violet lactone. Suitable thermochro collector can capture the microbe and have an indicator to
mic dyes can be based on mixtures of leucodyes with suitable identify the microbe (e.g., gram positive or gram negative
other chemicals, which display a color change (usually bacteria, etc.). The collector allows immobilization of the
between a colorless leuco form and the colored form of the microbes that can be sent to the lab.
dye) dependent on the temperature. 0101. In some embodiments, the mask can have certain
0096. Thermochromic materials which can be used in the colors for the malleable member (e.g., strip) So the user can
current application also include, but are not limited to, spiro know how to wear the mask. For example, the nose piece can
be a certain color of the malleable member and the malleable
lactones, fluorans, spiropyrans, or fulgides. Weak acids that
can be used as proton donors include bisphenol A, parabens, member of the chin piece can be a different color than the nose
1,2,3-triazole derivatives, and 4-hydroxycoumarin. These piece. Alternatively, the outside of the mask can be marked
weak acids can function as a proton donor to cause a dye with a different color to indicate the part of the mask to be
molecule to change between its leuco form and its protonated worn on the nose and that part of the mask to be worn on the
mouth.
colored form. Stronger Bronsted acids (better proton donors)
can also be used but they tend to make the color change Methods of Making
irreversible. Other thermosensitive dyes that can be used
include an oxazine-based leucothermosensitive dye (such as 0102 The facemask may be formed from a variety of
that sold under the trade mark CSB-12 by Hodogaya Chemi materials and fabrics, such as woven reusable fabrics and
cals Co), a spiropyran-based leucothermosensitive dye (such nonwoven disposable fabrics or webs. As used herein, the
as that sold under the trade mark CSR-13 by Hodogaya term "nonwoven fabric' or "nonwoven web' or "nonwoven
Chemicals Co), a quinoline-based thermosensitive dye (such material' means a web having a structure of individual fibers
as that sold under the trade mark CSY-13 by Hodogaya or threads that are randomly interlaid, but not in an identifi
Chemicals Co) or the like. able manner or pattern as in a knitted fabric. Nonwoven
0097 Specific thermosensitive dyes that can be used in the fabrics or webs have been formed from many processes, for
thermochromic material are non-toxic and are known to acti example, meltblowing processes, spunbonding processes,
vate attemperatures in the range of 21 to 51° C. and which are and bonded carded web processes.
available from SICPA Securink Corporation of Springfield, 0103) As used herein, the term "spunbond' or "spunbond
Va. These dyes include 744020TC (thermochromic blue), fibers' or "spunbonded fibers' refers to small diameter fibers
744010TC (thermochromic turquoise), 744027TC (thermo that are formed by extruding molten thermoplastic material as
chromic yellow), 73401OTC (thermochromic rose), filaments from a plurality of fine, usually circular capillaries
724010TC (thermochromic orange), 754027TC (thermo of a spinneret with the diameter of the extruded filaments then
chromic green). There are also thermochromic dyes which being rapidly reduced, for example, as in U.S. Pat. No. 4.340,
US 2016/00 15098 A1 Jan. 21, 2016
563 to Appelet al., and U.S. Pat. No. 3,692,618 to Dorschner nique involves Subjecting a material to a pair of electrical
et al., U.S. Pat. No. 3,802,817 to Matsuki et al., U.S. Pat. Nos. fields wherein the electrical fields have opposite polarities.
3,338,992 and 3,341,394 to Kinney, U.S. Pat. No. 3,502,763 Electret treatment results in a charge being applied to the
to Hartman, and U.S. Pat. No. 3,542,615 to Dobo et al. filtration medium that further increases filtration efficiency by
0104. As used herein, the term “meltblown” or “melt drawing particles to be filtered toward the filter by virtue of
blown fibers’ means fibers formed by extruding a molten their electrical charge. Electret treatment can be carried out
thermoplastic material through a plurality of fine, usually by a number of different techniques. One technique is
circular, die capillaries as molten threads or filaments into described in U.S. Pat. No. 5,401.446 to Tsai and incorporated
converging high Velocity, usually hot, gas (e.g. air) streams herein by reference in its entirety. Other methods of electret
that attenuate the filaments of molten thermoplastic material treatment are known in the art, such as that described in U.S.
to reduce their diameter, which may be to microfiber diam Pat. No. 4,215,682 to Kubik et al., U.S. Pat. No. 4,375,718 to
eter. Thereafter, the meltblown fibers are carried by the high Wadsworth, U.S. Pat. No. 4,592,815 to Nakao and U.S. Pat.
Velocity gas stream and are deposited on a collecting Surface No. 4,874,659 to Ando, incorporated herein by reference in
to form a web of randomly disbursed meltblown fibers. Such their entirety.
a process is disclosed, for example, in U.S. Pat. No. 3,849.241 0108. Alternatively, the mask may include a layer of
to Butin et al. expanded polytetrafluoroethylene (PTFE) membrane for fil
0105. The facemask may be formed from a single layer or tration, such as those manufactured by W. L. Gore & Associ
multiple layers of material or a composite of multiple layers. ates. A more complete description of the construction and
In the case of multiple layers, the layers are generally posi operation of such materials can be found in U.S. Pat. No.
tioned in a juxtaposed or Surface-to-surface relationship and 3,953,566 to Gore and U.S. Pat. No. 4,187,390 to Gore,
all or a portion of the layers may be bound to adjacent layers. incorporated herein by reference in their entirety.
The multiple layers of a composite may be joined to form a 0109. In some embodiments, the facemask comprises one
multilayer laminate by various methods, including but not or more layers individually or combined made of medical
limited to adhesive bonding, thermal bonding, or ultrasonic grade tissue, spun bound polypropylene, cellulose material,
bonding. meltblown polypropylene, spun bound high density polyeth
0106. One composite material suitable for use with the ylene, and/or low density polyethylene.
present application is a spunbond/meltblown/spunbond 0110. In some embodiments, one or more layers of the
(SMS) laminate. An SMS laminate may be made by sequen mask may be impervious or Substantially impervious to liquid
tially depositing onto a moving forming belt first a spunbond (e.g., spun bound polypropylene, and/or meltblown polypro
fabric layer, then a meltblown fabric layer and last another pylene layer(s)), which may cause liquid to bead on one or
spunbond layer and then bonding the laminate in a manner more surfaces or layers of the mask.
described below. Alternatively, the fabric layers may be made 0111. In some embodiments, the facemask can be made by
individually, collected in rolls, and combined in a separate providing the filter material and inserting or attaching the
bonding step. Multilayer laminates may have multiple melt malleable stiffening members to the mask, where at least one
blown layers or multiple spunbond layers in many different malleable stiffening member is partially bent, crimped,
configurations and may include materials other than nonwov creased, folded, and/or angled and attached to or in the nose
ens. Examples of Such other materials include wovens, films, portion of the mask, either on the inside of the mask or outside
foam/film laminates and combinations thereof, for example, a of it and then attaching a second malleable stiffening member
spunbond/film/spunbond (SFS) laminate. Examples of other to the lower portion of the mask for the chin and/or jaw area;
composite materials Suitable for use in the present invention and attaching securing members to the mask, either on the
inside of the mask or outside of it.
include, but are not limited to, those described in U.S. Pat. No.
4,041,203 to Brocket al., U.S. Pat. No. 5,169,706 to Collier, 0112. In some embodiments, the bend portion is pinched,
et al., U.S. Pat. No. 5,145,727 to Potts et al., U.S. Pat. No. crimped, bent, creased, folded, or angled toward the inner
5,178,931 to Perkins et al., U.S. Pat. No. 4,374,888 to surface or outer surface of the facemask by about 1 to 10
Bornslaeqer, and U.S. Pat. No. 5,188,885 to Timmons et al., degrees or by 1 mm to about 20 mm by hand or machine,
which are all incorporated herein by reference. before, during or after it is attached or imbedded in the mask.
0107 The facemask of the present application may These include crimping machines having stops, posts, or the
include a layer of material, for example, a nonwoven material, like that allow the bend portion to be formed.
suitable for filtration. The filtration material may be made 0113 Having now generally described the invention, the
from a meltblown nonwoven web and, in some embodiments, same may be more readily understood through the following
may be subject to electret treating. As used herein, the term reference to the following examples, which are provided by
“electret” or “electret treating refers to a treatment that way of illustration and are not intended to limit the present
imparts a charge to a dielectric material. Such as a polyolefin. invention unless specified.
The charge includes layers of positive or negative charges Examples
trapped at or near the Surface of the polymer, or charge clouds
stored in the bulk of the polymer. The charge also includes 0114 Tables 1-3 below display the differential pressure or
polarization charges that are frozen in alignment of the pressure drop between the interior of the facemask and the
dipoles of the molecules. Methods of subjecting a material to Surrounding environment using a facemask of the present
electret treating are well known by those skilled in the art. disclosure having nanofiberlayers. Tables 1-3 also display the
These methods include, for example, thermal, liquid-contact, differential pressures measured using a facemask without a
electronbeam, and corona discharge methods. One particular discrete nanofiber layer and a three layer melt-blown non
technique of Subjecting a material to electret treating is dis woven fiber facemask without a discrete nanofiber layer.
closed in U.S. Pat. No. 5,401,466, the contents of which are Three separate trials runs were performed for each facemask
herein incorporated in its entirety by reference. This tech as represented by Tables 1, 2 and 3, respectively. Air was
US 2016/00 15098 A1 Jan. 21, 2016
directed through an inner Surface of the mask representing the 0118 FIG. 9 is a graphic illustration showing different
flow of a wearer's breath during exhalation. Differential pres pressure differentials with various masks. The pressure dif
sure drop was measured for airflows of 25, 125, 250 and 500 ferentials were lower with the nanofiber masks indicating
liters per minute. The results are displayed below. reduced deflection and better filtration.
0119. By having the nanofibers on the inside surface of the
TABLE 1. outer layer or on the middle layer or inner layer or in place of
Mask1
the middle layer, there is low pressure differential between
layers and there is enhanced filtration efficiency. There is also
Differential Pressure enhanced bidirectional flow of air. In some embodiments, the
nanofibers can be integrally adhered (e.g., applied) to the
Air flow Face 3 layer 3 layer melt-blown inside of the outer layer material.
liters/min (I'm) mask nanofiber (nf) nonwoven fiber (mb)
0.120. It will be apparent to those skilled in the art that
25 8.47 O46 8.14 various modifications and variations can be made to various
125 42.1 3.03 38.7
250 78.3 4.31 75.3
embodiments described herein without departing from the
500 141 15.8 127 spirit or scope of the teachings herein. Thus, it is intended that
various embodiments cover other modifications and varia
tions of various embodiments within the scope of the present
teachings.
TABLE 2 What is claimed is:
Mask2 1. A facemask, comprising: an inner layer comprising non
Air Flow Differential Pressure
woven fiber material configured to contact a wearer's nose
and mouth; a middle layer disposed on the inner side of the
(1/m) Face mask 3 layer inf 3 layer mb outer layer and comprising a nanofiber material; an outer
layer disposed on the middle layer and comprising nonwoven
25
125
10
55.3
O416
2.79
8.48
49.4
fiber material, the outer layer configured to contact an exter
250 97.1 4.17 90.6 nal environment, the facemask having upper and lower edges
500 187 9.82 158 and at least one pleat disposed between at least the upper and
lower edges and configured to fit over a chin of the wearer
when unfolded, the at least one pleat configured for folding
TABLE 3
and unfolding the facemask such that when folded the face
mask is configured to assume a generally flat storage configu
Mask3 ration and when unfolded the facemask is configured to cover
at least the nose and mouth of the wearer.
Airflow Differential Pressure 2. A facemask according to claim 1, wherein the nanofiber
(1/m) Face mask 3 layer inf 3 layer mb material of the middle layer is coated on the inner layer and/or
outer layer in one or more discrete coatings.
25 11.2 O.S48 12.3 Cfm 3. A facemask according to claim 1, wherein the nanofiber
125 57.9 2.82 62 Cfm
250 116 5.81 116 Cfm material is disposed on a nonwoven, spunbond fiber layer of
500 221 11.8 222 cfm the middle layer.
4. A facemask according to claim 1, wherein each nanofi
0115. As shown in Tables 1-3, the differential pressures ber of the nanofiber material has a diameter comprising at
least about 150 times Smaller than the diameter of each fiber
measured for the facemask of the present disclosure is as of nonwoven fiber material.
much as approximately 18 times lower than the differential 5. A facemask according to claim 1, wherein the nanofibers
pressures measured for facemasks without discrete nanofiber layer comprises a metal organic framework disposed on the
layers. The differential pressure is directly related to the nanofiber layer.
amount of air that gets deflected above and below the face
mask. Therefore, a lower differential drop associated with the 6. A facemask according to claim 1, wherein the nanofiber
use of the facemask of the present disclosure results in a material is hydrophilic or hydrophobic and draws moisture
reduced amount of air deflection and an increased amount of away from the inner and/or outer layer.
air that passes through the facemask rather than around the 7. A facemask according to claim 1, wherein the outer,
facemask. Facemasks without discrete nanofiber layer(s) middle, and/or inner layer comprises an antimicrobial agent.
demonstrated higher air deflection and therefore less airflow 8. A facemask according to claim 1, wherein the nanofiber
through the facemask. material increases in hydrophilicity or hydrophobicity in a
0116. The nanofiber coating can have a thickness from direction from the inner layer to the middle layer such that a
between 0.03 grams per square meter (gSm) to about 1.0gsm, moisture concentration gradient is formed between the inner
or 1-60gsm. Further, each surface of the filter material can layer and middle layer with the inner layer having the least
have multiple coatings of nanofiber layers to increase the moisture and the middle layer having the most moisture when
thickness of the nanofiber coating. The length of each nanofi the mask is worn.
ber can be below approximately 0.01 deniers. 9. A facemask according to claim 1, further comprising a
0117 FIG. 8 is a graphic illustration showing different malleable stiffening member attached to or within the face
mask filtration. Those marked with “T” were taped to the mask proximate to the upper edge, the malleable stiffening
face; those not marked with a T were not taped. The nanofiber member configured to conform the inner layer to at least a
masks had greater filtration than other masks. nose portion and a cheek portion of the face of the wearer.
US 2016/00 15098 A1 Jan. 21, 2016
10. A facemask according to claim 9, wherein the mal inner layer comprising nonwoven fiber material configured to
leable stiffening member comprises a bend portion indicating contact a wearer's nose and mouth; a middle layer disposed
at least the inner layer and the nose portion of the facemask by on the inner layer and comprising a nanofiber material; an
having a portion of the facemask elevated when the facemask outer layer disposed on the middle layer and comprising
is in the folded storage configuration and the facemask com nonwoven fiber material, the outer layer configured to contact
prises a means for securing the facemask to the wearer's face. an external environment, the facemask having upper and
11. A facemask according to claim 9, further comprising a lower edges and at least one pleat disposed between at least
second malleable stiffening member attached to or within a the upper and lower edges and configured to fit over achin of
lower edge of the facemask, the second malleable stiffening the wearer when unfolded, the at least one pleat configured
member configured to conform the facemask to at least achin for folding and unfolding the facemask such that when folded
portion and ajaw portion of the face of the wearer, the second the facemask is configured to assume a generally flat storage
malleable stiffening member being Smaller in length than the configuration and when unfolded the facemask is configured
malleable stiffening member. to cover at least the nose and mouth of the wearer.
12. A facemask according to claim 11, wherein the second 22. A method according to claim 21, wherein each nanofi
malleable member comprises a bend portion indicating at ber of the nanofiber material has a diameter comprising at
least the inner layer and the chin and/or jaw portion of the least about 150 times Smaller than the diameter of each fiber
facemask by having a portion of the facemask elevated when of nonwoven fiber material.
the facemask is in the folded storage configuration. 23. A method according to claim 21, further comprising a
13. A facemask according to claim 12, wherein the mal malleable stiffening member attached to or within the face
leable stiffening member is pre-crimped to conform to the mask proximate to the upper edge, the malleable stiffening
nose and cheek portion of the wearer, and the second mal member configured to conform the inner layer to at least a
leable stiffening member is pre-crimped to conform to the nose portion and a cheek portion of the face of the wearer.
chin and jaw portion of the face of the wearer. 24. A method according to claim 23, further comprising a
14. A facemask according to claim 1, wherein the facemask second malleable stiffening member attached to or within a
comprises a temperature, moisture, and/or pathogen collector lower edge of the facemask, the second malleable stiffening
disposed on the outer, inner, or middle layer. member configured to conform the facemask to at least achin
15. A facemask according to claim 5, wherein the facemask portion and ajaw portion of the face of the wearer, the second
comprises an antimicrobial disposed in or on one or more malleable stiffening member being Smaller in length than the
layers. malleable stiffening member.
16. A facemask according to claim 14, wherein the collec 25. A method of making a facemask, the method compris
tor comprises a removable nanofiber strip. ing providing an inner layer comprising nonwoven fiber
17. A method of reducing pressure differential in a face material configured to contact a wearer's nose and mouth;
mask, the method comprising: providing an inner layer com disposing a middle layer on the inner layer, the middle layer
prising nonwoven fiber material configured to contact a wear comprising a nanofiber material; disposing an outer layer on
er's nose and mouth; a middle layer disposed on the inner the middle layer, the outer layer comprising nonwoven fiber
layer or inner side of outer layer and comprising a nanofiber material, the outer layer configured to contact an external
material; an outer layer disposed on the middle layer and environment; and forming at least one pleat disposed between
comprising nonwoven fiber material, the outer layer config upper and lower edges of the facemask, the at least one pleat
ured to contact an external environment, the facemask having configured to fit over a chin of the wearer when unfolded, the
upper and lower edges and at least one pleat disposed between at least one pleat configured for folding and unfolding the
at least the upper and lower edges and configured to fit over a facemask Such that when folded the facemask is configured to
chin of the wearer when unfolded, the at least one pleat assume a generally flat storage configuration and when
configured for folding and unfolding the facemask Such that unfolded the facemask is configured to cover at least the nose
when folded the facemask is configured to assume a generally and mouth of the wearer.
flat storage configuration and when unfolded the facemask is 26. A method according to claim 25, further comprising
configured to cover at least the nose and mouth of the wearer. attaching a malleable stiffening member to or within the
18. A method according to claim 17, wherein each nanofi facemask proximate to the upper edge, and conforming the
ber of the nanofiber material has a diameter comprising at malleable stiffening member to at least a nose portion and a
least about 150 times Smaller than the diameter of each fiber cheek portion of the face of the wearer.
of nonwoven fiber material. 27. A method according to claim 26, further comprising
19. A method according to claim 17, further comprising a attaching a second malleable stiffening member to or within
malleable stiffening member attached to or within the face the lower edge of the facemask; conforming the second mal
mask proximate to the upper edge, the malleable stiffening leable stiffening member to at least a chin portion and a jaw
member configured to conform the inner layer to at least a portion of the face of the wearer, the second malleable stiff
nose portion and a cheek portion of the face of the wearer. ening member being Smaller in length than the malleable
20. A method according to claim 19, further comprising a stiffening member; and packing the facemask.
second malleable stiffening member attached to or within a 28. A stack of facemasks, each face mask comprising: an
lower edge of the facemask, the second malleable stiffening inner layer comprising nonwoven fiber material configured to
member configured to conform the facemask to at least achin contact a wearer's nose and mouth; a middle layer disposed
portion and ajaw portion of the face of the wearer, the second on the inner layer and comprising a nanofiber material; an
malleable stiffening member being Smaller in length than the outer layer disposed on the middle layer and comprising
malleable stiffening member. nonwoven fiber material, the outer layer configured to contact
21. A method of enhancing filtration efficiency of airborne an external environment, the facemask having upper and
particles in a facemask, the method comprising: providing an lower edges and at least one pleat disposed between at least
US 2016/00 15098 A1 Jan. 21, 2016
the upper and lower edges and configured to fit over achin of ing member attached to or within the facemask proximate to
the wearer when unfolded, the at least one pleat configured the lower edge, the second malleable stiffening member con
for folding and unfolding the facemask such that when folded figured to conform the inner layer to at least achin portion and
the facemask is configured to assume a generally flat storage a jaw portion of the face of the wearer; and each facemask is
configuration and when unfolded the facemask is configured stacked so that each second malleable stiffening member is
to cover at least the nose and mouth of the wearer. stacked substantially parallel to each other so that the inner
29. A stack of facemasks according to claim 28, wherein layer of the facemasks all face in the same direction.
each face mask further comprises a malleable stiffening 31. A stack of facemasks according to claim 29, wherein
member attached to or within the facemask proximate to the each malleable stiffening member comprises a concave por
upper edge, the malleable stiffening member configured to tion that is stacked on top of one another so that the inner layer
conform the inner layer to at least a nose portion and a cheek of the facemasks all face in the same direction.
portion of the face of the wearer and each facemask is stacked 32. A stack of facemasks according to claim 30, wherein
so that each malleable stiffening member is stacked Substan each second malleable stiffening member comprises a con
tially parallel to each other so that the inner layer of the
facemasks all face in the same direction. cave portion that is stacked on top of one another so that the
30. A stack of facemasks according to claim 29, wherein inner layer of the facemasks all face in the same direction.
each face mask further comprises a second malleable stiffen k k k k k