U.S. patent application number 13/434553 was filed with the patent office on 2012-11-01 for surgical mask.
This patent application is currently assigned to ALLEGIANCE CORPORATION. Invention is credited to Chris Aguilar, Stephanie Carroll, Joe Miller, Joseph PALOMO, Sara Wegener.
Application Number | 20120272973 13/434553 |
Document ID | / |
Family ID | 47066940 |
Filed Date | 2012-11-01 |
United States Patent
Application |
20120272973 |
Kind Code |
A1 |
PALOMO; Joseph ; et
al. |
November 1, 2012 |
SURGICAL MASK
Abstract
A surgical mask provides a wide range of wearers with a good fit
and improved comfort, facilitates proper use of the mask, and
reduces or eliminates fogging of eyewear, as compared with typical
masks. The mask may include a pair of ties that are joined to the
upper, central, and lower parts of either side of the body of the
mask with the assistance of restraint members. The mask may also
include a sealing member that reduces or eliminates gaps between
the wearer's face and the upper part of the mask by forming a seal
between the wearer's face and the mask in use. In addition, the
mask may include a barrier panel that reduces or prevents the
wearer's breath from escaping through the mask and rising to the
wearer's eyewear.
Inventors: |
PALOMO; Joseph; (Antioch,
IL) ; Carroll; Stephanie; (Winthrop Harbor, IL)
; Wegener; Sara; (Libertyville, IL) ; Aguilar;
Chris; (El Paso, TX) ; Miller; Joe; (El Paso,
TX) |
Assignee: |
ALLEGIANCE CORPORATION
McGaw Park
IL
|
Family ID: |
47066940 |
Appl. No.: |
13/434553 |
Filed: |
March 29, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13103570 |
May 9, 2011 |
|
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13434553 |
|
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61332536 |
May 7, 2010 |
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Current U.S.
Class: |
128/863 |
Current CPC
Class: |
A41D 13/1115
20130101 |
Class at
Publication: |
128/863 |
International
Class: |
A41D 13/11 20060101
A41D013/11 |
Claims
1. A mask comprising: a body portion for covering a wearer's face;
and a sealing member that conforms to the wearer's face to provide
a seal between the body portion and the wearer's face.
2. The mask of claim 1, wherein the sealing member is attached to
an upper part of the body portion.
3. The mask of claim 1, wherein the sealing member includes a
fold.
4. The mask of claim 3, wherein the sealing member forms a pocket
that conforms to the wearer's face and reduces or prevents the
wearer's breath from escaping from gaps between the wearer's nose
and cheeks and an upper part of the body portion by at least
partially closing the gaps and channeling the breath away from the
gaps.
5. The mask of claim 3, wherein the sealing member includes a
center section, two side sections, and two semi-arcuate regions
between the center section and the side sections.
6. The mask of claim 5, wherein the center section is narrower than
the side sections and the semi-arcuate regions.
7. The mask of claim 3, wherein the sealing member has a
rectangular shape.
8. The mask of claim 1, wherein the sealing member is formed of a
flexible material.
9. The mask of claim 8, wherein the sealing member is formed of a
flexible soft material that exhibits an air permeability of 10
cubic feet/min or less, as measured by the WSP 70.1 standard, or is
air impermeable.
10. The mask of claim 1, wherein the sealing member is formed of
foam.
11. The mask of claim 1, wherein the body portion comprises
pleats.
12. A mask of claim 1, further comprising: a single set of ties or
a single strap for securing the mask to the wearer's face; and a
set of restraint members positioned at the body portion for
orienting or restraining the single set of ties or a single strap
to the wearer's face.
13. The mask of claim 12, wherein the set of restraint members
includes a set of sleeves.
14. The mask of claim 12, wherein the set of restraint members
includes a set of loops.
15. The mask of claim 12, wherein the set of restraint members are
formed of elastic or flexible materials.
16. The mask of claim 1, further comprising: a barrier panel that
reduces or prevents vapor from the wearer's breath from passing
through the body portion.
17. The mask of claim 16, wherein the barrier panel is made of a
material that exhibits air permeability of 10 cubic feet/min or
less as measured by the WSP 70.1 standard or is vapor
impermeable.
18. The mask of claim 16, wherein the barrier panel is positioned
on or within the body portion.
19. A mask of claim 1, further comprising: a stiffening member that
reduces or prevent the collapse of the body portion into the
wearer's face.
20. The mask of claim 19, wherein the stiffening member is
positioned on or within the body portion.
21. The mask of claim 1, further comprising: a deformable member
that may be bent or pressed by a wearer into a configuration that
allows the body portion to conform to the wearer's face.
22. The mask of claim 21, wherein the deformable member is
positioned on or within an upper part of the body portion.
23. A mask comprising: a body portion for covering a wearer's face,
having an upper part; and a sealing member that conforms to the
wearer's face and reduces or eliminates gaps that may be present
between the wearer's nose and cheeks and the upper part of the body
portion.
24. A mask comprising: a body portion for covering a wearer's face,
having an upper part; and a sealing member that conforms to the
wearer's face and reduces or prevents the wearer's breath from
escaping from gaps between the wearer's nose and cheeks and the
upper part of the body portion by at least partially closing the
gaps and channeling the breath away from the gaps.
Description
RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Patent Application No. 61/332,536 titled "Surgical Mask" filed May
7, 2010 and U.S. patent application Ser. No. 13/103,570 filed May
9, 2011. The related applications are incorporated herein by
reference in their entirety.
FIELD OF THE INVENTION
[0002] The invention relates to a surgical mask that provides a
wide range of wearers with a good fit and comfort, while
facilitating proper use of the mask and reducing fogging of the
wearer's eyewear.
BACKGROUND OF THE INVENTION
[0003] Medical professionals wear surgical masks to prevent
contamination of a patient's surgical or wound site with the
wearer's nasal and oral bacteria that may result from the wearer
talking, sneezing, or coughing during a medical procedure, such as
surgery. Surgical masks also protect the wearer's mouth, nose and
mucosa from contacting splashes or sprays of the patient's blood or
other body fluids and from airborne microorganisms.
[0004] Typical masks include a body that covers the nose and mouth
of the wearer and two sets of ties that are attached to the body
that the wearer must tie behind his/her head to secure the mask to
his/her face. Having two sets of ties provides the masks with some
adjustability as the wearer may position the ties to suit his/her
comfort and preference. Usually, one set of ties is attached to the
upper part of the body of the mask and is secured around the upper
part of a wearer's head, and the other set of ties is attached to
the lower part of the body of the mask and is secured around the
lower part of a wearer's head.
[0005] The presence of two sets of ties for securing the mask
presents the opportunity for improper use, however, which often
results from the wearer's desire to increase his/her comfort while
wearing the mask. For example, a wearer may secure only the upper
part of the mask to the upper part of his/her head using one set of
ties, while allowing the lower part of the mask and the
corresponding ties to hang freely around the neck. Consequently,
the bottom of the wearer's nose and mouth may be exposed to
microorganisms from the patient's surgical or wound site. A wearer
may alternatively secure the set of ties corresponding to the lower
part of the mask and loosen the set of ties corresponding to the
upper part of the mask, allowing the mask to hang at his/her neck,
to increase his/her comfort during a break in a medical procedure.
The wearer may then fail to secure the ties corresponding to the
upper part of the mask when he/she is back in close proximity with
a patient. As a result, the wearer's nose and mouth may be exposed
to the patient's surgical or wound site. These practices are
violations of protocol and may cause the loose set of ties and the
mask to become an obstruction between the wearer and the patient,
possibly hindering the performance of the medical procedure.
[0006] Masks with two sets of ties also provide a wearer the
opportunity to reuse a mask, since the wearer is able to remove one
set of ties while partially maintaining the mask on his/her head
using the other set of ties. The wearer may later re-tie the other
set of ties, as the need arises. This practice is especially
problematic when the wearer encounters a different patient, as
he/she may re-secure a partially attached and previously-used mask
that has possibly been contaminated, instead of removing and
discarding the previously-used mask, as protocol dictates. Another
problem with having two sets of ties is that since the two sets of
ties are secured to a wearer's head independently of each other,
improper tying and placement of either set of ties may compromise
the overall protection offered by the mask.
[0007] In addition to surgical masks, wearers often wear eyewear,
such as glasses or protective goggles, while performing medical
procedures. A common disadvantage of typical masks is that a
wearer's eyewear may fog when vapor from the wearer's exhaled
breath escapes from or through the upper part of the mask and rises
into his/her eyewear. This problem is exacerbated when there is a
large gap between the upper part of the mask and the wearer's face
or when the wearer's breath goes through the upper part of the
mask. To prevent fogging and to reduce heat build-up in a typical
mask, wearers often fail to secure the set of ties corresponding to
the lower part of the mask so that vapor can escape through the
bottom of the mask, which is a violation of protocol, as discussed
above.
[0008] Another problem with typical masks is that they fit too
loosely or tightly on a wearer's face, causing the wearer
discomfort. Some masks are so loosely fitted that they migrate
during head movements or common facial movements associated with
talking. This requires the wearer to adjust the mask, which is
difficult and distracting during a medical procedure. Moreover,
contacting a mask with a gloved hand during a medical procedure is
a violation of protocol as the mask is not considered to be
"sterile" and it may contaminate the sterile glove. Migration of
the mask may be so significant that the mask partially blocks the
eye region, potentially leading to a decreased field of vision and
exposure of the wearer's nose and mouth. Some masks, such as
respirator-type masks, fit very tightly against a wearer's face to
reduce the chance of exposing the wearer to the patient's bacteria
or exposing the patient to a wearer's nasal and oral bacteria. They
do not, however, conform to the contours of the wearer's face,
which causes the wearer discomfort.
[0009] The problems of improper use, fogging of a wearer's eyewear,
and insufficient wearer comfort associated with a typical mask
discussed above stem from an unsatisfactory fit of the mask against
the wearer's face. In an effort to alleviate these concerns,
hospitals and other medical care facilities must carry multiples
shapes and sizes of surgical masks to fit the dimensions and to
suit the preferences of all wearers. Typical masks range from those
with flat parts that cover the nose and mouth of the wearer to
those of highly contoured cone and "duckbill" styles, which must be
made available in many styles to fit a wide range of wearers.
[0010] Thus, there is a need to develop a mask that solves the
disadvantages of improper use, fogging of eyewear, and insufficient
wearer comfort of a typical mask, while providing a wide range of
wearers with a good fit.
SUMMARY OF THE INVENTION
[0011] The invention relates to a surgical mask that provides a
wearer with improved comfort, facilitates proper use of the mask,
and reduces or eliminates fogging of eyewear, as compared with
typical masks. The mask also provides a wide range of wearers with
a good fit.
[0012] The mask may include a single pair of ties, or alternatively
a single strap, that is attached to the upper, central, and lower
parts of either side of the body of the mask in conjunction with
one or more pairs of flexible restraint members. The restraint
members are attached to or integral with the body of the mask at or
adjacent to the sides of the body of the mask. The ties and
restraint members may orient the upper, central, and lower parts of
the mask to the corresponding portions of a wearer's face. The ties
and restraint members allow the mask to be donned easily and assist
a wearer in complying with protocol. Further, this configuration
reduces the potential for reuse of a mask. The location of the ties
and restraint members also allow the mask to fit wearers of a wide
range of shapes and sizes.
[0013] In some embodiments, the mask may include a sealing member
that is attached to or is integral with the upper part of the mask
so as to be in contact with the wearer's nose and cheeks in use.
This sealing member reduces or eliminates any gaps between the
wearer's face and the upper part of the mask by forming a seal
between the wearer's face and the mask. Preferably, the sealing
member, alone or in conjunction with the upper part of the mask,
forms at least one pocket that exhibits low vapor transmission or,
more preferably, vapor impermeability, from the wearer's face
through the upper part of the mask. This configuration reduces or
eliminates vapor from the wearer's exhaled breath from escaping
from the upper part of the mask and fogging the wearer's eyewear.
The sealing member is preferably soft and flexible to provide
comfort and adjustability to the wearer.
[0014] In some embodiments, the mask may include one or more
barrier panels that are joined to or integral with the mask. The
one or more barrier panels form a barrier that reduces or
eliminates the wearer's breath from escaping through the body of
the mask and rising and fogging the wearer's eyewear. For example,
if the one or more barrier panels are positioned at the upper part
of the body of the mask, the one or more barrier panels preferably
direct the wearer's breath toward the central and lower parts of
the mask so that it may escape through the body of the mask and/or
out from the sides.
[0015] The mask of the invention may include any combination of
these and other features, as discussed below.
DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a front view of a mask according to one embodiment
of the invention.
[0017] FIG. 2 is a front view of a mask according to another
embodiment of the invention.
[0018] FIG. 3 is an expanded view of a mask according to one
embodiment of the invention.
[0019] FIG. 4 is an expanded view of a mask according to another
embodiment of the invention.
[0020] FIG. 5 is a front view of a mask according to another
embodiment of the invention.
[0021] FIG. 6a is a back view of a sealing member having a fold,
according to one embodiment of the invention.
[0022] FIG. 6b is a back view of a sealing member showing a pocket
created by a fold, according to one embodiment of the
invention.
[0023] FIG. 7 is a front view of a mask of the invention donned by
a wearer.
[0024] FIG. 8 is side view of a mask according to one embodiment of
the invention donned by a wearer.
[0025] FIG. 9 is side view of a mask according to another
embodiment of the invention donned by a wearer.
[0026] FIG. 10 is a front view of a mask according to one
embodiment of the invention having a strap and a cinching
attachment.
[0027] FIG. 11 is a front view of a mask according to another
embodiment of the invention having a strap and a cinching
attachment.
[0028] FIG. 12 is a side view of a mask having a cap according to
an embodiment of the invention donned by a wearer.
[0029] FIG. 13 is a graph showing a distribution of facial size
bivariate cell numbers according to an embodiment of the
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0030] The surgical mask of the invention overcomes the
disadvantages of typical masks discussed above. In particular, the
mask of the invention provides a wearer with improved comfort,
facilitates its proper use, and reduces or eliminates fogging of
eyewear, as compared with typical masks. The mask also provides a
wide range of wearers with an improved fit.
[0031] Various aspects of the mask may be illustrated by describing
components that are attached and/or joined together. As used
herein, the term "attached" is used to indicate either a direct
connection between two components or, where appropriate, an
indirect connection to one another through intervening or
intermediate components. In contrast, when a component is referred
to as being "joined" to another component, there are no intervening
or intermediate components present.
[0032] The mask may include ties that are integral with the mask or
may be attached to the mask either directly or indirectly. The mask
may include a pair of ties, or alternatively a single strap, that
are attached to the body of the mask at or adjacent to the sides of
the body of the mask. For example, the ties may be attached to the
lower edge of the mask in a parallel or perpendicular alignment
with the lower edge of the mask. Preferably, the ties are attached
parallel to the lower edge of the mask so as to provide the mask
with a better fit against the lower part of a wearer's face in
use.
[0033] In one embodiment of the invention as shown in FIGS. 1 and
3, the ties 20 may be joined directly to the lower part of either
side of the body of the mask 70. However, it is also possible to
join the ties to the central or upper part of the body of the mask,
or to join the ties to the restraint members, as discussed
below.
[0034] The ties may secure the upper, central, and lower parts of
the mask to the corresponding portions of a wearer's face as the
wearer dons the mask and pulls the ties behind his/her head. The
ties may be attached to the upper, central, and lower parts of
either side of the body of the mask in conjunction with one or more
pairs of flexible restraint members that are attached to or
integral with the body of the mask.
[0035] The restraint members may be positioned at or adjacent to
the sides of the body of the mask. The restraint members may be
positioned parallel to, perpendicularly to, or at an angle from the
sides of the body of the mask. The restraint members may take a
variety of shapes and configurations including, but not limited to,
sleeve, loop, rectangular, triangular, tapered, and curved
shapes.
[0036] The ties may be attached to the restraint members in many
ways. For example, the ties may be passed through, aligned with, or
joined to the restraint members by any possible method including,
but not limited to, ultrasonic welding, heat welding, adhesive
bonding, or by stitching.
[0037] In the embodiment shown in FIGS. 1, 3, 8, 10, and 12, the
ties are attached by passing through flexible restraint members 30
formed as sleeves along the sides of the body 70 of the mask. The
restraint members 30 may or may not extend all the way to the lower
edge of the mask. Preferably, the restraint members 30 extend along
the sides of the body 70 of the mask and end above the lower edge
of the mask. The lower edge of the mask is preferably configured to
be positioned under the wearer's chin. Alternatively, the restraint
members 30 may extend all the way to the lower edge of the
mask.
[0038] In another embodiment shown in FIGS. 2, 4, 9, and 11 the
ties are attached by passing through flexible restraint members 80
and 82 formed as loops in the upper and central parts of the body
70 of the mask, respectively.
[0039] In some embodiments, more than two pairs of restraint
members may be positioned at or adjacent to the sides of the body
of the mask. In an embodiment shown in FIG. 5, pairs of restraint
members 92 are attached to the upper, central, and lower parts of
either side of the body of the mask and are joined together with
ties 94 at a position distant from the body of the mask. These
restraint members 92 may be formed integrally with each other, or
one or more of the restrained members 92 may be formed integrally
with the ties 94.
[0040] When the wearer secures or pulls the ties around his/her
head while donning the mask, the restraint members conform toward
the wearer's cheeks to orient and/or restrain the ties and to cinch
the sides of the mask to the wearer's face. Preferably, the
restraint members are configured to orient or cinch both sides of
the lower, central, and upper parts of the body of the mask toward,
and optionally in contact with, the wearer's face. As the body of
the mask cinches, the body of the mask forms a chamber that covers
at least the wearer's mouth and lower nose. The chamber has a
generally contoured shape, but its shape varies based on how
tightly the wearer secures the ties behind his or her head.
[0041] A wearer may optionally secure the ties while utilizing
some, but not all, of the restraint members. Thus, the wearer may
achieve a better fit of the mask against his/her face and provide
greater comfort.
[0042] The ties may be made of flexible materials including, but
not limited to, polyolefins, polyolefin alloys, and polyolefin
elastomers. The materials may include fibers such as spunbond
fibers and bi-component fibers in a core and sheath configuration
such as a polyethylene sheath/polypropylene core.
[0043] The restraint members may be made of elastic materials that
stretch towards the sides of the wearer's face so as to provide the
mask with greater comfort and a better fit against the wearer's
face in use. For example, when the restraint members are in a
sleeve configuration, the sleeves are preferably made of an elastic
material that stretches in one direction. The sleeve restraint
members may be oriented at the sides of the mask so as to stretch
in a direction perpendicular to the sides of the mask. The elastic
material may include, but is not limited to, nonwovens, such as SMS
with an elastic polyolefin, a spunbond made with elastic
polyolefin, or knitted polyolefins or other polymers with elastic
components.
[0044] The restraint members may also be made of flexible materials
including, but not limited to, polyolefins, polyolefin elastomers,
polyolefin alloys, and polyolefins or polyester with spandex. The
materials may include fibers such as spunbond fibers, bi-component
fibers in a core and sheath configuration such as a polyethylene
sheath/polypropylene core, knitted polyester and knitted
polyolefins.
[0045] The presence of polyolefins such as polyethylene in the ties
and restraint members is preferred because it makes them softer and
more comfortable to a wearer. However, any desired soft material
may be used. The presence of elastomeric materials in the ties and
restraint members is preferred because it allows the mask to
stretch and conform to the wearer's face, particular during facial
movements and while talking, thus providing a better fit and
greater comfort to the wearer.
[0046] The ties and/or restraint members may be integral with the
body of the mask or they may be joined to the body of the mask by
any possible method including, but not limited to, stitching, heat
welding, ultrasonic welding, and adhesive bonding.
[0047] In another embodiment of the invention, the ties may form
earloops that are used with the restraint members, as discussed
above. In yet another embodiment shown in FIGS. 10 and 11, a single
strap 22 may be used instead of a pair of ties. The strap may be a
single continuous piece, for example, that is integral with or
attached to the body of the mask. For example, each end of the
strap 22 may be joined to the lower part of either side of the body
of the mask 70, as shown in FIGS. 10 and 11. Alternatively, it is
possible to join the strap to the central or upper part of the body
of the mask, or to join the strap to the restraint members, as
discussed above. The strap may be made of the same materials as the
ties.
[0048] The strap may be used with a cinching attachment that
secures the strap to the wearer's head as the wearer pulls the
strap towards his/her head. The cinching attachment may be attached
to the strap so that the strap can be cinched to tighten behind the
wearer's head. The cinching attachment preferably secures both
sides of the strap so that the strap does not slip and loosen the
mask from the wearer's head. For example, a cinching attachment 24
may be positioned near the middle of the strap 22, as shown in
FIGS. 10 and 11.
[0049] The cinching attachment may include, but is not limited to,
a button spring clip.
[0050] The strap and cinching attachment may be used with a cap
that lies against the wearer's head to provide added comfort. As
shown in FIG. 12, when a cap 26 lies against the wearer's head, a
cinching attachment 24 may be used to secure a cinched strap 22 to
the wearer's head. The cap may have any desirable configuration
including, but not limited to, circular, oval, square, triangular,
etc. The cap may be made from materials including, but not limited
to, polyethylene, polypropylene, cardboard, and polyester.
[0051] The restraint members and ties or strap enable the mask to
remain secured to a desired location on the wearer's face and allow
only minimal movement of the mask as the wearer talks or makes
facial movements. The restraint members in combination with the
ties or strap also provide a good fit and adjustability of the mask
against both sides of a wearer's face.
[0052] The wearer may secure the ties or strap around the crown,
back, or lower part of his/her head, depending on his/her personal
preference, providing adjustability and comfort. The adjustability
of the ties or strap and restraint members allow the mask to
conform to fit wearers having faces with a wide range of shapes and
sizes. The mask also accommodates a wide variety of hairstyles,
including ponytails, or when the hair is covered in a protective
wrap, such as a surgeon's cap or bouffant.
[0053] The wearer may secure the ties or strap together behind
his/her head as tightly or as loosely as he/she desires, while
still covering his/her nose and mouth. The ties or strap and
restraint members allow the body of mask to fit snugly against the
wearer's face. If desired, an almost "respirator-type" seal may be
formed between the mask and wearer's face, while providing greater
comfort than a typical respirator or mask. A wearer may optionally
leave gaps between the central part of the mask and his/her face to
provide greater comfort.
[0054] Further, this configuration of ties or strap and restraint
members allows a wearer to don the mask easily and assists a wearer
in complying with protocol. In addition, the configuration of the
ties or strap of the invention reduces the potential for improper
reuse of a mask.
[0055] In some embodiments of the invention, the mask includes a
sealing member. The sealing member may be attached to or be
integral with the upper part of the body of the mask on the inner
surface that faces the wearer's nose and cheeks in use. The sealing
member reduces or eliminates gaps that may be present between the
wearer's nose and cheeks and the upper part of the mask, thereby
reducing or eliminating fogging of eyewear. In particular, the
sealing member conforms to a wearer's face to provide a seal
between the mask and nose and cheeks.
[0056] The sealing member preferably forms at least one pocket
between the mask and the wearer's face. The at least one pocket may
be formed by the sealing member alone, or in conjunction with the
inner surface of the upper part of the mask. A pocket may be
configured to reduce or prevent the wearer's breath from escaping
from gaps between the wearer's nose and cheeks and the upper part
of the mask by closing the gaps and channeling the breath away from
the gaps. For example, a pocket may channel a wearer's breath so
that it may escape through any gaps between the central part of the
mask and the wearer's face.
[0057] FIGS. 1-5 shown one sealing member 40, but more than one
sealing member may be used. The sealing member may have a uniformly
wide shape, such as rectangular. Alternatively, a sealing member 40
may be narrower at a center section 46 corresponding to the bridge
of the nose and/or at right and left side sections 48, as shown in
FIGS. 1-5. Having a narrower center section 46 at the nose assists
in maintaining the mask in position and may reduce or eliminate
migration of the mask into the field of vision and upsetting the
placement of eyewear. Preferably, as shown in FIGS. 1-6, the
sealing member includes two semi-arcuate regions between the center
section and the side sections.
[0058] The sealing member may be made of any material that is
flexible so that it can conform to the contours of a wearer's face.
Preferably, the sealing member may be made of a flexible soft
material. Even more preferably, the sealing member may be made of a
flexible soft material that exhibits low water absorption and vapor
transmission, such as an air permeability of 10 cubic feet/min or
less as measured by the WSP 70.1 standard or is vapor impermeable,
such as a foam. A sealing member made of foam may provide comfort
and adjustability to the wearer. For example, the foam may be made
of a closed-cell polyethylene EVA copolymer foam that is
crosslinked using an electron irradiation process, such as the foam
sold under the trade name Volara Type G.RTM..
[0059] The sealing member may be integral with the upper part of
the body of the mask, or it may be attached to the upper part of
the body of the mask, preferably on the inner surface thereof. The
sealing member may be joined to the body of the mask by any
possible method including, but not limited to, stitching, heat
welding, ultrasonic welding, and adhesive bonding.
[0060] According to a preferred embodiment of the invention, the
sealing member may be folded and attached to the upper part of the
mask. In this embodiment, an attachment section of the sealing
member is attached to the body of the mask across its width and a
folded over section folds over the attachment section. The folded
over section may be about 0.5 to about 4 times the width of the
attachment section at its widest point. When the mask is donned,
the folded over section contacts the wearer's nose and cheeks. The
attachment section and the folded over section thus form an
integral pocket at the upper part of the mask. This embodiment is
preferred over an embodiment without the attachment section,
although the attachment section is not necessary, as a pocket may
also form between the sealing member and the inner surface of the
upper part of the mask.
[0061] FIGS. 6a and 6b show an embodiment of the sealing member 40
having a folded over section 42 and an attachment section 44. In
this embodiment, two pockets may be formed between the folded over
section 42 and the attachment section 44.
[0062] In an embodiment of the invention, the folded over section
and the attachment section may be sealed together at the center
section and/or at the side sections. The seal at the center section
and the side sections may be achieved by any possible method
including, but not limited to, heat welding and ultrasonic welding.
At least a seal at the center section is preferred, since such a
seal results in two pockets on either side of the center section,
which further improves vapor trapping.
[0063] In some embodiments of the invention, the mask includes one
or more barrier panels that are attached to or are integral with
the mask. The barrier panel forms a barrier that reduces or
prevents vapor from the wearer's breath from passing through the
body of the mask and rising to and fogging the wearer's eyewear.
Preferably, the barrier panel directs the wearer's breath toward
the sides of the body of the mask or toward other portions of the
body of the mask where the barrier material is not present, so that
the breath can preferably escape out from the sides of the central
part of the mask or through the other portions of the body of the
mask.
[0064] The barrier panel may be positioned at any part of the body
of the mask. Preferably, the barrier panel is positioned at the
central and/or upper part of the body of the mask, on an outer
surface opposite the surface that contacts the wearer's face. If
the one or more barrier panels are positioned at the upper part of
the body of the mask, the one or more barrier panels preferably
direct the wearer's breath toward the central and lower parts of
the mask so that it may escape through the body of the mask and/or
out from the sides. The barrier panel may also be positioned in
between any layers that make up the body of the mask, or adjacent
to additional components of the mask, such as the sealing member,
on the inner surface.
[0065] The barrier panel may be positioned at the body of the mask
across its entire width, or it may be positioned at discrete
locations. For example, the barrier panel may be placed in the
central part of the body of the mask to direct the flow of vapor to
the sides of the body of the mask.
[0066] A barrier panel 50 may have a rectangular shape as shown in
FIGS. 1-5, or its width may be varied. For example, the barrier
panel may have an arcuate or semi-arcuate shape.
[0067] The barrier panel may be made of any material that exhibits
low vapor transmission, such as an air permeability of 10 cubic
feet/min or less as measured by the WSP 70.1 standard or is vapor
impermeable including, but not limited to, polyolefins such as
polyethylene and polypropylene. The barrier panel may be
transparent, opaque, colored, or printed.
[0068] The barrier panel may be attached to the body of the mask by
any possible method including, but not limited to, stitching, heat
welding, ultrasonic welding, and adhesive bonding.
[0069] In some embodiments, the mask may include one or more
stiffening members that are positioned on or within the body of the
mask. The stiffening members provide rigidity to the body of the
mask to reduce or prevent the collapse of the mask into the
wearer's face as the wearer inhales. For example, the body of the
mask may include two stiffening members 60, as shown in FIGS. 1-5,
that correspond to where a wearer's nostrils and mouth would be
positioned, as shown in FIGS. 7-9.
[0070] The stiffening members may be formed, for example, by heat
or ultrasonically welding the material(s) forming the body of the
mask. The stiffening members may also be formed by placing a strip
of material on top of or between the layers of the body of the mask
to provide rigidity. Alternatively, the stiffening members may be
formed by placing strips of a polymeric adhesive on the body of the
mask or between its layers at various locations along its
width.
[0071] If the stiffening members are formed from a strip of
material, the material may include, but is not limited to,
polyolefins such as polypropylene and polyethylene, cardboard,
paper, polyethylene terephthalate, or any semi-stiff polymer. The
stiffening members may be joined to the body of the mask by any
possible method including, but not limited to, heat welding,
ultrasonic welding, and adhesive bonding. The stiffening members
may also be formed by applying an acrylic or hot melt adhesive on
top of or between the layers of the body of the mask.
[0072] The stiffening members may have a variety of shapes, sizes,
and configurations that provide the body of the mask with
sufficient rigidity to withstand collapse of the mask with the
wearer's inhaled breath. For example, the stiffening members may be
straight, curved, angled, continuous, or discontinuous. Preferably,
the stiffening members have a generally rectangular shape, as shown
in FIG. 1.
[0073] In addition, the stiffening members may be positioned
horizontally, vertically, or at an angle on the body of the mask.
Preferably, the stiffening members are positioned horizontally on
the body of the mask, as shown in FIGS. 1 and 3.
[0074] The rigidity of the body of the mask provided by the
stiffening members may be varied by altering their width, length,
and thickness and by varying the type and amount of material or
adhesive used.
[0075] In some embodiments, the mask may include one or more
deformable members. The deformable member may be bent or pressed by
a wearer into a configuration that allows the body of the mask to
conform to a wearer's face. In particular, the deformable member
may assist in forming the seal between the sealing member and the
wearer's face as it can maintain the sealing member in a desired
configuration corresponding to the contours of the wearer's face.
For example, the deformable member may be positioned at the upper
part of the body of the mask corresponding to where a wearer's nose
and cheeks would be positioned in use.
[0076] The deformable member may be positioned on a surface of the
body of the mask, within layers of the body of the mask, or between
the body of the mask and the sealing member. For example, as shown
in FIG. 3, a deformable member 100 may be positioned between the
upper part of the body of the mask and the barrier panel 50.
[0077] The deformable member may be made of any deformable material
that retains its shape after being bent or pressed by a wearer,
such as a metal. Possible metals that may be used in the deformable
member include, but are not limited to, aluminum, such as Aluminum
1350, and steel. The deformable member may also comprise two or
more wires, such as thin steel wires, each preferably having a
diameter of 1/16 inch or less, embedded in a polypropylene film
strip.
[0078] The deformable member may have a variety of shapes, sizes,
and configurations that allow a wearer to bend or press it to
conform the body of the mask to a wearer's face. For example, the
deformable member may be straight, curved, angled, continuous, or
discontinuous. In an embodiment of the invention, as shown in FIG.
3, the mask includes a deformable member 100 that has a continuous
rectangular shape. Alternatively, the deformable member may have an
arcuate shape.
[0079] The deformable member may be attached to the body of the
mask by any possible method including, but not limited to, heat
welding, ultrasonic welding, and adhesive bonding. For example,
heat welding and ultrasonic welding may be used to encapsulate a
deformable member within the layers that form the body of the mask.
Alternatively, an adhesive may be applied to a deformable member to
attach it to the body of the mask.
[0080] The body of the mask may be made of any material that
substantially covers the mouth and nose of a wearer. The material
forming the body of the mask may have a variety of shapes and
configurations that allow it to conform to the wearer's face, such
as a generally rectangular shape, a contoured shape, or a
combination of shapes. For example, the central part of the lower
part of the body of the mask may have one or more curves to allow a
better fit against a wearer's chin. Generally, it is preferred that
the lower part of the body of the mask is straight so that the mask
may be folded flat.
[0081] In an embodiment of the invention, the body of the mask
includes pleats 72, as shown in FIGS. 1 and 3. The pleats 72 expand
when mask 10 is donned by a wearer, as shown in FIGS. 7 and 8 and
they preferably fold flat so that the mask 10 can lay flat for easy
packaging and storage.
[0082] The pleats may be formed by folding the material and joining
the sides of the body of the mask by any available method
including, but not limited to, stitching, ultrasonic welding, heat
welding, etc. to hold the pleats in place.
[0083] The body of mask may be made of any suitable material that
allows a wearer to breathe through it including, but not limited
to, nonwoven materials such as wet laid, dry laid, spunlaced,
spunbond, meltblown, spunbonded-melt blown-spunbonded (SMS),
carded, thermoplastic fibers, regenerated fibers, and bicomponent
fibers such as sheath-core fibers. These nonwovens may be made of
materials including, but not limited to, polyolefins such as
polyethylene and polypropylene, polyesters such as PET, natural
fibers, and cellulose materials. The nonwovens forming the body of
mask may comprise mixtures of two or more of the foregoing fiber
types.
[0084] Further, the body of the mask may include one or more layers
of such materials. For example, the body of the mask may be made of
four layers including an outer layer of spunbond/spunbond
polypropylene, an intermediate layer of calendered bi-component
polyethylene/PET, a middle filtration layer of meltblown
electret-treated polypropylene, and an inner layer of wet laid
cellulose. The body of the mask may also be made of three layers
including an outer layer of spunbond/spunbond polypropylene, a
middle filtration layer of meltblown electret-treated
polypropylene, and an inner layer of spunbond/spunbond
polypropylene, for example.
[0085] Binding material may optionally be attached to the body of
the mask to attach the various components of the mask and/or to
provide the mask with smooth edges. For example, binding material
may be positioned between the deformable member and the barrier
panel to attach the deformable member to the upper part of the
mask. In addition, binding material may be attached to the lower
part and sides of the mask. When attached to the sides of the mask,
the binding material may be used to hold any pleats in the body of
the mask in place.
[0086] Binding material may also be attached to or formed
integrally with the ties. For example, when binding material is
attached to the lower part of the mask, ties may be formed by
extending the binding material to form ties. Alternatively, the
ties may be attached to the binding material at the upper part
lower part, and/or sides of the mask.
[0087] The binding material may be attached to the mask by any
available method including, but not limited to, stitching,
ultrasonic welding, heat welding, etc. The binding material may be
made of any suitable material that may be joined to the body of the
mask including, but not limited to, nonwoven materials such as wet
laid, dry laid, spunlaced, spunbond, meltblown, spunbonded-melt
blown-spunbonded (SMS), carded, thermoplastic fibers, regenerated
fibers, and bicomponent fibers in a core and sheath configuration
such as a polyethylene sheath/polypropylene core, and knitted
materials. These nonwovens may be made of materials including, but
not limited to, polyolefins such as polyethylene and polypropylene,
polyolefin elastomers, polyolefin alloys, polyesters such as PET,
natural fibers, and cellulose materials.
[0088] To adequately protect both the wearer and patient from fluid
transfer, the body of the mask may provide some level of fluid
resistance. Typically, when the body of the mask includes a higher
number of layers, it provides a higher fluid resistance. For
example, the body of the mask may provide a fluid resistance of at
least 160 mm Hg according to the ASTM F1862 Fluid Resistance to
Synthetic Blood standard. The body of the mask also preferably
meets the requirements of High Barrier according to ASTM F2100
standard.
[0089] Each layer of the body of the mask may have a basis weight
of from about 0.25 oz/sq. yd., to about 4.0 oz/sq. yd. For example,
the total weight of all layers of the body of the mask may be about
2.4 oz/sq. yd.
[0090] The mask of the invention may include any combination of the
features discussed above.
Experimental 1
[0091] The ability of the mask of the invention to prevent fogging
of a wearer's eyewear and to restrict movement on a wearer's face
as compared to three other masks that are commonly used by medical
professionals was tested on a group of thirty random participants.
The mask tested was similar to the embodiment shown in FIGS. 1 and
3, which includes sleeves as reinforcement members, and one set of
ties. The mask also included a sealing member with two pockets
similar to that shown in FIGS. 6a and 6b.
[0092] The commonly-used masks tested were the Cardinal Health
Secure-Gard.RTM. Fluid Resistant Surgical Mask with Fog-Free Strip
mask (Ref. AT74535), the Kimberly-Clark TECNOL.RTM.
FLUIDSHIELD.RTM. Fog-Free Surgical Mask (Ref. 48207), and the 3M
High Fluid Resistant Surgical Mask (Ref. 1835). Any markings on the
masks, such as manufacturer names, that may allow a participant to
identify one of the tested masks were covered by the moderators
prior to testing.
[0093] All four of the masks tested had pleats in the body of the
mask and deformable members positioned at the upper part of the
mask corresponding to where a wearer's nose and cheeks would be
positioned in use. The Cardinal Health Secure-Gard.RTM. mask and
the Kimberly-Clark TECNOL.RTM. FLUIDSHIELD.RTM. mask included flat
rectangular pieces of foam attached to the upper part of the mask
on the inner surface that faces the wearer's nose and cheeks in
use, while the 3M High Fluid Resistant Surgical Mask did not.
[0094] The Cardinal Health Secure-Gard.RTM. mask, the
Kimberly-Clark TECNOL.RTM.FLUIDSHIELD.RTM. mask, and the 3M High
Fluid Resistant Surgical Mask did not include a sealing member with
pockets, a barrier panel, or stiffening members in the body of the
mask, as did the mask of the invention. In addition, the Cardinal
Health Secure-Gard.RTM. mask, the Kimberly-Clark TECNOL.RTM.
FLUIDSHIELD.RTM. mask, and the 3M High Fluid Resistant Surgical
Mask each included two sets of ties. One set of ties was attached
to the upper part of the body of the mask to be secured around the
upper part of a wearer's head, and the other set of ties was
attached to the lower part of the body of the mask and to be
secured around the lower part of a wearer's head.
[0095] The moderators measured the participants' facial length and
width at the beginning of the testing using sliding and spreading
calipers. These measurements were recorded and each participant was
assigned a bivariate cell number based on the 25-Member NIOSH Panel
shown below.
[0096] The moderators asked each participant to don a bouffant cap
or surgeons cap. The moderators then asked the participant to
randomly select one of the four masks and to don the mask, using a
mirror to assess appropriate mask placement. The moderators asked
the participants to make any necessary adjustments to ensure a
proper fit. The moderators asked each participant to look in the
mirror and take note of the position of the mask on the face. The
moderators asked each participant to pay attention to the position
of the mask on the nose, the distance from the eyes, and the
location of the ties. The moderators informed the participants that
once the testing was underway, he/she may not touch the mask or
adjust its position on their face. If a participant was not wearing
glasses, the moderators asked him/her to don protective eyewear
over the mask.
[0097] Various exercises were performed to test the anti-fogging
and movement of each mask on the participants' faces. The
participants' answers of "yes" or "no" regarding whether any
fogging occurred after each exercise were recorded by the
moderators. The moderators instructed each participant to remain
still and continue breathing normally. The moderators gave each
participant a word search puzzle and a pen, and ask him/her to
complete the puzzle. After one minute, the moderators asked each
participant whether they observed any fogging of the eyewear, and
if so, if the fogging was impairing his/her ability to perform the
task of completing the puzzle. The moderators then instructed each
participant to continue working on the word search puzzle and begin
taking slow, deep breaths. After one minute, the moderators asked
each participant whether they observed any fogging of the eyewear,
and if so, if the fogging was impairing his/her ability to perform
the task of completing the puzzle.
[0098] The moderators instructed each participant to stop working
on the word search puzzle, remain seated, and slowly turn his or
her head from side to side as far as possible while breathing
normally. After one minute, the moderators asked each participant
whether they observed any fogging of the eyewear. The moderators
instructed each participant to remain seated and slowly move his or
her head up and down, alternating between looking at the ceiling
and the floor. After one minute, the moderators asked each
participant whether they observed any fogging of the eyewear.
[0099] The moderators instructed each participant to read out loud
a passage of text, which was provided by the moderators, making
sure that the participant spoke slowly and loudly enough to be
heard by the moderators. After one minute, the moderators asked
each participant whether they observed any fogging of the eyewear,
and if so, whether the fogging impaired his/her ability to perform
the task of reading the passage. The moderators instructed each
participant to make an expression such as smiling or frowning.
After thirty seconds, the moderators asked each participant whether
they observed any fogging of the eyewear. The moderators instructed
each participant to resume work on the word search puzzle, remain
still, and continue breathing normally. After one minute, the
moderators asked each participant whether they observed any fogging
of the eyewear, and if so, if the fogging was impairing his/her
ability to perform the task of completing the puzzle.
[0100] The moderators then asked each participant to look in the
mirror and assess the position of the mask on his/her face. The
moderators asked each participant whether the mask moved on his/her
face during the exercises. In particular, the moderators asked each
participant whether the mask contacted their lips during the
exercises as a a result of the mask collapsing inward towards
his/her face. A rating of 0 signified no lip contact, a rating of 1
signified occasional lip contact, and a rating of 2 signified that
lip contact was maintained during the exercises.
[0101] The moderators then asked each participant to remove the
eyewear and the surgical mask. The moderators then asked each
participant to select one of the remaining masks and to don the
mask, using a mirror to assess appropriate mask placement. The
steps discussed above were repeated for all four masks.
[0102] The participants' responses regarding the fogging and
movement of each mask are summarized below in Table 1. The mask of
the invention is denoted as "A", the Cardinal Health
Secure-Gard.RTM. mask is denoted as "B", the Kimberly-Clark
TECNOL.RTM. FLUIDSHIELD.RTM. mask is denoted as "C", and the 3M
High Fluid Resistant Surgical Mask is denoted as "D". Each
participant's response for whether fogging occurred after each
exercise for each mask was condensed into one "yes" or "no" answer
for each mask. If fogging was reported during any one or more of
the seven exercises for a particular mask, the condensed response
for that mask was reported as "yes". If fogging was not reported
during any of the exercises, the condensed response for that mask
was reported as "no".
TABLE-US-00001 TABLE 1 Size bivariate Test cell Fog Fog Fog Fog
Movement Movement Movement Movement Subject number A? B? C? D? A?
B? C? D? 1 4 Yes Yes Yes Yes 0 2 2 0 2 2 No No No Yes 2 0 1 1 3 4
Yes No Yes Yes 0 0 0 0 4 7 Yes Yes Yes Yes 0 0 0 1 5 7 No Yes Yes
Yes 0 0 0 0 6 2 Yes Yes Yes Yes 0 0 0 0 7 2 No Yes Yes Yes 0 1 1 1
8 8 Yes Yes Yes Yes 0 0 0 0 9 8 Yes Yes Yes Yes 0 0 0 0 10 4 Yes
Yes Yes Yes 1 0 1 0 11 7 No Yes Yes Yes 0 0 0 0 12 1 Yes No Yes Yes
0 1 0 0 13 8 Yes Yes Yes Yes 0 1 2 0 14 1 No Yes Yes Yes 1 1 1 1 15
4 Yes Yes Yes Yes 0 0 0 0 16 10 Yes Yes Yes Yes 0 1 0 1 17 1 Yes
Yes Yes Yes 2 1 0 2 18 3 No Yes Yes Yes 0 0 0 0 20 8 No Yes Yes Yes
0 0 1 0 20 4 Yes No Yes Yes 0 1 1 1 21 4 Yes Yes No No 0 1 0 0 22 2
No No No No 0 2 0 0 23 2 Yes Yes Yes Yes 1 0 0 0 24 1 No Yes Yes
Yes 0 0 1 1 25 7 No Yes Yes Yes 0 0 0 0 26 3 No No No Yes 0 0 0 0
27 2 Yes Yes Yes Yes 0 2 0 0 28 7 No No No Yes 0 1 1 1 29 7 No No
No Yes 0 0 2 1 30 4 No No No Yes 0 1 2 0 % of participants 46.7%
30.0% 23.3% 6.7% with NO fogging % of participants 83.3% 56.7%
60.0% 66.7% with NO lip contact % of participants 10.0% 33.3% 26.7%
30.0% with occasional lip contact % of participants 6.7% 10.0%
13.3% 3.3% with maintained lip contact
[0103] As shown in Table 1, the participants found that the mask of
the invention provided higher anti-fogging abilities as compared to
the three commonly-used masks. In particular, 46.7% of the
participants found that the mask of the invention exhibited no
fogging, while the closest of the commonly-used masks, the Cardinal
Health Secure-Gard.RTM. mask, exhibited no fogging for only 30.0%
of the participants. The percentage of participants that
experienced no fogging with the mask of the invention, 46.7%,
represents a 55.6% improvement in anti-fogging abilities as
compared to the Cardinal Health Secure-Gard.RTM. mask, a 100%
improvement as compared to the Kimberly-Clark TECNOL.RTM.
FLUIDSHIELD.RTM. mask, and a 600% improvement as compared to the 3M
High Fluid Resistant Surgical Mask.
[0104] The data in Table 1 also demonstrates that the participants
experienced less contact of the mask of the invention with their
lips during the exercises as a result of the mask collapsing inward
towards his/her face as compared to the three commonly-used masks.
In particular, 83.3% of participants experienced no contact of the
mask of the invention with their lips, while the closest of the
commonly-used masks, the 3M High Fluid Resistant Surgical Mask,
provided only 66.7% of the participants with no lip contact. The
percentage of participants that experienced no lip contact with the
mask of the invention, 83.3%, represents a 24.9% improvement as
compared to the 3M High Fluid Resistant Surgical Mask, a 38.9%
improvement as compared to the Kimberly-Clark TECNOL.RTM.
FLUIDSHIELD.RTM. mask, and a 47% improvement as compared to the
Cardinal Health Secure-Gard.RTM. mask. The mask of the invention
also provided low occasional and maintained lip contact as compared
to the other masks tested.
[0105] The participants in this test had a wide range of facial
sizes, as indicated by the varied size bivariate cell numbers
summarized in Table 1. The distribution of size bivariate cell
numbers is summarized in FIG. 13.
Experimental 2
[0106] The fit and comfort of a mask of the invention was tested on
a group of 12 participants. The mask used was similar to the
embodiment shown in FIGS. 2 and 4, which includes loops as
restraint members.
[0107] The moderators first asked the participants a series of
questions about the type of mask they currently wear at work,
whether they wear eyewear, and whether they experience any fogging
of eyewear while wearing the current mask. If the participant
experienced fogging of eyewear, the participant was asked how they
typically reduce or prevent the fogging. These responses included,
for example, moving the glasses and lifting the mask, and taping or
adjusting the nose wire.
[0108] The moderators then measured the facial width, facial
length, nose length, and nose protuberance, or how far the nose
protrudes from the face, of each participant. The facial widths
ranged from about 10.6 cm to about 15 cm, the facial lengths ranged
from about 9.5 cm to about 13.9 cm, the nose lengths ranged from
about 4.5 cm to about 5 cm, and the nose protuberances ranged from
about 1.5 cm to about 2.6 cm.
[0109] The moderators administered a stroop color test, which is a
logic puzzle, to get a baseline reading on the participant's
ability to respond to the questions. Next, the moderators asked the
participants to try on the mask. The moderators noted whether each
participant wore the mask at the crown, back or lower part of the
head. The participants filled out an evaluation sheet containing
questions regarding their perceived comfort and fit of the mask.
Specifically, the participants were asked to rate how easy the mask
was to don, its breathability in and out, the overall physical
comfort, and the comfort of various parts of the mask such as the
chamber of the mask, the upper part of the mask, and sealing
member. The rating was done on a scale of 1 to 5, with 1 as the
worst rating, and 5 as the highest rating. The participants were
also asked if the mask caused fogging of their eyewear, whether
there was a little or a lot of fogging, and where the fogging
occurred. The participants were also asked whether the mask stayed
in place while talking and making head movements from side to side
and up and down. If the mask moved, participants were asked to note
where exactly the movement occurred.
[0110] Next, the participants were then asked to do some light
physical activities for five minutes, such as moving books around.
Then, the participants were asked to take the stroop color test
again for another five minutes, while wearing the mask, to
determine whether the presence of the mask distracted them while
taking the test. The participants again filled out an evaluation
sheet with the same questions regarding perceived comfort, fit, and
whether fogging occurred. They were also asked whether the mask
provided adequate facial coverage, how easy the mask was to doff,
whether they liked the appearance of the mask, and whether they
preferred it compared to their current mask.
[0111] The participants' answers were converted from the scale of
1-5 to percent favorability. The participants' answers are
summarized in Table 2 below. A dash "-" indicates that when a
particular criteria was not tested or was not applicable.
TABLE-US-00002 TABLE 2 First Second Overall Evaluation Evaluation
(% Criteria (% favorable) (% favorable) favorable) Breathability In
93 98 -- Breathability Out 87 92 -- No Fogging 83 83 -- Overall
Physical Comfort 88 90 -- Ease of Donning -- -- 78 Chamber Size
Comfort -- -- 87 Upper Part Comfort -- -- 93 Sealing Member Comfort
-- -- 88 No Mask Movement -- -- 75 Adequate Facial Coverage -- --
94 No Distraction During -- -- 97 Stroop Test Ease of Doffing -- --
100 Appearance of Mask -- -- 100 Prefer vs. Current -- -- 93
[0112] As shown in Table 2, the participants found the mask of the
invention to provide high levels of comfort in both the first and
second evaluations. Specifically, the participants found the mask
to be easy to don and to provide excellent breathability and
comfort. Notably, the participants found that the mask caused very
little fogging of their eyewear and did not move significantly
during the routine head and facial movements that occurred while
performing the light physical activities. In addition, the
participants stated that the mask provided adequate facial
coverage, was easy to doff, and the appearance was favored by the
participants. It was also found that the presence of the mask did
not cause much distraction during the stroop color test. Overall,
93% of participants preferred the mask of the invention over the
mask they currently use.
Experimental 3
[0113] In another set of tests, participants were asked to compare
the ability to control fogging, the fit, and the comfort of the
mask of the invention with their currently-used mask. The mask of
the invention used in the tests was similar to the embodiment shown
in FIGS. 1 and 3, which includes sleeves as reinforcement members
and one set of ties. The mask also included a sealing member with
two pockets similar to that shown in FIGS. 6a and 6b. The
participants' were not asked to identify their currently-used mask,
but to use its performance as a point of comparison to the
performance of the mask of the invention.
[0114] The tests were conducted on 136 random participants, who
were medical professionals at five medical facilities. The
participants included 25 surgeons and 111 nurse/circulators,
physician's assistants, and surgical/scrub technicians. The testing
was performed by having the participants wear the mask of the
invention during an actual medical procedure that they were
performing, which typically lasted between approximately twenty
minutes and three hours. It was noted that there were no mask
failures during the testing procedures, indicating the clinical
acceptability of the mask of the invention.
[0115] After completing the medical procedures, the participants
were asked to fill out surveys regarding the mask of the
invention's ability to control fogging, its fit, and the level of
comfort it provided, when compared to his/her currently-used mask.
The participants were also asked whether they preferred the mask of
the invention or their currently-used mask and whether they would
use the masks of the invention again. The participants answers to
the survey questions are summarized in Table 3 below.
TABLE-US-00003 TABLE 3 Somewhat Mask of Currently- Better or
Somewhat the Used Much Worse or Question invention Mask Better Same
Worse Did fogging occur? 6% 74% -- -- -- Of the surgeons, did
fogging 4% -- -- -- -- occur? How did the mask of the -- -- 65% --
-- invention's ability to control fogging compare to the currently-
used mask? How did the mask of the -- -- 69% 11% 20% invention's
overall fit compare to the currently-used mask? How did the mask of
the -- -- 64% 18% 18% invention's level of comfort compare to the
currently-used mask? Do you prefer the mask of the 60% 34%
invention or your currently-used mask? Of the surgeons, do you
prefer the 76% 24% mask of the invention or your currently-used
mask?
[0116] As indicated in Table 3 above, when asked whether they
experienced fogging with their currently-used mask and the mask of
the invention, 74% of the participants reported fogging with their
currently-used mask, while only 6% of the participants reported
fogging with the mask of the invention. Only one surgeon out of 25,
or 4%, reported fogging with the mask of the invention. 65% of the
participants ranked the mask's ability to control fog as "somewhat
better" or "much better" than their currently-used mask. These
results indicate that the mask of the invention produces
substantially less fogging than the masks currently-used by the
participants.
[0117] The participants were asked to compare the overall fit of
the mask of the invention with their currently-used mask. 69% of
the participants rated the fit of the mask as "somewhat better" or
"much better" than their currently-used mask. The participants were
also asked to compare the level of comfort of the mask of the
invention with their currently-used mask. 64% of the participants
rated the mask of the invention as "somewhat better" or "much
better" than their currently-used mask. These results indicate that
the mask of the invention provides a substantially better fit and
higher level of comfort than the masks currently-used by the
participants.
[0118] The participants were asked whether they preferred the mask
of the invention or their currently-used mask. 60% of the
participants preferred the mask of the invention, 34% of the
participants preferred their currently-used mask, and 6% did not
answer the question. Of the surgeons, 76% preferred the mask of the
invention.
[0119] The participants were asked whether they would wear the mask
of the invention again. 68% of the participants said that they
would "definitely" or "probably" wear the mask of the invention
again, while 15% of the participants said "probably not" or
"definitely not" wear the mask of the invention again.
[0120] The results discussed above in Experimental 1, Experimental
2, and Experimental 3 demonstrate that the masks of the invention
provide wearers of a wide range of sizes with reduced fogging of a
wearer's eyewear, reduced contact with a wearer's lips, and
improved comfort and fit, as compared with commonly-used masks. The
masks of the invention also facilitate their proper use as they
include only one set of ties or one strap, while commonly-used
masks include two sets of ties.
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