Note: Descriptions are shown in the official language in which they were submitted.
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The present invention relates generally to an
improved face mask assembly particularly adapted for
use with infants and, more particularly, to an
improved medical face mask assembly including a
detachable pacifier.
Normal operative procedures require a patient to
~be ~ ~ prior to surgery in order to reduce the
prohLems associated with regurgitated material during
an operation. As a consequence, patients are often
hungry and thi~sty when anesthesia is induced. Often
therefore, many pa~ients, such as infants, will cry
during pre-operative procedures making anesthesia
induction difficult. Many children will suck
vigorously a~ the edge of a standard face mask as the
anesthesiologist attempts to place the mask over
infants' faces. While such suckling quiets a child,
it will often prevent the ~ace mask from being pro-
perly positioned on the child's face and, therefore,
prevent a tigh~ seal from being formed around the edge
of the mask in order to perform a smooth and rapid
inhalational induction of an anesthetic gas.
Additionally, the smell and/or taste of such masks may
be unappealing and therefore less acceptable to a
child. Accordingly, many pediatric anesthesiologists
have resorted to giving a pacifier to the infant prior
to inducing the anes~thesia. Giving a pacifier to the
in~ant, however, usually requires the anesthesiologist
to use a larger face mask, which increases the dead
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space (the term "dead space" beiny deined as the
volume of space which can contain and trap a potentially
unacceptably large quantity of user-exhausted carbon
dioxide that can be rebreathed by a patient and inc]udes
anatomical areas, such as the oropharynx and trachea,
as well as the physical space between the interior of
a medical face mask and the portion of the sur~ace
area of the face the mask covers) and makes it more
difficult to maintain a tight fit of the mask to the
face. Increasing the dead space can lead to respira-
tory complications. Where an infant is provided with
a separate pacifier during anesthesia induction,
should it be necessary to perform a ventilatory
procedure, the mask and pacifier often have to be
removed in order that proper suctioning can be
accomplished.
A prior art face mask is shown in U.S. Patent No.
1,000,706. U.S. Patent Nos. 1476194 and 3139088
illustrate inhaling devices including tubes adapted to
be inserted in the mouth. U.S. Patent Nos. 2521084,
3809079 and 4470413 show face mask assemblies with air
ways adapted to be inserted into the mouth of a
patient. None of these devices are satisfactory in
calming infant patients during anesthesia induction.
While pacifier assemblies are certainly known (see
U.S. Patent No. 2612165) none are adapted to be
attached to medicaI face masks, such as those used for
anesthesia induction or respiration functions.
~ It is a general object of the present invention to
~ provide an improved face mask assembly which ~educes
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or overcomes the above-noted problems.
A more specific object o~ the present invention is
to provide an isnproved face mask assembly de~igned to
promote suckling and quiet the patient while providing
an adequate passageway for transporting air or an
anesthetic gas to a patient.
Another specific object of the present invention
is to provide an improved face mask a6sembly including
a detachable pacifier and designed so as to more
easily provide a tight seal around the face mask.
And another specific object of the present inven-
tion is to provide an improved fa~e mask usable with
or without a detachable pacifier.
Still another object of the present invention is
to provide an improved face mask assembly including a
pacifier attachable to a face mask in such a manner so
as to prohibit oral entrainment or swallowin~ by the
patient of all or portions of the assembly.
Yet another specific object of the present inven-
tion is to provide a face mask as embly including anattachable pacifier incorporated with a flavoring or
fragrance so as tO enhance the acceptance of the
assembly by an infant patient.
And still another specific object of the present
invention is to provide an improved face mask assembly
including an attachable pacifier in which a ven-
tilation procedure can be performed without removing
the assembly from the patlent.
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Generally speaking the present invention provides a
product comprising: a plastic face mask adapted to extend over
at least the nose and mouth; and Pragrance means incorporated
in the plastic face mask ~or provlding a predetermined
fragrance.
Furthermore, the present invention provides a pacifier
adapted to be secured to a face mask during pre-operative and
operative procedures and detached and used separately from the
face mask during pre- and post-operative care, the pacifier
comprising: (a) an integrally-formed elongated element
including wall means having a base end defining an orifice, a
tip end opposite the base end and defining a hole, a non-
collapsible passageway extending through the element from the
orifice to the hole, and at least one aperture extending
through the wall means into the passageway, the tip end being
adapted to be positioned in the oropharynx of the user when the
pacifier is used; and (b) fragrance means embedded in the
elongate element for providing a predetermined fragrance.
Other objects of the invention will in part be obvious
and will in part appear hereinafter. The invention,
accordingly, comprises the product possessing the features,
properties and relation of components which are exemplified in
the following detailed disclosure, and the saope of the
appIication of whiah will be indlcated by the claims.
For a fuller understanding of the nature and objects of
the pres~ent invention, reference should be
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had to the following detailed description taken in
connection with the accompanying drawings, wherein:
Fig. 1 is a front view of the preferred embodiment
of the face mask a~sembly of the present invention;
Fig. 2 is a longitudinal cross-sectional view
taken along line 2-2 of Fig. l;
Fig. 3 is a longitudinal cross-sectional view of
the preferred embodiment of the pacifier-shield
a~sembly of the present invention; and
Fig. 4 is a front view of the assembly of Fig. 3.
The assembly of the present invention includes the
medical face mask 10 (shown in Figs. 1-2) and the
pacifier 12 (shown in Figs. 1-4) detachably secured to
the face mask 10. The pacifiec is constructed so that
it can also be secured to the shield 14 (shown in
Figs. 3-4) for pre- and post-operative care.
The face mask 10 is generally contoured to extend
over at le~st the nose and mouth of the wearer of the
mask so that the edges of the mask tightly contact the
face of the wearer. Although the preferred embodiment
is described as being primarily useful with patients
who are infants~ it can also be used with older
children as well as adults. Accordingly, the actual
size of the mask can vary to accommodate different age
2s groups and the shape of the mask also may be varied to
accommodate diffe~ent type~ of facial contours, e.g.,
wide and narrow cheek bones, small and large chins,
etc. The face mask 10 includes ~he nose cover portion
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16 and mouth and cheek cover portion 18, portions 1
and 18 being defined by the outer edge rim 20
extending around the periphery of the back of the face
mask. The rim 20 preferably i5 rounded smooth to
avoid sharp edyes, and if desired provided with a
cushion material (not shown), so as to comfortably
engage the face of the wearer while maintaining an
air-tight seal. The cover portions 16 and 18 on the
rear side of the mask create a hollow space 22,
defined by the inclined inner surfaces 24 and inner
wall 26. Space 22 receives the portions of the face
covered by the face mask and defines with the face a
confined air space which is a part of the dead space.
As is well-known, the dead space should be minimized,
especially where the mask is used for anesthesia
induction so as to minimize the rebreathing of expired
carbon dioxide.
The mask 10 also includes an opening 28,
approximately centered in the mouth and cheek cover
portion 18 of the mask and extending from the front
of the mask through the inner wall 26 opposite the
location of where the mouth is located when the mask
is worn by a patient. The opening is preferably of
a cylindrical cross-section for receiving, for example,
a face mask connector (not shown) which may or may not
be provided with an expiratory valve, as is well-known.
Although not shown, a metal brushing may be inserted
in the opening 28 for accommodating the connector and
a multiprong head strap hook may be provided at the
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front of the mask around the opening for connecting a
head strap so that the mask can be held clo~ely in
place. To the extent described, the mask is similar
to many currently commercially-available face mask3.
S If desired, when for example the pacifier ia not
needed, the face mask can be used alone in the same
manner as comparable prior art face masks.
The mask lO i~ modified in accordance with the
present invention to include an inward radially-
directed annular flange 30 formed at the baak end ofopening 28 so that the pacifier 12 can be attached.
Flange 30 includes the annular shoulder 32 disposed in
a plane parallel to the inner wall 26 and the
cylindrical surface 33 coaxially disposed with the
lS center axis of opening 28.
The pacifier 12 is an elongated, integrally-formed
elementO The pacifier is made 50 as to define the
non-collapsable passageway 34. The pacifier also
includes a hole 36, preferably at its tip, com-
municating with passageway 34. The pacifier is alsopreferably provided with at least one aperture 3~ in
the wall of the pacifier, between the base portion of
th~ pacifier and the tip at a position so that (l) the
aperture 38 communicatea with the ~pace 22 of the mask
10 when the pacifier is attached to the mask, and
(2) gas provided to the mask through opening 28 into
the passageway 34 of the paci~ier 12 will also pas~
thr~yh the aperture 38 into the space 22. As shown,
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the preferred embodiment of the pacifier includes four
such apertures equiangulary disposed around the
elongated axis of the pacifier. The base of the
pacifier is open and is provided with coupling means
preferably in the form of a riny 40 circumferentially
disposed around and integrally formed as the base of
the pacifier, for attaching the pacifier to the mask
10 or shield 14. Ring 40 includes the annular outwardly
directed radial flange 42 having an annular shoulder 44.
The flange 42 has a diameter approximately the same as
opening 28, but larger than cylindrical surface 33 so
that the flange 42 will freely slide axially in opening
28 but will be restrained by flange 30 of the mask when
pacifier 12 is secured to the mask lO. An annular
groove 46 is disposed on the outer surface of ring 40
of the pacifier adjacent the shoulder 44. An annular
lip 48 also radially extends out from the outer surface
of ring 40 of pacifier 12 and is disposed adjacent the
groove 46 so as to form an annular channel between the
lip 48 and flange 42. The lip 48 has a smaller outside
diameter than the outside diameter of the flange 42,
and is provided with a beveled outer edge, larger in
diameter at the base end of the lip so as to form the
edge tip 49, for reasons which will be more evident
hereinafter.
The pacifier 12 can be easily and securely attached
to the mask 10 by sliding the pacifier 12 tip
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end first through the front of opening 28, pushing the
pacifier through until the annular shoulder 44 of the
flange 42 of the ring 40 contacts the annular shoulder
32 of flange 30 of mask 10. The lip 48 will engage
S the inner cylindrical surface 33 of flange 30 as the
pacifier is pushed, but will easily slide through due
to the beveled shape of the outer edge of the lip 48.
The edge tip 49 formed at the base end of the lip 48
will engage the inner wall 26 of mask 10 at the
10 opening of the flange 30 helping to lock the pacifier
in place such that the flange 30 is disposed in the
annular channel provided between flange 42 and lip 48.
The annular groove 46 provides some flexibility
be~ween the flange 42 and lip 48 ~o that the pacifier
can be detached from the mask by merely pushing the
pacifier in the opposite direction, i.e., back out the
front of opening 28. Wlth su~ficient axial force the
lip 48 will disengage wall ~ of the mask 10 and be
forced through the opening of flange 30.
When used with the mask 10, the pacifier 12 is
positioned to extend from the interior of the mask 12
and is capable of being inserted into the mouth of the
wèarer so as to occupy a substantial portion of the
anatomical space of the oropharynx and depress the
tongue of the wearer of the mask. An anesthetic gas
can be introduced through the opening 28 where it will
pass through passageway 34 of the pacifier through
apertares 38 into the air space 22 80 that the wearer
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can breathe the gas through the nose. Thus, the mask
will be more readily received ancl easily positioned
with respect to an infant when anesthesia is induced.
Should it be necessary to ventilate while the mask is
in position, the entire mask can be removed, or if
desired, a catheter can be inserted through opening 28
of the mask and through passageway 34 so that ~he end
of the catheter is positioned between the apertures
38 and hole 36 and suction can be provided through
hole 36 at the tip. It should be appreciated that the
face mask assembly can be used for any application
where the mask 10 is to be placed on the patient's
face, including, but not limited to anesthesia
induction and respiration functions.
As shown in Figs. 3 and 4, the pacifier 12 can
also be secured to a shield 14 for pre- and post-
operative care. The shield is provided with an
aperature 50 defined by an inner lip 52 of reduced
thickness for extending in the groove 46 between
the flange 42 and lip 48 when the pacifier is attached.
The aper~ture 50 has approximately the same diameter as
the lip 48 and is smaller in diameter than that of the
flange 42 of the ring 40 of pacifier 12 so that the
pacifier can be easily pushed through the aperture 50
in the same manner so that the pacifier is securely
held in place. The shape of the shield may take any
shape with an annular disk shape being preferred
s1nce no sharp edges are provided.
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The mask 10, pacifier 12 and shield 14 may be made
of any biologically-compatible and structurally-
durable material, such as a polyethylene or a polyvinyl
chloride. The pacifier 12 should be made of a material
strong enough so that when the pacifier is inserted in
the mouth and sucked on, the passageway 34 will remain
non-collapsible, clearly distinyuishing it from
standard feeding nipples. Preferably, the face mask
and/or shield means and the pacifier are provided with
a fragrance and/or taste which is appealing to the
patient to make it more acceptable, for example, to
infants. The fragrance can be provided, for example,
by adding 6% by weight of a fragrance concentrate
to a polyvinyl chloride matrix, and forming the various
components by injection molding.
The mask 10, pacifier 12 and shield 14 provide
several advantages. The mask assembly is designed to
promote suckling and quiet the patient while providing
an adequate passageway for transporting air or an
anesthetic gas to a patient. The mask can be used
with or without the pacifier. When the pacifier is
used with the mask a tight seal can easily be
achieved around the face mask even with the smallest
of infants. The pacifier can be secured to the face
mask in such a manner so as to prohibit excessi~e oral
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entrainment or swallowing by the patient of all or
portions of the assembly. The pacifier may be pro-
vided with a flavoring or fragrance so as to enhance
patient acceptance of the assembly. The mask and
pacifier assembly is designed to 0asily per~orm a ven-
tiLation procedure wi~hout removing the assembly from
the patient. The design of the assembly is such that
the smallest applicable face mask can be us~d with
each patient. Thus, the physical dead space for a
given size patient will be ~ubstantially minimized.
The use of the pacifier attached to the face mask also
helps properly orient the mask when placing it over
the patients face. Additionally, with the presence of
the pacifier in the oropharynx of the patient ceduces
the anatomical dead space. Finally, the pacifier is
constructed to be easily attached to a ~ace mask for
pre-operative and operative procedures, and used with
the attachable shield 14 for pre-and post-operative
care.
Since certain change~ may be made in the above
product assembly without departing from the scope of
the invention herein involved, it is int~nded that all
matter contained in the above description or shown in
the accompanying drawings shall be interpreted in an
illustrative and not ln a limiting sense~
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