Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
~301000
Backaround of the Invention
A person suffering from asthma may have rather
considerable trouble in breathing when suffering from
an asthmatic attack, due to swelling in the bronchii
and due to secretion of mucous. There are various
anti-asthmatic pills that are effective, but which
generally are somewhat slow-acting. There are also
medications available for intraveneous treatment which
work quite rapidly, but which require administration by
skilled medical personnel. ~or most patients the
promptest, immediately available relief is by way of an
inhalant. Epinephrine or other suitable asthmatic
medication is packaged with a suitable diluent in a
small pressurized canister or cartridge which interfits
with a mouthpiece. The patient places the mouthpiece
in his mouth, and depresses the cartridge, thereby
releasing a measured amount of medication which is
inhaled through the mouthpiece.
Some patients do not inhale properly, and the
mouthpiece may not be completely effective in
cooperation with the cartridge to convert the
medication into a mist which is deposited in the proper
bronchial area to relieve the asthmatic attack. Often
-. - . . .
.; ;. ...... .
i301000
--2--
there are small droplets, rather than a mist, and this
may be compounded by improper inhalation which results
in much of the medication simply going into the throat
and stomach where it is ineffective against the
asthmatic attack.
In our prior United States Letters Patent 4,470,412 we
have disclosed a remarkably efficient and low-cost
inhalation valve in the nature of an extended
mouthpiece for a broncho dialator which aids the
asthmatic sufferer in properly inhaling, and in
breaking up droplets into a mist form. This inhalation
valve has achieved extensive commercial success.
Our inhalation valve as discussed above is for use by a
patient who can take the mouthpiece thereof into his
mouth and inhale and exhale through the mouthpiece.
Babies or small children cannot be relied upon properly
to hold the mouthpiece in the mouth, and indeed the
baby's mouth may be too small for the mouthpiece.
Furthermore, it cannot be ascertained with certainty
under some conditions whether a baby or small child is
properly inhaling and exhaling.
Objects and Summary of the Present Invention
It is an object of the present invention to provide a
pediatric inhalation valve for use by babies and small
children which has an adapter thereon fitting over the
baby's mouth and nose and sealing to the face, whereby
breathing by the baby effects proper inhalation and
exhalation through the valve.
.,. ~ ,. ~
.: ,:,:
.; :~ . ... :
1301000
72466-5
The invention provides a pediatric medication inhaler comprising a
body having an entering upstream end and an exit downstream end,
means at said entering end for receiving structure for applying
in,halation medication, one-way valve means in said body permitting
air and medication to flow from said entering end to said exit end
and preventing flow from said exit end to said entering end, and a
mask-type adapter adapted to conform to an infant's face secured
to said exit end having a first substantially frustoconical
portion having a flared sidewall with an open base and an open
apex with said apex secured in pneumatically sealed relation to
said exit end, an integral second substantially frustoconical
portion of pliable material coaxial with said first portion and
having a flared sidewall and an open base and an open apex, said
second portion apex being integral with said first portion base
and said second portion sidewall flaring outwardly from said first
portion at a greater angle than said first portion flares
outwardly from said exit end and said second portion base having
an outer annular edge defining said open base, the interior
surface of the side wall of said second portion consisting of a
frustoconically shaped surface extending from said open apex to
said open base and thereby, at least ad~acent said outer edge,
being adapted`to conform to an infant's face when in surface
engagement therewith, and signal means mounted in said adapter
first portion sidewall for providing a human perceptible signal
upon breathing by said infant.
Preferably the signal means generates a sound upon inhalation and
f~
i301000
~ 24GG-5
exhalation so that a party applying the inhalation valve and
medication to a baby may be sure that the medication is being
breathed in.
The adapter is preferably molded of foam plastic or rubber
material, and the portion thereof adjacent to the inhalation valve
is relatively thick to provide a degree of rigidity thereto.
However, the outer portion of the adapter that fits against the
face of the infant tapers to a thinner wall section, whereby it is
considerably more flexible and adaptable, and also comfortable to
the user.
The Drawings
The invention will best be understood with reference to the
following text when taken in connection with the acco~panying
drawings wherein:
Figure 1 is a longitudinal sectional view illustrating our
pediatric inhalation valve formlng the subject matter of the
present invention;
Figure 2 is a right-end view thereof,
r~ 3a
~,
i30~000
--4--
Figure 3 is a bottom view thereof;
Figure 4 is a fra~mentary axial sectional view similar
to a part of Figure 1 and showing a modification of the
invention; and
Figure 5 is a fragmentary top view of the embodiment of
Figure 4.
Deta~ Disclosure of the Illustrated Embodiment
As is well known, and as is summarized in our prior
patent 4,470,412, a small pressurized canister or
cartridge, sometimes referred to as a nebulizer, is
charged with epinephrine or other suitable
anti-asthmatic medication in a suitable diluent, and
under pressure. The cartridge fits into a receiving
end of a right angle mouthpiece, the opposite end of
which is placed in the asthmatic sufferer's mouth. The
cartridge is pressed down, being squeezed between the
index finger and thumb underlying the mouthpiece. This
causes a valve stem in the cartridge to press against
the reaction base in the mouthpiece to discharge a
- measured quantity of medication into the mouthpiece.
The discharge is supposed to be in the form of a mist,
but in fact often contains small droplets. The patient
inhales, and the mist passes into the mouth, and
hopefully into the bronchial tubes to provide asthmatic
relief. The patient is then supposed to hold his
breath for a ~hort time, and subsequently to inhale
slowly through nearly closed lips. However, as noted
heretofore, some of the medication may simply be in the
form of droplets rather than mist, and the droplets
.. : , . . .
, '.: ' . . ,
: . ; .
."',.. '- . .~.. ", :'
, .. . .
1301000
generally are simply swallowed and do not reach the
bronchial tubes to effect their intended purpose.
As i~ disclosed in detail in our aforesaid prior
patent, we have found that the drops can be broken up
into a mist and the patient can be more or less forced
to inhale properly through the use of a inhalation
va}ve forming the subject of our prior patent
4,470,412. This inhalation valve is shown herein in
somewhat less detail, but sufficient for an
understanding in combination with a pediatric adapter
or face mask.
With reference first to Figure 1, there is shown an
inhalation valve 14 comprising a cylinder 16 preferably
molded of a suitable plastic material. The cylinder is
provided at its entering end (the left end in Figure 1)
with a radially inwardly directly flange 18 of limited
extent. This flange retains a generally frustoconical
elastomeric adapter 20 which receives the exit end of
the right angle mouthpiece 12. The fructoconical shape
and the elastomeric nature of the adapter 20 are such
that mouthpieces of widely different sizes and
configurations can be gripped securely.
At the opposite end of the cylinder 16 there is an
outwardly extending peripheral flange 22 having at its
extremity an axially extending cylindrical flange 24.
At its extremity the cylindrical flange 24 is provided
with an inwardly directed flange 26 which is
interrupted at arcuately spaced locations for
bayonneting of teeth of a part subsequently to be
described therewith.
: ... ..
' . . . .
.~.. ,.,. :, .
, .. . .
:,',. ' :. .
... .
.. .. . .
i30iO00
Inwardly o~ the flange 22 and at the exit end of the
cylinder there is a spider 30. The spider may be
molded integrately with the cylinder 16, but more
conveniently is a separate plastic piece which is
secured within the cylinder by way of known techniques
such as cementing, sonic welding, etc. The spider
comprises an annular ring 32 having formed therewith a
plurality of radial ribs joined together at the center
at 36. By way of example in our prior patent 4,470,412
there are eight such ribs, but the precise number is
not critical. There should, however, be one pair of
ribs extenaing diametrically across the spider in a
horizontal direction as the parts are oriented in
Figure 1.
Further structure at the exit or right end of the
cylinder 14 is similar to that in our prior patent
4,470,412, but differs in detail therefrom. A somewhat
elongated cylinder 40 is of proper diameter to fit just
within the inner edge of the flange 26, and has a
radially extending flange 42 which tlhserieb~erdreufpi~ei3gtoteeth
permit axial assembly past the flange 26, with rotation
from the assembling position securing the cylinder 40
and flange 42 in place.
A resinous plastic or elastomeric diaphram 44 lies
immediately to the right of the spider 30 and has its
outer periphery trapped between the flange 22 and the
flange 42. The diaphram is imperforate except for a
horizontal slit 4 5 extending across the horizontal
radial ribs connected to the center 36. Thus, when-
there is any air pressure to the left from the exit end
'.':'.,;'"''',". ' ' .' :" ' ."' ', '
. . . , .,; , - ., ., .: . -
,, : , . .:.
: .. . . . -
~30~000
of the valve 14 the diaphram is pushed firmly against
the spider 30r and substantially no air flow is
permitted to the left. However, upon inhalation, the
pressure is from left to right, and the diaphram
deflects away from the spider as indicated in broken
lines in Figure 1, opening the slit to a fairly wide
aperture 46 and permitting air flow (and medication
flow~ therethrough.
The pedia.tric inhalation valve of the present invention
is completed by an adapter or fitting 46 in the nature
of a face mask. The adapter 46 is molded of a
resiliant foam material sculc~seads ~eOlalm rubber cOlro~Odmcell
plastic, and includes an inner section 48 of qenerally
frustoconical shape and shallow angle. At its inner
extremity the portion 48 has a cylindrical surface 50
which ~nuggly engages the outer surface of the cylinder
40. The wall of the frustoconical portion 48 is
relatively thick at 52 at the inner end thereof~ and
thins out to a thinner section 54 adjacent the outer
margin thereof. At the outer margin 56 the fitting 46
flares outwardly at a wider angle forming a flange 58
extending to the periphery 60 of the fitting. The
wall of the flange is thickest at 62 adjacent the
extremity 56 which is in the nature of a.knee or
inflection, although somewhat thinner than the wall at
54, and tapers to a relatively thin section 64 adjacent
the periphery 60. As may be seen in Figure 2 the
periphery 60 is circular in outline as i8 the knee 56.
However, neither is a true circle, since they do not
lie in planes, but rather are shaped as shown in Figure
3. Specifically, and i8 shown also in Figure 1, the
periphery of the flange 58 extends further to the right
:.. .. ....
.. ,:. .- :
: : . . . .
130~)00
somewhat above the center line as indicated at 66, and
then indents to the left at 68 in the top portion on a
vertical median plane. It tapers to the left also
below the extreme extension at 66 to an indentation 70
S to a greater degree than the indentation 68. The
periphery 60 of the adapter thus will fit above the
nose in engagement with the face and down along the
cheeks to the chin, the indentation 68 engaging
approximately at the bridge of the nose, and the
indentation 70 engaging the chin.
The adapter is completed by the provision of a whistle
72 incorporated in an aperture in the upper portion of
the body 48 along the vertical median plane. This
whistle is of a type frequently used in children's
squeezed toys, and will emit a whistling sound when air
is expelled through it. The whistle may incorporate a
one-way valve mechanism so as not to pass air upon
inhalation, although this is not critical since it
would provide only a small amount of bypass air that
would not hurt anything. The whistle has a central
bore 74 which serves as the outlet valve upon
exhalation, and upon exhalation makes an audible
whistling sound so that the person administering
asthmatic medication to the infant will know that the
infant is exhaling. A oertain amount of noise may be
generated by the whistle upon inhalation, and this is
moderately beneficial although not essential.
The pediatric inhalation valve as heretofore shown as
described will be understood as incorporating an
inhalation valve generally similar to that disclosed in
our prior patent 4,470,412, plus the foam adapter
, ,. ,.. : -
.. , . ,:; : :
.. ~: ~: . ::
: - . - . .: .. .
130~000
described. The adapter, being thin in its outer
portions, is readily adaptable to the cont~res of an
individual infant's face, and is comfortable to the
- infant, and therefore nonthreatening. In fact, if the
infant is not too frightened from the asthmatic attack,
he may derive some pleasure from the whistling of the
whistle upon exhalation.
The adapter may be discarded in movin~ from one patient
to another or it may be washed and reused.
A modification of the adapter of the present invention
is shown in Figures 4 and 5, wherein similar parts are
identified by like numerals with the addition of the
suffix ~. In this case the adapter is somewhat in the
nature of a sandwich, including a base 80 having a body
48a of narrow taper fitting over the cylindrical flange
40 and flaring outwardly at 58a to the outer periphery
60a. This base is of substantially uniform thickness,
and includes a whistle 72a similar to the one
previously described. The base 80 is of a foam
elastomeric or preferably plastic construction, and
like the adapter 46 is o a closed cell type to avoid
absorption of moisture.
At its upper portion as seen best in Figure 5 the more
widely flared portion 58a is provided with a forwardly
extending indentation or offset portion 82 in order
best to accommodate an infant's nose.
The base portion i 8 made of a flexible but relatively
stiff foam plastic material. A much softer foam ring
84 is secured to the inner or concave urface of the
J.,"'''''', '.".,.'".'"'
'.,',".',', " ' . , ~',. ,""'"
''''"'''.'''" '~' ",' '
13010{)0
-10-
outwardly flared portion 58a by any suitable means such
as an adhesive. The ring 84 conforms closely to the
shape of the outwardly flared portion 58~. This ring
is also made of a foam plastic, but of a much softer
nature for better conformability to the infant's face.
This foam ring 84 also is of a closed-cell nature, and
preferably is a foam plastic, although it could be an
elastomeric substance.
Finally, a rather thin ring 86 is secured to the înner
or concave surface of the ring 84. This ring is of a
closed-cell elastomeric or preferably plastic foam, and
is of the type having a surface skin. The surface skin
also is preferred on the adapter 46 and on the base
portion of adapter 46a. The ring 86 is rather thin and
conforms to the shape of the ring 84 and the outwardly
flared portion 58a, specifically including a forward
projection or indentation 88 aligned with the
indentation 82. Since the ring 86 is intended to
conform to the infant' s face, largely due to the
softness of the ring 84, the ring 86 is of a rather
thin construction, the important aspect thereof being
the surface skin which provides a pleasant touch to the
infant's face and which is readily washed with no
danger of moisture absorption.
In one specific embodiment of the invention the maximum
diameter of the adapter is on the order of 3 to 3-1~2
inches.
The specific examples of an invention as herein shown
and described are for illustrative purposes only.
Various changes in structure will no doubt occur to
,.. . :
.',:, : :
., :, .. .
. ", . .
i~oiooo
those skilled in the art, and will be understood as
forming a part of the present invention insofar as they
fall within the spirit and scope of the appended
- claims.
s
... ,~,, . :
