AU620375B2

AU620375B2 - Pediatric asthmatic medication inhaler

Info

Publication number: AU620375B2
Application number: AU29969/89A
Authority: AU
Inventors: Alfred G. Brisson; Exequiel Dela Cruz; Christopher Nowacki
Original assignee: TRUDELL PARTNERSHIP HOLDINGS L
Current assignee: Packard Medical Supply Centre Ltd; TRUDELL PARTNERSHIP HOLDINGS Ltd
Priority date: 1989-02-15
Filing date: 1989-02-15
Publication date: 1992-02-20
Anticipated expiration: 2009-02-15
Also published as: AU2996989A

Description

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AUSTRALIA

PATENTS ACT 1952 620 3 7rm COMPLETE SPECIFICATION

(ORIGINAL)

FOR OFFICE USE Short Title: Int. Cl: Application Number: Lodged: 0 0 SComplete Specification Lodged: 6 Accepted: *o Lapsed: Published: Priority: 0 Priority: S Related Art: Name of Applicant: Address of Applicant:

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Actual Inventors: Address for Service: TO BE COMPLETED BY APPLICANT I I C CE)Lfc\N-DqyGT.iAS-MACAtILEY

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t 4"IT' Y1ri -Lc. I' 48 Bridge; Road', -Richmond," Victoria 3121 Australia C~cA; Ca i A^ i CHRISTOPHER NOVACKI, ALFRED G. BRISSON and EXEQUIEL DELA CPJUZ CALLINANS, Patent Attorneys, of 48-50 Bridge Road, Richmond 3121, Victoria, Australia.

Complete Specification for the invention entitled: "PEDIATRIC ASTHMATIC MEDICAL

INHALER".

The following statement is a full description of this invention, including the best method of performing it known to us:p L. -la PEDPIATRIC ASTHMATIC MEDICATION INHALE Background of the invention 0 00 A mersatons suffeingbl for astmamayhav tratetwhc 000 Scnsildrabetroubesineatin when suffpateng from anotst mdatic viltae efetivei bt wich a Sgneallyt aEpsoehats-cin g. Tro herbe arehmalso medications avalaled forh inutraee treatent ich 00a 00 15 workl quiessrizdynbutero tig which reur diittib silled medthic peronel.Fms patients the uhic prompismot, immedtsely avilbe crreie ishbyewyofa inhlasn. Epiephieoohrsure mutoeictble ashmici miadto g ispakaed wiuthasutbledcenei.

o withpic a a mothiee Te optet placsthve motpic inophistmoth andderse the cartridge ovr therb Smeiatien nto nomit inhal proplytad inthepoe bronchial area to relieve the ast),hmatic attack. Often 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 *0 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.

SUMMARY OF THE INVENTION According to a broad form of the invention there is provided a pediatric i 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 #4tt inhalation 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 molded from rubber or plastic adapted to conform to an infant's face secured to said exit end l 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 il ~IWIL1-U1-~- -3portion 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 sidewall of said second portion consisting of a frustoconically shaped surface extending from said open apex to said base and thereby, at least adjacent 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 audible signal upon breathing by said infant.

The Drawings The invention will best be understood with reference to the following text when taken in connection with the accompanying drawings wherein: '4 Figure 1 is a longitudinal sectional view illustrating our pediatric inhalation o valve forming the subject matter of the present invention; oFigure 2 is a right-end view thereof; a o o a 0 j ii "s iGj" -4- Figure 3 is a bottom view thereof; Figure 4 is a fragmentary 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.

at 0 0004 0°0 10 Detailed Disclosure of the Illustrated Embodiment Co 0 0 As is well known, and as is summarized in our prior 0004 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 0440 under pressure. The cartridge fits into a receiving o:o end of a right angle mouthpiece, the opposite end of which is placed in the asthmatic sufferer's mouth. The S0 20 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 0 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 short 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

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generally are simply swallowed and do not reach the bronchial tubes to effect their intended purpose.

As is 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 an inhalation valve 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 o directed flange 18 of limited extent. This flange retains a 01~5 generally frustoconical elastomeric adapter 20 which receives the exit end of the right angle mouthpiece 12. The frustoconical shape and the elastomeric nature of the adapter 20 are such that mouthpieces of widely different sizes and confjgura- 00 0 tions 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 bayoneting of teeth of a part subsequently to be described therewith.

Inwardly of 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 extending 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 is interrupted thereby defining teeth to permit axial assembly past the flange 26, with rotation from the assembling position ~securing the cylinder 40 and flange 42 in place.

0 90 o 0 A resinous plastic or elastomeric diaphragm 44 lies immedi- 04 0 ately to the right of the spider 30 and has its outer periphery trapped between the flange 22 and the flange 42. The diaphragm is imperforate except for a horizontal slit 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 of the valve 14 the diaphragm is pushed o ;ii firmly against the spider 30, and substantially no air flow is t, permitted to the left. However, upon inhalation, the pressure is from left to right, and the diaphragm 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 pediatric 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 resilient foam material, such as closed cell foam rubber or closed cell foam plastic, r i -7and includes an inner section 48 of generally frustoconical shape and shallow angle. At its inner extremity the portion 48 has a cylindrical surface 50 which snuggly 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 is 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 is shown also in Figure 1, the periphery of the flange 58 extends further to the right P. t b 0a it

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~irarrrr*lr~~~lc r~~lYICL=LYY?~I -8somewhat 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 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 t~he cheeks to the chin, the indentation 68 engaging approximately at the bridge of the nose, and the indentation 70 engaging the chin.

8416 0o The adapter is completed by the provision of a whistle 000 72 incorporated in an aperture in the upper portion of 0 1 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 0000 -D 00 is expelled through it. The whistle may incorporate a 0 00 00000 one-way valve mechanism so as not to pass air upon inhalation, although this is not critical since it o 20 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 certain 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

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-9described. The adapter, being thin in its outer portions, is readily adaptable to the contures 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 moving from one patient 10 to another or it may be washed and reused.

0004 °0 A modification of the adapter of the present invention #000 is shown in Figures 4 and 5, wherein similar parts are S" identified by like numerals with the addition of the suffix a. 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 oo 40 and flaring outwardly at 58a to the outer periphery S 60a. This base is of substantially uniform thickness, CI 20 and includes a whistle 72a similar to the one previously described. The base 80 is of a foam elastomeric or preferably plastic construction, and 4 like the adapter 46 is of a closed cell type to avoid S0 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 is made of a flexible but relatively stiff foam plastic material. A much softer foam ring 84 is secured to the inner or concave surface of the 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 58a. 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.

S. 10 Finally, a rather thinring 86 is secured to the inner or concave surface of the ring 84. This ring is of a closed-cell elastomeric or preferably plastic foam, and o* o is of the type having a surface skin. The surface skin 00 a "o also is preferred on the adapter 46 and on the base a is p e on te a e.

portion of adapter 46a. The ring 86 is rather thin and 0ee conforms to the shape of the ring 84 and the outwardly flared portion 58a, specifically including a forward o projection or indentation 88 aligned with the indentation 82. Since theAring 86 is intended to conform to the infant's face, largely due to the softness of the ring 84, theFing 86 is of a rather 0 thin construction, the important aspect thereof being oo othe 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 b -11those 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.

04 04 4 o 44 4 ~3 4 4444 444~~ 4 44 44 4 0444 4 40 40 4 44 4 0 44 4 44 4444 0 40 44 4 4 44 44 4 4 44 04 4 4 4 44 4 44

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4 44 44 4 444 4

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Claims

1. 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 inhalation 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 molded from rubber or plastic adapted to conform to an infant's face secured to s..d 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 i: a flared sidewall and an open base and an open apex, said second portion apex S '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 sidewall of said second portion consisting of a frustoconically shaped surface extending from said o" open apex to said base and thereby, at least adjacent 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 audible signal upon breathing by said infant.

2. An inhaler of claim 1, wherein said signal means comprises a whistle. I4III~

3. An inhaler of claim 1 or claim 2, wherein said first portion is made of pliable material and is thickest adjacent said exit end at said body and tapers outwardly therefrom for enhanced flexibility.

4. An inhaler of claim 3, wherein said second portion is thickest adjacent said first portion and tapers thinner outwardly therefrom. /1V iM7i -13- An inhaler of claim 1, wherein said second portion is in the form of a continuous ring, and further including a relatively softer ring on the interior surface thereof adjacent said outer edge adapted to engage an infant's face.

6. An inhaler of claim 5, and further including a thin face ring on said relatively softer ring and having an outer surface skin adapted to engage an infant's face.

7. An inhaler of any one of claims 1 to 7, substantially as hereinbefore described with reference to any one of Figs. 1 to DATED this 16th day of April 1991. TRUDELL PARTNERSHIP HOLDINGS LIMITED 0 and 66 0 PACKARD MEDICAL SUPPLY LIMITED By their Patent Attorneys: CALLINAN LAWRIE a 66 C6 0 k. 1.