CA1301001C - Pediatric medication inhaler - Google Patents

Pediatric medication inhaler

Info

Publication number
CA1301001C
CA1301001C CA000591723A CA591723A CA1301001C CA 1301001 C CA1301001 C CA 1301001C CA 000591723 A CA000591723 A CA 000591723A CA 591723 A CA591723 A CA 591723A CA 1301001 C CA1301001 C CA 1301001C
Authority
CA
Canada
Prior art keywords
bubble
inhaler
wall
infant
thickness
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CA000591723A
Other languages
French (fr)
Inventor
Exequiel Dela Cruz
Christopher Nowacki
Alfred G. Brisson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Trudell Medical Ltd
Original Assignee
Trudell Medical Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Trudell Medical Ltd filed Critical Trudell Medical Ltd
Application granted granted Critical
Publication of CA1301001C publication Critical patent/CA1301001C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0013Details of inhalators; Constructional features thereof with inhalation check valves
    • A61M15/0016Details of inhalators; Constructional features thereof with inhalation check valves located downstream of the dispenser, i.e. traversed by the product
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0086Inhalation chambers

Abstract

Abstract of the Disclosure A pediatric medication inhaler is provided for cooperation with a medica-tion dispersing cylinder and a supply of medication. The inhaler is a one piece device in the nature of a mask molded of integral plastic or elastomer.
The invention is characterized in having a bubble of relatively thin wall projecting from the mask-like device, which bubble flexes inwardly upon inhalation so that a person providing medication to the infant can watch for inhalation.

Description

~301~01 This appli~ation comprises an improvement on and is related to the Asthmatic Medication Inhaler shown in United States Patent No. 4,809,692, Christopher Nowacki, Alfred G. Brisson and Exequiel Dela-Cruz entitled "Pediatric Asthmatic Medication Inhaler".
Back~round Of The Invention A person suffering from Asthma may have rather considerable trouble in breathing when suffering from an asthmatic attack, due to the swelling in the bronchii and due to secretion of mucous. There are various anti-asthmatic pills that are effective, which generally are somewhat slow acting. There are also medications available for intravenous treatment which work quite rapidly, but which require administration by skilled medical personnel. For 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 whlch interfits wlth a mouthpiece. The patient places the mouthplece 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 cartrldge to convert the medic~tion into a mist which is deposited in the proper bronchial area to relieve the asthmatic attack. Often there are small droplets, rather than a mist, and this may be compounded by improper inhalation which results in much , r~

IMPPOVED PEDIAq~C AS~IC INHAL~ C~lINUED
~30100i o~ tlle r~icatiorl simply goir~; into the thrvat and stomach where it is ineffec-tive a~ainst the asthmatic attack.
In the prior U.S. Patent 4,470,412 in the names of Christopher Nowacki and Alfr~ed G. Brisson, there is disclosed a remarkably efficient and low cost inhalation valve in the na.ure of an extended mouthpiece for a broncho dialator which aids the asthmatic sufferer in properly ir haling, ancl in breaking up droplets into a mist form. This inhalation valve has achieved extensive comrnercial success.
The inhalation valve as discussed above is for use by a patlent who can take the mouthpiece thereof into his mouth and inhale and exhale through the mouthpiece. Infants, including babies and small children, cannot be relied upon properly to hold the rnouthpiece in the mouth, and indeed, the infant' s mouth may be too small for the rnouthpiece. Furthermore, it cannot be ascer-tained with certainty under sorne conditions whether a baby or small child is properly inhaling and exhaling.
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In applio~tion C'criaI No. b58,683, referenced above, there is disclosed a pediatric asthmatic inhaler which includes a mask-like adaptor fitting over the infant's mouth and nose and sealing to the face, whereby breathing by the infant effects proper inhalation, and exhalation throuyh the valve. A whistle-like device is provided in the adaptor which generates sound upon either or both inhalation and exhalation, whereby a party applying the inhalation valve and medication to an infant may be sure that the rnedication is being breathed in. Ihis prior pediatric asthmatic medication inhaler works satisfactorily under most conditions. However, for an infant, particularly a baby, in which the volume of inh~l~tion or exhalation may be rather small, and wherein the ., ~, ., ': ' ''. ' . .:; . .: :. .
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130100i ~inhalation or exhalation might also be rather weak, the sound generated is not very loud. Under some circumstances in a noisy environment it may be difficul~ to hear the sound, and with very low-level respiration the whistle may fail to generate any audible sound. The tapered foam molding of the inhaler requires a rather expensive mold, and the whistle must be inserted as a separate manufacturing step, or requires sophisticated molding techniques if the whistle is to be molded in place.
Summary Of The_Present Invention In accordance with the present invention, there is provided a pediatric medication inhaler comprising an integral mask-like device molded of flexible plastic material or the like having a central through-opening and including a first portion adapted to grip a cyllnder in which medication i8 dispersed, a second portion of shallow taper and extending from said first portion, a third frusto-conical portion of substantlally greater taper extending from said second portion and adapted to fit snugly against an infant's face covering the mouth and nose, said thlrd portion having an integral wedge-shaped outward extension for accommodating the infant's nose, an outwardly pro~ecting bubble integral wi~h said second portion, said second portion having a wall of predetermined thickness and said bubble having a wall that is substantially thinner than the predetermined thickness of said wall of said second portion for enhanced flexibility, whereby said bubble flexes inwardly upon inhalation by said infant for visual observation by an attendant of such inhalation.
The bubble is normally convex outwardly, and retains its ,~ r~ 3 'h~

130100i shape upon exhalation or rest. However, upon inhalation, even of a small degree, the bubble will flex inwardly, where by the adult administering the device may readily observe it 3a ~.~. r, ~P~1ED PEDIA~C A~A~:C ~A~ ~U~
130iOOi visually. n,e plastic n~terial is o~ uniform consistency free of bubbles.
I.e., it is not a foam, and thereby it is simpler and quicker in rnolding.
The Drawings Ihe lnvention will best be understood with reference to the following text when taken in connection with the accanpanying drawings wherein:
Fig. l is a perspective view of an improved pediatric asthmatic inhaler c~nstructed in accordance with the present invention;
Fig. 2 is a side view thereof;
Fig. 3 is a right end view thereof;
Fig. 4 is a left end view thereof;
Fig. 5 is a longitudlnal sectional view taken substantially along the line 5-5 in Flg. 3;
Fig. 6 is a side view of the inhaler as applied to an infant's face and upon inhalation; and Fig. 7 is a view sirnilar to Fig. 6, but taken upon exhalation.
Detailed Disclosure of the Illustrated ~nbodiment As is well known, and as is summarized in prior U.S. Patent 4, 470, 412, a srnall pressurized canister or cartridge, sometimes referred to as a nebulizer, is char~ed with epinephrine or other suitable anti-asthmatic medication and 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 asthma-tic sufferer's mouth. The cartridge is pressed down, being squeezed between the index fir~ger and thumb underlying the mouthpiece. m ls causes a valve stern in the cartridge to press against the reaction base in the rnouthpiece to dis-charge a measured quantity of rnedication into the rnouthpiece. The discharge ls .,. ,, : .: . :.
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supposed to be in the form Or a mist, but ln fact o~ten contains snall droplets. Ihe patient inhales and the mist passes into the mouth and hopefully into the bronchial tubes to provlde asthmatic relief. Ihe patient is then supposed to hold his breath for a short time, and subsequently to inhale slowly through nearly closed lips. However, as noted heretofor~, some of the medica-tlon may simply be in the fo~n of droplets rather than mist, and the droplets generally are sin~ly swallowed and do not reach the bronchial tubes to effect thelr intended purpose.
As is disclosed in detail in the aforesaid prior Patent 4,470,412, 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 the inhalation valve fo~ning the subject matter of said patent. Only a portion of the valve is shown herein for an understanding in combination with a pedlatric adaptor or face mark. Such an inhalation valve 14, is shown fragmentarily in Figs. 6 and 7, and comprises a cylinder 16 preferably molded of a sultable plastlc material. The end of the inhalation valve 14 to which the right angle mouthpiece carrying the medication canister is not shown, but thls is well-known, and for example ls shGwn in aforesaid U.S. Patent 4,470,412. A resinous plastic or el~stomeric diaphragm 44 is disposed advacent t~e end of the cylinder 16 and is provided with a horizontal slit 46. A spider (not shown) lies upstream of the diaphragm 44 and backs up the diaphragm so that the diaphragm cannot flex upstream (to the right in Fig. 6) but only downstream upon inhalation. Further details vf the diaphragn structure may be seen in aforesaid U.S. Patent 4,470,412, or in o7 ~
~l ~ ACQ ~Q-~r~.~-~ ~rr-- ~v~r ~v~vv~
The pedlatric asthmatic inhaler of the present invention ls completed by ". :.: ... ::.:

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: :............... . . :. . :
:. :.: :: .. :. -~D PE~C AS~{Aq~:C ~ALEF~ a~

an adaptor or fittir~ 36 in the nature of` a face ma~k. The adaptor 36 ls molded of a soft plastlc material of uniform consistency and density, such as slllcone rubber. me adaptor 36 ls axlally open and con~lnuous, and at lts entering end has a short sectlon 48 of eternally very shallow taper, and whlch ls internally substantially Or cyllndrlcal shape for enclrcling and grlpping the enterlr~g end of the lnhalatlon valve 14. A frustoconical section 50 Or sllghtly greater taper than the sectlon 48 flares outwardly from the sectlon 48. Finally, a face engaging portion 52 rlares outwardly from the sectlon 50 at a much shallower angle. The face engaging portlon 52 is adapted to engage the face of an infant 54 in sealing en~agement so as to prevent ingress or egress Or air between the fittir~ 36 and the face.
The difference ln taper between the sections 48 and 50 ls so little that there is scarcely any parting line visible, but one is shown at 54 in the drawirygs to lllustrate the difference in taper. There is a parting line 56 between the center sectlon 50 and the section or flange 52, although this is not so rnuch a definlte line as it ls a sharply curved or rolled area.
An upstanding bubble or bllster 58 extends radially outwardly from the adaptor or fitting 36, being integral therewith, and has a rounded end or nose 60 termlnatir~ substantially at the parting line 54. Except for the nose the blister is slightly less than a semicylinder and terminates at a short cylindrical section 62 Or thickened material afror~ing a shape having a certain degree Or stablllty to the rear end Or the bubble or blister 58. Frcn the section 62 an extended portion or the flange 52 extends generally radially outwardly at 64 and 'ies generally over the ridge Or the nose Or the infant 54, conformln~ to the shape Or the ad~acent portion of the face.

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:.............. ,. ~ ~ .
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~ P~C AS~MA~C ~ ~
i30100i Ihe second and third sections or portlons of the adaptor or fltting 36 are of uniforn thi~knesses save for the bubble, namelyJ the first portion is thlclcer. m e particular dimensions of a speciflc example include an inside diameter of the inhalation valve cylinder 16 receiving portlon 48 of approximately 1.420 inches. m is and other cross sectlons are substantlally clrcular. m e inside of thls portlon is cylindrical, but the outer surface tapers at 2 to facilitate ld release. me lnside may flare outwardly at the entering end to facllltate asse~bly with the cylinder 16. The thlckness Or thls portion is .122 inch. m e axial length of this sectlon ls .375 lnch.
The intermediate sectlon 50 has an axlal len3th of .618 inch and flares outwardly at 10. The thlckness ls .090 lnch. m e internal dlameter at the partin~ line 56 ls 1.753 lnch.
m e final sectlon or flange 52 ls also .090 inch thlck, the axial length is 1.016 inch, and the exit dlameter is approximately 2.926 lnches, the outward t~pe bein~ 30. Ihe thlckness of the bubble or bllster 58 and of the flared noseplece 64 ls .oo6 inch. m e thickness of the intermedlate strengthening portlon 62 ls .078 inch at the forward shoulder 62 thereof, and tapers the ~unction with the flared noseplece 64, wlth the same thlclkness thereof, such Junction hereinafter being identified by the numeral 70. The bubble 58, includins the rounded nose 60 thereof is approximately .973 inch in length axially of the adaptor or fitting 36 and forwardly of the shoulder 68~ The bubble is .762 lnch in width, and the rounded end has a radius of .375 inch in proflle.
Sillcon rubber is lnert and causes no skin lrritatlon, and can be or otherwlse heat sterllized without deterioration. The materlals are translucent so the infant's nose and mouth can be seen. Wall thickness and . .

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~VED PEDL~C ASn~AqlC ~ ~
13010Q~
hardnes~ in a range c~ 50-65 dl~meter are optimlzed for sh~pe retentlon and conformablllty to the infant's face.
As ls shown in Figs. 6 and 7, the rear portion or flange 52 adapts by flexing to accommodate fully to the face of the infant 54, even though the adaptor or fltting 36 might be used on lnfants of rather substantlally different slzes. The flange forms an airtight seal wlth the face. Thus, when the patlent ls exhallng, or is resting between breaths, the bubble extends outwardly as shown in Fig. 7. However, when the patlent inhales as shown in Fig. 6 the decreased pressure within the adaptor causes the bubble to deflect inwardly as at 72 under the pressure of exterior amblent air as indicated by the arrow 74. It ls thus easy for the person adminlstering the medication to observe inhalatlon, even in a nolsy environment. The shiny exterlor appearance of the plastlc materlal allows the deflection to be seen even in rather dim light Reference has been made to asthmatlc medicatlon, but lt wlll be apparent that other medications could be inhaled with the present inventlon.
The speciflc example ls for lllustratlve purposes only. Varlous changes wlll no doubt occur to those skllled in the art, and wlll be understood as forming a part o~ the inventlon insofar as they fall wlthin the splrlt and scope of the appended claims.

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Claims (7)

1. A pediatric medication inhaler comprising an integral mask-like device molded of flexible plastic material or the like having a central through-opening and including a first portion adapted to grip a cylinder in which medication is dispersed, a second portion of shallow taper and extending from said first portion, a third frusto-conical portion of substantially greater taper extending from said second portion and adapted to fit snugly against an infant's face covering the mouth and nose, said third portion having an integral wedge-shaped outward extension for accommodating the infant's nose, an outwardly projecting bubble integral with said second portion, said second portion having a wall of predetermined thickness and said bubble having a wall that is substantially thinner than the predetermined thickness of said wall of said second portion for enhanced flexibility, whereby said bubble flexes inwardly upon inhalation by said infant for visual observation by an attendant of such inhalation.
2. A pediatric medication inhaler as set forth in claim 1 wherein said bubble extends onto said third portion.
3. A pediatric medication inhaler as set forth in claim 2 wherein said third portion has a wall of set thickness, and further including a rim adjacent the edge of said bubble joining said bubble to said third portion and of greater thickness than said third portion wall for enhanced rigidity at that location.
4 A pediatric medication inhaler as set forth in claim 2 wherein said inhaler has an axial length, said bubble being axially elongated and having a rounded nose at the end thereof on said second portion.
5. A pediatric medication inhaler as set forth in claim 1 wherein said third portion has a wall of preset thickness and adapted to conform to an infant's face, and the wedge-shaped extension is of lesser thickness than said third portion wall thickness for further enhanced flexibility for conforming to an infant's nose and the adjacent portion of its face.
6. A pediatric medication inhaler as set forth in claim 1 wherein the said first portion has a wall of thickness greater than said predetermined thickness for enhanced dimensional stability for gripping a medication dispersing cylinder.
7. A pediatric medication inhaler as set forth in claim 1 wherein the inhaler comprises a one-piece molding of silicone rubber.
CA000591723A 1988-05-19 1989-02-22 Pediatric medication inhaler Expired - Lifetime CA1301001C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US07/164,230 US4832015A (en) 1988-05-19 1988-05-19 Pediatric asthmatic inhaler
US07/164,230 1988-05-19

Publications (1)

Publication Number Publication Date
CA1301001C true CA1301001C (en) 1992-05-19

Family

ID=22593549

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000591723A Expired - Lifetime CA1301001C (en) 1988-05-19 1989-02-22 Pediatric medication inhaler

Country Status (11)

Country Link
US (1) US4832015A (en)
EP (1) EP0344879A1 (en)
JP (1) JPH01320067A (en)
KR (1) KR910005214B1 (en)
AU (1) AU618789B2 (en)
BR (1) BR8901027A (en)
CA (1) CA1301001C (en)
FI (1) FI891690A (en)
NZ (1) NZ227875A (en)
PH (1) PH24829A (en)
PT (1) PT90600A (en)

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Also Published As

Publication number Publication date
AU618789B2 (en) 1992-01-09
JPH01320067A (en) 1989-12-26
PH24829A (en) 1990-10-30
BR8901027A (en) 1990-10-09
NZ227875A (en) 1990-12-21
KR910005214B1 (en) 1991-07-24
AU3080489A (en) 1989-11-23
FI891690A0 (en) 1989-04-10
EP0344879A1 (en) 1989-12-06
PT90600A (en) 1989-11-30
JPH0548708B2 (en) 1993-07-22
FI891690A (en) 1989-11-20
US4832015A (en) 1989-05-23
KR890016981A (en) 1989-12-14

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