CA1184460A

CA1184460A - Inhalation valve

Info

Publication number: CA1184460A
Application number: CA000424011A
Authority: CA
Inventors: Christopher Nowacki; Alfred G. Brisson
Original assignee: Trutek Research Inc
Current assignee: Trudell Medical International
Priority date: 1982-03-19
Filing date: 1983-03-18
Publication date: 1985-03-26
Also published as: US4470412A

Abstract

Abstract An inhalation valve is presented for use with a known antiasthmatic medication cartridge and mouthpiece to simplify patient inhalation and to improve mist forma-tion. A cylindrical passageway receives the known mouth-piece and is provided with an elastomeric diaphragm having a slit therein. An upstream spider backs up the diaphragm.
Upon inhalation the diaphragm flexes and stretches to open the slit, and the diaphragm seals off exhaust passages.
On exhalation the diaphragm backs against the spider which seals the slit, the diaphragm moving away from and opening the exhaust passages.

Description

Nowacki et al Case 1 IN~LATIO-l~ VALVE
_.

Background of the Inv~ntion A person sufferin~ from asth~a may when suEfering an asthmatic attack have ra~'ner considerable trouble in breathing, due to swelling in the bronchi and due to secretion of mucus. There are various antiasthmatic pills that are effective, but w'nicl~ generally are some-what slow-acti-ng. There are also medications available for intravenous trea-tmen~ which work quite rapidly, but which require adrninistration by skilled ~ledical pe-rson-nel. For r.lost patients the promptestj im~lediately available relief is by way oF an in'nalant. Epinephrine or other suitable asthmatic medication is packaged with a sultable Ziluent in a small pressurized cannister or cartridge which interfits with a nouthpiece. The patient places the mouthpiece in his mouth, and depresses ~he cartridge, thereby releasin~ a measured amolmt of medi-cation which is inhaled through the r.louthpiece.

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 roper bronchial area to relieve the astl.lr.latic attac~. Often there are small droplets, rather than a mist, and tLlis may be compounded by imDroper inhalation which results in much o the medication simply goin~ into the throat and stomach where it is ineffective ~.

agai.nst the asthmatic attack.
Objects and Summary of the Invention _ In accordance with the present i.nvent;on a valve accompany-i.ng an extended mouthpi.ece for a broncho dilator of the type just descri.bed ;s prov;.ded wh;.ch aids the asthmat;c sufferer in properly i.nhali.ng, and in breaking up droplets ;nto a m;.st form.

Thus, the pr;.nc;.ple object of the present invent;on i.s to prov;.de an ;.mproved valve for convert;.ng ep;nephr;ne or other broncho d;.lator ;.nto a proper m;st for i.nhalat;.on by a person suffer;ng an asthmat;c attack.

It is a further object to the present ;nvent;on to prov;.de a valve as just noted wh;.ch ;.s cooperable w;th a large number of exi.sting commerc;.al broncho d;lator mouthp;.eces for prov;.d;.ng i.mproved m;.st and ;.nhaling by the pat;ent.

It Eurther i.s an object of the present ;nventi.on to pro-v;.de a un;.versal extensi.on f;tt;ng for broncho d;.lators ;.nclud;.ng a one-way valve wh;.ch opens upon ;.nhalation without bypass;.ng any ambi.ent a;.r ;.nto the ;.nhaled m;st, and wh;.ch closes upon exhalat;.on w;.th the exhaled breath bypassed and not enter;.ng ;.nto the chamber conta;.n;.ng the broncho d;.lator mi.st.

A further object of the present inventi.on i.s to prov;.de an ;.nhalat;.on valve i.nclud;ng an elongated body defi.n;.ng a passageway hav;ng an enteri.ng upstream end and an ex;.t downstream end, means at sa;.d enteri.ng end for rece;.ving structure for apply;.ng ;.nhalat;.on medi.cat;on, a mouthp;.ece at sa;.d ex;.t end for rece;.pt ;.n a pat;.ent's mouth, an elastomer;c d;.aphragm havi.ng a central opening there;.n and an ;.mperforate port;.on outwardly of the central open;ng, , - ~

-2a-means engagi.ng said di.aphragm adjacent the periphery thereof and mounting sa;.d d-iaphragm adjacent sai.d ex;t end transversely of said passageway, said diaphragm flex;.ng downstream and freeing sai.d open;ng for passage of med;cat;.on upon i.nhalat;on by a pat-ient, backup means ;mmed;.ately upstream of sa;d diaphragm preventing flex;ng of sa;d d;.aphragm upstream upon exhalat;on by a pat;.ent and includ;ng a member ly;.ng across sa;d open;.ng and agai.nst wh;ch sai.d d-i.aphragm is pressed upon exhalation to seal said open;.ng to prevent retrograde flow upon exhalation, an annular flange extend;.ng upstream from said mouthp;.ece and termi.nat;ng at a rim presenti.ng a valve seat normally spaced from sa;.d d;aphragm downstream thereof, exhaled air from sai.d mouthp;.ece passi.ng between sa;d r;.m and sa;.d d;aphragm, and exhaust port means dLsposed outwardly of sa;.d annular flange to exhaust exhaled a;.r to the atmosphere, the ;.mperforate port;.on of the d;aphragm present;.ng a valve surface movable ;.n unlson with the port;.on of the di.aphragm contain;ng the central open;.ng and juxtaposed to the r;.m valve seat in pos;.ti.on for engagement thereaga;.nst w;.th flex;ng of sai.d d;aphragm upon ;.nhalat;.on and br;.ng;ng the valve surface of sa;.d d;aphragm ;.nto engagement w;th sa;.d r;.m valve seat to seal off sa;.d exhaust port means and d;.sengagement from the r.i.m valve seat upon exhalat;.on to exhaust through the exhaust port means.

In carry;.ng out the forego;.ng and other objects and advantages, we have prov;.ded an extens;.on f;.tti.ng for broncho d;lators hav;.ng an elastomer;c recei.ver fitt-ing about the ex;.sti.ng mouthpiece of a commerci.al broncho d;.lator dev;.ce. Th;.s rece;.ver -is at the enter;.ng end of a cyl;nder, wh;ch cyl;nder has a mouthp;.ece at the oppos;.te end. An elasto-mer;.c valve ;s prov;.ded between the cyl;nder and the mouthp;.ece, wh;ch valve compr;.ses a generally ~ ~ 8 ~

flat diaphragm having a sli~ therein. Upon inhala~ion the diaphragm flexes to permit opening of the slit so that mist will pass through the cylinder into the bronchial passages of the asthmatic sufferer. When the patient exhales the diaphragm is forced flat against a suppor~ing spider with the slit effectively sealed. Bypass opening,s are provided to permit exhaust of the exhaled breath into the atmosphere. These e~haust openings are closed by the diaphragm upon inhalation so tha~ only the epinephrine or the like mist is inhaled without ~eing mixed wi~h ambient air.

The Drawings The invention will best be understood with reference to the following te~t when taken in connection with the acco~panying drawings, wherein:

Fig. 1 is a view illustrating a broncho dilator device as found in t'ne prior art;

Fig. 2 is a side view partly in longitudinal section illus~rating the novel inhalation valve forming Lhe subject matter of the present invention;
Fig. 3 is a cross-sectional view taken substantially along the line 3-3 in Fig. ? illustrating the spider which backs up the elastomeric valve diaphragm; and Fig 4 is a cross-sectional view taken substantially along the line 4-4 showing ~he elastomeric diaphragm.

Detailed Disclosure of the Illustrative Emboaimen~

Reference first should be made to Fig. 1 for an understand-ing of the prior art. A small pressurized cannister or cartridge, sometimes referred to as a nebuli~er, is charged wit'n epinephrine or other suitable antias-thr.latlc medica-tion in a suitable diluent, and under pressure. The cartridge fits into a receiving end of a right angle mouth-piece 12, the opposite end o' which is placed in theasthmatic sufferer's mouth. The cartrldge is pressed down, being squee~ed between the index ~inger and the thu~b underlying the mouthpiece. This causes a valve stem in the car~rid~e to press against a reaction base in the mouthpiece to discharge a measured quantity of Medication into the mouthpiece. The aischarge is supposed to be in a form of a mist, but in fact o~ten contains small droplets. The patient înhales, and the mist passes into the mouth, and hopefully into tlle bronchial tubes to provide asthmatic relief. The patient îs then supposed to hold his bre~th for a short time, and subsequently to inhale slowly through nearly closed lîps. However, as noted heretofore, some of the medication may simply be in the form of droplets rather than mist, and the drople.ts ge-nerally do not reach the bronchial tubes to effecc their inte-nded purpose.

We have found that the drops can ~e broken up into a ~ist, and the patient can be more or less forced to in'nale pro-perly with the use of the inhalation valve forming the subject matter of the present invention, and lor which reference s'nould be had particularly LO Fig. 2, and also to Figs. 3 and 4.

As shown in Fig. 2 there is 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 Fig. 2) with a radially inwardly direc~ed flange 18 of limi~ed extent. This flange retains a generally frus~oconical elastomeric adapter 20 whicn receives the mouthpiece 1~ reviously referred to. The ~rustoconical shape and the elastomeric na-ture of the adapter 20 is such that mouthpieces of widely differing sizes and configurations can be securely gripped.

At the opposi~e end oE the cylinder 16 there ls an out-wardly extending peripheral flange 22 having at its extremity an axially exLending cylindrical flange ~4.
At its extremity the cylindrical flange 24 is provided with an internal ~aper ~G having a right angle shoulder or stop surface 2~ behind i-t; 24, 26 can be spaced teeth.
Also at the exit end of the cylinder t~ere is provided a spider 30 which is shown also in Fig. 3. The spider 30 r.lay be molded integrally with Lhe cylinder 16, but more conveniently is a separate plastic piece which is secured witllin the cylinder by known tecl~nlques, such as a cement, ~onîc welding, ecc. The spider comprises an annular ring 32 having formed integrally therewith a plurality of rac.ial ribs 34. joined together at the center at 36. As shown in Fig. 3 there are eight such ribs.
The precise num~er is not critical, bu~ tllere should be one pair of ribs extending diametrically across the spider, sucn pair in the present instance being identified by numeral 38. T'ne fitting 14 further includes a mouth-piece element 40 having a generally cylindrical, slightly tapered mouthpipe 42 to be received in the person's r!louth.
The mouthpipe has at i~s entering end a radially e~tending flange or disc 44 which partway out is provided with a cylindrical flange 46 extending in the entering direction, opposite to the mouthpipe 42. At its periphery t'ne disc 44 is provided with a cylindrical flange 48 also extending in the direction of the receiving end of the cylinder 16 i.e., opposite ~o ~he mou~hpipe 42. IntermecliaLe the cylindrical flanges 46 and 4~ the disc 44 is provided with an annular array of spaced apertures 50 ~or exhaust of exhaled air.

The flange 48 is axially somewhat longer tllan t'ne flange 46, as will be el~plained s'nortly, and it is provided at its extremity with a radially e~tending annular flance 52 which snaps over t'ne ~apered surface 26 and behind the shoulder 28 so that the mouthpiece element 40 is held in assembled position with the cylinder 16. The entering end face of the flange 52 is provided with an annular recess 54, and the confronting face of the flange 22 on the cylinder 16 is provided ~ith a complementary rib 56.
An elastomeric diaphragm 58 is trapped between the flange 52 and the flange 22, being securely held ln place by the complementary rib 56 and recess 54. As is particularly seen in Fig. 4, the diapl~ragm 58 is provided with a diametral slit 60 which in rela-~ed positlon lies across the aligned ribs 38. As now will be seen, the relative shortness of the ring or flange 46 as compared wit7n the flange 4~ provides for clearance space 62 between the flange 46 and the diaphragm 58.
In order to use the present inhalation valve, the mouth-piece 12 of the prior art is inserted in -the me~ber 20, as previously described. The mouthpipe 22 is recelved in the rnouth of the person suffering an asthmatic attack.
The cartridge is pressed down in tne mouthpiece to release a measured amount of medication, in accordance with the prior art. However, rather than the misted medication passing directly tllrougll the mouchpiece into the mouth of the person using it, the mist is passed into the cylinder 16. The elongated flow path provided by the cylinder allows furtller opport~ity for droplets to atomize or evaporate into a mist. As the person innales, the diaphragm 58 deflects toward the person's mouth, as illustrated in broken lines in Fig. 2, -thus allowing the slic 60 to open, and thus to pa.ss the misted ~edication.

~34~

Movement of the medication past the spider 30, and past the edges of the slit, enhances evaporation or dispersion of droplets into the desirefl misk form. It is not necessary for the patient to engage in any artiFicial or learned process of breaching, since he need only inhale, and exhale. Upon exhalation the diaphragm returns to its initial flat posîtion with the slit 60 sealing across the aligned ribs 3~. Air passes t1nroug~ the clearance space 62 as indicated by the arrows 54, and out through the holes 50 as as indicated by the arrows 66. Upon inhalation the deflection of tne diaphragm causes the diaphragm to press against t~e free end of t'ne cylindrical flange ~6, and there~y to prevent any outside air from being drawn in along with ~he medication. Floating of the diaphragm back and forth upon alternate inhalation and exhala~ion also aids in breaking up any d~-oplets into mist form.

As noted, the parts are molded of suitable plastic material, with the exception of the diap'hragm, which is an elastomeric material; silicone rubber is one particular material that has been found satisfactory for this purpose.
The device is readily washed or cleansed in alcohol, and hence is capable of extended use. However, the cost of production is low, and it is not necessary to preserve the device indefinitely.

It will now be apparent that we have invented an improved valve or e~tension piece for use with a conventi.onal broncho dilator inhalation device which would cooperate with a large number of prior art devices, which is remarkably easy for the aschmatic sufferer to use, and which provides ir.lproved formation of mist. The simplicity of inhalation for the asthmatic sufferer, and the improved misting resulc in rnore of the antiasthmatic medication ending u~ in the bronchi for relief of the asthmatic attack, thereby minimizing bypassing of ~he medication tllrough the t'nroat and stomac'n where i~ does no good.

The speci~ic example of the invention as herein shown and described is for illustra~ive purposes only. Various changes will no doubt occur to ~hose s~illed in the art, and will be u~derstood as forming a part of the present invention insofar as they ~all wîthin the spirit and scope of Lhe appended clairls.

Claims

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. An inhalation valve including an elongated body defining a passageway having an entering upstream end and an exit downstream end, means at said entering end for receiving structure for applying inhalation medication, a mouthpiece at said exit end for receipt in a patient's mouth, an elastomeric diaphragm having a central opening therein and an imperforate portion outwardly of the central opening, means engaging said diaphragm adjacent the periphery thereof and mounting said diaphragm adjacent said exit end transversely of said passageway, said diaphragm flexing downstream and freeing said opening for passage of medication upon inhalation by a patient, backup means immediately upstream of said diaphragm preventing flexing of said diaphragm upstream upon exhalation by a patient and including a member lying across said opening and against which said diaphragm is pressed upon exhalation to seal said opening to prevent retrograde flow upon exhalation, an annular flange extending upstream from said mouthpiece and terminating at a rim presenting a valve seat normally spaced from said diaphragm downstream thereof, exhaled air from said mouthpiece passing between said rim and said diaphragm, and exhaust port means disposed outwardly of said annular flange to exhaust exhaled air to the atmosphere, the imperforate portion of the diaphragm presenting a valve surface movable in unison with the portion of the diaphragm containing the central opening and juxtaposed to the rim valve seat in position for engagement thereagainst with flexing of said diaphragm upon inhalation and bringing the valve surface of said diaphragm into engagement with said rim valve seat to seal off said exhaust port means and disengagement from the rim valve seat upon exhalation to exhaust through the exhaust port means.

2. An inhalation valve as set forth in claim 1 wherein said central opening comprises a diametral slit.

3. An inhalation valve as set forth in claim 2 wherein said mouthpiece includes an annular transverse plate, a tubular portion extending downstream from said annular transverse plate adjacent the inner margin thereof for receipt in a patient's mouth, said annular flange being spaced outwardly of said tubular portion and extending upstream from said annular transverse plate.

4. An inhalation valve as set forth in claim 3 wherein said exhaust port means comprise openings in said annular transverse plate outwardly of said annular flange.

5. An inhalation valve as set forth in claim 2 wherein said backup means comprises a spider.

6. An inhalation valve as set forth in claim 1 wherein said mouthpiece includes an annular transverse plate, a tubular portion extending downstream from said annular transverse plate adjacent the inner margin thereof for receipt in a patient's mouth, said annular flange being spaced outwardly of said tubular portion and extending upstream from said annular transverse plate.

7. An inhalation valve as set forth in claim 5 wherein said exhaust port means comprise openings in said annular transverse plate outwardly of said annular flange.

8. An inhalation valve as set forth in claim 1 wherein said backup means comprises a spider.

9. An inhalation valve as set forth in claim 1 wherein said receiving means at said entering end comprises an open ended frusto-conical elastomeric member secured to the entering end of and extending into said body.