DK168983B1

DK168983B1 - Inhalation device for active powder or liquid medicament - in which active medicament is sucked into a chamber by movement of a piston

Info

Publication number: DK168983B1
Application number: DK029791A
Authority: DK
Inventors: Hans Bisgaard
Original assignee: Hans Bisgaard
Priority date: 1991-02-20
Filing date: 1991-02-20
Publication date: 1994-07-25
Also published as: DK29791D0; DK29791A

Abstract

Active substance (from 22) for inhalation is sucked into a chamber (10) by movement of a chamber wall (12) between a position in which the wall provides a minimum volume, and a position in which it provides a maximum volume, for the chamber. The wall is biased (by 16) to its maximum volume position and the dispersed active substance is sucked from the chamber by the patient (29) through mouthpiece (24).

Description

i DK 168983 B1in DK 168983 B1

Opfindelsen angår et inhaleringsapparat til brug i forbindelse med et reservoir for et aktivt pulver- eller væskeformigt stof og med et dispergeringskammer, i hvilket det aktive stof kan bringes i dispergeret tilstand, og som 5 afgrænses af én eller flere vægdele, der kan bevæges mellem stillinger, i hvilket kammeret henholdsvis har et minimums-og et maksimumsvolumen, samt med et mundstykke, ved hjælp af hvilket en patient kan indsuge dispergeret aktivt stof fra dispergeringskammeret.The invention relates to an inhalation apparatus for use in connection with a reservoir for an active powder or liquid substance and with a dispersing chamber in which the active substance can be dispensed and defined by one or more wall parts which can be moved between positions. , in which the chamber has a minimum and a maximum volume, respectively, and with a nozzle, by means of which a patient can aspirate dispersed active substance from the dispersing chamber.

10 Fra SE-B 437.935 og WO 81/02982 kendes inhaleringsapparater af denne art til anvendelse i forbindelse med et reservoir i form af en aerosolbeholder, der indeholder det aktive stof, der skal inhaleres, og en drivgas, der normalt er freon. Når et apparat af denne kendte type skal anvendes, 15 puster patienten først i mundstykket, så at dispergeringskammeret indtager sit maksimumsvolumen. Derefter åbnes aerosolbeholderens udtømningsventil, så at drivgas og en passende dosis af det aktive stof bringes til at strømme ind i og blive dispergeret i det udspilede dispergerings-20 kammer. Patienten kan nu ved at foretage en indånding gennem mundstykket indsuge luft, drivgas og det deri dis-pergerede aktive stof fra dispergeringskammeret, idet dette samtidigt klapper sammen og derved kommer til at indtage sit minimumsvolumen.From SE-B 437.935 and WO 81/02982 inhalers of this kind are known for use in connection with a reservoir in the form of an aerosol container containing the active substance to be inhaled and a propellant which is normally freund. When an apparatus of this known type is to be used, the patient first breathes into the mouthpiece so that the dispersing chamber occupies its maximum volume. Then the aerosol container discharge valve is opened so that propellant gas and an appropriate dose of the active substance are caused to flow into and be dispersed in the dispensed dispersion chamber. The patient can now, by inhalation through the mouthpiece, suck in air, propellant gas and the active substance dispersed therein from the dispersing chamber, as this simultaneously collapses and thereby consumes its minimum volume.

25 Ved anvendelse af disse kendte apparater, hvis funktion er betinget af anvendelsen af en aerosolbeholder, vil patienten nødvendigvis indsuge den i aerosolbeholderen anvendte drivgas. Indåndingen af sådanne drivgasser fremkalder imidlertid ofte uønskede bivirkninger hos patienterne.By using these known apparatus, the function of which is contingent upon the use of an aerosol container, the patient will necessarily aspirate the propellant gas used in the aerosol container. However, inhalation of such propellant gases often produces undesirable side effects in patients.

30 Der kendes imidlertid også forskellige former for inhalatorer, hvis funktion er baseret på, at en patient, der skal benytte inhalatoren, udelukkende under udnyttelse af sin egen lungekapacitet ved en kraftig indånding frembringer en luftstrøm gennem inhalatoren. Denne luftstrøm forårsager, 35 at aktivt stof fra reservoiret for det aktive stof føres DK 168983 B1 2 ind i luftstrømmen og dispergeres i denne luftstrøm. Disse kendte inhalatorers effektivitet er således i væsentlig grad afhængig af patientens evne til at frembringe en kraftig indåndingsluftstrøm. Dette betyder, at mindre børn 5 og voksne patienter, hvis lungefunktion på den ene eller anden måde er svækket, ikke er i stand til at bruge disse kendte inhalatorer på en effektiv måde.However, various forms of inhalers are also known, the function of which is based on the fact that a patient who is to use the inhaler solely by utilizing his own lung capacity by a strong inhalation produces an air flow through the inhaler. This air flow causes the active substance from the active substance reservoir to be introduced into the air stream and dispersed in this air stream. Thus, the effectiveness of these known inhalers is substantially dependent on the patient's ability to produce a strong inhalation air flow. This means that smaller children 5 and adult patients whose lung function is somehow impaired are not able to use these known inhalers effectively.

Ved opfindelsen er der imidlertid blevet tilvejebragt et inhaleringsapparat af den indledningsvis nævnte art, der 10 uden anvendelse af særlige drivgasser muliggør en effektiv dispergering af et aktivt pulver- eller væskeformigt stof i luften i apparatets dispergeringskammer, selv om patienten har en svag eller svækket lungefunktion.In the invention, however, an inhalation apparatus of the kind mentioned above has been provided which, without the use of special propellant gases, allows for effective dispersion of an active powder or liquid substance in the air in the dispensing chamber of the apparatus, even if the patient has a weak or impaired lung function.

Inhaleringsapparatet ifølge opfindelsen er ejendommeligt 15 ved, at det har bevægeorganer indrettet til at bevæge den eller de bevægelige vægdele således i retning af maksimumsvolumenet, at der i dispergeringskammeret frembringes et undertryk, der er tilstrækkeligt til fra reservoiret at indsuge aktivt stof i dispergeringskammeret i dispergeret 20 tilstand. Ved hjælp af bevægeorganerne kan den eller de bevægelige vægdele føres i retning af maksimumsvolumenet med en sådan kraft eller hastighed, at der i dispergeringskammeret frembringes et undertryk af en passende størrelse. Dette betyder, at der frembringes en luftstrøm, der fra den 25 omgivende atmosfære føres ind i dispergeringskammeret, og som er passende kraftig til forårsage en effektiv dispergering af det aktive stof fra reservoiret.The inhalation apparatus according to the invention is characterized in that it has moving means adapted to move the movable wall part (s) in the direction of the maximum volume that a negative pressure is produced in the dispersing chamber sufficient to suck active substance into the dispersing chamber in the dispersing chamber 20. condition. By means of the moving means, the movable wall part (s) can be guided in the direction of the maximum volume with such force or velocity as to produce in the dispersion chamber a vacuum of a suitable size. This means that an air stream is generated which is introduced from the ambient atmosphere into the dispersion chamber and which is suitably powerful to cause an effective dispersion of the active substance from the reservoir.

Når det aktive stof således uden brug af en særlig drivgas er blevet dispergeret i luften i dispergeringskammeret, kan 30 patienten uden vanskeligheder gennem mundstykket fra dispergeringskammeret indsuge luft og aktivt stof, der således kommer ind i patientens lunger.Thus, when the active substance has been dispersed in the air in the dispersing chamber without the use of a special propellant, the patient can easily, through the mouthpiece of the dispersing chamber, suck in air and active substance thus entering the patient's lungs.

Inhaleringsapparatet ifølge opfindelsen kan i sig selv indeholde et reservoir for aktivt stof og de nødvendige mid- DK 168983 B1 3 ler til at bringe dette stof ind i den luftstrøm, der indsuges i dispergeringskammeret, når dettes bevægelige vægdele føres mod maksimumsvolumenet. Inhaleringsapparatet kan imidlertid i stedet være indrettet til at blive for-5 bundet med en anden inhalator af den type, hvis funktion er baseret på patientens egen indsugningskraft, som fx beskrevet i svensk patentskrift nr. 453.566.The inhalation apparatus of the invention may itself contain an active substance reservoir and the means necessary to bring this substance into the air stream which is sucked into the dispersion chamber as its movable wall portions are directed toward the maximum volume. However, the inhaler may instead be arranged to be connected to another inhaler of the type whose function is based on the patient's own suction power, as described, for example, in Swedish Patent No. 453,566.

Når patienten indsuger luft og aktivt stof i lungerne fra dispergeringskammeret, må der enten ske en sammenklapning 10 af dispergeringskammeret, eller den indsugede luft må kunne erstattes af indstrømmende luft fra atmosfæren. En sådan strøm af erstatningsluft kan fx strømme ind gennem reservoiret eller gennem den nævnte separate inhalator. Inhaleringsapparatet kan endvidere være forsynet med ventilor-15 ganer indrettet til at bringe dispergeringskammeret i forbindelse med den omgivende atmosfære, når kammeret indtager sit maksimumsvolumen. Disse ventilorganer kan betjenes manuelt, eller de kan være indrettet til at åbne automatisk, når eller umiddelbart før dispergeringskammeret 20 indtager sit maksimumsvolumen. Derved kan der opnås en turbulensfrembringende pludselig luftindstrømning i dispergeringskammeret .When the patient inhales air and active substance into the lungs of the dispersion chamber, either a collapse 10 of the dispersion chamber must occur or the aspirated air must be replaced by inflowing air from the atmosphere. Such a flow of replacement air may, for example, flow through the reservoir or through said separate inhaler. Further, the inhaler may be provided with fan means adapted to bring the dispersing chamber into contact with the ambient atmosphere as the chamber occupies its maximum volume. These valve means can be operated manually or they may be arranged to open automatically when or immediately before the dispersing chamber 20 occupies its maximum volume. Thereby, a turbulence-producing sudden air inflow into the dispersion chamber can be obtained.

Dispergeringskammeret kan udgøres af eller omfatte en sam-mentrykkelig gummibold, en sammenklappelig bælg eller en 25 lignende pumpeindretning med deformerbare vægge, der fra en sammentrykket eller sammenklappet tilstand under indvirkning af sin iboende elastiske kraft eller ved hjælp af særlige elastiske tilbageføringsorganer kan føres til en udspilet stilling. Ved den foretrukne udførelsesform har 30 dispergeringskammeret imidlertid form af en cylinder med et stempel, der er forskydeligt mellem en fremskudt og en tilbageført stilling.The dispersing chamber may be constituted or comprise a compressible rubber ball, collapsible bellows or similar pump device with deformable walls which, from a compressed or collapsed state under the influence of its inherent elastic force or by special elastic return means, position. However, in the preferred embodiment, the dispersing chamber is in the form of a cylinder having a piston which is slidable between an extended and a reversed position.

Stemplet kan have en stempelstang, ved hjælp af hvilken stemplet manuelt kan trækkes fra sin fremskudte stilling 35 eller topstilling til sin tilbageførte stilling eller bund- DK 168983 B1 4 stilling således, at der i dispergeringskammeret indsuges luft indeholdende dispergeret aktivt stof. For at man kan opnå en mere ensartet indsugning og dispergering af aktivt stof i dispergeringskammeret fra gang til gang, er det 5 imidlertid hensigtsmæssigt at lade bevægelsen af stemplet fra dets fremskudte til dets tilbageførte stilling ske under påvirkning af en kraft, der er i hovedsagen den samme fra gang til gang, og hvis størrelse kan vælges således, at lufthastigheden bliver optimal. Stemplet er således for-10 trinsvis fjederpåvirket i retning mod sin tilbageførte stilling, og der kan findes udløselige låseorganer indrettet til at fastholde stemplet i dets fremskudte stilling. Stemplet kan da manuelt og mod fjederkraften føres til sin fremskudte stilling eller til topstillingen, i hvilken 15 dispergeringskammeret indtager sit minimumsvolumen, og stemplet kan udløseligt fastlåses i denne stilling. Når låseorganerne udløses, vil stemplet hurtigt under påvirkning af fjederkræfterne blive ført til sin tilbageførte stilling, i hvilken dispergeringskammeret indtager sit 20 maksimale volumen, og der vil derved i retning mod disper-geringskammeret blive frembragt en kraftig luftstrøm, i hvilken der indsuges aktivt stof fra reservoiret.The plunger may have a plunger by means of which the plunger can be manually pulled from its advanced position 35 or top position to its retracted or bottom position such that air containing dispersed active substance is drawn into the dispersing chamber. However, in order to achieve a more uniform intake and dispersion of active substance in the dispersion chamber from time to time, it is appropriate to allow the movement of the piston from its advanced to its returned position under the influence of a force which is substantially the same. the same from time to time, and whose size can be chosen so that the airspeed becomes optimal. Thus, the piston is preferably spring-loaded in the direction of its retracted position, and releasable locking means may be provided to hold the piston in its advanced position. The plunger can then be moved manually and against the spring force to its advanced position or to the top position, in which the dispersing chamber occupies its minimum volume, and the plunger can be releasably locked in this position. When the locking means are released, the plunger will quickly be brought back to its return position, under the influence of the spring forces, in which the dispersing chamber occupies its maximum volume, thereby producing a vigorous flow of air into which active substance is sucked in from the dispersing chamber. reservoir.

Der kan i cylindervæggen være udformet én eller flere gennemgående åbninger, der i stemplets tilbageførte stilling 25 er beliggende umiddelbart inden for stemplet og forbinder dispergeringskammeret med den omgivende atmosfære. Disse åbninger vil i forbindelse med stemplet danne de ovenfor omtalte ventilorganer, idet dispergeringskammeret automatisk bringes i forbindelse med atmosfæren gennem disse 30 åbninger, umiddelbart før dispergeringskammeret indtager sit maksimale volumen. Når de nævnte åbninger afdækkes af stemplet, vil der under den allersidste del af stempelbevægelsen som følge af vakuumet i dispergeringskammeret strømme luft ind i dette gennem de nævnte åbninger. Denne 35 luftindstrømning frembringer inde i dispergeringskammeret lufthvirvler, som fremmer dispergeringen af det aktive stof i luften i dispergeringskammeret.One or more through-openings may be formed in the cylinder wall, which in the returned position 25 of the piston are located immediately within the piston and connect the dispersing chamber with the surrounding atmosphere. These openings, in connection with the piston, will form the valve means mentioned above, the dispersing chamber being automatically connected to the atmosphere through these openings, immediately before the dispersing chamber occupies its maximum volume. When the said openings are covered by the plunger, air will flow into it through the said openings during the very last part of the piston movement due to the vacuum in the dispersing chamber. This air inflow creates air vortices within the dispersing chamber which promote the dispersion of the active substance in the air in the dispersing chamber.

DK 168983 B1 5DK 168983 B1 5

Ved hjælp af et mundstykke, der kan stå i permanent forbindelse med dispergeringskammeret, eller som kan anbringes på dette efter indsugningen af det aktive stof, kan patienten indsuge dispergeret aktivt stof fra dispergeringskam-5 meret som nævnt ovenfor. For at hindre, at det aktive stof blæses ud af dispergeringskammeret og går til spilde, hvis patienten kommer til at puste i mundstykket, er der i mundstykket fortrinsvis anbragt en envej sventil, der kun tillader strømning i retning bort fra dispergeringskammeret.By means of a nozzle which can be permanently in communication with the dispersing chamber, or which can be applied to it after the intake of the active substance, the patient can suck in dispersed active substance from the dispersing chamber as mentioned above. In order to prevent the active substance from being blown out of the dispersion chamber and wasted if the patient is breathing in the mouthpiece, a one-way swivel is preferably arranged in the mouthpiece which only allows flow in the direction away from the dispersion chamber.

10 Mundstykket kan hensigtsmæssigt være forbundet med en udåndingskanal, der indeholder en envej sventil, som er indrettet til kun at tillade strømning i retning bort fra mundstykket. Patienten kan da gennem mundstykket frit ånde ind og ud, idet indåndingsluften så vil komme fra disper-15 geringskammeret, medens udåndingsluften vil strømme ud gennem envejsventilen i udåndingskanalen.Conveniently, the nozzle may be connected to an exhalation duct containing a one-way swivel which is adapted to allow flow only in the direction away from the nozzle. The patient can then freely breath in and out through the mouthpiece, the inhalation air then coming out of the dispersing chamber, while the exhalation air will flow out through the one-way valve in the exhalation duct.

Det reservoir eller det magasin, hvorfra det aktive stof afgives, kan være indrettet til at afgive det aktive stof i standardiserede doser svarende til, hvad der passer til en 20 voksen person, se fx ovennævnte svenske patentskrift. Denne standarddosis er imidlertid for stor, når patienterne er børn. Dispergeringskammeret kan imidlertid ifølge opfindelsen være opdelt i et forkammer, der er indrettet til at blive forbundet med reservoiret, og et hovedkammer. For-25 kammeret kan så være aftageligt forbundet med hovedkammeret via en forbindelseskanal, og mundstykket kan være indrettet til at kunne forbindes med forkammerets del af forbindelseskanalen, når forkammeret er adskilt fra hovedkammeret. Alternativt kan forkammeret være forbundet med hovedkam-30 meret via en envej sventil, der kun tillader strømning fra forkammeret til hovedkammeret. I dette tilfælde kan mundstykket være permanent eller aftageligt forbundet med forkammeret. Når der på den ovenfor beskrevne måde er blevet dispergeret aktivt stof i det af et forkammer og et 35 hovedkammer bestående dispergeringskammer, kan forkammeret eventuelt fjernes fra hovedkammeret og forsynes med mund- DK 168983 B1 6 stykket, hvis dette ikke allerede er anbragt på forkammeret. Derefter kan patienten inhalere luften og det deri dispergerede aktive stof fra forkammeret, men ikke fra hovedkammeret. Forkammerets volumen kan vælges således, at 5 den mængde aktivt stof, der dispergeres i luften i forkammeret, passer til den pågældende patient, fx når dette er et barn.The reservoir or magazine from which the active substance is delivered may be adapted to deliver the active substance in standard doses corresponding to what is suitable for an adult, see, for example, the above-mentioned Swedish patent. However, this standard dose is too high when patients are children. However, according to the invention, the dispersing chamber can be divided into a pre-chamber arranged to be connected to the reservoir and a main chamber. The pre-chamber may then be removably connected to the main chamber via a connecting channel, and the mouthpiece may be arranged to be connected to the front chamber portion of the connecting channel when the pre-chamber is separated from the main chamber. Alternatively, the front chamber may be connected to the main chamber via a one-way swivel allowing only flow from the front chamber to the main chamber. In this case, the nozzle may be permanently or removably connected to the anterior chamber. When, in the manner described above, active substance has been dispersed in the dispersing chamber of a pre-chamber and a main chamber, the pre-chamber may optionally be removed from the main chamber and provided with the mouthpiece if this has not already been placed on the pre-chamber. The patient can then inhale the air and the active substance dispersed therein from the anterior chamber, but not from the main chamber. The volume of the anterior chamber may be selected such that the amount of active substance dispersed in the air in the anterior chamber is suitable for the patient concerned, for example, when this is a child.

Forkammeret kan eventuelt være således indrettet, at dets volumen er indstilleligt. Forkammeret kan eksempelvis have 10 form af en cylinder med et deri forskydeligt stempel, som kan fastlåses i en ønsket stilling. På denne måde kan forkammerets volumen tilpasses barnets alder. Hvis patienten eksempelvis er et barn, der skal have en mængde aktivt stof svarende til halvdelen af den dosis, som en voksen 15 skal have, kan forkammerets volumen indstilles således, at det omtrent bliver lig med hovedkammerets volumen.The pre-chamber can optionally be arranged so that its volume is adjustable. The prechamber may, for example, be in the form of a cylinder with a piston displaceable therein which can be locked in a desired position. In this way, the front room volume can be adjusted to the child's age. For example, if the patient is a child who needs to have an amount of active substance equal to half the dose that an adult should have, the volume of the anterior chamber can be adjusted to be approximately equal to the volume of the main chamber.

Der kan i stedet anvendes et forkammer, hvis volumen er i hovedsagen uforanderligt. I dette tilfælde kan der til in-haleringsapparatet høre to eller flere forkamre med for-20 skellige volumener og/eller former. For en given patient kan man da vælge et forkammer med et passende volumen.An anterior chamber may be used instead, the volume of which is substantially unchangeable. In this case, two or more ventricles of different volumes and / or shapes may be associated with the inhaler. For a given patient, one can then choose an anterior chamber with an appropriate volume.

Mundstykket kan som nævnt være fast forbundet med forkammeret, men er fortrinsvis aftageligt forbundet med dette, idet man da kan anvende samme mundstykke til flere for-25 skellige forkamre. Når forkammeret er blevet adskilt fra hovedkammeret, kan den til forkammeret hørende del af forbindelseskanalen, hvis den ikke indeholder en envejsven-til, lukkes, fx ved hjælp af et dæksel, og mundstykket kan monteres et andet passende sted af forkammeret.As mentioned, the nozzle can be firmly connected to the anterior chamber, but is preferably removably connected thereto, since the same nozzle can be used for several different anterior chambers. When the anterior chamber has been separated from the main chamber, the portion of the connecting duct belonging to the anterior chamber, if it does not contain a one-way valve, can be closed, for example by means of a cover, and the nozzle can be mounted at another suitable location of the anterior chamber.

30 Mundstykket kan have form af en enhed, der omfatter udåndingskanalen og den dertil hørende envejsventil, så at patienten kan indånde den i forkammeret værende luft med det deri dispergerede aktive stof ved naturligt at ind- og udånde gennem mundstykket.The mouthpiece may be in the form of a unit comprising the exhalation duct and the associated one-way valve, so that the patient can breathe into the air present in the chamber with the active substance dispersed therein by naturally inhaling and exhaling through the mouthpiece.

DK 168983 B1 7DK 168983 B1 7

Opfindelsen vil i det følgende blive nærmere forklaret under henvisning til tegningen, på hvilken fig. 1 viser en udførelsesform for inhaleringsapparatet ifølge opfindelsen set fra siden og delvis i snit, 5 fig. 2 viser det samme som fig. 1 umiddelbart efter, at inhalingsapparatet er blevet aktiveret, fig. 3 viser set i perspektiv det i fig. 1 og 2 viste inhaleringsapparat, hvor dispergeringskammeret er forsynet med et forkammer, og 10 fig. 4 viser set i perspektiv forkammer og mundstykke fjernet fra hovedkammeret.The invention will now be explained in more detail with reference to the drawing, in which: FIG. 1 is a side elevational view, partly in section, of an embodiment of the inhaler according to the invention; FIG. 2 shows the same as FIG. 1 immediately after the inhaler has been activated; FIG. 3 is a perspective view of the embodiment of FIG. 1 and 2, wherein the dispersing chamber is provided with a pre-chamber, and FIG. 4 is a perspective view of the front chamber and mouthpiece removed from the main chamber.

Det på tegningen viste inhaleringsapparat har en cylindrisk beholder eller et cylindrisk dispergeringskammer 10, der opadtil er lukket ved hjælp af en lågdel 11. Inde i den 15 cylindriske beholder 10 er der forskydeligt monteret et stempel 12 (fig. 1 og 2), der er forbundet med en stempelstang 13, og som er bevægelig mellem en øverste stilling, der i fig. 2 er vist med punkterede linjer, og en nederste stilling, der i fig. 1 og 2 er vist med fuldt 20 optrukne linjer. Stempelstangen 13, der strækker sig op gennem en på lågdelen 11 udformet rørformet del 14, er ved sin øverste ende forsynet med et fingergreb 15, der som vist kan have form af en ring. En skruefjeder 16, der omslutter stempelstangen 13, og hvis ender ligger an mod 25 henholdsvis stemplet 12's overside og en øverste endevæg 17 på den rørformede del 14, påvirker stemplet 12 i retning mod dets i fig. 1 viste fremskudte stilling, og stemplet 12 kan udløseligt fastlåses i sin i fig. 2 med punkterede linjer viste øverste stilling ved hjælp af et udløseligt 30 låseorgan 18. Dette låseorgan 18 kan som vist være anbragt ved den rørformede del 14's øverste ende og være indrettet til at samvirke med stempelstangen 13. Eksempelvis kan låseorganet 18 have form af et i forhold til den rørformede del 14 forskydeligt rasteorgan, der kan indgribe med et på 35 stempelstangen udformet, ikke vist anlæg eller bryst.The inhaler shown in the drawing has a cylindrical container or cylindrical dispersion chamber 10 which is closed upwardly by means of a lid part 11. Inside the 15 cylindrical container 10 a piston 12 (Figs. 1 and 2) is slidably mounted. connected to a piston rod 13 and movable between an upper position shown in FIG. 2 is a dotted line and a bottom position shown in FIG. 1 and 2 are shown with 20 fully drawn lines. The piston rod 13 extending through a tubular portion 14 formed on the lid portion 11 is provided at its upper end with a finger grip 15 which, as shown, may take the form of a ring. A coil spring 16 enclosing the piston rod 13, and the ends of which abut 25 to the upper side of the piston 12 and an upper end wall 17 of the tubular part 14, respectively, actuates the piston 12 in the direction thereof in FIG. 1 and the piston 12 can be releasably locked in its position shown in FIG. 2 in dotted lines, the upper position shown by a releasable 30 locking means 18. This locking means 18 may, as shown, be arranged at the upper end of the tubular part 14 and be arranged to cooperate with the piston rod 13. For example, the locking means 18 can take the form of a locking member 18. in relation to the tubular member 14 displaceable resting means which can engage with a piston rod, not shown, shown on the piston rod.

DK 168983 B1 8 På lågdelen 11 er der endvidere udformet to opadrettede rørstudse, henholdsvis 19 og 20. Rørstudsen 19 er som vist i fig. 1 og 2 indrettet til at kunne optage mundstykket 21 af en konventionel inhalator 22, der eksempelvis kan være 5 af den type, som er vist og beskrevet i svensk patentskrift nr. 453.566. En mundstykkeenhed 23, der omfatter et mundstykke eller en maske 24, er aftageligt påsat rørstudsen 20. Mundstykkeenheden 23 danner en inhalationskanal, som via rørstudsen 20 forbinder masken 24 med den cylindriske 10 beholder 10's indre rum. Mundstykkeenheden 23 har endvidere en udåndingsstuds 25, som danner en fra indåndningskanalen afgrænset udåndingskanal. Indåndingskanalen indeholder en kontraventil 26, der fx kan være en klapventil, som tillader luftstrømning gennem indåndingskanalen i retning fra 15 beholderen 10 mod masken eller mundstykket 24, men som hindrer luftstrømning i modsat retning. Endvidere indeholder udåndingskanalen en kontraventil 27, der tillader udstrømning af luft gennem udåndingskanalen, men hindrer indstrømning af luft gennem denne.DK 168983 B1 8 On the cover part 11, further upwardly two pipe spigots 19 and 20 are respectively formed. The pipe spigot 19 is as shown in fig. 1 and 2 arranged to accommodate the nozzle 21 of a conventional inhaler 22, which may be, for example, 5 of the type shown and described in Swedish Patent No. 453,566. A nozzle unit 23 comprising a nozzle or mask 24 is removably attached to the pipe nozzle 20. The nozzle unit 23 forms an inhalation channel which connects through the pipe nozzle 20 to the inner space of the cylindrical container 10. The nozzle unit 23 further has an exhalation nozzle 25 which forms an exhalation duct bounded by the inhalation duct. The inhalation duct contains a non-return valve 26 which may, for example, be a flap valve which allows air flow through the inhalation duct in the direction from the container 10 towards the mask or nozzle 24, but which prevents air flow in the opposite direction. Furthermore, the exhalation duct contains a non-return valve 27 which allows the outflow of air through the exhalation duct but prevents the flow of air through it.

20 Ved normal anvendelse af inhalatoren 22 indfører patienten inhalatorens mundstykke 21 mellem læberne og foretager derefter en kraftig indånding, hvorved en standardiseret dosis af et pulverformigt inhalationsmiddel dispergeres i en luftstrøm, der bringes til at strømme gennem inhalatoren 25 22. Der findes imidlertid patienter, fx børn eller voksne med svækket lungefunktion, der ikke er i stand til at foretage en tilstrækkelig kraftig indsugning til, at inhalatoren 22 kan virke optimalt. Dette problem kan løses ved anvendelse af det i fig. 1 og 2 viste inhaleringsap-30 parat, der virker på følgende måde:In normal use of the inhaler 22, the patient introduces the mouthpiece 21 of the inhaler between the lips and then takes a vigorous breath, thereby dispersing a standardized dose of a powdered inhalant in an air stream which is caused to flow through the inhaler 25 22. However, there are patients, e.g. children or adults with impaired lung function who are unable to make a sufficiently strong intake for the inhaler 22 to function optimally. This problem can be solved by using the one shown in FIG. 1 and 2, the inhalation apparatus shown operating as follows:

Ved hjælp af fingergrebet 15 trækkes stemplet 12 til dets øverste stilling, der i fig. 2 er vist med punkterede linjer, hvorved fjederen 16 trykkes sammen, og stemplet og stempelstangen fastlåses i denne tilbagetrukne stilling ved 35 hjælp af låseorganet 18. Når låseorganet 18 udløses, bevæges stemplet 12 under påvirkning af fjederkraften fra DK 168983 B1 9 fjederen 16 hurtigt mod sin nederste stilling, der i fig.By means of the finger grip 15, the piston 12 is pulled to its upper position, which in FIG. 2 is shown in dotted lines whereby the spring 16 is compressed and the piston and the piston rod are locked in this retracted position by the locking means 18. When the locking means 18 is released, the piston 12 is moved under the spring force from the spring 16 from the spring 16 towards the spring 16. its lower position, which in fig.

1 og 2 er vist med fuldt optrukne linjer. Da lågdelen 11 er aftageligt, men tæt fastgjort til beholderen 10's øverste rand, og da kontraventilen 26 hindrer indsugning af luft 5 gennem mundstykkeenheden 23, vil det vakuum, der som følge af stemplet 12's pludselige nedadgående bevægelse frembringes inde i den cylindriske beholder 10, forårsage indsugning af en kraftig luftstrøm gennem inhalatoren 22. Derved vil den nævnte standardiserede dosis af inhalerings-10 middel blive dispergeret i den i beholderen 10 indsugede luft. Beholderen 107s cylindriske væg kan ved sin nederste ende være forsynet med én eller flere gennemgående åbninger 28, der alle fortrinsvis ligger i nogenlunde samme ringe afstand fra beholderens bund. Når stemplet 12 under sin 15 nedadgående bevægelse passerer disse åbninger, vil der yderligere kunne strømme luft ind i beholderen gennem åbningerne 28, hvilket frembringer en forøget turbulens i beholderen 10 og medvirker til opnåelse af en god disper-gering af det pulverformige inhaleringsmiddel i beholderen.1 and 2 are shown in solid lines. Since the lid portion 11 is detachable but tightly attached to the upper edge of the container 10, and as the check valve 26 prevents suction of air 5 through the nozzle assembly 23, the vacuum created by the abrupt downward movement of the piston 12 will cause inside the cylindrical container 10 suction of a strong air stream through the inhaler 22. Thereby, the said standard dose of inhalant 10 will be dispersed in the air sucked into the container 10. The cylindrical wall of the container 107 may at its lower end be provided with one or more through openings 28, all preferably at approximately the same small distance from the bottom of the container. As the piston 12, during its downward movement, passes through these openings, air may further flow into the container through the openings 28, causing increased turbulence in the container 10 and contributing to obtaining a good dispersion of the powdered inhalant in the container.

20 En patient 29 (fig. 2) kan nu anbringe masken 24 således, at den slutter tæt omkring næse og mund, og patienten kan derefter ved at foretage én eller flere dybe indåndinger indsuge luften med det dispergerede inhalationsmiddel fra beholderen 10. Når patienten foretager en indånding, vil 25 luften fra beholderen 10 som antydet med en pil 30 i fig. 2 strømme gennem rørstudsen 20, mundstykkeenheden 237s indåndingskanal og den deri anbragte kontraventil 26 og ned i patientens lunger. Når patienten foretager en udånding, vil udåndingsluften via kontraventilen 27 strømme ud gennem 30 udåndingsstudsen 25, men kontraventilen 26 hindrer, at der kommer udåndingsluft ned i beholderen 10. Ved hjælp af inhalatoren 227s doseringsindretning kan der nu fremføres en ny standarddosis af inhaleringsmiddel, hvorefter inhaler ingsapparatet igen kan betjenes som beskrevet ovenfor.A patient 29 (Fig. 2) can now place the mask 24 to close tightly around the nose and mouth, and the patient can then, by taking one or more deep breaths, suck in the air with the dispersed inhalant from the container 10. When the patient makes Inhalation, the air from the container 10, as indicated by an arrow 30 in FIG. 2 flows through the tube nozzle 20, the inlet passage of the nozzle unit 237 and the non-return valve 26 disposed therein into the patient's lungs. When the patient exhales, the exhalation air via the non-return valve 27 flows out through the exhalation nozzle 25, but the non-return valve 26 prevents exhaled air from entering the container 10. A new standard dose of inhalant can then be fed into the inhaler 227 and then inhaled. The apparatus can again be operated as described above.

35 Den standarddosis af inhaleringsmiddel, der er passende for en voksen patient, vil være for stor, når patienten er et barn. Man kunne naturligvis afpasse dosen til barnets DK 168983 B1 10 størrelse, men dette ville indebære den ulempe, at der skulle markedsføres et større antal forskellige inhalatorer 22 med doser, der er forskellige for de forskellige inhalatorer. Dette problem kan imidlertid løses ved hjælp af 5 inhaleringsapparatet ifølge opfindelsen.35 The standard dose of inhalant appropriate for an adult patient will be too high when the patient is a child. Of course, the dose could be adjusted to the child's size, but this would involve the disadvantage that a greater number of different inhalers 22 should be marketed at doses different for the different inhalers. However, this problem can be solved by the inhaler of the invention.

Fig. 3 viser det i fig. 1 og 2 viste inhaleringsapparat, hvor inhalatoren 22 er fjernet fra rørstudsen 19, der til gengæld er tæt lukket ved hjælp af et dæksel eller en prop 31. Mundstykkeenheden 23 er fjernet fra rørstudsen 20, på 10 hvilken der er anbragt et T-stykke 32, der indeholder en kontraventil 33, som tillader luft at strømme fra T-styk-kets frie grene og ned i beholderen 10, men ikke den modsatte vej. På T-stykkets ene gren 34 er mundstykkeenheden 23 monteret, medens der på T-stykkets anden gren 35 er 15 monteret en hjælpecylinder eller et forkammer 36. Cylinderen 36's indervæg slutter tæt omkring grenen 35, på hvilken der kan være udformet perifere tætningslæber, og på cylinderen 36's anden ende kan der være anbragt en ringformet manchet 37 af gummi, plast eller et andet elastisk 20 materiale, og manchetten 37 afgrænser en åbning, der tjener til at optage inhalatoren 22's mundstykke 21.FIG. 3 shows that in FIG. 1 and 2, the inhaler 22 is removed from the pipe nozzle 19, which in turn is closed tightly by means of a cover or plug 31. The nozzle unit 23 is removed from the pipe nozzle 20 on which 10 is fitted a T-piece 32 containing a non-return valve 33 which allows air to flow from the free branches of the T-piece down into the container 10, but not the opposite way. On the one branch 34 of the T-piece, the nozzle unit 23 is mounted, while on the other branch 35 of the T-piece 15 an auxiliary cylinder or an anterior chamber 36 is mounted. The inner wall of the cylinder 36 ends tightly around the branch 35 on which peripheral sealing lips may be formed, and On the other end of the cylinder 36 may be an annular sleeve 37 of rubber, plastic or other elastic material 20, and the sleeve 37 defines an opening which serves to receive the mouthpiece 21 of the inhaler 22.

Det i fig. 3 viste inhaleringsapparat kan betjenes på tilsvarende måde som beskrevet ovenfor. Når stemplet 12 under påvirkning af skruefjederen 16 bevæges til sin neder-25 ste stilling, vil det i beholderen 10 frembragte vakuum bevirke, at der suges en luftstrøm gennem inhalatoren 22, hvorved der i luftstrømmen dispergeres en standarddosis af inhaleringsmidlet. Luft med deri dispergeret inhaleringsmiddel vil således fylde både forkammeret eller hjælpecy-30 linderen 36 og den cylindriske beholder eller hovedkammeret 10. Derefter kan luft og inhaleringsmiddel fra hjælpecylinderen 36 og kun fra denne på den tidligere beskrevne måde af patienten indsuges ved ånding gennem masken 24.The FIG. 3 inhalers may be operated in a similar manner as described above. When the piston 12, under the action of the coil spring 16, moves to its lower position, the vacuum produced in the container 10 causes an air flow to be drawn through the inhaler 22, thereby dispersing in the air flow a standard dose of the inhalant. Thus, air with inhalant dispersed therein will fill both the anterior chamber or the auxiliary cylinder 36 and the cylindrical container or the main chamber 10. Thereafter, air and inhalant from the auxiliary cylinder 36, and only from it in the manner previously described by the patient, can be drawn in by breathing through the mask 24.

T-stykket 32 og de derpå monterede dele kan eventuelt 35 fjernes fra rørstudsen 20, før patienten indånder luftenOptionally, the tee 32 and the parts mounted thereon may be removed from the tube socket 20 before the patient inhales the air

Claims

25 PATENT REQUIREMENTS

An inhalation apparatus for use in conjunction with a reservoir (22) for an active powder or liquid substance and with a dispersing chamber (10) in which the active substance may be dispersed and delimited by one or more wall parts ( 12) which can be moved between positions in which the chamber (10) has a minimum and a maximum volume, respectively, and with a nozzle (24), by means of which a patient (29) can suck in dispersed active substance from the dispersing chamber (10). ), Characterized in that it has moving means (16) adapted to move the movable wall part (s) (12) in the direction of the maximum volume so that a negative pressure sufficient to produce a negative pressure is produced in the dispersing chamber (10). to inject from the reservoir (22) active substance into the dispersed chamber in the dispersed state.

An inhaler according to claim 1, characterized in that the dispersing chamber (10) is arranged to be brought into contact with a conventional inhaler (22).

An inhalation device according to claim 1 or 2, characterized in that it has valve means (12, 28. adapted to bring the dispersing chamber (10) into contact with the ambient atmosphere as the chamber 15 occupies its maximum volume.

Inhaler according to any one of claims 1-3, characterized in that the chamber is in the form of a cylinder (10) with a piston (12) slidable between an extended and a reversed position.

An inhaler according to claim 4, characterized in that the plunger (12) is spring-loaded in the direction of its retracted position and that releasable locking means (18) are provided for holding the plunger in its retracted position.

An inhaler according to any one of claims 1-5, characterized in that one or more through-openings (28) are formed in the cylinder wall, which in the position returned by the plunger (12) is located immediately within the plunger and connects the dispersing chamber. with the ambient atmosphere. DK 168983 B1 13

An inhalation device according to any one of claims 1-6, characterized in that a one-way valve (26) is provided in the nozzle (24) which only allows flow in 5 directions away from the dispersion chamber (10).

An inhalation device according to claim 7, characterized in that the nozzle (24) is connected to an exhalation duct (25) containing a one-way valve (27) arranged to allow flow only in the direction away from the nozzle.

An inhalation device according to any one of claims 1-8, characterized in that the dispersing chamber is divided into a pre-chamber (36, 38) arranged to be connected to the reservoir (22) and a main chamber (10). .

Inhaler according to claim 9, characterized in that the anterior chamber (36, 38) is connected to the main chamber (10) via a one-way valve (33), which only allows flow from the anterior chamber to the main chamber.

Inhaler according to claim 9 or 10, characterized in that the front chamber (36, 38) is removably connected to the main chamber (10).

An inhalation device according to any one of claims 9-11, characterized in that the volume of the anterior chamber is adjustable.

An inhalation device according to any one of claims 9-11, characterized in that the prechamber (36, 38) has a substantially unchangeable volume. DK 168983 B1 14

An inhaler according to claim 13, characterized in that it has two or more associated front chambers (36, 38) of different volumes and / or shapes.

An inhaler according to any one of claims 8-14, characterized in that the nozzle is in the form of a unit (23) comprising the exhalation duct (25) and the associated one-way valve (27).