CA2093809A1

CA2093809A1 - Inhaler

Info

Publication number: CA2093809A1
Application number: CA002093809A
Authority: CA
Inventors: Franco Del Bon; Luigi Del Bon
Original assignee: Individual
Current assignee: Individual
Priority date: 1991-08-15
Filing date: 1992-08-14
Publication date: 1993-02-16
Also published as: FI931661A0; WO1993003782A1; FI931661A7; JPH06504223A; HU9301090D0; AU651910B2; EP0553326A1; AU2421192A; HUT64242A

Abstract

ABSTRACT
The invention relates to a method with which a preferably powder type preparation is measured out for an inhalation.
The preparation for this is transferred from a reservoir to the correspondingly channelled inhalation flow produced by the patient on inhaling the product, such that the inhalation flow is swirled at the same time and the preparation is flushed out by the vortex into the current of air and is distributed in it. The inhalation instrument with which the method is carried out has a dosing element (25) which is mounted so that it has limited movement, in an outlet hole (24) of a reservoir (21), such that a dosing recess (26) at the side, in one extreme position, is located inside the reservoir (21) and, in its other extreme position, is located in the inhalation channel (11). The dosing element is actuated by the patient inhaling the product by way of an elastic element (30) or by way of a sealing cap for the mouth orifice (12) of the inhalation channel (11), whereby, with each movement of the dosing recess (26) from the reservoir (21) to the inhalation channel (11), one dose of the preparation is made available for inhalation. The inhalation instrument has a vibration mechanism with which the powder preparation is held loosely and pourably. Moreover, the inhalation instrument has a blocking mechanism (3) (which blocks the dosing operation if inhalation is not carried out with sufficient strength) and/or a dose-counting mechanism.

(Fig. 2)

Description

2~93~9 I~HAL~R
~, The invention relates to medicinal technique and con6ists o~ a method, according to the yeneral name ~iven to the independent claim, for measuring out a preferably powder type inhalation preparation, and an inhaler corresponding to the general name given to the independent claim for a device to be used for carrying out the procedure.

Inhalation is a well-known method, for example, for applying medicaments intended for absorption in the airways and in the lungs. For this purpose, various inhalers have appeared on the market with which liquid or powder type preparations can n be sprayed, by means of pressure or propellant gas, into or in front of the mouth cavity and, by inhaling, passed into the airways. The effectively active dose thus depends not only on the size of the dose effectively available in the inhaler, but also on the particle size and the force of inhalation. The larger the particles, the more likely they are to be removed from the inhalation stream and deposited in the mouth cavity and not in the airways; the weaker the inhalation stream produced by the patient inhaling the substance, the more particles from ~.
the inhalation stream are deposited in the mouth cavity.

To provide a constant, effectively active dose per inhalation ~-it should be ensured, by suitably designing the inhaler, that first of all a constant dose of the preparation is made available per inhalation, secondly that the particle size of the preparation in the inhalation stream remains as constant as possibla, and thirdly that the patient is compelled to inhale with a certain force. This i9 achieved, for example, with the inhaler which is described in the Swiss patent application no.
02500/90-4 submitted by the same applicant. This inhaler has 2~93~09 a reservoir containing a preparation in li.quid, dissolved, or suspended form, a pre-determined dose of which ie sprayed manually, through a jet, into an inhalation channel. By means of a blocking mechanism it is ensured that dosing and spraying are only possible i~ the person inhaling the product inhales with a possibly adjustable inhalation force, i.e. when he produces, in the inhalation channel, a flow of air against his mouth cavity which is sufficient to propel enough of the metered preparation in the direction o~ his airways. The method and the inhaler described in the application m~ntioned are limited to liquid preparations, i.e. they can be used for solid preparations only if they are dissolved or suspended in a solvent or a propellant gas.

The task addressed by the invention is therefore to provide a method and an inhaler with which preparations in powder form, i.e. without solvent or propellant gas, can be measured out for inhala~ion in the inhalation stream produced by the patient on inhaling. The preparation should be distributed as uniformly as possible in the inhalation stream. The dosing process should be actuated manually by the person inhaling the product such that only one dose is delivered by a single actuation and so that it is simple for the person inhaling to control the inhalation so that he only receives one dose per inhalation.

This problem is solved by the method according to the invention and by the independent method claim for measuring out an inhalation preparation (preferably a powder type preparation) for inhalation, and by the inhalation instrumen-t according to the invention described in the independent claim relating to the device.

According to the method to which the invention relates, the ::
air flow (inhalation stream) produced by inhalation is channelled in an inhalation channel and one dose of the - - . .
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~ . , . .:

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preparation obtained from a reservoir is trans~erred to -the inhalation channel in such a way ~hat the vortex in the inhalation stream uniformly distributes the preparation in this flow. Swirling is produced by an obstruction which is inserted in the inhalation stream and iB of such a shape that swirling is produced on its downstream side. The dose of preparation on this downstream side, in the 3wirling area, is thus entrained in the inhalation stream. In the case of a powder type preparation, it will be ensured, by previous vibration, that the powder is loose, and consists as far as possible of particles of equal size which can be easily entrained by the swirling inhalation stream; if it is a liquid, a dissolved or suspended product, it is sprayed, by pressure, into the swirling air stream.

To ensure sufficient air stream force on inhalation, the inhaler according to the invention has a blocking mechanism which allows dosing only if the inhalation stream produced in the inhaler on inhalation attains a pre-determined force. The ~-inhaler can also be designed such that the strength of the inhalation stream necessary for dosing can be adjusted by the person inhaling the substance. The advantages of such a b~ocking mechanism are described in detail in the patent application, already mention~d, submitted by the same ~
applicant who is assumed here to be known. ~-Inhaler versions with no blocking mechanism are used for persons inhaling whose production of a strong inhalation stream cannot be expected, and for those whose coorqination of the initiation of the dosing and inhalation is unlikely to be achieved. In these instruments, the actuation of dosing i9 associated wi-th the removal of a sealing cap from the inhaler hole through which the product is inhaled. Further dosing is only possible if the sealing cap has been replaced over the hole and is again removed. By so doing, the person inhaling the product is able to receive only one dose per inhalation.

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, -2~9380~

The method and the inhaler according to the invention are described in detail with the aid of the following figures: :

Fig. 1 Illustration of the principle of the method ufied for entraining a do~e in the inhala-t.ion stream;

Fig. 2 An example of one version ol. the inhaler a¢cording to the invention, with finger actuation and blocking mechanis~, in cros6 section and in the po6ition at ~ rest;

Fig. 3 The inhaler according to figure 2, in the dosing position, i.e. one dose being delivered for inhalation;

Fig. 4 Another example of a version of the inhaler according to the invention, with lever actuation, in cross section and in the position at rest;

Fig. 5 The inhaler according to figure 4, in the dosing posltion; ~ . ;

Fiy. 6 Another example of a version of the inhaler according to the invention, without blocking mechanism, with a sealing cap, and which is actively associated with the dosing, in cross section, and in the position of rest;
., . ~ .:
Fig. 7 The inhaler according to fig. 6, in the dosing ~. -position;

Figs. 8 & 9 Another version of the inhaler according to the ~
invention, with æealing cap (position at rest, and in ~-the dosing position);

: - :: . . . : .. -..... .. ,, .:. . ..

2~38~9 Figs. 10 ~ 11 Another version of the inhaler accord.ing to the invention, similar to figs. 8 and 9.

Figs. 12 & 13 Another version of the inhaler according to the invention, similar to figs. 8 and 9;

Fig. 14 Another version o~ part of the device for vibrating the preparation;

Fig. 15 Another version of part of the device for returning the dosing element to the position at rest;

Figs. 16, 17 & 18 Other versions of the reservoir for inhalars according to figs. 12 and 13;

Figs. 19 & 20 Various versions of a reservoir level indicator;

Figs. 21 & 22 A version of the inhaler according to the invention, with dosing in the inhalation s~-ream by spraying;

~igs. 23 & 25 Another version of an inhaler according to the invention, in cross section, in the position at rest and in the dosing position;

Figs. 24 & 26 A view from above of the inhaler shown in figs.
23 and 25;

Fig. 26A A view from above of the back of the inhaler (shown in figs. 23 and 25) on the opposite side of the mouth orifice;

Fig. 27 A view from above of another version of the inhaler according to the invention;
:

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Fig. 28 A view from above of the junction of one half of the inhaler shown in f.ig. 27;
igs. 29-34 Detailed views of various version6 of the mouthpiece of the inhaler according to the invention illustrated in figs. 23 to 26;
igs. 35-37 Various detail variants in the mouthpiece area of the inhaler according to the invention;
igs. 38-40 Various detail views of design po6sibilitie~ for measuring out into moulded recesses; ~.`
igs. 41-43 Detail views of various versions of the reservoir of the inhaler according to the invention; ~.
igs. ~4-47 Detail views of various vPrsions of the seal between dosing element and reservoir of the inhaler according to the invention;
igs. 48-50 Detail views of various production methods for producing ~ibrations in the stream of air; ~ :

Figs. 51-55 Detail sketches relating to production methods ~;
for producing mechanical vibrations in the ::~
inhaler according to the invention.

: ' 2~38a9 Fig. 1 shows in diagrammatic form a stream of air produced by inhalation, in which, for example, a cylindrical obstacle W
projects at right angles to the direction of flow. In the direction of flow behind the obstac:Le, a vorte~ field is produced whose swirling action flushes out a subs-tance located in a dosing cavity D, which is then entrained by the air stream. The more abrupt the surface exhibited by the obstacle at right angles to the direc-tion of flow, and reduced in the direction of flow, the more pronounced is the 9W~ rling behind the obstacle. A cylindrical object, a~ shown in the figure, produces les6 swirling than an obstacle with, say, a rear surface running at right angles to the direction o flow. In addition, however, the cylindrical obstacle has the advantage over any other shape of obstacle in that it can easily be sealed to a reservoir relative to which it must be able to move - an advantage which is utilised for the dosing mechanism according to the invention.

Figs. 2 and 3 show an example of one version of the inhaler according to the invention. It is an instrumen~ in which dosing of the preparation is only po6sible if the user inhales with a certain force. A sphere in a channel inclined in the gravitational force direction is used as a blocking mechanism.
In its position at rest, the sphere blocks the dosing operation (with no inhalation stream, or with only weak inhalation stream). If the inhalation stream is strong enough, the sphere moves in the channel and thus permits dosing.

The inhaler according to figs. 2 and 3 consists essentially of an inhaler 1 and a dosing element 2. The inhaler 1 is used, in addition, to channel the air flow produced by inhalation.
In the version lllustrated in figs. 2 and 3, it is also provided with the previously mentioned blocking mechanism 3 which i8 activated by the same air flow. The dosing element 2 is also used to pass a dose of the preparation for inhalation , : : .: .
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: :' . . ' , . ' . - -2~g3~9 into the inhalation channel, 80 that the preparation is entrained hy the inhalation stream and can be driven into the patient~s respiratory tract. The doslng element 2 has a reservoir 21 for the preferred powder type preparation, and a dosing mechanism 22.

The inhaler 1 has an inhalation channel 11, one end of which, facing the patient inhaling the produc-t, is formed by a mouth orifice 12; the other end is formed by an air supply channel 13 which, preferably, is constricted compared with the inhalation channel 11. The patient produces an air ~low -through the inhalation channel 11 - from the air channel 13 to the mouth orifice 12 - by placing his mouth over the orifice 11 and inhaling.

The inhaler 1 has another channel (channel 14 which contains a sphere 16) which joins the inhalation channel 11 at a point close to the mouth orifice 12 with a connecting hole 15. The sphere-containing channel 14 is designed in such a way that if the inhaler is in the correct position for inhaling ti.e. in ~:
the position illustrated in figs. 2 and 3), from the connect-ing hole 15 onwards, it is inclined in the direction of gravity. The bo~tom end of the sphere-containing channel 14 is formed by an inlet air orifice 17 or 17'. The diameter of the sphere 16 and the sphere-containing channel 14 are so mutually adapted that the sphere 16 can move freely in the sphere-containing channel, but the outlet orifice 15 and the air inlet orifice 17 (or 17') are so constricted that the sphere is held back in the channel 14.

If the inhaler is held in the inhalation position, the sphere 16 is driven by gravity to -the bottom end of the sphere-containing channel 1~ (fig. 1, position at rest). If an air flow L is produced in the inhalation channel 11 by inhaling, an air flow L' is produced at the same time through the sphere-containing channel 1~ which, provided it is strong :,: ,, . . . ~ . :

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2~93~03 enough, drives the sphere 16 from the bottom end of the sphere-containing channel 14 towards the upper end (fig. 2, dosing position). When the sphere 16 is clear of the bottom end of the sphere-containing channel 14, a key part 23 of the dosing mechanism 22, with its end through a corresponding hole 18 in the area of the sphere-containing channel 14,'can move downwards to enable dosing.

The reservoir ~1 is arranged in a corresponding guide 14 of the inhaler 1 a~ove the inhalation channel 11 (lnhaler~s inhalation position) and has an exit hole 24 at its bottom end, opening into the inhalation channel 11. It narrows preferably towards this outlet hole. The bottom end of a dosing element 25 that can be moved from outside, and which extends through the exit hole 24, is provided with a dosing recess 26. The dosing element 25 is matched to the exit hole, and can be moved to a limited extent through it so that it always seals the exit hole 24, and the dosing recess 26 is positioned, in one extreme position of the dosing element 25, inside the reservoir (position at rest~, and in the other extreme position, outside the reservoir 21, in the inhalation channel ll (dosing position~. The key part 23 is fitted at the bottom end of the dosing element 25, outside the reservoir 21. As already mentioned, the key part extends through the hole 18 into the area of the sphere 16 and blocks or does not block the dosing, depending on the position of the sphere 16.

The dosing recess 26 is positioned in the dosing element 25 in such a way that it lies in the inhalation channel ll on the downstream side of the dosing element 25, i.e. facing the mouth orifice 12. The dosing recess 26 is shaped in such a way that the whole of it can be washed out by the swirling of the inhalation stream, i.e the shallowest possible, narrow or pointed and easily accessible areas. Its capacity, which is defined by its internal surface area and the continuous surface of the dosing element, is so dimensioned that it can 20938~9 accept a dose of the preparation nece6sary for one inhalation.

The dosing element 25 iB placed in t;he exit hole 24 in a moun-ting element 33. This element 33 is used both as a reservoir seal and for a dose of the s-tored preparation which must be transferred from the reservoir 21 to the dose recess 26, such that it contains only the pre-determined volume. A6 already mentioned, the 3-fold function of the mounting element -33 (if a cylindrical dosing element 25 i~ us,ed) can be carried out simply by a circular seal. This, with advantage, has a rectangular cross section, but may also consist, for example, of two O-rings arranged one above the other.

At the top, the reservoir 21 is closed by a cover 27 provided with a cover hole 28 opposite the exit hole through which the dosing element 25 passes, so that it also closes this hole.
With advantage, the part of the dosing element 25 passing through the hole 28 in the cover has a smaller diameter than the part passing through the exit hole 24. The dosing element 25 is also located in the hole in the cover in a mounting ~:
element 33', which at the same time serves as a reservoir seal. Since also the part of the dosing element extending from the hole 28 in the cover is, with advantage, of cylin-drical design, a suitable O-ring or an equivalent sealing device can be used as a mounting element 33'.

A head part 29 moulded on to the end of the dosing element 25 is, for example, positively secured to an elastic element, the dosing element 25 being held by its elastic force against gravitational force in the position of rest, and is also driven back into its position of rest. The elastic device may, for example, be a hemispherical elastic bellows 30, which is arranged positively connected or loosely lying over the cover 27, and on its inside has a form closure part 31 to which the corresponding head part 29, alco formed as a positive connection part, is secured. The dosing element 25 . .

2~93~9 is actuated by pressing the bellows 30 against the inhalation channel 11 with the finger, whereby the bellows is compressed.
As soon as the ~inger pressure is relaxed, the bellows 30 returns to its original shape, so that the dosing element 25 is returned to its position of rest.

The movement of the dosing element 25 is limited, for example, by the key part 23 which, on the one hand, is close to the bottom wall of the inhalation channel 11 and, on the other, i5 close to the bottom wall of the reservoir 21.

Since the preparation is preferably in powder form, the inside of the reservoir 21 is shaped such that the preparation can pour easily towards the exit hole 2~. For this reason, the bottom, horizontal limiting surfaces inside the reservoir are eliminated by designing the bottom wall of the container and, for example, dosing element diameter constrictions so that they incline obliquely downwards.

To ensure that the powder trickles back freely to~ards the exit hole 24 and the dose recess 26, it is advisable to design the dosing element 2 such that before and/or with its activation, the powdex is automatically vibrated, and hence is moved in the direction of gravity. In the versions illus-trated in figs. 2 and 3, this is accomplished by the bellows 30 which is so shaped that, on deforming by finger pressure, it must be deformed to produce a certain shape, then snaps automatically into an end position, and that, on release, it snaps back into its strainless position; this movement must not be gradual. Due to these two jerky movements, the powder in the reservoir is vibrated twice with each inhalation, and is thus kept in a loose condition, and moves in the direction of gravity.

For inhalation purposeæ, the person inhaling the product putæ
the inhaler with the mouth orifice to hi~ mouth, breathes in :
. .

- 2~93809 deeply, and presses the bellows 30 with one finger. By so doing, he produces the ai.rflows L and L'. Due to the airflow :~:
L', the sphere 16 moves upwards in the sphere-containing channel 14. If the alr~low L' is strong enough, the sphere 16 is moved out o~ the area o~ -the key part 23, so that the key part 23, and hence the dosing element 25, can be moved down-wards by finger pressure until the key part 23 is positioned at the bottom of the inhalation channel 11, and the dosing recess 26 i9 located in the inhalation channel (dosing position). Due to the already mentioned movement character-istic of the bellows 30, it is ensured that, during the downward movement of this dosing element 25, the preparation is vibrated so that it moves towards the exit hole 24 and fills the dosing recess 26. At the end of the dosing element movement, the preparation in the inhalation recess 26 is subjected to the swirling airflow L in this area, and is moved by it towards the airways of the person inhaling the product.
On releasing the pressure on the bellows 30, the dosing element 25 moves upwards again; on concluding the inhalation, the sphere 16 in the sphere-containing channel 14 moves down again so that the instrument is again in the position of rest.

For patients who cannot apply the necessary inhalation force, it is possible to incline the inhaler against the mouth orifice 12 in such a way that the sphere-containing channel 14 inclines towards the hole.15, and the sphere 16 is moved by gravitational force towards the hole 15 and enables dosing to take place.

The bottom end of the sphere-containing channel 14, with advantage, is closed with a plug 19 which can be provided with the inlet air hole 17'. Assembling the instrument iB thereby simplified, since the sphere 16 can be introduced into the sphere-containing channel 14 when the instrument is ~inished, and the plug then inserted. The shape of the plug 19 must be such that the axis of the key part 23 lies ~urther towards khe - , , , . .; . .
. ... . . . ..

2 0 ~ 9 hole 15 of the sphere-containing channel 11 than the mid-point o~ the sphere 16 in its position at rest. By providing a suitable co~er or slide, or by suitably shaping the plug 19, the inlet hole 17 or 17' may have a cross se~tion that can be varied by the person inhaling the product. By this means, the inhalation force necessary for moving the sphere 16 can be adju~ted according to the condition of the person inhaling.
For a very healthy condition, a minimum inlet hole can be provided, or the latter can be completely dispensed with, the inlet channel 13 of the inhalation channel 11 above the hole 18 being used as an inlet hole of the sphere-containing channel 14. In addition, the sphere may be made of a heavier metal, or even a metal ball and a plug 19 can be provided with a magnet.

The version illustrated in figs. 2 and 3 of the inhaler ~-according to the invention is a dosing inhaler 2 in the form of a replaceable cartridge. This includes the reservoir 21 with cover 27, the dosing element 25 with key part 23, and a bellows 30 secured to the head 29. The cartridge must be introduced into the guide 14 such that the dosing recess 26 faces the mouth orifice 12, and the key part 23 is located in the hole 18 between the inhalation channel 11 and the sphere-containing channel 14. To ensure that the cartridge can be easily and correctly inserted in the guide 14, the dosing element 25 is preferably fixed so that it cannot rotate in the reservoir 21, e.g. by means of a suitable positive locking device between the container wall and the bellows 30, and is provided with a vertical groove, while the guide 14 has a corresponding comb, e.g. the wall of the air supply channel 13. The cartridge can then only be inserted in the guide 14 in such a way that the comb rests in the groove, thus defining the position of the cartridge. The wall of the reservoir 21 is slightly elastic (at least in the area of the exit hole 24 and/or designed using form clo~ures so that, on inserting the cartridge into the corresponding hole in the inhalation . '~;' ', 1.

: , . , . , , 209380~

channel, it is secured under tension and/or is positively locked.

The design of the inhaler with a dosing element in the form of a replacement cartridge i8 proving advantayeous, since the inhaler does not have to be discarded after the preparation has been consumed and since, due -to a reservoir capacity adapted to the life of the preparation, overageing of the preparation can be avoided.

Figs. 4 and 5 show another version of the inhaler according to the invention whose most important parts and mode of operation correspond to the version according to figs. 2 and 3. The corresponding parts are therefore also denoted by the same reference numbers.

The bellows 30, to which the dosing element 25 is secured as in the version according to figs. 2 and 3, is not actuated in ~his version by finger pressure but by a levar 41 which is attached to the guide 14 via a swivel 42. If the end 41.1 of the lever 42 is raised, its other end is forced against the bellows 30, which is thereby deformed.

As illustrated in figs. 3 and 4, the lever 41 can be designed as a hollow lever which at least partly surrounds the bellows 30. In addition, the bellows can be provided with grooves 43, and the inside of the lever 41 can have at least one grating 44 which, on actuating the lever 41, rub against each other.
This sets up a vibration in the bellows 30 which is trans-mitted to the wall of the reservoir 21, and vibrates -the preparation.

The various versions of the inhaler according to the invention as shown in figs. 6 to 11 are of advantage for patients who can apply less inhalation force, and also for those with coordination problems or who find it difficult to actuate the . ~

2093~ D9 inhaler wi~h one hand or one finger on the in~trument in the inhalation position. Such devices have no blocki.ng,mechanism which necessita~es actuating the dosing operation during inhalation. In all these versions, however, the inhaler must be brought from a position of rest to an inhalation configu-ration, e.g. by opening a sealing cap that otherwise closes the mouth orifice. By so doing, the dosing element is released for actuation or is moved directly into its dosing position. The dosing element is returned to its position of rest when the inhaler is returned to its rest configuration with the sealing cap closed. The main advantage of these design variants is that only one dose can actually be administered per inhalation. Between two dosings, the mouth orifice must be closed with the sealing cap, i.e.
inhalation must at least be interrupted, and the inhaler must be moved from its inhalation position.

A further advantage of the version according to figs. 6 to 11 - as also of all other versions with sealing cap described above - is that the mouth orifice of the inhalation channel is closed and is therefore prevented from becoming contaminated, and that the sealing cap is secured to the instrument and cannot therefore be mislaid.

These design versions are also shown in exploded form, and each in the position of rest (figs. 6, 8 and 10) and in the dosing position (figs. 7, 9 and 11).

Figs. 6 and 7 show a version with an angled i.nhalation channel 11.1 such that the part of the inhalation channel .in which the preparation is metered - as in the versions already described - is at right angles to the direction of movement of the dosing element ~5, while the part of the inhalation channel 11.1 facing the mouth orifice 12 is parallel to the direction of movement of the dosing element 25, so that, in the --inhalation position of the instrument ~as illustrated), the - . , ~ . . . .

,,, :: '. ~ : '; ' ' ' ' . ;'':~ ';: . ' '~ :. ' , ` :, 2~9~809 dosing element 25 is moved in the hori~ontal direction. To enable easy cleaning of the inhalation 1l.1, despite its angled shape, it is advisable to make the part of it facing away from the mouth orifice 12 accessible by means of a hole 64 and a suitable cover 65.

On the side of the instrument provided with the mouth orifice 12, a sealing cap 62, rotatable about a swivelling axis 61, iB
provided which, by means of a lever system, i8 actively associated with the dosing element 25. Only one part 63 of the lever system which acts directly on the dosing element 25 is illustrated in the figure. If the sealing cap 62 is slid away from the mouth orifice 12, the part 63 presses on the dosing element 25 and moves it into the dosing position. If the sealing cap 62 is slid bac~ over the mouth orifice 12, the dosing element 25 is returned to the position of rest by a corresponding elastic element (see also fig. 15) or by a ...
suitable bent connection between part 63 and the top end of the dosing element 25.

Figs. 8 and 9 represent another version of the inhaler ;~.
according to the invention, and is provided with a sealing cap. The upper part of the reservoir 21 and the dosing element 25.2 are similar in design to that of ~igs. 2 to 5 and are therefore not illustrated.

The inhaler 1.2 has no blocking mechanism, and consists solely .~
of an inhalation channel 11.2 to which a guide 14 for the ::
reservoir is fitted. The inhalation channel 11.2 has an upper hole 91 into which the exit hole 2~ of the reservoir 21 opens, and a lower hole 92, opposite this hole 91, whose opening is at least as large as the cross section of the dosing element 25. The sealing cap 62.2 seals the mouth orifice 12 of the inhalation channel 11.2 and, from this point onwards, is .
extended, along the outer wall o~ the inhalati.on channel 11.2, :~
to a point above the hole 92. The sealing cap 62.2 i8 . ~ .

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~93~9 extended to -the inhalation channel 11.2 ~or opening the mouth orifice 12, and completely removed in the direction of the arrow R. The dosin~ element 25.2 i8 designed s~ch that, in the re6t position, it passes right through the inhalation channel 11.2, through the hole 92 and, with the sealing cap 62.2 closed, comes to rest on the latter, and is thus blocked.
The dosing element is unblocked by removing the sealing cap 62.2, i.e. the dosing element 25.2 can be passed through the hole 92 and thereby brought to the dosing position. Actuation of the dosing element 25.2 can be conceived as a si.mple finger pres~ure on its head part (not illustrated in the figure). No elastic element which returns the dosing element to the rest position need be preseIlt so that, for the return movement of the dosing element 25.2 to the rest position, the sealing cap 62.2 must be replaced.

For the vibration of the contents of the reservoir 21, there are grooves 93 on the underside of the o~ter wall of the inhalation channel 11.2 and on the surface of the rail-shaped extension of the sealing cap 62.2, facing this underside, at right angles to the direction of movement of the sealing cap.
These grooves engage with each other (fig. 8) so that, on moving the sealing cap 62.2, the combs between the grooves of one part jump from one groove of the other part into the next, and thereby cause the whole inhaler to vibrate.

Figs. 10 and 11 show another version of a sealing cap 62.3 blocking the dosing process. In this version, also, the ~, inhalation channel 11.3 has a bottom hole 92 for the dosing element 25.3 The sealing cap 62.3 is also shaped in such a way that it extends over the whole of the underside of the inhaler. In the area of the inhalation channel 11.3, which is as fiar as possible from the mouth orifice 12, the sealing cap 62.3 is flexibly attached to the wall of the inhalation channel. In one area immediately next to the mouth oriflce 12, the outer wall of the inhalation channel 11.3 has grooves 2~3809 100 at the side, running e~sentially at right angles to the ~lexing movement~ and ~he inside of the sealing cap 62.3 in the same area is provided with grooves 100, running essentially parallel to the grooves L00 of the inhalatlon channel 11.3. These grooves also inlerlock and, with a flexing movement of the sealing cap 62.3, cause the whole inhaler to vibrate.

Figs. 12 and 13 show one version of the inhaler according to the invention in which, not only the the backward m~vement of the dosing element (as for the versions according to figs. 8 to 11), but also its movement in the dosing position, i.e. the dosing i.tself, i8 produced directly on opening the sealing cap. Since, in such a case, an upper end of the dosing element 25.4 which projects from the reservoir on the side opposite the inhalation channel has no function, the dosing element 25.4 is only of minimum length, and above, in the reservoir, is closed by a drip cone~).The sealing cap 62.4 i6 similar in shape to that of the sealing cap of figs. 10 and 11 (62.3) and is also attached in a flexible manner to the wall of the inhalation channel. Opposite the bottom hole ~2 in the inhalation channel, the sealing cap 62.4 also has a hole 121 whose area can be so enlarged towards the outside that a follower 122 fitted to the bottom of the dosing element 25.4, with a neck 123, and which extends into this opening, cannot be pulled from this hole 121.

Using the swivelling movement of the sealing cap 62.4 for opening the mouth orifice 12, the dosing element 25.4 is drawn into the dosing position (fig. 12) using the ~ollower 122 trapped in the hole 121. On closing the sealing cap 62.4 again,~the dosing element 25.4, which has a larger cross-sectional area than the smallest hole area of hole 121, is again moved to the position at rest (fig. 13).

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2093~9 For the vibration in ~his version, there i~ a ratchet 124 between the dosing ele~ent 25.4 which i8 provided wi.th grooves 125, and a pin 126 (fitted to the reservoir 21.4 or to the inside wall of the inhalation channel in the area of the exit hole 24) which engages in the grooves 125.

Movement of the dosing element 25.4 in -this version is limited, on the one hand, by the follower 122, whose neck 123 is clamped in the hole 121 of the sealing cap 62.4 and, on the other, by limit s-tops 127 which are fitted to the dosing element 25.4 in the area of the drip cone 120.

The guide 14.4 is shown in cross section in fi~. 13. An elongated hole 128 extending over the full height of the reservoir is thereby visible, enabling the level of the preparation in the reservoir 21.4 to be seen. For example, a scale 130 is fitted in the area of the hole 128. In con-nection with figs. 19, 20 and 21, level indicating devices of this type are described.

The reservoir 21.4 of a version according to figs. 12 and 13 ;~
can be of a shape differing from that of the reservoir of tha previous versions, since the top of it, which must not cause ~ `~
actuation, can be of any design. For example, as illustrated in figs. 12 and 13, it can be open at the top and be provided with a sealing plug 129. The reservoir 21.4, `for example, can thus be refilled. The sealing plug 129 can also serve, additionally, as a container for a drying agent. Further versions for reservoirs with only one hole for the dosing element are described in connection with figs. 16, 17 and lB.

Fig. 14 illustrates another version of the inhaler according to the invention in which, again, a dosing element 25.5 iB
actuated from above. In this version, the vibration function is assured by a ratchet 124.5, which is fitted between an elastic element (e.g. a bellows 30.5) and the top of the ~.

' :: , . ;
.: . : , , ~093809 reservoir 21.5. The bellows 30.5 has, for example, an internal web l~1 with grooves; the upper, outer wall of the reservoir 21.5 has a pin 142 which extends into -the groove area and, with a deformation of the bellows, jumps from one groove to the next. To ensure that ~ribration commences before the movement of the dosing element 25.5 and that the dosing recess 26 is filled, by vibrating, before it i6 moved into the area of the exit hole 24, the upper end of the dosing element 25.5 is not secured to the bellows 30.5, but iB designed in such a way that, when the bellows 30.5 iB in the position at rest, there i6 a 6pace between the head portion of the dosing element 25 and the bellows 30.5 (or the web 141). When the bellows 30.5 is deformed, the ratchet 124.5 i8 initially actuated and the dosing element is moved only after closing the space between the bellows 30.5 (or web) and the dosing element 25.5. The movement is limited by a limit stop -~
shoulder 141a on the web 141.

Since, in a version of this type, the dosing element 25.5 cannot be returned to the position at rest by the bellows . :
30.5, further elastic elements 143 are fitted between the head part of the dosing element 25.5 and the upper, oute~ wall of :
the reservoir 21.5 which, on deformation of the bellows, are .: .
also deformed and which, on releasing the pressure on the :~
bellows, revert to their original shape and return the dosing ~ .
element to the position at rest. ~ .

Fig. 17 shows another version of elastic elements that can be used for the purpose of returning the dosing element 25.6 to its position at rest. It consists of a spring element fitted in the inhalation channel 11.6 which, for example, can take the form of an elastic rod 151, pointed towards the bottom end of the dosing element, and which is so designed and fitted that it is swung out from its position at rest by the dosing movement of the dosing element 25.6.

. : . . .: ,, . : .. . , ,. .... , . , :

2~g3~
Possible forms of the reservoir are 6hown in ~i~s. 16, 17 and 18. The individual versions are differentiated in terms of produc-tion, filling, sealing, ecoloqy, etc.

Fig. 16 illustrates a reservoir 21.7 in the form of a tube 161, open at both ends before sealing, the end further from the inhalation channel beig closed with a plug 129.7 with a sealing element, while the end facing the inhalation channel is closed with a closing element 162 with integrated mounting and sealing element 33.7.

Fig. 17 shows a blown or drawn tube 171, e.g. of glass, which is closed towards the top ~the end facing away from the inhalation channel) and towards the bottom (from the end facing the inhalation channel), and is closed with a closing element 162.8 with integrated mounting and sealing element 33.8.

Fig. 18 shows a reservoir with a closing element 126.9 which has a heat-welded collar 181. To this heat-welded collar a reservoir, consisting, for example, of a laminate, multilayer or other film ~182) with barrier action, i8 welded. This reservoir may have an internal support 183 (closed or partly fragmented form). With the exception of the closing element 162.9 which i8 relatively rigid, nearly all other parts are fairly flexible. ;

Figs. 19 and 20 show versions of reservoir level indicating devices. These devices are based on the idea not to monitor the effective level of preparation in the reservoir, but to count the metered doses using a mechanical device coupled with the dosing device. ~ince, in the case of a replaceable reservoir, the counting mechanism i6 ~eplaced at the same time, and thus constitutes a disposable instrument, it must be simple and cheap to produce and may, under certain circumstances, also be designed as a disposable mechanism, --.: .. . . ..

2~3~09 i.e. readjustment for a refilled container by the person operating the instrument must not be possible in any case.

Fig. 19 shows a dose-counting mechanism of this kind in which a thread 191, coloured differently in its end area 192, is wound on, using a ratchet wheel 193, and is run past an inspection window 194. The ratchet wheel 193 iB actively combined with the dosing mechanism i.n such a way that it is rotated further by one tooth with each dosing. In 80 doing, the fibre is successively wound on until its differently coloured end appears in the inspection window 194, indicating that the preparation in the reservoir will soon be used up.
A mechanism of this kind can be fitted, for example, in the hollow lever 41 (figs. 4 and 5).

Fig. 20 shows another version of a dose-counting mechanism.
This consists of a spindle 201 on whiçh a nut 202, with a nut guide 203, runs in a guideway 204 that is visible from the outside of the inhaler. The spindle 201 is actively combined with the dosing mechanism such that it rotates slightly with each dose delivered, whereby the lock nut 202 moves in the guideway against a mark 205 indicating the consumption of the product in the reservoir. -Figs. 21 and 22 illustrate a version of the inhalation instrument accoxding to the invention whose inhaler 1 corresponds to that of the version shown in figs. 2 and 3.
The dosing element 2.10 consists essentially of a pressurized container filled with propellant gas, which also contains the preparation and which is provided with an outlet valve that can be activated by finger pressure, as is normal for a pressurized container of this type. The pressurized container is inserted in the guide 14 in such a way that its spray outlet 211 in the inhalation channel 11.10 is facing the mouth cavity 12, and the actuating button 212 is located on the bottom internal wall of the inhalation channel. By pressing 20~3~9 the container in the direction of the inhalation channel (fig.
22), the outlet valve i6 opened, and one dose of the preparation is sprayed in-to the rotational field produced in the inhalation air current by pressing the actuating button 212.

It is clear that, in the above versions of the inhalation instrument according to the invention, the dosing recess 26 can also be arranged to rotate through 180 about the longitudinal axis o~ the dosing element. It can also be arranged to rotate through angles differing by up to approximately 45 from these two positions (0 and 180 respectively).

Further versions of the inhalation instrument according to the invention are illustrated in figs. 23 to 55. These differ from the versions described above, mainly in that the dosing -element is arranged, not essentially at right angles to the air flow, but essentially parallel to it when using the inha1ation instrument, i.e. it is so arranged that it can be moved essentially horizontally.

Figs. 23 and 24 show such a sectioned illustration of the version of the inhalation instrument and the dosing configuration viewed from above, i.e. with the dosing element in the dosing position while figs. 25 and 26 illustrate the same inhalation instrument in the configuration at rest, i.e. ;
with the dosing element in its position at rest.

As shown in the illustration, the instrument has an Plongated, essentially parallelepiped or cylindrical main body 500, in which a dosing element 525, in the form of a tube, i~ placed essentialy horizontally between a position at rest and a dosing position in such a way that it can be slid longi-tudinally. The dosing element 525 could al90 be in the form of a solid rod. A mouthpiece 512 is secured to the front end ,' :'~

2~9380~
of the main body 500. An actuating cap 550 -tha-t can slide to and fro is fitted parallel to the dosiny elemen-t 525, between a closed position (fig. 25) and an open position (fig. 23), in such a way that it can be slid -to and fro. The dosing element 525 is kinematically coupled with the actuation cap 550 approximately in the centre 551 of the front end 552 of the cap, so that by sliding the actuation cap 500 betweén its two end positions the dosing element 525 travels with it, between its two end positions.

An essentially funnel shaped reservoir 521 i6 constructed in the front area of the main body 500, and leads into an exit hole 524 which is closed by the sliding dosing element 525. A
cover 527 seals the reservoir 524 at the top.

A dose counting mechanism is tilted in the rear area of the main body 500 and includes a toothed gear wheel 580, a ratchet wheel 581 with a driving pin 582, a non-return lock 583 and a pawl 5~4 which is fitted to the dosing element 525 and can be moved with it. With each movement of the dosing element 525 from its position at rest (fig. 25) to its dosing position (fig. 23~, the pawl 584 engages in the ratchet wheel 581 and rotates it by one additional tooth. After each complete revolution of the ratchet wheel 581, its driving pin 582 rotates the counting wheel 580 which is provided with a scale indicating the doses delivered by one more tooth. The scale of the counting wheel 580 can be read through a window 553 of the actuation cap 550.

The tubular dosing element 525 i9 flexibly mounted in the area in front of and behind the reservoir 521 by means of two mounting elements 533 and 533', whose construction is explained again in more detail in connection with the figures 44 to 47. A dosing recess 526, which is so axranged that, in the rest position o the dosing element 525 it is positioned in the area of the mouthpiece 512 and, in the dosing position . .: - .:: , . . .
,. : ::. , . - . : :. ..
,. :, :. , - 'i . ` ' ' , .: . :
:: . - . , . , :. : .

-2~938~9 of the dosing element 525 it is positioned in the area of the ou~let hole 52~. The construction of the dosing rece~s 526 is explained again in detail in connection with the figures 38 to 40. `~

The front of the mouthpiece 512 has an air exit hole 513, and two or more air inlet channels 514 at the side. The latter, with the dosing element 525 in the rest position, essentially face the dosing recess 526 and produce at thls point the already mentioned swirling. The shape and arrangement of the air inlet channels 514 is explained again in more detail in -connection with figures 29 to 34.

The bottom of the main body 500 is provided with a corrugation 505 which acts in conjunction with a nap 554, which is located at the bottom o~ the actuation cap 550 and at its front 552 an elastic reed 555 that can be made to vibrate is ;
provided. As is evident, particularly from fig. 26A, the reed 555 is separated, by two slits 556 in the side and front of the actuation cap 550, from the other parts of the latter. On `
moving the actuating cap 550 between their two end positions, the reed 555 is excited to mechanical vibrations which are transmitted, via the actuating cap 550, to the dosing element 525. Similarly, vibrations are also produced in the main body 500 which act on the inhalation preparation in the reservoir 521. Another nap 557, approximately in the middle o~ the reed 555, transmits vibrations to points on the main body 500.
Further details for producing the vibrations are again explained in connection with figs. 48 to 55.

The mode of operation of the inhaling instrument, according to figs. 23 to 26, is essentially the same as that of the versions of the inhaler according to the inventlon already described. Before inhaling, the dosing element 525 i6 brought from its position at rest shown in fig. 25 into its dosing ~`
position shown in fig. 23 by means of the actuating cap 550.

. . ~ , : . ~
,, , ,~

20938~
By means of gravity, and a66isted by the vibrations produced in the receiver 521 and the dosing e:Lement 525 due to the displacement, the dosing recess 526 :i5 filled with an amount of inhalation preparation correspond:ing to its capacity. The dosing element 525 is then returned l:o its position at rest, which i6 also the inhalation pOSitiOII, and the inhaler is placed next to the mouth. On inhaling, air is drawn in through the air inlet channels 51~ in the mouthpiece 512 and is swirled in the area of the dosing recess 526. ~y BO doing, the inhalation preparation is washed out from the dosing recess 526 and is distributed in very ~ine form in the air current. The latter, together with the inhalation preparation suspended in it, finally reaches the patient's airways through the eir exit hole 513 of the mouthpiece 512.

Fig. 28 shows one version of the inhaler similar to that of figs. 23 to 26 which is optimised, with regard to manufacture, by using a plastics injection moulding technique. One hal~ of the instrument without the actuation cap is shown in the view of the parting joint. As can be seen, ~he main body 600 and the mouthpiece 612 are formed as one piece. In addition to the upper air inlet channels 614, another air inlet channel 615 is provided in the bottom part of the mouthpiece 612 which emerges near the outlet hole 613 and, by suitable dimension-ing, can be used for further optimising the flow conditions.

It is also seen from fig. 28 that the reservoir 621 (as also in the other versions) is constructed essentially as a double cone, i.e. has a constriction 62B just above its exit hole 624. setween this and the exit hole 624, or the dosing element (not visible here), pockets 629 are formed in this way in which inhalation preparation collects, so that even if the inhaler is kept tilted, satisfactory filling of the dosing recess and hence correct dosing is ensured.

;

.. . . .
, ~,093809 Two circular cavities 633 are used ~o fit the mountirlg elements ~not shown here) ~or the dosing element.

Unlike the version shown in figs. 23 to 26, the vibration mechanism is designed slightly differently, since the reed 655 is not constructed on the actuation cap (not shown here) but on the main body 600, and i8 provicled with ribbing 605, while the actuation cap i9 provided with a corresponding nap acting in conjunction with the corrugation. The mode of operation of the vibration mechanism, however, is analogous.
In addition, a web 670, with an opening 671, is provided which connects the base of the reed 655 with the wall part of the main body 600 surrounding the reservoir 621, and which transmits the vibrations produced by the reed directly to the reservoir 621. At the top of the main body 600, another reed 690 is provided with a nap 691 at its free end which works in conjunction with a corresponding corrugation on the actuation cap (not shown here), and likewise produces vibrations which are transmitted to the reservoir 621. Another web 692 is used for assisting the transmission o~ vibrations.
.
Fig. 27 shows the inhaler as viewed from above with a few variations of detail. An additional vibration mechanism is seen which engages directly at the side of the part of the main ~ody forming the reservoir 621. This vibration mechanism is formed by a corrugation 693 constructed on the actuation cap 650 and a tooth 694 produced on the outside of the reservoir 621. In addition, undercuts 695 and 696 of the `
reservoir 621 can be seen, which are also used to act on the oscillations or vibrations developing in the reservoir. By suitably selectin~ and arranging or di~ensioning the various vibration devices, vibrations forms and combinations of vibration forms, adapted to the particular inhalation preparation, can be produced, so that even with difficult, i.e. poorly flowing inhalation preparations and extremely small doses (as little as ~0.1 mg~, accurate and reliable , , - 2~ -: .- :'.:: : ` ' :, ',.',, :: ~' ~. ' . . , ' ' :
: : ~ . - :

2~938~9 dosing is ensured.

Figs. 29 to 34 show various design valJiants of the mouthpi~ce.
According to figs. 29 and 30, the top of the mouthpiece 712 iB
provided with four addi-tional air inlet channels 713 to 716, which are arranged approximately in a square and are especially matched to this square construction of the dosing recess according to fig. 38. Figs. 31 and 32 show a mouth-piece 722 with two upper air inlet channela 723 and 724 that run obliquely to the front, and also a similarly oblique bottom air inlet channel 725. This mouthpiece is adapted to the obliquely constructed dosing recess according to fig. 39, but it is of course also suitable for the other dosing recess variants. Finally, figs. 33 and 34 show a mouthpiece 732 with two side air inlet channels 733 and 734 at right angles to the axis, and also an air inlet channel 735 entering obliquely from above. By suitably designing and arranging the air inlet channels and adapting them to the shape of the dosing recess provided for the dosing element, optimum air emptying of the latter and swirling of the inhalation preparation in the air current can be achieved.

Figs. 35 to 37 show detailed sections o~ different versions of the mouthpiece 512. According to fig. 35, the front end of the tubular or rod shaped dosing element 52S is provided with an aerodynamically formed point 745, which extends to a point just before the exit hole of the mouthpiece, and ensure6 additional swirling of the inhalation preparation in the air current and also a further breakdown of any existing aggre-gates. The obstructions 746 and 747, which are provided in the version6 shown in fig6. 36 and 37, above and slightly in front of the position at rest of the dosing recess 526, also have a similar purpose. The shape of the poi.nt 745 and the obstacles 746 and 747 can of course be adapted according to the flow conditions and requirements.

- 2~ -..... . . . . .. .. .

' ' . ~

~ ~ .

2~93~9 Figs. 38 to 40 sl~ow dif~erent ver6ions of the dosing recess in the dosing element 525. According to ~igs. 38 and 40, the dosing recess 750 i6 0~ an essentially square design and has two essentially square projections 751 and 752, 50 that the actual cavity is approximately the shape o-f a figure eight.
As the hatched area of fig. 38 shows, the two projections could also be divided so that efe~tively four projections would be present. According to fig. 39, the dosing recess 760 includes two approximately diagonal notches 761 and ~62. In both desi~n variants, the actual cavities in the longitudinal direction of the dosing element 525 are only relatively short so that the normally elastic mounting elements 533 of the dosing element cannot enter the cavities, no matter what the position of this element, so that precise and constant dose measurement is assured.

Figs. 41 to 43 show details of the construction of the reservoir 521. Fig. 41 shows a view from above with the cover removed, while fig. 42 shows a section at right angles to the longitudinal direction, and fig. 43 shows a section parallel to the longitudinal direction of the dosing element 525.

It is seen that the reservoir is fitted at both sides of the ;.
dosing element 525 with a suitable flat sliding sur~ace 771 and 772 respectively, which projects at the side up to a point almost reaching the edges o~ the dosing recess 526. By this means, the inhalation preparation is introduced, in the best possible manner, into the cavity of the dosing recess 526.
Moreover, the dimensions of the exit hole 524 of the reservoir 521 in the longitudinal direction of the dosing element 525 are essentially larger than the dosing recess 526, so that the latter remains within the exit hole during part of its displacement, and is properly filled.

~: ~ ' ' . . '::. .' '?
. ' ~ ' , . :: ` ' : , .

2~3g~9 Fi~s. ~4 to 47 show detailed views from which various construction pos~ibilitie6 of the mounting elements for the dosing element 525 are evident.

ccording to fig. 44, the mounting elements consist of two slit o-rings 781 and 782. Accordiny to ~ig. 45, two radially superimposed O-rings 783a and 783b are provided in each case.
According to fig. 46, two O-rings 784a and 784b lie close together in the longitudinal direction in each ca3e. In the version shown in fig. 47, only one O-ring 785 is provided in each case, but this is supported additionally on an oblique shoulder area 786 of the dosing element 525. Common to both versions is the fact that on the one hand they exert only a relatively slight pressure on the surface of the dosing element 525 in the radial direction and, on the other, they do not significantly obstruct the vibrations of the dosing element 525 produced by the vibration mechanism.

As already mentioned, the dosing element in all versions can ~;
be constructed in the form of a tube or a solid rod. With a tubular construction, however, further degrees of freedom are achieved regarding the production of oscillations or vibrations, so that optimal adaptation to the properties of the inhalation preparation i6 possible. ``

Fig. ~8 shows a tubular dosing element 825 which is hollow throughout and is equipped at its free end with additional air channels 826 and 82~ for changing the flow conditions.
Optionally, the inside of the front end of the tube can also be extended in the form of a funnel, which is explained by the `-lines 828 and 829. At the rear end of the tube, there i8 a miniature projection 830, by means of which the tube or dosing element 825 can be so clamped in the front 552 of the actuation cap 550 that it is admittedly kinematically coupled with it in the axial direction but can freely oscillate or vibrate.

.... . , . . . ~

- . , :

~ . -2~3~09 The tubular, rear, likewise open dosing element 835 of fig.49, has a point 837 closed except for a jet 836. On its rear end there is a bead-type -thickening B3~ with which it is mounted in a circular groove 839 of the front 552 of the actuating cap 550. Inside the dosing element 835, there i8 a flexible disc 8~0 which is excited to vibration by the air flowing through the dosing element and hence also produces acoustic vibrations which, with suitable dimensioning, like-wise is beneficial when filling the dosing recess 526.

According to ~ig. 50, there is a vibrating disc 841 at the open end of the mouthpiece 512 and projects into the front end of the tubular dosing element 845. Alternatively, or additionally, another flexible disc 850 or suchlike can be fitted between the dosing element 845 and the mouthpiece 512, which is also excited to vibration by the current of air and thus exerts a tapping movement on the dosing element 845.
This can assist the emptying of the dosing recess 526 and the swirliny of the inhalation preparation in the current of air.
. .
Further details for the production of oscillations and vibrations in the inhaler according to the invention are evident from figs. 51 to 55. - ;

Fig . 51 shows the reservoir 521 and the section of the dosing element 525 below it. A helical spring 860 is fitted in the reservoir which is fl0xibly mounted on the cover 527 on the one hand, and on the dosing element 525 on the other. The bottom end of the spring 860 rests on a shoe 861. If vibra tions are transmitted to the reservoir 521 and/or the dosing element 525, the helical spring 860 performs a sort of dancing movement which breaks down agglomerates of the inhalation preparation, and ensures precise filling of the dosing recess 526.

.. . .

-: ~ : : : . . . .: : , : .:

: . : -2093~09 The tapping element 870, illu8trate~ in fig. 52, which iB
arranged diagonally and loosely in the reservoir 521 and which, on vibration, carries out a ~apping movement, produces a similar e~fect Its bottom part 871 is in the form of a shovel and, so to speak, moves the inhalation preparation into e dosing recess 5~6.

~i~. 53 shows a section of fig. 25. The corru~ation 505 of ~he main body 500, and also the ~re~ ~nd o~ the reed 555 of .~le actuation cap 550 with the nap 554, are ~h~wn in magnified ,o}ln. As is evident, the corrugation 505 i6 provided with leeth of a different design in order to produce vibrations of different forms. By this means, one and the same instrument i-~n be used for inhalation preparations possessing different properties.

According to fig. 54, a pin 880, loosely inserted in the reed, with an approximately conical surface, is provided instead of the nap 554. Fig. 55 finally shows one variant in which the teeth of the corrugation 505 and the nap 554 are unsymmetri-cally constructed on the reed 555 in order to produce different vibration spectra in the two movement directions.
It is clear that corrugations used for producing vibrations can be arranged not only on the underside of the main body 500, but also on its upper side or on the side walls. In addition to, or instead of, the web 692 shown in fig. 28, other cams analogous to the cam 694, projecting from inside wall of the reservoir 621 and, for example, with a cam fitted to the outside of the reservoir analogous to the cam 694, can collaborate in order to produce specific vibration patterns in the reservoir. -Finally, it should be mentioned that the corrugations on the main body or on the ac~uating cap may also exhibit a linear pattern whereby further variations in the production of vibrations are possible.

, ., . . . ~ . . . ... .. . . .

:: ~
, . : .

. ~ -: : : . : , .

Claims

PATENT CLAIMS

1. Method for metering an inhalation preparation, preferably a powder inhalation preparation, characterised by the fact that the current of air produced by inhaling is channelled in an inhalation channel and swirled in at least one area, and that a dose of the preparation is transferred from a reservoir to the inhalation channel in such a way that the dose is driven by the vortex produced into the inhalation stream and is distributed in it.

2. Method according to claim 1, characterised by the fact that the dosing is activated by manual actuation by the patient inhaling the product.

3. Method according to one of the claims 1 or 2, charac-terised by the fact that before and/or on activating the dosing system, the preparation is vibrated.

4. Method according to one of the claims 1 to 3, charac-terised by the fact that the activation of the dosing system is blocked until the patient inhaling the product produces an inhalation flow of a certain strength.

5. Method according to claim 4, characterised by the fact that the strength of inhalation necessary for triggering the release of the dosing system is adjustable.

6. Method according to one of the claims 4 or 5, charac-terised by the fact that activation of the dosing system is blocked by positively blocking devices which are triggered by the inhalation flow as soon as it attains a certain strength, so that the dosing system can be activated and which, if the inhalation flow is weaker, automatically prevents dosing again.

7. Method according to claim 6, characterised by the fact that the positive blocking systems consist of a sphere which is movably mounted in a sphere-containing channel inclined towards gravity and through which air flows in at least one part.

8. Method according to one of the claims 4 to 7, charac-terised by the fact that the blocking system can be released by the patient inhaling the product, if necessary even without inhalation.

9. Method according to one of the claims 1 to 3, charac-terised by the fact that one dose of the preparation is measured out in the inhalation channel if the inhalation instrument is brought from a configuration at rest into an inhalation configuration, and that a further dose is only measured out if the inhalation instrument is brought from the inhalation configuration into the configuration at rest and returned to the inhalation configuration.

10. Method according to claim 9, characterised by the fact that one dose of the preparation is measured out into the inhalation channel if the inhalation channel is open for an inhalation, and that a further dose is only measured out if the inhalation channel is again closed and then opened again.

11. Method according to one of the claims 1 or 2, charac-terised by the fact that the preparation is sprayed, by means of increased pressure through a jet, into the swirling field downstream of the dosing element.

12. Inhalation instrument for inhaling a preferably powder form of inhalation preparation with which the method according to one of the claims 1 or 2 is carried out, characterised by the fact that it has an inhalation channel (11) in which an air stream produced by the patient is channelled, a reservoir (21) in which the inhalation preparation is loosely stored, and a dosing mechanism (22) with which the inhalation preparation is transferred in single doses from the reservoir (21) to the inhalation channel (11), the dosing mechanism (22) being designed such that the inhalation preparation is transferred, on its downstream side to the inhalation flow.

13. Inhaler according to claim 12, characterised by the fact that the dosing mechanism (22) has a dosing element (25) with a dosing recess (26) arranged at the side in the area of one end of it, such that the dosing element (25) can move to a limited degree in an outlet hole (24) of the reservoir (21), so that the dosing recess (26) is located in one extreme position of the dosing element (25) inside the reservoir (21) and, in the other extreme position of the dosing element (25), outside the reservoir (21) in the inhalation channel (11).

14. Inhalation instrument according to claim 13, charac-terised by the fact that the dosing element (25) is mounted (so that it has limited freedom of movement) in another opening (28) opposite the exit hole (24) in the reservoir (21), and that the head end of the dosing element projecting from this opening (28) is connected to actuation and/or elastic type devices.

15. Inhalation instrument according to claim 14, charac-terised by the fact that an elastic bellows (30) is fitted to the head end of the dosing element (25) and which is used as a finger pressure actuated device and as an elastic device.

16. Inhalation instrument according to claim 14, charac-terised by the fact that an elastic bellows is fitted to the head end of the dosing element which is used as an elastic device, and that the actuating agent consists of a hinged lever which is flexibly secured to the inhalation instrument so that the bellows can be deformed by its hinged movement.

17. Inhalation instrument according to one of the claims 12 to 16, characterised by the fact that it has a blocking mechanism (3) with whose aid dosing is blocked if an inhalation current of a certain strength does not flow through the inhalation channel.

18. Inhalation instrument according to claim 17, charac-terised by the fact that the blocking mechanism has a sphere which is loosely supported in a channel, the channel being arranged such that it is inclined towards gravity in the inhalation position of the inhalation instrument, and that at least part of the inhalation flow passes through it and that part (23) of the dosing mechanism (22) extends to the sphere area and can be blocked by it in one position.

19. Inhalation instrument according to claim 12, charac-terised by the fact that it has a sealing cap (62) for the mouth orifice (12) and that the sealing cap (62) is actively connected with the dosing element (25).

20. Inhalation instrument according to claim 19, charac-terised by the fact that the sealing cap (62) is flexibly fitted to the instrument, and is actively connected, via a lever system (60), with the head end of the dosing element (25) such that, with a movement of the sealing cap (62) from its closed to its open position, the head end of the dosing element is forced against the reservoir (21).

21. Inhalation instrument according to claim 13, charac-terised by the fact that the dosing element extends as far as possible into an aperture (92) in the wall of the inhalation channel opposite the exit hole (24).

22. Inhalation instrument according to claim 21, charac-terised by the fact that the end of the dosing element with the dosing recess (26) is actively connected with a sealing cap for the mouth orifice.

23. Inhalation instrument according to one of the claims into 22, characterised by the fact that it has a vibration device in which parts are moved relatively to one another, and which, on actuation or returning to the position at rest, produce a vibration of the preparation in the reservoir.

24. Inhalation instrument according to one of the claims 12 to 23, characterised by the fact that the dosing device is in the form of a replaceable cartridge.

25. Inhalation instrument according to one of the claims 12 to 24, characterised by the fact that it has a refillable reservoir with a plug (129) positioned opposite the outlet hole (24).

26. Inhalation instrument according to claim 25, charac-terised by the fact that the plug (129) is designed such that it can be used as a container for a drying agent.

27. Inhalation instrument according to one of the claims 12 to 26, characterised by the fact that it has a dose counting mechanism.

28. Inhalation instrument for a preferably powder-type inhalation preparation with a mouthpiece (512) forming an inhalation channel in which an airflow produced by the patient, on inhaling, is channelled, with a reservoir (521) in which the inhalation preparation is loosely stored and, with a dosing mechanism (525, 526) with the dose-wise inhalation preparation, can be transferred from the reservoir (521) to the inhalation channel, characteri-sed by the fact that the dosing mechanism includes a rod-shaped or tubular dosing element (525) on whose outer surface there is a dosing cavity in the form of a dosing recess (526), whereby the dosing element (525), by means of an actuating device (550), can be moved to and fro, in its longitudinal direction, between a position of rest, in which the dosing recess (526) is located in the mouthpiece (512), and a dosing position in which -the dosing recess is located below the reservoir (521) actively connected with it, and that in the mouthpiece (512) air inlet channels (514) are provided which, with the dosing element (525) in the position at rest, directs an airstream produced by the patient on inhaling, on to the dosing recess (526) in such a way that the innhalation preparation is flushed from the dosing recess (526) and is swirled in the current of air.

29. Inhalation instrument according to claim 28, characterised by the fact that it has a longish main body (500) which forms the reservoir (521) and that an actuating cap (550), fitted to the main body (500) so that it can move between two end positions, and which forms the actuating device for the dosing element (525).

30. Inhalation instrument according to one of the claims 28 or 29, characterised by the fact that it is provided with a counting mechanism (580 to 584) for the doses issued, which is coupled with the actuating system (550) and is incremented by it.

31. Inhalation instrument according to one of the claims 28 to 30, characterised by the fact that the reservoir (521) is designed essentially funnel-shaped and is provided with two lateral sliding surfaces (771, 772) with respect to the longitudinal direction of the dosing element (525), and which guide the inhalation preparation stored in it into the dosing recess (526), if the dosing element is in its dosing position.

32. Inhalation instrument according to one of the claims 28 to 31, characterised by the fact that the reservoir (521) has a constriction (628) just above the dosing element (525) located just below it which, together with the dosing element (525), forms pockets (629) for the inhalation preparation.

33. Inhalation instrument according to one of the claims 28 to 32, characterised by the fact that the reservoir (521) has an elongated outlet hole (524) which is closed by the dosing element (525) and, in the longitudinal direction, extends further than the dosing recess (526), so that the latter remains in the area of the outlet hole (524) during part of the displacement of the dosing element (525).

34. Inhalation instrument according to one of the claims 28 to 33, characterised by the fact that it is equipped with a vibration mechanism (505, 554, 555) that can be activated by the displacement of the dosing element (525) which produces mechanical vibrations in the reservoir (521) and/or in the dosing element (525).

35. Inhalation instrument according to claim 34, characterised by the fact that the vibration mechanism is formed by a flexible reed (555) formed on the main body (500) or the activating device (550), and a corrugation (505) on the actuation device (550) or on the main body (500) acting in conjunction with the flexible reed.

36. Inhalation instrument according to claim 35 characterised by the fact that devices (670) are provided which transmit the vibrations produced by the vibration mechanism to the reservoir (521).

37. Inhalation instrument according to one of the claims 34 to 36, characterised by the fact that two or more vibration mechanisms (505, 555; 690 to 692; 693, 694) are provided which produce vibration of various forms at different points of the instrument.

38. Inhalation instrument according to one of the claims 34 to 37, characterised by the fact that devices (840, 841) are provided for producing acoustic air vibrations in the tubular dosing element (525).

39. Inhalation instrument according to one of the claims 34 to 38, characterised by the fact that, in the mouthpiece (512), devices (850) are provided for producing tapping pulses on the dosing element (525).

40. Inhalation instrument according to one of the claims 34 to 39, characterised by the fact that the vibration mechanism produces different vibration forms, depending on the direction of movement of the dosing element (525).

41. Inhalation instrument according to one of the claims 34 to 40, characterised by the fact that an essentially loosely mounted comminution system (860, 870) is fitted in the reservoir (521) which is excited to an irregular jumping, dancing, tapping or vibrating movement by mechanical vibrations introduced into the reservoir, whereby agglomerates in the inhalation preparation are broken down, and filling of the dosing recess (526) in the dosing element (525) with inhalation preparation is improved.

42. Inhalation instrument according to claim 41, characterised by the fact that the comminution device is formed by a helical spring (860) which, on the one hand, is supported on the cover (527) of the reservoir (521) and, on the other hand, is supported preferably by way of a shoe (861) on the dosing element (525).

43. Inhalation instrument according to claim 41, characterized by the fact that the comminution device is formed by a rod (870), which is arranged essentially diagonally and loosely, or capable of vibration in the reservoir (521) and lies with its bottom, preferably shovel-shaped end (871), on the dosing element (525).

44. Inhalation instrument according to one of the claims 28 to 43, characterised by the fact that in the mouthpiece (512) in the dosing recess area in the position at rest (526), an obstruction (746,747) is provided which produces swirling in the current of air in the dosing recess area.

45. Inhalation instrument according to one of the claims 28 to 44, characterised by the fact that, on the front mouthpiece end of the dosing element (525), an aero-dynamically formed device (745) is provided which causes swirling of the inhalation preparation suspended in the inhalation air current.

46. Inhalation instrument according to one of the claims 28 to 45, characterised by the fact that the dosing element (525), at both sides of the reservoir (521), is movably supported in a mounting device (533) such that the vibrations transmitted to the dosing element are attenuated as little as possible.

47. Inhalation instrument according to one of the claims 28 to 46, characterised by the fact that the dosing element (525) on both sides of the reservoir (521) is introduced movably into a mounting element (533), whereby the latter (533), with only slight pressure, lies close to the dosing element (525).

48. Inhalation instrument according to one of the claims 46 and 47, characterised by the fact that the dosing recess (526) on the dosing element (525) is so designed that, in the direction of movement of the dosing element (525), it is at no point so large that the mounting element (533) can enter the cavity of the dosing recess (526).