WO1993003782A1

WO1993003782A1 - Inhaler

Info

Publication number: WO1993003782A1
Application number: PCT/CH1992/000164
Authority: WO
Inventors: Franco Del Bon; Luigi Del Bon
Original assignee: Bon F Del; Luigi Del Bon
Priority date: 1991-08-15
Filing date: 1992-08-14
Publication date: 1993-03-04
Also published as: AU651910B2; FI931661A0; JPH06504223A; HUT64242A; HU9301090D0; CA2093809A1; EP0553326A1; FI931661A; AU2421192A

Abstract

A process is disclosed for dosing a preferably powdery inhalation composition. The composition is brought from a reservoir into an inhalation stream generated by the inhaling person and channeled in such a way that the inhalation stream swirls at the same time, dissolving and distributing the composition in the stream. The inhaler for applying the process has a dosing element (25) movably mounted within limits in an outlet (24) of the reservoir (21) in such a way that a lateral dosing recess (26) is located, in one of its extreme positions, within the reservoir (21) and in its other extreme position within the inhalation channel (11). The dosing element is actuated by the inhaling person by means of a spring element (30) or closing cap for the mouth (12) of the inhalation channel (11). Each displacement of the dosing recess (26) from the reservoir (21) into the inhalation channel (11) releases a dose of composition for inhalation. The inhaler has a vibrating mechanism that keeps the powdery composition loose and flowable. In addition, the inhaler may have a locking mechanism (3) that stops dosing when inhalation is not sufficiently strong and/or a dose counting mechanism.

Description

INHAIAΗONSGERAT

The invention is in the field of medical technology and relates to a method according to the preamble of the independent method claim for dosing a preferably powdered inhalation preparation for inhalation and an inhalation device according to the preamble of the independent device claim for performing the method.

Inhalation is a well-known method, for example to bring medication for absorption into the airways and lungs. For this purpose, various inhalation devices are on the market, with which liquid or powdery preparations are accelerated into or in front of the oral cavity by pressure or propellant gas and into the airways through inhalation. The dose of the preparation which is effectively effective depends not only on the size of the dose actually made available in the inhalation device, but also on the particle size and on the strength of the inhalation. The larger the particles are, the sooner they will drop out of the inhalation stream in the oral cavity and not get into the airways, the weaker the inhalation stream that the inhaler generates, the more particles will already drop out of the inhalation stream in the oral cavity . In order to keep the effectively effective dose per inhalation constant, appropriate design of the inhalation device should ensure that, firstly, a constant dose of the preparation is made available per inhalation, and secondly that the particle size of the preparation in the inhalation flow is as possible is constant and that thirdly the patient is forced to inhale with a certain force. This is achieved, for example, with the inhalation device which is described in Swiss patent application No. 02500 / 90-4 by the same applicant. This inhalation device has a storage container with a liquid, dissolved or suspended preparation, from which a specific dose is sprayed through a nozzle into an inhalation channel by manual actuation. A blocking mechanism ensures that dosing and spraying is only possible if the inhaler inhales with a possibly adjustable inhalation strength, that is, if he creates an air flow in his inhalation channel against his oral cavity that is strong enough to provide a sufficient amount Accelerate part of the metered preparation in the direction of its respiratory tract. The method and inhalation device described in the abovementioned application are limited to liquid preparations, which means that they can only be used for solid preparations if they are dissolved or suspended in a solvent or propellant.

It is the object of the invention to demonstrate a method and to create an inhalation device with which powdered preparations can also be metered into the inhalation stream generated by the inhaler without solvent or propellant gas for inhalation. The preparation should be distributed as regularly as possible in the inhalation flow. The dose should be activated manually by the inhaler in such a way that only one dose is dosed by a single activation, so that it is easy for the inhaler to control the inhalation in such a way that he doses only one dose per inhalation. This object is achieved by the method according to the invention according to the independent method claim for dosing an inhalation preparation, preferably a powder preparation, for inhalation and by the inhalation device according to the invention according to the independent device claim.

According to the method according to the invention, the air flow (inhalation flow) generated by the inhalation is channeled in an inhalation channel and a dose of the preparation is brought into the inhalation channel from a storage container in such a way that the vortices of a vortex field caused by the design of the inhalation device in the Inhalation stream distribute the preparation regularly in this stream. The vortex field is created by an obstacle which is introduced into the inhalation stream and which is shaped in such a way that a vortex is created on its downstream side. On this downstream side in the area of the vortex field, the dose of the preparation is brought into the inhalation stream by the dosage. If it is a powdered preparation, previous vibration ensures that the powder is loose and can therefore be easily and in the form of particles of the same size as possible captured by the swirled inhalation stream; if it is a liquid, dissolved or suspended product, it is sprayed into the swirled air stream by pressure.

In order to guarantee a sufficient strength of the air flow during inhalation, the inhalation device according to the invention can have a blocking mechanism which only releases the dosage if the inhalation flow which is generated by inhalation in the inhalation device reaches a certain strength. The device can also be designed in such a way that the strength of the inhalation flow necessary for metering can be adjusted by the inhaler. The advantages of such a blocking mechanism are detailed described in the aforementioned patent application by the same applicant, which is assumed to be known here.

Device designs without a blocking mechanism are used for inhalers who cannot be expected to generate a strong inhalation current and for those who cannot be expected to coordinate the triggering of the metering and inhalation. In these devices, the triggering of the dosage is coupled with the removal of a cap from the opening of the inhalation device through which inhalation takes place. A further dosage is only possible when the cap is back on the opening. has been put on and opened again. This prompts the inhaler to dose only one dose per inhalation.

The method according to the invention and the inhalation device according to the invention are to be described in detail with reference to the following figures. Show:

Figure 1 shows the principle of the process for metering into the inhalation stream;

FIG. 2 shows an exemplary embodiment of the inhalation device according to the invention with finger actuation and blocking mechanism, cut and in the rest position;

FIG. 3 the inhalation device according to FIG. 2, in the dosing position, that is, presenting a dose for the inhalation;

FIG. 4 shows another exemplary embodiment of the inhalation device according to the invention with lever actuation, cut and in the rest position; FIG. 5 the inhalation device according to FIG. 4, in the dosing position;

FIG. 6 shows a further embodiment of the inhalation device according to the invention without a blocking mechanism with a closure cap which is operatively connected to the dosage, cut and in the rest position;

FIG. 7 the inhalation device according to FIG. 6, in the dosing position;

FIGS. 8 and 9 show a further embodiment of the inhalation device according to the invention with a closure cap (rest position and dosing position);

FIGS. 10 and 11 show a further embodiment of the inhalation device according to the invention such as FIGS. 8 and 9;

FIGS. 12 and 13 show a further embodiment of the inhalation device according to the invention such as FIGS. 8 and 9;

FIG. 14 shows a further embodiment of the sub-device for vibrating the preparation;

FIG. 15 shows a further embodiment of the sub-device for moving the metering element back into the rest position;

FIGS. 16, 17 and 18 further embodiments of the storage container for inhalation devices according to FIGS. 12 and 13;

Figures 19 and 20 different embodiments for a level indicator in the storage container. FIGS. 21 and 22 show an exemplary embodiment of the inhalation device according to the invention with a dosage into the inhalation stream by spraying,

FIGS. 23 and 25 show a further exemplary embodiment of an inhalation device according to the invention in a sectional illustration in the rest or dosing position,

FIGS. 24 and 26 each show a top view of the inhalation device of FIGS. 23 and 25,

FIG. 26A is a plan view of the rear of the inhalation device of FIGS. 23 and 25 facing away from the mouth opening,

FIG. 27 shows a top view of a further exemplary embodiment of the inhalation device according to the invention,

FIG. 28 shows a top view of the parting plane of one half of the inhalation device of FIG. 27,

FIGS. 29-34 show detailed views of different embodiments of the mouthpiece of the inhalation device according to the invention from FIGS. 23 to 26,

FIGS. 35-37 various detailed variants in the mouthpiece area of the inhalation device according to the invention,

FIGS. 38-40 different detailed views of design options for metering indentations,

FIGS. 41-43 show detailed views of various configurations of the storage container of the inhalation device according to the invention,

FIGS. 44-47 show detailed views of various configurations of the seal between the metering element and the storage container of the inhalation device according to the invention, Figures 48 - 50 detailed views of different ways of generating vibrations in the air flow and

FIGS. 51-55 show detailed sketches regarding the generation possibilities of mechanical vibrations in the inhalation device according to the invention.

(Continued on page 8)

FIG. 1 shows schematically an air flow generated by inhalation, into which, for example, a cylindrical resistance body W projects perpendicular to the direction of flow. In the direction of flow behind the resistance body, a vortex field is created, the vortex of which wash out a substance located in a dosing recess D, which is then transported away from the obstacle by the air flow. The more abruptly the area that the resistance body has perpendicular to the direction of flow is reduced in the direction of flow, the stronger the swirling behind the resistance body. A cylindrical body, as shown in the figure, generates less turbulence than a resistance body with, for example, a rear surface running perpendicular to the direction of flow. In addition, however, the cylindrical resistance body offers the advantage over any other shaped resistance body that it can be easily sealed against a storage container, relative to which it has to be movable, an advantage which should be used for the metering mechanism according to the invention.

Figures 2 and 3 show an exemplary embodiment of the inhalation device according to the invention. It is a device in which the dosage of the preparation is only possible if the user inhales with a certain strength. A ball in a channel inclined towards gravity serves as the blocking mechanism. In its rest position (without inhalation flow or with a weak inhalation flow) the ball blocks the metering. If the inhalation current is strong enough, the ball is moved in the channel and thus releases the dosage. The inhalation device according to FIGS. 2 and 3 essentially consists of an inhaler 1 and a metering device 2. The inhaler 1 serves to channel the air flow generated by the inhalation. In the embodiment shown in FIGS. 2 and 3, it also has the blocking mechanism 3 already mentioned, which is activated by the same air flow. The dosing device 2 serves to bring a dose of the preparation for inhalation into the inhalation channel so that the preparation can be grasped by the inhalation flow and driven into the respiratory channels of the inhaler. The dosing device 2 has a storage container 21 for the preferably powdery preparation and a dosing mechanism 22.

The inhaler 1 has an inhalation channel 11, the end of which directed towards the inhaler is formed by a mouth opening 12 and the other end of which is formed by a supply air channel 13 which is preferably narrowed with respect to the inhalation channel 11. The inhaler creates an air flow through the inhalation channel 11, from the supply air channel 13 to the mouth opening 12, by placing his mouth on the mouth opening 11 and inhaling.

The inhaler 1 has a further channel, the ball channel 14, which opens into the inhalation channel 11 near the mouth opening 12 with a mouth opening 15 and which contains a ball 16. The ball channel 14 runs in such a way that, when the inhaler is in the correct position for inhalation (position shown in FIGS. 2 and 3), it is inclined away from the mouth opening 15 in the direction of gravity. The lower end of the ball channel 14 is formed by a supply air opening 17 or 17 '. The diameters of the ball 16 and the ball channel 14 are coordinated with one another in such a way that the ball 16 can move freely in the ball channel 14, but the orifice opening 15 and the supply air opening 17 (or 17 ′) are narrowed in such a way that they Retain ball channel 14. If the inhalation device is held in the inhalation position, the ball 16 is driven by gravity to the lower end of the ball channel 14 (FIG. 1, rest position). If an air flow L is generated by inhalation in the inhalation channel 11, an air flow L 'is simultaneously generated by the ball channel 14, which, provided it is strong enough, drives the ball 16 from the lower end of the ball channel 14 towards the upper end (FIG. 2, Dosing position). When the ball 16 releases the lower end of the ball channel 14, a key part 23 of the metering mechanism 22, which reaches with its end through a corresponding bore 18 into the area of the ball channel 14, can move downward, which makes metering possible.

The reservoir 21 is in a corresponding guide 14 of the inhaler

I arranged above the inhalation channel 11 (inhalation position of the inhalation device) and has one at its lower end in the inhalation channel

II opening opening 24. It preferably narrows towards this outlet opening. A dosing element 25, which extends through the outlet opening 24 and can be moved from outside the storage container, has a dosing indentation 26 at its lower end. The dosing element 25 is matched to the outlet opening 24 and is movable by it in such a way that it always closes the outlet opening 24 and that the dosing indentation 26 is positioned in one extreme position of the dosing element 25 inside the storage container 21 (rest position), in the other extreme position outside the storage container 21 in the inhalation channel 11 (dosing position). At the lower end of the metering element 25, outside of the storage container 21, the key part 23 is fixedly arranged, which, as already mentioned, extends through the bore 18 into the region of the ball 16 and, depending on the position of the ball 16, blocks the metering or not.

The Dosierεinformung 26 is positioned on the metering element 25 such that it is in the inhalation channel 11 on the downstream side of the Dosierele- mentes 25, that is directed against the mouth opening 12. The Dosiereinfor¬ formation 26 is shaped such that it can be washed out in its entirety by the vortices of the inhalation stream, that is, as little as possible deep and without areas that are difficult to access, narrow or limited at an acute angle. Its volume, which is determined by its inner surface and the continuously continued surface of the metering element, is dimensioned such that it can accommodate a dose of the preparation necessary for inhalation.

The metering element 25 is supported in the outlet opening 24 in a bearing element 33. This bearing element 33 serves at the same time as a seal of the storage container and to separate a preparation dose moved from the storage container 21 in the dosing recess 26 from the stored preparation in such a way that it only comprises the predetermined volume. As already mentioned, the triple function of the bearing element 33 in the case of a cylindrical metering element 25 can simply be taken over by an annular seal. This advantageously has a rectangular, upright ^' cross section, but can also consist, for example, of two O-rings arranged one above the other.

Towards the top, the storage container 21 is closed off by a cover 27, which has a cover opening 28 opposite the outlet opening 24, through which the metering element 25 extends, so that it also closes this opening. Advantageously, the part of the metering element 25 which extends through the cover opening 28 has a smaller diameter than the part which extends through the outlet opening 24. The dosing element 25 is also mounted in the lid opening in a bearing element 33 ', which at the same time serves as a seal for the storage container. Since the part of the metering element 25 which extends from the lid opening 28 is advantageously cylindrical, a corresponding O-ring or an equivalent sealing means can simply be used as the bearing element 33 '. A head part 29 formed on the upper end of the metering element 25 is, for example, positively attached to a spring element, by means of the spring force of which the metering element 25 is held in the rest position against gravity and is also driven back into the rest position. The spring element can be, for example, a hemispherical, elastic bellows 30, which is arranged in a form-fitting or loosely resting manner over the cover 27 and has on its inside a form-fitting part 31 to which the head part 29, which is likewise shaped as a form-fitting part, is fastened in a form-fitting manner. The dosing element 25 is actuated by pressing the bellows 30 against the inhalation channel 11 with a finger, the bellows 30 being compressed. As soon as the finger pressure subsides, the bellows springs back into its original shape, so that the metering element 25 is returned to its rest position.

The movement of the metering element 25 is limited, for example, by the key part 23, which on the one hand abuts the lower wall of the inhalation channel 11 and on the other hand on the lower wall of the storage container 21.

Since the preparation is preferably in powder form, the interior of the storage container 21 is shaped in such a way that the preparation can easily trickle against the outlet opening 24. For this reason, lower, horizontal delimitation surfaces in the interior of the storage container are avoided by designing the lower container wall and, for example, constrictions of the metering element diameter so that it slopes downwards.

In order to ensure trouble-free pouring of the powder against the outlet opening 24 and the metering indentation 26, it is advantageous to design the metering device 2 in such a way that the powder before and / or when it is activated vibrates automatically and is moved towards gravity. In the embodiment shown in FIGS. 2 and 3, this is realized by the bellows 30, which is shaped in such a way that it has to be deformed to a certain shape when deformed by finger pressure, then automatically snaps into an end position and that it Release snaps back into its de-energized position and does not gradually move into it. These two jerky movements cause the powder in the storage container to vibrate twice with each inhalation, thereby keeping it loose and moving it in the direction of gravity.

For inhalation, the inhaler therefore places the inhalation device with the mouth opening 12 on his mouth, breathes in strongly and presses the bellows 30 with a finger. As a result, he generates the air flows L and L \. Driven by the air flow V, the ball 16 moves in the ball channel 14 towards the top. If the air flow L 'is strong enough, the ball 16 is moved out of the area of the key part 23, so that the key part 23 and thus the dosing element 25 are moved downward by the finger pressure until the key part 23 on the lower wall of the inhalation channel 11 stands up and the Dosiereinformung 26 is in the inhalation channel (Dosieφosition). The already mentioned movement characteristic of the bellows 30 ensures that the preparation is vibrated during this downward movement of the dosing element 25, so that it moves against the outlet opening 24 and fills the dosing recess 26. After the metering element movement has ended, the preparation in the inhalation indentation 26 is exposed to the air flow L swirled in this area and is moved by it against the respiratory tract of the inhaler. When the pressure on the bellows 30 decreases, the dosing element 25 moves up again, when the inhalation decreases, the ball 16 in the ball channel 14 moves down again, as a result of which the device is again in the rest position. - U -

For patients who cannot provide the necessary inhalation strength, there is the possibility of inclining the inhaler towards the mouth opening 12 such that the ball channel 14 sinks against the mouth opening 15 and the ball 16 moves against the mouth opening 15 by gravity and the dosage releases.

The ball channel 14 is advantageously closed at its lower end with a plug 19 which can carry the supply air opening 17 '. This simplifies the assembly of the device, since the ball 16 can be inserted into the ball channel 14 on the finished device and the plug can then be fitted. The shape of the plug 19 is to be selected such that the axis of the key part 23 lies further against the mouth opening 15 of the ball channel 11 than the center of the ball 16 in its rest position. The supply air opening 17 or 17 'can have an opening cross section which can be varied by the inhaler by means of a corresponding cover or slide or by a corresponding shaping of the stopper 19. As a result, the inhalation strength, which is necessary for moving the ball 16, can be adjusted depending on the condition of the inhaler. For a very high condition, a minimal supply opening can be provided or it can be dispensed with entirely, the supply channel 13 of the inhalation channel 11 serving as the supply opening of the ball channel 14 via the bore 18. In addition, the ball can consist of a heavier material or it can even a metallic ball and a plug 19 can be provided with a magnet.

The embodiment of the inhalation device according to the invention shown in FIGS. 2 and 3 shows a metering device 2 in the form of an exchangeable cartridge. This includes the storage container 21 with a lid 27, a metering element 25 with a key part 23 and a bellows 30 attached to the head part 29. The cartridge must be inserted into the guide 14 in such a way that the Dosiereinformung 26 is directed against the mouth opening 12 and that the key part 23 comes to rest in the bore 18 between the inhalation channel 11 and Kugelka¬ channel 14. So that the cartridge can be inserted in the correct position in the guide 14 without difficulty, the metering element 25 is advantageously arranged in the storage container 21 in a rotationally secured manner, for example by means of a corresponding form fit between the container wall and bellows 30, and shows a vertically running channel while the guide 14 has a corresponding comb, for example the wall of the supply air duct 13. The cartridge can then only be inserted into the guide 14 in such a way that the comb comes to lie in the groove, as a result of which the position of the cartridge is defined. The wall of the storage container 21 is at least in the area of the outlet opening 24 slightly elastic and / or with positive locking means, so that the cartridge is tensioned and / or positively attached when inserted into the corresponding opening in the inhalation channel.

The design of the inhalation device with a dosing device as an exchange cartridge proves to be advantageous, since the inhaler does not have to be thrown away after the preparation has been used up and because an overfill of the preparation can be avoided by a filling volume of the storage container adapted to the life of the preparation.

FIGS. 4 and 5 show a further embodiment of the inhalation device according to the invention, which corresponds in essential parts and in the mode of operation to the embodiment according to FIGS. 2 and 3. For this reason, the corresponding parts are identified by the same reference numbers.

The bellows 30, to which the metering element 25 is fastened, as in the embodiment according to FIGS. 2 and 3, is not used in this embodiment Finger pressure actuated, but by a lever 41 which is pivotally attached to the guide 14 about a pivot point 42. If the lever 42 is lifted at one end 41.1, its other end 41.2 presses against the bellows 30 and deforms it.

As shown in FIGS. 3 and 4, the lever 41 can be designed as a hollow lever which at least partially surrounds the bellows 30. The bellows 30 can be provided with grooves 43 and the lever 41 on its inside with at least one grid 44 which rub against each other when the lever 41 is actuated. This creates a vibration in the bellows 30, which is transmitted to the wall of the storage container 21 and vibrates the preparation.

The embodiments of the inhalation device according to the invention as shown in FIGS. 6 to 11 are advantageous for inhalers who are unable to produce much inhalation strength, and also for those with coordination difficulties or difficulties in order to use a hand or a finger on the inhalation device in the inhalation position To be able to operate the doser. Such devices do not have a blocking mechanism which makes it necessary to actuate the dosage during inhalation. In all of these embodiments, however, the dosage requires that the inhalation device be brought from an idle configuration into an inhalation configuration, for example by opening a closure flap which closes the mouth opening. As a result, the dosing element is released for actuation or moved directly into its dosing position. The dosing element is moved back into its rest position when the inhalation device is brought back into its rest configuration with the closure cap closed. The central advantage of these design variants is that only one dose can really be dosed per inhalation. Between two doses, the mouth opening must be closed with the cap that _ ^ _

This means that the inhalation must at least be interrupted and the inhalation device must be moved out of its inhalation position.

Another advantage of the embodiments according to FIGS. 6 to 11, as well as all other described embodiments with a closure cap, is that the mouth opening of the inhalation channel can be closed and thus protected against contamination, and that this closure cap is attached to the device and cannot be lost as a result.

These embodiments are also cut and each shown in the rest position (Figures 6, 8 and 10) and in Dosieφosition (Figures 7, 9 and 11).

FIGS. 6 and 7 show an embodiment with an angled inhalation channel 11.1, such that the part of the inhalation channel into which the preparation is metered, as in the embodiments already described, is directed perpendicular to the direction of movement of the metering element 25, during the part of the inhalation channel 11.1 directed towards the mouth opening 12 is directed parallel to the direction of movement of the metering element 25, such that the metering element 25 is moved in the horizontal direction in the inhalation position of the device (as shown). So that the inhalation channel 11.1 can be easily cleaned despite its angled shape, it is advantageous to make its part facing away from the mouth opening 12 accessible, for example, through an opening 64 and a corresponding cover 65.

On the side of the device which carries the mouth opening 12 there is a closure cap 62 which can be pivoted about a pivot axis 61 and which is operatively connected to the metering element 25 by a lever system. In the figure, only one part 63 of the lever system acting directly on the metering element 25 is shown. represented. If the closure cap 62 is folded away from the mouth opening 12, the part 63 presses on the dosing element 25 and moves it into the dosing position. If the closure cap 62 is pivoted again over the mouth opening 12, the metering element 25 is moved back into the rest position by a corresponding spring element (see also FIG. 15) or by a corresponding articulated connection between part 63 and head end of the metering element 25

FIGS. 8 and 9 represent a further embodiment of the inhalation device according to the invention with a closure cap. The upper part of the storage container 21 and the metering element 25.2 are designed similarly to those of FIGS. 2 to 5 and are therefore not shown.

The inhaler 1.2 has no blocking mechanism, it only consists of an inhalation channel 11.2 on which a guide 14 for the storage container is attached. The inhalation channel 11.2 has an upper opening 91 into which the outlet opening 24 of the storage container 21 opens and a lower opening 92 opposite this opening 91, the opening area of which is at least as large as the cross-section of the metering element 25. The closure cap 622 closes the mouth opening 12 of the inhalation channel 112 and is elongated away from it in such a way that it is formed extends along the outer wall of the inhalation channel 112 to beyond the opening 92. The closure cap 622 is pulled along the inhalation channel 112 to open the mouth opening 12 and is completely removed in the direction of the arrow R. The metering element 252 is designed such that it is at rest in the transverse position the inhalation channel 112 through h the opening 92 is sufficient and, when the closure cap 622 is closed, stands on it and is thereby blocked. By removing the closure cap 622, the metering is unblocked, that is to say the metering element 252 can pass through the opening 92 and thereby in the metering position. _ ^ _

be brought. The actuation of the metering element 25.2 is conceivable as a simple finger pressure on its head part (not shown in the figure). There should be no spring element which drives the metering element back into the rest position, so that the closure cap 62.2 must be put on again for the return movement of the metering element 25.2 into the rest position.

For the vibration of the contents of the storage container 21, grooves 93 are provided on the underside of the outer wall of the inhalation channel 11.2 and on the surface of the rail-shaped extension of the closure cap 62.2 facing this underside, transverse to the direction of movement of the closure cap. These grooves 93 engage in one another (FIG. 8) in such a way that when the closure cap 62.2 is moved, the ridges jump between the grooves of one part from one groove of the other part to the next and thereby cause the entire inhalation device to vibrate.

FIGS. 10 and 11 show a further embodiment of a closure cap 62.3 blocking the dosage. In this embodiment too, the inhalation channel 11.3 has a lower opening 92 for the metering element 25.3. The closure cap 62.3 is also shaped such that it extends over the entire underside of the inhalation device. In the area of the inhalation channel 11.3 which is furthest away from the mouth opening 12, the closure cap 62.3 is pivotably attached to the wall of the inhalation channel. In a region directly adjoining the mouth opening 12, the outer wall of the inhalation channel 11.3 has lateral grooves 100 which run essentially perpendicular to the pivoting movement and the inside of the closure cap 62.3 is in the same area with grooves running essentially parallel to the grooves 100 of the inhalation channel 11.3 singe. These grooves also interlock and produce a swivel movement of the closure cap 62.3 a vibration of the entire inhalation device.

FIGS. 12 and 13 show an embodiment of the inhalation device according to the invention, in which only the return movement of the metering element (as for the embodiments according to FIGS. 8 to 11), but also its movement in the dose position, that is the dose itself, by opening the cap is effected directly. Since in such a case an upper end of the metering element 25.4, which protrudes from the storage container on the side opposite the inhalation channel, has no function, the metering element 25.4 has only a minimal length and is closed off at the top in the storage container with a trickle cone 120 . The closure cap 62.4 has a similar shape to the closure cap of FIGS. 10 and 11 (62.3) and is also pivotally attached to the wall of the inhalation channel. Opposite the lower opening 92 in the inhalation channel, the closure cap 62.4 also has an opening 121, the opening area of which is open extended towards the outside in such a way that a driver 122 with a neck 123 attached to the underside of the metering element 25.4, which extends into this opening 121, cannot be pulled upwards out of this opening 121.

With the pivoting movement of the closure cap 62.4 to open the mouth opening 12, the dosing element 25.4 is pulled into the dosing position (FIG. 12) by means of the driver 122 caught in the opening 121. When the closure cap 62.4 is closed again, the metering element 25.4, which has a larger cross-sectional area than the smallest opening area of the opening 121, is pushed back into the rest position (FIG. 13). In this embodiment, a ratchet 124 for vibration is provided between the metering element 25.4, which is provided with grooves 125, and a mandrel 126 which is attached to the storage container 21.4 or to the inner wall of the inhalation channel in the region of the outlet opening 24 and which engages in the grooves 125 , provided.

In this embodiment, the movement of the metering element 25.4 is limited on the one hand by the driver 122, the neck 123 of which is stuck in the opening 121 of the closure cap 62.4, and on the other hand by stops 127 which are attached to the metering element 25.4 in the region of the trickle cone 120.

In FIG. 13, the guide 14.4 is shown uncut. This shows a slit-shaped opening 128 that runs over the entire height of the storage container and can be used to check the fill level of the preparation in the storage container 21.4. For example, a scale 130 is attached in the area of the opening 128. Devices for such a level control are to be described in connection with FIGS. 19, 20 and 21.

The supply container 21.4 of an embodiment according to FIGS. 12 and 13 can be shaped differently than the supply container of the preceding variants, since its upper side, which does not have to serve for actuation, can be designed in any way. For example, as shown in FIGS. 12 and 13, it can be open towards the top and carry a sealing plug 129. This makes the reservoir 21.4 refillable, for example. The sealing plug 129 can also serve as a further function as a container for a drying agent. Further embodiments for storage containers with only one opening for the metering element are described in connection with FIGS. 16, 17 and 18. FIG. 14 shows a further embodiment of the inhalation device according to the invention, in which again a metering element 25.5 actuated from above is used. In this embodiment, the vibration function is taken over by a ratchet 124.5, which is located between a spring element, for example a bellows 30.5, and the The bellows 30_5 carries, for example, an inner web 141 with grooves, the upper outer wall of the storage container 21.5 has a mandrel 142 which extends into the area of the grooves and jumps from one groove to the next when the bellows is deformed the vibration begins before the metering element 25_5 moves and so the metering indentation 26 is filled by vibration before it moves into the area of the outlet opening 24, the upper end of the metering element 25_5 is not attached to the bellows 30.5, but is inflated in this way, that in the rest position of the bellows 30.5 between the head part d he dosing element 25_5 and the bellows 30.5 (or there is a distance between the web 141) If the bellows 30_5 is deformed, the ratchet 124.5 is first actuated and the metering element is moved only after the distance between the bellows 30.5 (or web) and the metering element 25.5 has been overcome. The movement is limited by a stop shoulder 141a on the web 141.

Since in such an embodiment the dosing element 25_5 cannot be moved back from the bellows 30_5 to the rest position, further spring elements 143 are arranged between the head part of the dosing element 25_5 and the upper outer wall of the storage container 21-5, which likewise when the bellows 30.5 are deformed be deformed and return to their original shape when the pressure on the bellows is released and pull the dosing element into the rest position.

FIG. 15 shows a further embodiment of spring elements that can be used for the function of placing the dosing element 25.6 in its resting position. _ ^ _

sition to move back. This is a spring element which is arranged in the inhalation channel 11.6 and which, for example, can be in the form of an elastic rod 151 which is directed towards the lower end of the metering element and which is designed and arranged such that it is moved by the metering movement of the metering element 25.6 is deflected from its rest position.

16, 17 and 18 show possible shapes for the storage container. The individual embodiments differ in terms of manufacture, filling, sealing, ecology, etc.

Thus, FIG. 16 shows a storage container 21.7 in the form of a tube 161 which is open on both sides before the closure and whose end facing away from the inhalation channel is closed with a plug 129.7 with a sealing element, while its end directed towards the inhalation channel is closed with a closing element 162 integrated bearing and sealing element 33.7.

FIG. 17 shows a blown or drawn tube 171, for example made of glass, which is closed towards the top (end facing away from the inhalation channel) and towards the bottom (end facing towards the inhalation channel) with a closure element 162.8 with integrated bearing and sealing element 33.8 is.

FIG. 18 shows a storage container with a closure element 126.9, which has a thermal welding collar 181. For example, a storage container made of a laminate, multilayer or other film (182) with a barrier effect is welded onto this thermal welding collar. This storage container can have an inner support 183 (closed or partially opened). broken form). With the exception of the locking element 162.9, which is relatively rigid, practically all other parts are quite flexible.

FIGS. 19 and 20 show embodiments of fill level display devices for the storage container. These devices are based on the idea not to monitor the effective state of the preparation in the storage container, but rather to count the doses with a device that is mechanically coupled with the dosing. Since the counting mechanism in the case of an exchangeable storage container is replaced together with it and thus represents a disposable device, it must be simple and inexpensive to manufacture and may also be designed as a disposable mechanism, that is to say a provision for a full container by the Operators need not necessarily be possible.

FIG. 19 shows a can counting mechanism of this type in which a thread 191 colored differently in its end region 192 is wound up with a ratchet wheel 193 and is guided past a viewing window 194. The ratchet wheel 193 is operatively connected to the metering mechanism in such a way that it is rotated one tooth further with each metering. The thread is wound up successively until its differently colored end appears in the viewing window 194 and indicates that the supply of preparation is running low, such a mechanism can be arranged in the hollow lever 41 (FIGS. 4 and 5), for example.

Figure 20 shows another embodiment of a can counting mechanism. This consists of a spindle 201 on which a nut 202 with a nut guide 203 runs in a guideway 204 which is visible from the outside of the inhalation device. The spindle 201 is operatively connected to the metering mechanism in such a way that it is somewhat different with each metering - dt) -

rotates, whereby the non-rotatable nut 202 moves in the guideway against a mark 205 marking the emptying of the storage container

FIGS. 21 and 22 show an embodiment of the inhalation device according to the invention, the inhaler 1 of which corresponds to that of the embodiment according to FIGS. 2 and 3. The metering device 2.10 essentially consists of a pressure container filled with propellant gas, which also contains the preparation and which carries an outlet valve which is customary for such a pressure container and can be activated by pressing. The pressure container is inserted into the guide 14 in such a way that its spray outlet 211 in the inhalation channel 11.10 is directed against the mouth opening 12 and the actuating head 212 stands up on the lower inner wall of the inhalation channel. Pressure on the container in the direction of the inhalation channel (FIG. 22) the outlet valve is opened and a dose of the preparation is sprayed into the swirl field generated by the actuating head 212 in the inhalation stream

It goes without saying that, in the described exemplary embodiments of the inhalation device according to the invention, the metering indentation 26 can also be arranged rotated by 180 "(about the longitudinal axis of the metering element). One of the two positions is furthermore an angle of up to approximately 45 ° (0 ° or 180 ^* ) unscrewed arrangement possible.

FIGS. 23-55 show further embodiments of the inhalation device according to the invention. These differ from the above-described embodiments in principle in that the metering element is not arranged essentially transversely to the air flow, but essentially parallel to it, that is to say essentially horizontally displaceably when the inhalation device is in use.

Figures 23 and 24 show such an embodiment of the inhalation device in a sectional view and in supervision in the metering configuration, i.e. with the dosing element in the dosing position, and FIGS. 25 and 26 show the same inhalation device in the rest configuration, i.e. with the dosing element in its rest position.

According to the illustration, the device comprises an elongated, essentially approximately parallelepipedic or cylindrical base body 500, in which a metering element 525 in the form of a tube between a rest position and a dose position is essentially axially longitudinally displaceably mounted. The metering element 525 could also be designed as a full rod. At the front end of the basic body 500, a mouthpiece 512 is attached. On the rear end of the basic body, an actuating cap 550 is mounted so that it can be moved back and forth parallel to the metering element 525 between a closed position (FIG. 25) and an open position (FIG. 23). The metering element 525 is coupled kinematically to the center wall 551 of the end wall 552 of the actuating cap 550, so that by moving the actuating cap 500 between its two end positions, the metering element 525 is also displaced between its two end positions.

An essentially funnel-shaped storage container 521 is formed in the base body 500 in the front area thereof, which opens at the bottom into an outlet opening 524, which is closed by the displaceable metering element 525. A lid 527 closes off the storage container 524 at the top. A can counting mechanism is arranged in the rear area of the basic body 500. This comprises a toothed counter wheel 580, a ratchet wheel 581 with a driving pin 582, a backstop 583 and a drive pawl 584, the latter being arranged on the metering element 525 and being movable with it. Each time the metering element 525 moves from its rest position (FIG. 25) into its metering position (FIG. 23), the drive pawl 584 engages in the ratchet wheel 581 and rotates it further by one tooth. After each full rotation of the ratchet wheel 581, its driver pin 582 rotates the counting wheel 580, which is provided with a scale for the dispensed cans, by one tooth. The scale of the counter wheel 580 can be read through a window 553 of the actuating cap 550.

The tubular dosing element 525 is mounted in the area in front of and behind the storage container 521 by means of two bearing elements 533 and 533 ', the formation of which is explained in more detail in connection with FIGS. 44-47, and is capable of oscillation. Furthermore, a dosing indentation 526 is provided on the top of the dosing element 525, which is arranged such that it is in the rest position of the dosing element 525 in the region of the mouthpiece 512 and in the dosing position of the dosing element 525 in the region of its outlet opening 524. The formation of the metering indentation 526 is explained in detail in connection with FIGS. 38-40.

The mouthpiece 512 has an air outlet opening 513 on its front side and two or more air supply channels 514 on the side. When the dosing element 525 is in its rest position, the latter are essentially directed towards the dosing indentation 526 and generate the swirling already mentioned there. The shape and arrangement of the air supply channels 514 is explained in detail in connection with FIGS. 29-34.

The underside of the basic body 500 is provided with a corrugation 505 which interacts with a knob 554 which is arranged at the end of an elastic tongue 555 which is formed on the underside of the actuating cap 550 and which continues in the end wall 552 of the same. As can be seen in particular from FIG. 26A, the tongue 555 is separated from the other parts of the latter by two slots 556 in the side wall and the end wall of the actuating cap 550. When the actuating cap 550 is moved between its two end positions, the tongue 555 is excited to mechanical vibrations which are transmitted to the metering element 525 via the actuating cap 550. 500 vibrations are also generated in the basic body, which act on the inhalation preparation in the storage container 521. Another knob 557 approximately in the middle of the tongue 555 transmits vibrations to the base body 500 at specific points. Further details on the generation of the vibrations are explained in connection with FIGS. 48-55.

The mode of operation of the inhalation device according to FIGS. 23-26 is essentially the same as that of the embodiments of the inhalation device according to the invention already described above. Before inhalation, the dosing element 525 is brought from its rest position shown in FIG. 25 into the dose position shown in FIG. 23 by means of the actuating cap 550. By gravity and supported by the vibrations generated in the displacement movement in the storage container 521 and the dosing element 525, the dosing formation 526 is filled with an amount of inhalation preparation corresponding to its capacity. The dosing element 525 is then returned to its rest position, which is also the inhalation position, and the inhalation device is placed on the mouth. By inhalation, air is sucked through the air supply channels 514 into the mouthpiece 512 and swirled in the area of the dosage information 526. As a result, the inhalation preparation is rinsed out of the dosing infor- mation 526 and finely distributed in the air flow. The latter, together with the inhalation preparation suspended in it, finally reaches the patient's airways through the air outlet opening 513 of the mouthpiece 512.

FIG. 28 shows an embodiment variant of the inhalation device analogous to that of FIGS. 23-26, which is optimized with regard to the production by means of plastic injection molding technology. One half of the device is shown without the actuating cap, in a view of the parting plane. As can be seen, the base body 600 and the mouthpiece 612 are formed in one piece. In addition to the upper air supply channels 614, a further air supply channel 615 is provided in the lower part of the mouthpiece 612, which opens out in the vicinity of the outlet opening 613 and can be used for further optimization of the flow conditions by suitable dimensioning.

It can also be seen from FIG. 28 that the storage container 621 (as in the other exemplary embodiments) is preferably essentially double-conical, that is to say it has a constriction 628 just above its outlet opening 624. Between this and the outlet opening 624 or the (not visible here In this way, pockets 629 are formed, in which inhalation preparation accumulates, which ensures that the dosage formation is correctly filled and thus correct dosage even when the inhalation device is held at an angle.

Two ring-shaped cavities 633 serve to accommodate the (not visible here) storage elements for the dosing element.

In contrast to the embodiment of FIGS. 23-26, the vibration mechanism is designed somewhat differently in that the tongue 655 is not formed on the actuating cap (not shown here) but on the base body 600 and is provided with corrugations 605 while the actuating cap is provided with a corresponding knob which interacts with the corrugation. The functioning of the vibration mechanism is however analog. In addition, a web 670 provided with a passage opening 671 is provided, which connects the base point of the tongue 655 with the wall part of the basic body 600 surrounding the reservoir 621 and introduces the vibrations generated by the tongue directly into the reservoir 621. On the top of the basic body 600, in the rear area there is a further tongue 690, which has a knob 691 at its free end, which cooperates with a corresponding corrugation on the actuating cap (not shown here) and likewise generates vibrations and into the Introduces reservoir 621. Another web 692 serves to support the transmission of vibrations.

Figure 27 shows the inhalation device in plan view with some detail variants. An additional vibration mechanism can be seen, which acts directly on the side of the part of the base body forming the reservoir 621. This vibration mechanism is formed by a corrugation 693 formed on the actuating cap 650 and a tooth 694 integrally formed on the outside of the storage container 621. Furthermore, undercuts 695 and 696 of the storage container 621 can be seen, which also serve to influence the vibrations or vibrations that form in the storage container . Appropriate selection and arrangement or dimensioning of the various vibrating agents makes it possible to achieve a wide range of oscillation forms and combinations of oscillation forms, adapted to the respective inhalation preparation, so that even with difficult, ie sluggishly flowable inhalation preparations and extremely small dosing quantities (down to <0.1 mg) an exact and reliable dosage is guaranteed. FIGS. 29-34 show different design variants for the mouthpiece. According to FIGS. 29 and 30, the mouthpiece 712 is provided on its upper side with four additional air supply channels 713-716, which are arranged approximately in a square and are specially matched to the square configuration of the dosage indentation according to FIG. 38. FIGS. 31 and 32 show a mouthpiece 722 with two upper air supply ducts 723 and 724 running obliquely to the front and a lower air supply duct 725 also opening at an incline. This mouthpiece is matched to the obliquely formed metering recess according to FIG. 39, but of course also for the other dosage formation variants are suitable. FIGS. 33 and 34 finally show a mouthpiece 732 with two lateral air supply channels 733 and 734 opening perpendicular to the axis and an air supply channel 735 opening obliquely from above. By designing and arranging the air supply channels and adapting them to the shape of the metering element provided on the metering element an optimal emptying of the latter and swirling of the inhalation preparation in the air stream can be achieved.

FIGS. 35-37 show detail sections from various embodiments of the mouthpiece 512. According to FIG. 35, the front end of the tubular or rod-shaped metering element 525 is provided with an aerodynamically shaped tip 745, which extends to just before the outlet opening of the mouthpiece and for one causes additional swirling of the inhalation preparation in the air flow and further breakdown of any existing clumps. Resistor bodies 746 and 747 also have an analogous purpose, which in the embodiments of FIGS. 36 and 37 are formed on the upper wall of mouthpiece 512 above and somewhat before the rest position of metering recess 526. It goes without saying that the shape of the tip 745 and the resistance bodies 746 and 747 can be adapted depending on the flow conditions and requirements.

FIGS. 38-40 show different forms of formation for the dosing indentation on the dosing element 525. According to FIGS. 38 and 40, the dosing indentation 750 has an essentially rectangular shape and has two essentially rectangular elevations 751 and 752, so that the actual cavity approximately has the shape of a Has eight. The two elevations could, as indicated by the broken line in FIG. 38, also be divided into themselves, so that effectively four elevations would be present. According to FIG. 39, the dosing recess 760 comprises two approximately diagonally trending elongated notches 761 and 762. Both design variants have in common that the actual cavities only have a relatively short extension in the longitudinal direction of the metering element 525, so that the generally elastic bearing elements 533 of the metering element cannot penetrate into the cavities in any movement position of the latter so that a defined and constant dosage is guaranteed.

Figures 41-43 show details of the design of the storage container 521. Figure 41 shows a view from above with the cover removed, Figure 42 shows a section transverse to the longitudinal direction and Figure 43 shows a section parallel to the longitudinal direction of the metering element 525.

It can be seen that the storage container is equipped on both sides of the metering element 525 with an inclined flat sliding surface 771 and 772, respectively, which protrudes laterally to practically directly onto the side edges of the metering device 526. As a result, the inhalation preparation is optimally guided into the cavity of the metering recess 526. Furthermore, the dimension of the outlet opening 524 of the storage container 521 in the longitudinal direction of the metering element 525 is substantially larger than the metering indentation 526, so that it remains within the outlet opening during part of its displacement movement and is filled more reliably.

FIGS. 44-47 show detailed views, from which various design options for the bearing elements for the metering element 525 emerge.

According to FIG. 44, the bearing elements consist of two slotted O-rings 781 and 782. According to FIG. 45, two O-rings 783a and 783b lying radially one above the other are provided. According to FIG. 46, two O-rings 784a and 784b lie side by side in the longitudinal direction. In the exemplary embodiment in FIG. 47, only a single O-ring 785 is provided, but this is additionally supported on the sloping shoulder surface 786 on the metering element 525. Alien embodiments have in common that, on the one hand, they exert only a relatively low pressure in the radial direction on the surface of the metering element 525 and, on the other hand, practically do not hinder the vibrations of the metering element 525 generated by the vibration mechanism.

As already mentioned, the metering element in all embodiments can be tubular or as a full rod. Leave in a tubular design However, there are still further degrees of freedom with regard to the generation of vibrations or vibrations, so that an optimal adaptation to the properties of the inhalation preparation is possible.

FIG. 48 shows a tubular metering element 825, which is hollow throughout and is equipped at its front, free end with additional air channels 826 and 827 for influencing the flow conditions. Optionally, the inside of the front tube end can also be funnel-shaped, which is indicated by lines 828 and 829. At the rear tube end there is a tapered extension 830, by means of which the tube or dosing element 825 is clamped in the end wall 552 of the actuating cap 550 in such a way that it is kinematically coupled to the latter in the axial direction, but can oscillate or vibrate freely .

The tubular metering element 835 of FIG. 49, which is likewise open at the rear, has a tip 837 which is closed except for a nozzle 836. At its rear end it has a bead-shaped thickening 838 with which it is mounted in an annular groove 839 in the end wall 552 of the actuating cap 550. Arranged in the interior of the metering element 835 is a resilient lamella 840 which is excited to oscillate by the air flowing through the metering element during operation and thus additionally generates acoustic vibrations which, with suitable measurement, are also favorable for the filling of the metering indentation 526 impact.

According to FIG. 50, an oscillatable lamella 841 is located at the open end of the mouthpiece 512 and protrudes into the front end of the tubular metering element 845. As an alternative or in addition, a further resilient lamella 850 or the like can be arranged between the metering element 845 and the mouthpiece 512, which is also excited to oscillate by the air flow and in the process exerts a knocking movement on the metering element 845. This can favor the emptying of the dosing indentation 526 and the winding of the inhalation preparation in the air stream.

Further details of the generation of oscillations and vibrations in the inhalation device according to the invention can be seen in FIGS. 51-55.

FIG. 51 shows the storage container 521 and the portion of the metering element 525 underneath. A coil spring 860 is arranged in the storage container, which is resiliently supported on the cover 527 on the one hand and on the metering element 525 on the other. The lower end of the spring 860 sits on a shoe 861. When vibrations are introduced into the storage container 521 and / or the metering element 525, the helical spring 860 executes an approximately dancing movement which breaks up agglomerations of the inhalation preparation and for a precise filling the Dosungeinformung 526 provides.

The tapping element 870 shown in FIG. 52, which is arranged approximately diagonally loosely in the storage container 521 and performs a tapping movement when vibrated, has a similar effect. Its lower part 871 is designed like a shovel and to a certain extent pushes the inhalation preparation into the dosage indentation 526.

FIG. 53 shows a detail of FIG. 25. The enlarged view shows the corrugation 505 of the basic body 500 and the free end of the tongue 555 of the actuating cap 550 with the knobs 554. As can be seen, the corrugation 505 is equipped with teeth of different shapes. to generate vibrations of different shapes. In this way, one and the same device can be used for inhalation preparations with different properties.

According to FIG. 54, instead of the knob 554, a pin 880 is inserted loosely into the tongue and has an approximately spherical surface. Finally, FIG. 55 shows a variant in which the teeth of the corrugation 505 and the knobs 554 on the tongue 555 are designed asymmetrically in order to generate different oscillation spectra in the two directions of displacement. It goes without saying that corrugations used to generate vibrations can be arranged not only on the underside of the base body 500, but also on its top side or on the side walls. In addition to or in parts of the web 692 shown in FIG. 28, further webs 621 projecting laterally from the inner wall of the storage container and e.g. interact with a cam attached to the outside of the storage container analogously to cam 694 in order to generate defined oscillation patterns in the storage container.

Finally, it should also be mentioned that the corrugations on the base body or on the actuating cap can also have a serpentine curve, which results in further possible variations in the generation of vibrations.

Claims

PATENT CLAIMS

1. A method for dosing an inhalation preparation, preferably a powdered inhalation preparation, for inhalation, characterized in that the air flow generated by the inhalation is channeled in an inhalation channel and swirled in at least one area and that a dose of the preparation from a storage container is in such a manner is brought into the inhalation channel that the dose is driven into the inhalation flow by the generated vortex and distributed in this.

10

A method according to claim 1, characterized in that the Dosie¬ tion is activated by manual actuation of the inhaler.

Method according to one of claims 1 to 2, characterized in that the preparation is vibrated before and / or when the dosage is activated.

4. The method according to any one of claims 1 to 3, characterized in that the activation of the dosage is blocked until the inhaler generates an inhalation stream of a certain strength.

5. The method according to claim 4, characterized in that for the 25th

Release of the dosage necessary inhalation strength is adjustable.

6. The method according to any one of claims 4 or 5, characterized gekennzeich¬ net that the activation of the dosage is blocked by form-locking means that are released by the inhalation stream as soon as it reaches a certain strength, so that the dosage are activated can, and if the inhalation flow weakens, automatically block the dosage again.

7. The method according to claim 6, characterized in that the positive locking means consist of a ball which is movably mounted in a ball channel inclined against the force of gravity and through which at least part of the inhalation flow flows

8. The method according to any one of claims 4 to 7, characterized in that the blockage by the inhaler can be released without inhalation if necessary.

Method according to one of claims 1 to 3, characterized in that a dose of the preparation is dosed into the inhalation channel when the inhalation device is brought from an idle configuration into an inhalation configuration, and that a further dose is only dosed when the inhalation device is brought from the inhalation configuration into the rest configuration and back into the inhalation configuration.

10. The method according to claim 9, characterized in that a dose of the preparation is dosed into the inhalation channel when the inhalation channel is opened for inhalation, and that another Dose is only dosed when the inhalation channel is closed and opened again.

11. The method according to any one of claims 1 or 2, characterized in that the preparation is sprayed by means of increased pressure through a nozzle into the vortex field downstream of the metering element.

12. Inhalation device for inhaling a preferably pulverulent inhalation preparation with which the method according to one of claims 1 or 2 is carried out, characterized in that it has an inhalation channel (11) in which an air flow generated by the inhaler channels has a storage container (21) in which the inhalation preparation is stored loosely and a dosing mechanism (22) with which the inhalation preparation is brought in doses from the storage container (21) into the inhalation channel (11), the dosing mechanism ( 22) is designed such that the inhalation preparation is brought into the inhalation flow on its side lying downstream in the inhalation flow. 20th

13. Inhaler according to claim 12, characterized in that the

Dosing mechanism (22) has a dosing element (25) with a dosing recess (26) 25 arranged laterally in the area of its one end such that the dosing element (25) is mounted in an outlet opening (24) of the storage container (21) in such a way that it can be moved Dosing indentation (26) is in one extreme position of the dosing element (25) inside the storage container (21), in the other extreme position of the dosing element (25) outside the 30 storage container (21) in the inhalation channel (11)

14. Inhalation device according to claim 13, characterized in that the metering element (25) in a further, the outlet opening (24) ge opposite openings (28) in the storage container (21) is also mounted with limited mobility and that from this opening (28 ) projecting head end of the metering element is connected to actuating and / or 5 spring means

15. Inhaler according to claim 14, characterized in that on

An elastic bellows (30) is attached to the head end of the dosing element (25) and serves as an actuating means by the pressure of the fingers and as a spring means

16. Inhalation device according to claim 14, characterized in that an elastic bellows is attached to the head end of the metering element, which serves as spring means and that the actuating means consist of a pivotable lever which is pivotably attached to the inhalation device such that its pivoting movement the bellows can be deformed. 20th

17. Inhalation device according to one of claims 12 to 16, characterized in that it has a blocking mechanism (3) with the aid of which the dosage is blocked unless an inhalation stream of a certain strength flows through the inhalation channel.

18. Inhalation device according to claim 17, characterized in that the blocking mechanism comprises a ball which is loosely mounted in a channel, the channel being arranged such that it is in Inhalation position of the inhalation device is inclined against gravity and that at least part of the inhalation flow flows through it and that part (23) of the metering mechanism (22) reaches into the area of the ball and blocks it in one position can be. 5

19. Inhalation device according to claim 12, characterized in that it has a closure cap (62) for the mouth opening (12) and that the closure cap (62) is operatively connected to the metering element (25).

20. Inhaler according to claim 19, characterized in that the

Closure cap (62) is pivotally attached to the device and a lever system (60) is operatively connected to the head end of the metering element (25) in such a way that when the closure cap (62) is pivoted from its closed to its open position, the head end of the dosing element is pressed against the reservoir (21). 20th

21. Inhalation device according to claim 13, characterized in that the metering element extends into a through opening (92) opposite the outlet opening (24) in the wall of the inhalation channel 25.

22. Inhalation device according to claim 21, characterized in that the end of the dosing element carrying the dosing recess (26) is operatively connected to a closure cap for the mouth opening

23. Inhalation device according to one of claims 12 to 22, characterized in that it has vibrating means on parts that are relatively moved when actuated, which cause a vibration of the preparation in the storage container when actuated or moved back into the rest position. 5

24. Inhalation device according to one of claims 12 to 23, characterized in that the metering device is designed as an exchangeable cartridge 10

25. Inhalation device according to one of claims 12 to 24, characterized in that it has a refillable storage container with a stopper (129) 15 positioned opposite the outlet opening (24)

26. Inhaler according to claim 25, characterized in that the

Plug (129) is designed such that it can serve as a container for a desiccant.

27. Inhaler according to one of claims 12 to 26, characterized in that it has a can counting mechanism. 25th

28. Inhalation device for a preferably powdered inhalation preparation, with a mouthpiece (512) forming an inhalation channel in which an air flow generated by the inhalation is channeled, with a storage container (521) in which the inhalation preparation is stored loosely, and with one Dosing mechanism (525, 526) with which the inhalation preparation can be introduced in doses from the storage container (521) into the inhalation channel, characterized in that the dosing mechanism comprises a rod-shaped or tubular dosing element (525), on the outer surface of which a dosing cavity is in the form a metering recess (526) is arranged, wherein the metering element (525) by means of an actuating member (550) in its longitudinal direction between a rest position, in which the metering recess (526) is in the mouthpiece (512), and a metering position, in which the metering formation below the storage container (521) in communicating connection m it is located, can be moved back and forth, and in the mouthpiece (512) there are air supply channels (514) which, when the metering element (525) is in the rest position, direct an air flow generated by the inhaler onto the metering recess (526) such that the inhalation preparation is blown out of the dosing recess (526) and swirled in the air stream.

29. Inhalation device according to claim 28, characterized in that it has an elongated basic body (500) which forms the storage container (521), and that on the basic body (500) an actuating cap (550) movable to and fro between two end positions is arranged displaceably is the. the actuator for the metering element (525) forms.

30. Inhalation device according to one of claims 28 and 29, characterized gekennzeich¬ net that it is provided with a tooth mechanism (580-584) for the dispensed doses, which is coupled to the actuator (550) and is incremented by it.

31. Inhalation device according to one of claims 28-30, characterized in that the storage container (521) is essentially funnel-shaped and is provided with two lateral sliding surfaces (771, 772) with respect to the longitudinal direction of the metering element (525), which slide surfaces store the stored therein Guide the inhalation preparation into the dosing recess (526) when the dosing element is in its dosing position.

32. Inhalation device according to one of claims 28-31, characterized in that the storage container (521) has a constriction (628) just above the metering element (525) carried out below it, which pockets together with the metering element (525) Form (629) for the inhalation preparation.

33. Inhalation device according to one of claims 28-32, characterized in that the storage container (521) has an elongated outlet opening (524) which is closed off by the metering element (525) and which is greater in the longitudinal direction than the metering indentation (526 ), so that the latter remains in the region of the outlet opening (524) during part of the displacement movement of the metering element (525).

34. Inhalation device according to one of claims 28-33, characterized in that it is equipped with a vibration mechanism (505, 554, 555) which can be activated by the displacement movement of the metering element (525), the mechanical vibrations in the storage container (521) and or in the metering element (525).

35. Inhalation device according to claim 34, characterized in that the vibration mechanism is formed by an elastic tongue (555) formed on the base body (500) or on the actuating member (550) and a corrugation (505) cooperating with it on the actuating member (550) or is formed on the basic body (500).

36. Inhalation device according to claim 35, characterized in that means (670) are provided which introduce the vibrations generated by the vibration mechanism into the storage container (521).

37. Inhalation device according to one of claims 34-36, characterized in that two or more vibration mechanisms (505, 555; 690-692; 693, 694) are provided, which generate vibrations of different shapes at different locations on the device.

38. Inhaler according to one of claims 34-37, characterized in that means (840, 841) for generating acoustic air vibrations are provided in the tubular metering element (525).

39. Inhalation device according to one of claims 34-38, characterized in that means (850) for generating knocking impulses on the dosing element (525) are provided in the mouthpiece (512).

40. Inhalation device according to one of claims 34-39, characterized in that the vibration mechanism generates different forms of vibration depending on the direction of movement of the metering element (525).

41. Inhalation device according to one of claims 34-40, characterized in that in the storage container (521) an essentially loosely mounted shredding member (860, 870) is arranged, which by means of mechanical vibrations introduced into the storage container to an irregularly bouncing, dancing , beating or oscillating movement is stimulated, as a result of which agglomerations in the inhalation preparation are broken up and the filling of the dosing recess (526) in the dosing element (525) with inhalation preparation is improved.

42. Inhalation device according to claim 41, characterized in that the comminuting member is formed by a helical spring (860), which is located on the one hand on the lid (527) of the storage container (521) and on the other hand, preferably via a shoe (861), on the metering element (525) supports.

43. Inhalation device according to claim 41, characterized in that the comminuting member is formed by a rod (870) which is arranged approximately diagonally loosely or oscillates in the storage container (521) and with its lower, preferably shovel-shaped end (871) rests on the dosing element (525).

44. Inhalation device according to one of claims 28-43, characterized in that a resistance body (746, 747) is provided in the mouthpiece (512) in the area of the dosing infor- mation (526) which is in the rest position and which has a Wi einelfeld in the area of the dosing infor Airflow generated.

45. Inhalation device according to one of claims 28-44, characterized in that an aerodynamically shaped organ (745) is provided at the front end of the metering element (525), which causes a swirling of the inhalation preparation suspended in the inhalation air flow.

46. Inhalation device according to one of claims 28-45, characterized in that the metering element (525) is mounted on both sides of the storage container (521) in a bearing element (533) so that the vibrations introduced into the metering element are as little as possible be dampened.

47. Inhalation device according to one of claims 28-46, characterized in that the dosing element (525) is displaceably guided on both sides of the storage container (521) in a bearing element (533), the bearing element (533) being applied to the dosing element with only slight pressure (525) is present.

48. Inhalation device according to one of claims 46 and 47, characterized gekennzeich¬ net that the Dosiereinformung (526) on the metering element (525) is designed such that it has no such extent in the direction of movement of the metering element (525) that the bearing element (533) can penetrate into the cavity of the dosing indentation (526).