EP0553326A1 - Inhalateur - Google Patents

Inhalateur

Info

Publication number
EP0553326A1
EP0553326A1 EP92917223A EP92917223A EP0553326A1 EP 0553326 A1 EP0553326 A1 EP 0553326A1 EP 92917223 A EP92917223 A EP 92917223A EP 92917223 A EP92917223 A EP 92917223A EP 0553326 A1 EP0553326 A1 EP 0553326A1
Authority
EP
European Patent Office
Prior art keywords
inhalation
dosing
storage container
metering
preparation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP92917223A
Other languages
German (de)
English (en)
Inventor
Franco Del Bon
Luigi Del Bon
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP0553326A1 publication Critical patent/EP0553326A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/007—Mechanical counters
    • A61M15/0071—Mechanical counters having a display or indicator
    • A61M15/0075—Mechanical counters having a display or indicator on a disc
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0091—Inhalators mechanically breath-triggered
    • A61M15/0095—Preventing manual activation in absence of inhalation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0091—Inhalators mechanically breath-triggered
    • A61M15/0096—Hindering inhalation before activation of the dispenser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0091—Inhalators mechanically breath-triggered
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder

Definitions

  • 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.
  • 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 .
  • inhalation device 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.
  • 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.
  • 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.
  • the inhalation device 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.
  • 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.
  • 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.
  • 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. 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;
  • 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.
  • 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. 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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
  • 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).
  • 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 Dosier ⁇ informung 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the metering device 2 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.
  • 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.
  • 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 (Dosie ⁇ osition).
  • the ball channel 14 is advantageously closed at its lower end with a plug 19 which can carry the supply air opening 17 '.
  • a plug 19 which can carry the supply air opening 17 '.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • a closure cap 62 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.
  • a 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. _ ⁇ _
  • 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.
  • 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.
  • 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.
  • 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.
  • the closure cap 62.4 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.
  • the dosing element 25.4 is pulled into the dosing position (FIG. 12) by means of the driver 122 caught in the opening 121.
  • 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).
  • 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.
  • 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.
  • 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.
  • it can be open towards the top and carry a sealing plug 129.
  • the sealing plug 129 can also serve as a further function as a container for a drying agent.
  • 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.
  • 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
  • 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. _ ⁇ _
  • 16, 17 and 18 show possible shapes for the storage container.
  • the individual embodiments differ in terms of manufacture, filling, sealing, ecology, etc.
  • 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.
  • 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).
  • 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.
  • 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
  • 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
  • FIGS. 25 and 26 show the same inhalation device in the rest configuration, i.e. with the dosing element in its rest position.
  • 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.
  • a mouthpiece 512 is attached at the front end of the basic body 500.
  • 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.
  • the drive pawl 584 engages in the ratchet wheel 581 and rotates it further by one tooth.
  • 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.
  • the dosing element 525 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the base body 600 and the mouthpiece 612 are formed in one piece.
  • 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.
  • 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.
  • 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.
  • 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.
  • a further tongue 690 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.
  • 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 .
  • FIGS. 29-34 show different design variants for the mouthpiece.
  • 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. 29 and 30 show different design variants for the mouthpiece.
  • 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. 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.
  • FIGS. 35-37 show detail sections from various embodiments of the mouthpiece 512.
  • 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.
  • 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.
  • 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
  • Figure 43 shows a section parallel to the longitudinal direction of the metering element 525.
  • 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.
  • the inhalation preparation is optimally guided into the cavity of the metering recess 526.
  • 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.
  • the bearing elements consist of two slotted O-rings 781 and 782.
  • two O-rings 783a and 783b lying radially one above the other are provided.
  • two O-rings 784a and 784b lie side by side in the longitudinal direction.
  • 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.
  • 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.
  • 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.
  • a resilient lamella 840 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.
  • 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.
  • 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.
  • FIGS. 51-55 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.
  • 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.
  • 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.
  • FIG. 54 instead of the knob 554, a pin 880 is inserted loosely into the tongue and has an approximately spherical surface.
  • 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.
  • 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.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pulmonology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Un procédé permet de doser une composition d'inhalation de préférence pulvérulente. La composition contenue dans un réservoir est introduite dans le courant d'inhalation généré et canalisé par la personne qui utilise l'inhalateur et canalisé de sorte que le courant d'inhalation tourbillonne en même temps et que la composition soit diluée et distribuée par le tourbillon dans le courant. L'inhalateur de mise en oeuvre du procédé comprend un élément de dosage (25) monté mobile de manière limitée dans un orifice de sortie (24) du réservoir de sorte qu'une moulure latérale de dosage (26) se situe dans une de ses positions extrêmes, dans le réservoir (21), et se situe dans l'autre position extrême dans le canal d'inhalation (11). La personne qui utilise l'inhalateur actionne l'élément de dosage au moyen d'un élément à ressort (30) ou d'un capuchon de fermeture de l'embouchure (12) du canal d'inhalation (11). Chaque déplacement de la moulure de dosage (26) entre le réservoir (21) et le canal d'inhalation (11) met à disposition une dose de la composition d'inhalation. L'inhalateur comprend un mécanisme vibreur qui empêche la composition pulvérulente de s'agglutiner et de cesser de s'écouler. L'inhalateur peut en outre comprendre un mécanisme de blocage (3) qui bloque le dosage lorsque l'on n'inhale pas suffisamment fort et/ou un mécanisme de comptage des doses.
EP92917223A 1991-08-15 1992-08-14 Inhalateur Withdrawn EP0553326A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH240991 1991-08-15
CH2409/91 1991-08-15

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EP (1) EP0553326A1 (fr)
JP (1) JPH06504223A (fr)
AU (1) AU651910B2 (fr)
CA (1) CA2093809A1 (fr)
FI (1) FI931661A0 (fr)
HU (1) HUT64242A (fr)
WO (1) WO1993003782A1 (fr)

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DE102006029753A1 (de) 2006-03-10 2007-09-13 Alfred Von Schuckmann Inhalator für pulverförmige Substanzen
WO2007124406A2 (fr) 2006-04-21 2007-11-01 3M Innovative Properties Company Compteur de doses
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FI931661A (fi) 1993-04-14
HU9301090D0 (en) 1993-08-30
AU2421192A (en) 1993-03-16
JPH06504223A (ja) 1994-05-19
AU651910B2 (en) 1994-08-04
CA2093809A1 (fr) 1993-02-16
HUT64242A (en) 1993-12-28
FI931661A0 (fi) 1993-04-14
WO1993003782A1 (fr) 1993-03-04

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