WO2015024653A1 - Inhalateur - Google Patents

Inhalateur Download PDF

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Publication number
WO2015024653A1
WO2015024653A1 PCT/EP2014/002270 EP2014002270W WO2015024653A1 WO 2015024653 A1 WO2015024653 A1 WO 2015024653A1 EP 2014002270 W EP2014002270 W EP 2014002270W WO 2015024653 A1 WO2015024653 A1 WO 2015024653A1
Authority
WO
WIPO (PCT)
Prior art keywords
inhaler
metering ring
triggering
chamber
tensioning
Prior art date
Application number
PCT/EP2014/002270
Other languages
English (en)
Inventor
Marcus Knell
Guido Endert
Alexander Christ
Horst Wergen
Original Assignee
Boehringer Ingelheim Vetmedica Gmbh
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 Boehringer Ingelheim Vetmedica Gmbh filed Critical Boehringer Ingelheim Vetmedica Gmbh
Publication of WO2015024653A1 publication Critical patent/WO2015024653A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D7/00—Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals
    • A61D7/04—Devices for anaesthetising animals by gases or vapours; Inhaling 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
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0013—Details of inhalators; Constructional features thereof with inhalation check valves
    • 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
    • A61M15/0073—Mechanical counters having a display or indicator on a ring
    • 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
    • A61M15/0086—Inhalation chambers
    • 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
    • A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • 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
    • A61M15/0093—Inhalators mechanically breath-triggered without arming or cocking, e.g. acting directly on the delivery valve
    • 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
    • A61M15/08—Inhaling devices inserted into the nose
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
    • B05B11/1042—Components or details
    • B05B11/1052—Actuation means
    • B05B11/1056—Actuation means comprising rotatable or articulated levers
    • 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
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0018—Details of inhalators; Constructional features thereof with exhalation check valves
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • 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
    • A61M2250/00—Specially adapted for animals
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/0005—Components or details
    • B05B11/0037—Containers
    • B05B11/0038—Inner container disposed in an outer shell or outer casing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
    • B05B11/109—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle the dispensing stroke being affected by the stored energy of a spring
    • B05B11/1091—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle the dispensing stroke being affected by the stored energy of a spring being first hold in a loaded state by locking means or the like, then released
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B7/00—Spraying apparatus for discharge of liquids or other fluent materials from two or more sources, e.g. of liquid and air, of powder and gas
    • B05B7/0012—Apparatus for achieving spraying before discharge from the apparatus

Definitions

  • This invention relates to an inhaler for metered spraying of a pharmaceutical agent preparation, preferably for insertion into a nostril, in particular a horse's nostril, with an indicator, whereby the indicator has a metering ring, mounted to rotate around an axis of rotation, with indicator means for displaying a number of still available or already administered doses.
  • This invention relates in particular to a so-called Soft Mist Inhaler (SMI), i.e., an inhaler that produces an atomized spray (aerosol) that propagates only comparatively slowly.
  • SMSI Soft Mist Inhaler
  • such inhalers are in particular inhalers in which an aerosol is dispensed at a speed of less than 2 m/s, preferably approximately 1.6 m/s or less, and quite especially preferably less than 1 m/s (in each case measured at a distance of 10 cm from a discharge nozzle) and/or in which the dispensing or spraying of a dose - of preferably 10 to 50 ⁇ of a pharmaceutical agent preparation - lasts longer than 0.7 s, in particular approximately 1 s or longer.
  • WO 2005/079997 A1 discloses an inhaler that represents an SMI in terms of this invention.
  • the known inhaler As a reservoir for a pharmaceutical agent preparation that is to be sprayed, the known inhaler has an insertable, rigid container with an inner bag with the pharmaceutical agent preparation and a pressure generator with a mainspring for delivery and spraying of the pharmaceutical agent preparation. The spraying is done without propellant, namely under the action of the force of the mainspring.
  • the known inhaler has an inhalation valve, which is arranged laterally to a discharge nozzle.
  • WO 2004/091704 A1 discloses an additional device for intermediate storage of a sprayed pharmaceutical agent preparation in a chamber, also called a spacer.
  • the additional device is inserted into a so-called Metered Dose Inhaler (MDI).
  • MDI Metered Dose Inhaler
  • An MDI has a pressurized container that contains the pharmaceutical agent preparation to be sprayed as well as propellant.
  • the propellant causes the pharmaceutical agent preparation to be dispensed at comparatively high pressure and correspondingly high speed and with a high mass stream. Therefore, the dispensing occurs for only a very short time, in particular for less than 0.4 s, and in most cases for approximately 0.15-0.39 s.
  • the short dispensing time is disadvantageous for an inhalation, since the intake for inhalation usually lasts significantly longer.
  • the comparatively high speed of more than 2 m/s, often even up to or over 8 m/s, with which the aerosol is usually administered by an MDI, is also disadvantageous for uptake into the lungs, since the particles (droplets) of the aerosol are deposited for the most part on the wall of the user's throat because of the high speed in the case of direct inhalation.
  • the known additional device is provided for an MDI and serves to slow down the aerosol, in particular by lengthening the flow path. For this reason, such additional devices are also called spacers. In addition, the additional device serves to ensure intermediate storage for the aerosol that is produced.
  • WO 01/78818 A2 discloses an inhaler for the nose.
  • the inhaler has a pump cylinder that can be actuated manually and an adapter, arranged thereon, with a chamber for intermediate storage of an aerosol that is produced.
  • the pump cylinder is not an SMI in terms of this invention. Rather, a short and strong actuation of the pump cylinder is necessary in order to achieve an acceptable spraying, so that the characteristics correspond to those of an MDI, if, by means of the pump cylinder, an aerosol can be produced at all with the very small droplets desired for inhalation in the lungs.
  • WO 94/17753 A1 discloses an inhalation device for large animals, such as horses.
  • the inhalation device comprises an MDI, which releases an aerosol in an additional device with a tubular section.
  • the aerosol is sprayed in the longitudinal direction of the tubular section.
  • a soft adapter can be connected to the tubular section, which adapter is designed for insertion into a horse's nostril.
  • the inhalation device has a handle with a corresponding, manually actuatable, pivotable actuating element. Upon actuation of the actuating element, the MDI is shifted linearly, ensuring that a metering valve of the MDIs is opened and aerosol is released into the tubular section.
  • WO 2010/149280 relates to a Soft Mist Inhaler with an additional device for intermediate storage of a sprayed pharmaceutical agent mixture in a chamber.
  • the additional device has an inhalation valve for intake of incoming air into the chamber and for blocking in the opposite direction.
  • the inhaler has a dispensing device that is connected to the additional device in order to make possible a dispensing of aerosol to a patient to be treated.
  • the inhalation valve is hinged laterally and therefore opens up on one side, which deflects the incoming air stream.
  • WO 04/026380 A1 relates to a dry powder inhaler with a metering ring, which carries indicator means.
  • the metering ring is driven by a gear drive, which is comparatively expensive and susceptible to error.
  • the object of this invention is to indicate an inhaler, especially preferably an SMI, in which the indicator is easy to operate, economical, and rugged.
  • the metering ring is moved or rotated by a triggering device of a pressure generator of the inhaler.
  • the inhaler thus has the triggering device that is designed in particular to prevent or to trigger the administration of the pharmaceutical agent preparation or spraying.
  • a triggering device can be used in particular at the same time or by a movement of the triggering device for inhibition and/or release of the pressure generator in order to drive the metering ring and in this way to change the display of the number of doses that are still available or already administered.
  • the indicator has a pivot or swivel arm, which can form the triggering device or a part of the triggering device.
  • the metering ring can be moved or rotated by pivoting or swiveling the pivot or swivel arm.
  • the metering ring is thus rotated in particular by a pivoting or swiveling drive movement rather than, as is often common, converting a lateral or rotational movement into a metering ring movement.
  • the metering ring can be driven with very few elements, which reduces the probability of failure of the inhaler relative to the indicator.
  • a pivoting or swiveling movement or pivoting or swiveling in terms of this invention is preferably a rotational movement or a movement rotating around a swivel axis, which in the freedom of movement is limited in such a way that no complete rotation is possible.
  • a pivoting or swiveling movement is a rotational movement that is structurally limited, preferably to less than 180°, in particular less than 90°.
  • the metering ring is especially preferably driven by pivoting or swiveling of the pivot or swivel arm of the triggering device, whereby the triggering device is suitable at the same time for preventing or triggering the formation of an aerosol.
  • Another main aspect of this invention that can also be achieved independently relates to a method in particular for displaying a number of still available or already administered doses of a pharmaceutical agent preparation.
  • an indicator is made available for metered spraying of the pharmaceutical agent preparation, whereby an indicator of the inhaler has a metering ring, mounted to rotate around an axis of rotation, with indicator means for displaying the number of still available or already administered doses.
  • the metering ring is moved or rotated in such a way that the pivot or swivel arm is pivoted or swiveled around a pivot or swivel axis and/or the pressure generator is triggered.
  • Fig. 1 shows a side view of an inhaler according to the proposal
  • Fig. 2 shows a cutaway of the inhaler, according to the proposal, in the area of the detensioned pressure generator
  • Fig. 3 shows a cutaway of the inhaler, according to the proposal, in the area of the tensioned pressure generator
  • Fig. 4 shows a section of the inhaler, according to the proposal, in the area of the lever gear in the rest position
  • Fig. 5 shows a section of the inhaler, according to the proposal, in the area of the lever gear in the tensioned position
  • Fig. 6 shows a simplified, partial cutaway of the inhaler, according to the proposal, in the area of the indicator for display of doses that are still available or already administered with a pump device and tensioning device;
  • Fig. 7 shows a simplified, partial cutaway of the inhaler, according to the proposal, in the area of the indicator for display of doses that are still available or already administered without a pump device;
  • Fig. 8 shows an exploded drawing of an inhalation valve according to the proposal
  • Fig. 9 shows a simplified, partial cutaway of the inhaler, according to the proposal, in the area of the closed inhalation valve
  • Fig. 10 shows a simplified, partial cutaway of the inhaler, according to the proposal, in the area of the opened inhalation valve
  • Fig. 1 shows a section of the chamber with a dispensing device of the inhaler, according to the proposal, in the area of the respiration indicator in the rest position;
  • Fig. 12 shows a section of the chamber with a dispensing device of the inhaler, according to the proposal, in the area of the respiration indicator in the expiratory position
  • Fig. 13 shows a section of the chamber with a dispensing device of the inhaler, according to the proposal, in the area of the respiration indicator in the inhalation position
  • Fig. 14 shows a section of the chamber with a dispensing device of the inhaler, according to the proposal, in the area of the respiration indicator in accordance with an alternative embodiment in the rest position;
  • Fig. 15 shows a section of the chamber with a dispensing device of the inhal- er, according to the proposal, in the area of the respiration indicator in accordance with an alternative embodiment in the expiratory position;
  • Fig. 16 shows a section of the chamber with a dispensing device of the inhaler, according to the proposal, in the area of the respiration indicator in accordance with the alternative embodiment in the inhalation position;
  • Fig. 17 shows a segmented view of the inhaler, according to the proposal, in accordance with a second embodiment
  • Fig. 18 shows a second segmented view of the inhaler, according to the proposal, in accordance with the second embodiment
  • Fig. 19 shows another segmented view of the inhaler, according to the proposal, in accordance with the second embodiment
  • Fig. 1 shows a view of an inhaler 1 according to the proposal.
  • the inhaler 1 has a discharge nozzle 2 that is indicated in dotted lines in Fig. 1 and that preferably is designed for forming an aerosol 3 with a pharmaceutical agent preparation 4.
  • the inhaler 1 is designed in particular as a Soft Mist Inhaler in the above- mentioned sense. The latter is explained in more detail below based on the cutaways according to Figures 2 and 3.
  • the inhaler 1 preferably comprises a container 12 with the pharmaceutical agent preparation 4.
  • the container 12 thus forms a reservoir for the pharmaceutical agent preparation 4 that is to be sprayed.
  • the container 12 preferably contains an adequate amount of pharmaceutical agent preparation 4 or active ingredient for multiple doses of the pharmaceutical agent preparation 4, i.e., to make possible multiple sprayings or applications.
  • a typical container 12 occupies a volume of approximately 2 to 10 ml.
  • the container 12 have a volume that is smaller than 50 ml, preferably smaller than 30 ml, and in particular smaller than 20 ml. In this way, a compact design of the inhaler 1 and consumability within the shelf life of the pharmaceutical agent preparation 4 can be ensured.
  • the pump device 24 or the delivery tube 19 can be moved upward again in the case of the now-closed non- return valve 23 by depressurization of the tensioning device 21 and can now act as a plunger.
  • the pump device 24 is shifted linearly or axially with the delivery tube 19, in particular only by the tensioning device 21. This pressure expels the pharmaceutical agent preparation 4 through the discharge nozzle 2, wherein it is formed into the preferably respirable aerosol 3, as indicated in Figs. 1 and 2.
  • lever gear 29 have at least two levers configured for gear reduction, preferably with the elbow lever 30 and an one-sided lever 30.
  • the elbow lever 30 can be driven by means of the one-sided lever 35.
  • the one-sided lever 35 can be hinged on one end and can be loaded with a force F on another end.
  • the one-sided lever 35 can have a shorter lever arm 36 with a length r1 and a longer lever arm 37 with a length r2, wherein the shorter lever arm 36 can correspond to the first lever arm 32 of the elbow lever 30.
  • the force ratio under the assumption of perpendicular forces with force F acting on the end point of the second lever arm 33, facing away from the pivot point, for example by manual actuation, is F' F*r2/r1.
  • the length of the longer lever arm 37 preferably corresponds to more than twice, in particular more than three times, the length of the shorter lever arm 36.
  • the actuating lever 26 can be brought up to the housing 14 of the inhaler 1 , can rest against the housing 14 and/or be oriented at least essentially parallel to the housing section 38 adjacent to the actuating lever 26.
  • the housing section 42 can form a handle or a grip.
  • the actuating lever 26 In the rest position, the actuating lever 26 preferably projects from the housing 14 or housing section 42. In this case, it can be provided that the actuating lever 26 at its pivot point 41 has a preferably hinge-like joint and/or rests against the housing 14, at an increasing distance from the pivot point 41 but arranged further removed from the housing 14, i.e., is swiveled or swung or pivoted away from the housing 14.
  • the actuating lever 26 together with the arm 38 preferably forms the elbow lever 30.
  • the latter is securely hinged preferably only on one end in the pivot point 41.
  • the elbow lever 30 is driven or actuated in such a way that the pivot point 41 of the actuating lever 26 is shifted with the arm 38, ensuring that the pump device 24 preferably can move axially.
  • the pump device 24 is preferably mounted axially.
  • the pump device 24 be secured against rotating around the longitudinal axis L.
  • the arm 38 is preferably designed to be L-shaped and/or in the manner of a fork. In this way, the arm 38 can encompass the delivery tube 19. In this way, the force exerted by the lever gear 29 can be introduced uniformly, in particular via the pump device 24, into the tensioning device 21 .
  • the L shape helps to minimize the movement space for the elbow lever 30.
  • the arm 38 is formed forklike or as a tensioning fork, wherein two preferably L-shaped sections are connected by an arm, wherein the arm is a joint and/or the ends of the sections facing away from the arm are designed for introducing force into the tensioning device 21 . In this way, the housing volume can be minimized.
  • the arm 38 can have an arc shape or the like.
  • the inhaler according to the proposal preferably comprises the triggering device 27, which is designed - when the tensioning process is completed - to secure the tensioning device 21 and/or the pump device 24 preferably snugly against movement.
  • the triggering device 27 can be designed, in particular in the case of manual actuation, to make possible, in particular to trigger, a movement of the pump device 24 caused by the tensioning device 21.
  • the triggering device 27 is thus preferably designed to block the forming of aerosol and to release it in the activation.
  • the housing 14, in particular the housing section 42, in particular a gripping area of the housing 14, can have, carry and/or encase the pressure generator 20, the pump device 24, and/or the tensioning device 21.
  • the tensioning mechanism 28 is preferably designed for conversion of a rotational movement, in particular a pivoting or swiveling movement, of the actuating lever 26 in a linear tensioning movement that is axial here.
  • a pivoting or swiveling movement in terms of this invention is preferably a rotational movement or a movement rotating around a pivot or swivel axis, which is limited in the freedom of movement in such a way that no complete rotation is possible.
  • a swiveling movement in terms of this invention is a rotational movement, which is limited by construction, preferably to less than 180°, in particular less than 90°.
  • the triggering device 27 can preferably automatically and/or by friction and/or by overlapping block a movement of the pump device 24 induced by the tensioning device 21.
  • the triggering device 27 By activation of the triggering device 27, in particular by movement against a movement ensuring that the triggering device 27 blocks the pump device 24 against movement, the movement of the pump device 24 can be released, and the pump device 24 can be moved or driven by means of the tensioning device 21.
  • the aerosol 3 can be formed from the pharmaceutical agent preparation 4 as described above.
  • the triggering device 27 can optionally be secured with a triggering blocker 46 against the triggering of the releasing of aerosol.
  • the triggering blocker 46 can automatically secure the triggering device 27 against triggering. It is preferred that the triggering blocker 46 automatically releases the triggering device 27 as soon as the actuating lever 26 has again reached its rest position. Then, the triggering device 27 can be actuated, for example manually, in particular by actuating an actuating element 56, in particular a button, or automatically. The triggering device 27 can be activated or actuated automatically when reaching the tensioned position and/or when the actuating lever 26 again reaches its rest position. In particular, the triggering by the triggering device 27 comprises a release of the pump device 24, so that the pump device 24 can be moved by the tensioning device 21 and in this way the aerosol 3 can be realized.
  • the actuating lever 26 can have a reset element 47 such as a spring, which is designed to move the actuating lever 26 into its rest position or to hold it there.
  • the tensioning device 21 can bring the actuating lever 26 back into the rest position via the tensioning mechanism 28. It is preferred, however, that after the tensioning process, the tensioning mechanism 28 be completely detached from the pump device 24, so that the pump device 24 can be moved independently of the tensioning mechanism 28 by the tensioning device 21 . Therefore, it is preferred that a reset element 47, independent of the tensioning device 21 , be provided, for example a spring, a rubber seal, or the like, acting on the actuating lever 26 in the direction of the reset position.
  • a pivot or swivel axis of the actuating lever 26 at the pivot point 41 can be arranged crosswise and spatially offset relative to the longitudinal axis L of the inhaler, in particular an axis that corresponds to the direction of movement of the pump device 24 and/or the discharge direction of the discharge nozzle 2. In this way, it can be achieved that the pivot point 41 of the actuating lever 26 with the housing 14 does not impede the flow of the aerosol 3. Furthermore, in the spatially offset arrangement of the pivot point 41 relative to the longitudinal axis L, the elbow lever 30 can be operated closer to its extension, i.e., with a greater lever action.
  • the inhaler 1 is designed for metered spraying of the pharmaceutical agent preparation 4 and has an indicator 48, which has a metering ring 50, mounted to rotate around an axis of rotation 49, with indicator means 51 for displaying a number of still available or already administered doses, in particular, i.e., a dose indicator.
  • Figs. 6 and 7 show in sections essential parts of the indicator 48 with and without a pressure generator 20.
  • the metering ring 50 preferably comprises a preferably axial through passage 52.
  • the through passage 52 can be arranged and designed in such a way that the pressure generator 20 or parts thereof, in particular the pump device 24, can be arranged in the through passage 52.
  • the metering ring 50 can thus be arranged around the pressure generator 20 or the pump device 24.
  • the metering ring 50 can be guided in a groove or link.
  • other guide means in particular at least three, preferably at least four, guide arms 53 can be provided, which are mounted to rotate the metering ring 50 and/or to prevent a lateral or axial movement.
  • Different indicator means 51 can furthermore be combined; for example, the same metering ring 50 can include still available or already administered doses, dashes to display in each case a dose consisting of multiple triggerings and/or a colored, for example, red, marked area, which can warn of a reduced remaining amount of the pharmaceutical agent preparation 4.
  • the same metering ring 50 can include still available or already administered doses, dashes to display in each case a dose consisting of multiple triggerings and/or a colored, for example, red, marked area, which can warn of a reduced remaining amount of the pharmaceutical agent preparation 4.
  • other solutions are also possible.
  • the inhaler 1 in particular the housing 14, can have a window 54 for visibility of the metering ring 50 arranged in the inhaler 1 (cf. also Fig. 1 ).
  • the metering ring 50 can be moved or rotated by the triggering device 27.
  • the triggering device 27 can be assigned to the pressure generator 20, in particular wherein the triggering device 27 can block and/or release the pressure generator 20.
  • the pressure generator 20 is especially preferably designed or works mechanically as a pump. The same triggering device 27 can be used for driving the metering ring 50.
  • the inhaler 1 in particular the triggering device 27, has a pivot or swivel arm 55, wherein the metering ring 50 can be moved or rotated by pivoting or swiveling the pivot or swivel arm 55.
  • the pivot or swivel arm 55 is configured as a blocking ring or section of a blocking ring for blocking and releasing the pressure generator 20. It is preferred that, by means of the pivoting or swiveling movement of the pivot or swivel arm 55, the metering ring 50 be driven in order to have the display track the number of still available or already dispensed doses in preferably each individual triggering of the inhaler 1.
  • the metering ring 50 can be transported with release of the pump device 24 or the tensioning device 21. Then, the tensioning device 21 is tensioned again with the tensioning mechanism 28. As an alternative or in addition, the metering ring 50 is driven in - or by - locking or pivoting or swiveling of the pivot or swivel arm 55.
  • the pivot or swivel arm 55 can be pre-tensioned against the positive device 57, preferably against the pump device 24, in particular against the holder 25, so that the pivot or swivel arm 55 can secure the pressure generator 20 automatically against triggering by friction when the tensioning process is completed.
  • the pivot or swivel arm 55 is clamped in particular by means of a spring against the pump device 24.
  • the pivot or swivel arm 55 reaches the coupling device 60, in particular an upper edge, recess, or the like, of the pump device 24, preferably automatically swivels laterally over the edge, into the recess, or in another way forms a positive fit, which prevents an axial pump movement of the pump device 24.
  • a drive of the metering ring 50 can be prepared, so that the metering ring 50 can be rotated (again) with triggering.
  • the actuating lever 26 be longer than 10 cm, preferably longer than 12 cm, in particular longer than 14 cm and/or shorter than 20 cm, preferably shorter than 18 cm, and in particular shorter than 16 cm, and/or can be swiveled by more than 5°, preferably more than 10°, in particular more than 15° and/or less than 45°, preferably less than 40°, and in particular less than 35°.
  • the inhaler 1 preferably comprises a non-return device 58, which blocks a rotation of the metering ring 50 in one direction and/or allows a rotation of the metering ring 50 only in a direction of rotation.
  • the triggering device 27, in particular the pivot or swivel arm 55 has a drive device 59, which is configured to rotate the metering ring 50, preferably by pivoting or swiveling the pivot or swivel arm 55.
  • the metering ring 50 can have a coupling device 60 for driving the metering ring 50 by the drive device 59, in particular a drive track or a positive device, preferably a gear.
  • the coupling device 60 is formed on a front surface and/or by a gear, in particular with asymmetrical tooth flanks.
  • the drive device 59 can be configured to engage in the coupling device 60 of the metering ring 50.
  • the drive device 59 comprises a carrier, a detent pawl, a tongue, or the like or is designed as a carrier, detent pawl or tongue.
  • the drive device 59 comprises a carrier, a detent pawl, a tongue, or the like or is designed as a carrier, detent pawl or tongue.
  • the drive device 59 comprises a carrier, a detent pawl, a tongue, or the like or is designed as a carrier, detent pawl or tongue.
  • the drive device 59 comprises a carrier, a detent pawl, a tongue, or the like or is designed as a carrier, detent pawl or tongue.
  • 59 is flexible, bendable, and/or has an edge for engagement in the coupling device
  • the pivot or swivel arm 55 can swivel preferably more than 2°, in particular more than 4°, and/or less than 45°, preferably less than 30°, in particular less than 20°, and in the illustrative example approximately 5° to 10°.
  • the drive device 59 can engage with the coupling device 60 and can be moved via or relative to the coupling device 60. In this way, the drive device 59 can be moved into a position in which the drive device 59 can be coupled at another point in the coupling device 60, in particular in the next or another tooth of the gear.
  • the metering ring 50 can be rotated successively, preferably triggering for triggering, in each case by at least essentially the same angle. It is preferred that the drive device 59 and the coupling device 60 be designed and arranged relative to one another so that the drive device 59 drives the coupling device 60 in one direction and can be shifted in the opposite direction relative to the coupling device 60.
  • the coupling device 60 is preferably provided on a front side of the metering ring 50, and the indicator means 51 is provided on an outer peripheral surface of the metering ring 50.
  • the angle of rotation of the metering ring 50 be between 0.5° and 1.5° per triggering. In this way, on the one hand, a precise enough display can be achieved, and, on the other hand, a sufficient number of doses that can be metered can be achieved.
  • the metering ring 50 is designed to indicate more than 120, preferably more than 150, and/or less than 250, preferably less than 220, and in particular approximately 180 doses.
  • a characteristic of this solution consists in that the drive device 59 can be moved preferably by pivoting or swiveling the pivot or swivel arm 55 around a first axis of rotation 61 on a driving means track 62.
  • the coupling device 60 of the metering ring 50 can be moved around a second axis of rotation 63 on a metering ring track 64.
  • the driving means track 62 and the metering ring track 64 indicated in Figs. 6 and 7 by arrows, be different.
  • the driving means track 62 and the metering ring track 64 intersect, preferably only once.
  • the position of the axes of rotation 61 and 63 can be different.
  • the first axis of rotation 61 of the driving means 62 lies within the metering ring track 64 or the metering ring 50.
  • the driving means track 62 and the metering ring track 64 can have different radii. It is preferred that the first axis of rotation 61 and the second axis of rotation 63 be arranged at least essentially parallel to one another or point spatially in the same direction.
  • the drive device 59 especially preferably comprises a detent pawl or another carrier, and the coupling device 60 comprises an especially asymmetrical gear.
  • the drive device 59 have a guide surface 65, which is designed to rotate the metering ring 50 by moving the guide surface 65 along the coupling device 60, in particular the gear, of the metering ring 50. In this way, a pivoting or swiveling of the pivot or swivel arm 55 can be implemented especially effectively in a rotational movement of the metering ring 50.
  • the guide surface 65 can be inclined relative to a tangent to the driving means track 62, preferably so that the movement of the guide surface 65 makes possible an advancing of the metering ring 50.
  • the guide surface 65 moves the metering ring 50 by means of a tooth of the coupling device 60 with a movement of the drive device 59 with the guide surface 65, which removes the drive device 59 from the second axis of rotation 63 of the metering ring 50.
  • other design solutions are also possible.
  • the drive device 59 can be pre-tensioned against the coupling device 60. With this, it can be achieved that the drive device 59 can slide over the coupling device 60 when moving in a direction blocked by the non-return device 58 and can drive the metering ring 50 again to a changed position. To this end, the drive device 59 can be spring-loaded or elastically deformable. Furthermore, it is preferred that the drive device 59 be tongue-shaped, elongated and/or flat. In this way, a pre- tensioning can be realized especially easily and effectively, which ensures a secure drive and at the same time supplies the elasticity that prompts the drive device 59 to move toward the rotational direction relative to the coupling device 60.
  • the drive device 59 is preferably fastened to the pivot or swivel arm 55, molded-on and/or formed in one piece with the pivot or swivel arm 55.
  • the drive device 59 can also be shifted only laterally in order to drive the metering ring 50.
  • the metering ring track 64 and the now straight drive means track 62 intersect.
  • the guide surface 65 can be designed in such a way that guiding of the guide surface 65 along the coupling device 60 makes possible a drive of the metering ring 50.
  • still other design solutions are also conceivable.
  • the metering ring 50 can have an outside diameter that is larger than 1 cm, preferably larger than 1.5 cm, in particular larger than 1.8 cm, and/or smaller than 4 cm, preferably smaller than 3.5 cm, and in particular smaller than 3 cm. This makes possible a detailed application of the indicator means 51 , in particular a fine scale.
  • an inhalation valve 66 is provided, which is depicted in Fig. 8 as an exploded drawing, closed in Fig. 9, and open in Fig. 10.
  • the inhalation valve 66 comprises a valve element 67, in particular a valve flap or membrane.
  • the valve element 67 is preferably flexible, bendable, flat, thin, disk-like, conical at least in sections and/or membrane-like.
  • the valve element 67 can have silicone or LSR (liquid silicone) or be formed therefrom.
  • the inhalation valve 66 is preferably arranged outside of the chamber 6, but can also form part of the chamber 6.
  • the inhalation valve 66 is designed for intake of ambient air 8 into the chamber 6, wherein the inhalation valve 66 is preferably blocked or throttled in the reverse direction in particular so that in the case of exhalation, no air and no aerosol from the chamber 6 can be released through the inhalation valve 66 into the environment.
  • the inhalation valve 66 is preferably designed as a nonreturn valve or membrane-like valve, with or without pre- tensioning in the closed position.
  • other design solutions are also possible.
  • the valve element 67 is designed to be annular and comprises an outer edge 68 and an inner edge 69.
  • the valve element 67 is fastened to the outer edge 68, and the inner edge 69 forms the boundary of an through passage 70 of the valve element 67.
  • the inhalation valve 66 has a valve body seat 72 for the valve element 67, which corresponds to the inner edge 69.
  • the inhalation valve 66 is preferably configured so that in the case of excess pressure in the chamber 6 relative to the environment or in the case of a respiratory process in the chamber 6, the inhalation valve 66 closes, wherein the valve element 67 rests or is pressed snugly on the valve body seat 72 - cf. Fig. 10. In a respiratory process, the inhalation valve 66 is opened, and this allows ambient air 18 to flow in through the inhalation valve 66 into the chamber 6. To this end, it is provided that the valve element 67 forms an opening, which makes it possible, by deforming on its inner edge 69, for the ambient air 18 to flow in. ln the illustrative example, the outer edge 68 of the valve element 67 is snugly fastened all the way around.
  • An opening of the inhalation valve 66 is carried out on the inner edge 69 of the valve element 67.
  • the valve element 67 is lifted from the valve body seat 72 by a pressure differential in the flow direction, ensuring that an opening in the area of the through passage 70 is made.
  • the inhalation valve 66 thus preferably opens only on the inner edge 69.
  • the discharge nozzle 2 is preferably arranged in the through passage 70.
  • the discharge nozzle 2 can be arranged so that an aerosol 3 released by the discharge nozzle 2 can be released through the through passage 75 or can be introduced into the chamber 6.
  • the combination of the aerosol release in the area of the through passage 75 or 70 and the opening of the inhalation valve 66 on the inner edge 69 advantageously results in that an air stream that passes through the inhalation valve 66 can form a jacket around the aerosol 3, as is known from, for example, turbofan engines of aircraft for sound insulation.
  • the concentration of active ingredients is thus preferably reduced in the edge area of the flow. In this way, it is achieved that only comparatively few particles of the pharmaceutical agent preparation 4 or the aerosol 3 come into contact with a wall of the chamber 6 or the dispensing device 7 and are deposited.
  • the inhalation valve 66 according to the proposal thus advantageously results in an especially efficient releasing of the aerosol 3 with the pharmaceutical agent preparation 4.
  • the inhaler 1 has a stop 71 for the valve element 67 on a side of the valve element 67 that faces away from the valve body seat 72.
  • the stop 71 can prevent an overexpansion and damage of the valve element 67.
  • the stop 71 furthermore makes it possible, when the valve element 67 is at rest, to pre-specify a flow geometry, which in an adequate valve opening is at least essentially independent of the size of the volume flow, which passes through the open inhalation valve 66.
  • the chamber 6 with the valve element 67 in the open position forms a closed flow wall 73 and/or nozzle.
  • the chamber 6 have the stop 71 that corresponds to the inner edge 69 of the valve element 67, on which the valve element 67 rests snugly in the open position, ensuring that the closed flow wall 73 is realized.
  • flow detachment which would be associated with the forming of eddies or vortices, can be avoided, wherein eddies or vortices can cause particles of the pharmaceutical agent preparation 4 from the aerosol 3 to make increased contact with the chamber 6 or to precipitate in the chamber 6.
  • valve element 67 with the chamber 6 form a nozzle, in particular by a flow cross-section decreasing by means of the valve element 67 in the direction of flow and then increasing by the chamber 6 in the direction of flow.
  • a valve nozzle can be realized, ensuring that a forming of aerosol can be supported by the discharge nozzle 2.
  • the inhalation valve 66 is preferably rotationally symmetrical to the longitudinal axis L of the inhaler 1 or to a dispensing direction of the discharge nozzle 2. In this way, a passage of the air flow that is especially free of eddying is made possible by the inhalation valve 66, thereby reducing the probability that aerosol components will then condense.
  • the inhalation valve 66 has a collecting device 74 for solid and/or liquid substances.
  • the collecting device 74 preferably has the valve body seat 72 and/or a receptacle 45 for the discharge nozzle 2.
  • the collecting device 74 can have a through passage 75 to accommodate the discharge nozzle 2 or for the aerosol 3 being run through.
  • the collecting device 74 can be designed to collect secretions or condensates, in particular nasal discharges or respiratory condensates, in order to prevent the latter from crusting and blocking the inhalation valve 66, in particular the valve element 67, and/or the discharge nozzle 2 or an opening of the discharge nozzle 2.
  • the collecting device 74 can adjoin the valve body seat 72 or form the valve body seat 72.
  • the collecting device 74 is formed in the shape of a groove, bowl or shell.
  • the collecting device 74 has an annular groove, whose outer edge forms the valve body seat 72 and/or whose inner edge has a sealing edge or sealing lip 76, which forms the through passage 75, an opening for accommodating and/or guiding the discharge nozzle 2 through.
  • the valve body seat 72 can directly form the sealing edge or sealing lip 76 for accommodating and/or guiding the discharge nozzle 2 through, in particular when the inhaler is realized without a collecting device 74. Guiding the discharge nozzle 2 or the aerosol 3 through can also be implemented in other ways.
  • the discharge nozzle 2 be taken up in the inhalation valve 66, be encompassed by the inhalation valve 66, and/or be arranged in the through passage 70 of the valve element 67.
  • the pharmaceutical agent preparation 4 or the aerosol 3 is guided through the through passage 70 into the chamber 6.
  • the inhalation valve 66 is designed as a one-way valve or non-return valve. To this end, the inhalation valve 66 can make possible a flowing-in of the ambient air 18 through the inhalation valve 66 and/or can prevent an exiting of air or aerosol 3 through the inhalation valve 66.
  • the through passage, breakthrough or opening 70 of the discharge nozzle 2 is preferably arranged downstream from the valve body seat 72 and/or a valve plane that is formed by the valve body seat 72. In this way, it can be achieved that the aerosol 3 is applied only after passage of the air 18 through the inhalation valve 66, and consequently no aerosol components condense on the valve element 67.
  • the discharge direction of the discharge nozzle 2 be at least essentially identical to a main direction of flow of the air 18 from the inhalation valve 66.
  • the discharge direction of the discharge nozzle 2 and the main direction of flow of the air 18 from the inhalation valve 66 are parallel and/or coaxial, in particular relative to the longitudinal axis L. In this way, an especially efficient aerosol transport is ensured.
  • the stop 71 preferably formed by the intake opening of the chamber 6, preferably corresponds in shape and diameter to the inner edge 69 of the valve element 67. In this way, an especially uniform flow wall 73 can be achieved, ensuring that eddies or vortices and eddy- or vortex- induced deposition of aerosol components can be avoided.
  • the stop 71 is formed by an edge of an intake opening 85 of the chamber 6. This advantageously makes possible continuous flow guidance and flow forming of the air 18 in the flow through the inhalation valve 66 into the chamber 6.
  • the intake opening 85 of the chamber 6 can have a section that conically narrows in the opening direction.
  • the conically-narrowing section is preferably designed to be free-standing or forms a collar-shaped extension of the chamber 6, which can end in the intake opening 85.
  • the outer edge 68 of the valve element 67, the inner edge 69 of the valve element 67, the valve body seat 72, the collecting device 74 and/or the stop 71 can be designed at least essentially annular and/or can be arranged with one another in such a way that the focal points or geometric foci lie on a common axis, in particular the longitudinal axis L of the inhaler 1 .
  • the longitudinal axis L preferably corresponds to the linear direction of movement of the pump device 24 and/or the discharge direction of the discharge nozzle 2.
  • the inhalation valve 66 can have a fastening element 77 for circumferential fastening of the valve element 67, in particular on its outer edge 68.
  • the inhalation valve 66 can furthermore have a clamping ring 78 for clamping the valve element 67 to the fastening element 77.
  • the valve element 67 is thus clamped between the fastening element 77 and the clamping ring 78.
  • the valve element 67 can also, however, be connected preferably snugly with the fastening element 77 in another way or can be fastened to the latter, in particular by an adhesive connection. A frictional connection by means of the clamping ring 78 is preferred, however.
  • valve element 67 By the fastening element 77, the clamping ring 78 or in another way, the valve element 67 can be clamped or pre-tensioned against the valve body seat 72.
  • the valve element 67 thus snugly rests in a rest positionor without the application of force on the valve element 67 preferably on the valve body seat 72. This can be achieved, on the one hand, by clamping or gripping, as an alternative or in addition also by the shape or internal stress of the valve element 67 or in another way.
  • the inhalation valve 66 is designed with pre-tensioning in the closed position. However, other design solutions are also possible.
  • the inhaler 1 can have incoming air openings 79 in particular on the intake side or upstream from the inhalation valve 66, openings that make possible a flow of ambient air 18 to the intake side of the inhalation valve 66.
  • the incoming air openings 79 are formed by through passages of the housing 14.
  • the fastening element 77, the collecting device 74, and/or the valve body seat 73 can be connected to one another via at least one arm, in particular can be formed in one piece.
  • the inhaler 1 has a respiration indicator 80, which has a wall section 81 of a chamber wall 82 that forms the chamber 6 or is formed in this way.
  • the wall section 81 is configured to indicate a respiratory activity by deforming and/or movement.
  • the respiration indicator 80 is designed to indicate a pressure differential between the inside space and the surrounding area of the chamber 6.
  • the wall section 81 can be designed to be expandable, flexible, deformable, curved, dome-shaped and/or membrane-like. In this way, it is made possible that comparatively small pressure differentials also lead to a deforming or movement in order to indicate the respiratory activity.
  • the respiration indicator 80 can preferably be nontransparent, translucent, or opaque. This facilitates the reading.
  • the wall section 81 can be designed to be at least partially deformed in the shape of a vault or dome or curved in another way under the action of breathing in, out or through the chamber 6. In this case, a peak 83 or vault can be formed, in particular by a pressure differential acting on the wall section 81 between the inside space and surrounding area of the chamber 6 and the wall section 81 thus being deformed in a corresponding way.
  • the peak 83 can be facing the inside space of the chamber 6.
  • a concave deforming is thus formed.
  • the chamber 6 preferably has rounded walls, a concave deforming of the wall section 81 , i.e., especially already present if a convex basic shape is at least partially compensated for.
  • a deforming in the intake from or through the chamber 6 or in the case of underpressure in the chamber 6 relative to the surrounding area in which as a result, the concave deforming also leads to a concave surface in the area of the wall section 81.
  • the wall section 81 is preferably designed in such a way that under the action of breathing in the chamber 6 or in the case of overpressure in the chamber 6 relative to the surrounding area, it is convexly deformed or curved or deformed or curved in such a way that the peak 83 is formed on a side facing away from the inside space of the chamber 6.
  • the convex deforming forms in an already convex basic shape in a rest positionor the like of the wall section 81 , i.e., a convex basic shape is curved in a more convex manner by the convex deforming.
  • the wall section 81 can be deflected or deviated at least partially under the action of breathing in, out, and/or through the chamber 6.
  • the deflection or deviation is carried out preferably by material deforming or material expansion.
  • the latter is preferably carried out elastically or reversibly, so that an indication of respiratory activity can be implemented in multiple ways.
  • a material deforming or material expansion or other movement or deviation of the wall section 81 is preferably more than 0.5 mm, in particular more than 1 mm or 2 mm, in the illustrative example more than 3 mm, and/or less than 20 mm, preferably less than 15 mm, and in particular less than 10 mm.
  • Such a material deforming or material expansion or other deviation is optically readily detectable.
  • Too large material expansion can, however, result in the formation of volume differences of the chamber 6 or in an influencing of the flow characteristic of the chamber 6 by changing the flow wall. Disruptions of the flow path can result in an increased deposition of aerosol components on the chamber wall 82, i.e., in a loss of active ingredient.
  • the wall section 81 can have multiple stable states.
  • the wall section 81 can occupy (only) two stable states, in which the wall section 81 is curved in each case.
  • the wall section 81 can have a material excess increasing inward or a curved basic shape. If the shape of the wall section 81 is compensated for by exerting a force, for example by a pressure differential, the wall section 81 turns into a reverse shape.
  • Such an unstable or changing behavior offers the advantage that a strong movement of the change can readily be detected by eye over a comparatively short time.
  • an acoustic signal or the like can also be generated by a change in the shape direction.
  • the respiratory sensor 80 can thus acoustically signal respiration.
  • the wall section 81 is thus preferably designed to turn or to change from a concave to a convex shape or vice versa, preferably under the action of breathing in, out, or through the chamber 6 or by the pressure differential that acts on the wall section 81.
  • the inhaler 1 is preferably designed so that in the case of an intake process in the chamber 6 relative to the surrounding area, an underpressure results, which is considerably greater than 0.2 hPa, preferably greater than 0.5 hPa, and in particular greater than 1 or 2 hPa.
  • the underpressure is considerably less than 10 hPa, preferably less than 5 hPa, and in particular less than 4 or 3 hPa.
  • a pressure differential of more than 0.2 or 0.5 hPa is advantageous in order to make possible a sufficient deviation, deforming or movement of the wall section 81.
  • an indication of the respiratory activity is especially easy by a comparatively large deforming of the wall section 81 .
  • An underpressure of less than 10, 6 or 5 hPa is preferred since the underpressure accompanies a corresponding intake resistance for the patient or other user of the inhaler 1 - a correspondingly lower underpressure than an effective and complete inhalation thus supports.
  • An underpressure of less than 4 or 3 hPa is especially preferred.
  • the wall section 81 is preferably designed to indicate the respiratory activity in the case of the described pressure differentials in particular via a shape.
  • the shape or maximum deviation of the wall section 81 can lie in a range of between 0.5 mm and 20 mm in the case of the described pressure differentials.
  • the pressure differentials in an expiratory process can deviate from those under the action of breathing out or through the chamber 6.
  • the inhaler 1 preferably has the inhalation valve 66, which automatically closes under the action of breathing in the chamber 6.
  • the dispensing device 7 is preferably designed for use in a bodily orifice, in particular in a nose hole or nostril 9. Therefore, an expiratory process can be carried out by an alternative bodily orifice, such as another nose hole or the like. In the chamber 6, an overpressure or dynamic pressure results in such a case in an expiratory process in the chamber 6.
  • the pressure differential adjoining the wall section 81 due to the dynamic pressure in the chamber 6 can be less than 50 hPa, preferably less than 40 or 30 hPa, and in particular between 5 and 15 hPa, relative to the surrounding area of the chamber 6. Therefore, it is preferred that the wall section 81 be designed to make possible a shape outward in the case of corresponding pressure differentials, which allow a non-destructive indication of a respiratory activity, in particular between 0.5 mm and 20 mm.
  • the wall section 81 can be designed so that under the action of breathing in the chamber 6, a noticeable shape of, for example, 1 to 5 mm results; the shape in an opposite direction during the intake process, i.e., under the action of breathing out or through the chamber 6, however, precipitates comparatively little and lies, for example, between 0 mm and 1 mm.
  • the respiratory activity can be indicated, since at least the presence or absence of a deforming or movement can be detected. It thus may be enough that a movement and/or deforming can be detected by eye only in the case of an expiratory process, and a beginning intake process is indicated in that a deforming or movement of the wall section 81 is inferred.
  • the inhaler 1 is provided with the respiration indicator 80, wherein the inhaler 1 has the chamber wall 82 that forms the chamber 6 and a dispensing device 7, wherein the dispensing device 7 for fluidic connection of the chamber 6 to the bodily orifice is introduced or inserted into the bodily orifice, or is applied on the bodily orifice. Then, a patient can breathe through and/or in the inhaler 1.
  • the respiration indicator 80 which has the wall section 81 of the chamber wall 82 or is formed in this way, is observed, and, depending on the deforming and/or movement of the wall section 81 , the dispensing of medication, in particular the forming of aerosol, is triggered. It is a goal to start the forming of aerosol at the beginning of an intake process so that the aerosol 3 can be inhaled as quickly and completely as possible.
  • the wall section 81 has a shape or peak that faces away from the inside space of the chamber 6, and a forming of aerosol is triggered as soon as this shape decreases or as soon as this shape disappears or changes. In this way, the forming of aerosol can be synchronized in an advantageous way with the intake process.
  • the pressure differential between the inside and outside of the chamber 6 can be determined decisively by cross-sections or fluidic properties of the inhalation valve 66 or the intake opening 85 of the chamber 6.
  • the inhaler 1 or the intake opening 85 of the chamber 6 is designed to exhibit flow resistance, by which under the action of breathing in, out, or through the chamber 6, an underpressure and/or overpressure can be generated in the chamber 6 relative to the surrounding area, by which the wall section 81 can be deformed and/or moved.
  • the detectability of the deforming or movement can be supported in that the respiration indicator 80 has an indicator means 84.
  • the indicator means 84 can be designed to react with the deforming or movement of the wall section 81 , in particular by a change in the color or color intensity, a change in the reflection or transmission properties relative to visible light, by (enhanced) movement, and/or acoustically.
  • a hologram can be applied to the wall section 81 that produces color and reflection changes even in the case of very small positional changes of areas of the wall section 81 , which changes can be clearly detectable by eye even if the movement or deforming was difficult to detect as such with the naked eye.
  • a pin or arm can be provided in the area of the wall section 81 , and said pin or arm converts the deforming or movement of the wall section 81 into a more significant movement.
  • the wall section 81 can be inserted or is insertable, preferably by friction, into the chamber wall 82. Also, the wall section 81 can be connected snugly, in particular in an airtight or pressure-sealed way, with the chamber wall 82 and sprayed, bonded, welded or clamped on the chamber wall 82. As an alternative, the wall section 81 can also be formed by the chamber wall 82. A snug fastening of the wall section 81 to the chamber wall 82 has the advantage that the respiration indicator 80 according to the proposal draws no secondary air, which would be disadvantageous for the transport of aerosol and furthermore could lead to active ingredient losses via eddying of the aerosol 3 guided into the chamber 6.
  • the respiration indicator 80 in particular the wall section 81 , is preferably arranged outside of the flow, thus the air stream is preferably not impeded by the chamber 6 or the releasing of aerosol.
  • the inhaler is preferably closed or designed to be airtight between the intake opening 85 of the chamber 6 and an outlet 10 of the dispensing device 7.
  • the wall section 81 and the chamber wall 82 can have different materials and/or material thicknesses. In this case, it is preferred that the material of the wall section 81 be more flexible, slightly more expandable, and/or thinner than the material of the chamber wall 82. This makes possible a movement or deforming of the wall section 81 by which respiratory activity can be indicated.
  • the wall section 81 can have a connecting means for fastening in a through passage 88 of the chamber wall 82.
  • the wall section 81 can thus be inserted or is insertable into an through passage 88 of the chamber wall 82.
  • the wall section 81 has a frame 86, which can limit the wall section 81 and can have a contour that corresponds to a limitation or an end of the through passage or through passage 88 of the chamber wall 82.
  • the frame 86 or another connecting means is preferably configured for airtight and/or pressure-sealed connection of the wall section 81 with the chamber wall 82.
  • the connecting means can encompass a limitation of the through passage 88 of the chamber wall 82, or the limitation of the through passage 88 of the chamber wall 82 is configured for encompassing the edge or frame of the wall section 81.
  • the connecting means can include an edge with a U-shaped cross section that is configured to encompass/receive the edge of the through passage 88 of the chamber wall 82.
  • the frame 86 can be bonded with the chamber wall 82.
  • the respiration indicator 80 is preferably arranged above or facing the user in a position of use of the inhaler 1 .
  • the inhaler 1 can be provided in particular for use with a horse 5.
  • the dispensing device 7 be designed for use in a horse's nostril 9, wherein the position of use can relate to an inhaler 1 inserted into the horse's nostril 9.
  • the respiration indicator 80 can be arranged above and/or on the right relative to the longitudinal axis L in the direction of flow of the inhaler 1 , which can comply with the dispensing direction of the discharge nozzle 2. This enables an angle of observation, from which the movement of the wall section 81 is especially easy to observe.
  • the wall section 81 can have a surface area that is larger than 0.5 cm 2 , preferably larger than 1 cm 2 , in particular larger than 2 cm 2 , and/or smaller than 25 cm 2 , preferably smaller than 20 cm 2 , and in particular smaller than 15 cm 2 .
  • a larger surface area of the wall section 81 greater deviations at the same pressure differential can be generated, which promotes a clearness of display of the respiration indicator 80.
  • a very large wall section 81 leads to the fact that the flow geometry of the inhaler 1 can change based on the pressure differential between the inside space of the chamber 6 and the surrounding area, which at least in the case of more significant changes can lead to an increased condensation of the pharmaceutical agent preparation 4 from the aerosol 3.
  • a very large wall section 81 can lead to instabilities of the chamber 6.
  • the preferred values therefore represent a good compromise between the advantages and disadvantages that are connected with different surface areas of the wall section 81.
  • the wall section 81 can continue a jacket line or contour line of the chamber wall 82 adjoining the wall section 81 without a pressure differential between the inner and outer sides and/or can align with the chamber wall 82 adjoining the wall section 81. This makes possible an outside shape of the chamber 6 that is uniform in a state of rest without a pressure differential; this reduces susceptibility to contamination and furthermore is also aesthetically advantageous.
  • the wall section 81 can have a sealing surface for attachment to a boundary of the through passage 88, wherein the sealing surface is designed to be attached snugly to the boundary of the through passage 88 when inserting the wall section into the through passage 88.
  • the inhaler 1 can be designed to generate a pressure loss or underpressure in the chamber 6 that is greater than 0.5 hPa, preferably greater than 1 hPa, in particular greater than 2 hPa, and/or less than 10 hPa, preferably less than 6 hPa, and in particular less than 4 hPa.
  • the wall section 81 can have an elastomer, latex, nitrile rubber, neoprene, polyurethane, styrene-ethylene-butadiene-styrene, styrene-butadiene rubber and/or silicone, or can be at least essentially formed therefrom.
  • the wall section 81 can have a material - or be formed therefrom - which has an elasticity module of smaller than 0.1 kN/mm2, preferably smaller than 0.05 kN/mm2, and in particular smaller than 0.02 kN/mm2.
  • the wall section 81 has a wall thickness that is less than 300 ⁇ , preferably less than 200 ⁇ , in particular less than 150 ⁇ , and/or greater than 10 ⁇ , preferably greater than 20 ⁇ , and in particular greater than 50 ⁇ . In this way, a reliable display can be ensured.
  • the wall section 81 can be designed to generate a mechanical stress increasing disproportionately with increasing deviation or expansion. In this way, damage by overexpansion can be prevented.
  • the wall section 81 can be arranged removed or at a distance from the outlet 10 and/or the intake opening 85 by more than 3 cm, preferably more than 4 cm, and/or less than 10 cm, preferably less than 8 cm. In this way, the respiration indicator 80 is also visible during use and, moreover, is arranged so that sufficient pressure differentials occur through the respiratory process.
  • the wall section 81 can have a main extension surface with a surface normal in the center relative to the main extension direction of the wall section, wherein the normal a) is crosswise, in particular perpendicular, to a main flow direction in the area of the wall section 81 ; b) is crosswise, in particular perpendicular, to a releasing direction of the discharge nozzle 2; and/or c) encompasses an angle in a spraying in a main flow direction in the area of the wall section 81 and/or in a spraying in the releasing direction of the discharge nozzle 2, of the inhaler 1 with a releasing direction in the area of the outlet 10 of the adapter, which angle is more than 30°, preferably more than 40°, in particular more than 45°, and/or less than 80°, preferably less than 70°, and in particular less than 65°. Surprisingly enough, it has been shown that at such a position, visibility and function are optimal.
  • the respiration indicator 80 in particular the wall section 81 , can be used for a sealing test.
  • the inside space of the chamber 6 can be tensioned starting from the dispensing device 7.
  • the inhalation valve 66 can close in such a case.
  • the overpressure that forms can, also independently of a respiratory process, be indicated by the respiration indicator 80. In this way, a sealing test or the like can be performed.
  • the sealing test can serve in particular to check for adequate sealing between the chamber 6 and the dispensing device 7, between the chamber 6 and the housing 14, and/or between the housing 14 or the chamber 6 and the inhalation valve 66.
  • the inside space formed by the chamber 6 and/or the dispensing device 7 can be tensioned and closed.
  • An overpressure that is generated in this way can be indicated by the respiration indicator 80.
  • a pressure loss can be indicated in particular by the movement or deforming of the wall section 81. In this way, a leak, which leads to a pressure loss, can be indicated by the respiration indicator 80 or the wall section 81.
  • the respiration indicator 80 can be designed in a continuous display of the respiratory activity and/or pressure change between the inside space of the chamber 6 and the surrounding area.
  • breathing in, out, and/or through the chamber 6 leads to a continuous pressure fluctuation corresponding to the respiratory activity.
  • Such a continuous pressure fluctuation can advantageously be indicated continuously by the respiration indicator 80 according to the proposal. In this way, it is possible to differentiate in an advantageous way between multiple sections, in addition to the respiratory direction, even within the intake and expiratory phases. This makes possible an especially exact determination of a triggering time.
  • the respiration indicator 80 can be designed to indicate respiratory activity analogously, in particular by a deviation, position and/or deforming that is/are at least essentially continuous and/or correspond(s) to the pressure differential between the inside space and the surrounding area of the chamber 6.
  • a deviation, position and/or deforming that is/are at least essentially continuous and/or correspond(s) to the pressure differential between the inside space and the surrounding area of the chamber 6.
  • other solutions are also possible.
  • the tensioning mechanism 28 can also be realized for triggering an MDI or independently by an SMI.
  • the inhalation valve 66 can also be used for other purposes beyond the inhalers and can be realized individually.
  • the indicator 48 according to the proposal can likewise also be realized individually and independently for displaying already released or still available pharmaceutical doses, preferably in combination with a triggering mechanism.
  • the same is true for the respiration indicator 80, which can also be integrated in a wall of other devices. Synergistic effects result in particular in a combination of the tensioning mechanism 28, triggering concept and/or indicator 48 with a metering ring 50 owing to the resource-conserving multiple use of components. Fig.
  • FIG. 14 shows the respiration indicator 80, according to the proposal, in a variant of the manner in which the respiration indicator 80 is preferably connected to the chamber 6 in a resting manner.
  • the respiration indicator 80 is shown in the rest position.
  • reference is preferably made to a state of the respiration indicator 80 in which the internal pressure corresponds at least essentially to the ambient pressure of the chamber 6.
  • the wall section 81 is preferably at least essentially level or flat.
  • Fig. 15 shows the deviation of the wall section 81 in the case of overpressure in the chamber 6, breathing in the chamber 6 and/or in expiratory position.
  • Fig. 16 shows the deviation of the wall section 81 in the case of underpressure in the chamber 6, with breathing out or through the chamber 6 and/or in the inhalation position.
  • the respiration indicator 80 is designed to signal breathing in, out and/or through the chamber 6 by display of the pressure differential between the inside space and the surrounding area of the chamber 6.
  • Figs. 1 1 to 13 The features and properties of the respiration indicator 80 from Figures 14 to 16 preferably correspond to those previously explained in connection with Figs. 1 1 to 13 and vice versa.
  • the chamber 6 can also have an indicator means 84. It is preferred that the chamber 6 be deformable only in the area of the wall section 81 by respiratory activity. Preferably, the chamber 6 is predominantly or at least essentially dimensionally stable. In particular, the chamber wall 82 predominantly or at least essentially is stable so that a deforming of the chamber 6 or the chamber wall 82 is prevented by differential pressures between the inside space and the surrounding area of the chamber 6, which can be realized under the action of breathing.
  • the at least essentially dimensionally-stable part of the chamber 6 preferably has the through passage 88.
  • the through passage 88 is preferably sealed airtight by the wall section 81.
  • the wall section 81 is, as already explained previously, preferably flexible in such a way that breathing that is done in, out or through the chamber 6 or a pressure differential realized in this way between the inside space of the chamber 6 and the surrounding area of the chamber 6 results in a preferably visible deforming of the wall section 81.
  • the wall section 81 or a part thereof that can be deformed by respiratory activity preferably has a surface area that is less than 20%, preferably less than 15%, in particular less than 10% of the surface area of the chamber wall 82 and/or the surface of the chamber 6. It is preferred that the chamber 6 be more than 80%, preferably more than 85%, and in particular more than 90% dimensionally stable.
  • the wall section 81 preferably comprises less than 20% or 15%, in particular less than 10%, of the chamber wall 82 that forms the chamber 6. In this way, it can be avoided in an advantageous manner that the flow geometry of the inside space of the chamber 6 is influenced under the action of the respiratory activity in, from or through the chamber 6.
  • the respiration indicator 80 or the wall section 81 is held in a resting manner on the chamber 6.
  • the chamber 6 in the illustrative example has a connecting section 87, to which the wall section 81 can be clipped or locked.
  • the connecting section 87 preferably surrounds the through passage 88, in particular continuously.
  • the connecting section 87 surrounds the through passage 88 of the chamber 6 in an annular and/or frame-like manner.
  • the connecting section 87 is preferably designed to be in the form of a flange or socket.
  • the connecting section 87 is preferably molded-on or in with the chamber wall 82 or formed in one piece with the chamber wall 82.
  • a connecting section 87 that is screwed, glued or welded to the chamber 6 or connected to the chamber 6 in some other way.
  • the connecting section 87 preferably comprises an undercut or indentation 89.
  • the undercut or indentation 89 is preferably designed to hold the wall section 81 in a particularly positive, non-positive and/or resting manner.
  • the wall section 81 is engaged in the undercut or indentation 89.
  • the wall section 81 can be held on the chamber 6 and/or connected to the chamber 6.
  • the wall section 81 is bonded, in particular glued, welded, formed and/or molded, to the chamber 6.
  • the wall section 81 is bonded to the connecting section 87.
  • the wall section can be bonded to the wall section 81 and/or the chamber 6 at the connecting section 87 or the undercut or indentation 89.
  • Gluing the wall section 81 to the chamber 6 can provide advantages regarding a flexible or elastic connection, which can be non-permanent or detachable. Welding the wall section 81 to the chamber 6 can provide advantages regarding a very durable, permanent connection. Forming or molding the wall section on the chamber 6 can provide advantages regarding a durable and reliable airtight connection, where providing the undercut or indentation 89 does not need to be provided.
  • the wall section 81 is bonded to the chamber 6 and/or to the connecting section 87 and/or to the undercut or indentation 89 in addition to a form fit of the wall section 81 with the chamber 6 and/or to the connecting section 87 and/or to the undercut or indentation 89. This enables an even more reliable and durable connection.
  • the chamber 6 and/or the connecting section 87 comprising a projection 91.
  • the projection 91 surrounds the through passage 88 preferably on a radial outer side.
  • the projection 91 preferably forms a bead that is directed radially outward and/or that extends preferably continuously.
  • the projection 91 preferably forms the undercut or indentation 89.
  • the undercut or indentation 89 can also be formed by one or more locking catches or in some other way.
  • the forming of the undercut or indentation 89 by the projection 91 in particular the projection 91 that runs continuously around the through passage 88, offers the advantage, however, of a secure fixing of the wall section 81 while achieving good sealing action simultaneously.
  • the wall section 81 is clipped or locked to the connecting section 87 or positively held in some other way on the connecting section 87.
  • a fastening section 90 of the wall section 81 preferably engages in the connecting section 87 or the undercut or indentation 89. In this way, the wall section 81 can be held in a secure and airtight manner on the chamber 6 in an advantageous way.
  • the connecting section 87, in particular the projection 91 is preferably encompassed by the fastening section 90 of the wall section 81. In this way, a preferred airtight clipping or locking connection between the wall section 81 and the other chamber wall 82 can be realized.
  • the clipping or locking of the wall section 81 to the connecting section 87 of the chamber 6 offers the advantage of a simple assembly and interchangeability of the wall section 81 .
  • a defective wall section 81 can also be interchangeable in an advantageous way by the end-user on the spot.
  • the wall section 81 preferably comprises an elastic material, impermeable material or rubber-like material or consists thereof.
  • the wall section 81 in the fastening section 90 has a higher material strength than in an area overlapping the through passage 88. In this way, a more reliable holding of the wall section 81 can be ensured.
  • the chamber wall 82 is at least essentially rigid apart from the wall section 81 and/or so as to be at least essentially unresponsive to respiratory activity, e.g., breathing in, out or through the chamber 6.
  • chamber wall 82 can be deformable by higher forces including pressure differentials between inside and outside of the chamber 6 which are at least more than ten, in particular more than hundred times higher or lower than the pressure differentials which can be achieved by respiratory activity.
  • the chamber wall 82 apart form wall section 81 preferably is at least essentially stable in form under respiratory activity.
  • the through passage, breakthrough or opening preferably are used synonymously and can be replaced by one another.
  • Figs. 7 and 18 show a view of the pressure generator 20 and the actuating lever 26 of the inhaler 1 according to another embodiment.
  • the pressure generator 20 with the pivot or swivel arm 55 is shown.
  • Fig. 20 shows the pivot or swivel arm 55 without the pressure generator 20.
  • Figures 21 to 24 show a segmented view of the pressure generator 20 with the actuating lever 26 in different positions.
  • the inhaler 1 is preferably designed to be operable with only one hand. This has the advantage that the second hand of an operator is available for other activities, in particular holding a horse 5.
  • An aspect of this invention that can also be achieved independently relates to an inhaler 1 , preferably for insertion into a nostril 9, in particular a nostril of a horse 5, with a pressure generator 20 that can be driven by a tensioning device 21 for discharging a pharmaceutical agent preparation 4, wherein the tensioning device 21 can be tensioned by movement of a tensioning part, in particular the actuating lever 26, from a first position of the tensioning part into a second position of the tensioning part, wherein the inhaler 1 is designed to block the discharge of the pharmaceutical agent preparation 4 and to produce the discharge of the pharmaceutical agent preparation 4 after movement of the tensioning part from the second position back into the first position by a repeated movement of the tensioning part from the first position in the direction of the second position.
  • the above-mentioned aspect relates to the use of the tensioning part, which is also used for tensioning the tensioning device 21 , for triggering. It surprisingly has been shown, that the use of the same part for tensioning and triggering enables a very sturdy and resource-preserving design. In particular, no knobs that are small and thus difficult to operate under adverse conditions or sensitive parts or the like are necessary.
  • the tensioning part preferably is configured such that a force F is introducible into the tensioning part.
  • the tensioning part has a grip portion, a handle or part for manual operating the tensioning part.
  • the tensioning part preferably is adapted to forward or introduce the force F acting on the tensioning part for tensioning the tensioning device 21.
  • the tensioning part can be adapted to prepare or enable discharging the pharmaceutical agent preparation 4.
  • the tensioning part can be adapted to prepare the inhalator 1 or the pressure generator 20 and/or the pump device 24 for discharging the pharmaceutical agent preparation 4.
  • the tensioning part preferably is movable, relocatable and/or slidable, preferably repeatedly.
  • the tensioning part preferably is movable, relocatable and/or slidable, wherein the tensioning device 21 is tensioned and/or the inhaler 1 , the pressure generator 20, the pump device 24 and/or discharge of pharmaceutical agent preparation 4 is triggered and/or driven.
  • the tensioning part is especially preferably realized by the actuating lever 26, since the latter enables both the above-explained advantages relative to the tensioning process as well as a precise control of the triggering even under rough environmental conditions.
  • the tensioning part can also be realized as a knob, switch, rocker or as some other movable part.
  • the tensioning part in particular the actuating lever 26, is preferably pre-tensioned in the first position, in particular the rest position , also called the resting position.
  • the reset element 47 brings about the reset into the first position and/or the pre-tensioning into the first position.
  • the reset element 47 is a spring, in particular a compression spring and/or a spiral spring in the illustrative example of Figs. 17 to 24.
  • the triggering device 27 preferably comprises the tensioning part. It is preferred that the triggering device 27 be designed to enable a triggering process only in the case of a tensioned tensioning device 21. When the tensioning device 21 is untensioned or only pre-tensioned, the triggering device 27 preferably prevents a triggering.
  • the triggering device 27 is thus preferably designed to enable or to prevent the triggering as a function of a tensioning state or a preparation or suitability for triggering and/or for discharging the pharmaceutical agent preparation 4.
  • the triggering is preferably prevented when and/or as long as the tensioning device 21 has not yet reached a preset tensioning state or the inhaler 1 is not ready or prepared in some other way for discharging the pharmaceutical agent preparation 4.
  • the triggering is prevented when and/or as long as the tensioning device 21 , the pressure generator 20, the pump element 24 and/or the holder 25 is/are not yet blocked or is/are secured against triggering.
  • the triggering by means of the tensioning part is preferably enabled when the tensioning of the tensioning device 21 reaches a preset tensioning, the inhaler 1 is prepared for administering the pharmaceutical agent preparation 4, and/or when a blocking of the pressure generator 20, in particular the pump device 24 or the holder 25, is carried out.
  • the triggering of the pump process, the pressure generation and/or the discharge of the pharmaceutical agent preparation 4 is preferably carried out after the tensioning process is concluded.
  • the triggering is carried out only after tensioning the tensioning device 21 by moving the tensioning part from the first position, in particular a rest position, in an actuating direction and after the tensioning part returns opposite the actuating direction into the first position with repeated movement in the actuating direction.
  • the triggering by movement of the tensioning part, in particular from the first position is carried out up to a trigger point.
  • the distance over which the tensioning part can be moved up to the trigger point is preferably smaller than the distance that the tensioning part must be moved in the actuating direction in order to tension the tensioning device 21 completely and/or to block the pressure generator 20, the pump device 24 and/or the holder 25.
  • the distance up to the trigger point, at which the tensioning part induces the triggering is preferably less than 50%, preferably less than 40% or 30%, in particular less than 20%, or 15% of the distance of the tensioning device up to a point at which the tensioning device 21 is completely tensioned. In this way, a quick triggering can be ensured, since triggering does not require switching hands or any major movement.
  • the aspect of the triggering based on Figs. 21 to 24 is explained in more detail, in which different movement states of the triggering device 27 are depicted. Furthermore, the invention is hereinafter explained in more detail with the tensioning lever 26 as a tensioning part. The basic idea can, however, be transferred to other tensioning part.
  • the pivot or swivel arm 55 blocks the pressure generator 20, in particular the pump device 24 and/or the holder 25, preferably in a positive manner and preferably when the tensioning process of the tensioning device 21 is concluded.
  • the pump device 24 or the holder 25 is moved axially, preferably first against a force realized by the tensioning device 21 , until the pivot or swivel arm 55 reaches the positive device 57, in particular an edge or a projection of the pump device 24 or the holder 25.
  • the tensioning device 21 is tensioned.
  • the energy stored in the tensioning device 21 can drive the pressure generator 20, preferably a mechanical pump mechanism for discharging the pharmaceutical agent preparation 4.
  • the pivot or swivel arm 55 is preferably clamped or pre-tensioned against the pump device 24 or the holder 25. As can be seen from Figs. 17 and 18, the pivot or swivel arm 55 can be pre-tensioned with a pre-tensioning device 93, in particular a (tension) spring, against the pump device 24 and/or the holder 25, cf. also Fig. 19.
  • a pre-tensioning device 93 in particular a (tension) spring
  • the pivot or swivel arm 55 preferably automatically forms a positive fit with the positive device 57.
  • the forming of the positive fit is carried out by the pre-tensioning or clamping of the pivot or swivel arm 55.
  • the pivot or swivel arm 55 is flush with the positive device 57 or the edge of the pump device 24 and/or the holder 25. In this way, an axial movement brought about by the tensioning device 21 or pump movement of the pump device 24 or holder 25 is blocked.
  • pivot or swivel arm 55 engages in a recess or some other positive device 57 in such a way that the discharge of the pharmaceutical agent preparation 4 is blocked.
  • other forms of blocking the pressure generator 20 at the end of the tensioning process are also possible, for example by a lock and/or frictional connection.
  • a position of the pivot or swivel arm 55 in which an axial movement brought about by the tensioning device 21 or pump movement of the pump device 24 or holder 25 is blocked, is also referred to hereinafter as a blocking position.
  • the release position is preferably a starting position from which the pivot or swivel arm 55 is moved into the blocking position after an initial or repeated tensioning process.
  • a movement of the pivot or swivel arm 55 back into the release position releases the drive of the pump device 24 or the holder 25 by the tensioning device 21.
  • the pressure generator 20 can be driven by means of the tensioning device 21.
  • the tensioning device 21 shifts the pump device 24 or the holder 25 axially, preferably exclusively by spring force or clamping force.
  • the pivot or swivel arm 55 is preferably held or mounted on a shaft 92 and/or mounted to pivot or swivel (cf. Figs. 19 and 20).
  • the shaft 92 is depicted only in sections in Fig. 20 and preferably in a stationary manner, in particular connected to the housing 14, the housing section 42, or a receptacle for the pressure generator 20, molded thereon or formed in one piece.
  • the pivot or swivel arm 55 is preferably mounted to pivot or swivel on the shaft 92.
  • the pivot or swivel arm 55 can be configured to embody a linear movement.
  • the pivot or swivel arm 55 can also be movable by a (partial) linear movement or shifting in the blocking position and/or in the release position.
  • the pivot or swivel arm 55 is preferably designed to block a pressure generation with the pressure generator 20, in particular an axial movement of the pump device 24 or the holder 25, preferably as already explained above.
  • the movement of the pivot or swivel arm 55 is carried out in the release position; the release and/or the triggering of the discharge of the pharmaceutical agent preparation 4 is/are preferably carried out by the actuating lever 26.
  • Fig. 21 shows the actuating lever 26 in the rest position, wherein the tensioning device 21 is untensioned or only pre-tensioned.
  • the actuating lever 26 preferably projects from the housing 14 and/or forms a maximum pivoting angle a with the longitudinal axis L.
  • the actuating lever 26 is moved in the direction of the housing 14 and/or moved in such a way that the pivoting angle a is reduced. In this way, the tensioning device 21 is tensioned, in particular as previously described in connection with Figs. 4 and 5.
  • a triggering mechanism 27 is provided, which has a triggering element 94.
  • the triggering element 94 is preferably coupled to the actuating lever 26, in particular hinged on the actuating lever 26.
  • the triggering element 94 is preferably a push rod.
  • the triggering element 94 preferably has an activating section 95 for moving the pivot or swivel arm 55 from the blocking position into the release position.
  • the activating section 95 is located at a distance from a preferably wedge-like shifting area 96 of the pivot or swivel arm 55.
  • the triggering element 94 is guided in such a way that the activating section 95 does not move the pivot or swivel arm 55 during the tensioning process.
  • the triggering element 94 is guided in such a way that the activating section 95 does not move the shifting area 96 or slides on the latter.
  • at least one guide means 97 is provided, on which the triggering element 94 is guided in such a way that the activating section 95 runs past the pivot or swivel arm 55 or the shifting area 96. In this way, the pivot or swivel arm 55 can form the triggering blocker 46 with the triggering element 94.
  • the guide means 97 are formed by stationary elements, in particular pins. In Figs. 17 to 24, the guide means 97 are shown only in sections for reasons of clarity.
  • Fig. 22 shows the end of the tensioning process.
  • pivoting angle ⁇ which encompasses the actuating lever 26 with the longitudinal axis L, is minimal.
  • the pivot or swivel arm 55 furthermore forms the positive fit with the positive device 57, which can be seen in Fig. 22 in such a way that the shifting area 96 and/or the pivot or swivel arm 55 is shifted in the direction of a center axis of the pump device 24 or the holder 25.
  • the actuating lever 26 is moved back into the position in which the actuating lever 26 preferably projects from the housing 14 and/or encompasses a maximum pivoting angle ⁇ with the longitudinal axis L.
  • the pivot or swivel arm 55 is located in the blocking position, and the tensioning device 21 is tensioned.
  • the shifting area 96 is preferably brought toward the activating section 95, in particular in comparison to its position in the release position.
  • the pivot or swivel arm 55 is held in its release position.
  • the pump device 24 that slides along on the pivot or swivel arm 55 blocks the movement of the pivot or swivel arm 55 back into the blocking position.
  • the triggering element 94 is guided in such a way that after the pivot or swivel arm 55 is moved into its release position, the activating section 95 is shifted relative to the shifting area 96 in such a way that the pivot or swivel arm 55 is prevented from moving beyond the release position.
  • the triggering device 27 is designed in such a way that after reaching the release position of the pivot or swivel arm 55, the activating section 95 slides past the pivot or swivel arm 55 as the actuating lever 26 continues to move in the direction of the second position or in the triggering direction. In this way, in an advantageous manner, a high triggering sensitivity with simultaneous sturdy design is made possible, since damage of the pivot or swivel arm 55 is prevented.
  • the inhaler 1 comprises at least two levers 30, 35 designed for force multiplication.
  • the inhaler 1 comprises a one-sided lever 35, which is designed for gear reduction and/or force multiplication and/or drives the elbow lever 30.
  • the lever gear 29 and/or the actuating lever 26 and/or the elbow lever 30 is/are preferably designed for force multiplication.
  • the lever gear 29 and/or the actuating lever 26 preferably increase(s) a force F that acts on the actuating section 40.
  • the lever gear 29 and/or the actuating lever 26 are preferably designed in such a way that a force F that acts on the actuating section 40 has an increased effect on the tensioning device 21 via the lever gear 29 and/or via the actuating lever 26.
  • the one-sided lever 35 preferably comprises a shorter lever arm 36, in particular as a load arm, and a longer lever arm 37, in particular as a force arm, preferably wherein the shorter lever arm 36 corresponds at least essentially to a lever arm 32 of the elbow lever 30.
  • the lever gear 29 is preferably designed in such a way that with a uniform force F that acts on the actuating section 40 with increasing deviation of the actuating lever 26 in the actuating direction, the force that acts on the tensioning device 21 increases.
  • the lever gear 29 is designed to tensioning the tensioning device 21 , preferably accomplished by a spring, in particular a compression spring, as the deviation of the actuating lever 26 increases in the actuating direction, wherein as the tensioning of the tensioning device 21 increases, the force that is to be exerted on the actuating section 40 of the actuating lever 26 or that is realized by the actuating section 40 of the actuating lever 26 decreases.
  • the lever gear 29 comprises or consists of at least two levers, in particular the elbow lever 30 and the one-sided lever 35, or it is designed in at least two stages.
  • the lever gear 29 is reduced in multiple stages, or the gear reduction ratio, i.e., the ratio between the drawn-off or resulting and fed force, in one or more stages, in particular each stage, of the lever gear 29 is greater than or equal to 1.
  • the one-sided lever 35 is especially preferably designed as the first stage of the lever gear 29, and the elbow lever 30 is designed as the second stage of the lever gear 29.
  • the elbow lever 30 is designed as the second stage of the lever gear 29.
  • other design solutions are also possible.
  • the one-sided lever 35 preferably produces a reduction gear or force multiplication of the force F that is fed by the user to the one-sided lever 35 and that acts on the inhaler 1 , wherein the gear ratio of the one-sided lever 35 has in particular a constant value of greater than or equal to 1 . Consequently, the force F' that is drawn off or that is caused by the one-sided lever 35 is preferably greater than or equal to the supplied force F.
  • the elbow lever 30 of a gear reduction or force multiplication especially preferably produces the force F' resulting because of the one-sided lever 35 or fed to the elbow lever 30.
  • the gear ratio of the elbow lever 30 preferably increases with increasing actuation of the inhaler 1 or the actuating lever 26 and/or is greater with increasing tensioning of the tensioning mechanism 28 or the force multiplication.
  • the gear ratio of the elbow lever 20 preferably is always greater than one. Preferably, the gear ratio increases with movement of the actuating lever 26 in the actuating direction.
  • the elbow lever 30 is preferably hinged on one end on the housing 14.
  • the elbow lever 30 is preferably designed to introduce force on an end hinged on the housing via a hinge in the receptacle 45 and/or the pump device 24.
  • the elbow lever 30 preferably produces a force component in the longitudinal direction L.
  • the elbow lever 30 preferably directly produces a tensioning of the tensioning device 21.
  • the elbow lever 30, in particular directly, acts on the receptacle 45 connected in a rigid manner to the tensioning device 21.
  • the force F' resulting because of the one-sided lever 35 or the actuating lever 26 or acting on the additional tensioning mechanism 28, in particular the elbow lever 30, preferably corresponds to the force F on the actuating section 40 multiplied by the factor of the gear ratio of the one-sided lever 35.
  • the force F" that results because of the elbow lever 30 or that acts on the tensioning device 21 preferably corresponds to the force F' that acts on the elbow lever 30, multiplied by the factor of the gear ratio of the elbow lever 30, preferably wherein the force F' corresponds to the force F multiplied by the factor of the gear ratio of the one-sided lever 35.
  • the length of the one-sided lever 35, the lever arm 36, the lever arm 37 and/or the actuating lever 26 is variable, in particular adjustable.
  • the longer lever arm 37 and/or the actuating lever 26 can preferably be folded out for further extension and/or via a hinge or like a telescope or can be extended in some other way.
  • the actuating section 40 of the actuating lever 26 has a surface structuring for protection against sliding and/or an adhesive or rough surface.
  • the actuating section 40 is provided with an elastic or flexible and/or rubber-like layer.
  • the tensioning mechanism 28 is preferably designed to tension the tensioning device 21 in the case of a movement of the actuating lever 26 from the rest position into the tensioned position.
  • rest position and resting position and first position are preferably synonymous or interchangeable.
  • tensioned position, pressure position, and second position are synonymous to one another or interchangeable.
  • the rest position, resting position, first position and/or tensioned position, pressure position, and/or second position are preferably end positions. ln the case of a movement of the actuating lever 26 from the tensioned position back into the rest position, the tensioning device 21 preferably remains tensioned.
  • the pressure generator 20 is driven and/or the pharmaceutical agent preparation 4 is pumped and/or discharged. This is preferably carried out by a triggering and/or independently of the tensioning process.
  • the actuating lever 26 can be pivoted or swiveled between the pressure position/tensioned position/first position and the resting position/rest position /second position.
  • the actuating lever 26 can be moved in some other way relative to the housing 14.
  • design solutions are possible in which the actuating lever 26 can be moved, preferably shifted and/or pressed, by means of a guide, in particular a linear guide, relative to the housing 14 between the pressure position/tensioned position/first position and the resting position/rest position/second position.
  • the lever gear 29, in particular the actuating lever 26, can preferably be locked, clamped or engaged in the tensioned position and/or in the resting position, for example for transport and/or in order to prevent an inadvertent actuation of the actuating lever 26.
  • the one-sided lever 35 and/or its longer lever arm 37 is/are preferably formed between the pivot point 41 of the actuating lever 25 and the actuating section 40.
  • the short lever arm 36 is preferably shorter than the long lever arm 37.
  • the long lever arm is more than twice as long as the short lever arm 36.
  • the pivot point 41 of the actuating lever 26 rests at least essentially on or in the vicinity of the longitudinal axis L of the inhaler 1.
  • the pivot point 41 is less than 3 cm, preferably less than 2 cm, and in particular less than 1 cm from the longitudinal axis L and/or less than the length of the first lever arm 32 and/or the second lever arm 33 from the longitudinal axis L.
  • the force F" of the lever gear 29 that in particular acts on the pump device 24 acts at least essentially on the longitudinal axis L
  • a good transmission of force to the pump device 24 and/or the tensioning device 21 can be achieved.
  • the actuating lever 26 is mounted on two pivot points 41 , in particular in the manner of a fork.
  • the actuating lever 26 at least partially encompasses the chamber 6. In this way, a more compact inhaler 1 can be achieved.
  • other design solutions are also possible.
  • the housing section 42 or the stop 43 preferably bounds the pivoting angle ⁇ of the actuating lever 26.
  • the stop 43 and/or the angle that is formed between the stop 43 and the longitudinal axis L or maximum pivoting angle ⁇ can be adjusted.
  • the stop 43 can occupy different predefined positions in order to individually adjust the maximum pivoting angle ⁇ for different users and/or to vary the amount of dosage.
  • There may be different tensioned positions and/or positions of rest that are preferably adjustable or presettable. It is possible that the tensioning mechanism 28, in particular because of an altered resting position, limits a movement of the pump device 24 or the holder 25.
  • the pivot or swivel arm 55 or another triggering blocker device can then be designed to block the pump device 24 and/or the holder 25 in different positions that correspond in particular to adjustable or presettable tensioned positions.
  • the pivot point 44 or the joint 31 is mounted to move relative to the actuating lever 26, for example by means of a floating bearing.
  • the pivot point 44 or the joint 31 can be run in an advantageous way in a guide, in particular in a linear guide, in or on the actuating lever 26.

Abstract

La présente invention concerne un inhalateur pour pulvériser des doses d'une préparation d'agent pharmaceutique avec un indicateur, l'indicateur ayant un anneau gradué qui est monté pour pivoter autour d'un axe de rotation et qui a un moyen indicateur pour afficher un nombre de doses encore disponibles ou déjà administrées, l'anneau gradué pouvant être déplacé ou entraîné en rotation par un dispositif déclencheur d'un générateur de pression.
PCT/EP2014/002270 2013-08-20 2014-08-19 Inhalateur WO2015024653A1 (fr)

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EP13004112 2013-08-20
EP13004112.2 2013-08-20

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WO2020169915A1 (fr) 2019-02-22 2020-08-27 Aptar France Sas Dispositif de distribution de produit fluide
WO2020239569A1 (fr) 2019-05-24 2020-12-03 Boehringer Ingelheim Vetmedica Gmbh Inhalateurs ainsi que dispositif de protection et indicateur de respiration

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WO1994017753A1 (fr) 1993-02-12 1994-08-18 Minnesota Mining And Manufacturing Company Appareil de distribution d'aerosol
WO1996006011A2 (fr) 1994-08-11 1996-02-29 Boehringer Ingelheim Kg Recipient a capuchon de fermeture et procede de remplissage de recipients sans formation de bulles de gaz
WO2000049988A2 (fr) 1999-02-23 2000-08-31 Boehringer Ingelheim International Gmbh Cartouche de liquide
WO2001078818A2 (fr) 2000-04-14 2001-10-25 Trudell Medical International Inhalateur nasal
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WO2004091704A1 (fr) 2003-04-16 2004-10-28 Trudell Medical International Appareil antistatique pour l'administration de medicaments
WO2005079997A1 (fr) 2004-02-24 2005-09-01 Boehringer Ingelheim International Gmbh Pulverisateur
US20090211578A1 (en) * 2005-08-01 2009-08-27 Ian Fletcher Inhaler valve
WO2010149280A1 (fr) 2009-06-25 2010-12-29 Boehringer Ingelheim Vetmedica Gmbh Inhalateur

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Publication number Priority date Publication date Assignee Title
GB1317315A (en) * 1970-12-17 1973-05-16 English Numbering Machines Mechanical impulse counter
WO1994017753A1 (fr) 1993-02-12 1994-08-18 Minnesota Mining And Manufacturing Company Appareil de distribution d'aerosol
WO1996006011A2 (fr) 1994-08-11 1996-02-29 Boehringer Ingelheim Kg Recipient a capuchon de fermeture et procede de remplissage de recipients sans formation de bulles de gaz
WO2000049988A2 (fr) 1999-02-23 2000-08-31 Boehringer Ingelheim International Gmbh Cartouche de liquide
WO2001078818A2 (fr) 2000-04-14 2001-10-25 Trudell Medical International Inhalateur nasal
US20020170928A1 (en) * 2001-05-15 2002-11-21 Jerry Grychowski Medicament applicator
WO2004091704A1 (fr) 2003-04-16 2004-10-28 Trudell Medical International Appareil antistatique pour l'administration de medicaments
WO2005079997A1 (fr) 2004-02-24 2005-09-01 Boehringer Ingelheim International Gmbh Pulverisateur
US20090211578A1 (en) * 2005-08-01 2009-08-27 Ian Fletcher Inhaler valve
WO2010149280A1 (fr) 2009-06-25 2010-12-29 Boehringer Ingelheim Vetmedica Gmbh Inhalateur

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020169915A1 (fr) 2019-02-22 2020-08-27 Aptar France Sas Dispositif de distribution de produit fluide
FR3093002A1 (fr) * 2019-02-22 2020-08-28 Aptar France Sas Dispositif de distribution de produit fluide
CN113453739A (zh) * 2019-02-22 2021-09-28 阿普塔尔法国简易股份公司 流体制剂分配装置
WO2020239569A1 (fr) 2019-05-24 2020-12-03 Boehringer Ingelheim Vetmedica Gmbh Inhalateurs ainsi que dispositif de protection et indicateur de respiration

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