NZ724462B2

NZ724462B2 - Container, nebulizer and use

Info

Publication number: NZ724462B2
Application number: NZ724462A
Authority: NZ
Inventors: Joachim Eicher; Herbert Graessl; Mike Janetzko; Andree Jung; Martin Meisenheimer; Herbert Wachtel; Robert Gerhard Winkler; Gilbert Wuttke; Ying Yu
Original assignee: Boehringer Ingelheim International Gmbh
Priority date: 2014-05-07
Filing date: 2015-05-04
Publication date: 2021-08-31

Abstract

object of the present invention is to provide a nebulizer and a container for a nebulizer as well as a use of an indicator device allowing easy and/or secure operation and handling and/or a compact and/or reliable construction, preferably while allowing replacement of the container without replacement of any housing part of the nebulizer. The object is achieved by a unit for a nebulizer, a nebulizer including the unit, or by a method for connecting a container with an indicator device according to the invention. The unit for a nebulizer comprises: a container containing a fluid and comprising a rigid housing which is made of metal, and an indicator device for counting and indicating a number of uses performed or still possible with the container, wherein the indicator device comprises an indicator housing which is made of plastic wherein the housing of the container comprises a protrusion, and the indicator housing comprises a collar or a gripping section, and the collar or the gripping section of the indicator housing grips over the protrusion of the housing of the container, wherein the collar or gripping section has been bent over the protrusion in an ultrasonic forming process so that the indicator housing is inseparably connected with the housing of the container opposite to an outlet or head of the container. The method is for connecting a container with an indicator device for counting and indicating a number of uses performed or still possible with the container, wherein the container is for use with a nebulizer and contains a fluid and comprises a rigid housing which is made of metal, and wherein the indicator device comprises an indicator housing which is made of plastic wherein the indicator device is arranged at a base of the container, wherein a collar or a gripping section of the indicator housing is bent over a protrusion of the container, in particular over an edge of the container, by ultrasonic forming, so that the indicator housing is inseparably connected with the housing of the container opposite to an outlet or head of the container. ement of any housing part of the nebulizer. The object is achieved by a unit for a nebulizer, a nebulizer including the unit, or by a method for connecting a container with an indicator device according to the invention. The unit for a nebulizer comprises: a container containing a fluid and comprising a rigid housing which is made of metal, and an indicator device for counting and indicating a number of uses performed or still possible with the container, wherein the indicator device comprises an indicator housing which is made of plastic wherein the housing of the container comprises a protrusion, and the indicator housing comprises a collar or a gripping section, and the collar or the gripping section of the indicator housing grips over the protrusion of the housing of the container, wherein the collar or gripping section has been bent over the protrusion in an ultrasonic forming process so that the indicator housing is inseparably connected with the housing of the container opposite to an outlet or head of the container. The method is for connecting a container with an indicator device for counting and indicating a number of uses performed or still possible with the container, wherein the container is for use with a nebulizer and contains a fluid and comprises a rigid housing which is made of metal, and wherein the indicator device comprises an indicator housing which is made of plastic wherein the indicator device is arranged at a base of the container, wherein a collar or a gripping section of the indicator housing is bent over a protrusion of the container, in particular over an edge of the container, by ultrasonic forming, so that the indicator housing is inseparably connected with the housing of the container opposite to an outlet or head of the container.

Description

CONTAINER, NEBULIZER AND USE In one aspect of the ion there is provided a Unit for a zer, the unit comprising a container containing a fluid and comprising a rigid g which is made of metal, and an indicator device for counting and indicating a number of uses performed or still possible with the container, wherein the indicator device is fixedly ed at a base of the ner; and wherein the tor device comprises an indicator housing which is made of plastic, wherein the housing of the container comprises a protrusion, and the indicator housing comprises a collar or a gripping section, and the collar or the gripping section of the indicator housing grips over the protrusion of the housing of the container, wherein the collar or gripping section has been bent over the protrusion in an onic forming process so that the indicator housing is inseparably connected with the housing of the container opposite to an outlet or head of the container.

In another aspect of the invention there is provided a method for connecting a container with an indicator device for counting and indicating a number of uses performed or still possible with the container, wherein the container is for use with a zer and contains a fluid and comprises a rigid g which is made of metal, and wherein the indicator device comprises an indicator housing which is made of plastic wherein the indicator device is arranged at a base of the container, wherein a collar or a gripping section of the indicator housing is bent over a protrusion of the container, in particular over an edge of the container, by ultrasonic forming, so that the tor housing is inseparably connected with the housing of the container opposite to an outlet or head of the container.

A 1 discloses a nebulizer. A container can be inserted into a housing of the nebulizer. The housing is closed by a lower g part. By rotating the housing part the drive spring can be put under tension and fluid can be sucked into a compression chamber of the pressure generator. Simultaneously, the container is moved into the lower g part in a stroke movement within the nebulizer and when tensioned for the first time the container may be pierced through its base by a piercing element in the lower g part to allow venting of the container. After manual ng a button, the drive spring is released and moves the delivery tube into the pressure chamber so that the fluid is put under re by the drive spring and is delivered or atomized through a nozzle into a mouthpiece as an aerosol, without the use of propellant gas. Thus, the container is moving axially forth and back during conveying of the fluid to be nebulized, and during re generation and nebulization.

The container may be connected inseparably with the housing part by a securing device forming a transportation lock for holding the container unmovable in a delivery state.

The nebulizer ses an indicator device for counting and/or indicating a number of uses performed or still possible. The indicator device blocks further use in a locked state when a predetermined number of uses has been reached or exceeded with the current container.

Then, the container can be replaced to-gether with a g part and the nebulizer can be used further with the new container.

US 7,823,584 B2 discloses a similar nebulizer, wherein a counter device can be integrated into a housing part that is geable or eable together with the container, which is inseparable from the housing part.

WO 04694 A1 discloses an inhaler for powdery nces with an indicator device which may comprise a worm gear for driving an indicator element.

Object of the present invention is to provide a nebulizer and a container for a nebulizer as well as a use of an indicator device allowing easy and/or secure operation and handling and/or a compact and/or reliable construction, preferably while allowing replacement of the container without replacement of any housing part of the nebulizer.

The above object is achieved by a unit according to claim 1 or by a nebulizer according to claim 5 or by a method according to claim 6. Preferred embodiments are t of the subclaims.

The present invention relates to a zer for nebulizing a fluid, preferably liquid medicament, from a replaceable container containing the fluid, and relates to the container.

Preferably, an indicator device is provided for counting and/or in-dicating the number of uses already performed or still le with the container.

In particular, the indicator device or an associated locking device can lock the container and/or nebulizer or can cause the locking of the container and/or zer against further use in a locked state when a predetermined number of uses has been reached or exceeded with the respective container.

Preferably, the nebulizer ses a housing part which can be detached from the nebulizer or opened for replacing the container.

Preferably the zer and/or container cannot be used anymore in the locked state when the indicator device has detected that a predetermined number of uses has been reached or exceeded, in particular with the respective ner.

Preferably, the locking of the nebulizer against further use can be me by replacing the container, in particular ing the indicator device, against one not yet used.

The indicator device is preferably inseparably connected with the container or with a container housing of the container, but ble from the nebulizer or its housing and from the housing part, so that the indicator device is replaceable together with the ner. This allows reuse of the nebulizer and the housing part with another container including another indicator device. Thus the overall size of the components to be exchanged is kept small, so that the replacement packages are size reduced, so that transport of a large number of packages is facilitated.

Preferably, the indicator device or its housing is fixedly or inseparably arranged at a bottom of the container and/or opposite to an outlet of the ner. This al- lows a very compact construction. Further, the indicator device does not inter- fere with the fluidic connection of the container to the nebulizer or vice versa.

Preferably, the tor device or its housing is connected to or secured at the container or its housing by snapping, clamping, gluing, screwing, hot pressing, welding, in particular ultrasonic forming or g, or the like.

In particular, the connection n the housing of tor device and the container is a direct connection wherein a form-fit connection (positive connec- tion) and/or a frictional tion (i.e. "force-fit" or non-positive connection) is achieved. A direct connection can be realized in particular by respective interen- gagement of the container housing or its edge on one hand and the indicator housing or a respective gripping section or collar on the other hand. Preferably the ng section or collar of the indicator housing engages with a protruding edge or with indentions on the housing of the container. For instance, the direct connection can be achieved by cold-forming or snap-fit or hot crimping / periph- eral flanging. In particularly, the indicator housing and the container g can be connected by deforming the gripping section or collar of the indicator housing so that it engages with the housing of the container, i.e. by forming or bending the gripping section over a protrusion and/or into an indention at the housing of the container. Preferably a tool is used for forming or bending the collar or the gripping n, whereby the tool is moved longitudinally over the container to- wards the ner base, edge and/or gripping n and/or a connection ar- ea, in particular wherein the tool comprises a preferably conical end section for g the collar or gripping section towards the container and/or radially in- wardly.

The deformation of the collar or gripping section is preferably achieved by crimp- ing / peripheral flanging (preferably using an input of heat) ably n by means of the forming tool electric or inductive and/or mechanical energy is em- ployed. For instance, the gripping n or collar can be deformed in a hot stamping process employing an ically heated hot bar or in a process using ultrasonic excitation of longitudinal and/or torsional vibrations within the material (preferably a plastic) of the gripping section or collar.

Alternatively, the connection between the housing of indicator device and the container may be an indirect connection wherein the indicator device and the container are connected by means of an (additional) tion t. With the connection element, the achieved connection may be a form-fit connection and/or a force-fit connection and/or an substance-to-substance bond (for in- stance achieved by gluing or g). For instance, the connection element may be a r part which is cold-formed / crimped or heat shrinked onto the container housing / edge of the ner and the indicator housing so that the indicator device and the container are fixed to each other along the longitudinal axis. Alternatively the connection element may be a spreadable part or radial flexible part like a retaining ring or spring-lock washer which connects the con- tainer housing and the indicator housing by (partial) spreading in between them.

Alternatively, the connection element may be (injection) molded onto the hous- ing of the container and/or the indicator housing.

Preferably, the indicator device or its housing is attached to the container or its housing such that the indicator device is secured against rotation relative to the container. This non-rotational securement or anti-twist securement allows or fa- cilitates detachment or change of the ner by ng the indicator device or its housing.

The securement against relative rotation is preferably achieved by form-fit en- nt. The securement can be realized in particular by tive interen- gagement of the container housing or its edge on one hand and the indicator housing or a respective ng section on the other hand. However, any other suitable connection, such as a connection by force-fit, can be used to achieve the preferred ment against relative rotation of the indicator device or its g with the container or its housing.

Preferably, the indicator device or its g or a gripping portion is connected to or with the container such that a user can detach — in particular more easily — the container from the housing by grabbing the tor device, its housing or the gripping portion, in particular by axially pulling and/or rotating the indicator device or its g, so that the container is detached or detachable from the associated nebulizer. In particular, the ation of ng the indicator de- vice and, thus, the container, during axially pulling allows a lower force to detach the container from the nebulizer or its holder, preferably in consideration of the gliding forces (e.g. between container and nebulizer or holder and/or between container and conveying tube) than the effective holding forces without relative movement, i.e. without ve rotation between container and nebulizer. This facilitates in particular detachment and/or change of the container.

Preferably, the container is attached or attachable with its head and/or its side or end opposite to the indicator device to the nebulizer or a holder of the nebulizer.

Preferably, the container is attached or attachable to the nebulizer by snap-fit, in particular, a head or end of the container is connected or connectable with a holder rably within the nebulizer) by snap—fit or clamping.

Preferably, the indicator device or its housing comprises a gripping portion, in particular such as a flattening, ion, protection or riffle, so that a user can easily and/or securely grab and hold the indicator device, in particular for rotat- ing and/or axially pulling the indicator device and, thus, the ner connected with the indicator device. This facilitates the handling and operation.

Preferably, the indicator device or its housing or the gripping portion forms a de- tachment or removal tool or aid or is used as such.

Independently from the provision of the indicator device, a gripping portion may be provided and/or connected with the container or its g, in ular at the lower end or base of the ner, in particular as indicator device or in- stead of the indicator device, in order to facilitate detachment of the container as described above. In this case, the gripping portion may have a similar form, in particular an at least essentially cylindrical form, as the indicator housing or a dif- ferent form. The connection of the gripping portion and container is realized preferably as described for the indicator device and container.

The above aspects of the present invention and the further aspects described below can be realized independently from each other, and in any combination.

Further advantages, features, characteristics and aspects of the present inven- tion will become apparent from the claims and the ing description of a pre- ferred embodiment with reference to the gs. It shows: Fig. 1 a schematic n of a known zer in a non-tensioned state; Fig. 2 a schematic section, rotated 90° compared with Fig. 1, of the known nebulizer in a tensioned state; Fig. a schematic section of a nebulizer with an inserted container in a non-tensioned state according to a preferred embodiment of the present invention; Fig. a partial enlargement of the encircled part of Fig. 3; Fig. a perspective view of the n of the zer according to Fig.

Fig. an enlargement of the encircled part of Fig. 5; Fig. a schematic exploded view of an tor device according to a preferred embodiment of the present invention; Fig. an axial section of the tor device in an actuated state; Fig. an axial section of the indicator device in a locked state; Fig. 10 a perspective section of the indicator device in an actuated state; Fig. 11 a perspective section of the indicator device in an released state; Fig. 12 a partial enlargement of the nebulizer similar to Fig. 4, but in a par- tially tensioned state; Fig. 13 a partial enlargement of the nebulizer similar to Fig. 4, but in a fully ned state; Fig. 14 a partial section of the nebulizer similar to Fig. 4, but in an interme- diate state during a dispensing stroke; Fig. 15 a partial section of the nebulizer similar to Fig. 4, but with an indica- tor device of the container in a locked state; 1O Fig. 16 a schematic section of the nebulizer in the locked state after next tensioning with partially opened housing part and with locked lock- ing device; Fig. 17 a l enlargement of the led part of Fig. 13; Fig. 18 a schematic n of the nebulizer r to Fig. 3 with unlocked locking device; Fig. 19 a schematic section of the indicator device in the initial state ac- cording to a modified embodiment; Fig. 20 a perspective section of the indicator device according to Fig. 19; Fig. 21 a partial section of the container with the associated indicator de- vice with undeformed gripping section; Fig. 22 a partial section of the container with the associated indicator de- vice with ed gripping section; Fig. 23 a perspective view of the container and separated indicator device; Fig. 24 a radial n of the container with the indicator device of Fig. 22 in the region of the gripping section; and Fig. 25 a side view of the container with the ated indicator device for 1O showing a gripping n.

In the Figures, the same nce ls are used for identical or similar parts, resulting preferably in corresponding or able properties and advantages , even if the associated description is not repeated.

Figs. 1 and 2 show a known nebulizer1 for atomizing a fluid 2, particularly a highly effective pharmaceutical composition, medicament or the like, diagram— matically shown in a non-tensioned state (Fig. 1) and in a tensioned state (Fig. 2). The nebulizer1 is constructed in particular as a portable inhaler and prefera- bly operates only mechanical and/or without propellant gas.

When the fluid 2, preferably a , more particularly a pharmaceutical compo- sition, is nebulized. an aerosol 14 (Fig. 1) is formed or dispensed, which can be breathed in or inhaled by a user. Usually the inhaling is done at least once a day, more particularly several times a day, preferably at set intervals, depending on the complaint or illness from which a patient is suffering.

The nebulizer 1 is provided with or comprises an insertable or replaceable con- tainer 3 containing the fluid 2. The container 3 thus forms a reservoir for the fluid 2, which is to be nebulized. Preferably, the container 3 contains multiple doses of fluid 2 or active substance in particular sufficient to provide up to 200 dosage units or doses, for example, i.e. to allow up to 200 sprays or applications. A typi- cal container 3, as disclosed in WO 96/06011 A1, holds e.g. a volume of about 2 to 20 ml.

Further, the number of doses contained in the container 3 and/or the total vol- ume of the fluid 2 contained in the container 3 can vary depending on the fluid 2 or respective medicament and/or depending on the container 3 and/or depend- ing on the necessary medication or the like.

Preferably, the container 3 can be replaced or exchanged, wherein the total number of uses of the nebulizer1 and thus the number of containers 3, which can be used with the same nebulizer 1, is preferably restricted, e.g. to a total number of four or five containers 3. A1 discloses additionally such a ction to the total numbers of containers 3 which can be used with the same nebulizer 1.

The container 3 is ably substantially cylindrical or cartridge-shaped and once the nebulizer 1 has been opened the container 3 can be inserted therein preferably from below and changed if desired. It is preferably of rigid construc- tion, the fluid 2 in particular being held in a sible bag 4 in the container 3.

In ular, the container 3 comprises a venting opening or hole 23 which is opened before or during first use.

The nebulizer 1 comprises a delivery mechanism, preferably a pressure genera- tor 5, for conveying and nebulizing the fluid 2, particularly in a preset and option- ally in an adjustable dosage amount.

The nebulizer 1 or pressure tor 5 comprises preferably a holder 6 for re- leasably holding the container 3, a drive spring 7 associated to the holder 6, only partly shown, and/or a blocking element 8 ably in form of or with a button for ably manual actuation or depressing. The blocking element 8 can catch and block the holder 6 and can be manually operated to release the holder 6 al- lowing drive spring 7 to expand.

The zer 1 or pressure generator 5 ses preferably a conveying ele- ment, such as a conveying tube 9, a non-return valve 10, a pressure chamber 11 and/or a nozzle 12 for nebulizing the fluid 2 into a mouthpiece 13.

The completely inserted ner 3 is fixed or held in the nebulizer 1 via the holder 6 such that the conveying element fluidically connects the ner 3 to the nebulizer 1 or pressure tor 5. Preferably, the conveying tube 9 pene- trates into the container 3.

The nebulizer 1 or holder 6 is preferably constructed so that the container 3 can be exchanged.

When the drive spring 7 is axially tensioned in the tensioning process, the holder 6 with the container 3 and the conveying tube 9 are moved downwards in the gs and fluid 2 is sucked out of the container 3 into the pressure chamber 11 of the pressure tor 5 through the non-return valve 10. In this state, the 2O holder 6 is caught by the blocking element 8 so that the drive spring 7 is kept compressed. Then, the nebulizer 1 is in the tensioned state.

During the subsequent relaxation in the nebulization process after actuation or pressing of the blocking element 8 the fluid 2 in the pressure chamber 11 is put under pressure as the conveying tube 9 with its now closed non-return valve 10 is moved back in the pressure chamber 11, here in the drawings upwards, by the relaxation or force of the drive spring 7 and now acts as a pressing ram or piston. This pressure forces the fluid 2 through the nozzle 12, pon it is nebulized into the aerosol 14, as shown in Fig. 1, and, thus, dispensed.

Generally, the nebulizer1 es with a spring pressure of 5 to 200 MPa, preferably 10 to 100 MPa on the fluid 2, and/or with a volume of fluid 2 delivered per stroke of 10 to 50 ul, ably 10 to 20 ul, most preferably about 15 ul. The fluid 2 is converted into or nebulized as aerosol 14, the droplets of which have an aerodynamic diameter of up to 20 um, preferably 3 to 10 um. Preferably, the generated jet spray has an angle of 20° to 160°, preferably 80° to 100°. These values also apply to the nebulizer 1 according to the teaching of the present in- vention as particularly preferred . 1O A user or patient (not shown) can inhale the aerosol 14, preferably while an air supply can be sucked into the mouthpiece 13 through at least one optional air supply opening 15.

The nebulizer 1 comprises preferably a housing 24 and/or ) housing part 16 and optionally a biasing or inner part 17 preferably which is rotatable relative thereto (Fig. 2) and/or has an upper part 17a and a lower part 17b (Fig. 1).

The nebulizer 1 or housing 24 comprises preferably a (lower) housing part 18.

This part 18 is in particular manually operable, and/or releasable fixed, particu- larly fitted or held onto the inner part 17, preferably by means of a retaining ele- ment 19. ably, the housing parts 16 and 18 and/or other parts form the housing 24 of the nebulizer 1.

In order to insert and/or replace the container 3, preferably the housing 24 can be opened and/or the housing part 18 can be detached from the nebulizer 1, in- ner part 17 or g 24.

Generally and preferably, the container 3 can be inserted before the housing 24 is closed and/or before the housing part 18 is connected to the housing 24. The container 3 may be inserted, opened and/or fluidically connected to the delivery mechanism tically or simultaneously when (completely) connecting the housing part 18 to the housing 24/ nebulizer 1 and/or when (completely) closing the housing 24 / nebulizer 1. Preferably, the container 3 is open or fluidically connected when tensioning the nebulizer 1 for the first time with the current con- tainer 3.

Preferably, the nebulizer 1 or drive spring 7 can be manually ted or ten- sioned or loaded, in particular by actuation of an actuation member, here - 1O ably by rotating housing part 18 or any other component.

The ion member, preferably the housing part 18, can be actuated, here ro- tated relative to the upper housing part 16, carrying with it or driving the inner part 17. The inner part 17 acts on a gear or transmission to transform the rota- tion in an axial movement. As a result the drive spring 7 is tensioned in the axial ion by means of the gear or transmission (not shown) formed between the inner part 17, in particular its upper part 17a, and the holder 6 and acting on the holder 6. During tensioning the container 3 is moved axially rds until the container 3 assumes an end position as shown in Fig. 2. In this ted or ten- sioned state the drive spring 7 is undertension and can be caught or held by the blocking element 8. During the nebulizing process the container 3 is moved back into its original position (non-tensioned position or state shown in Fig. 1) by (the force of) the drive spring 7. Thus the container 3 es a lifting or stroke nt during the tensioning process and during the nebulizing process.

The housing part 18 preferably forms a cap-like lower housing part and/or fits around or over a lower free end n of the container 3. As the drive spring 7 is tensioned the container 3 moves with its end portion (further) into the housing part 18 ortowards the end face thereof, while an aeration means, such as an ax- ially acting spring 20 arranged in the housing part 18, comes in contact with base 21 of the container 3 and pierces the container 3 or a base seal or foil 50 thereon with a piercing element 22 when the container 3 makes contact with it for the first time, to allow air in or aeration, preferably by opening or ng venting hole 23. The venting hole 23 allows for pressure compensation inside the container 3 when fluid 2 is drawn from the container 3 during the actuation of the nebulizer 1.

The nebulizer 1 comprises preferably an indicator device 25, which counts in ular actuations of the nebulizer 1, preferably by detecting its tensioning or the rotation of the inner part 17 relative to the upper part 16 or housing 24. Pref- erably, the counter device 25 or an associated locking device 26 locks the nebu- lizer 1 against (further) ion or use, e.g. blocks further rotation of the hous- ing part 18 / inner part 17 and, thus, tensioning of the nebulizer1 or its drive 1O spring 7 and/or blocks actuation of the ng element 8, in a locked state when a certain number of actuations or operations or discharged doses has been reached or exceeded.

In the following and with reference to the further figures, a preferred embodiment of the nebulizer 1, container 3, tor device 25 and/or locking device 26 is described and shown according to the invention, wherein primarily important as- pects and differences will be bed and the previous aspects, es and explanations apply ably onally or correspondingly even without repe- tition.

Fig. 3 shows the nebulizer 1 with the ner 3 and indicator device 25 accord- ing the present invention in a schematic section (longitudinal section) in the non- tensioned state with completely closed nebulizer housing 24 and, thus, closed housing part 18, wherein the container 3 including the proposed indicator device 25 are inserted into or received within the nebulizer 1 and/or housing 24.

Fig. 4 shows an enlarged partial section of the encircled part of Fig. 3. Fig. 5 shows a perspective view of the section of the nebulizer 1 of Fig. 3. Fig. 6 shows a partial enlargement of the encircled part of Fig. 5.

The nebulizer 1 has preferably a longitudinal form or axis which ponds to the axial direction and/or to the main dispensing direction and/or to stroke movement of the container 3 during tensioning and dispensing.

In the shown non-tensioned state, the nebulizer 1 or its mouthpiece 13 is prefer- ably closed by a mouthpiece cover 27. The mouthpiece cover 27 is preferably pivotable to allow opening of the mouthpiece 13 for using the nebulizer 1.

Preferably, the tor device 25 is directly and/or unreleasably secured or fixed to or connected with the container 3. In particular, the indicator device 25 is associated to a respective ner 3. If the container 3 of the nebulizer 1 is re- placed, the tor device 25 is necessarily or positively replaced as well.

Preferably, the indicator device 25 is fixedly arranged at the bottom or container base 21 of the container 3 and/or opposite to an outlet or head 28 of the container In the present embodiment, the indicator device 25 is preferably directly con- nected to or abuts at an outer case or preferably rigid housing 29 of the n- er 3.

Preferably, the indicator device 25 and the ner 3 are connected by form-fit and/or snap-fit.

In particular, the indicator device 25 circumvents and/or grips over a (lower or ) edge 30 and/or any other protrusion or the like of the container 3. In the present embodiment, the edge 30 is a little bit wider in diameter so that it pro- trudes radially over the essentially cylindrical outer form of the side wall of the container 3 / container housing 29.

The diameter of the indicator device 25 is preferably at least essentially equal to or ly greater than the diameter of the container 3 or its edge 30.

The edge 30 is ably formed between the side wall and the bottom or base 21 of the container 3 or container g 29. Preferably, the edge 30 is formed by flanging, ing, bending or crimping or by any other suitable material- forming process.

The indicator device 25 comprises a g 31 and/or preferably has an at least essentially cylindrical form.

The indicator device 25 or its housing 31 is preferably attached to the container 3 or its base 21 or housing 29 with an at least essentially flat and/or axial side.

The indicator device 25 or its housing 31 comprises preferably a holding or grip- ping section 32 for connecting the indicator device 25 with the container 3. Preferably , the gripping section 32 circumvents the edge 30 and/or grips around or over the edge 30.

In the present embodiments, the gripping section 32 is preferably annular and/or grips over the edge 31 at ons distributed over the circumference of the edge 30 or container 3.

Preferably, the indicator device 25 and the container 3 are connected with each other by a snap—fit or click connection. Preferably, the container 3 and the indica- tor device 25 are connected with each other by axially snapping one part on the other.

Preferably, the gripping n 32 is sufficiently elastic in radial direction so that the container 3 can be entered axially with its edge 30. In the present embodi— ment, the gripping n 32 preferably comprises a respectively inclined inser- tion face to facilitate ion of edge 30 into the annular gripping section 32 or between circumferentially distributed gripping sections 32.

It has to be noted that other constructional solutions are possible for connecting the container 3 or its housing 29 with the indicator device 25 or its housing 31 or vice versa. In particular, the two parts can be connected with each other addi- tionally or atively by welding, brazing, gluing, screwing, clamping, hot- pressing, or the like.

Fig. 7 shows in a schematic, exploded view the tor device 25 according to the red embodiment of the present invention.

The indicator or its housing 31 comprises preferably an upper part 33 and a low- er part 34.

Preferably, the upper part 33 holds or forms the gripping section 32.

The indicator device 25 ses preferably an indicator element 35 and an associated actuation element 36 and/or a transmission 40 or gear 41 for index- ing the indicator element 35 or for causing the indexing of the indicator element The indicator device 25 is for counting and/or indicating a number of uses per- formed or still possible with the respective or associated container 3. Preferably, the indicator element 35 comprises markings 37, such as one or more symbols, numbers, coloured or shaded areas or the like, for at least roughly indicating the number of uses y performed with or still le with the respective con- tainer 3. In the present embodiment, the indicator element 35 is preferably rotat- able and/or ses a circumferential wall or outer surface with the at least one marking 37.

The indicator housing 31 comprises preferably a window 31a, in particular in the circumferential wall through the relevant marking 37 is visible for a user or pa- tient, preferably through the housing part 18 which is in particular transparent.

The actuation element 36 comprises preferably an actuation arm 38 which, in- tern ses preferably a free or actuation end 39, for direct or indirect actua- tion or ng of the indicator element 35. ng means that the indicator element 35 is moved forward in increments or steps.

Preferred is an indirect actuation or driving so that the actuation element 36 or its arm 38 actuates or drives the indicator element 35 via a transmission 40. In the present ment, the transmission 40 results in a reduction and/or is re- alized as a worm device.

The indicator device 25 or transmission 40 comprises preferably a gear 41 and/or a worm 42. Most preferably, the worm 42 is directly formed by the gear 41 so that the gear 41 forms a worm gear and preferably comprises radially pro- truding teeth 43 in which at least one ution of the worm 42 is formed (compare the ntal or axial sections of the mounted indicator device 25 shown in Figs. 8 and 9).

The gear 41 comprises preferably an axle, in particular one or more axle sec- tions 44 which may y protrude on opposite sides as realized in the present embodiment.

The actuation element 36 causes a rotation of the gear 41 around an axis pref- erably perpendicular to the direction of nt of the actuation element 36, the axis preferably being arranged in a horizontal plane identical or parallel to the plane given by the movement of the actuation element 36.

The gear 41 is bly held preferably by the housing 31 or lower housing part 34, preferably by two g ns 45 of the lower part 34. Preferably, the bearing sections 45 comprise recesses for rotatably holding the axle sections 44. However, other constructional solutions are possible as well.

The housing 31 or lower part 34 bears preferably the indicator element 35 such that it can rotate. In the present embodiment, the lower part 34 comprises pref- erably two bearing portions 46 arranged on opposite radial sides and y pro- truding for rotatably bearing the indicator element 35. The actuation element 35 1O and/or ission 40 are preferably arranged at least essentially in between the bearing portions 46.

The indicator device 25 comprises preferably an actuation spring 47, in particu- lar for biasing the actuation element 36 into a preferred direction and/or for driv- ing the indicator element 35 Fig. 8 shows in a horizontal or axial section the mounted tor device 25 in an actuated state where the actuation element 36 has been moved or pushed rds, namely starting from the first position shown in Figs. 3 to 6 towards the left into a second position which is shown in Fig. 8.

Fig. 9 shows in a similar section as Fig. 8 the indicator device 25 in a locked state where the actuation element 36 is in a , third position.

It can been seen from Figs. 8 and 9 that protrusions 60 of the indicator element (not shown in Figs. 8 and 9) extend axially, wherein always at least one pro- trusion 60 is caught in the worm 42 so that a worm drive is formed between the gear 41 and the indicator element 35. Thus, any rotation of gear 41 is trans- formed in a reduced rotation of the tor element 35. Further, a permanent engagement between the gear 41 and the tor element 35, more precisely between at least one protrusion 60 and the worm 42, is ensured. However, other constructional solutions or couplings between the gear 41 and the indicator ele- ment 35 are possible.

Fig. 10 shows the mounted indicator device 25 in a perspective section in the ini- tial, first position and state. Fig. 11 shows the indicator device 25 in a similar perspective section, but with released actuation element 36, Le. just before the locked state is d.

Preferably, the transmission 40 or gear 41 forms a worm (helical groove) 42 with at least one convolution, preferably a with about 1.5 or more convolutions, so that always at least one engaging element of the indicator element 35 or of any other ission component, in ular the inwardly or axially projecting pro- trusion 60, engages in the worm 42. Thus, rotation of the gear 41 around its preferably transversal axis results in a rotation of the indicator element 35 around its preferably longitudinally ed rotation axis. However, other con- structional solutions are possible as well.

Preferably, the teeth 43 are relatively long and/or extend radially iently so that the sions are securely guided within the convolutions of the worm 42, in between the teeth 43, and that the actuation portion 39 can still move in radial direction between the sion 60 engaging into the worm 42 and the gear 41 in order to actuate or rotate the gear 41 in the desired . For this purpose, the actuation portion 39 may engage into respectively deep cutouts between the teeth 43 in order to be able to move below the respective projection 60.

The indicator device 25 comprises preferably a piercing part 48 (compare Fig. 3 to 6).

The piercing part 48 is arranged within the indicator device 25 or its g 31.

The piercing part 48 is preferably axially moveable.

The piercing part 48 is preferably moveable such that it can protrude s the container 3 and/or can open an aeration opening, preferably the venting hole 23, of the container 3, in particular by breaking or piercing a foil 50 covering the venting hole 23.

In the present embodiment, the piecing element 48 comprises preferably an opening end or tip 49 which can open or pierce the foil 50 covering the container base 21, in particular an indention 51 formed in the container 3 or its base 21. 1O Preferably, the indention 51 comprises a break through which forms the venting hole 23. However, other constructional solutions are possible as well.

Fig. 12 shows in a partial enlargement similar to Fig. 4 a lower portion of the nebulizer 1 in an intermediate state after partial tensioning. The indicator device 25 is in an actuated state as shown in Fig. 8 (second position).

The nebulizer 1 or housing part 18 comprises preferably a driving part 52 for driving or actuating the tor device 25 when using the nebulizer 1, in partic- ular for actuating the indicator device 25 in se to any ning of the nebulizer1 and/or any (axial or stroke-like) movement of the container 3.

Preferably, the driving part 52 is arranged or formed in the housing part 18, in particular on the axial end face or bottom 53 of the housing part 18.

Preferably, the driving part 52 is arranged centrally and/or extends y.

Preferably, the g part 52 is at least ntially rical and/or pin-like or bolt-like. ably, the driving part 52 is held by the housing part 18 and/or integrally formed by the housing part 18.

In the preferred embodiment, the movement of the container 3 and, thus, of the tor device 25 during the tensioning (downward nt in the drawings) and/or during pressurization and dispensing (upward nt in the drawings) and/or one or both of the respective end positions in the non-tensioned state and tensioned state, respectively, can be used for actuating the indicator device 25, Le. for counting. ably, the relative movement of the container 3 and/or indicator device 25 within the nebulizer 1 is used for actuating or triggering the indicator device 25 and/or counting.

When ning the nebulizer 1 and/or moving the indicator device 25 down- wards, the driving part 25 enters or engages through an insertion opening 54 of the indicator device 25 or its housing 31, in particular axially.

Preferably, the driving part 52 and the insertion opening 54 are arranged central- 2O ly and/or axially aligned.

In the present embodiment, the driving part 52 actuates the actuation element 36, Le. moves the actuation element 36 from an initial first position shown in Fig. 3 to 6, to an actuated second position shown in Fig. 9.

Preferably, the actuation spring 47 biases the actuation element 36 into the first In the present embodiment, the actuation element 36 is moveable back and forth n the first and second positions for indexing the indicator element 35, in particular for incrementally rotating the gear 41 in one direction to tively drive the indicator element 35. As any rotation of gear 41 is transformed in a re- duced rotation of the indicator element 35, thus every movement of the actuation element 36 from the first to the second position or vice versa results in a move- ment of the indicator element 35.

In the present embodiment, the ion element 36 is moveable transversally, preferably perpendicularly, to the longitudinal or dispensing direction of the con- tainer 3 or nebulizer 1 and/or to the stroke movement of the container 3 and/or 1O indicator device 25.

Preferably, the actuation element 36 is moved from the more central first posi— tion radially outwards to the second position, in particular against the force of the associated, preferably helical ion spring 47 biasing the ion element 36 in opposite direction.

In the second position, the actuation element 36 has been moved with its actua- tion arm 38 or actuation portion 39 out of engagement with gear 41 as indicated in Figs. 8 and 12.

Fig. 13 shows in a r enlarged n as Fig. 12 the fully tensioned state.

In the ) tensioned state, the container 3, more precisely the aeration open- ing or venting hole 23, is opened at least when the nebulizer 1 is tensioned with a container 3 for the first time.

Preferably, the opening of the container 3 or venting hole 23 for aeration is real- ized by ng or breaking, in particular of foil 50.

The g or piercing can be effected directly by the driving part 52. a- tively, the opening or piercing can be effected ndently from the driving part 52, e.g. by means of the aeration spring 20 with the piercing element 22 similar to the embodiment shown in Fig. 2. atively, as in the present em- bodiment, the g or piercing can be ed indirectly, preferably via the piercing part 48 which is preferably actuated by the driving part 52.

Preferably, the piercing part 48 is formed as separate part and/or provided by the indicator device 25 and/or arranged within the indicator device 25.

In the preferred embodiment, the piercing part 48 is held axially moveable by a support structure 55 of the indicator device 25, housing 31, upper part 32 and/or indicator element 35, as schematically indicated in Figs. 10 and 11.

Preferably, the piercing part 48 and/or the support structure 55 are a one-piece- construction with a further part of the indicator devices 25, e.g. with the indicator t 35 or with the indicator housing 31, especially with the upper part 33 of the tor housing 31. 2O Preferably, the piercing part 48, support structure 55 and the further part of the indicator device 25 are made of plastic in an injection molding process.

Preferably, the support structure 55 comprises flexible arms or ribs for holding the piercing part 48 y moveable.

Alternatively the piercing part 48 can be constructed as separate, axially movea- ble part, which is optionally spring biased in the longitudinal or axial direction away from the container 3, so that the piercing tip 49 is retracted from the con- tainer 3 in the non—tensioned state.

It has to be noted that the piercing part 48 is preferably ed within the indi- cator device 25 or its housing 31, but can protrude ds in the actuated state.

The opening or piercing can be repeated each time the nebulizer 1 is tensioned, i.e. each time when the container 3 reaches its end position in the tensioned state.

The ng part 48 may be biased into its retracted or initial position shown in Fig. 3 to 6, in particular by a preferably ally formed biasing arm, spring or the like, preferably by the support ure 55.

The piercing part 48 may comprise a compensation portion, such as a flexible arm 56, for compensating any tolerances in axial direction. Such tolerances can occur in particular due to variations during production, in particular variations of the length of the container 3 and/or other components, variations of the connec- tions of the container 3 with the tor device 25, variations of the length of the indicator device 25 or its housing 31, variations of the axial position of the container 3 within the holder 6, and the like. Thus, ent distances between the free end of driving part 52 and the counter-face of the piercing element 22 can result. The construction is such that the driving part 52 and the piercing el- ement 22 ate in any case such that the d piercing is ensured.

The compensation portion allows axial compression — here by radial flexing of arms 56 — when a predetermined axial force is exceeded in order to avoid any damage of the container 3 and/or any other component of the nebulizer 1. Thus, in the preferred embodiment the driving part 52 first moves the piercing part 48 towards the container base 21 into the piercing position and further axial move- ment of the driving part 52 is compensated by the compensation portion, prefer- ably by the flexible arms 56 being spread radially outwards, giving way to the tip of the driving part 52 for entering a central recess in the piercing part 48 (on the side opposite to the piercing tip 49).

The piercing part 48 comprises preferably at least one axial channel, in particu- lar one or more axially extending s 57 circumferentially buted around the circumference of tip 49, in order to ensure unblocked aeration or venting even if the piercing part 48 stucks or stays in the foil 50 or piercing position.

Fig. 14 shows in a similar enlargement as Fig. 4, 12 and 13 an intermediate state of the rization or dispensing process, i.e. when the container 3 has been moved partially upwards again. In this state, the driving part 52 has been withdrawn from the indicator device 25 or through the insertion opening 54 par— 1O tially such that the actuation t 36 starts to return to its initial or first posi- tion due to the force of the actuation spring 47. Finally, after sufficient withdrawal of the driving part 52, the actuation element 36 s into the first position shown in Figs. 3 to 6 when the back movement is completed.

The back movement of the container 3 and/or of the actuation element 36 actu- ates preferably the indicator device 25 or gear 41 and/or is detected or counted.

In particular, the actuation element 36 or its arm 38 or actuation portion 39 transmits the back movement or movement from the second to the first position to the transmission 40. In particular, this movement causes an incremental rota- 2O tion of gear 41.

Thus, in the present ment, the nt of the container 3 and/or indi- cator device 25 within the nebulizer 1 during dispensing is preferably used to ac- tuating or triggering the indicator device 25 and/or for counting.

In the present embodiment, the actuation arm 38 or its portion 39 abuts against one tooth 43 of gear 41 during the back movement and, thus, turns the gear 41 due to the back movement one step further, in the drawings in clockwise direc- tion.

Preferably, the indicator device 25 comprises a ratchet 58 preventing any coun- ter-rotation of the transmission 40 or gear 41. Into the t embodiment, the ratchet 58 is formed by a flexible arm extending from the housing 31, in particu- lar lower housing part 34, and/or meshing with or engaging into the gear 41 or its teeth 43.

In the end position, i.e. in the non-tensioned state, the driving part 52 is prefera- bly further or completely retracted from the indicator device 25, the indicator housing 31 and/or insertion opening 54 as shown in Fig. 3 to 6.

The transmission 40 or gear 41 orms the actuation, in particular the (back- ward) movement of the actuation element 36 or its arm 38 / actuating portion 39, into an indexing of the indicator element 35. The transmission ratio or transmis- sion function of the transmission 40 or gear 41 may be designed or constructed such that a reduction or non-linear driving or indexing is achieved. In the present embodiment, the transmission 40 or gear 41 forms preferably a worm drive for achieving a desired ion.

The movement of the actuation element 36 — in particular from the first on to the second position — results in that the actuation arm 38 or its actuation por- tion 39 are moved out of engagement with the gear 41, in ular can be pulled over the next tooth 43. Hereby, the arm 38 is flexed out. The subsequent nt in opposite direction, i.e. the back movement or movement from the second to the first position, results in that the ion arm 38 or its ion portion 39 contacts the next tooth 41 and can it the at least essential |ine- ar movement of the arm 38, more precisely the preferably linear nt of the actuation element 36, into a rotation of the gear 41, more precisely in an in- dexing of gear 41 by preferably one tooth 43.

Preferably, the teeth 43 are asymmetrical, i.e. comprise differently inclined shoulders on one side and the other side in order to facilitate and/or ensure the incremental actuation and movement in only one rotational direction by the back and forth movement and ment of the actuation arm 38.

Preferably, the actuation element 36 is linearly moveable and/or forms a g carriage.

Preferably, the actuation element 36 is ted and/or held ly by the housing 31, in particular lower part 34 of the g 31. However, other con- structional solutions are possible as well.

The actuation spring 47 acts preferably between the housing 31 or lower part 34 on one hand and the actuation element 36 on the other hand.

In the present embodiment, the spring 47 is preferably already compressed and/or biased in the first position and/or biases the actuation element 36 such that it at least partially closes or blocks the insertion opening 54.

Preferably, the actuation t 36 comprises an inclined gliding surface 59 at its part protecting into or over the insertion opening 32 in the first position. This surface 59 is inclined such that the insertion of the driving part 52, Le. its axial movement or abutment, is transformed into a transversal or radial movement of the actuation element 36.

Alternatively or additionally, such a surface 59 can also be formed at the driving part 52 to achieve the desired transformation of the axial movement into a trans- versal or radial movement by means of an inclined plane.

Therefore, the ion or rotation of the transmission 40 or gear 41 is prefera- bly ed by the force of the actuation spring 47 or any other pressure or en- ergy store or spring means. This results in the advantage that no additional force is necessary for driving the indicator device 25 or its indicator element 35. Con- sequently, the pressurization and dispensing s is not disturbed.

Further, the triggering of the counting or ion of the ission 40 / gear 41 is effected preferably by the pressurization or sing process or move- ment, i.e. during the actual dispensing of fluid 2, Le. usually during actual use or inhalation.

The actuation spring 47 biases the actuation element 36 preferably towards closing the insertion opening 54.

Usually, the movement of the actuation element 36 is restricted so that it does not tely close the insertion opening 54 before the locked state is reached.

This limitation is realized in the present embodiment preferably via a control means or n 62 against which a control part 63 abuts in particular to restrict the back movement of the actuation element 36 at the first position.

The abutment is shown in particular in Fig. 10. However, other constructional solutions are possible as well.

After the number of uses of the nebulizer 1 with the container 3 has reached or exceeded a predetermined number of uses as ed or registered by the in- dicator device 25, a locked state is entered and the nebulizer 1 will be locked against further use with the current container 3 and/or the container 3 will be locked against r use with the nebulizer 1.

In particular, the indicator device 25 comprises a blocking part 61 which blocks further use of the container 3 and/or closes or blocks the insertion opening 54 in the locked state as schematically shown in the schematically enlargement of Fig. which shows a similar part as Fig. 4 and 12 to 14. In this shown state, the container 3 has returned to its non—tensioned position and the g part 52 has been retracted from the indicator device 25. During the last dispensing or pres- surization process, the indicator device 25 has moved the tor element 35 one step further and detected or registered that the predetermined number of uses has been reached or exceeded and, thus, that the locked state shall be en- tered.

In the present embodiment, the indicator element 35 comprises preferably a control portion 62 which releases the actuating element 36 for detection of the locked state which s in locking the nebulizer 1 or current container 3 against further use.

Preferably, the l portion 62 comprises a cut out or recess which allows or initiates movement of the blocking part 61 into a blocking position. ably, the blocking part 61 blocks or closes the insertion opening 54 in the blocking po- sition, i.e. in the locked state. Preferably the control portion 62 is a wall or ridge on the inside of the rotatable indicator element 35.

Preferably, the blocking part 61 is ated into the indicator device 25 or its housing 31.

The blocking part 61 is preferably moveable transversally or perpendicular to the udinal or sing direction of the container or nebulizer1 and/or of the direction of stroke movement of the container 3.

Preferably, the blocking part 61 blocks the actuation or insertion nt of the driving part 52, in particular relative to the indicator device 25 and/or (suffi- cient) insertion of the driving part 52.

Preferably, the blocking part 61 is linearly le and/or formed by a sliding carriage. However, other constructional solutions are possible as well. ably, the blocking part 61 is biased into its blocking position, in the present embodiment preferably by actuation spring 47 or any other suitable biasing means.

Preferably, the blocking part 61 closes or blocks the ion opening 54 of the indicator device 25 after the last dose of fluid 2 has been dispensed and when the locked state has been d or detected. This detection is preferably real- ized in that the blocking part 61 or any associated ent, such as l part 63, can pass the control portion 62 in the locked state, most preferably by 1O spring force, in particular by the force of actuation spring 47 or the like, as schematically shown in Fig. 11.

Preferably, the blocking part 61 is connected with or formed by the actuation el- ement 36 or vice versa. Most preferably, the blocking part 61 forms a wall or side, preferably flat side (preferably the bottom side), of the actuation element 36. However, other constructional ons are possible as well.

In the present embodiment, the actuation element 36 can move in the locked state from the first position into the third position, i.e. preferably in the opposite direction than the movement into the second position.

In the present embodiment, the actuation element 36 can close the insertion opening 54 preferably completely in the third position (blocking position).

With other words, the blocking position of the blocking part 61 corresponds pref- erably to the third position of the actuation t 36.

In the locked state or third position, the actuation element 36 has moved with the actuation arm 38 or its portion 39 further in the actuation direction so that the ac- n portion 39 has passed the previous tooth 43 in the rotation direction of gear 41 as indicated in Fig. 15.

Preferably, the actuation element 36 is constructed to block further use of the container 3 in the locked state or third position (blocking position).

Preferably, the ion element 36 is moveable back and forth between the first and second position for indexing the indicator element 35 and is moveable into a third position to block further use of the container 3 in the locked state.

In particular, the closed indicator device 25 or blocking part 61 results in particu- lar in that the container 3 cannot move inside the closed g of the nebulizer 1 in the stroke-like fashion as previously and as required for normal or further use so that normal use is prevented.

In ular, the locking of the indicator device 25 or insertion g 54 s in that the nebulizer1 or housing part 18 is at least partially opened when the nebulizer 1 is tensioned once more or when it is partially tensioned. Fig. 16 shows this state (partially tensioned nebulizer 1 with partially opened housing part 18) in a schematic, longitudinal section of the nebulizer 1. During the ten- sioning process the container 3 is moving downwardly together with the indicator device 25. Starting from the non-tensioned state (upper position of the container 3), the indicator device 25 abuts soon with its blocking part 61 / actuating ele- ment 36 t the member usually actuating the indicator device 25, here the g part 52, so that a further usual downward movement is not possible.

In particular, the blocking part 61 restricts the axial lity of the container 3 in the nebulizer 1 in the locked state, preferably by preventing the driving part 52 from insertion into the tor device 25 or restricting its insertion in the locked state. Due to the force applied when tensioning the nebulizer1 and due to the resulting axial force in the movement of the container 3, the housing part 18 will be moved ds or relative to the nebulizer 1, inner part 17 or upper part 16 er with the container 3 and indicator device 25 during the further tension- ing movement in axial direction in the locked state.

The above common downward nt of container 3, indicator device 25 and housing part 18 is possible due to a respectively constructed fastening of the housing part 18 at the nebulizer 1. In particular, the ing force is select- ed or set such that it can be overcome by the downward movement of the con- tainer 3.

In the present embodiment, the retaining element 19 engages with a retaining nose 64 in a respective ing recess 65 in the housing part 18 or vice versa. 1O Thus, substantially an indention can be realized. However, the abutting shoul- ders which extend at least essentially radially of the nose 64 on one hand and the recess 65 on the other hand are slightly inclined, preferably by about 1° to 5° to the radial plane such that the axial force of the tensioning process can over- come the retaining force provided by the engagement of the nose 64 into the re- cess 65 so that the retaining element 19 is flexed radially and the retaining en- gagement is overcome. Consequently, the housing part 18 is moved downward- ly as well and, thus, is pushed at least partly from the nebulizer 1 or separated from the upper housing part 16 and/or pushed from the inner part 17.

This pushing or axial displacement of the g part 18 or any other opening of the nebulizer 1 results preferably in that the nebulizer 1 is locked against fur- ther use by means of the locking device 26. Therefore, the indicator device 25 or its blocking part 61 indirectly effects indirectly via the opening of the nebulizer 1 the d locking of the nebulizer 1 in the locked state.

In the red ment, the locking device 26 blocks tensioning of the nebulizer 1 in the locked state.

Preferably, the locking device 26 ses a moveable locking element 66 and an associated locking spring 67. The g element 66 is preferably axially moveable between a locked position and an ed position. The locking ele- ment 66 is preferably biased into the locked position by the locking spring 67.

In the locked position, the locking element 66 is preferably in its lower axial posi- tion shown in Fig. 16. Fig. 17 shows an enlargement of the encircled area of Fig.

In the locked on, the locking element 66 blocks rotation of the inner part 17 relative to the outer part 16 and, thus, blocks (further) tensioning of the nebulizer 1. This is preferably achieved in the t embodiment in that the locking ele- ment 66 moves or engages preferably axially into a respective pocket 68 formed 1O in the upper part 16 such that said relative rotation is blocked. In particular, the locking element 66 engages with an engagement portion 69 into the respective recess or pocket 68 such that any further rotation and/or back rotation is pre- vented. However, other constructional solutions are le as well.

The locking device 26, in particular the locking element 66 and the locking spring 67, are preferably arranged and/or supported by the inner part 17 and/or extend between the inner part 17 and upper part 16.

The nebulizer 1, inner part 17 or locking device 26 comprises preferably a cover 2O 70 covering the locking device 26 at least on the periphery of the lower part 17b of the inner part 17 in order to prevent or at least complicate any undesired ma- nipulation of the g device 26 or locking element 66 by a user or patient.

Fig. 18 shows the nebulizer1 in a similar schematic n as Fig. 16, r with the locking device 26 in the unlocked position, i.e. the g element 66 in the upper position. The locking device 26 or g element 66 is brought into this position or unlocked preferably only by closing the nebulizer 1, in particular by the housing part 18 in the completely attached or closed on.

In the shown embodiment, the housing part 18 comprises a preferably finger-like and/or y extending actuator 71 which extends into the locking device 66 and/or into the cover 70 and/or axially abuts and/or pushes the locking element 66 into its unlocking position (upper position), as shown in Fig. 18. Thus, only the completely closed nebulizer1 or housing part 18 unlocks the g device 26 and, thus, unlocks the zer 1.

The actuator 71 is preferably arranged within the g part 18 so that any manipulation is not possible or at least complicated.

When the nebulizer 1 is in the locked state and, preferably when the nebulizer 1 or its housing part 18 has been opened partially by the last tensioning process, any further use of the nebulizer1 with the container 3 and the indicator device in its locked state is not possible. The locking device 26 locks preferably au- tomatically. Preferably, the locking spring 67 biases the locking element 66 into the locking position, so that upon at least partial opening of the nebulizer1 or (axial) displacement of its housing part 18, the locking device 26 or its locking element 66 can move and moves into the locking position.

Preferably, the g element 66 is moveable tially or only) in axial di- rection.

After replacement of the current container 3 with its locked indicator device 25 (blocking part 61 in the blocking position) against a new container 3 including a new or reset indicator device 25, the zer1 or its housing part 18 can be closed completely again. Thus, the nebulizer 1 or its locking device 26 can be or is unlocked again. Preferably, the actuator 71 pushes the locking element 66 back into its unlocking position.

Thus, the g device 26 is reset or unlocked again, preferably by ete- ly) closing the nebulizer 1, its housing 24 or housing part 18, and the nebulizer1 can be used with the new container 3 as previously.

It has to be noted that the insertion opening 54, which is ably arranged centrally and/or opens in axial direction and/or allows axial insertion of an actua- tor element, in ular the driving part 52 in the present embodiment, can also be formed as a recess, groove, indention or the like and/or can be arranged at any position or location at the indicator device 25 with any orientation.

Alternatively, the insertion opening 54 or its closing can also be omitted. Instead, the indicator device 25, actuation element 36 or blocking part 61 can more or 1O less directly communicate with or e the locking device 26 or, for example, the retaining t 19 or blocking element 8 in order to cause a direct or indi- rect locking of the nebulizer 1 or container 3 against further use.

Fig. 19 shows in a tic section the indicator device 25 according to a mod- ified ment of the present invention. Fig. 20 shows a perspective view of the section ing to Fig. 19.

In the following, only relevant differences are described so that the previous ex- planations and aspects apply in addition, in particular in the same or similar manner, without repetition.

In the modified embodiment, the actuation arm 38 and ion portion 39 do not engage in between the worm drive, i.e. between the gear 41 and the engag- ing protrusions 60 of the driven part, here namely the indicator element 35, but engage with or actuate the gear 41 on another side or the side opposite the worm drive, here preferably in Fig. 19 from below and not from above. In particu- lar, the actuation arm 38 extends more or less in a radial plane and/or more or less in a common plane with the actuation spring 47 and/or blocking part 61 or the sliding carriage part of the ion element 36.

Preferably, the actuation arm 38 or portion 39 engages with the gear 41 on the side opposite the container 3 or gripping section 32.

In the modified embodiment, the indicator device 25 counts preferably when the nebulizer1 is tensioned, i.e. during the tensioning process and not during the dispensing process as provided in the initial embodiment of the present inven- tion.

In particular, the actuation element 36 or its arm 38 drives or rotates the trans- mission 40 or gear 41, when the driving part 52 is inserted into the indicator de- vice 25, its housing 31 or its insertion opening 54 and/or when the actuation el- ement 36 is moved from the first position to the second on and/or when the actuation element 36 is pushed transversally by the driving part 52. In the oppo- site direction, the actuation arm or its actuation portion 39 passes the next tooth 43 of the gear 41, Le. does not drive the gear 41.

In the modified embodiment, the indicator device 25 or counting is not driven by the force of the actuation spring 47 or any other spring or energy store, but by the relative movement of the indicator device 25 within the nebulizer 1 or by the insertion of an actuator element, such as the driving part 52. r, other uctional ons are possible as well.

In the modified embodiment, the blocking of the carriage / actuation element 36/ looking part 61 to move into the third or looking on are released during the tensioning when a predetermined number of uses is d or exceeded.

Then, the carriage / actuation element 36 / blocking part 61 abut against the driving part 52 e the counting occurs during the tensioning. When the nebulizer1 is actuated or when the blocking element 8 is sed, the nebu- lizer1 is triggered and the (last) dose of fluid 2 is zed. During this nebuli— zation, the driving part 52 is removed from the indicator device 25 or insertion opening 54 so that the carriage / actuation element 36 / blocking part 61 are free to move into the third or looking position due to the force of the actuation spring 47 or any other spring means.

During the next tensioning, the nebulizer1 or its housing 24 or housing part 18 will be lly opened when the driving part 52 abuts t the closed indica- tor device 25, in particular against the carriage / actuation t 36/ blocking part 61 restricting or closing the insertion opening 54.

In the previous embodiment, the counting or actuating of the indicator device 25 takes place or occurs when dispensing fluid, i.e. when the g part 52 is withdrawn from the insertion opening 54. There, the carriage / actuation element 1O 36/ blocking part 61 are released during the last use of the nebulizer1 or dis- pensing, i.e. when moving from the second to the first position so that the car- riage / actuation element 36 / blocking part 61 can move further directly into the third or unlocking position. Thus, any later dispensing is not possible.

In both cases, i.e. in the us embodiment and in the modified embodiment, the tor device 25 blocks full axial or stroke-movability of the container 3 within the nebulizer 1 in the locked state and/or causes at least partially g of the nebulizer housing 24 and/or housing part 18 in the locked state, in particu- lar when the nebulizer 1 is tensioned at least partially for the last time with the 2O current container 3.

Further, the at least l opening of the nebulizer 1 or its housing 24 or hous- ing part 18 results in that the nebulizer1 is blocked, in particular cannot be ten- sioned any further or used any further, with the current container 3.

Figs. 19 and 20 show the indicator device 26 according to the present invention in the non-actuated or initial state and/or with the actuation t 36 in the first position. The control part 63, which s preferably upwards and/or in axial direction, abuts against the preferably ring-like control portion 62 which is preferably formed by or at the indicator element 35. Preferably, the control por- tion 62 has a radial ce to the outer wall of the indicator element 35 so that the control part 63 can move in between and that the actuation element 36 is free to move between the first and second positions, while the abutment of the control part 63 against the control portion 62 prevents movement of the actua- tion element 36 from the first position further towards the third position and/or r to (complete) closing the insertion opening 54.

Preferably, the protrusions 60 are dent-like and/or are tapered towards its free ends.

Preferably, the protrusions 60 are formed on or connected with the control por- tion 62.

Generally, the insertion opening 54 is ed preferably with a l surface or edge to facilitate insertion of the g part 52 or the like.

Preferably, the support structure 55 forms or ses one or more flexible arms for moveably holding the piercing part 48, preferably in the center of the indicator device 25 or its housing 31 or a respective opening of the housing 31, so that the piercing part 48 is usually held inside the indicator device 25 but can move and in ular protrude outwards and/or towards the container 3 for opening or piercing aeration. However, other constructional solutions are possi- 2O ble.

Generally, the indicator device 25 and the container 3 form an inseparable as- sembly or unit, which has to be ed completely after use, in ular after reaching the locked state. However, it is also possible that the container 3 and indicator device 25 are supplied or offered as a kit which can be assembled by the use or t.

Generally, the indicator device 25 cannot be reset after reaching the locked state so that it cannot be reused. However, it is also possible to modify the indicator device 25 such that it can be reset and reused. In this case, the indicator device has to be separated from the present container 3 and connected with a new (unused) container 3. Most preferably, such a container change would automati- cally reset the indicator device 25.

Generally, the actuation element 36 or blocking part 61 is moveable preferably ly, in particular like a sliding carriage. In particular, a sliding carriage is formed.

Preferably, the sliding ge forms a base part of the actuation element 36 or ng part 61.

Preferably, the sliding carriage, actuation t 36 or blocking part 61 is moveably held by sliding guides 72 on opposite sides, preferably on te sides of the ion opening 54, as schematically shown in Figs. 8 and 9. Pref- erably, the guides 72 are formed by respective rails or the like of the housing 31 or its lower part 34 which grip over tive edges or base portions 73 of the actuation element 36 or blocking part 61 to form the desired sliding guidance.

However, other constructional solutions are possible as well.

Instead of the preferably linear or sled-like moveable actuation element 36 and/or blocking part 61, any other motion, in particular a radial and/or pivotal movement, is possible, in particular for partially or completely closing the inser- tion opening 54.

Alternatively, the actuation t 36 and/or blocking part 61 can move out- wards from the indicator device 25 or its housing 31, preferably transversally and/or at one side of the indicator g 31 for locking at least one engage- ment possibility and/or actuating any other component in the locked state or for locking the nebulizer1 and/or container 3.

Alternatively or additionally, the actuation element 36 and/or blocking part 61 can engage into or abut against a section or contour of the housing part 18 and/or nebulizer housing 24 or the like in order to ct or prevent operation or movement in the locked state in order to block further use of the nebulizer 1 and/or container 3 in the locked state.

The actuation t 36 and/or blocking part 61, in particular also when acting radially, are preferably biased by spring 47 or any other spring means. The spring or spring means can be formed integrally and/or by c parts or piec- es. Alternatively, a spiral or clock spring or any other spring, such as helical spring 47 or the like, could be used for biasing the actuation element 36 and/or 1O blocking part 61, preferably into the locked state.

It is also possible that the driving part 52 directly drives or actuates the gear 41.

In this case, the driving part 52 is ably elastically ted by the housing part 18, in particular via a spring means (not shown), in particular for compensat- ing axial tolerances and/or allowing radial or ersal flexing of the driving part 52. Additionally or atively, the driving part 52 may be flexible in order to allow transversal flexing for engaging with the gear 41 only in one ion of relative axial movement to the gear 41 to rotate the gear 41 only in one rotation- al direction.

The indicator device 25 can comprise any other counting mechanism, in particu- lar as described in A1, page 4, line 19 to page 10, line 13, which is incorporated herein by reference. Such a counting mechanism can also trigger, release or actuate the actuation element 36 and/or blocking part 61.

When using this ng mechanism, the rotatable indicator element 35 can al- so release or control the release of the carriage, actuation element 36 or block- ing part 61 in the locked state to move into the third or locking position or close the insertion opening 54.

It is also possible that the carriage or blocking part 61 is independent from the counting. In particular, the driving part 52 may engage the hub of the ng mechanism shown in A1 or the like and/or drive or actuate the indicator device 25 or counting without actuating the carriage or blocking part 61.

In this case, the functions are separated. The ge and/or blocking part 61 are preferably used only for restricting or closing the insertion opening 54 in the locked state, but not for actuating or driving the indicator device 25 of its count- ing mechanism or transmission 40 or indicator element 35 or the like.

The container 3 or indicator device 25 or insertion opening 54 may be ed with a protection (not shown), which covers in particular the insertion opening 54 before the first use.

Preferably, the protection has to be removed before the container 3 and/or indi- cator device 25 can be inserted into the nebulizer1 or housing part 18.

Preferably, the protection extends transversally over the tor device 25 or its housing 31 and/or over the container 3 and/or has a larger diameter than the indicator device 25 and/or container 3, in particular such that it does not fit into the nebulizer1 or housing part 18.

Preferably, the tion can be removed only irreversibly, i.e. cannot be re- connected after l.

Preferably, the protection covers or closes the insertion g 54 and/or the indicator device 25.

Preferably, the protection is connected to the indicator device 25 or container 3 by form-fit or force-fit and/or by a snap-fit or click-fit.

Preferably, the indicator device 25 or its housing 31 is inseparably and/or rota- tionally asymmetrical connected with the container 3 or its housing 29. This can be realized differently.

Fig. 21 shows in a schematic partial section the container 3 with the associated indicator device 25. The container 3 or g 29 is ted with the indica- tor device 25 or its housing 31 ally or additionally by gluing, in particular by means of glue 74 as schematically indicated in Fig. 21.

The glue 74 may be arranged at the axial end-face or base 21 and/or at a cir- cumferential portion, such as edge 30 or housing 29, of the container 3.

In the shown embodiment, the glue 74 is arranged between the gripping section 32 and the housing 29 or edge 30. However, the gripping section 32 is optional and can be omitted. Instead, the indicator device 25 or its housing 31 may com- prise an at least essentially flat e that is connected, in particular glued, to the container 3 or vice versa.

Preferably, the container 3 and/or indicator device 25 and/or connection are formed or constructed such that the glue 74 does not flow into the indicator de- vice 25 or its housing 31 and/or into the center and/or into the venting hole 23.

Preferably the container 3 or its base 21 is preferably tightly pressed onto the in- dicator housing 31 during the forming of the connection y the respective surfaces of container 3 and of indicator housing 31 form a stop or seal between the glue 74 and the venting hole 23 or the center of the indicator device 25. Al- ively an annular stop or seal (for instance formed of suitable preferably elastomeric material attached onto the indicator g 31 or the ner 3 or in form of an additional — preferably elastomeric — sealing component) may be provided (not shown), in particular before applying the glue 74.

Preferably, the glue 74 covers the end or end face or base 21 of the container 3 or the radial sides of the container edge 30 and/or indicator housing 31 only in an annular or ring section or parts thereof, e.g. in circumferentially spaced ring sections or the like. ably, the container 3 or its housing 29 is made of metal, in ular alu- minum.

Preferably, the indicator housing 31 is made of plastic, in particular ABS or the like.

Preferably, the glue 74 is hardened by radiation or light, in particular laser light or UV radiation. The hardening by radiation, in particular by radiation with ultra- violet light or laser light, may be used to accelerate the hardening process of the glue 74 and, thus, to ze production time.

Preferably, the glue 74 has in its hardened or final (set) state characteristics that are similar to the material characteristics of at least one of the components (for ce of the indicator device 25 or its housing 31), in particular similar to ABS or the like.

Instead of glue 74, any other suitable firm bond can be used to connect the indi- cator device 25 with the container 3, such as snapping, clamping, forming or welding or the like, depending on the used materials, stability, ease of produc- 2O tion, production costs and the like. It is also possible to provide one or more de- fined indentions, recesses or the like at the container 3, into which snap hooks of the indicator device 25 or its housing 31 can engage in order to realize a form-fit connection, optionally in combination with a press-fit.

As already mentioned, the glue 74 (which is a connection element forming an adhesive bond or substance-to-substance bond) is optional. Alternatively, the tor device 25 can be ted with the container 3 by deformation of the gripping section 32, in particular by ultrasonic forming or hot-pressing. Without glue 74, Fig. 21 shows the container 3 with associated indicator device 25 be- fore deformation and/or before inward bending of gripping section 32. Fig. 22 shows the container 3 with associated indicator device 25 in a schematic partial section similar to Fig. 21, wherein the ng section 32 has been deformed and/or grips over a portion or edge 30 of container 3 with a greater diameter to preferably connect the container 3 or its housing 29 with the indicator device 21 or its housing 31 by form-fit, in ular it engagement in axial ion.

Preferably, the gripping section 32 or a collar on the tor housing 31, is de- formed or bent over the edge 30 or the like by hot-pressing / hot stamping or ul- trasonic forming or any other suitable process. Preferably, the gripping n 32 is made of plastic.

Preferably, a tool, in particular a heated forming tool (for hot-pressing / hot 1O stamping) or an ultrasonic sonotrode, is moved longitudinally over the container 3 towards the container base 21, edge 30 and/or ng section 32 and/or connection area, ably wherein the heated tool or ode ses a preferably conical end section for forming the softened gripping section 32 in the desired manner, in particular towards the container 3 and/or radially inwardly.

Particularly preferable is a connection process employing ultrasonic excitation and/or a heated forming tool (a "thermode" or hot bar). In the ultrasonic excita- tion process, a sonotrode is used to couple ultrasonic energy into the part (here the gripping section 32) which is formed by the tool shape around the gripping 2O section 32 and which is made out of plastic. The ultrasonic energy excites mo- lecular ions by which the c is softened and/or (partly) melted. The vi- brations can be excited in a longitudinal, transversal, elliptical (longitudinal plus transversal mode) or torsional (rotational mode) way. The longitudinal mode creates tensile stress the transversal or rotational mode shear stress in the in- duced material. For forming a rotationally symmetrical part, longitudinal, elliptical or onal modes can be applied. An elliptical or torsional mode of vibration is preferred, as it has been shown that a torsional or elliptical excitation can be much better controlled than the longitudinal excitation because a much lower amount of incoupled energy is needed and the ultrasound waves have a com- paratively short reach so that the risk of secondary bonds of nearby parts is much lower.

In a hot stamping or hot pressing process thermal energy is coupled directly into the plastic of the part to be form-shaped (the gripping section 32 in case of the shown embodiment).

When the gripping section 32 or a like collar of the indicator device or of the indi- cator housing 31 has been sufficiently plastified or softened or melted by the ul- trasonic excitation or transferred thermal energy, the gripping section 32 or the collar is form-shaped or pressed preferably onto the edge 30 of the container 3 or onto a protrusion on the container g 29 or into an indention in the con- tainer g 29. After the actual form shaping, the energy input (coupling of ul- trasonic or thermal energy into the plastic material / into the gripping section) is ended and, preferably, the tool which is used for the form-shaping of the gripping section 32 remains in the position it assumed for the form-shaping until the plas- tic has cooled down (at least below the plastifying or melting ature) and/or solidified in the newly shaped form, before the tool is withdrawn from the work- piece (container with attached indicator device/ indicator housing). The cooling of the form-shaped plastic or gripping section can be accelerated by cooling the tool used for the form shaping or by using a form-shaping tool with a (control- able) cooling. Thus the processing time for attaching the indicator device 25 to the ner 3 or housing 29 of the container 3 can be reduced.

The connection which results of the form-shaping process involving hot-pressing / hot stamping or ultrasonic excitation ses a form-fit between the thus beaded or flanged collar or gripping section 32 and the container g 29.

Due to material shrinkage occurring during the cooling / solidification of the plas- tified / molten material the connection could also se a force-fit, as well.

Thus the indicator device 25 or indicator housing 31 is fixed and/or inseparably connected with the container 3 or the container g 29. Preferably, the con- nection achieved by the form-shaping process is a rigid connection in which the connected components (here the ng section 32 or indicator housing 31 and the ner housing 29) are unmovable in relation to each other, i.e. they can- not be separated and lly they cannot be moved otherwise against each other. In particular, they cannot be rotated relative to each other.

The ng n 32 grips preferably over or into a respective ut, in- dention or the like in order to realize the preferred form-fit connection between the indicator device 25 or its housing 31 and the container 3 or its housing 29.

The gripping section 32 can form a ring and/or can extend uously in cir- ential direction. Alternatively, the gripping section 32 can be interrupted and/or formed by circumferentially distributed portions or the like. The latter may facilitate the deformation.

Preferably, the container housing 29 comprises a rotationally asymmetrical, i.e. rcular, section for engagement with the indicator device 25 or its housing 31 in order to realize the anti-twist securement with the indicator housing 31 or vice versa. In particular, this section may comprise an indention, protrusion, or flattening 75 as schematically shown in the perspective view of Fig. 23 wherein the container 3 and indicator device 25 are shown separately before ly.

Preferably, the rotationally asymmetrical section or flattening 75 is formed at the lower end or edge 30 of the container housing 29.

Preferably, the rotationally asymmetrical section comprises an indention or pro- trusion or flattening 75 in radial and/or tangential direction and/or forms a non- circular contour.

In the present ment, two or more rotationally asymmetrical sections or flattenings 75 are provided, preferably on opposite or different sides and/or circumferentially spaced.

As already ned, the container 3 or edge 30 can also be provided with one or more depressions, recesses, a riffle or any other r instead of or in addi- tion to the flattenings 75, preferably made by knurling, into which the gripping section 32 can flow or engage when ed or melted during the preferred hot pressing or onic forming. This enhances the inseparability and/or relative unmovability of the container 3 and the indicator device 25.

Preferably, the container 3 and the tor device 25 can be connected with each other in any onal position to each other.

The indicator device 25 or its g 31 or gripping section 32 comprises pref- erably at least one engagement section 76 for ment with or into the rota- tionally asymmetrical section or flattening 75 or the like, wherein the engage- ment section 76 preferably abbots against the onally asymmetrical section or flattening 75.

Preferably, the rotationally asymmetrical section or engagement 75 and the en- gagement section 76 engage such that a firm rotational connection is formed be- tween the container 3 or its housing 29 on one hand and the indicator device 25 or its housing 31 on the other hand, preferably by form-fit engagement.

In the shown embodiment, engagement section 76 is preferably formed by a ra- dial inwardly protruding projection or shoulder, preferably formed by the indicator housing 31 or gripping section 32. However, the engagement portion 76 can al- so be formed ly by a respective deformation of the gripping section 32 or the like.

Preferably, two or more engagement ns 76 are provided or formed for form-fit engagement with respective rotationally asymmetrical sections or flatten- ings 75 as indicated in the schematical radial section of Fig. 24 along line XXIV- XXIV of Fig. 22.

However, other constructional solutions are le as well in order to realize the desired non-rotational connection of the indicator device 25 in container 3.

Further, it has to be considered that even a small onal play between the container 3 and the indicator device 25 may be regarded as a preferred non- rotational connection of the container 3 with the indicator device 25 or vice ver- Thus, the housing 31 of the indicator device 25 is secured against rotation rela- tive to the housing 29 of the container 3 preferably by form-fit engagement or firm bond as explained above.

The anti-twist securement of the container 3 with the indicator device 25 can be realized by the form-fit engagement as described above and/or by gluing of both parts together. Further, it is le to use the form-fit engagement for anti-twist securement in combination with another connection, such as by gluing, for axial securing or connecting the container 3 with the indicator device 25 or vice versa.

Preferably, the indicator device 25 or its g 31 may be used or grabbed by a user (not shown) to detach the ner 3 form the nebulizer 1 (in particular for container replacement), in particular for ing the container head 28 from the holder 6 after opening or detaching the housing part 18. In particular, the us- er rotates and/or axially pulls the indicator device 25 or its housing 31, and, thus, can detach the container 3 from the nebulizer 1 or holder 6. Due to the anti-twist securement of the container 3 and the indicator device 25, the user can a- bly rotate the container 3 (via the indicator device 25) relatively to the conveying tube 9 or nebulizer1 and thus diminish the adhesion between the ner head 28 and the conveying tube 9. Thus the drag forces ary to take the container 3 out of the nebulizer1 or to pull the container head 28 away from the ing tube 9 are diminished, i.e. an exchange of the container 3 is facilitat- Then, the container 3 can be preferably axially withdrawn from the zer 1 and, if desired, replaced by a new container 3 together with an associated new indicator device 25. ably the indicator device 25 or its housing 31 or container 3 comprises at least one griping portion to tate grabbing, in particular of the indicator device or its housing 31. Preferably, the griping portion comprises at least one flat- tening, riffle 77, indention 78 and/or projection 79 as schematically ted in Fig. 25 which shows the container 3 and connected indicator device 25 in a side View.

In the shown embodiment, the indicator device 25 comprises preferably two rif- fles 77 on opposite sides as schematically shown in Fig. 24.

Preferably, the gripping portion is located at a circumferential wall of the indica- tor housing 31 and/or on the lower end-face or part 34 of the indicator device 25.

However, the gripping portion could be arranged or fixed alternatively or addi- tionally on the container 3, its base 21 or edge 30 independently from the indica- tor device 25.

Thus, the ng portion can be used in any case to more easily detach the container 3 from the nebulizer 1 or holder 6 independently from the provision of the tor device 25.

As already mentioned, individual features, aspects and/or principles of the em- bodiments described may also be ed with one another as desired and may be used particularly in the shown nebulizers 1 but also in similar or different zers.

Features of the different embodiments can be combined or exchanged.

Unlike freestanding equipment or the like the proposed nebulizer 1 is preferably designed to be le and in particular is a mobile hand operated device.

The proposed solution may, however, be used not only in the nebulizers 1 spe- cifically described here but also in other zers or inhalers, e.g. powder in- halers or so-called metered dose inhalers.

Preferably, the fluid 2 is a liquid, as already mentioned, especially an s pharmaceutical formulation or an ethanolic pharmaceutical formulation. Howev- er, it may also be some other pharmaceutical formulation, a suspension or the like. ing to an alternative embodiment the fluid 2 may also comprise particles or powder. In this case, instead of the expulsion nozzle 12, some other kind of supply device may be provided, especially an expulsion opening (not shown) or a supply channel (not shown) for supplying the fluid to or powder or the like into the mouthpiece 13. The optional air supply opening 15 then serves to supply ambient air preferably in parallel so as to general or allow an airflow with a suffi- cient volume for breathing in or inhaling through the mouthpiece 13.

If necessary the fluid 2 may also be ed by means of a propellant gas.

Preferred ingredients and/or formulations of the preferably medicinal fluid 2 are listed in particular in WO 15200 A1, preferably on pages 25 to 40, or in EP 2 614 848 A1, paragraphs 0040 to 0087, which are incorporated herewith by nce. In particular, these may be s or non-aqueous solutions, mix- tures, formulations containing ethanol or free from any solvent, or the like.

List of reference numerals 1 nebulizer 24 nebulizer housing fluid 25 indicator device container 30 26 locking device bag 27 mouthpiece cover pressure tor 28 head holder 29 container g drive spring 30 container edge 1O LOOOVO3CJ‘I-D-OON blocking element 35 31 indicator housing conveying tube 31 a window _\_\ _\O non-return valve 32 gripping section pressure chamber 33 upper part 12 nozzle 34 lower part 13 iece 40 35 indicator element 14 aerosol 36 actuation element air supply opening 37 marking 16 upper housing part 38 actuation arm 17 inner part 39 actuation n 17a upper part of inner part 45 40 transmission 17b lower part of inner part 41 gear 18 housing part (lower part) 42 worm 19 retaining element 43 tooth 2O aeration spring 44 axle section 21 container base 50 45 bearing section 22 piercing element 46 bearing portion 23 venting hole 47 actuation spring 48 piercing part 75 flattening 49 piercing tip 76 engagement section 5o foil 77 riffle 51 on 35 78 indenﬁon 52 driving part 79 projection 53 bottom 54 insertion opening 55 support structure 56 flexible arm 57 groove 58 ratchet 59 surface 6o protrusion 61 blocking part 62 control portion 63 control part 64 retaining nose 65 retaining recess 66 locking t 67 locking spring 68 pocket 69 engagement portion 7o cover 71 actuator 72 g guide 73 base portion 74 glue

Claims

1. Unit for a zer, the unit comprising: a container containing a fluid and comprising a rigid housing which is made of metal, an indicator device for counting and indicating a number of uses performed or still possible with the container, wherein the indicator device is fixedly arranged at a base of the container; and wherein the indicator device comprises an indicator housing which is made of plastic, wherein: the housing of the ner comprises a protrusion, and the indicator housing comprises a collar or a gripping section, and the collar or the gripping section of the indicator g grips over the sion of the housing of the ner, wherein the collar or ng section has been bent over the protrusion in an ultrasonic forming process so that the indicator housing is inseparably connected with the housing of the ner te to an outlet or head of the container.

2. Unit according to claim 1, characterized in that the indicator housing is secured t rotation relative to the housing of the container.

3. Unit according to claim 1 or 2, characterized in that the housing of the container comprises a rotationally asymmetrical section, preferably an indention, protrusion, or flattening, to secure the indicator hous-ing against rotation relative to the housing of the container.

4. Unit according to any one of the preceding claims, characterized in that the indicator device or the tor housing comprises riffle, indention or projection.

5. Nebulizer for a fluid, the nebulizer comprising: a replaceable unit comprising a container containing the fluid and an indicator device for counting and indicating a number of uses performed or still possible with the container; a nebulizer housing for receiving the container; a housing part which can be detached from the zer housing for replacing the unit; and wherein the container is moveable axially within the closed nebulizer housing during nebulization, wherein the indicator device comprises an indicator housing which is inseparably connected with a housing of the container, but separable from the nebulizer housing and housing part, so that the indicator device is replaceable together with the container, wherein the unit is constructed according to any one of the preceding claims.

6. Method for connecting a container with an indicator device for counting and indicating a number of uses performed or still possible with the container, wherein the container is for use with a nebulizer and contains a fluid and comprises a rigid housing which is made of metal, and wherein the tor device comprises an indicator housing which is made of plastic; n the indicator device is arranged at a base of the ner; and wherein a collar or a gripping section of the indicator g is bent over a protrusion of the container, in particular over an edge of the ner, by ultrasonic g, so that the indicator housing is inseparably connected with the g of the container te to an outlet or head of the container.

7. Method according to claim 6, characterized in that an ultrasonic sonotrode is used as a tool for bending the collar or the gripping section and thus for connecting the indicator housing with the housing of the container.

8. Method according to claim 7, characterized in that for bending the collar or the gripping section, the tool is moved longitudinally over the container towards the container base.

9. Method according to claim 7 or 8, characterized in that the tool ses a conical end section for forming the collar or gripping section towards the ner and/or radially inwardly.

10. Method according to any one of claims 6 to 9, characterized in that molecular vibrations are excited longitudinally in the material of the collar or gripping section.

11. Method according to any one of claims 6 to 9, characterized in that molecular vibrations are d transversally in the material of the collar or gripping section.

12. Method according to any one of claims 6 to 9, characterized in that molecular vibrations are excited elliptically in the material of the collar or gripping section.

13. Method according to any one of claims 6 to 9, characterized in that molecular vibrations are excited torsionally in the material of the collar or gripping section.

14. Nebulizer comprising the unit of claim 1, substantially as herein described with reference to the