A nebulizer and a housing part comprising a blocking device as well as use of a blocking device are proposed. The blocking device blocks a rotatable element of a counter device in a defined rotational position until the nebulizer is closed.

The present invention relates to a nebulizer for nebulizing a fluid, to the use of a blocking device, and to a housing part, all as more fully described herein.

WO 2006/125577 A2 discloses a nebulizer which comprises, as a reservoir for fluid which is to be atomized or nebulized, an insertable rigid container having an inner bag containing the fluid and a pressure generator with a drive spring for delivering and atomizing the fluid. The container is pre-installed in nebulizer in a delivery state. The pre-installed container is held by a transportation lock unmovable within the housing in the delivery state in order to avoid any undesired opening of the container. Before being used for the first time a lower housing part of the nebulizer is completely closed. Thus, the pre-installed container is opened by a delivery tube piercing a sealing and a septum to fluidically connect to the inner bag of the container. Further, the transportation lock is opened so that the container can move inside the nebulizer back and forth.

By rotating the lower 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 housing 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 housing part to allow venting of the container. After manual operation of a blocking element the drive spring is released and moves the delivery tube into the pressure chamber so that the fluid is put under pressure by the drive spring and is delivered or atomized through a nozzle into a mouthpiece as an aerosol, without the use of propellant gas.

WO 2007/022898 A2, US 2011/0011393 A1, and WO 2012/162305 A1 disclose a similar nebulizer. A container can be inserted into a housing of the nebulizer. The housing is closed by a lower housing part. The container is moving axially forth and back during conveying of the fluid to be nebulized, and during pressure generation and nebulization. A counter device can be arranged in the lower housing part. The counter device locks the nebulizer against further use if a predetermined number of operations has been reached or exceeded. Then, the housing part may be replaced together with the counter device and the container. The container may be connected inseparably with the housing part. Further, the nebulizer comprises a device for permanently locking the nebulizer when a certain number of containers have been used or when a certain number of operations have been reached.

Object of the present invention is to provide a nebulizer, use or housing part allowing easy and/or improved handling and/or secure or defined counting.

According to one aspect of the present invention, the nebulizer comprises a blocking device for blocking a rotatable element arranged at a housing part of the nebulizer. The blocking device blocks the rotatable element in a defined rotational position when the housing part is not (completely) connected to a housing of the nebulizer or when the nebulizer or its housing is not (completely) closed by the housing part. With other words, the blocking device blocks the rotatable element in a defined rotational position preferably until connecting the housing part to the housing and/or until the rotatable element is in meshing engagement with a drive member for rotationally driving the rotatable element. Preferably, the blocking device is opened or released or the blocking is terminated upon or by the (complete) connection of the housing part with the housing. The drive member is arranged at the housing or nebulizer and comes into meshing engagement with the rotatable element in particular when the housing part is connected to the housing or nebulizer and/or the housing is (completely) closed by the housing part.

The blocking device provides a defined rotational position of the rotatable element and/or prevents undesired actuation of a counter device associated to the rotatable element or driven by the rotatable element and, thus, supports a secure or defined counting and/or allows easy or improved handling as connecting of the housing part to the housing is facilitated. In particular, a undefined rotational position or non-matching rotational position of the rotatable member relative to the drive member can be avoided.

The present invention relates also to the housing part itself, wherein the housing part is provided with the counter device comprising the rotatable element and the associated blocking device as mentioned above so that the same advantages can be achieved.

The present invention further relates to the use of a blocking device for blocking a rotatable element of a housing part in a defined rotational position when the housing part is separate from a housing of a nebulizer. The blocking device unlocks the rotatable element automatically when the housing part is at least essentially or completely connected to the housing so that the rotatable element can be rotated to drive preferably a counter device or any other mechanism arranged in or at the housing part. This supports in particular easy and/or improved handling and/or secure or defined counting due to the defined rotational position of the rotatable element.

Preferably, the drive member has a predefined rotational position as well when the housing part is detached from or not (completely) connected to the housing or nebulizer, this rotational position is matching with the defined rotational position of the rotatable element such that the rotatable element and drive member can be brought into meshing engagement—in particular by axial relative movement—without any difficulties, in particular without any required rotational movement of the drive member and/or rotatable element.

According to another aspect of the present invention, the nebulizer is preferably adapted to pull or bias the rotatable element axially towards the drive member or, in particular, into particularly full engagement or secure engagement with the drive member. This is done preferably selectively, in particular depending on the rotational position of an indicator or control member or device for counting. Thus, axial play can be minimized and/or a secure meshing and/or driving of the rotatable element can be achieved, in particular when mounting the (lower) housing part (with counter device) at the nebulizer.

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

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

FIGS. 1 and 2show a known nebulizer1for atomizing a fluid2, particularly a highly effective pharmaceutical composition, medicament or the like, diagrammatically shown in a non-tensioned state (FIG. 1) and in a tensioned state (FIG. 2). The nebulizer1is constructed in particular as a portable inhaler and preferably operates only mechanical and/or without propellant gas.

When the fluid2, preferably a liquid, more particularly a pharmaceutical composition, is nebulized, an aerosol14(FIG. 1) is formed, 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 nebulizer1is provided with or comprises an insertable or replaceable container3containing the fluid2. The container3thus forms a reservoir for the fluid2, which is to be nebulized. Preferably, the container3contains multiple doses of fluid2or 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 typical container3, as disclosed in WO 96/06011 A1, holds e.g. a volume of about 2 to 20 ml.

It has to be noted that the dose can vary, in particular depending on the fluid2or medicament. The nebulizer1can be adapted respectively.

Further, the number of doses contained in the container3and/or the total volume of the fluid2contained in the container3can vary depending on the fluid2or respective medicament and/or depending on the container3and/or depending on the necessary medication or the like.

Preferably, the container3can be replaced or exchanged, wherein the number of containers3, which can be used with the same nebulizer1, is preferably restricted, e.g. to a total number of four or five containers3.

The container3is preferably substantially cylindrical or cartridge-shaped and once the nebulizer1has been opened the container3can be inserted therein preferably from below and changed if desired. It is preferably of rigid construction, the fluid2in particular being held in a collapsible bag4in the container3. In particular, the container3comprises a venting hole31which is opened before or during first use.

The nebulizer1comprises a delivery mechanism, preferably a pressure generator5, for conveying and nebulizing the fluid2, particularly in a preset and optionally in an adjustable dosage amount. The nebulizer or pressure generator5comprises preferably a holder6for releasably holding the container3, a drive spring7associated to the holder6, only partly shown, and/or a blocking element8preferably in form of or with a button for preferably manual actuation or depressing, which blocking element8can catch and block the holder6and can be manually operated to release the holder6allowing drive spring7to expand. The nebulizer1or pressure generator5comprises preferably further a conveying element, such as a conveying tube9, a non-return valve10, a pressure chamber11and/or an nozzle12for nebulizing the fluid2into a mouthpiece13. The completely inserted container3is fixed or held in the nebulizer1via the holder6such that the conveying tube9penetrates into the container3. The holder6is preferably constructed so that the container3can be exchanged.

When the drive spring7is axially tensioned in the tensioning process the holder6with the container3and the conveying tube9are moved downwards in the drawings and fluid2is sucked out of the container3into the pressure chamber11of the pressure generator5through the non-return valve10. In this state, the holder6is caught by the blocking element8so that the drive spring7is kept compressed. Then, the nebulizer1is in the so-called activated or tensioned state.

During the subsequent relaxation in the nebulization process after actuation or pressing of the blocking element8the fluid2in the pressure chamber11is put under pressure as the conveying tube9with its now closed non-return valve10is moved back in the pressure chamber11, here in the drawings upwards, by the relaxation or force of the drive spring7and now acts as a pressing ram or piston. This pressure forces the fluid2through the nozzle12, whereupon it is nebulized into the aerosol14, as shown inFIG. 1.

Generally, the nebulizer1operates with a spring pressure of 5 to 200 MPa, preferably 10 to 100 MPa on the fluid2, and/or with a volume of fluid2delivered per stroke of 10 to 50 μl, preferably 10 to 20 μl, most preferably about 15 μl. The fluid2is converted into or nebulized as aerosol14, the droplets of which have an aerodynamic diameter of up to 20 μm, preferably 3 to 10 μm. Preferably, the generated jet spray has an angle of 20° to 160°, preferably 80° to 100°. These values also apply to the nebulizer1according to the teaching of the present invention as particularly preferred values.

A user or patient (not shown) can inhale the aerosol14, preferably while an air supply can be sucked into the mouthpiece13through at least one optional air supply opening15.

Preferably, the nebulizer1or drive spring7can be manually activated or tensioned, in particular by actuation of an actuation member.

The nebulizer1comprises preferably a housing or (upper) housing part16and optionally a biasing or inner part17preferably which is rotatable relative thereto (FIG. 2) and/or having an upper part17aand a lower part17b(FIG. 1).

The nebulizer1comprises preferably an in particular manually operable (lower) housing part or cap18releasable fixed, particularly fitted or held onto the inner part17, preferably by means of a retaining element19.

Preferably, the housing parts16and18and/or other parts form a housing of the nebulizer1. In order to insert and/or replace the container3, preferably the housing can be opened and/or the housing part18can be detached from the nebulizer1or its housing. Generally and preferably, the container3can be inserted before the housing is closed and/or before the housing part18is connected to the housing. Preferably, the container3is inserted, opened and/or fluidically connected to the delivery mechanism automatically or simultaneously when (completely) connecting the housing part18to the housing/nebulizer1and/or when (completely) closing the housing/nebulizer1.

The actuation member, preferably the housing part18, can be actuated, here rotated relative to the upper housing part16, carrying with it or driving the inner part17. As a result the drive spring7is tensioned in the axial direction by means of a gear or transmission (not shown) formed between the inner part17, in particular its upper part17a, and the holder6and acting on the holder6. During tensioning the container3is moved axially downwards until the container3assumes an end position as shown inFIG. 2. In this activated or tensioned state the drive spring7is under tension and can be caught or held by the blocking member8. During the nebulizing process the container3is moved back into its original position (non-tensioned position or state shown inFIG. 1) by the drive spring7. Thus the container3executes a lifting or stroke movement during the tensioning process and during the nebulizing process.

The housing part18preferably forms a cap-like lower housing part and fits around or over a lower free end portion of the container3. As the drive spring7is tensioned the container3moves with its end portion (further) into the housing part18or towards the end face thereof, while an aeration means, such as an axially acting spring20arranged in the housing part18, comes in contact with base21of the container3and pierces the container3or a base seal thereon with a piercing element22when the container3makes contact with it for the first time, to allow air in or aeration.

The nebulizer1comprises preferably a counter device23, which counts in particular actuations of the nebulizer1, preferably by detecting its tensioning or the rotation of the inner part17relative to the upper part16or housing. Preferably, the counter device23or an associated lock locks the (further) actuation or use of the nebulizer1, e.g. blocks further rotation of the housing part18/inner part17and, thus, tensioning of the nebulizer1or its drive spring7and/or blocks actuation of the blocking element8, when a certain number of actuations or operations or discharged doses has been reached or exceeded.

A preferred construction and mode of operation of the inhaler or nebulizer1will now be described in more detail with reference toFIGS. 3 to 5, but emphasizing only essential differences from the nebulizer1according toFIGS. 1 and 2. The remarks relating toFIGS. 1 and 2thus apply preferably accordingly or in a similar manner, while any desired combinations of features of the nebulizer1according toFIGS. 1 and 2and the nebulizer1described below are possible.

Preferably, the container3is pre-installed. This can be realized in particular as shown in WO 2006/125577 A2 or as described in the following.

FIG. 3shows the nebulizer1in a delivery state with preferably pre-installed container3, which is still closed. In this state, the housing of the nebulizer1is not completely closed, in particular the housing part18is not completely pushed on the inner part17.FIGS. 4 and 5show the nebulizer1in an activated state with the housing completely closed and with the container3opened. InFIG. 4, the nebulizer1or drive spring7is tensioned, i.e. the container3is in its lower position.FIG. 5shows the nebulizer1in a non-tensioned state, e.g. after dispensing or nebulizing of one dose of the fluid2; the container3is in its upper position.

The container3comprises a fluid outlet24for outputting the fluid2to be dispensed. In particular, the fluid outlet24allows a fluidic connection between the container3or its bag4on one hand and the nebulizer1, its pressure generator5or the conveying element on the other hand.

The fluid outlet24has an inner closure25that is preferably formed by a septum, a membrane, a plastic seal or the like and/or is provided inside the container3. Optionally, a second or outer closure26can be provided such that successive opening is possible by means of one common element, in particular the conveying element or conveying tube9or the like, and/or by piercing.

Preferably, the first or inner closure25is formed or supported by a closure part27extending from the outlet or head end of the container3into the container3or bag4. The second or outer closure26is preferably located adjacent to the head or axial end of the container3and/or held or connected to a flange28, which can be formed by the closure part27or any other suitable part. However, other constructional solutions are possible.

In the delivery state according toFIG. 3, the container3has been pre-installed, i.e. inserted into the nebulizer1. However, the container3or its fluid outlet24is not yet opened. In particular, the second closure26is already opened, but not the first closure25. This is achieved in particular in that the housing of the nebulizer1is closed only partly, i.e. not completely, in the delivery state.

In particular, the container3is attached to or held by or secured in the housing part18, in particular by a transportation lock29, which is preferably arranged within or at the housing part18. The transportation lock29holds the container3preferably temporarily, in particular before attaching the housing part18to the nebulizer1and/or in the delivery state. In particular, the transportation lock29holds the container3fixed during the fluidic connection of container3and/or during the mechanic connection of container3, here with holder6. Preferably, the transportation lock29holds the container3fixed during opening, in particular piercing, the container3.

In the delivery state, in which the nebulizer1can be shipped or delivered to the user or is still packed, the nebulizer1or the housing part18is preferably secured, in particular by means of a securing member30, e.g. a banderole, such that the container3and/or housing part18are held sufficiently spaced from the nebulizer1or upper housing part16and/or prevented from being completely closed or completely inserted or pushed on the conveying element or tube9, the housing or inner housing part17or the like and/or such that (complete) opening of the container3, namely of the first closure25, is prevented.

Once the security member30has been removed a user (not shown) can push the housing part18fully on in the axial direction and thereby open the container3, i.e. first closure25, by inserting the conveying element or conveying tube9.FIGS. 4 and 5show this activated state with the housing part18pushed fully on and/or the container3open (fluidically connected to the nebulizer1or its pressure generator5or the conveying element or tube9).

FIG. 4shows the nebulizer1or container3in the activated state, the container3, i.e. first closure25, is open, i.e. the container3or its fluid2is fluidically connected to the nebulizer1or its pressure generator5, and the housing part18has been pushed fully on in the axial direction. In order to bring the holder6into (complete) engagement with the container3at the head end and then be able to move the container3back and/or forth for the suction/tensioning and pressing strokes, it may be necessary to tension the nebulizer1or it drive spring7for the first time. During this tensioning process the holder6is moved together with the conveying tube9axially towards or into the housing part18, thus bringing the holder6into (complete) engagement with the container3and preferably also moving or pressing the container3against the piercing element22in the region of the base of the housing part18and thereby piercing or opening a venting hole31in the container base21.FIG. 4shows the nebulizer1in this tensioned and activated state. The holder6is engaged with the container3and the conveying tube9has been fully inserted into the container3.

FIG. 5shows the nebulizer1in the relaxed, non-tensioned state, i.e. after atomization or discharge of a dose of the fluid2. The holder6and the container3are in the upper position. The holder6is still engaged with the container3and remains engaged during the further uses of the nebulizer1. Further, the container3is still open and fluidically connected, i.e. the nebulizer1remains activated.

To prevent unwanted opening of the container3, particularly of the first closure25, in the delivery state of the nebulizer1, and/or to prevent (axial) movement of the container3relative to the associated housing part18before complete closing of the nebulizer1, preferably the transportation lock29is provided. By frictional, forcible or interlocking engagement, for example, the transportation lock29prevents the container3from undesirably moving axially.

Preferably, the opening of the transportation lock29occurs automatically when closing the nebulizer1or its housing completely, i.e. when snapping or pushing on the housing part18completely towards the upper housing part16. During this (preferably linear, axial or telescopic) closing movement, the transportation lock29is opened and the container3released in axial direction preferably during or after piercing or opening the container3and/or preferably during only a last part of the movement and/or just little before the final completely closed position is reached or just when the final completely closed position is reached.

During the closing movement in which preferably parts17and18are joined, the transportation lock29is preferably opened by the direct or indirect interaction with or actuation by the housing of the nebulizer1, the inner part17or its lower part17bor the like. Preferably, the container3and/or first closure25are opened as well as the transportation lock29by means of a common actuation and/or component, here the closing movement of the nebulizer1or its housing or bottom part18.

FIGS. 4 and 5show the transportation lock29in the open position, i.e. wherein the container3is free to move axially.

In the following, a preferred embodiment of the nebulizer1according to the present invention will be described in more detail with reference to the further Figures, wherein only essential differences from the nebulizer1described above or shown inFIGS. 1 to 5will be emphasized or described. Thus, the remarks relating toFIGS. 1 to 5apply preferably accordingly or in a similar manner, while any desired combinations of features are possible.

FIG. 6shows the nebulizer1in a perspective side view with not yet mounted, i.e. separated (lower) housing part18(partly cut open for illustration purposes) with associated container3. The container3has not been inserted or pre-installed in the nebulizer1yet. With other words, the nebulizer1has not been assembled yet or is not in the preferred delivery state yet.

FIG. 7shows the nebulizer1in a schematic section as well as the container3and housing part18which are still separated from the (upper part of the) nebulizer1.

The nebulizer1or its housing or housing part18comprises preferably a securing device32which may have different functions. The securing device32may hold the container3such that the container3is moveable back and forth within the completely closed housing for conveying the fluid2, pressure generation and/or nebulization, wherein the securing device32may ensure that the container3is inseparable from the housing or housing part18. Thus, only complete replacement of the housing part18together with the respective container3is possible. Alternatively or additionally, the securing device32may form the transportation lock29. Alternatively or additionally, the securing device32may prevent that the used container3and/or used housing part18can be (re)connected to or used with the nebulizer1once more.

When the securing device32or transportation lock29is closed, the container3is held or counter-beared for opening by inserting the conveying element or tube9, preferably wherein a press-fit is formed between the conveying element or tube9and the container3or closure part27, and/or for (completely) connecting the container (head) to the holder6. With other words, the transportation lock29or securing device32form preferably a counter-bearing for the container3during closing of the nebulizer1.

When the securing device32or transportation lock29is closed, the container3is held spaced from the piercing element22.

The securing device32is preferably located or arranged or fixed at or in the housing part18as shown inFIGS. 6 and 7.

Preferably, the securing device32comprises or consists of a metal and/or stamped part and/or consists of a single, unitary part. The securing device32may consist of two or more parts, preferably connected by means of gluing, crimping, riveting, welding, or the like.

Preferably, the securing device32is made of steel, in particular spring steel. Preferably, the securing device32is produced from sheet material by cutting, stamping or the like and/or by bending. Preferably, the securing device32or a part thereof forms a cage, in particular encompassing the container3or an end portion thereof, in particular the container base21.

Preferably, the securing device32comprises holding elements33and/or locking elements34. The elements33and/or34are preferably designed like arms, fingers, leaves or the like. In particular, the elements33and34are alternately distributed over the circumference of the container3. Preferably, the securing device32comprises multiple holding elements33and multiple locking elements34, in particular three or more holding elements33and three or more locking elements34. Preferably, the elements33and34extend at least essentially axially and/or in the direction of the back and forth movement of the container3and/or in the direction of the longitudinal or main extension of the nebulizer1or main dispensing direction of the aerosol14.

Preferably, the elements33and34are held by or connected with a base35of the securing device32, as shown inFIG. 8.FIG. 8shows the nebulizer1in a schematic side view with already partly mounted housing part18and with some cut-away portions. The transportation lock29or securing device32is still closed or locked, i.e. the container3is still securely held so that it cannot axially move (axially means in the direction of the back and forth or stroke movements).

Preferably, the securing device32or base35comprises or holds the piercing element22for piercing the container3, i.e. opening the container base21or its venting hole31or a respective sealing of the container3or the like in the activated and tensioned state, i.e. when the container3reaches its lower end position. In the shown and preferred embodiment, the piercing element22is formed by a respective bending of a spring portion36of the securing device32or its base35. The spring portion36can support or facilitate the (complete or final) connection of the container3to the holder6.

The securing device32or base35comprises preferably at least one or multiple fixing portions37for fixing the securing device32at or in the nebulizer1or housing or housing part18. In particular, the fixing portions37may fix the securing device32when it is pressed into the housing part18by cooperating with the sidewall of the housing part18. However, it is also possible to overmold the securing device32, its base35, the fixing portions37or the like. Moreover, the securing device32could be connected with the housing part18or the like in any other suitable manner, in particular, by a separate fixing member, by gluing or the like.

As already mentioned, the securing device32preferably forms the transportation lock29for holding the container3unmovable in the housing or housing part18in the delivery state of the nebulizer and/or before attaching the housing part18to the nebulizer1. In this situation (in particular in the delivery state), the container3or a preferably radially protruding and/or circumferentially extending part or edge38thereof, preferably formed at the container base21, is held preferably in a form-fit manner and/or between the holding elements33and locking elements34, in particular between respectively formed or bent end portions33aand34aof the elements33and34, respectively, as shown inFIGS. 6 to 8.

In the shown embodiment, the container3and/or edge38is caught between the end portions33aand34a, preferably alternatively. The holding elements33and/or end portions33agrip or extend over the edge38, and the locking elements34or its end portions34agrip or extend under the edge38, so that the edge38and container3are securely held in between, in particular by form-fit, preventing any axial movement of the container3relative to the securing device32and relative to the associated housing part18in this state or delivery state, i.e. with locked transportation lock29/securing device32.

Preferably, the end portions33aand/or34aare formed like claws or the like and/or extend preferably radially inwardly.

Preferably, the elements33and/or34can flex with its free ends radially outwardly.

Preferably, the securing device32is designed such that the associated container3can be connected with the securing device32by a respective axial force or movement, wherein the elements33and/or34flex preferably automatically outwardly as required to receive the container3in the locked position as shown inFIGS. 6 to 8. However, if necessary, a suitable tool (not shown) or the like could be used alternatively or additionally for assembly if necessary.

For example, the ends of the end portions33acould be inclined such that the container3may be inserted into or connected with the securing device32by a respective axial movement so that the holding elements33flex outwardly to allow passing of edge38.

Preferably, the holding elements33or its end portions33aprevent separation of the container3from the securing device32and, thus, from the associated housing part18or the like.

In the present embodiment, the holding elements33extend preferably above the end portions33aand/or form or comprise preferably arm-like guiding and/or locking portions33b. These axial extensions and/or these portions33bextend axially beyond the end portions33aand/or may cooperate with the container3or its edge38during axial assembly of the container3with the securing device32such that the holding elements33are flexed sufficiently outwardly so that the edge38can pass the end portions33aand the container base21can be seated on the end portions34aof the locking elements34.

The locking elements34preferably comprise actuation portions34bat its free ends extending axially beyond the end portions34a. The actuation portions34bmay radially guide the container3and/or facilitate insertion of the container3or its edge38between the free ends of the locking elements34although the locking elements34are preferably radially inwardly biased as well as the holding elements33.

When, the container3is held with its edge38between the end portions33aand34a, the transportation lock29/securing device32is closed, i.e. the container3cannot move axially within the housing part18or nebulizer1.

For opening the transportation lock29or securing device32, the locking elements34and/or its end portions34aare flexed preferably radially outwardly so that the container3can freely move axially, in particular restricted such that the edge38can only move axially within the securing device32and/or that the axial movement is restricted (in the drawings upwardly) by the holding elements33or its end portions33band/or such that the container3cannot be separated from the securing device32. This opening of the transportation lock29or securing device32will take place when activating the nebulizer1, when using the nebulizer1for the first time and/or when completely closing the nebulizer1. Then, the container3can axially move, in particular back and forth and/or with its edge38between the end portions33aand the piercing element22in the present embodiment. This situation is schematically shown in the schematic section according toFIG. 9which shows the nebulization with closed housing or housing part18and with opened transportation lock29/securing device32.

InFIG. 9, the container3is shown in its lower position similar toFIG. 4, in particular, wherein the container base21is in contact with the piercing element32. However, the nebulizer1is not shown in the tensioned state, i.e. the holder6is not in its lower position, i.e. the holder6is not yet connected with the upper end or head of the container3. Normally, the holder6would be connected to the container3in this situation with the container3in the lower position. With other words, usually the nebulizer1or drive spring7would be tensioned in the situation with the container3being in the lower position.

Preferably, the container is finally or completely or correctly connected to holder6when tensioning the nebulizer1or its drive spring7for the first time after completely closing the nebulizer1. However, it is generally also possible that the nebulizer1is in the tensioned state, i.e. the drive spring7is already tensioned and the holder6is in the lower position, before or during (first) assembly with lower housing part18. Consequently, the holder6should directly connect with the container3when completely closing the housing part18, and the situation shown inFIG. 9should normally not occur.

InFIG. 9, the end portions34aare moved radially outwardly in order to open the transportation lock29or securing device32. This is achieved preferably by flexing the locking elements34radially outwardly. This can be achieved in particular by acting on the actuation portions34b.

Preferably, the transportation lock29is opened or the locking elements34are flexed outwardly when completely closing the nebulizer1or its housing part18, in particular by cooperation with or abutment of the inner part17, its lower part17b, a retaining part39and/or a securing part40. The retaining part39is preferably arranged at the upper housing part16or inner part17. The securing part40is preferably arranged in the lower housing part18.

The retaining part39is connected to the lower or free end of the inner part17or its lower part17bin order to hold, bear or support an end (the lower end) of the drive spring7.FIGS. 3 to 5show a preferred construction of the retaining part39. It is preferably formed as a ring and/or provided with hooks or the like for interconnection with the inner part17. In the preferred embodiment, the retaining element19forms a unitary component or portion of the retaining part39. However, other constructional solutions are possible.

In the embodiment shown inFIGS. 3 to 5, a preferably ring-like securing part40opens the transportation lock29, in particular flexible arms of the transportation lock29, to allow axial movement of the container3. This securing part40keeps the transportation lock29or its flexible arms open when the nebulizer1or its housing part18has been completely closed. The securing part40is pushed axially downwards by abutment of the inner part17or retaining part39within the housing part18when completely closing the nebulizer1.

In the preferred embodiment shown inFIGS. 6 to 15and particular inFIG. 9, the nebulizer1, housing part18or securing device32comprises the preferably ring-like securing part40for opening the transportation lock29/securing device32or its locking elements34. In particular, the securing part40is pushed axially downwards when closing the nebulizer1so that it is moved between the locking elements34or its actuation portions34band exerts an axial force radially outwards. Preferably, an inclined plane converts the axial or closing movement into an opening or radial movement which forces the actuation portions34bradially outwardly when the securing part40is forced axially downwardly, here by abutment of the retaining part39, in particular in the axial end position shown inFIG. 9.

Preferably, the securing part40and/or locking elements34or actuation portions34bcomprise a respectively inclined guiding surface41or the like to convert the axial closing movement or movement of the securing part40into the desired radial opening movement of the locking elements34or actuation portions34band, thus, of the end portions34ato open the transportation lock29, in particular when the housing has been completely closed or when the housing part18has been pushed completely on the nebulizer1.

However, other constructional solutions are possible to realize opening of the transportation lock29or securing device32or its locking elements34or end portions34awhen closing the nebulizer1or its housing parts18.

In the preferred embodiment the securing part40serves alternatively or additionally another purpose. Namely, the securing part40prevents the locking portions33bfrom moving radially apart or flexing radially outwards before the nebulizer1is assembled with its housing part18for the first time.

As already mentioned, the securing device32prevents preferably that a container3can be connected to or used with the nebulizer1once more. In particular, the securing device32can prevent that a used housing part18or used container3can be reconnected to the nebulizer1once it has been detached from the nebulizer1. Thus, the securing device32prevents any undesired reuse of the container3and/or housing part18with its preferably inseparable container3.

In the present embodiment, the undesired reuse is prevented in that the locking portions33bforce apart or move apart or radially and/or outwards at least after the used container3and/or housing part18has been detached from the nebulizer1such that the used container3and/or housing part18cannot be connected to or used with the nebulizer1once more. Preferably, the locking portions33bare biased such that the locking portions33bforce apart or move radially and/or outwards after release.

In the preferred embodiment, the locking portions33bare held together or held against moving apart, radially and/or outwards by the securing part40(schematically indicated inFIG. 7) before the container3and the associated housing part18have been connected to the nebulizer1for the first time. In this pre-assembly state, the securing part40is located preferably near the free ends of the locking portions33band/or it encompasses that locking portions33bsuch that locking portions33bare held sufficiently close together to be inserted with its free ends within the retaining part39and/or drive spring7when pushing the housing part18axially onto the nebulizer1or its inner part17, in particular lower part17b.

The securing part40may cooperate with the locking portions33bor protrusions33cthereof (shown inFIG. 9) preferably such that the securing part40is held by a preferably radial engagement and/or frictional force in its (upper) position holding the locking portions33bor holding elements33together in the pre-assembly state. Later during assembly, in particular during complete closing of the housing or pushing on the housing part18, the locking portions33bare moved into the retaining part39and drive spring7, while the securing part40is moved axially downwards or towards the securing device32, the container base21and/or bottom part of the end of the housing part18. Then, the end position or completely assembled position is reached as shown inFIG. 9. In this state, the radially biased locking portions33bare held together by the drive spring7as the securing part40does not hold the locking portions33btogether any more.

Preferably, the securing part40has opened the transportation lock29or locking elements34in the last part of the closing movement or just when completely closing the nebulizer1as already mentioned.

The schematic section ofFIG. 10shows the housing part18together with its associated container3after it has been used and separated from the nebulizer1. The securing part40remains preferably in its lower position. The transportation lock29is (still) open. The container3is shown in its upper position where it is held by the end portions33aof the holding elements33when detaching the container3from the nebulizer1, in particular from the holder6and the conveying element or tube9.

FIG. 10shows that the locking portions33bhave been forced apart, in particular due to its biasing or elastic force, here moved radially outwardly with its free ends in particular due to its preferably radial biasing or elastic force. This forced apart position of the locking portions33bblocks reconnection of the container3and/or housing part18and/or securing device32with the nebulizer1. Thus, the already used container3cannot be reused. Thus, misuse of the container3or nebulizer1can be prevented.

The securing part40may additionally secure the holding elements33or its end portions33aagainst radial opening when the securing part40is in its lower position as shown inFIGS. 9 and 10. In this case, the securing part40contacts the holding elements33preferably on the outer side to prevent or restrict any outward flexing. Thus, the securing device32or its holding elements33or end portions33aare secured against opening so that the container3or its edge38is securely held within the securing device32or the cage formed by the securing device32or holding elements33.

In the preferred embodiment, the counter device23is arranged preferably at the housing part18as schematically shown inFIGS. 7 to 10.

The counter device23counts the actuations or operations of the nebulizer1or the discharged doses, preferably for the respective container3.

Preferably, the counter device23counts actuations or operations by detecting the rotation of the inner part17relative to the upper part16of the housing. With other words, the counter device23may count the tensioning the nebulizer1or its drive spring7. However, other constructional solutions are possible.

Preferably, the counter device23comprises a threaded spindle or shaft42with an associated, preferably unitary formed drive gear43. The counter device23comprises preferably further a rider44associated to the threaded shaft42and cooperating with the threaded shaft42such that the rider44is axially moved along the threaded shaft42as the shaft42is rotated.

The threaded shaft42is rotatable beared preferably in the lower housing part18and/or extents preferably parallel to the axial or longitudinal direction of the nebulizer1and/or to the axial or stroke movement of the container3.

The drive gear43is located preferably at an upper end of the threaded shaft42and/or housing part18, in particular such that it can mesh with a preferably inner toothing45of the housing or upper housing part16of the nebulizer1in the assembled state, i.e. when the housing of the nebulizer1is completely closed, as schematically shown inFIG. 9.

The counter device23or its rider44, in particular the axial position of the rider44along the threaded shaft42, may show or indicate the number of operations, in particular of tensioning, actuations or doses, which have already been performed or used with the current container3or which can still be performed with the current container3. This operation number can in particularly been shown by a pointer46and/or an associated scale or the like which are visible reasonable through a corresponding window or transparent part of the housing part18. It has to be noted that the number has not be shown precisely. In particular, it may be sufficient that the counter device23, the rider44or its pointer46give a rough indication of the number. For this purpose, it may be sufficient if the scale shows only different colored areas or regions roughly indicating said number. Further, it has to be noted that other constructional solutions are possible as well.

The counter device23works preferably mechanically. This allows a very simple and robust construction and a very secure operation.

The counter device23may control or provide preferably locking of the nebulizer1, indicating any required container replacement and/or container counting. For this purpose, the monitoring23or the rider44comprises preferably an actuation part47as schematically shown inFIG. 8. The actuation part47is preferably ridge-like and/or extending in axial direction and/or towards the upper housing part16and/or upwards.

The counter device23is associated to the respective housing part18and, thus, preferably to only one container3and counts operations of the nebulizer1with the respective container3, i.e. counts (only) the number of doses of fluid2removed or still removable from this container3. It has to be noted that the first container3may be pre-installed together with the associated housing part18in the delivery state. This pre-installment is optional. Preferably, further separate containers3are delivered together with the nebulizer1, wherein each container3is inseparably connected with an associated housing part18and, thus, with an associated counter device23. Preferably, the counter device23or threaded shaft42of each housing part18is designed or provided with inhibition or brake means, such that any undesired counting or rotation is prevented before the respective housing part18is mounted to the nebulizer1.

The nebulizer1comprises preferably a device48for counting the number of containers3that have been used or still can be used with the nebulizer1and/or for indicating or displaying said container numbers and/or symbols indicating container replacement and/or end of use. This device48is preferably for monitoring and/or user guidance.

Preferably, said numbers and/or symbols are visible or shown through a transparent part or window49of the nebulizer1, in particular located in the upper housing part16as schematically indicated inFIG. 6. In particular, said numbers and/or symbols are shown at a side face of the nebulizer1. Other arrangements or constructional solutions are possible.

FIG. 11shows the nebulizer1without lower housing part18and without container3in a schematic side view, wherein parts of the upper housing part16have been cut-away so that the monitoring or guidance device48of the nebulizer1is better visible.

The nebulizer1or device48comprises preferably a member50for indicating or displaying said container number, symbols, a status, and/or user instructions, e.g. relating to container replacement, and/or for controlling locking of the nebulizer1. Thus, the member50is also called indicator member and/or control member. Preferably, both functions are achieved by the same or one single member50. However, it is also possible that the indicator member and the control member are formed by separate parts or multiple parts. Preferably, the following description shall be understood in such a broad sense.

Preferably, the nebulizer1or device48comprises a spring51for driving or moving, in particular rotating, the member50. This spring51is shown inFIGS. 7, 8, 9 and 11. Preferably, the member50is driven or rotated—in particular in multiple steps and/or from an initial (rotational) position to a final (rotational) position—only by spring force or by means of the spring51.

The spring51is preferably a helical, sleeve-like, ring-like and/or torsional spring and/or a leg spring. It is preferably located coaxially with and/or adjacent to the driven member50

The spring51is preferably mounted in a biased state so that it applies a rotational force to the member50. For this purpose, the spring51is supported with one end or leg at the nebulizer1, in particular at the upper housing part16, and engages with its other end or leg with member50, e.g. by abutting a respective shoulder or bearing portion67(shown inFIGS. 12 and 13) of the member50or the like.

FIG. 12shows a preferred embodiment of the member50in a schematic side view.FIG. 13shows the member50in a perspective view.

The member50is preferably formed by a unitary and/or molded part. The member50is preferably at least essentially ring-like and forms or comprises a preferably closed ring.

The member50comprises or is provided with numbers52indicating said container number, and/or with said symbols53for user guidance, in particular for indicating container replacement and/or end of use of the nebulizer1. Preferably, the numbers52and symbols53are shown and/or arranged on the member50such that one or more numbers52and one or more symbols53alternate. In particular, between preferably consecutive numbers52one or more symbols53are arranged and/or shown such that these symbols53indicate e.g. necessary container replacement, opening of the nebulizer1, closing of the nebulizer1or the like. This may be communicated or indicated by respective arrows, colors, marks or the like as symbols53. Further, the last symbol53may indicate end of use of the nebulizer1or complete locking of the nebulizer1, e.g. by an “X” or the like. This symbol53may be shown for example when the allowable number of operations or actuations of the nebulizer1have been reached or exceeded of the last container3that may be used with or in the nebulizer1, i.e. indicating total or final locking of the nebulizer1. In the present embodiment, preferably a sequence of at least two different symbols53is shown between different or consecutive numbers52. This sequence of symbols53comprises preferably a first symbol53(e.g. arrow downwards) indicating opening of the nebulizer1for container replacement and a second symbol53(e.g. arrow upwards) indicating closure of the nebulizer1for completing container replacement. However, it is also possible to show only one, potentially similar or identical symbol53between the different or consecutive numbers52, such as one symbol53indicating container replacement. Preferably, only one special or end symbol53, such as “X”, is shown at the end when the allowable number of operations or actuations of the nebulizer1has been reached or exceeded for the last container3and/or when the nebulizer1is finally blocked and/or when no further container3can be inserted.

The member50comprises preferably engagement or stop portions54which are preferably formed by radial protrusions or the like in the present embodiment. The stop positions54are used preferably to allow or realize a stepwise movement or rotation (indexing) of the member50.

The member50comprises further preferably blocking portions55which extend preferably axially and/or cooperate with the retaining element19to selectively lock the nebulizer1or housing part18against opening, in particular by selectively blocking the retaining element19against depressing or radial inward movement.

The member50comprises preferably control portions56for controlling or driving an associated lock57of the nebulizer1. The control portions56are formed preferably by protrusions or indentions or inclined guiding surfaces or the like which preferably extend radially and/or which are preferably formed on an outer circumference of the member50or its ring portion. However, other arrangements are possible as well.

The lock57is preferably formed by a locking member58or a portion59thereof, which is preferably tongue-like, leaf-like and/or flexible.FIG. 14shows in a perspective view the locking member58.FIG. 15shows in other perspective view the locking member58.

The locking member58is preferably made of metal and/or formed by plate material and/or a stamped part or the like. The locking member58is preferably ring-like and/or sleeve-like.

The portion59is preferably bent or indented or provided with such a form, in particular in radial direction and/or provided with a crimp, corrugation60or the like, for cooperating with the member50and/or at least one or more or all of the control portions56, in particular such that depending on the rotational movement or position of the member50the portion59is radially flexed, in particular outwards, or not. For example, the control portions56are indented or recessed so that a portion59is not flexed radially outwards if the respective corrugation60, which extends radially inwards from the respective portion59, is received in a portion56located adjacent to this corrugation60on the inner side. If the member50is in another rotational portion, the corrugation60may abut on the non-recessed outer periphery of member50so that the respective portion59is flexed outwards and the lock57is closed. Thus, the lock57is driven or controlled, namely closed and opened, by means of the control member50, in particular depending on its rotational position.

As already mentioned, the device48or member50is preferably driven by spring force, in the present embodiment by the force of spring51. In particular, the member50is rotated or indexed stepwise by means of the force of the spring51, wherein a ratchet or stop mechanism is provided to ensure the only stepwise moving or rotating of the member50. In particular, stop means engage with the stop portions54of the member50. In the present embodiment, the mechanism or stop means are preferably formed by one or two stop elements61. The stop elements61are preferably formed like arms and/or by the locking member58. The stop elements61are preferably elastically flexible to selectively allow a stop portion54to pass, i.e. to selectively allow the member50to index one step further, or to block a stop portion54and, thus, member50against further rotation. Preferably, the stop elements61are biased into a stopping position such that each stop element61extends into the way of movement of the stop portions24such that no stop portion54can pass the respective stop element61.

Preferably, at least two stop elements61are provided and preferably offset such that stop elements61can be actuated alternatively to allow the member50to index or move further by one step, i.e. by one rotational movement or increment when the stop elements61are alternatively actuated, e.g. flexed, in particular in axial and/or radial direction, to allow one stop portion54to pass. The stop elements61are preferably flexed upwards to allow the respective stop portion54to pass. The actuation of the stop elements61will be explained in more detail below.

The stop elements61or its free ends may be provided with a broadened abutment or engagement body or surface, in particular by respectively bending the element or arm61, by overmolding or the like. Each stop element61may be provided with a contact element61aas schematically shown inFIG. 8. The contact element61amay be formed by overmolding and/or may be shoe-like. The contact element61amay form a stop or abutment for the stop portions54such that the member50is blocked against further rotation by force of spring51when the stop element61or contact element61ais in the blocking position, here in the lower position shown inFIG. 8where one stop portion54abuts the contact element61aand cannot pass in circumferential direction. Here, the stop element61or contact element61ahas to be moved upwards or axially so that the blocked stop portion51can pass and the member50can index one step further in circumferential direction.

In the following, the operation and handling of the nebulizer1will be explained in more detail.

The nebulizer1may be delivered with a pre-installed container3and pre-attached housing part18. In this case, the nebulizer1or its housing part18is not completely closed so that the container3is not yet fluidically connected or opened.

Alternatively the nebulizer1may be delivered with a separate container3and housing part18. In this case the container3and the housing part18are preferably pre-assembled, i.e. form a unit that is separate from the nebulizer1.

In any case, the nebulizer1is preferably delivered together with multiple containers3, e.g. four or five containers3, wherein each container3is inseparably connected to an associated housing part18. These units of containers3and housing parts18can be exchanged so that the nebulizer1can be used with multiple containers3one after the other.

In both cases, the container3is preferably held unmoveably at or within the housing part18by the closed transportation lock29or securing device39.

In both cases, the housing part18comprises preferably a coding, e.g. by one or more grooves, protrusions, ribs62or the like distributed around the inner circumference of the housing part18and/or axially extending, as schematically indicated inFIG. 10. This coding corresponds to the container3or the respective fluid2associated to the housing part18. The coding matches to a complementary coding at the nebulizer1, in particular at the inner part17or retaining part39, and is preferably formed by respectively arranged and/or dimensioned indentions, coding portions63, such as protrusion, indentions, recesses or the like, in particular formed by or at the retaining ring or part39, as schematically shown inFIG. 11. Only when the codings match, the housing part18and, thus, the container3can be pre-installed and/or (completely) connected to or with the nebulizer1.

Before (completely) closing the nebulizer1or its housing part18, the device48or indicator member50may indicate by a respective symbol53, such as an arrow pointing upwards, to completely close the nebulizer1or housing part18.

When the housing part18is completely closed, the container3associated to the housing part18is fluidically connected to the nebulizer1. This is detected or registered by the nebulizer1or device48. This detection of the connection of the housing part18and, thus, of an associated container3is preferably realized mechanically, in particular by actuating one of the stop elements61to allow the member50to index one step further, i.e. until the other stop element61stops further indexing or rotation of the member50. In the present embodiment, this registration or actuation is preferably achieved by a protrusion64formed at the housing part18, in particular at its upper front face, as shown in particular inFIG. 7. When completely closing nebulizer1, the protrusion64abuts one associated stop element61or contact element61aand consequently flexes the stop element61or contact element61aupwards such that it does not stop a corresponding stop portion54of the member50anymore, but allows the member50to move or rotate one step further, i.e. until the other stop element61, which has not been flexed out of engagement in this state, stops further rotation by stopping a corresponding stop portion54, preferably another one of stop portions54.

As already mentioned, the container3is preferably inseparable from the housing part18, the associated counter device23and/or associated securing device32. Thus, after connection of a new container3with the nebulizer1, the associated counter device23starts counting of the number of operations or uses of the respective container3that have already been performed or still can be performed. This operation number may be indicated or shown by the counter device23or its rider44or pointer46as already mentioned, while the device48or member50preferably only shows the container number52, i.e. the number of containers3that have already been used or still can be used with the nebulizer1.

Preferably, the nebulizer1is blocked against opening until the current container3has been (sufficiently) emptied, and/or until a predetermined number of operations or actuations has been reached or exceeded. This blocking of the nebulizer1or its housing part18against opening and/or container replacement is preferably achieved by a respective blocking portion55of the member50located below the retaining element19in this state as schematically indicated e.g. inFIG. 9, such that the retaining element19cannot be depressed, i.e. the nebulizer1cannot be opened and the housing part18cannot be detached.

When a predetermined number of operations or actuations of the nebulizer1has been reached, the nebulizer1is blocked against further use with the current container3. This blocking is also called first locked state.

The first locked state is entered preferably by means of the counter device23. In particular, the rider44or its actuation part47cooperate with the device48to enter the first locked state, when a predetermined number of operations have been reached or exceeded with the current container3. Particularly, the rider44or its actuation part47reach an upper axial position in this state and actuate a respective stop element61or contact element61athat is in blocking position or engagement with a stop portion54. Thus, the stop element61or contact element61ais preferably flexed or deformed such that the previously stopped stop portion54can pass and the member50is free to index one step further by the force of spring51.FIG. 8shows a situation, in which the rider44and actuation part47are already near the upper position and near the position to actuate the associated stop element61or contact element61a. However, in the state shown inFIG. 8one stop portion54and the member50are still blocked against rotating one step further.

The above indexing of the member50by one step leads to the first locked state. In this state, the nebulizer1or retaining element19is unblocked so that it can be opened. In particular, the blocking portion55blocking actuation of the retaining element19in the previous state is moved further, so that the retaining element19is not blocked any more, but can be actuated or pushed in order to allow detachment of the housing part18for container replacement.

In the first locked state the nebulizer1, device48or member50indicates preferably by a respective symbol53, in particular by an arrow pointing downwards, that container replacement is necessary and/or that the nebulizer1is locked against further use with the current container3.

By the above indexing of the member50to reach the first locked state, the nebulizer1is locked against further use. This is achieved in particular in that the member50drives the lock57to lock the nebulizer1against further actuation, preferably against further tensioning of the drive spring7and/or against rotating of the housing part18. This is preferably realized in that the rotation of the member50flexes the lock57or portion59of the locking member58radially outwards so that the flexed portion59leaves its non-locking position, into which it is biased, and locks further rotation of the inner part17relative to the upper housing part16. This locking is in particularly achieved in that a free end of the portion59engages into a respective toothing or against respective abutment surfaces formed at the inner surface of the upper housing part16. In this respect it has to be noted that the device48is preferably arranged or mounted on inner part17, particular on its upper part17a, wherein the preferably ring-like locking member58is preferably arranged around the rotatable member50. The locking member58is preferably secured against rotation relative to the inner part17by respective form fit engagement, preferably of the inner part17or at least one protrusion17cthereof into a recess65of the locking member58. In the present embodiment, the recess65is preferably formed like a pocket or a portion cut-out of the periphery from one axial side. In particular, the locking member58may be provided with two or more recesses65as schematically shown inFIGS. 14 and 15, for engagement of respective protrusions17cor the like, in particular of the associated inner part17. However, other constructional solutions are possible as well.

Consequently, only member50is rotatable relative to inner part17and, thus, to locking member58. However, locking member58is rotatable together with inner part17relative to upper housing part16.

As already mentioned, the control member50is moveable, in particular rotatable, relative to locking member58. This relative rotation is meant when any rotation or indexing of the control member50is mentioned. In this context, it has to be considered that the device48and the locking member58are rotated together with the inner part17, but this rotation is different as this is the movement for tensioning the energy store, here spring7, and/or for delivering or sucking fluid2out of the container3by in particular axial movement of the conveying element or tube9.

The construction mentioned above, results in that the device48is rotated together with the inner part17each time the lower housing part18is rotated, i.e. when tensioning the drive spring7. This rotation is preferably performed in 180° steps. Therefore, the device48or indicator member50comprises preferably two sets of respective number52and/or symbols53that are shown alternately through the window49.

Thus, the member50comprises preferably two groups of numbers52and/or symbols53, each group with the respective sequence of numbers52and/or symbols53, wherein the groups are arranged offset by 180° on the member50. This offset correspondence to the rotational angle for each rotational actuation of the lower housing part18and inner part17for tensioning the nebulizer1/drive spring7.

Preferably, the control portions56and/or the peripheral parts of the control member50in between the portion56form an inclined or control plane or surface cooperating with the portion59or its cam or corrugation60such that the lock57or the locking can be actuated alone by the force of the spring51acting on the member50. In particular, the spring51or member50drives the lock57. Further, the member50controls the lock57or the locking. As the member50also forms an indicator member, the indicator member drives the lock57or locking as well.

In the present embodiment, the locking member58is preferably arranged outside or around the control member50at least around a cylindrical main part of control member50. In particular, the locking member58encompasses or covers at least substantially the cylindrical main part of the control member50. The locking member58comprises preferably two openings66(shown inFIGS. 14 and 15) that are alternately aligned with window49depending on the rotational position of inner part17and, thus, of the locking member58so that the respective number52and/or symbol53is visible through the window49and through locking member58.

In the first locked state, the member50is preferably stopped against further rotation by the protrusion64where any other part corresponding to the attachment of the housing part18. When the housing part18is detached from the nebulizer1or its upper housing part16or inner part17for container replacement, this detachment is registered by unblocking the further movement or rotation of the member50. In particular, a stop portion54of the member50which has been stopped by protrusion64or the like, can pass after detachment of the housing part18so that the member50can index one step further. In this further rotational position, the nebulizer1is still in its first locked state, i.e. is still locked against further use, in particular against further actuation or tensioning of the drive spring7. However, the member50may show the next symbol53, in particular an arrow pointing upwards, indicating that a new container3has to be connected and/or that a new housing part18has to be connected to the nebulizer1. This situation correspondents to the initial situation before first assembly of the nebulizer1with the housing part18as already described.

It has to be noted that the blocking element8is preferably blocked against actuation, in particular against release of the holder6and drive spring7in the first locked state. This actuation locking will also be achieved by the device48or member50.

When the housing part18and the associated container3have been replaced, this is registered by the device48, in particular by actuation of the corresponding stop element61by means of the protrusion64. Then the member50indexes one step further and shows the next container number52. Then, the lock57is reset, i.e. opened or unlocked again. Thus, the nebulizer1is unlocked and can be used further with the new container3. Simultaneously, the container3or housing part18is preferably locked again against opening or container replacement, in particular in that the next blocking portion55is positioned below retaining element19to prevent actuation of the retaining element19which is necessary for opening the nebulizer1.

The above sequence can be repeated, i.e. new containers3and new housing parts18can be used one after the after with the nebulizer1, wherein the device48or indicator member50displays or shows the container number52and, preferably, symbols53for user guidance, in particular to indicate any necessary container replacement and/or indicating to open and close the nebulizer1or the like. The container number52relates in particular to the number of containers3that have already been used with the nebulizer1or still can be used with the nebulizer1. In particular, one or more symbols53are displayed or shown alternately with the consecutive container numbers52. This is realized preferably by one comment component, namely indicator member50. However, other constructional realizations are possible.

Further, the display of the container numbers52and/or symbols53works preferably only mechanical.

In particular, the device48and/or the lock57work only mechanical.

After a predetermined number of containers3have been connected to or with the nebulizer1, the nebulizer1will be blocked against further container replacement. After using the lastly inserted or connected container3, the nebulizer1will enter the final locked state, i.e. the second locked state, preferably where the lock57or nebulizer1is blocked against resetting and/or the nebulizer1or housing part18is blocked against opening. This second locked state is entered in particular after the predetermined number of operations has been reached or exceeded with the ultimate, current container3. Similar to the previous process the counter device23or its rider44or actuation part47actuates the device48, in particular the corresponding stop element61to allow to index the member50one step further into its final rotational position. Thus, the second locked state is entered.

In the second lock state, the control member50cannot be rotated any further. This is realized in the present embodiment in particular in that the bearing portion67abuts one protrusion17cof the inner part17engaging into one of the recesses65. However, other constructional solutions are possible in order to realize the desired rotational stop or blocking for the control member50in the final rotational position, i.e. in the second locked state.

In the second locked state, the device48or member50does not allow opening of the nebulizer1or housing part18as it would be in the case in the first locked state. Instead, the member50comprises a respectively designed, preferably sufficiently long blocking portion55to block the retaining element19further against actuation and, thus, to block the nebulizer1against opening and container replacement.

In the second locked state, the nebulizer1can be locked against further actuation, in particular against tensioning of the drive spring1and/or rotation of the housing part18or inner part17. This can be realized by actuating the lock57, in particular by flexing portion59radially (preferably outwards) by the member50or its corresponding control portion56. In the second locked state, the nebulizer1is preferably locked against any further discharge of fluid2, in particular by blocking actuation of the blocking element8. This is preferably also realized by device48.

Therefore, the nebulizer1cannot be used anymore after the second locked state has been entered. The second locked state is not reversible. In particular, resetting or unlocking of the lock57is not possible, but prevented in the second locked state.

As already outlined above, some general aspects or ideas of the nebulizer1according to the preferred embodiment can be summarized as indicated in the following.

The device48consists preferably only of two parts (control member50and locking member58) or three parts (control member50, spring51and locking member58), but provides multiple functions, in particular displaying of numbers42and/or symbols53and/or user instructions, locking of the nebulizer1against further use, locking of the nebulizer1against tensioning, and/or locking of the nebulizer1against opening or container replacement.

The nebulizer1may comprise the indicator member50for showing numbers, in particular container numbers52and alternately symbols53indicating container replacement and/or nebulizer opening and/or closing.

The indicator member50may be moved or rotated stepwise by the force of the spring51.

The indicator member50may drive the lock57of the nebulizer1such that the nebulizer1is locked against further use in the first locked state, when the container3has to be replaced, wherein the first locked state is reset by indexing the indicator member50and/or resetting the lock57if the container3and/or housing part18have been replaced.

The indicator member50is preferably ring-like.

The indicator member50works or shows the numbers52and/or symbols53mechanically.

The nebulizer1comprises preferably the lock57for locking the nebulizer1against further use in the first locked state, in particular when the container3has to be replaced.

Preferably, the first locked state is reset by resetting the lock57, if the container3and/or housing part18have been replaced. With other words, the lock57is preferably resettable and can be used further after container replacement. In particular, an exchange or replacement of the lock57is not necessary to reuse the nebulizer1.

The nebulizer1comprises preferably the control member50for controlling or driving the lock57.

The control member50is preferably moved or rotated stepwise by the force of the spring51.

The lock57and/or first locked state is preferably blocked against resetting in the second locked state.

The second locked state is preferably entered when a predetermined number of containers3has been used or inserted into the nebulizer1and, preferably after a predetermined number of operations has been performed or exceeded with the nebulizer1after inserting the last container3.

The control member50is preferably ring-like.

Preferably, the control member50forms the indicator member or vice versa.

The control member50displays preferably the numbers52of containers3that have been used or still can be used and/or the symbols53indicating containing replacement and/or user guidance or nebulizer handling.

The control member50blocks preferably opening of the nebulizer1and/or container replacement until a predetermined number of operations has been reached or exceeded with the current container3.

Preferably, the nebulizer1is locked against opening or container replacement, in particular by means of the control member50, in the second locked state.

Preferably, the nebulizer1is locked against opening or container replacement, in particular by means of the control member50, before the first locked state has been reached.

Preferably, the lock57locks the nebulizer1in the first and/or second locked state against conveying fluid2into the pressure generator5and/or against tensioning of the drive spring7of the nebulizer1and/or against rotation or turning of the housing part18or inner part17.

Preferably, the housing part18has to be replaced each time the container3is replaced. In particular, the container3is inseparable from the housing part18and/or counter device23or vice versa.

The securing device32, in particular its moved apart locking portions33b, preferably prevent that the used and/or detached container3can be re-connected to or reused with the nebulizer1once more and or prevent that a used or detached housing part18can be reconnected to the nebulizer1once more.

Preferably, the housing part18can be or has to be detached or opened for replacing the container3.

Preferably, the securing device32is associated to the container3preventing that a used container3can be connected or used with the nebulizer once more.

FIGS. 16 to 26show aspects of the nebulizer1and housing part18according to the present invention. One inventive aspect deals with the preferred realization of blocking a rotatable element in a defined rotational position and/or with the provision or use of a blocking device74for blocking a rotatable element preferably in a defined rotational position. Another inventive aspect deals with the engagement of the device48for user guidance and/or counting (of containers3) or of the indicator or control member50with the rotatable element, in particular the threaded shaft42.

FIG. 16shows the nebulizer1in a schematic section wherein the housing part18is not (completely) connected to the nebulizer1or its housing, in particular not (completely) shifted on the inner part17. In this non-closed state, the rotatable element, here the threaded shaft42and/or drive gear43, are not in meshing engagement, i.e. do not mesh, with an associated drive member, here toothing45. In this context, it has to be noted that the counter device23and/or rotatable element, in particular the threaded shaft42and/or drive gear43, are arranged preferably in or at the housing part18, wherein the drive member, in particular toothing45, is arranged preferably at the nebulizer1or its housing or any other component, preferably at the upper part16or the like.

FIG. 17shows an enlargement of the encircled area ofFIG. 16. In this non-closed state, the rotatable element (drive gear43) and the drive member (toothing45) are not in meshing engagement and the blocking device74blocks any significant rotation of the rotatable element preferably in a defined rotational position.

FIG. 18shows in a perspective schematic view the similar area with the blocking device74in the same blocking state.

In particular, the blocking device74is associated to or forms part of the counter device23.

The blocking device74is preferably arranged at or within the housing part18, in particular near a bottom68of the housing part18.

In particular, the blocking device74is arranged in a preferably longitudinal extending pocket, bulge or recess69, preferably formed in or by a side wall of the preferably cup-like housing part18.

Preferably, the counter device23or its threaded shaft42is received or arranged in the bulge or recess69.

In the present embodiment, an optional holding member72is arranged in the housing part18or bulge/recess69. Preferably, the holding member72bears or holds the counter device23or threaded shaft42. In the present embodiment, the holding member72extends preferably essentially over the entire axial length of the bulge or recess69.

The blocking device74cooperates preferably with an engagement portion70of the rotatable element and/or an associated component, here the threaded shaft42, for blocking rotation of the threaded shaft42and, thus, of the drive gear43. Blocking of shaft42results namely in blocking of the drive gear43against rotation. The drive gear43and the shaft42are preferably connected or in rotational engagement, in particular formed as a unitary piece.

The engagement portion70is preferably arranged at or near an end of the shaft42, in particular near the lower end of the shaft42and/or at the end opposite the drive gear43.

The blocking device74engages or contacts preferably the engagement portion70for blocking, in particular by form-fit.

The blocking device74comprises preferably a blocking part75which has a receiving opening76for receiving the engagement portion70for rotational blocking of the rotatable element. The receiving opening76has a preferably non-circular cross section, in particular at least essentially complementary to the non-circular cross-section of the engagement portion70and/or so that the engagement portion70can be received in the blocking part75or its receiving opening76—in particular in only one defined or multiple defined rotational positions—such that the rotatable element (shaft42/drive gear43) can be blocked against rotation.

The engagement portion70comprises preferably a non-circular cross section, as indicated in particular inFIG. 19, which is a schematic section along line XIX-XIX ofFIG. 17.FIG. 19showing the engagement of the engagement portion70into the blocking part75or its receiving opening76.

In this context and in general, it has to be mentioned that a small rotational play may be acceptable and shall not mean that the rotational position of the rotatable element is not defined or that the rotatable element is not blocked against rotation.

In the present embodiment, the blocking part75or its receiving opening76on one hand and the rotatable element or shaft42or the engagement portion70on the other hand interact preferably radially for blocking rotation. However, an axial interaction or engagement or meshing is additionally of alternatively possible. Preferably, the blocking device74or blocking part75or receiving opening76block the rotatable element (shaft42) against rotation by form-fit engagement, here by engagement with engagement portion70.

The blocking part75itself is preferably blocked against rotation and/or held or guided such that it cannot rotate.

Preferably, the rotational blocking depends on the preferably axial position of the blocking device74or its blocking part75or the receiving opening76relative to the engagement portion70.

The blocking part75is preferably axially moveable or depressible for unblocking the rotatable element or shaft42/drive gear43.

Preferably, the housing part18, the holding member72or guiding portions73hold or guide the blocking part75in particular such that it can be moved (preferably against a holding or elastic force or the like) relative to the shaft42or engagement portion70, in particular axially and/or downwardly, in particular to move the blocking part75or receiving opening76out of rotational engagement with engagement portion70.

In the present embodiment, the blocking part75is held by a holding or elastic force and/or force-fit in its blocking position and/or can be moved out of its blocking position only by overcoming a holding or elastic force or a force-fit or the like.

In particular, the blocking device74or blocking part75comprises at least one holding arm or part77, here two holding parts77, for holding or securing the blocking part75in the blocking position and/or against movement downwardly or into the non-blocking position. In particular, the at least one holding part77abuts with an inclined surface on a counter part or face, preferably formed by the holding part72or any other component of the housing part18such that the holding part77has to flex and, thus, provides the holding or elastic force which has to be overcome for moving the blocking part75from the shown blocking position into the non-blocking position explained below. In the present embodiment, in particular two holding parts77are arranged on opposite sites and hold the blocking part75in the blocking position. These holding parts77have to be flexed towards each other and/or towards the blocking part75when moving the blocking part75from the blocking position into the non-blocking position, i.e. axially downwardly inFIGS. 16 to 18.

Preferably, the guiding portions73are formed by the housing part18or holding member72.

Preferably, the guiding portion73are essentially rib-like and/or extend on opposite sides of the blocking part75and/or in axial direction.

The blocking device74or blocking part75blocks the rotatable element or shaft42preferably in a defined rotational position until connecting the housing part18to the housing, in particular until completely closing the housing of the nebulizer and/or until the rotatable part (drive gear43) comes or is in meshing engagement with the associated drive member (toothing45).

Preferably, the blocking device74or its blocking part75unlocks the rotatable element automatically when the closed state is at least essentially or completely reached and/or when the rotatable element is in meshing engagement with the drive member.

Preferably, the blocking device74or blocking part75is actuated directly or indirectly by the housing, the inner part17, the retaining part39or the securing part40, in particular the blocking part75is pushed or shifted axially and/or downwards (the shaft42preferably remains in its axial position), when closing the nebulizer1or its housing, i.e. when connecting the housing part18(completely) to the nebulizer1, housing or inner part17.

Preferably, the rotatable element, in particular drive gear43, and the drive member, in particular toothing45, are moved axially together and/or are brought in radial/circumferential engagement when closing the nebulizer1or connecting the housing part18.

Preferably, the nebulizer1is constructed or designed such that the housing part18has a defined rotational position when the housing part18is connected to the nebulizer1or its housing or upper part16, and that the drive member (toothing45) has a defined rotational position relative to the position of the housing part18, housing or upper part16and, thus, to the rotatable element, here drive gear43, when connecting the housing part18to the nebulizer, i.e. when closing the housing/nebulizer1.

FIG. 20shows the nebulizer1in a schematic section with completely closed housing, i.e. in the closed state, and with actuated or opened blocking device74, i.e. with the blocking part75in the non-blocking position.FIG. 21shows an enlargement of the encircled area ofFIG. 20.FIG. 22shows the similar area in a schematic perspective view.FIG. 23shows in a schematic section similar toFIG. 19, but in another plane, namely along line XXIII-XXIII ofFIG. 21, the engagement portion70of the rotatable element or threaded shaft42rotatably held or beared in the blocking part75.

In the closed state (the nebulizer1or housing is closed), the rotatable element (drive gear43) is in meshing engagement with the drive member (toothing45). Further, the blocking device74has been opened or is open and, thus, does not block rotation of the rotatable element, here of shaft42and drive gear43.

In the present embodiment, the blocking part75is preferably axially moved out of rotational engagement with the engaging portion70for unblocking the rotatable element in the closed state, i.e. in its non-blocking position.

In particular, the blocking part75is axially moved or depressed just at the end or just before the end of the closing movement (axial and/or relative movement of the housing part18to the nebulizer1or upper part16and/or onto the inner part17in the present embodiment).

In the present embodiment, the inner part17or retaining part39preferably actuates or depresses the optional securing ring or part40arranged in the housing part18. And the securing part40in turn actuates or opens the blocking device74, in particular moves or depresses the blocking part75out of blocking or rotational engagement.

In the present embodiment, the blocking part75comprises preferably at least one protrusion78, in particular in form of an arm or the like, against which the actuating element, here the securing part40, abuts during the closing movement for actuating or moving the blocking part75out from its upper axial position, i.e. blocking position shown inFIG. 16toFIG. 18, into its lower axial or non-blocking position shown inFIG. 20toFIG. 22. Preferably, the protrusion78extends or protrudes radially and/or inwardly. In the present embodiment, two arms or protrusions78are provided or formed at or by the blocking part75.

In the non-blocking position, the blocking device74or blocking part75preferably bear the shaft42or a bearing portion71thereof, in particular in a portion79adjacent to the receiving opening76, so that the shaft42can rotate.

Preferably, it is impossible to manually open, actuate or unblock the blocking device74. In particular, the blocking device74is designed or constructed such that it can be opened or actuated or unblocked only (automatically) by connecting the housing part18to the housing or nebulizer1and/or by completely closing the housing or nebulizer1and/or when the rotatable element and drive member are brought in meshing engagement. This facilitates the handling and/or results in a very secure handling and/or avoids misuse by a user.

A further preferred aspect of the present invention is that the rotatable element (threaded shaft42) is preferably axially biased or pulled towards the drive member or into particularly full or secure engagement with the drive member (toothing45) when the housing part18comprising the counter device23is attached to the nebulizer1, but preferably not in the first locked state. Preferably, this is provided by the device48or the indicator/control member50.

In the present embodiment, the device48or indicator/control member50comprises preferably at least one holding portion80, preferably multiple holding portions80, as schematically indicated inFIG. 24.FIG. 24shows in a schematic side view the nebulizer1without housing part18, but with counter device23or member50(partly broken away) and at least with the rotatable element (threaded shaft42) and the associated rider44.FIG. 25shows a partial enlargement of the encircled area ofFIG. 24.

The holding portions80are preferably circumferentially spaced so that the rotatable element or threaded shaft42can pass between two neighboring holding portions80depending on the rotational position of member50, in particular for replacement of container3and housing part18including the counter device23.

In the present embodiment, each holding portion80comprises preferably a gliding surface or ramp81which is preferably inclined.

The rotatable element or threaded shaft42comprises in particular a collar82which is preferably disc-like.

During normal use or in the activated state, the nebulizer1biases or pulls the rotatable element or threaded shaft42preferably into engagement with and/or an axially towards the drive member or toothing45. In particular, the member50indexes or rotates one step further (automatically) when the (new) housing part18is attached to the nebulizer1(here initiated preferably by protrusion64) so that the member50or a holding portion80pulls or biases the rotatable element/threaded shaft42into meshing engagement and/or axial direction.

For this biasing or pulling, one of the holding portions80preferably abuts axially and/or grips under the collar82to pull or secure the rotatable element or threaded shaft42in a desired axial position and/or to pull or push the rotatable element or threaded shaft42or its drive gear43in meshing engagement with the drive member or toothing45. This situation is shown schematically inFIG. 26which corresponds toFIG. 25but shows the member50in a different rotational position where one holding portion80cooperates with or engages at the rotatable element or its collar82.FIG. 20shows this engagement or cooperation schematically in radial section.

The holding portion80or its optionally provided ramp81is preferably pointed into the moving direction, i.e. in the circumferential direction of rotation, in order to securely engage with or grip under the collar82when the member50indexes one step further to engage with the rotatable element or threaded shaft42or collar82.

As already mentioned, individual features, aspects and/or principles of the embodiments described may also be combined with one another as desired and may be used particularly in the nebulizer according toFIGS. 1 and 5but also in similar or different nebulizers.

Unlike freestanding equipment or the like the proposed nebulizer1is preferably designed to be portable and in particular is a mobile hand operated device.

The proposed solution may, however, be used not only in the nebulizers1specifically described here but also in other nebulizers or inhalers, e.g. powder inhalers or so-called metered dose inhalers.

Preferably, the fluid2is a liquid, as already mentioned, especially an aqueous pharmaceutical formulation or an ethanolic pharmaceutical formulation. However, it may also be some other pharmaceutical formulation, a suspension or the like.

According to an alternative embodiment the fluid2may also comprise particles or powder. In this case, instead of the expulsion nozzle12, 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 mouthpiece13. The optional air supply opening15then serves to supply ambient air preferably in parallel so as to general or allow an airflow with a sufficient volume for breathing in or inhaling through the mouthpiece13.

If necessary the fluid2may also be atomized by means of a propellant gas.

Preferred ingredients and/or formulations of the preferably medicinal fluid2are listed in particular in WO 2009/115200 A1, preferably on pages 25 to 40, or in EP 2 614 848 A1, paragraphs 0040 to 0087, which are incorporated herewith by reference. In particular, these may be aqueous or non-aqueous solutions, mixtures, formulations containing ethanol or free from any solvent, or the like.