WO2011154295A2

WO2011154295A2 - Medical device having a counter having a preset counting range, device having counter variation

Info

Publication number: WO2011154295A2
Application number: PCT/EP2011/059028
Authority: WO
Inventors: Markus Kaemper; Torsten Kramer-Brennecke; Mahmut Sakar; Ralf Thoemmes
Original assignee: Boehringer Ingelheim International Gmbh
Priority date: 2010-06-08
Filing date: 2011-06-01
Publication date: 2011-12-15
Also published as: WO2011154295A3; WO2011154295A4

Abstract

The invention relates to a hand-held medical device having a counter, preferably a dose dispenser such as an atomizer for dispensing dosed amounts of a drug preparation. The mechanical counter comprises a plurality of individual components, of which at least one is designed in such a way that said component can be installed in a quasi-subsequent manner as the last part after the assembly of the atomizer. Said component, with which a characteristic counter function such as preferably the display of the count is associated, is irreversibly connected to the housing of the atomizer. By installing a counter component subsequently, the design of the counter, for example the counting range, can be postponed until the time at which the drug formulation is fixed, in other words the dosage specifications with which the device is to be used. A preferred example is a liquid atomizer having a spindle/rider counter, wherein a rider to be installed differently from case to case is attached to a housing part from outside as an individual component. When said housing part is rotated relative to another housing part, a counter spindle supported there is driven. The rider is located on said counter spindle as the component that indicates the count. The rider on said counter spindle forms not only the indicator of the counter; the position of the rider on the spindle determines the counting range and the triggering of a blocking mechanism when the end of the counting range is reached.

Description

"Medical device with counter with pre-set counting range"

Device with counter variation

The present invention relates to a metered device for administering medical formulations in which the count is triggered in a purely mechanical manner. In particular, this device is a hand-held device with metering function such as an injector or atomizer, as used for inhalation of liquid or powdered drug formulations. The counter records the number of operations on this handset. A large number of medical devices and dose dispensers and also concrete atomizers are known from the state of the art, in which the user can read off, with the help of counters or indicators such as fill level displays, how many units are still available in the device for administration. Here are the different types of counters or displays: Looking aside from the direct view into a container filled with liquid, so there are counters, in which purely mechanical processes take place - for example, a transport of gears, the passage of a marker strip or a marked disc, - and such counters in which digital displays are used. What they all have in common is that there is a counting process in the device. This process takes place inside the device, incorporated into its functional sequences, only the display is usually visible from the outside. The previous counters are controlled in this sense from the inside.

The requirements for devices with counters depend in particular in handheld devices such as nebulizers on the drug formulation to be administered and its concentration, the associated patient therapy or on-site conditions and can therefore vary widely. In particular, the required count ranges and the required timing of counting can vary widely. In some applications, blocking of the device is also required if the number of actuations provided per device was achieved. Thus, with a counter with blocking, there are varying numbers of possible actuations of the device until the blockage prevents further activation or actuation. For the manufacturer of such devices, this means a high degree of inflexibility in stocking and storage: Depending on the equipment to be produced, different component sets must be stored, which increases both the bearing stock and the submixing risk of components. In the factory production of the devices, the subsequent combination with a specific drug formulation or generally the subsequent use of the device is also determined by the counter selection. In this way, stockpiles have to be produced for the individual uses, the storage costs increase again and the manufacturer can not respond flexibly to changes in demand on the market.

A nebulizer for nebulizing liquid pharmaceutical formulations for inhalation and having a level indicator based solely on mechanical processes has been offered for years under the name of "Respimat®" by Boehringer Ingelheim KG. This purely mechanical, miniaturized high-pressure nebulizer is available in the W091 / No. 14468 A1, WO97 / 12687 A1 and WO09 / 047173. With this atomizer, the function of which can be taken from FIG. 1 shown below, a liquid pharmaceutical formulation of a rigid container with an inner bag inserted into the atomizer, as in WO96 / 0601 1 AI and WO00 / 49988 A2, conveyed from the inner bag by means of a piston pump driven by a helical gear and atomized by a spring-driven pressure generator through a microstructured nozzle to a respirable aerosol Details of possible microstructures for the discharge nozzle used in the atomizers are in the documents WO94 / 07607, WO99 / 16530 and WO2005 / 000476A1.

The starting point for the invention presented here is, in particular, an atomizer with integrated counting device, as described in WO09 / 047173 and whose precursor is shown in document W097 / 24586A1. The respective atomizer has two mutually rotatably mounted housing parts, the rotation of which axially clamps both the inner drive spring of the pressure generator relative to each other and leads to the filling of the pressure chamber with drug formulation. During the relative rotation, a threaded spindle of the counting device arranged in parallel with the axis of rotation is also driven. The rotation of the threaded spindle, in turn, moves a rider attached to it along the principles of a worm thread. The position of this rider with respect to associated Zählmarkierungen indicates the still possible to be issued doses of the system. The rider is provided with an actuating arm, by which he actuates a blocking device in its end position, as it is also shown in the document WO04 / 024340A1. This blocking device then prevents the relative rotation of the housing parts and thus the tensioning of the drive spring, ie the activation of the atomizer.

The present invention has for its object to provide a comparison with the prior art improved device for administering medical formulations - in particular a hand-held device such as a nebulizer or injector - specify that has a multi-part counter, in which the count is triggered in a purely mechanical manner. The counter contained should be suitable in particular with regard to the above-mentioned flexibility aspects for mass production. The devices associated with this counter should in this case be as independent as possible of the later use, i. in particular, be independent of the later patient therapy, according to which the number of operations per device differs depending on drug formulation and dosage.

Said object is achieved according to the invention by a device for administering medical formulations, which has a multi-part counter, in which the counting is triggered in a purely mechanical manner, and in which determines the initial mounting position of a counting component indicating the size of the counting range of the counter , Advantageous developments are described below and in detail with reference to the figures.

A feature of the present invention is that not as previously in the prior art, the interaction of several components determines the counting range of the counter, but the design or adjustment of the counting range is moved to a single component that does not take over other functions of the device or especially in nebulizers or injectors is not involved in the sputtering or injection process. In this way, the actual mechanism of the device is not affected by the Zählwerksbauteilen, and the production and a function-oriented examination of the actual device technology can be advantageously decoupled from the complete installation of the counter or the final determination of the counting range.

The size of the counting area determining component is preferably also the counting indicating component and preferably designed so that it is irreversibly mounted on the outside of the housing of the device or at another located there Zählwerksbauteil when it is mounted. The advantage of this construction is that the design of the counting area is shifted into a component which can be retrofitted from the outside after the actual medical device has been manufactured.

Another feature of the present invention is that only one type of component of the counter is kept variable. This is preferably a counting indicating, triggering or decisively determining the counting range of the counter component. With the installation of this component either the number of counting steps triggered per triggering of the counting mechanism or the range of the counting range is determined. In the case of a variably held component, which triggers the count, this triggers preferably per triggering of the counting mechanism up to 5 counts on the counter from. In this way, in the simultaneous production of equipment or atomizers with different counters storage can be minimized and the risk of sub-mixing of wrong parts in a production line are kept low. In addition to the counter, a method for producing or mounting the counter is presented in the device, its special feature is that at least one component triggering or displaying the count or a decisive decisive determining the component is installed only after the assembly of all other items of the device , At the time of installation of the counting triggering device, the device is already operational except for the counter functions, provided it is equipped with a container of drug formulation or the like. If necessary, the component triggering or displaying the count is selected for installation in the device as a function of the counter range to be set from a selection of prefabricated components which result in different counting ranges. Advantage of this invention is the flexible use of factory-produced devices, since you can delay the decision on their use and thus on their count range to the time at which the individual devices or in particular atomizers are packaged together with drug containers. Thus, regardless of the later use of the devices can be produced in stock, and you can respond quickly to market needs.

Another feature of the inventive method for producing a device with counter is that after installing the at least one counting-indicating component - ie after completion of the assembly of both the counter and the device as a whole - the count range by means of performing a variable number of initialization steps or an externally supplied from the outside tool is adjustable. In this way, the counter of the device can be finely adjusted to very specific numbers of intended device actuations, so that especially in combination with the variability of the counting range by the appropriate choice of a counting triggering or counting range determining component, the counter to any number of only very few to several hundred operations can be preset.

The term counter here is to be understood as a multi-part mechanism by which actuating operations on the corresponding medical device either individually or be recorded in a respective defined number. The meter is typically combined with an associated indicator or indicator that allows the user to read the amount of remaining drug unit dosage units. In addition to or independently of an indication, the counter may trigger an actuation block according to presets. This blocking mechanism is not necessarily part of the counter. In a preferred embodiment, however, the counter is assigned a blocking mechanism which blocks the operation of the device, particularly after the administration of 10, 14, 30, 60 or 90 doses.

In the preferred embodiment, the counter is based on purely mechanical functional sequences, in particular on a spindle drive or a gear drive. The associated counting triggering member has a toothed structure, cam or other engageable structure with which a spindle or a gear or a ring gear or the like is rotated. A counting step in this context is a single turning step on this driven rotating part, i. For example, the smallest possible partial rotation of a spindle or the further rotation of a gear around a tooth. The component determining the counting range in these specific examples would be the spindle or the final gear in a successive drive of several gears. A spindle determines in a counter the counter range by their length and thread pitch and possibly also with a corresponding default setting of the guided by her indicator. The component indicating the count is driven by the mechanical functions on a scale indicating the counter reading. In the preferred embodiment, the indicating member is a rider mounted on the spindle with an internal thread and having a tapered shape in the shape of an arrowhead. By the spindle drive, it moves along a Zählmarkierung, for example, a scale attached to the housing.

In the devices for administering medicinal formulations shown here, preference is given to hand devices such as atomizers or injectors with which liquids are dispensed in defined volumes, ie atomized or injected. The term "liquid" includes in addition to pure liquids and solutions in addition Dispersions, suspensions, suspensions (mixtures of solutions and suspensions) or the like.

The term "medical formulation" or "drug formulation" in addition to medicaments in the present invention beyond Therapeutica or the like, in particular any kind of means for inhalation or other use to understand. In this sense, the invention also relates to atomizer equipped with a counter, with which a powdered drug formulation is atomized for inhalation.

The individual features of the present invention can be used independently or combined with each other.

Further advantages, features, characteristics and aspects of the present invention will become apparent from the claims and the following description of preferred embodiments with reference to the drawing. The drawings show in:

1 is a schematic section of a nebulizer in the untensioned state,

Fig. 2 is a schematic, rotated by 90 ° relative to Fig.1 section of the atomizer

1 in the tensioned state,

Fig. 3 is a schematic side view of the atomizer

Fig. 4 is a schematic, exploded view of the individual parts of the counter, wherein the upper housing part of the atomizer is shown with inserted tooth inserts in a schematic half-section

Fig. 5 is a schematic view from below of the upper housing part of the atomizer with two different tooth inserts used

Fig. 6 shows schematically another embodiment of a spindle-rider counter in the figures the same reference numerals are used for the same or similar parts, with corresponding or comparable properties and advantages are achieved, even if a repeated description is omitted.

Fig. 1 and 2 show a schematic representation of a known hand-operated device in which the proposed counter (41) can be used. In the apparatus of Fig. 1 and 2 is a propellant gas-free atomizer (1), the per each actuation cycle outputs the respective predetermined amount of a liquid (2) as a preferably respirable aerosol (14). This aerosol (14) with droplets with aerodynamic diameters of preferably 3 to 10 micrometers can be inhaled by a user, not shown. By replacing the nebulization nozzle (12) of this device with an injection nozzle, all nozzle-independent operating principles remain unchanged, so that the relationships described below are valid analogously for injectors, even if for reasons of simplicity only nebulizers are mentioned.

During operation of the atomizer, a distinction is made between the unstressed state with an empty metering volume in the pressure chamber (11) (FIG. 1) and the tensioned state with a filled pressure chamber (11) (FIG. 2).

When clamping the atomizer (1) its upper housing part (16) is rotated relative to the housing inner part (17) and lower housing part (18) by a fixed angle of rotation. This angle of rotation is preferably an integral fraction of 360 ° and is 180 ° in the illustrated example. By means of an internally arranged helical gear, a piston pump is driven by the relative rotation, so that a predetermined, optionally adjustable amount of liquid (2) from the container (3) conveyed into the pressure chamber and at the same time tensioned the drive spring (7) of the pressure generator (5) becomes (state as in Fig. 1). When triggering the atomizer (1), ie upon actuation of a locking element (8) stored in the drive spring (7) energy of the pressure generator (5) is released: The previously used for the liquid promotion hollow piston (9) now presses with a closed check valve (10) in the pressure chamber (5), so that the predetermined amount of liquid is discharged from there through the nozzle (12). The device is now in the relaxed state again (Fig. 2). The counter (41) is preferably based on purely mechanical operating principles and is driven in the illustrated example by the relative rotation of the housing inner part (17) to the upper housing part (16). In this case, so clamping operations on the atomizer as an operating form of the atomizer (1) are detected and counted. However, other constructive solutions are possible. In the illustrated example, the counter (41) has a threaded spindle (42) with an associated tab (43) which can be moved linearly, in particular by turning the threaded spindle (42), as indicated in FIGS. 1 and 3. The threaded spindle (42) is preferably arranged substantially parallel to the central axis of rotation of the atomizer (1) and on the outside of the casing of the housing inner part (17) in the region of the lower part (17b). Here, the threaded spindle (42) is preferably laterally latched or einklippsbar in a pivot bearing on the housing inner part (17).

The rider (43) is outside of the housing inner part (17) longitudinally displaceably guided by the threaded spindle (42) and forms in particular with her a self-locking S chneckengetriebe.

The threaded spindle (42) is preferably driven by a toothed structure (44) located inside the upper housing part (16) or by teeth (indicated in FIGS. 4 and 5) during relative rotation of the upper housing part (16) to the inner housing part (17) or rotated. For this purpose, the upper portion (42a) of the threaded spindle (42), which projects into the housing upper part (16) inside in the mounted state, has a corresponding toothing or engagement possibility for the toothed structure (44). If the housing inner part (17) with the threaded spindle (42) in the housing upper part (16) is rotated, the toothed, upper portion (42a) of the threaded spindle (42) runs along a freewheeling track in the housing upper part (16) until it reaches the toothed structure (FIG. 44), which rotate it and thus the entire threaded spindle (42) in its pivot bearing outside of the housing inner part (17).

In the illustrated example, the atomiser (1) has a housing bottom part (18) which is preferably transparent or at least provided with a viewing window on the counter (41) and which, after the axial insertion of the container (3) into the atomiser (1), from below via the lower one Part (17b) of the housing inner part (17) and the spindle-rider system is pushed or plugged. In this case, both systems are possible, which provide the interchangeability of the container (3) as well as those in which the container (3) in the atomizer (1) is preset and not removable. Fig. 1 shows an embodiment with exchangeable container (3). Here, the lower housing part (1 8) by means of a retaining element or safety closure (19) releasably secured, so that by pressing the same the lower housing part (18) is released and the container (3) can be exchanged or used.

In the - not shown here with reference to the figures - embodiment with pre-inserted container (3) this is already used ex works in the atomizer (1) or in an additional holding or securing element in the housing lower part (18). When sliding the lower housing part (1 8) on the housing inner part (17), for example, it slides over a ratchet web designed to slide only in one direction of movement or hooks into a variable, configurable latching after being completely pushed on. Further details on the design of such systems with pre-inserted container (3) can be found in the document WO06 / 125577.

In Fig. 3 is a schematic side view of an atomizer (1) with a transparent or at least partially transparent housing lower part (18) is shown, which protects both the counter (41) mechanically from the outside and also allows a clear view of it. The rider (43) associated with the counter (41) in the illustrative example is preferably provided with a tapered point pointing in the direction of a counting mark (45) disposed on the lower part (17b) of the housing inner part (17). This counter marking (45) is characterized in the illustrated example, in particular by grooves on the outer shell of the housing inner part (17). However, these may alternatively or additionally also be formed by corresponding markings, labels or the like affixed, in particular affixed, to the housing inner part (17) in addition to the tab (43). The counter (41) is read from the relative position of the rider (43) to the counting mark (45).

The atomizer (41) is designed such that the atomizer (1) is inhibited against re-actuation when a certain number of actuations have been performed or exceeded. The counting marks (45) in the representation example indicate the still possible actuations of the atomizer (1) - more precisely, the number of cans still to be dispensed - until the final blocking state is reached. Locking the nebulizer against actuation prevents the user from breathing in or out of aerosol (14) after draining the container (3). The aerosol is under Circumstances so fine that the user does not perceive it when inhaling in the mouth and throat and thus would not notice a reduction of the spray when emptying the container (3).

In order to trigger a blocking mechanism that brings about the final actuation lock, the tab (43) in the illustration example is preferably provided with an actuation arm (43a) which extends in particular parallel to the threaded spindle (42). When the rider (43) approaches its upper end position, its actuating arm (43a) extends axially beyond the threaded spindle (42) and dips beneath the housing upper part (16) along the inner housing part (17).

The blocking device is formed in the illustrated example by a locking spring (46), which is indicated in Fig. 1. The locking spring (46) is preferably designed as a folded and / or zweischklige leaf spring. The locking spring (46) is held by the housing inner part (17), preferably in an outwardly open longitudinal groove. One leg of the locking spring (46) is preferably on the groove bottom. The other leg is biased in the radial direction and springs behind a projection on the housing inner part (17) or by an annular groove on the inside of the housing upper part (16) against radial outwards.

When the predetermined or maximum number of actuations of the atomizer (1) is reached or exceeded and the rider (43) assumes its end position, he moves the locking spring (46) axially with the actuating arm (43a) (upward in FIG. 1) so that the prestressed leg is released and can rebound or engage radially outwards into a corresponding groove or recess on the inside of the housing upper part (16). Thus, the upper housing part (16) and the housing inner part (17) are connected in such a way via the locking spring (46) that a further relative rotation between the housing inner part (17) and upper housing part (16) is blocked. Thus, therefore, the clamping or further actuation of the atomizer (1) is blocked.

Depending on the choice of drug formulation or liquid to be used (2) or the requirements for different uses or requirements in different countries, different numbers of possible Operations of the atomizer needed until blocking. The counting ranges can be varied so that they can range from single to several hundreds, such as 500 actuations of the atomizer. The counting range can be designed both for use in atomizers with a single, possibly pre-set container as well as for use in atomizers with a set of interchangeable containers, ie in a reusable system. Particularly preferred here are the variants with counting ranges corresponding to the administration of 10, 14, 30, 60 and 90 doses considered. In this case, one dose may correspond to a plurality of atomizer actuations, preferably one dose corresponds to one to four atomizer actuations. Particularly preferred is an application mode in which the user must operate the atomizer once a day twice directly behind each other. In this specific case, one dose corresponds to two clamping and tripping operations. As a result, there are then required 20 actuations for the administration of 10 doses or 120 actuations for the administration of 60 doses. Depending on the required counting range, if the general dimensions of the atomizer are kept constant, the rider (43) on the counter (41) must be moved at different speeds on the threaded spindle (42) in the illustration.

In the present invention, a concept has been created in which as many components of the counter can be maintained unchanged in the described variety of variants. Rider (43), threaded spindle (42), length of Zählmarkierung (45) and release mechanism the blocking mechanism, ie for the locking spring (46) are identical for all variants. In particular, no different pitches of the threaded spindle (42) and associated internal threads on the tab (43) or different lengths of the actuating arm (43 a) are required. The variability is essentially displaced in the drive of the threaded spindle (42) through the housing upper part (16), in which the toothed structure (44) or specifically the number of teeth mounted therein is varied. Matched to the contours on the head (42a) of the threaded spindle (42) - possible detail contours of the spindle head of the font W097 / 24586 be removed - rotates during the relative rotation of the upper housing part (16) to the housing inner part (17) each have a pair of teeth on the inner edge of the housing upper part ( 16) the threaded spindle (42) by 180 °. in this connection it can be said that the toothed structure (44) "meshes" with the engagement possibilities on the head (42a) of the threaded spindle (42), the gap of a tooth pair snaps a nose on the head (42a) of the threaded spindle (42) and turns it. Of course, other groups of tooth-like projections in engagement with other spindle head structures are also conceivable for such further transport The number of tooth pairs distributed over the inner circumference of the housing upper part (16) determines the number of rotations of the threaded spindle (42) and thus the speed of the linear movement According to the invention, at least one drive element of the counter (41) or a component triggering the count, ie in this case a toothed structure (44), not directly on the actual atomizer or as in this case on the upper housing part (16 ), but forms, as shown in the schematic exploded view of Fig. 4, an independent component, which also after the assembly of the actual atomizer can be used so to speak late or subsequently.

In a preferred embodiment of the device several counting triggering components are installed, which trigger different numbers or equal count steps in direct comparison to each other depending on the requirement of the counter. This achieves better variability. Particularly preferred are two such counting triggering components used, the so-called Zahneinsätze (44 a and 44 b) in the illustration. The use of only one or more of these counting triggering components is also structurally possible. The actual atomizer functions - activation or clamping by relative rotation of two housing parts (1 6 and 1 7) resulting in filling the pressure chamber (5) and energy storage, the triggering by pressing a button with release of energy from the drive spring (7) and the sputtering principles - are completely independent of the presence of these tooth inserts (44a and 44b). The tooth inserts (44a and 44b) can be arbitrarily distributed over the circumference of the upper housing part (16) in the orbit of the head (42a) of the threaded spindle (42). As can be seen in FIG. 5, they can, for example, be arranged so uniformly that, viewed radially, they face one another on the circumference of the circumference and thus a potential material weakening of the corresponding housing component resulting from the original recess, ie here the upper housing part (16), as low as possible. An alternative advantageous arrangement is when the tooth inserts (44a and 44b) are arranged so that they trigger the count shortly before the completion of a 180 ° relative rotation between the upper housing part (16) and the housing inner part (17), ie preferably the toothed structure (44) in the rotation range of 120 ° to 175 ° on the inner circumference of the housing upper part (16) is located. This offers handling advantages, for example when it comes to triggering the blocking mechanism at the end of the counting range.

Preferably, they are irreversibly inserted from the outside into corresponding recesses after completion of the actual atomizer system. This can be done for example by the radial feed of the inserts from the outside, which are inserted into continuous recess or holes in the upper housing part (16), or by an axial insertion of such inserts outside along the lower part (17b) of the housing inner part (17) inside , downwardly open pockets on the upper housing part (16). Particularly preferably, this feeding of the inserts does not precede any dismantling steps. However, these are also possible for example in the form of a reversible opening of the housing lower part (18) by means of the safety closure (19).

In a preferred embodiment of the device, the at least one component triggering the count is irreversibly installed, in which case it is snapped and / or jammed and / or adhesively bonded and / or welded in particular to a housing part of the device. Due to the irreversible installation of the counting triggering component, the total counter is protected against manipulation. This is for patient safety, as it ensures that the display of remaining in the unit dose units depends purely on the number of actuations of the device and can not be changed or falsified by accidental or arbitrary detachment of a component. In the illustrated example, the tooth inserts (44a and 44b) are firmly connected to the corresponding component of the atomizer after assembly, preferably to the housing of the atomizer (1), such as the housing eob erteil (1 6). This connection is preferably a snap connection, but also a jamming, latching or gluing is possible. Alternatively, the tooth inserts (44a and 44b) z. B. In a laser or ultrasonic welding process to the housing of the atomizer (1) are welded. Preferably, both the tooth inserts (44a and 44b) and the upper housing part of the same material, preferably a thermoplastic having a suitable flexibility for snap connections and rigidity. However, it is also possible to add different color pigments to the material for the tooth inserts (44a and 44b). In this way one can use the color selection for tooth inserts (44a and 44b) with different toothed structures (44) or. For different counting step activations, make a coding of these components or even of the atomizer as a whole. Such differences in color can in turn reduce the risk of submergence while using different tooth inserts (44a and 44b) in parallel. However, the materials of the components can also be chosen arbitrarily from one another or in themselves differently.

In an alternative embodiment of the device, the housing part containing the mouthpiece (13) is made in one piece from two different materials. It is advantageous to use an upper housing part, the base body or its connection points to other components made of a different material than, for example, arranged on it mouthpiece (13). For the mouthpiece (13), different material requirements may sometimes be imposed on the body and joints in the context of drug compatibility, tolerability in oral contact and surface condition. The joints - the connected components would be, for example, the tooth inserts (44a and 44b), other housing parts or components of the internal pumping mechanism - must first and foremost high stability and strength and good processability, especially in terms of joining techniques.

In this case, the upper housing part (16) in a so-called two-component injection molding process integrally or materially made of two materials, for example, an ABS, ASA or AES polymer for the body and another material such as polypropylene , Polyethylene, a thermoplastic elastomer, silicone polymer or any other plastic for the mouthpiece (13) or the coating of the mouthpiece (13). Alternatively, the mouthpiece can be made together with the base body of the first material and the Connecting points, for example, in the joining region for the internal pump mechanism of the second material, preferably a suitable plastic.

Apart from the structures relevant for the triggering of counting steps, the drive elements or tooth inserts (44a and 44b) can have any desired external contours. In a preferred embodiment of the device, the counter drive is secured against manipulation, the counter (41) is not accessible from the outside in the region of its drive, in particular due to the shape of the housing contour. For this purpose, the at least one component triggering the count preferably closes flush with the housing after installation in the device. In this way, in the application example, the outer contour of the atomizer (1) through the tooth inserts (44 a and 44 b) continues. This is shown schematically in the left half of FIG. 4 with reference to an upper housing part (16) with inserted tooth inserts (44a and 44b). In the final assembled state, the surrounding housing, in this case the combination of upper housing part (16), inner housing part (17) and lower housing part (18), is designed so that it does not allow access to the general drive of the counter. This can be achieved, for example, by a bead or webs running around the lower edge on the housing upper part and / or projecting radially extending ribs on the housing inner part (17) in the region of the connection point to the housing upper part (16). In both cases, both the teeth (44) and the head (42 a) of the threaded spindle (42) so hidden in the gap between the upper housing part (16) and housing inner part (17) that they no longer accessible even with needle-like tools and thus against manipulation are protected.

If the atomizer (1) has at least two of these count-triggering components or tooth inserts (44a and 44b), then, depending on the design of the counter (41) or depending on the desired number of actuations of the atomizer (or as indicated by the blocking mechanism) ( 1) also different counting triggering components are used. Such a component can preferably trigger up to 5 counting steps during a functional cycle of the atomizer (1), ie a tooth insert (44a and 44b) has up to 5 tooth pairs or 10 individual teeth. In a preferred embodiment of the device, instead of a count-initiating device (44a, 44b), a component is inserted which does not initiate a counting step in the counting mechanism, so that an associated actuation of the device is not counted. Such a so-called dummy insert complements the selection of components with variable number of Zählschrittauslösungen. It has the same outer dimensions as the actual tooth inserts (44a and 44b) in the illustration example, but has no toothed structure (44) for further rotation of the threaded spindle (42). In the absence of the actual tooth inserts, these "dummies" serve to close said recesses in the housing of the atomizer (1) for protection against external contamination.These "dummies" are preferably used in combination with at least one component actually triggering the counting Counter (41) is designed for one of the larger counting ranges, so that the threaded spindle (42), for example, only at every second 180 ° relative rotation of the upper housing part (16) to housing inner part (17) rotate and so the rider (43) correspondingly slower in Direction blocking mechanism moves as if the threaded spindle (42) is moved at each relative rotation of the housing.

In the following Table 1, an example of possible combinations of counting triggering components and drive elements for different counting ranges for the special case of an otherwise constant spindle rider counter with two varying tooth inserts (44a and 44b) is shown.

Table 1: Combinations of possible tooth inserts for driving a spindle rider counter for different counting ranges The combinations of tooth inserts in Table 1 show how to create a multitude of different counters with a minimum of varying components can be replaced without having to exchange most of the individual components of the counter. Based on the concrete example, four different counting ranges can be opened with only inserts. The second tooth insert for the 120 count range in Table 1 is the triggering of zero counts by the "dummy" described above.

Optionally, in addition to this - depending on the size of the selected counting range under some coarse - setting the counting range still a fine adjustment desired. For this purpose, the activation or initialization of the rider (43) on the threaded spindle (42) can be used.

When installing devices with counters, it is desirable that the counter (41) during random or intentional handling steps in the assembly or testing process does not "mitläuft", but is - even regardless of installation of a counting triggering component - in a so-called rest position For the spindle-rider counter in the illustration example, this means that the threaded spindle (42), for example, has a lower area without a threaded structure, where the rider (43) is in the rest position If the activation of the counter is desired, the rider (43), with the aid of a tool on the spindle, becomes at the upper edge of this smooth area of the threaded spindle (42) pushed, and the threaded spindle (42) is rotated until the internal thread of the R Eiters (43) in fixed engagement with the thread of the threaded spindle (42). The rotation of the threaded spindle (42) is preferably caused by use of the counting triggering component or the tooth inserts (44a and 44b) by clamping operations on the atomizer (1), ie by the relative rotation between two housing parts. In this case, activation is particularly preferred in which the threaded spindle (42) is rotated at least 360 ° about its own axis, since then the rider (43) is reliably "tracked" onto it one and four nip at the nebulizer (1) (corresponds to the 30's and the 120's counting range in Table 1, since a count-step trigger a Thread spindle rotation by 180 ° corresponds). With regard to the counter, one can call each clamping operation as an initialization step in the context of the activation.

If a counting range is to be fine-tuned in addition to the activation, then additional initialization steps may be performed, such as when, for example, the required counting range at the atomizer (1) deviates from the arithmetic combination scheme from Table 1. For example, if one wishes to provide an atomizer for administering 14 cans of 2 atomizer actuations, the 30 actuation version shown in Table 1 must undergo two additional initialization steps to make the count range available for taking 14 instead of 15 cans.

Furthermore, a variation of the number of initialization steps can be used for the fact that the rider (43) always stands at the same point of the threaded spindle (42) with respect to the counting mark (45) at the final factory delivery of the atomizer (1). It is therefore intuitively apparent from Table 1 that in a counter (41) having a large counting range for, for example, 120 actuations, more initialization steps, i.e., more initialization steps, are performed. Clamping operations on the atomizer (1) with pushed up rider (43) must be performed as in a counter (41) for example, 20 actuations, in which the rider (43) relatively quickly per actuation on the threaded spindle (42) moves.

An alternative concept for the design of devices with as many counting areas while retaining as many components of the counter is to vary only one of the counting range determining or only the counting indicating component - in devices with blocking mechanism is the counting indicating component preferably also the Blocking mechanism triggering component that would otherwise have to undergo the same variation. In the atomizer (1) of the illustrative example, the tab (43) is at the same time the counting-indicating component as well as the component triggering the blocking mechanism. In the spindle-Reiterzählwerk the threaded spindle (42) is driven by the entrainment of its head (42 a) on a toothed structure (44) in the upper housing part (16) by the relative rotation of two housing parts. The threaded spindle (42) is - depending on the initial position of the rider (43) - the counting range determining component. In the preferred embodiment of this concept, the tab (43) is either varied according to the desired counting range or incorporated differently. The toothed structure (44) in the housing, the threaded spindle (42) and the release mechanism for the locking mechanism, ie for the locking spring (46) are identical here for all variants. There are now the possibilities either to vary the installation position of the rider (43) or to make the rider (43) possibly even variable. In both cases, the mounting position of the rider (43) on the threaded spindle (42) and the distance of its actuating arm (43a) to the release position of the blocking mechanism determines the counting range: the further up the rider (43), ie the closer the tip of the actuating arm (43a) is the trip position of the lock mechanism, the smaller the count range.

To vary are only the Zählmarkierung (45), which can be kept flexible, for example via adhesive labels, and possibly the tab (43).

This variable presetting can be carried out in different ways: A possibility shown by way of example in FIG. 6 is to carry out the connection between the rider (43) and the threaded spindle (42) in such a way that the rider is clipped onto it from the outside, which happens at any position can. In this case, it would be advantageous to use a threaded spindle (42) with a comparatively deep and robust threaded barrel into which the headwind on the rider (43) can insert itself nondestructively in the clip process. Here, it is advantageous, as shown in FIG. 6, to equip the rider (43) in addition to the actuating arm (43a) with an adjustment arm (43b) pointing in the opposite direction or to the starting area of the counter its length depends on the desired counting range of the atomizer (1). The lower end of the adjustment arm (43b) can come to a stop when mounting the rider (43) in the region of the lower installation space of the threaded spindle (42) at special contours on the housing inner part (17), so that by the adjustment arm (43b) the mounting position of the tab (43) or its default setting with respect to the Zählmarkierung is specified.

Another possibility is, separately from the atomizer (1) to thread the rider (43) on the threaded spindle (42) in the desired position or postpone. The Threaded spindle (42) can then be mounted on the atomiser (1) with a pre-set rider (43) or clipped onto the housing inner part (17).

Yet another possibility is to mount the rider (43) as desired at an early stage in the assembly process at the lower end of the threaded spindle (42) on the housing inner part (17) and then later, for example. by the intervention of a special tool in the lower spindle range to move the tab (43) in the context of a targeted activation to the desired starting position of the counting range. This can be done for example by a rotating tool that the threaded spindle (42) rotates until the rider (43) has reached the desired position while running along the thread (this would, however, at the same time such rotation of the housing inner part (17) and Housing top (16) are held so that the head (42 a) of the threaded spindle (42) in a recess on the inside of the circumference of the housing upper part (16) so that the threaded spindle (42) is freely rotatable).

Alternatively, the tab (43) may be designed so that it is resiliently spreadable, so its internal thread with a tool of the threaded spindle (42) spread away and can be moved without rotation on this, and then after pulling away the tool at the desired position to be discontinued on the threaded spindle (42) again.

In particular, no different pitches of the threaded spindle (42) and associated internal thread on the rider (43) are required.

For all these variants of the concept - retrofitted rider (43), subsequent assembly of the preset spindle-rider system, subsequent adjustment of the rider position - the atomizer (1) itself can be fully assembled with regard to its basic functions. Only the protective lower housing part (18) - designed to be reversibly removable here by opening the safety lock (19) - must be removed from the atomiser or the assembly of the lower housing part must be postponed until after the counter has been set.

The idea of relocating the differences of otherwise identical counters with different counting range into a component determining the counting range, which can be retrofitted to the system from the outside, can be transferred to almost all types of register. For example, many counters in medical hand-held devices include ring counters or gear-driven indicator rings that are radially mounted on the outer case or directly under the case shell. Disassembled as a ring in two or more parts, so you can postpone this after completion of the actual device and the Zählwerkantriebs from the outside either in several parts radially or put him or her over a last missing part that just makes up the counter difference eg by varying teeth , to complete. If the considered counting or indicator ring below the housing surface, so you can provide an opening in which one sets a two-part assembly, in which the ring segment is in turn rotatably mounted on a housing insert, which terminates flush with the outside surface of the housing.

The use of such counters is completely independent of the type of device: In addition to the atomizer for liquids described in detail in Figures 1 and 2, such variable counters can also be used in multi-dose Pulverzerstäubern or in injectors. In general, the present invention can be used across domains; even applications beyond the medical field are possible.

In the following, the preferred manufacturing / assembly process for the counter (41) and the installation of these components in the device and in particular in the atomizer (1) are summarized schematically: - Production of all items for counter (41) (especially in injection molding of plastic granules) and Device according to methods known in the art Assembly of the housing components with associated constant held individual components of the counter (41) by methods known in the art

Installation of the technology to complete the device, in particular installation of atomizer technology

Storage of the equipment until the decision to use it

Installation of components triggering the counting without disassembly on the device (if necessary to a completely different location than all previous manufacturing steps executable)

Activation or initialization of the counter - Possibly. Merging device, especially atomizer, with a container in the

Housing base (special case device with pre-set container)

This manufacturing process can be changed almost as desired, depending on the demands placed on the components as well as the complexity of the components and systems. The deciding factor in this invention is merely that the installation of at least one component triggering the count takes place after the assembly of all other individual components of the device or the last irreversible assembly step in the production of the actual device. Except for the counter functions, the device would be ready to function even without installation of this at least one component triggering the counting, subject to the provision of a container (3) containing the liquid (2) or a drug formulation.

The present invention has the following advantages:

High flexibility with regard to the use of the devices due to the possible setting of the counter after storage

- Low risk of mixing meter components, since only a minimal

Number of components for the production of devices with different counters is in circulation

With a minimum of variably held components, counters with many different counting ranges can be set up.

- Eliminating changeover times to production machines, since in the actual production of the devices initially no attributable to counter differences variants must be made more

Low storage costs, because on the one hand before production only a minimum of different component variants for the different counters must be stocked and on the other hand, only one type of equipment (namely the without

Register fixing) must be stored long term LIST OF REFERENCE NUMBERS

1 atomizer 44 toothed structure

2 liquid 44a first czarine insert

3 container 44b second tooth insert

5 Pressure generator 45 Counting mark

7 drive spring 46 locking spring

8 blocking element

9 hollow piston

10 check valve

11 pressure chamber

12 nozzle

13 mouthpiece

14 aerosol

16 housing upper part

17 housing inner part

17b lower part of the housing inner part

18 housing base

19 safety lock

40 button

41 counter

42 threaded spindle

42a head (the threaded spindle)

43 riders

43a operating arm (on the rider)

43b adjustment arm (on the rider)

Claims

Claims:

An apparatus for administering medical formulations having a multi-part counter in which the count is triggered in a purely mechanical manner, characterized in that the initial mounting position of a component indicating the count determines the size of the counting range of the counter.

2. Apparatus according to claim 1, characterized in that the counting indicating component is mounted externally on the housing of the device or accessible from the outside.

3. Apparatus according to claim 1 or 2, characterized in that the counting indicating component is irreversibly installed, wherein it is in particular verklippst with a housing part of the device or another component of the counter and / or snapped and / or locked.

4. Device according to one of the preceding claims, characterized in that the counting indicating component is tuned in its contours on the respective Zählbereich and in particular a despite varying display position at the time of installation has a constant end stop based on the lower portion of the Zählmarkierungen.

5. Device according to one of the preceding claims, characterized in that the counter is based on purely mechanical functional processes, in particular on spindle drives.

6. Device according to one of the preceding claims, characterized in that the counting-indicating component has a tapering in the form of an arrowhead structure and / or is movable along a Zählmarkierung.

7. Device according to one of the preceding claims, characterized in that the counter is associated with a blocking mechanism by which the operation of the device is locked, in particular after the application of 10, 14, 30, 60 or 90 doses.

8. Device according to one of the preceding claims, characterized in that the

Count indicating component having an actuating arm which triggers a locking mechanism when the end of the counting range is reached.

9. Device according to one of the preceding claims, characterized in that the counter can be activated from a rest position and / or that the counting range is adjustable by means of the implementation of a variable number of initialization steps.

10. A method of assembling a device according to claim 1, characterized in that at least one component indicating the count or a component determining the counting range is installed only after the assembly of all the other individual parts of the device.

11. The method according to claim 10, characterized in that at the time of installation of the counting indicating component o of the Z ählbereich determining component, the device is already ready for use except for the counter functions, if it is equipped with a container with drug formulation or the like.

12. The method according to claim 10 or 11, characterized in that the counting indicating component or the counting range determining component is selected from a selection of prefabricated components depending on the counting range to be set, the built the counter to different count ranges.

13. The method according to any one of claims 10 to 12, characterized in that the counting-indicating component and the counting range-determining component, in particular in the form of a preset spindle-rider combination already mounted preassembled on the device.

14. A method for assembling a device according to claim 1, characterized in that first the device with counter to a complete device is constructed and the counting range is set in particular by a subsequent adjustment of the counting-indicating component at a later date.

15. counter for installation in a device according to claim 1, characterized in that the

Form of the counting indicating component determines the counting range.

16. A device for administering medical formulations, which has a multipart counter (41) in which the counting is triggered in a purely mechanical manner, characterized in that the count by at least one independent and with respect to the application functions of the device independent component (44a, 44b) is triggered.

17. Apparatus according to claim 16, characterized in that the counting triggering component (44a, 44b) triggers up to 5 counting steps, in particular 1 or 2 counting steps, per triggering of the counting mechanism.

18. Apparatus according to claim 16 or 17, characterized in that instead of a

Counting triggering component (44a, 44b) is inserted a component that does not trigger a counting step in the counting mechanism, so that an associated operation of the device is not counted.

19. Device according to one of the preceding claims 16 to 18, characterized in that a plurality of different in particular the counting triggering components (44a, 44b) are installed.

20. Device according to one of the preceding claims 16 to 19, characterized in that the counter (41) based on purely mechanical functional sequences, in particular on spindle drives and / or the counting triggering member (44a, 44b) has a toothed structure (44).

21. Device according to one of the preceding claims 16 to 20, characterized in that the counter (41) in the region of its drive are not accessible from the outside.

22. Device according to one of the preceding claims 16 to 21, characterized in that it comprises a counter (41) associated with the blocking mechanism by which the operation of the device, in particular after the administration of 10, 14, 30, 60 or

90 doses is blocked.

23. Device according to one of the preceding claims 16 to 22, characterized in that the counter (41) can be activated from a rest position and / or that of Counting range by performing a variable number of

Initialization steps is adjustable.

24. Device according to one of the preceding claims 16 to 23, characterized in that the housing part, which includes the mouthpiece (13), is integrally made of two different materials.

25. A method for mounting a device according to claim 16, characterized in that at least one counting triggering component (44a, 44b) is installed only after the assembly of all other items of the device.

26. The method according to claim 25, characterized in that at the time of installation of the counting triggering component (44a, 44b), the device is already ready to function to the counter functions, provided that it with a container (3) with

Drug formulation or the like is fitted.

27. The method of claim 25 or 26, characterized in that the counting triggering component (44a, 44b), reversible or irreversible, is inserted from the outside into a recess in the housing of the device.

28. The method according to any one of claims 25 to 27, characterized in that for the

Installation in the device, the counting triggering member (44a, 44b) is selected depending on the set counter range of a selection of prefabricated components that are installed differently trigger count steps, or multiple counting triggering components (44a, 44b) from this selection of components be selected for a combination when installed in the device.

29. The method according to any one of claims 25 to 28, characterized in that after installation of at least one counter triggering the component (44a, 44b), the counter is activated in a separate process step.

30. Counter (41) for installation in a device according to claim 16, characterized in that at least one independent component (44a, 44b) per triggering of

Counter mechanism triggers up to five counting steps in the counter.