Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0065—Inhalators with dosage or measuring devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
  • A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
  • A61M11/007—Syringe-type or piston-type sprayers or atomisers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
  • A61M11/06—Sprayers or atomisers specially adapted for therapeutic purposes of the injector type
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0065—Inhalators with dosage or measuring devices
  • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
  • A61M15/007—Mechanical counters
  • A61M15/0071—Mechanical counters having a display or indicator
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
  • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
  • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
  • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
  • B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
  • B05B11/1001—Piston pumps
  • B05B11/1015—Piston pumps actuated without substantial movement of the nozzle in the direction of the pressure stroke
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
  • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
  • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
  • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
  • B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
  • B05B11/1042—Components or details
  • B05B11/108—Means for counting the number of dispensing strokes
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
  • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
  • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
  • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
  • B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
  • B05B11/109—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle the dispensing stroke being affected by the stored energy of a spring
  • B05B11/1091—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle the dispensing stroke being affected by the stored energy of a spring being first hold in a loaded state by locking means or the like, then released
• • G—PHYSICS
  • G06—COMPUTING; CALCULATING OR COUNTING
  • G06M—COUNTING MECHANISMS; COUNTING OF OBJECTS NOT OTHERWISE PROVIDED FOR
  • G06M1/00—Design features of general application
• • G—PHYSICS
  • G06—COMPUTING; CALCULATING OR COUNTING
  • G06M—COUNTING MECHANISMS; COUNTING OF OBJECTS NOT OTHERWISE PROVIDED FOR
  • G06M1/00—Design features of general application
  • G06M1/28—Design features of general application for zeroising or setting to a particular value
  • G06M1/286—Design features of general application for zeroising or setting to a particular value with dials, pointers, or similar type indicating means
• • G—PHYSICS
  • G06—COMPUTING; CALCULATING OR COUNTING
  • G06M—COUNTING MECHANISMS; COUNTING OF OBJECTS NOT OTHERWISE PROVIDED FOR
  • G06M3/00—Counters with additional facilities
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/27—General characteristics of the apparatus preventing use
  • A61M2205/273—General characteristics of the apparatus preventing use preventing reuse, e.g. of disposables
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/82—Internal energy supply devices
  • A61M2205/8275—Mechanical
  • A61M2205/8281—Mechanical spring operated

Definitions

• the present invention relates to a metered device for administering medical formulations in which the count is triggered in a purely mechanical manner.
• 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.
• 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.
• 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.
• 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
• a piston pump driven by a helical gear conveyed from the inner bag by means of a piston pump driven by a helical gear and atomized by a spring-driven pressure generator
• a microstructured nozzle to a respirable aerosol
• 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.
• 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 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.
• 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 ,
• 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.
• the actual mechanism of the device is not affected by the Zählwerksbau former, 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.
• this component either the number of counting steps triggered per triggering of the counting mechanism or the range of the counting range is determined.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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 Zählmark réelle, for example, a scale attached to the housing.
• liquid includes in addition to pure liquids and solutions in addition Dispersions, suspensions, suspensions (mixtures of solutions and suspensions) or the like.
• the invention also relates to atomizer equipped with a counter, with which a powdered drug formulation is atomized for inhalation.
• FIG. 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
• 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.
• 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.
• 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).
• 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.
• 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.
• 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).
• 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.
• Fig. 1 shows an embodiment with exchangeable container (3).
• 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.
• 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).
• 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).
• 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).
• actuation 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 apprisschklige 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.
• 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.
• one dose may correspond to a plurality of atomizer actuations, preferably one dose corresponds to one to four atomizer actuations.
• an application mode in which the user must operate the atomizer once a day twice directly behind each other.
• one dose corresponds to two clamping and tripping operations.
• the rider (43) on the counter (41) must be moved at different speeds on the threaded spindle (42) in the illustration.
• 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.
• 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.
• 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.
• 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.
• these inserts 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).
• this feeding of the inserts does not precede any dismantling steps.
• 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).
• 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.
• 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.
• the tooth inserts (44a and 44b) z. B. In a laser or ultrasonic welding process to the housing of the atomizer (1) are welded.
• 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.
• tooth inserts (44a and 44b) 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.
• the materials of the components can also be chosen arbitrarily from one another or in themselves differently.
• 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.
• 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).
• 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.
• the drive elements or tooth inserts (44a and 44b) can have any desired external contours.
• 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.
• the at least one component triggering the count preferably closes flush with the housing after installation in the device.
• 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).
• 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).
• 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.
• 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.
• 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.
• 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 Zähl Mahausaten. 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).
• 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.
• 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.
• the activation or initialization of the rider (43) on the threaded spindle (42) can be used.
• the counter (41) during random or intentional handling steps in the assembly or testing process does not "mitumble", but is - even regardless of installation of a counting triggering component - in a so-called rest position
• 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.
• 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).
• the counter one can call each clamping operation as an initialization step in the context of the activation.
• 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.
• 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.
• the tab (43) is at the same time the counting-indicating component as well as the component triggering the blocking mechanism.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• variable counters can also be used in multi-dose Pulverzerstäubern or in injectors.
• the present invention can be used across domains; even applications beyond the medical field are possible.
• 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.

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• 2011
  • 2011-06-01 WO PCT/EP2011/059028 patent/WO2011154295A2/de active Application Filing

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