Abstract:
The problem of the invention is to so develop known dispensers, that it is possible to very precisely determine the actual discharged medium volume. 
     A dispenser according to the invention has a media path, which leads from a medium storage container to a discharge opening. A delivery device for delivering medium is located in said media path. The media reservoir stores a medium, particularly a fluid, which preferably incorporates at least one pharmaceutical substance. A media discharge can be brought about by means of an operating means. According to the invention, on the dispenser is provided an electronic detecting device for detecting a quantity representing the amount of medium discharged.

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates to a dispenser for media, particularly for discharge of fluids. Such dispensers are used for discharging fluids containing at least one pharmaceutical substance in a clearly defined dose, particularly by atomized spraying. 
     The atomized discharge of such fluids can take place in intranasal manner. Preferably a precisely dosed, equal medium quantity is discharged into each of the two nostrils. Pharmaceutical substances or substance combinations, which can be discharged in this way, can e.g. be opiates, but in general terms reference is also made to other active substances, particularly anticephalalgics and analgesics. They can be used in medicaments for the treatment of chronic illnesses and/or requiring a continuous application (e.g. diabetes, cardiovascular diseases, etc.). The suitability of an active substance for such a discharge is dependent on the fact that the active substance can be absorbed by the mucosa, particularly the nasal mucosa. The introduction of the medium though the nasal mucosa is particularly advantageous, because it ensures a rapid absorption and rapid introduction into the body and particularly the cerebral region of the body. 
     Such dispensers have a storage container storing the corresponding medium. The storage container is linked by a media path with a dispenser discharge opening e.g. a spray nozzle. There is also an operable delivery device in the media path which delivers the medium from the storage container to the discharge opening. A delivery process takes place when an operating or actuating means is operated. The delivery device is generally constituted by a piston pump, so that the discharge medium quantity substantially corresponds to the volume of the working chamber of the piston pump. The piston pump are more particularly plunger pumps. 
     This quantity is not always reliable in establishing the quantity of the medium actually discharged. Firstly residual air quantities can be present in the pump piston, which is particularly the case after prolonged storage periods and prior to the first use of the dispenser, when priming of the dispenser is necessary. Priming is done by performing several discharge strokes until the flow path is completely filled with medium. It can also arise that on operating the dispenser no complete operating stroke is performed. It is known that often pumps are designed to force the user during each dispenser operation to perform a complete operating stroke and therefore also a complete discharge stroke of the delivery device. This is however, not always reliable. 
     OBJECT OF THE INVENTION 
     Therefore the object of the invention is to further develop dispensers in such a way that the actual discharge medium volume can be very precisely determined and other criteria of the discharge can be detected and processed. 
     SUMMARY OF THE INVENTION 
     A dispenser according to the invention has a media path leading from a medium storage container to a discharge opening. A delivery device for delivering medium is located in said media path. The media reservoir stores a medium, particularly a fluid, which preferably contains at least one pharmaceutical substance. The medium is discharged by operating an actuating means. The dispenser is provided with an electronic detection device for detecting a quantity representing the discharged medium quantity. By means of said detecting device, it is possible to detect the medium quantity actually discharged for each individual dispenser operation. 
     The detecting device comprises a flow volume meter located in the media path. The flow volume meter is preferably located between the delivery device and the discharge opening. It is particularly advantageous if the flow volume meter is located in an area of the medium path, where upstream there is only the discharge opening as a flow obstacle. This ensures that the specific medium volume flow actually passing through the discharge opening is detected. 
     The flow volume meter shall perform a quantitative flow measurement. It may be a thermal or inductive flow volume meter or a flow volume meter operating according to a pressure difference measuring method. The measuring range of the measuring method must be adapted to the volume of the medium to be discharged during one dispenser pump stroke. This volume is below 200 æl and is in particular between 30 and 150 æl. It shall be able to detect discharge which takes place within a short time interval, e.g. between 50 and 100 milliseconds. In addition, a high precision of measurement shall be ensured, because the discharged media are often those which contain pharmaceutical substances, which must be very precisely dosed, because e.g. in the case of an overdosage can give rise to health-prejudicing effects. 
     The delivery device can be designed as a manually operable reciprocating pump. By means of at least one sensor a signal at least indirectly representing the stroke path of the reciprocating piston can be detected. Furtheron, it is possible that the reaching of the upper dead centre position of a pump piston is detected by a limit switch, e.g. a keying switch, which is preferably constructed as a normally closed contact. Alternatively or additionally a further limit switch can be provided, which detects the leaving of the lower dead centre position of the pump. 
     By means of the limit sensor, detecting the upper dead centre position, it is possible to establish whether there has been a complete operation of the operating means and therefore a complete operating stroke of the pump. This measure can be used for balancing or adjusting and calibrating a flow volume meter. If a complete piston stroke is performed, the flow quantity detected by the flow volume meter must correspond to the volume of a piston stroke. For example, if additionally the leaving of the lower dead centre position is detected, it is then possible to establish whether the discharge has been performed in a single, complete, operating stroke. In particular such cases can be used for balancing or adjustment purposes for the detected flow volume meter signal. In particular, time drifts and similar characteristics, as well as the stochastic dispersion of the measuring signal of the measuring sensor can be partly compensated. It would also be possible by means of a path or displacement sensor to detect the path covered by the pump piston. On the basis of the displaced volume corresponding to this stroke path, it is then possible to determine the discharged medium quantity. This more particularly applies to fluid media, which are incompressible or can be looked upon as incompressible. The discharge quantity measurement effected indirectly through the path measurement can be additionally or alternatively carried out with respect to the flow volume measurement by means of a flow volume meter. On using both measuring methods, there can once again be a balancing of the two measurement results and it can be possible to increase the quality of the measurement result and precision. 
     Besides the detection of the discharged medium quantity, it is also possible to detect the time of dispenser operation in said detecting device. It is in particular possible to detect the time since the last dispenser operation. It is also possible to detect the time of the last operation or the date and time of the last operation. This detection can on the one hand be provided for recording the operations which have taken place, but on the other hand it is also possible for the dischargeable medium volume to take place as a function of preceding operations. It can e.g. be provided that in one operation only that medium quantity can be discharged which ensures that the discharged quantity over and beyond a certain time period does not exceed a specific, predetermined value. This can e.g. be appropriate if the medium contains addictive pharmaceutical substances or those having a lethal action in overdose and where a certain dosage over and beyond a certain period must not be exceeded. If at least there is a recording of the discharge behaviour of the dispenser, such information is preferably stored in the dispenser, particularly in the vicinity of the detecting device in such a way that it is filed that it can be polled and/or read out. If the discharge volume of a subsequent dispenser operation takes place on the basis of preceding dispenser operations and optionally on the basis of the time period which has elapsed since then, in the vicinity of the dispenser is provided a regulating device, which limits the maximum stroke of a pump. 
     In the vicinity of the discharge opening, it is possible to provide a measuring sensor, e.g. a temperature sensor. The sensor is in particular located in the immediate vicinity of the tip of a nose adaptor (olive) of the dispenser, in which the discharge opening is formed. It is possible to detect by means of the sensor whether a dispenser operation has taken place or should take place and whether the dispenser is placed at an intended application point, e.g. in the vicinity of a nasal ala. This measure can e.g. be used to prevent unintentional or unintended operations and uses of the dispenser as not to include the same in quantity detections. It is in particular possible to construct the sensor in such a way that it detects an ambient value or characteristic, such as the temperature, atmospheric humidity, brightness, etc. and no large time delay occurs during the measurements. Thus, a temperature sensor should e.g. not be located in the vicinity of a large thermal capacitance in order to be able to rapidly detect a change in the ambient temperature. As a function of the measuring signals of the sensor, it is consequently possible to conclude whether the application of the medium takes place at the intended application point, e.g. the nose. It is also possible to activate an operating barrier if it is established that there is no application at the intended application point or if an application is only permitted if it can be concluded that an application at the intended application point has been performed. Alternatively or additionally it is possible to only take account of such discharges in the detecting device, for which it is possible to conclude that they have been performed at the intended application point. The measuring sensor can in particular be a temperature sensor. However, a corresponding signal can also be detected by optical sensor technology or by measuring the composition of the ambient air (atmospheric humidity, CO 2  content). 
     By means of the sensor it is not only possible to detect at what point an application of the medium has taken place, it also being possible to establish the time pattern of the temperature of the medium or the medium storage area. Particularly in the case of thermally sensitive medicaments, it can be ensured that further media are not discharged, which e.g. as a result of thermal influences would have been modified in the meantime and are no longer suitable for use. 
     Additionally or alternatively to a regulating device for the discharge volume, it is also possible for the dispenser to have a switchable operating barrier. This operating barrier can in particular prevent a further operation of the dispenser within a time interval. The time interval can be determined as a function of quantities or values detectable in the detecting device, e.g. the detected discharged quantity. 
     It is also possible to provide in addition to the detecting device a data exchange device. The detecting device and data exchange device can be integrated into a single component, particularly a single electronic chip. The data exchange device is e.g. suitable to transmit signals or data detected in the detecting device to external data processing devices, especially in contactless manner. There can be a bidirectional data transmission. It is e.g. possible to use data transmission by means of infrared light or via transponders and the like. Data transmission by radio installations is also possible. Data transmission also permits a remote diagnosis, remote monitoring and/or remote treatment within local or non-local radio networks. If there is a bidirectional data transmission, the dispenser can also be interrogated from the outside and detected data can be interrogated. It is also possible to adjust or modify from the outside the operating state or parameters (duration of operating barriers, lifting or activating an operating barrier, discharge stroke volume, etc.), e.g. according to a doctor&#39;s prescription. The external data processing devices may include a base station and a evaluation station. The base station can be near the user of the dispenser and may include, besides storing, energy supply, memory and display functions, a remote data transmission module, e.g. a GSM modem, enabling a remote data transmission to a doctor&#39;s personal computer or an institution, for evaluation of the results of treatment and for amending it, if necessary. 
     On the operating means can be provided a sensor device permitting an identification and authentication of the user. The authentication of a user by means of invariable, endogenic features, e.g. fingerprints and ocular fundus, but also the inputting of a PIN code at a suitable input interface is suitable to check the justification to use the dispenser for each individual operation. This makes it possible to monitor the user particularly in those cases where the pharmaceutical substance is subject to a very precise observation and strict prescription rules, such as e.g. with opiates and other addictive medicaments. 
     These and further features can be gathered from the claims, description and drawings and the individual features, both singly and in the form of subcombinations, can be implemented in an embodiment of the invention and in other fields and can represent advantageous, independently protectable constructions for which protection is claimed here. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention is described in greater detail hereinafter relative to a preferred embodiment shown in the drawings. 
         FIG. 1  shows in a diagrammatic part sectional representation of a dispenser; 
         FIG. 2  shows a perspective view of a dispenser and a corresponding base station; and 
       FIG.  3 . shows a block diagram for explaining the cooperation of the dispenser with the sensors, the base station and an evaluation station. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       FIG. 1  shows a dispenser suitable for the discharge of media to be administered to the nose of a person undergoing treatment. A medium  11  containing at least one pharmaceutical substance or substance combination is stored in a storage container  21  of the dispenser  20 . The storage container  21  is retained in the interior of the dispenser  20 . A media path  22  leads from the storage container  21  via a delivery device  24 , which produces the discharge from the storage container, to the discharge opening  23  of the dispenser. The dispenser discharge opening  23  is situated at the tip of a nose olive or adapter  25 , which is used for the application of the dispenser in the vicinity of the nostrils of the person to be treated. The discharge opening  23  is a spray nozzle to permit an atomized discharge of the medium  11 . The media path  22  incorporates the medium delivery device  24 , which delivers the medium from the storage container  21  to the discharge opening  23 . The delivery device  24  is a manually operable single stroke plunger or reciprocating pump. It allows to accurately dose a discharged medium quantity. The dispenser  20  is operated by means of an operating means  26 , which produces a discharge stroke during each operation. The operating means  26  is constructed as an operating trigger. 
     A detecting device  40  is provided comprising an evaluation unit  41  and a data transmission device  42 . The data transmission device  42  is able to transmit data from the evaluation unit  41  to an external data processing station and vice versa. The data can be both recorded data and e.g. also programmable details, which are transmitted by the external data processing station to the evaluation unit  41 , in order to influence the discharge from the dispenser as a function of predetermined, individually adjustable dosage details. 
     For detecting the discharged quantity of medium, the detecting device  40  has a flow volume meter  43  and a path sensor  47 . The path sensor  47  detects the operating path of the operating means  26  and therefore the stroke of the pump  24  coupled thereto. This strokes serves as a measure for the discharged medium quantity. The flow volume meter  43 , which can e.g. be constructed as a differential pressure meter or as an inductive or thermal flow volume meter, provides a direct measure for the medium quantity discharged as opposed to the indirect measure for the discharge quantity measured by the path sensor  47 . Thus, the flow volume meter  43  is particularly located in an area of the media path  22 , which is as close as possible to the discharge opening  23  and where there are minimum possibilities for leaks and other disturbances. 
     A temperature sensor  45  is provided as a measuring sensor in the immediate vicinity of the discharge opening  23  close to the tip of the nose olive  25 . The temperature sensor  45  is positioned in such a way that between it and the external environment of the dispenser  20  a minimum thermal capacitance is formed, so that it can very rapidly detect temperature changes in the environment. This makes it possible to establish whether the nose olive is located in the vicinity of the patient&#39;s nose, because here due to the air flow of the air breathed out, the temperature must rise relatively accurately to a value in the range approximately of that of the human body temperature (37 to 42° C.). It is also possible to detect by means of the temperature sensor  45  whether the transportation and storage temperature have remained within ranges adapted to the medium. For this purpose the temperature data can be recorded considering temperature sensitivity and time of temperature exposure. Said recorded data can be read out prior to the delivery of the dispenser with the medium contained therein to the customer by means of the data transmission device  42  and can be checked. Thus, it is possible to control especially with medicaments where the life is very limited and very temperature-dependent, whether the quality of the medium is still completely adequate. The data transmission from the data transmission device to the fixed station can e.g. take place by means of corresponding infrared interfaces or transponders, but also by galvanic contact, e.g. a cable link. 
     The signal of a limit switch  44  can also be supplied to the evaluation unit  41  and it is then established whether there has been a complete discharge stroke of the delivery device  24 . This possibility can be used to make a comparison with the evaluated signals of the flow volume meter  43  or path sensor  47  in the evaluation unit  41  of the detecting device  40 . By means of a balancing of said sensor signals, it is e.g. possible to calibrate the same. It is possible via the dosing precision of the pump to conclude whether the volume of the medium quantity measured by the flow volume meter corresponds to the piston stroke volume, which is displaced in the corresponding cylinder during a complete discharge stroke. For this purpose the measurement difference should be very closed limited, because otherwise a defect is assumed requiring special checking. A corresponding e.g. optical and/or acoustic alarm message can then be generated. It is also possible for the evaluation unit  41  to detect who is using the dispenser  20 . This can e.g. take place by means of a fingerprint sensor  46  detecting the fingerprint of the user on the operating means  26 . It is also conceivable to use other sensors, e.g. a sensor located close to the discharge opening and e.g. suitable to detect the ocular fundus. The last-mentioned sensor can be particularly used if application is to take place in the vicinity of the eye of a patient. It is possible to only allow specific persons to use the dispenser. 
     To the extent that in the discharged medium quantity evaluation unit also detects the operating time, it is possible in quantity and time-dependent manner to limit or block operation of the dispenser. For this purpose the dosing device  28  is used in the embodiment shown. The dosing device  28  makes it possible to limit the maximum possible stroke path of the delivery device  24 , which is fixed by the operating path of the operating means. The limitation can be such that in one extreme limitation state the action of an operating barrier is reached, so that no media discharge is possible, whilst in the other extreme a complete piston stroke can be performed so as to permit the discharge of one or more piston strokes. Thus, on the one hand an operating barrier is obtained for preventing an overdosage of the medicine. The operating barrier may be constructed as described in EP 1125637 A, corresponding to U.S. patent application Ser. No. 09/780287, which is incorporated herein by reference. On the other, e.g. by moving averaging, the dischargeable medium quantity can be determined in such a way that it does not exceed a specific, maximum concentration. It is also possible to allow the subsequent administration of small amounts of medium, which are intended to ensure that there is no exceeding of the maximum concentration, e.g. as a function of an assumed decomposition rate in the body. Thus, in a patient and also over long periods, it is possible to ensure that there are only slight concentration fluctuations as a result of frequent medicament administration, whilst simultaneously preventing an overdose. 
     Besides moving averaging, other methods are naturally usable for determining the maximum discharge quantity which can be discharged during the next discharge stroke. Thus, it is e.g. possible to block a further discharge over a specific time period and then to continuously increase the maximum dischargeable dose over a specific, further time period until one or more complete operating strokes can be effected. 
       FIG. 2  shows the dispenser  20  which can be taken out of a base station  50  by hand. The base station  50  serves as storage for the dispenser  20 . The dispenser is provided with displays  51  in form of LCD-fields, in which data can be shown. The dispenser  20  has laterally projecting shoulders  52  which can be held between two fingers of a user, while he manually operates the dispenser by exerting pressure to the operating surface  53 . The operating surface  53  may include the sensor  46  of the identification device working by means of identifying a fingerprint of the authorized user (see FIG.  1 ). The sensor  46  may also be, as shown in  FIG. 2 , provided in a separate area at a sidewall of the dispenser. 
     In the actuation part  54  of the dispenser, which can be inserted into a corresponding recess  55  of the base station for storing, there is provided a connection or contact surface  56  for transferring data from the dispenser to the base station. This can be provided by an optocoupler, a galvanic contact, by inductive infrared transfer or by transponder. 
     The base station  50  contains a display  57  e.g. an LCD screen, on which data can be displayed. An antenna  58  for remote data transfer projects from the base station. 
       FIG. 3  shows the data acquisition system according to the invention in diagrammatic block representation. The dispenser  20  contains an electric energy supply  61  consisting of a battery or an accumulator, which can be recharged via the base station  50 . This part can be provided in a “throw away part”  60  of the dispenser which has to be separated from the rest of the dispenser and exchanged after each charge of medium or at least for every user. It contains also those of the sensors which may come into contact with the medium and/or the user and which have therefore, to be exchanged. This may be the temperature sensor  45 , the path sensor  47  and the limit sensor  44  as well as the flow sensor  43 . They feed their measured signals to a microcontroller or microcomputer  62  being situated in a re-usable  63  of the dispenser. The microcontroller, which is an electronic chip, is connected to an electronic memory  64 . The microcontroller controls the polling of the data from the sensors and controls the acquisition and evaluating functions as well as mechanical functions of the dispenser including display, identification, servo functions and data transfer.  FIG. 3  shows a display  51  (see also FIG.  2 ), the identification sensor  46 , and an acoustic signal generator, e.g. a beeper or buzzer  65 , and a servo device  28 . The servo device  28  can be used for blocking the discharge stroke or varying the discharge stroke length, as already described with reference to FIG.  1 . 
     The contact  56  is shown to symbolize the data output and transfer from the dispenser to the base station  50 . The base station also contains a microcontroller or a microcomputer  62  together with the corresponding electric supply etc. (not shown). The microcontroller controls the following the devices and features of the base station  50 : remote data transmission device  42 , e.g. GSM modem, providing a data transmission connection to the mobile telephone network, the display  57 , an electricity supply  61   a  (battery or mains operated), an acoustic single generator  65   a  and a memory  64   a.    
     The base station evaluates and processes data from one or more dispensers in greater extent and is able to transfer to the microcomputers of the dispensers orders which can be general program orders or orders which are produced by the microcomputer as a result of incoming data, e.g. for the servo device  28 . 
     The base station is also provided to transfer data, which are created in the dispenser and are processed there or in the base station via a remote data transfer device  42  to an external evaluation station  80 . From this evaluation station  80  data can also be transferred into the base station and/or the dispenser. This can be done, as shown in  FIG. 3  by using two mobile telephones  82  with data transfer ability and using a further GSM modem  42   a  in the evaluation station  80  which can be connected to a personal computer  81 . The PC can process and evaluate the data automatically or be operated by a doctor or by corresponding operating persons, and send corresponding data back to the dispenser via the base station in order to automatically control and program it so as to achieve an ideal treatment for the patient.