HK1175870B - Display device for a dispenser for medicinal product dose and use thereof - Google Patents

Description

Display device for a dispenser of a medicament portion and use of said display device

Technical Field

The present invention relates to a display device for a dispenser of medicament portions which requires administration of medicament portions with a regular cyclical reference to an administration time, and which comprises a display and electronic actuation means for the display. The invention also relates to the use of this display device for monitoring the administration of a pharmaceutical portion, in particular a portion of a hormone preparation, mainly a contraceptive portion, from a dispenser.

Background

The medicine needs to be taken regularly and, whenever possible, at a predetermined time or within a predetermined period of time in order to ensure its efficacy. Accordingly, there is a continuing effort to create aids to provide reminders to take medications. For persons who need to take several drugs daily, a very common aid is a box divided into several compartments that are manually filled with drugs for various periods of administration, e.g. for administration in the morning, in the noon and in the evening. Thus, the person taking the medication can at the respective time monitor whether the medication portion has been taken or not, respectively. However, these aids are prone to failure, since it is obvious that a person also needs to remember to take the drug portions at a given time or at a time scheduled for this purpose, for example, and first actually fill the cassette with the drug portions.

Accordingly, display devices for administering drugs have been developed that provide automatic administration reminders. For example, DE100355999a1 describes a medicine cartridge with an integrated timer. Such a cartridge comprises a plurality of compartments for containing pills, each compartment having an associated light emitting diode. The timer includes a digital display and operational control buttons for programming the timer. One light emitting diode is activated at the respective pre-programmed time at which the medication contained in the associated pill compartment needs to be administered, and the user is therefore aware of those pills to be taken. Acoustic and mechanical signal transmitters are also provided.

Furthermore, DE202004012232U1 describes a so-called pill clock. Such a pill clock first has a pill box combined with a digital clock. The purpose is for the user to carry with him the tablets to be taken and to remind the user to apply said tablets with a digital clock. The pillbox has six compartments for tablets. The digital clock is provided with a digital display for the actual time and six further digital displays providing reminders in various patterns for administering the tablets in the six pill box compartments. In one mode, the pill clock provides a reminder to administer the tablets accordingly using a countdown display. The user can also be provided with an audible application reminder. The pill clock can be worn on the wrist like a watch.

Furthermore, DE102004023641a1 discloses a device with a device for attachment to a blister of a contraceptive pill. The device is used to help properly administer contraceptive pills throughout the menstrual cycle and also takes into account non-administration periods. To this end, the device is designed such that a blister containing a contraceptive pill can be connected to the device, for example by means of a clip or a pocket, and possibly a detection device for inserting the blister into the device and/or for removing the blister from the device is additionally provided. A detection device for monitoring the filling level of the tablet unit can also be positioned in the blister. For example, opening a foil on a blister to remove a contraceptive pill from a tablet unit can activate a timer. The device has a display in the form of a digital time bell which displays the time remaining until the start of the alarm signal. The alarm signal can be emitted by means of a loudspeaker, a vibrator or a light emitting diode or the display. The display also shows the user which day she is currently on in the cycle.

US5,871,831A also shows a device that includes a computer with a plug-type contact strip for tablet blister insertion. The tablet blister is designed in a suitable manner such that the conductor tracks are positioned at those points on the foil which will split when the tablet is removed and thus will break when the foil splits, the conductor tracks being in electrical contact with the plug-type contacts positioned in the plug-type contact strip when the blister is inserted into the plug-type contact strip in the computer. The removal of the tablet can then be automatically registered. The computer has a digital display for the current time and/or the time at which the tablet will be administered next. An audible signal or LED can also provide a reminder to administer the pill. A first LED is used to indicate that the tablet is about to be taken, a second LED is used to indicate that administration is still too early, and a third LED is used to indicate that the time of administration has been exceeded.

Furthermore, DE10217929a1 discloses a device for dispensing tablets. Such a device is intended to receive a blister and has a push button for pushing the tablet out of the blister, as well as means for setting the timing of administration and means for displaying the timing of administration. The device provides a reminder to administer the tablet at a preset administration time. An alarm symbol on the LCD display serves this purpose. The device also automatically registers the removal of the tablet.

Although the above described device is suitable for providing an automatic reminder of the time of administration of a medicament portion, a variety of different indicator and alarm devices are used in the above described dispensers for this purpose. In individual cases, reminders are made repeatedly for administrations of the drug portions that may be forgotten initially or intentionally missed. However, the user is not fully aware of the administration status from this information. For example, it is not generally necessary to take the drug portions at precisely defined times. Furthermore, it is sufficient to take the drug portions within one time interval. Although DE202004012232U1 states that the user can set the frequency and interval at which alarms are repeated in order to make them also repeatable, the document does not state the relationship between the repeated alarms and the actual tolerance of the elapsed time and the actual elapsed time.

Disclosure of Invention

Further, it is an object of the present invention to provide a display device for administration of a medicament portion contained in a dispenser, with which the known disadvantages are avoided and the object is in particular to ensure an increased compliance when administering the medicament portion. The main objective is to enable the user to quickly and easily identify the current administration status of the drug portion. In particular, it is a further object to optically display to the user the necessary information about the current state of administration at a glance to ensure particularly reliable administration of, in particular, hormone preparations (primarily contraceptives). A further object is to provide the user with suggestions for possible remedies in case of incorrect operation and if the user forgets to take the medication portion, quickly, simply and without said user having to laboriously look up the document. Increased compliance in drug administration is also achieved by largely excluding incorrect handling, for example in the case where a user accidentally takes more than one drug portion but this administration is not taken into account in the administration record, or in the case where a drug portion is not taken but administration is incorrectly recorded in the administration record. A further object is to ensure the reliability of long-term administration, that is to say when the drug is administered for a longer time.

This object is achieved by a display device according to claim 1 and by the use of a display device according to claim 23. Preferred embodiments of the invention are shown in the dependent claims.

The display device according to the invention is used for monitoring the administration status of the drug portions by a user. The main objective is to show the status of administration of hormone preparations (and especially steroid hormone preparations such as used for contraception). Yet another object is to be able to monitor the administration of other drug moieties, such as hormone preparations for hormone replacement therapy, in a simple and reliable manner. For example, the display device can be used to monitor the status of the drug portion used to treat all chronic diseases. The use of a display device is particularly important when the drug portion is to be administered at a regular cyclical reference administration time. The main object of the display device according to the invention is therefore to monitor the status of administration of a contraceptive. In this case, the drug portion must be taken in a regular administration regime (in particular once a day), with an interruption phase of a duration of several days often following an administration phase of a duration of several days. The desired contraceptive effect may not be effective if the specified administration time is not followed.

In order to achieve the object according to the invention, the display device comprises a display and electronic actuation means for the display. In a manner according to the invention, the display comprises first visualization means for displaying a first period of time between a first reference administration time and the current time, the first reference administration time being characterized in that no medication portion is taken until the first reference administration time, even if intended.

Within the meaning of the present invention, reference to the time of administration is understood to be the time at which ideally the drug portion should be taken at this time, that is to say, for example, in the case of daily administration of the drug portion, for example, 7:00 or 9:00 or at another fixed time of day, however, in fact in all cases for the purpose of taking the drug regularly, it is sufficient for the drug portion to be taken within a time interval which includes the reference time of administration. The administration interval may, for example, last from a time 12 hours before the reference administration time up to a time of, for example, 2 hours or 24 hours after the reference administration time. In case the drug part is to be taken, for example, once a day, such reference administration time and administration interval will be determined daily. The reference administration time is preferably calculated from the time at which the medicament portion is first removed (from the medicament dispenser), particularly preferably in an administration cycle, and the specified administration cycle cadence. The respective reference administration time is then calculated from the respective time interval resulting from the cycle cadence and the time at which the medicament portion is first removed from the dispenser, this time again being equal to the first administration time of the medicament portion. Thus, the reference administration time in the case of a medicament portion taken once a day is in this calculation method n × 24 hours (n being an integer) after the medicament portion is removed from the dispenser for the first time in each case. If, in case the medication portions are to be taken once a day, a reference administration time is calculated with this method, the first medication portion is for example removed from the dispenser and thus has been taken by the user at 12:00 on the first day, this time of the following day (12:00) is the reference administration time and thus an additional reference administration time of the day occurs at 12:00 after the first day, it is intended that the medication portions are ideally taken at said reference administration time. Similarly, in the case of a drug taken twice daily, for example when the first removal and thus the first administration occurs at 7:00 and the second administration occurs after 12 hours, the reference time of administration for each subsequent day is calculated to be at 7:00 and 19: 00. In general, the reference administration time can also be calculated differently from the first removal of the medicament portion from the dispenser: for example, the reference administration time can be calculated from the last (e.g., three) actual administration times.

The display device thus has a display of exceeding the first reference administration time, that is to say the administration time at which the medication portion should be taken at that time, but the user has accidentally or intentionally not taken the medication portion until this first reference administration time.

Since the display device according to the invention has the above-mentioned first visualization means for displaying the time exceeding the first administration time, an integrated monitoring of the medication administration status is possible: the display of the excess time allows the user or physician to initiate corrective action to compensate for the lack of administration. Moreover, the user can immediately recognize when the time interval for administration has elapsed if he/she knows the time interval for taking the medication portion. The time interval can of course also be displayed separately on the visualization means and the user can thus recognize at a glance whether he/she can still take the medication portion in good time, i.e. within the time interval, although the first reference administration time has been exceeded.

The display device according to the invention is preferably advantageously used for the administration of contraceptives, and in this case in particular if the user follows a so-called flexible administration regime. Contraceptives generally need to be taken once a day, with the drug portion being taken daily during an administration period of 21 days and then a 7 day long break period in the case of conventional administration regimes. This administration cycle is then repeated again. Alternatively, the administration phase can also last 24 days and the discontinuation phase 4 days. Contraceptive preparations have also been proposed for administration according to a so-called flexible administration regime. In this case, the administration phase lasts at least 24 days (mandatory administration phase) and at most, for example, 120 days. The decision about the duration of the application phase is left to the user to make within said limits, that is to say, after the mandatory application phase has elapsed, the user himself can decide whether to start the interruption phase or not. However, the user must make this decision before the maximum time for the flexible phase has elapsed, that is to say in the present case before 120 days have elapsed. The flexible administration phase is typically followed by a 4 day off phase.

If the user fails to take the drug portion, she can use at least the condition exceeding the administration interval as a transition to the discontinuation phase if the administration phase has lasted at least 24 days (the discontinuation phase will result in contraception no longer being guaranteed before the administration phase expires). In particular, this first period for the time exceeding after the first reference application time can in this case be calculated as the period within the interruption phase. In this case the invention also serves to provide the user with a simple way of deciding on the transition from the administration phase to the interruption phase: for example, if the application time interval is exceeded, the user can decide to start the interruption phase, so that regular application can start again in the correct manner after the interruption of application. With conventional means for monitoring administration, this would only be possible if the user would theoretically monitor compliance with an administration regime having the highest possible level of self-organization. However, since the user would have to keep track of the time-out condition in this case, it is unlikely under normal conditions of daily distraction.

Thus, displaying a condition that exceeds the first reference administration time can provide a higher level of reliability in the context of administering the drug portion.

In a preferred embodiment of the invention, the display additionally comprises second visualization means for displaying a second period between the second reference application time and the current time. In this case, the second reference administration time is characterized in that it is in the predetermined administration time interval and that one drug portion has been taken in the predetermined administration time interval. The second period of time lasts at most to a first reference administration time chronologically subsequent to a second reference administration time. That is, when using a full scale second visualization means, if the drug portion is not taken before or is taken exactly at the first reference administration time, the display extends over the entire period between the second reference administration time and the first reference administration time. If the medication portion has not been taken by the time the first reference administration time has been reached, the first visualization means is activated and then displays a subsequent first period of time since the first reference administration time. The second period of time elapsed between the second reference application time and the first reference application time preferably remains displayed in this case, but can also be cleared, for example, if the period of time that has elapsed since the second reference application time is not displayed, but the period of time remaining until the next reference application time is displayed.

As with the first reference administration time, the second reference administration time also represents the time in the administration regime at which the drug portion ideally should be taken at that time. The only difference is that the drug portion has been taken in the case of the second reference administration time and has not been taken in the case of the first reference administration time. In this connection, the above explanations with reference to the time of administration also apply here.

A second period of time that has elapsed since a last second reference administration time of the drug portion in case of a correct drug administration is displayed by the second visualization means. Thus, the user can be provided with additional information about the current condition of the drug portion administration, if the administration instructions are correctly followed. Because, in case the administration is performed as instructed, the user can keep track of the period that has elapsed since the latest second reference administration time, said user can prepare for the next medication administration operation.

The second visualisation means preferably starts with the first removal of the medicament portion from the dispenser during an administration cycle. The second reference administration time and thus the first reference administration time is thus preferably determined and defined for the current administration cycle. The administration period is determined by the overall administration process, for example during the period of illness. In the case of continuous administration, for example for hormone replacement therapy, the administration cycle is likewise characterized by a first removal and, in the case of contraception, by an administration phase and an interruption phase, before the start of a new administration phase. The reference administration time is thus defined by the first removal of the medicament portion from the dispenser during the administration cycle.

Since the reference administration times are each preferably defined only for a single administration cycle, the user can redefine the reference administration times in a new cycle. This is advantageous when the reference administration time initially selected has proven impractical for the user and the user wishes to change the reference administration time.

While the second reference administration time is defined by the first removal of the medicament portion from the dispenser, the first reference administration time is found by the first reference administration time not taking the medicament chronologically after the second reference administration time. In this case, the first visualization means are therefore activated by the arrival of the first reference administration time, that is to say when no drug portion is taken at the first reference administration time. In this case, the first period of time that has elapsed since the first reference administration time is subsequent to the second period of time indicated since the second reference period of time. In this case, the first and second visualization means show simultaneously the period since the last second reference time, that is to say the reference administration time since it was characterized as being within a predetermined administration time interval in which the medication portion has been taken and thus correct administration has taken place.

A new second reference administration time is generated when the drug portion is taken. If in this case only the second visualization means has displayed the second period since the (previous) second reference administration time (since the nominal period for administering the drug portion has not elapsed yet), the display of the second period is cleared and a new second period is displayed, which shows the time difference between the current time and the new second reference administration time. In the latter case, this second period is a negative number, that is to say the initial second period between the current time and the new second reference application time which has not yet arrived is displayed. Alternatively, the second period of time can also be displayed in the form of a period of time until the next reference administration time, which period of time has not elapsed in this case. Since the second period until the next reference administration time is longer than the administration phase, this period, which has not elapsed yet, is preferably displayed in two scale parts: a first scale part showing the remaining period until the prior reference administration time, and a second scale part corresponding to the regular second period. Thus, during a further procedure, the areas regularly displayed over the application period are then preferably initially closed one after the other, and then only the regular areas are closed one after the other.

If the next reference administration time has been reached at the time of removal of the medication portion and the first reference administration time has thus been generated, such that the first visualization means also displays a first time period since this (newly generated) first reference time, the display of the first time period is cleared by the removal of the medication portion, and a new second time period is displayed, this display showing the time difference between the current time and the new second reference administration time. Because, in this case, the medication portion is taken first after the next reference administration time has elapsed but the medication portion is not taken, the second visualization means will display a second period of time that has elapsed since the new second reference administration time. In one possible method, the second reference administration time is set to new second reference administration times in the case where the preceding second reference administration time has been significantly exceeded, these new second reference administration times being shifted by two administration periods between in each case two successive reference administration times and not only by one, that is to say in this case the medicament portion is interrupted once. Alternatively and preferably, however, the display is only shifted by one removal period when the drug portion is removed, so that the user needs to remove a further drug portion in order to restart the correct rhythm of administration.

In a further preferred embodiment of the invention, a new second reference administration time is generated in case of a premature removal of the drug portion only if the drug portion was at the earliest within the administration time interval. If the removal time is still before the start of the administration time interval, the removal is not taken into account as drug administration and therefore the prior display of the second period of time remains, since in this case no new second reference administration time is generated. Conversely, if the medication is taken within the administration time interval before the second reference administration time is reached, a new second reference administration time is generated. In this case, a new negative second period, that is, the period between the current time and a later new second reference application time, is initially displayed. The new second reference administration time is also generated when the drug portion is first taken after the elapse of the administration time interval as explained above.

In a further preferred embodiment of the invention, the first visualization means are arranged in at least one first display region and the second visualization means are arranged in at least one second display region of the display.

Particularly preferably, the at least one first display region and the at least one second display region are adjacent to each other.

It is also preferred that the first visualization means is formed by at least one first indicator element.

It is also preferred that at least two first indicator elements are provided and that the first indicator elements are activated successively as time progresses. In this case, the first indicator element graphically represents the progression of time, rather than in the form of a numerical display.

The first indicator element can also represent a digital display. For example, the digital display can show the number of portions of medication still to be taken. Either or both of the first indicator element providing the graphical representation or the first indicator element displaying the number can be presented.

More preferably, the second visualization means are formed by at least one second indicator element.

More preferably, at least two second indicator elements are provided and the second indicator elements are successively opened or successively closed as time progresses. The second indicator element therefore preferably represents the progression of the time graphically, rather than in the form of a numerical display. If the indicator elements are closed successively with the advance of time, all indicator elements are initially displayed or at least the indicator elements which remain for a period until the next reference application time and then close with the advance of time.

The graphical display provides a quick, simple and fault-free identification of the first and second periods.

More preferably, each of the at least one first indicator element and/or each of the at least one second indicator element corresponds to a period of equal size, for example 1 hour, in the case of a graphical display.

A particularly advantageous improvement of the display of the first and second time periods is provided by each of the at least one first indicator element forming a segment in at least one loop and/or by each of the at least one second indicator element forming a segment in at least one second loop. Therefore, the advance of the time of the corresponding period can be recognized at first sight, as in a timepiece that displays the time in an analog manner.

The ability to identify the temporal progression in an easy and fast manner is further enhanced by the at least one first ring for the at least one first indicator element and the at least one second ring for the at least one second indicator element being concentric to each other. For example, if the second visualization device has an indicator element in an outer ring and the first visualization device has an indicator element in one or more inner rings, the indicator elements forming the ring will gradually fill the ring from the outside inwards as time progresses. Alternatively, the second indicator element can also be arranged together with the first indicator element in a first outer ring, and further second indicator elements can be arranged in further rings arranged further inwards.

For example, each of the first and second rings can represent a period of 1 day in each case. If the ring is composed of ring segments, each ring segment can represent 1 hour and therefore there are 24 ring segments in each case in one ring. It goes without saying that the ring and the period of the individual segments of the ring can be subdivided in other ways. The indicator piece may be substantially rectangular or otherwise take any other desired shape. For example, the indicator element may be circular or star-shaped. Alternatively, other indicator elements, such as bars or arrows that increase in size in a stepwise or continuous manner, are shown in a completely different illustration of the progression of time in proportion or otherwise clearly, and can of course be used instead of ring segments. The digital display digitally displays the progress of the time by providing time details.

In a particularly advantageous embodiment of the invention, the first indicator element of the first visualization means and the second indicator element of the second visualization means each represent a period of time that has elapsed or is still elapsed. As in the above-described embodiments, these first and second indicator elements can be arranged in the form of ring segments in one or more rings. In this case, a flat ring segment can be used for the first visualization means, and only the ring segment representing the frame can be used for the second visualization means. Particularly advantageously, the second indicator element of the second visualization device is shown in the form of a surrounding frame for a flat representation of the first indicator element of the first visualization device. Thus, the second indicator element of the second visualization device is in this case positioned in the same ring as the first indicator element of the first visualization device. However, as already described above, it is of course also possible to provide further first indicator elements of the first visualization means, which are positioned in a further ring in which there is no second indicator element of the second visualization means. For example, the first indicator element and the second indicator element together form an outer ring and the further first indicator element forms a further inner ring. As already indicated, at least some of the second indicator elements may also be on inwardly displaced rings. Other rings for the indicator piece, for example, rings which are situated more inwardly, are also possible in practice.

In a further advantageous refinement of the last described embodiment of the invention, the second indicator element of the second visualization device indicates the advance of time since the second reference application time by successively closing the initially displayed second indicator element. That is, when the medicament portion is removed and thus a second reference administration time is generated, all second indicator elements are initially displayed, that is to say the second indicator elements are shown for a period until the next (not yet reached) second reference administration time. However, if the second reference administration time has elapsed upon removal of the drug portion, not all second indicator elements of the second visualization means are displayed upon removal of the drug portion, but only those displays corresponding to a still-lasting period until the next reference administration time. In this case, the first indicator element of the first visualization device can be displayed successively with increasing time, as in the case described above. Thus, the second visualization means initially indicate the period of time remaining until the next reference administration time immediately after the removal of the drug portion, whereas the first visualization means immediately indicate the time excess that has occurred in case of a subsequent time excess.

Furthermore, the first visualization means can comprise a first region and a second region spatially delimited from the first region, the second region being used to show that a predetermined third time period has been exceeded. Incorrect administration may have serious consequences if the first reference administration time exceeds the predetermined third period of time without the user taking the medication portion. This will then be indicated, for example, by a representation in a first indicator element of a different (signal) color, for example, in a second area spatially delimited from the first area. For example, the indicator elements in the first and second regions may each represent a time of day, such that they can collectively show that the first reference administration time has exceeded 2 days. Indeed, it is of course also possible that the first reference administration time exceeds a shorter or longer period.

In a further preferred embodiment of the invention, a display for the number of medicament portions contained in the dispenser is additionally provided. This display can be, for example, a digital display. This provides the user with additional safety for administering the drug portions, as it ensures that the user can always ensure that at least one drug portion is always available. The user can thus make an adequate schedule for the upcoming journey.

In a further preferred embodiment of the invention, a display for the number of medication portions that have been taken during an administration cycle is additionally provided. This information can also be displayed by a digital display. The user is thus able to monitor the course of administration of the drug portions. In the case of a contraceptive with a flexible administration regime, the user can therefore make a decision as to when to start the break phase after the administration phase (mandatory administration phase) in which she has taken 24 contraceptive portions has elapsed. With respect to limitations, it is important when a decision is made regarding starting the break phase, since the break phase cannot be started before the mandatory administration phase has started and must be started at the latest after, for example, a total of 120 contraceptive parts have been administered.

In a further preferred embodiment of the invention, a display for the application interruption is additionally provided. This can be achieved by symbols suitable for this purpose. The user of the contraceptive will thus be shown that an administration break has been initiated and that no portion of the medication should be taken at present. The interruption phase typically lasts 4 days in a flexible regime. After the interruption phase has elapsed, the administration phase is started again in a new administration cycle. To this end, the user removes the first medicament portion in this new administration cycle and thus triggers the second visualization means and thus also defines a new reference administration time.

It goes without saying that the actuation means for displaying can also comprise a logic system, thereby preventing the initiation of the interruption phase if 24 medicament portions have not been taken in the current administration cycle (forced administration phase). This can be shown, for example, by indicating that no application interruption occurred or adding a strikethrough. An optically, acoustically and/or tactilely perceptible alarm signal can also be displayed.

In addition to the user being able to actively shift from the administration phase to the interruption phase when the medication is a contraceptive that can be administered in a flexible regime and when the user is no longer in the forced administration phase, the display device may provide for automatically initiating the interruption phase when the medication portion is used the last time before the minimum period of time. For example, it may be provided to automatically initiate the interruption phase when the second reference administration time is 72 hours ago. By switching to the interruption phase, it can be shown on the display that the interruption phase has lasted for 48 hours. This automatic switching is easy to occur when the user has reached the flexible administration phase. However, such automatic switching can also occur in a possible embodiment of the invention while the user is still in the mandatory phase. In this case, however, reliable contraception is no longer provided. The purpose of the automatic transition to the interruption phase is, however, again to obtain the correct application regime.

In a further preferred embodiment of the invention, the display for administration discontinuation comprises a display for days of administration discontinuation. This display can again be formed as a digital display.

In a further preferred embodiment of the invention, the first or second visualization means display the time period that has elapsed between the two reference application times during the application interruption. These reference administration times are calculated from the time the drug portion is first removed in the administration cycle, and are at the administration interruption period, as are the first and second reference administration times. Thus, the progress of time can also be tracked during the application interruption so that the user is always well aware of the status of the interruption phase during this phase.

In a preferred embodiment, the user may also be provided with a display that two medicament portions have to be taken when the second reference administration time is longer than 2 administration periods but preferably not longer than 3 administration periods, that is to say, in this case, the user removes all (two) medicament portions that he/she has not taken so far. In order to allow the user to take all the portions of the medication that he/she did not take in this case, it may be provided, for example, for the display of the time excess (by means of the first visualization means), that only one portion of the medication is cleared when it is removed only during the removal corresponding to the individual portion of the medication, that is to say during a period equivalent to a day in the case of daily administration of the portions of the medication. Thus, the display of the remaining time excess remains when only one drug portion is initially removed, however it is now less than 24 hours after this drug portion is removed. Only when the second medicament portion has also been administered, the display for time overrun is completely cleared and the display of the second visualization means (which display the period since the second reference administration time) is also at least partially cleared.

If the medication is a contraceptive that is taken in a flexible administration regime, this procedure can be provided virtually when the user is in the mandatory phase or in the flexible phase. If the time up to 48 hours (that is to say the period of up to 72 hours since the second reference administration time) is exceeded, preferably there is still no automatic transition from the administration phase to the interruption phase. However, if the period since the second reference administration time is 72 hours or more, that is to say 3 or more drug portions should be taken but not taken, the display automatically shifts to the interrupt phase. If the user is in the mandatory phase in this case, the display preferably additionally shows that an additional prevention device (back-up contraception) must also be used, since in these cases effective contraception is no longer provided. In this case, the user may be provided with an alarm and preferably also with an optical indication to use further prophylactic means in addition to the further administration of the drug portion by means of an optical and/or acoustic and/or tactile warning signal.

Additional contraceptive measures are in each case necessary when reliable contraception is no longer guaranteed. Reliable contraception is guaranteed only in the following situations:

in case of missing administration of a medication portion for one or several days within an irregular administration period of maximum 7 days, characterized in that the medication portion has been taken without interruption for at least 7 days before the first day of this period during which the medication portion is not taken, and that the last day of this period during which the medication portion is not taken is again a period during which the medication portion is taken without interruption for at least 7 days.

In other words, each irregular administration phase of several days between two phases with at least 7 days of regular administration cannot last more than 7 days to provide reliable contraception. Otherwise, additional contraceptive measures must be taken.

It has been found that reducing the content of active substances in a contraceptive does not lead to the risk of contraceptive protection in these cases.

However, if the above conditions are not met, additional contraceptive measures are required. The first day of need for additional contraceptive measures is the one day of missed administration following the 7-day irregular administration period described above with uninterrupted administration of the drug portion in less than 7 days. At this point, there is a missed administration period of more than 7 days, which has been interrupted by a period in which the 7-day drug portion does not interrupt administration, counted from the first day of missed administration until the last day of missed administration.

In other words, it is required that at least 7 days of the drug portion do not interrupt the administration phase after 7 consecutive irregular administration phases in order to maintain the contraceptive effect.

In addition, the need for contraceptive measures persists until an uninterrupted administration period of at least 7 days has elapsed.

The above rules are independent of whether no tablets are taken on the days (administration phase) on which tablets are to be taken according to a predetermined administration regime or whether the days occur in a break phase (that is to say the days on which no tablets are to be taken according to the administration regime). In other words, the day when no tablets were to be taken according to the administration regime was considered the day when administration was missed.

The display device is preferably designed in such a way that, under the above-mentioned conditions, it displays on a daily basis whether further contraceptive measures are required. To this end, an alarm symbol for the absence of contraception, for example, an exclamation mark ("!") can appear automatically on the display. According to the above explanation, this alarm symbol occurs under the following conditions:

a) generating a missed application period characterized by

i) The missed administration period follows a first administration period of uninterrupted administration of the drug portion for at least 7 days,

ii) the missed administration period is in turn preceded by a second administration period of at least 7 days required without interrupting the administration of the drug portion,

iii) no medication portion is taken on at least one day of the missed administration period,

iv) an uninterrupted administration period of at least 7 days is not included in the missed administration period,

v) no medication portion is taken on the first and last days of the missed administration period, and

vi) the missed administration period lasts more than 7 days;

b) the first day of alarm symbol occurrence is day 8 of the missed administration period;

c) the last day of occurrence of the alert symbol is day 7 of the second administration period, which is after the missing administration period and involves uninterrupted administration of the medication portion.

In a further preferred embodiment of the invention, the display device is a digital display device. In particular, the display device may be an LCD display device. For example, an OLED display may be provided. Alternatively, any other desired technique can be used.

Furthermore, the display device can also contain further indicating elements for other functions, such as a symbol for a lower battery state of charge, a symbol for displaying whether an audible alarm signal is activated or deactivated, a symbol for advising the user to take into account operating instructions, a symbol for indicating that a digital display is displaying the number of medication portions still in the dispenser, a symbol for indicating a lesser level of medication portions, a symbol for indicating that a digital display is displaying the number of medication portions that have been taken during an administration cycle, a symbol for confirming that a medication portion has been taken, and also a symbol as an alarm indication if the user tries to activate the interruption phase but cannot activate the interruption phase. These symbols can each be represented as a continuous display or in a flashing manner. Alternatively, or sometimes simultaneously, the symbols are preferably displayed on a display device. In addition, the display device can be designed in such a way that a further warning signal can be emitted which is perceivable optically, acoustically and/or tactilely.

The display device comprises electronic actuation means for the display. This may conveniently be a programmed or programmable microprocessor circuit.

The display device is preferably controlled by an operating control element on the dispenser. These operating control elements may be, in particular, buttons or other sensors. For example, a menu button and a confirmation button can be provided. The menu button is used to select a specific display or selection mode. The ok button is used to make possible selections in a particular mode.

In addition to the display, the dispenser can also comprise further optical indicating elements, such as LEDs, and further acoustic warning devices (loudspeakers) and/or mechanical warning devices (vibrators).

All indicator elements of the display device can be displayed in a continuous manner or in a flashing manner. In addition, the indicator elements can also be displayed in an intermediate (if possible contrasting) color, for example black, or all or else only individual indicator elements can be in a signal color, for example red. To emphasize the importance of the display of specific operational control states in the dispenser and display device, an increased degree can be provided, for example a colored (e.g., red) illustration can be provided instead of black. Alternatively or in addition, a flashing display can be selected instead of a continuous display.

Particularly preferably, the display device is combined with a dispenser for the medicament portions. In this case, the dispenser can trigger the display device without the user removing the medication portion as an intermediary, i.e. the removal of the medication portion immediately results in taking the removal of the medication portion into account without the user additionally having to perform a separate input operation for the removal. This triggering can be performed mechanically, electromechanically, electronically or in some other way. In particular, the dispenser can allow output of the medicament portion based on mechanical or electromechanical transmission of force from the operating means to the output unit, and can also provide mechanical or electromechanical transmission of force to act directly on the display device in case the medicament portion is removed, e.g. by means of a switch, so that removal without further manipulation by the user is recorded in the display device. The automatic triggering largely prevents incorrect operation control by making it impossible for the user to erroneously register removal in the display device.

The medicament portions are prepared as in conventional dispensers in the form of tablets, pills, coated tablets, and the like. In practice, the medicament portions can be packaged in the form of blisters. The drug portions are preferably packed in a cassette, that is to say arranged in a column. In this case, the medicament portion can be output through an axial opening in the cartridge.

Drawings

The invention will be described in more detail with reference to the following description of the drawings, which are given by way of illustration only and are not intended to be limiting of the invention.

Fig. 1 shows a front view of a dispenser with a display device according to the invention;

FIG. 2 shows a rear view of the dispenser;

fig. 3 shows a plan view of a display device according to the invention in a first embodiment of the invention;

fig. 4 shows the display of the display device according to the invention in a first embodiment of the invention before the first insertion of the cartridge and then in a different display mode;

figure 5 shows the display of a display device according to the invention in a first embodiment of the invention after the first removal of a tablet in an administration cycle;

fig. 6 shows the display before and after the tablet is removed before the second reference administration time elapses by the display apparatus according to the present invention in the first embodiment of the present invention;

fig. 7 shows the display of the display device according to the invention before and after the removal of a tablet before the start of an administration time interval according to the first embodiment of the invention;

fig. 8a shows the display of a changeover switch (on and/or off) of the display device according to the invention in a first embodiment of the invention after a first reference application time has been exceeded and additionally with an acoustic alarm function;

8b, 8c show the display of a display device according to the invention in a first embodiment of the invention after a first reference application time exceeds a given different first period of time;

fig. 9 shows the display of the display device according to the invention in a first embodiment of the invention when switching to the interruption phase;

fig. 10 shows the display of a display device according to the invention during an interruption phase in a first embodiment according to the invention;

fig. 11a shows the display of the display device according to the invention in a first embodiment of the invention before and after the removal of two tablets, without taking into account a second tablet administered after a short time exceeding the first reference administration time;

fig. 11b shows the display of the display device according to the invention in a first embodiment of the invention before and after the removal of two tablets, without taking into account the second tablet administered after a longer time exceeding the first reference administration time;

fig. 12a shows the display of the display device according to the invention before and after the removal of two tablets in a first embodiment according to the invention, also taking into account a second tablet administered after a short time exceeding the first reference administration time;

fig. 12b shows the display of the display device according to the invention before and after the removal of two tablets in the first embodiment of the invention, also taking into account a second tablet administered after a longer time exceeding the first reference administration time;

fig. 13 shows the display of a display device according to the invention in a first embodiment of the invention when automatically switching from the flexible phase to the interrupt phase;

fig. 14 shows the display of the display device according to the invention in a first embodiment of the invention when automatically switching from the forcing phase to the interrupting phase;

fig. 15 shows a display of a display device according to the invention in a lower battery state of charge in a first embodiment in accordance with the invention;

fig. 16 shows a display of a display device according to the invention in a second embodiment of the invention, with an alternative symbolic representation;

fig. 17 shows the display of a display device according to the invention in a second embodiment of the invention starting from a second reference application time in various stages in the progression over time;

fig. 18 shows the display of a display device according to the invention in a second embodiment of the invention starting from a first reference application time in various stages in the progression over time;

figure 19 shows the display of a display device according to the invention in a second embodiment of the invention over more than one application cycle in various stages in the progression over time;

fig. 20 shows the display of the display device according to the invention before and after tablet removal in a second embodiment of the invention;

fig. 21 shows the display of a display device according to the invention in a second embodiment of the invention after the start of an interruption phase; and is

Fig. 22 shows an example of administration of a pill and missed administration (no administration) within a contraceptive administration period.

Detailed Description

Like elements are provided with like reference signs. The tablets mentioned below serve as a simplification of the term drug portion. This term will therefore also include pills, coated tablets, capsules and other solid administration forms for distribution. In the following, the display device is shown and described for a pharmaceutical part which is a contraceptive and takes a flexible administration regime, that is to say with a mandatory administration period of 24 days, followed by a flexible administration phase (maximum of 120 days in total) up to an additional 96 days, and a subsequent 4-day interruption phase.

Fig. 1 shows a front view of a dispenser Sp for medicament. The lower part of the medicament cartridge Ka inserted axially into the dispenser from below can be seen in the lower region of the dispenser. The drug fraction is delivered from the bottom (arrow). To this end, the cartridge has an ejection mechanism on the lower surface operated by means of a lateral button Dt.

A display device having a display 1 and operation control buttons Me, OK is also mounted on the front face of the dispenser Sp. The menu key Me is used to select a designated display or selection mode on the display, and the Ok key Ok is used to confirm selection of a function displayed by the display.

Fig. 2 shows a rear view of the dispenser Sp. The casing of the dispenser Sp is centrally and axially provided on the back with a window Fe through which some of the tablets Ta contained in the box can be seen. A marker MK in the form of a line is also provided, this marker indicating a filling level at which the box contains exactly only 7 tablets. Thus, the user is also able to directly visually monitor the fill level of the tablet in the dispenser.

Fig. 3 shows a display 1 of a display device according to the invention with an enlarged view of a detail of the indicator element 20 positioned in the ring. This view is only intended to show all possible indicator elements and symbols on the display. All elements and symbols are generally not visible at the same time, but only on display.

The display is preferably an LCD display, which particularly preferably has a light-emitting device or at least optionally a light-emitting device. The indicator elements and symbols described herein need not be displayed continuously. During non-operation, that is to say during a phase in which the user does not operate the dispenser and the display device is not actuated by pressing any button, the display device can be automatically switched to a non-operating position in which the indicator elements and the symbols are not visible. The display device can be switched back to the active state, for example by pressing a button.

Most of the indicating elements and symbols of the display 1 are for example black to provide a good contrast with the background. However, some of the indicator elements and symbols can be of different colors.

The display 1 is equipped with sector-shaped indicator elements 20, 30, 40, which are positioned in a ring in each case. The rings are arranged concentrically with respect to each other. The second indicator elements 20 in the outer ring constitute second visualization means when taken together. 24 such fan-shaped second indicator elements form a ring. In the case of the present exemplary embodiment, these 24 second indicator elements would each represent 1 hour, and therefore the total of 24 second indicator elements represents 24 hours, that is to say 1 day. In order to show where the second indicator elements are located, indicator frames 210 are provided, which are also visible when the indicator areas 220 of the second indicator elements arranged in these frames are not displayed. The first indicator elements 30 and 40, when taken together, constitute the first visualization means. Whereas the first indicator member 30 is black, the first indicator member 40 can be red. In each case 24 such fan-shaped second indicator elements form a ring, and two rings of second indicator elements are provided. The first black indicating element 30 is arranged in the first region (central ring) and the first red indicating element 40 is arranged in the second region (inner ring). The second region is intended to show that a predetermined third period of time has been exceeded, the third period of time being represented by all of the first indicator elements 30 in the entire central ring. After the time for which all the second indicator elements 30 are completely displayed in the central ring has elapsed, the second indicator elements 40 are displayed in succession in the inner ring according to the progression of the time.

There is also a three digit numerical display 50 in the centre of the display 1, the numerical display having different meanings depending on the mode. The symbol 52 for the box is shown to the left of the numeric display. When this symbol and the numerical display are displayed simultaneously, the numerical display shows the number of tablets still in the box. This symbol can be displayed continuously or in a flashing manner, the latter being the case when there is no tablet in the box. Additionally, a symbol 54 for a calendar is shown to the right of the numeric display. When this symbol is displayed simultaneously with the numeric display, the numeric display shows the number of days that have elapsed in the current administration cycle.

Also, a symbol 60 for application interruption is located below the numerical display 50. When this symbol appears together with the numerical display, the numerical display shows the number of days that have elapsed in the interrupt phase.

Moreover, the alarm and information symbols 65 displayed in various conditions (in particular continuously or in flashing manner) are positioned to the left of the symbol 60 for application interruption. The alarm and information symbols can be shown in the display shown here as having had a strikethrough (struckthrough) added, or may not have had a strikethrough added. When shown as having added a strikethrough, this symbol is displayed together with the symbol for the interrupt phase and then indicates that the interrupt phase (still) does not have to start.

Also, a confirmation symbol 70, which is displayed as having been applied when confirming the removal of the tablet, for example, is positioned to the right of the symbol 60 for application interruption.

An informational symbol 80 for displaying whether the audible alarm indicator is activated (no strikethrough has been added) or deactivated (strikethrough has been added, as shown) is positioned above the digital display 50. An alert symbol 82 as a prompt to the user to consider the operating instructions is shown at the upper right and an alert symbol 84 for a lower battery charge state is shown at the left. Neither symbol is black, but is preferably red or other signal color to emphasize these displayed alert features. In addition, the alert symbol 82 can be generated not only with a continuous display, but also as a flashing display, which is the case when the user attempts to initiate the interruption phase during the mandatory administration period.

Fig. 4 shows the display 1 of the display device according to the invention in a first situation before the first insertion of the tablet-containing cassette into the dispenser and subsequently after said cassette has been inserted.

No indicator elements or symbols are visible on the display 1 (shown on the left) before the cartridge is inserted into the dispenser for the first time, because, in this case, the dispenser is designed such that the batteries in the dispenser are still not connected to the display device. The cartridge Ka is then inserted into the dispenser (step 1). The dispenser and display device are then actuated. The start-up display appears on the display 1 (default screen). Initially, only the audible information indicator 80, and the two horizontal dashed lines representing the numerical values displayed by the numerical display 50, are generated on the display as criteria. This representation is a standard representation of a display.

The available modes are displayed one after the other on the display 1 by means of the menu key Me which is now identified once or more than once:

after one press of the menu key Me (step 2), a first display mode is displayed in which the number of days that have elapsed in the administration cycle is displayed: the calendar symbol 54 is shown next to the two dotted lines of the numerical display 50, which dotted lines are still shown as normal in this phase. This is used to characterise in this phase before the tablet is first removed from the dispenser that the number of days that have elapsed in the administration cycle still cannot be displayed.

After the menu key Me is pressed twice (step 3), a second display mode is displayed in the second level, in which the number of tablets still contained in the box is displayed: the box symbol 52 appears next to the numeric display 50. This box symbol will indicate that in the present case 30 tablets are contained in the inserted box. The box symbols are generated in a continuous display rather than in a flashing manner. The box symbol flashes only when the number of tablets drops below e.g. 6 (preset value). In this case, box symbols indicating that only a few pills remain in the box are also hidden on the default screen.

After the menu key Me is pressed three times (step 4), a third display mode in which the audio alarm mode can be turned on or off is displayed in the third level. In addition to the display of the audible information display 80, a flashing warning/information symbol 65 is also shown.

After four presses of the menu key Me (step 5), a fourth display mode is displayed in the fourth level, in which the interruption phase starts or is displayed: the symbol 60 for applying the interruption is shown in the center of the bottom of the display 1. The numerical display 50 is centrally located and, in the present case, shows a single horizontal dashed line, instead of a single number for the number of interruption phases. The alarm symbol 82 is shown at the upper right and the alarm/information symbol 65 and the plus-delete line OK display at the lower left, because, in the present case, the user is still at the beginning of the application phase and therefore still cannot start the interruption phase.

The last mentioned two stages (third and fourth stage) can also be interchanged.

After the menu key Me is operated again (step 6), the display apparatus returns to the mode with the standard display. If the menu key is not operated for 3 seconds, the display device will similarly automatically return to the mode of the standard setting from one of the first to fourth display modes.

The user can now remove the tablet Ta from the dispenser (step 7). The administration protocol was initiated by removing the tablet. In particular, the second visualization means are first activated:

fig. 5 shows the display 1 of the display device after the first tablet has been removed. This time represents the second reference administration time if the tablet has been removed, for example at 7 o' clock. A ring of 24 indication frames 210 of the second visualization means, which indicate 1 hour each, appears on the display. As can be seen in the lower left portion of the view, the indicator frame 210 is still not filled by the indicator area immediately after the first tablet has been removed. Also, the display device shows a confirmation symbol 70 and an information symbol 80 for an audible alarm indicator. The confirmation symbol indicates that the tablet has been successfully removed for administration.

After the repeated operation of the menu key Me, the following displays are shown in the first to fourth display modes:

after one operation of the menu key (step 2), a first display mode appears, which indicates that 1 day has elapsed in the current administration cycle. After the menu key is operated twice (step 3), the second display mode appears, which still has 29 tablets in the display box. After three times of menu key operation (step 4), a third display mode appears in which the audible alarm mode can be turned on or off. After four times of operation of the menu keys (step 5), a fourth display mode appears, the interrupt phase starts or is displayed in this display mode. However, this is not possible at the current stage, since the user is still in the mandatory administration phase (alarm/information symbol 65 plus strikethrough) after only 1 pill is administered.

After the menu key Me is operated once again (step 6), the display 1 returns to the mode with the standard display. As time progresses, after the first tablet has been removed and administered, two of the following displays occur: the bottom center view shows that about 1 hour has elapsed since removal (the first indicator frame 210 of the second visualization device is filled with indicator areas). The lower right view shows that approximately two hours have elapsed since removal (two indicator frames 210 filled with indicator regions).

The further progression of the time is shown by way of example in the standard display in fig. 6. In the left side view of the display 1, approximately 13 hours have elapsed since the last second reference application time.

The tablets do not have to be taken at the reference administration time. It is sufficient that the tablets are taken within the application time interval. In the present case, the tablets can be taken, for example, at 12-hour intervals, 2 hours before or after the reference administration time. In the present case, the tablet Ta is taken within an administration time interval of 12 hours before the reference administration time (step 7). Thus, the commit symbol 70 is displayed in the display 1 which is displayed in response. Meanwhile, the remaining time until the next reference application time is shown in the sense of "negative time", from the indication frame 210 is first filled by the indication area located in the loop extending from the time of removal and application (-11 hours) to the current second reference application time. The indicator frame is then filled again in the normal manner by the indicator area, starting at the top from the first indicator element.

If the tablet Ta has been removed from the dispenser prematurely, that is to say before the start of the application time interval, a different procedure follows. This is shown by way of example in fig. 7. In this case, the second period since the last second reference administration time is only 11 hours. Consequently, the subsequent removal of the tablet Ta (step 7) is not recorded as an effective administration (confirmation symbol is not displayed, no change in the display of the second visualization means).

Fig. 8a shows the display 1 after the first reference application time has been exceeded (view of the lower left). In this case, the second indicator elements 20 of the second visualization means (the second indicator elements are all shown) and also 5 first indicator elements 30 (which indicate that the user has not taken any tablets after the first period of 5 hours beyond the first reference application time has elapsed) are shown in the outer ring. After repeated operation of the menu key Me, the user successively arrives at a first display mode showing that the user is on day 28 of the administration cycle (step 2), a second display mode showing that the cassette still has 18 tablets in it (step 3), and a third display mode with an option to activate or deactivate the audible information indicator 80 therein (step 4). In the present case, the information indicator is activated because the information symbol 80 is not erased. The state "acoustic alarm indicator off" is selected by operating the OK key OK (step 10). This selection can be cancelled by pressing the key again. It is generally possible to switch between these two states as desired.

In addition, the warning/information symbol 65 is shown in a flashing state in the present case. This means that the user can switch to the interruption phase at this application phase (flexible application phase).

Further views beyond the first reference time are shown in fig. 8b and 8 c: fig. 8b shows more than 18 hours (second indicator elements 20 all present and 18 first indicator elements 30 present) and fig. 8c shows more than 29 hours (second indicator elements 20 all present, first indicator elements 30 all present and 5 first indicator elements 40 present). The display in fig. 8b also shows that the user is on day 38 of the administration cycle, that is to say in the flexible administration phase. In the case of fig. 8c, the user is also advised to consider the operating instructions (alarm symbol 82) since the first reference application time is significantly exceeded by 29 hours.

Fig. 9 shows the transition to the interrupt phase:

the view of the display 1 at the lower left shows that the user has exceeded the first reference application time by 5 hours. This can be recognized by the displayed total first indicator elements 20 of the first visualization device and the 5 second indicator elements 30 of the second visualization device. By repeated operation of the menu key Me, the display apparatus is converted to the fourth display mode through the first to third display modes (steps 2, 3, 4, 5). The symbols 60 for the application interruption, the alarm/information symbols 65 and the numerical display 50 are displayed in this display mode. The alarm/information symbol indicates that the interrupt phase can begin. This is due to the fact that the user is on day 28 of the administration cycle (see display of the first display mode). The interrupt phase is started by operating the OK key (step 9). The numerical display 50 on the display 1 then indicates the first day that the user is in the interrupt phase.

The following displays can be seen in succession in the display 1 during the interruption phase (fig. 10):

proceeding from the administration period shown in the standard display with the display 1 shown in the lower left small scale, a fourth display mode is selected by operating the menu key Me (steps 2, 3, 4, 5). Wherein the user can choose to start the display presentation of the interrupt phase. This is indicated by the symbol 60 for the application interruption. The alarm/information symbol 65 also confirms that the interrupt phase can be initiated. In addition, the indicator element 20 of the second visualization means indicates that 5 hours have passed on this first day. This period is the period that has elapsed since the first reference administration time (see time display on the display of the second visualization means according to the larger view of the display). The transition is made to the interrupt phase by operating the OK key OK (step 9). The digital display 50 now indicates the first day that the user is in the interrupt phase.

The user does not take any tablets during the breaking phase. The display 1 shows the time period which has elapsed accordingly by means of the digital display 50 and the second indicator element 20 of the second visualization means. In the view shown here, 5 hours (that is, 5 hours in total) have elapsed since the reference administration time on the first day, 9 hours (that is, 33 hours in total) have elapsed since the reference administration time on the second day, 13 hours (that is, 61 hours in total) have elapsed since the reference administration time on the third day, and 23 hours (that is, 95 hours in total) have elapsed since the reference administration time on the fourth day. The display then immediately transitions to the start-up display. If a new tablet is taken in this case, the result is the sequence already described with reference to fig. 4, 5, whereas if no tablet is taken, the alarm symbol 82 appears permanently (shown last in the sequence of views in fig. 10). Thus suggesting to the user to consider the operation instruction. The sound signal can also be emitted, for example, for a few seconds to remind the user to start a new application period, and the sound signal is repeated several times, for example, at 15 minute intervals, at a specified rhythm.

When several tablets were immediately removed in sequence, the second removal operation was not considered for administration (fig. 11):

for example, if the first tablet Ta is taken 7 hours beyond the first reference application time (FIG. 11 a: left-hand view: second indicator elements 20 (outer ring) are all present and 7 first indicator elements 30 (inner ring) are present) (step 7), the device switches to a display whereby 7 hours have elapsed since the last second reference application time (FIG. 11 a: center view: 7 second indicator elements 20 are all present). In this case, the removal is acknowledged by the acknowledgment symbol 70. However, this is not considered administration anymore when the other tablet Ta is removed (fig. 11 a: right-hand view: no further change in the indicator member 20, no confirmation symbol is shown).

In another configuration, 30 hours have elapsed since the first reference administration time (FIG. 11 b: left-hand view: second indicator element 20 (outer ring) is fully presented, first indicator element 30 (center ring) is fully presented and 6 first indicator elements 40 (inner ring) are presented). In this case, the warning symbol 82 is hidden since the first reference application time is largely exceeded. Upon removal of the tablet Ta (step 7), the device switches to a display whereby 6 hours have elapsed since the last second reference application time (fig. 11 b: central view: 6 second indicator elements 20 are all present). The removal is acknowledged by the acknowledgment symbol 70. In this case, however, the user is advised to consider the operation instruction (alarm symbol 82 display). However, this is not considered administration anymore when taking another tablet Ta (fig. 11 b: right-hand view: no further change in the indicator member 20, no symbol confirmed).

In removing several tablets, which are assigned to different reference administration times, the second removal of the tablets is considered as administration (fig. 12):

for example, if the first tablet Ta is taken 15 hours beyond the first reference application time (FIG. 12: left-hand view: second indicator elements 20 are all present and 15 first indicator elements 30 are present) (step 7), the device switches to a display whereby 15 hours have passed since the second reference application time (FIG. 12: center view: 15 second indicator elements 20 are all present). The removal is acknowledged by the acknowledgment symbol 70. This is considered to be a further administration when removing another tablet Ta, since this second removal takes place within the time interval of the next reference administration time (this time interval starts at the reference administration time minus 9 hours). This application is again confirmed by the confirmation symbol 70. In addition, the display 1 now first shows a new second negative period: fig. 12a, right hand view, shows the second indicator element 20 counting "reference application time minus 9 hours" from the start of the indicator element 20.

In another configuration, 42 hours have elapsed since the first reference administration time (FIG. 12 b: left-hand view: second indicator element 20 is fully presented, first indicator element 30 is fully presented and 18 first indicator elements 40 are presented). In this case, the alert symbol 82 is hidden by exceeding the first reference application time to a significant extent. Upon removal of the tablet Ta (step 7), the device switches to a display whereby 18 hours have elapsed since the last second reference application time (fig. 12 b: central view: 18 second indicator elements 20 are all present). The removal is acknowledged by the acknowledgment symbol 70. However, also here, the user is advised to take into account the operating instructions, since the first reference application time is exceeded to a significant extent (alarm symbol 81 display). However, when taking another tablet Ta, this is considered as a further administration, since this second removal takes place within the time interval of the next reference administration time (this time interval starts at the reference administration time minus 12 hours). This application is again confirmed by the confirmation symbol 70. In addition, the device now first shows a new second negative period: fig. 12a, right hand view, shows the second indicator element counting "reference application time minus 6 hours" from the indicator element 20.

If the user does not take the tablet for a longer time, the display device automatically starts the breaking phase. Fig. 13 shows how the device automatically transitions from the flexible phase to the interrupt phase:

from the point at which 47 hours have elapsed (larger left-hand view: second indicator element 20 is fully presented, first indicator element 30 is fully presented and 23 first indicator elements 40 are presented) and the user is prompted by means of warning symbol 82 to proceed in view of the display of operating instructions, the device automatically switches to the (smaller) display 1 shown to the right after 2 hours of said first view, after which the user is now in the interrupt phase. This can be seen by means of the symbol 60 for the application interruption and the numerical display 50 is only one number. The digital display indicates that the user has been in the third day of the interrupt phase. This is due to the fact that removal of the tablet has now been delayed for a relatively long time of more than 48 hours. The more views in fig. 13 show the situation immediately after the end of the interruption phase and after a further time has elapsed without the user removing the tablet, respectively, the fourth day of the interruption (5 hours after the reference administration time).

Fig. 14 also shows such a case where the user shifts to the interruption stage in the case where the tablet is not taken in the compulsory administration period. Since in this situation contraception cannot be guaranteed because the pill cannot be administered in any case, the display device switches to an interruption phase to guide the user back to the administration phase. In this case, the display is not different from the display that occurs when transitioning from the flexible phase to the interrupt phase.

Fig. 15 shows the display 1 in a lower battery state of charge. In the left-hand view of fig. 15, the alert symbol 84 is shown for a lower battery charge condition. The display indicates that the user is in the administration phase (no symbol for the interruption phase). The state of charge of the battery is measured so that the application cycle can still be maintained until the end. The user will thus still be able to maintain the administration phase until the end of the interruption phase (central view). However, after the end of the interruption phase, the display device does not switch to the standard display, but closes the display (right-hand view).

Fig. 16 shows a second embodiment of the display device according to the invention. Instead of the first sector-shaped indicator elements 30, 40 and the second sector-shaped indicator element 20 in the three rings, only the sector-shaped first indicator elements in the two rings can be seen here, since these two types of indicator elements are not present at the same time in this embodiment. The first type of second indicator element 30 is black and the second type of second indicator element 40 is red to indicate to the user that a considerable time has elapsed.

In addition, the design of the symbols 60 for applying the interruption, the alarm and information symbols 65, the symbols 54 for the calendar and the information symbols 80 for activating and deactivating the alarm indicator differs in this case from the corresponding symbols of the first embodiment (see fig. 3). No acknowledgement symbols are provided. In addition, the arrangement of symbols is slightly different from those of the first embodiment.

Fig. 17 shows the start-up display on the display 1 (default screen) in various periods as time progresses: second fan-shaped indicator elements 20, which indicate the advance of time since the second reference application time (represented by the larger outer triangle 90), each represent 1 hour. Each of these indicator elements is constituted by a substantially rectangular frame. Initially, all indicator elements are activated to indicate to the user that the entire cycle is still available until the next reference administration time. In the present case, 1 hour has elapsed since the second reference administration time according to the view in fig. 17 (a). Since the last tablet was taken just prior to recording this display, the display has displayed only 23 indicator elements to indicate that only 23 hours remain until the next reference administration time. When the next display is recorded (fig. 17(b)), 6 hours have elapsed and thus the 6 indicator elements are also turned off. Thus, only 18 hours remain until the next reference administration time. Fig. 17(c), (d) and (e) show corresponding views 13 hours, 2 hours and 1 hour, respectively, before the next administration time.

If the next tablet is taken before the second reference administration time 90 is reached, the remaining extended period until the next second reference administration time for the next tablet administration needs to be displayed. This can be achieved, for example, by the entire second indicator element 20 of the second visualization device and, in addition, further indicator elements, which are, for example, in a ring offset inwards with respect to the outer ring and which correspond to a remaining period of time of more than 24 hours (not shown), which are displayed after removal of the tablet. If the next tablet is taken, for example 2 hours before the second reference administration time (according to fig. 17(d)), all the indicator elements 20 will be displayed in the outer ring and, in addition, 2 further indicator elements positioned at the points of the indicator elements shown in fig. 17(d) but offset inwards will be displayed in the ring further inwards in place after tablet removal. As the time advances further, only these two indicator elements will then first be cleared one after the other and then only the first indicator element will be closed in sequence, starting with the first indicator element located just to the right of the marking 90 for the second reference application time.

Fig. 18 again shows the start up display on the display 1 (default screen) in various stages advancing with time according to fig. 17, but in this case after the next reference administration time 90 has elapsed but no tablets have been taken. Thus, the most recent reference administration time is the first reference administration time. After reaching this reference application time but without taking the tablet, the second indicator element is cleared. After a time advance after the first reference application time, the first indicator elements 30, which indicate the time excess, appear successively. Fig. 18(a) shows that 1 hour has elapsed since the first reference administration time. Fig. 18(b) - (e) show further advancement of time, specifically, 7 hours, 12 hours, 19 hours, and 23 hours, respectively, since the first reference administration time. In addition, the numerical display 50 indicates that 1 tablet was not taken at this time. Also, a variant information symbol 80 (by the wave shown at the top left) for activating and deactivating the alarm symbol indicates that the application time has been exceeded.

Fig. 19 shows a further progression of time after more than 24 hours have elapsed since the first reference administration time. Fig. 19(a) shows a display showing 24 hours +1 hour (25 hours) since the first reference time. For this purpose, the further first indicator element 40 is now shown in the ring in a further inward position, with the exception of the first indicator element 30 in the outer ring. This further indicator element is preferably red to alert the user to the further time being exceeded. Also, the numerical display 50 indicates that 2 tablets are not currently being taken. In the further displays according to fig. 19(b) and 19(c), 24+9 hours (═ 33 hours) and 24+20 hours (═ 44 hours), respectively, have elapsed since the first reference administration time.

Fig. 20 shows the resulting display 1 before (fig. 20(a)) and after (fig. 20(b)) removal of a single tablet. Fig. 20(a) corresponds to the view in fig. 19 (c). Before tablet removal, the display indicated that 2 tablets were not taken. After 1 tablet is removed, the display now shows that 1 tablet has not yet been taken. This can be seen first on the digital display 50 and the first indicator element 40 is cleared and the first indicator element 30 is partially cleared. It is now necessary to take yet another tablet to again follow the desired rhythm. If this further tablet is taken, the first indicator member 30 is also cleared and (in the present case) shows a further 4 second indicator members (not shown) which indicate the period until the next reference administration time.

Fig. 21 shows the display 1 produced after the interrupt phase has started. The symbol 60 for the application interruption and the alarm and information symbol 65 appear in this case. Only these two symbols are displayed immediately after the start of the interrupt phase (fig. 21 (a)). After trial for several hours after the start, the display additionally shows the first day that the user is in the interrupt phase, specifically after 4 hours have elapsed (fig. 21 (b)). Fig. 21(c) shows the display generated the second day of the interrupt phase, specifically after 24+9 hours (═ 33 hours) after the start. Fig. 21(d) shows a corresponding display on the third day of the interrupt phase, after 24+24+9 hours (57 hours) after the start.

If the tablets used for contraception are not taken regularly, contraception can no longer be ensured under certain conditions. In this case, the user must use an additional contraceptive. This requirement can be displayed separately and specifically on the display 1 by means of an alarm symbol for the absence of contraception, for example by means of an exclamation mark ("|"). This warning symbol will only be displayed when sufficient contraceptive display is no longer guaranteed and will indicate to the user that additional contraceptive means are now required. Such a situation occurs if the tablets are not taken regularly. This depends firstly on the period in which the tablets have been administered correctly (that is to say regularly) and secondly on the period in which the tablets have been administered with interruption. Figure 22 shows the specific days of missed administration (correct administration: "o", no administration of "x") during the administration regime, which in both cases resulted in a state of contraceptive deficit. Therefore, additional contraceptive measures are required in this case (additional use of other contraceptive means is required). To this end, the alert symbol is displayed on a display:

each figure shows day 17, day 18, day 19, etc. extracted from the application calendar in the application regime shown (days are given in the first row). Tablet administration for the corresponding day is recorded with an "o" in the second row. If no tablets are taken, "x" is shown. The third row indicates whether further contraceptive measures ("|) or not are required on the respective day (no input in the relevant area). In the first case, this warning symbol appears on the display.

Figure 22a shows an example where the tablets were forgotten to be administered on days 28 and 36. In this case no additional contraceptive measures are required (no input in the third row) for the following reasons: the tablets were not taken only for an irregular administration period of 7 days (e.g., in the period from day 28 to day 34) and the day was preceded by a 7-day period (day 21 to day 27) in which the tablets were taken regularly. Also, the day on which the tablets were not taken (day 28) was followed by another 7-day period in which the tablets were regularly taken (day 29 to day 35). In this case, the missing administration period was only 1 day (day 28). If the user forgets to take the tablets again at a later date (at day 36), this does not result in additional contraceptive measures now having to be taken for the reasons mentioned above. The 7-day period between two days of missed administration (days 28 and 36) ensures ovulation inhibition. For this reason, no alarm symbol ("|) is activated on the display.

Fig. 22b shows an administration example for a case where no tablets were taken on day 28 and on days 34, 35, 36, and 37. In this case additional contraceptive measures are required: within the 7-day irregular administration period, there were two days without taking the tablet, specifically on days 28 and 34, counted from the first day (day 28) without taking the tablet after at least 7 days of uninterrupted administration. The last day within this 7-day period is not followed by at least a 7-day period in which the tablets were taken without interruption, because no tablets were taken on any of days 35, 36, and 37. The missed administration period is in this case 10 days as it extends from day 28 to day 37. The first day in need of additional contraceptive measures is day 8 after the 7-day irregular administration period described above starting from day 28. This day was day 35, since the 7-day period of irregular administration ended at day 34. The need for additional contraceptive measures continues until a period of uninterrupted administration of at least 7 days has elapsed again. Thus, the period in which additional contraceptive measures are required continues until day 44, since uninterrupted administration of day 7 is reached first on day 44. Thus, the alert symbol for lack of contraception was initiated from day 35 to day 44.

Fig. 22c shows an administration example in which no tablets were taken on days 34, 35, 36, and 37 and on day 40. In this case, no additional contraceptive measures are required: within the 7 day missing administration period, no tablets were taken for 5 days, specifically on days 34, 35, 36, 37 and 40, calculated from the first day (day 34) of non-administration after at least 7 days of non-interrupted administration. This 7 days is missing the last day of the administration period, that is to say day 40, followed by a period of at least 7 days (starting from day 41) in which the tablets are taken without interruption. Thus, the alarm symbol is not activated.

Fig. 22d shows an administration example where no tablets were taken on days 34, 35, 36, and 37 and then on day 41. In this case additional contraceptive measures are required: tablets were not taken for 4 days within the 7 day irregular administration period, specifically on days 34, 35, 36 and 37, calculated from the first day (day 34) on which tablets were not taken after at least 7 days of uninterrupted administration. The last day (day 40) within this 7-day irregular administration period is not followed by at least a 7-day period in which the tablets were taken without interruption, because no tablets were taken on day 41. The missed administration period actually lasts 8 days. The first day in need of additional contraceptive measures is day 8 after the 7-day irregular administration period described above. This day is day 41, since the 7-day irregular administration period ends at day 40. The need for additional contraceptive measures continues until a period of uninterrupted administration of at least 7 days has elapsed again. Thus, the period in which additional contraceptive measures are required continues until day 48, since uninterrupted administration of day 7 is reached first on day 48. Thus, the alert symbol for lack of contraception was initiated from day 41 to day 48.

Claims (17)

1. A display device for a dispenser (Sp) for a pharmaceutical portion (Ta) necessary for administering the pharmaceutical portion at a regular cyclical reference administration time, and comprising a display (1) and electronic actuation means for the display, characterized in that the display comprises first visualization means for displaying a first period of time between a first reference administration time and a current time, and in that the first reference administration time is characterized in that the pharmaceutical portion should be taken no later than said first reference administration time but not until the first reference administration time; the first visualization means is activated by reaching the first reference administration time if no drug portion is taken at the first reference administration time.

2. A display device for dispensers (Sp) of pharmaceutical portions (Ta) according to claim 1, characterised in that the display (1) additionally comprises second visualisation means for showing a second period between a second reference administration time and the current time, the second reference administration time being characterised in that it is in the predetermined administration time interval and that one of the pharmaceutical portions has been taken in the predetermined administration time interval, and the second period lasts at most up to the first reference administration time chronologically after the second reference administration time.

3. A display device for dispensers (Sp) of pharmaceutical portions (Ta) according to claim 2, characterised in that the second visualisation means is activated by first removing one of the pharmaceutical portions from the dispenser during an administration cycle.

4. Display device for a dispenser (Sp) for pharmaceutical moieties (Ta) according to one of claims 2 to 3, characterised in that the first visualisation means are arranged in at least one first display area and the second visualisation means are arranged in at least one second display area of the display (1), and that the at least one first display area and the at least one second display area are adjacent to each other.

5. Display device for a dispenser (Sp) for pharmaceutical portions (Ta) according to one of claims 1 to 3, characterised in that the first visual means are formed by at least one first indicator element (30, 40).

6. A display device for dispensers (Sp) of pharmaceutical portions (Ta) according to claim 5, characterised in that at least two first indicator elements (30, 40) are provided and that the first indicator elements are switched on successively as time progresses.

7. Display device for dispensers (Sp) for pharmaceutical portions (Ta) according to one of claims 1 to 3, characterised in that the second visualisation means are formed by at least one second indicator element (20).

8. A display device for dispensers (Sp) of pharmaceutical portions (Ta) according to claim 7, characterised in that at least two second indicator elements (20) are provided and that the second indicator elements are switched on successively as time progresses.

9. A display device for dispensers (Sp) of pharmaceutical portions (Ta) according to claim 5, characterised in that each of said at least one first indicator element (30, 40) and/or each of said at least one second indicator element (20) corresponds to a period of equal size.

10. A display device of a dispenser (Sp) for pharmaceutical portions (Ta) according to any one of claims 1 to 3, characterised in that the first visualizing means comprise a first area and a second area spatially delimited from the first area, the second area being adapted to show that the predetermined third time has elapsed.

11. Display device for a dispenser (Sp) for pharmaceutical portions (Ta) according to one of claims 1 to 3, characterized in that it additionally comprises a display (50, 54) of the number of pharmaceutical portions that have been taken during an administration cycle.

12. Display device for a dispenser (Sp) for pharmaceutical portions (Ta) according to one of claims 1 to 3, characterized in that it additionally comprises a display (60) for interruption of administration.

13. Display device for a dispenser (Sp) for pharmaceutical portions (Ta) according to claim 12, characterised in that the display (60) for interruption of administration comprises a display (50) for the number of days of interruption of administration.

14. Display device for dispensers (Sp) of pharmaceutical portions (Ta) according to claim 12, characterised in that the first and second visualization means display the time period elapsed between two reference administration times during the interruption of the administration.

15. Display device for a dispenser (Sp) for pharmaceutical portions (Ta) according to one of claims 1 to 3, characterised in that the display (1) additionally comprises an indicator element (82) for an alarm sign of the lack of contraception, which alarm sign is displayed on the display (1) if the following conditions are met:

a) failure to administer at least one drug portion for at least one day results in a missed administration period, which is defined by

i) A missed administration period following the first administration period of uninterrupted administration of the drug portion for at least 7 days,

ii) a missed administration period prior to a second administration period required to uninterrupted administration of the drug portion for at least 7 days,

iii) no medication portion is taken on at least one day of the missed administration period,

iv) an uninterrupted administration period of at least 7 days is not included in the missed administration period,

v) no medication portion is taken on the first and last days of the missed administration period, and

vi) a missed administration period lasting more than 7 days;

b) the first day of alarm symbol occurrence is day 8 of the missed administration period;

c) the last day of occurrence of the alert symbol is day 7 of the second administration period, which follows the missing administration period and involves uninterrupted administration of the medication portion.

16. Use of a display device according to one of the claims 1 to 15 for monitoring the portion of hormone preparation administered from the dispenser (Sp).

17. The use of claim 16, said hormone formulation portion being a contraceptive portion.