GB2263570A - Drug reminder - Google Patents

Abstract

An improved reminder means comprises an alarm clock which can be deactivated or held-off by sensing changes in the ambient conditions. It has sensors [1-3] which detect changes in the ambient conditions (mainly light and sound) and switches which allow the user to interact with the device. A timer [4] provides inputs to the control electronics [5]. The control electronics may be programmed for differing frequencies of reminder. The control means (typically a micro controller) decides whether to suppress or activate the reminder based on the ambient conditions. For example, if the device is in a dark place such as a bag or coat pocket it will not sound its alarm until the bag is opened and the device is presented to the light. The reminder is given using the output means [6] (usually an piezo electric sounder) which may on occasions be used as a sensor as well. A power supply [9] is needed and may be a solar cell or battery. In preferred embodiments the solar cell provides the optical sensing facility. <IMAGE>

Description

Drug Reminder Field of the Invention The present invention relates to active reminder means used in association with product packs and, in particular, to means which may be mounted on a pack to remind the user to take a drug.

Background to the Invention Many modern drugs have a requirement to be taken regularly. The contraceptive pill and other chronic drugs must be taken regularly to function correctly. Some drugs such as antibiotics require the user to complete the course in order to retain the efficacy of the drug in the future. Other common drugs, such as aspirin, may provide protection against cervical cancer if small doses are taken daily. As many people forget to take drugs on a regular basis - despite the fact that their life may depend upon it - it seems sensible to provide an active reminder means with the drugs.

Known drug reminder means are little more than alarm clocks. A timer is set to go off at prescribed intervals and the user takes an action and then resets it - this is an active reminder, it rings! A well known example of a passive reminder is the proverbial knot in a handkerchief. Every time that the handkerchief is used the knot is noticed and a reminder is made of some action which needs to be taken or avoided.

Existing systems have problems: An active system gives its alarm regardless of whether there is anyone present to hear it. Worse still when it is particularly unwelcome - in a cinema or at a business meeting. Passive reminders are often overlooked or ignored.

In general, reminders indicate to the user that they should perform an action while warnings stop the user doing something.

However, very important reminders may be considered to be warnings. Throughout the text 'warning' may generally substitute for 'reminder'.

It is an object of the present invention to provide a substantially improved reminder which responds to environment and/or to time and/or to the action of taking the drug. This reminder combines both active and passive concepts.

According to the present invention there is; one or more sensor means sensitive to ambient conditions such as; light, temperature, sound, vibration, electrical signals and the state of switches; a timer or clockicalendar means; a control means which may include memory; and one or more output means. The control means is capable of making decisions as to the most appropriate point at which to make a reminder based on one or more of; inputs from the sensor means, time, program or logic and its memory of past history. In this way the user may be reminded of something without irritation or embarrassment.

An advantage of the invention is that - in situations where the precise timing of the reminder is not critical - the reminder may be given at an opportune moment so as to reduce embarrassment and improve compliance.

Another advantage of the invention is that power is saved because the output means is usually triggered in, or by the presence of the user who is quickly able to reset the reminder means into a low power state.

In a preferred embodiment: The sensor means comprises; switches, and an optical sensor. The output means is via a beeper (piezo speaker) which may also be used as the microphone. The control means, timing means and memory is embodied in an integrated circuit as may other components of the invention.

Power is derived from either a solar cell or battery. The solar cell may act as the/an optical sensor. In operation the reminder means is supplied in an optionally programmed but dormant state.

The user sets the reminder means on the first occasion by pressing the set switch, the control means responding with the output of a confirmation signal. At an appropriate point typically after 24 hours but optionally user selected - a reminder is given by-way-of an audible beep.

Preferably, changes in the ambient conditions are sensed and used by the control means to determine when to make, or delay, the reminder. In the case of an optical sensor changes may include light level and the sudden transition from light to dark typically characterised by human actions such as; the switching of a light, the drawing of curtains or the opening of a drawer. The control means may contain adaptive filtering so as not to be triggered by the slow changes in light produced, for example, by the normal motion of the sun. The control means may be sufficiently sophisticated not to go off in very low light levels (which might indicate a cinema or theatre) even though a dramatic change from near zero to low light level has occurred. By use of a memory the control means may continuously calibrate the threshold light level indicative of suitable conditions to provide the reminder.

Preferably, the light sensor may comprise a solar cell capable of providing sufficient power when the output means is operational.

Sufficient power is stored in rechargeable means to provide power at all other times. In which case increases in light falling on the sensor/power means cause both the reminder to be activated and provide power for the output means.

Preferably, the beeper may be silenced by pressing the early/cancel switch. On occasions when the coming reminder is unnecessary - the user may have already performed the task for which the reminder is to be given - pressing the early/cancel switch cancels the next reminder. Thereafter operation continues as before. The early/cancel switch may be disabled for a period after operation so that the user cannot cancel the next reminder by mistake by pressing the switch twice in succession.

Preferably, the control means operates the beeper for short periods of time, in order to conserve power and avoid embarrassment. Initially the beep is unobtrusive. If, after a time, the control means receives no cancel signal and the conditions are still appropriate the beep changes in one-or-all-of; volume, pitch, duration, and rapidity. After this cycle the beeper remains silent for a time, repeating when another external signal is detected or after a period of time depending on the mode selected.

It may be that the reminder is missed. In some cases the control means - acting on information collected from the sensor means disables the output means for the complete period of the timer. In other cases the output means may go unnoticed and the control means receives no cancel signal. In these cases, it is preferable that the next reminder indicate both a reminder for the current time period and also a warning that the last reminder was missed. This is normally by-way-of a distinctly different audible tone or optical signal.

Preferably, pressing both switches simultaneously for an appreciable time may produce a short confirmation signal and reset the control means to its dormant state.

Preferably switches are of the normally open spring return type but alternatively they may be of other types, in particular a conductive track printed upon a surface which may easily tear, so breaking the connection.

Alternatively, the piezo speaker (beeper) may also act as a microphone (although one may be separately fabricated). Thus sound levels may be used instead of, or in conjunction with, changes in the ambient lighting conditions. The reminder may be delayed if: sound levels are too loud for the bleeper to be heard, if sound levels indicate an activity should remain uninterrupted or if sound levels indicate that the bleeper is in a container from which sound can not emanate. The reminder may be made when sound activity indicates the proximity of a user.

Optionally, the sound characteristic of handling might be used either to reset the control means or to hold the output on until such time as it has been clearly reset by user. Also, the large signals generated from tapping directly on the microphone may be used to replace the functions of the switches. Also, power may be derived from rectifying the AC signals derived from the microphone due to natural sound levels impinging upon it in its rest state.

The audio sensor means may be linked to a series of filters and/or to a means of measuring the intensity of the sound. Each filter gives an output co-responding to a particular frequency range. Handling or close proximity is characterised by sounds of high pitch and intensity, and short period. Speaking is characterised by medium pitched sounds of a moderate level which continue for some time. The control means may distinguish between these differing ambient conditions to determine when to make the reminder.

Alternatively, the control means may use a memory which logs details of operation and may have sophisticated means of output such as a two wire serial link. In this way the user or another interested party may later make use of the stored data.

Alternatively, the sensor means may respond to the rapid motion or changing proximity of a nearby object such as the human body using common sensing means such as capacitive or inductive proximity sensors, vibration sensors and such like.

Alternatively, the reminder means is reset by the action of opening, by incorporating sensors into the pack closure system (lid) or, in the case of some tablets, into the blister-pack structure. In particular by using electrically conductive lines on the pack whose electrical characteristics (capacitance, resistance, continuity) vary as the pack is used up.

Alternatively, by the incorporation of sensor means who's output varies with temperature, the reminder means may log time against temperature over a period. The mathematical integration of this record using an appropriate function relates to total energy input to the pack and also to the rate of bacterial growth within the pack. The output means gives an indication as to whether a safety limit has been reached.

Alternatively, the control means may incorporate a speech synthesizer so that verbal instructions may be given to the user via an output means.

Alternatively, the output may be by way of other means; a flashing light, electrochromic or liquid crystal display, other visual signal, mechanical vibrations and physical changes in structure or composition. In such cases it is relatively simple to substitute appropriately for references above to audible outputs (beeps). Combinations of output means may be necessary for reminders of different activities, giving information or providing degrees of warning.

Alternatively, the sensors or outputs may be linked by a radio, telephone or other means of remote communication. In this way inputs and outputs may be located some way from the operation of the control means.

Applications of the Invention The reminder means, in accordance with the present invention, may be used in many applications. For example, in a tamper evident closure, in a drug compliance aid, as a promotional gimmick or in clinical trials as a method of collecting data on drug use.

In the application of a drug compliance aid. The reminder means may be placed by the bed side light of the drug taker, the drug pack might be in a nearby drawer. If a reminder is due entering the bedroom and turning on the light activates the reminder means. Alternatively, forgetting to take their drug they turn their bedside light off and are given a reminder. The reminder means could be placed in any suitable location; in the bathroom by the mirror or in a make up bag. In each case the sudden change in light level caused by the user activates the reminder.

In the same application the pack may be transported around by the user in a receptacle such as a handbag, briefcase or jacket pocket.

The reminder means is attached or built into the outside of the pack such that its sensors are able to monitor the ambient conditions. The control means contains an algorithm for determining when to make the reminder. If light and/or sound levels are low and are not changing this indicates that the device is held within the receptacle. If light levels and sound intensity suddenly rise this indicates that the receptacle is being opened.

If light sensor levels fluctuate considerably around these high levels then the control means may determine that considerable levels of activity are present. If a reminder is due it is appropriate to give it at this point. By means of these simple logical rules the device does not go off in quiet theatres, at dinners or during business meeting, but waits until the user takes some action such as opening a handbag to find their keys.

It may also be adequate to keep the reminder device attached to some other item than the drug pack itself. This could commonly be a key-ring, wallet or other personal effect. The advantage is that these items are commonly used everyday. The disadvantage is that the drug pack may not necessarily be present at the time of the reminder. In some cases it may be sensible to have a third switch (remind me later) which allows the user to cancel the alarm for a period of time but be reminded again when they might have the drug pack at hand.

In the application of reminding a person to take a contraceptive tablet the reminder means is either integrated into the construction of the pack or attached to the pack by the user. Some contraceptive tablet packs - commonly called 'the 28 day pill use placebos in order to keep the user in their daily rhythm '. In this case a calendar facility is not necessary. More normally, in the case of a '21 day pill', the first use triggers both a 24 hour timer and a 28 day cycle. No alarms are given during the pill free days - when menstruation occurs. On the 29th day the alarm sounds at the normal time in order to remind the user to begin their next course. The reminder means could be unclipped or unscrewed from the existing pack and transfered to the new one.

If the cancel button is not pressed - indicating that a dose has been missed - the next alarm will be different indicating the need to take alternative precautions. The reminder means might incorporate a liquid crystal display of day and/or date to give further assurance to the user that they were taking the pill correctly.

In applications where drug compliance is very critical the sensor means may attempt to ensure that medication is taken. This might be by sensing the opening of the pack or other indication of compliance such as extreme vibration or sudden changes in the ambient light level. In a screw-top jar; by either an optical sensor, pressure switch or other common sensor means. In a blister pack; optionally by means of electrically conductive lines printed on the flat side of the pack. These lines being broken or otherwise disrupted from their normal state by the breaking of the membrane protecting the tablet.

Description of the Drawings The invention will now be further described by way of example with reference to the accompanying drawings, in which: Figure 1 shows schematically the elements of improved reminder means in accordance with some embodiments of the invention.

Figure 2 shows schematically a form which the invention may be presented to the user.

Figure 3 shows schematically a block diagram of one embodiment of the invention using sound as the primary sense.

Figure 4 shows schematically the output from an optical sensor in typical operation.

Figure 5 shows schematically details of fabrication using formed plastic.

Figure 6 shows schematically the different wirings which might be used in order to detect the taking of pills from a blister pack.

Figure 7 shows schematically the block diagram of one embodiment of the invention which possesses both audio and optical sensing means.

Referring now to the figures: Figure 1 shows in broad outline the elements required to construct an improved reminder means. The sensors [1-3] and the timer [4] provide inputs to the control electronics [5]. The control electronics may be programmed for differing frequencies of reminder through a simple interface using the switch lines. The control means decides whether to suppress or activate the reminder. The reminder is given using the output means [6] which may on occasions be used as a sensor as well. A power supply [9] is needed and may be a solar cell or battery. In preferred embodiments the solar cell provides the optical sensing facility.

Figure 2 shows a method of providing an embodiment which can be affixed by virtue of a self adhesive backing [1,2]. The sensors are effectively limited in range and so have a roughly described area of operation. An embodiment may be attached or fabricated within a clip which can be attached to a variety of objects without inflicting any damage. One example of such a clip is described simply as a pair of opposing jaws [5] with a pivot [6] and a spring [7] with the device set into the handle.

Figure 3 shows one embodiment of an electronic reminder. A piezo sounder [4] is used as a microphone, loudspeaker and a power source. The silicon chip [3] contains circuitry which may discriminate appropriate levels and frequencies of sound. The two switches (which in this instance are of the normally open, spring loaded variety) work as set and early/cancel as described earlier.

Pressing both switches simultaneously performs a reset. When initially fabricated the switching lines may be used as inputs in order to 'blow' fusible links which program the control means for one of a number of specific tasks. Once the control means is programmed the switch lines become normal switching inputs. On more sophisticated versions the application of specific signals to the switching lines may initiate a state where data is read using a simple serial link.

Figure 4 shows simply the variations in light which might be encountered by the reminder means when placed on a bed side table. The intensity of light falling upon the sensor [6] varies with the time of day [5]. Time intervals are indicated along the top of the graph [1-4]. These time intervals might be characterised as follows; In the morning the curtains are drawn letting light flood into the room [1], however a reminder is not due for some time. As the day progresses the light level rises and then begins to fall [2]. The bedside light is turned on [3] and then off [4]. At this point in time the control means recognises that the lighting conditions have changes dramatically (suggesting human presence), that it is time to give a reminder and that the reminder has not been cancelled. The reminder signal is given.

Figure 5 describes one method of fabrication using formed, printed plastic. It is made from a plastic such as polystyrene [7] which may be heat formed into a three dimensional shape as broadly described by the diagram. Six major cavities are required for the active components of the reminder means; a battery compartment [5], two switches [1], a piezo sounder chamber [3], a compartment for the microchip [2] and a transparent window for.

the light sensor [6]. Layers of conductive and insulating ink are printed onto the bottom surface of the plastic to form circuitry in similar fashion to surface mount PCB fabrication. A layer of glue is selectively printed to the underside and the plastic stuck onto a conductive surface [8]. This surface forms the other conductive path (earth) for the battery and switches. The switches [1] are respectively closed when localised pressure on the plastic moulding presses the conductive tracks [4] printed on the underside of moulding against the conductive surface [8].

The lower surface may either be a label or the pack itself. In the case of a label the bottom layer may be self adhesive, magnetic or fabricated as a clip [see figure 2]. The clip-on reminder means may thus be transfered from pack to pack as each pack is completed, or attached to something convenient. The microchip is attached using standard chip on board techniques and may be protected by an epoxy cap.

Figure 6 describes a variety of methods for running sensing wires to the blisters in a blister pack to detect that a tablet [5] has been removed. The reminder means [1] is linked to each blister by a wire fabricated in conjunction with the sealing membrane [6].

There are several differing wiring configurations: In the first case [2] there is a common wire and a sensor wire to each blister.

In the second case each blister may have a complete loop passing through it [3]. Alternatively, a single wire of measurable resistance [4] passes across all the locations in the reverse order to that in which they should be taken. The sensor means measures the length of the wire; either through its resistance, capacitance or other electrical characteristic. A combination of the above may be used.

Figure 7 describes one embodiment of the device where both sound and light sensor means are employed. Most of the functions can be fabricated on single ASIC. The control means [5] obtains inputs from the sensor means [2,13] via amplifiers [1, 11]. The light sensor 2 also produces electrical power which can be diverted to charging the battery [3] by means of a control signal.

The piezo device [13] may act as both a speaker and a microphone.

When used as a microphone inputs may either be squared up via a schmitt trigger [10] and input directly to the micro-processor or passed through one or more filters [8]. The output of these filters is rectified and converted to a suitable form for input to the microprocessor/logic. In this case by a voltage to frequency converter [7] but optionally by a variety of other means such as analogue to digital converters. A clock calendar function is provided by the logic algorithmically with reference to an oscillator, in this case a ceramic resonator. The memory may be of either fixed (ROM) or variable (RAM) form such that a variety of options for the alarm period can be stored in the same device and programmed through a switching line [14,15].

Claims (8)

Claims

1. A reminder/warning device which senses changes in the ambient conditions, such as light, sound, proximity, capacity and capacitance in order to initiate or hold-off an alarm.

2. A device as claimed in 1 where the alarm is additionally triggered with respect to time.

3. A device as claimed in 1 where the alarm is held-off due to the sound characteristic representing a situation which might be embarrassing.

4. A device as claimed in 1 where a clip or sticky pad is used to attach the reminder device to a thing or position which will be regularly encountered by the user thus providing a reminder zone in which a reminder will be made if the user enters that space or comes near a specific object.

5. A device as claimed in 1 where a combination of light, sound and other sensors are processed by an algorithm to determine the most appropriate moment to make the reminder.

6. A device as claimed in 1 where the output means can remind and instruct the user to follow a regime of medication i.e.

take a drug at predetermined times of day.

7. A device as claimed in 1 where the output means can indicate the authenticity or integrity of a container to which the device is attached with reference to sensors placed on or in said container

8. A reminder device substantially as described herein with reference to the figures and drawings.