GB2145699A - A device for monitoring the use of medicines - Google Patents

Abstract

A device for monitoring the use of medicines comprises a clock (B) which is settable to activate an audible or visible signal (J). In one embodiment a counter (L) and second timer (M) are incorporated and are settable independently of the clock (B) to energise the signal (J) at chosen intervals throughout a "day" commenced by the "alarm setting" of the clock (B). The device may include a container for medicines (not shown) a lid of which is controlled by a solenoid (H) in such a way that the lid can only be opened by pressing the button (F) at times when the signal (J) is energised. Alternatively, latch (E) of the circuit automatically unlocks the lid at the "alarm setting" of the clock (B), or when the second timer (M) times out, enabling the container to be opened manually. <IMAGE>

Description

SPECIFICATION A device for monitoring the use of medicines This invention relates to a device for monitoring the use of medecines.

The volume of drugs routinely prescribed in this country is staggering, and constantly on the increase. Deliberate drug abuse is a serious social problem, but is not the one toward which the present invention is aimed. Irrespective of the ethical considerations it is not considered feasible to prevent, by means of a commercially available device, a deliberate and determined attempt at suicide.

However, there is much evidence that overconsumption of sleep-inducing ortranquillising drugs is frequently inadvertent, especially on the part of the elderly and confused and these are, of course, the major consumers of such drugs. Accidents occur because a person who habitually takes a sleeping pill at night has no record of whether or not they have done so, on a particular occasion. Such a person is unlikely to know exactly how many tablets or capsules ought to be in the bottle if that night's dose has already been taken. In a typical scenario an elderly, infirm person suffering a wakeful night will take a second dose an hour or two from the first because they cannot remember having already performed the habitual action that night.The effect of the drug itself reinforces memory impairment and confusion to the extent that a third dose is more likely to be taken than was the second. Thus a vicious circle is originated which can result in massive, and quite unintentional, overdose. Even when elderly people are in care it may not be easy for those in charge of their medication to ensure that each patient only receives the correct dose at the correct time, especially since the patients themselves may give misleading information either through genuine error or in an attempt to obtain more than the proper dose.

In addition to those taking sleeping tablets, whose faculties may be impaired, there is another class of drug user that experiences difficulties at the present time. Patients suffering from certain conditions are obliged to take drugs at prescribed intervals. It may equally be harmful either to omit a dose or to exceed it, but confronted by a series of containers or packages the patient must exercise abnormal selfdiscipline and abnormal ingenuity to ensure that the prescribed regimen is strictly adhered to. For example, the doses for a particular day may be isolated in a separate container, and the alarm of a watch reset to time the taking of doses throughout the day. This is very onerous for the average individual and a mistake or omission will easily occur.

The present invention has for its principal object the provision of solutions to these problems.

In accordance with one aspect of the present invention there is provided a dose monitoring device for medicinal use, the device comprising a container for a medicinal product, the container comprising a mechanism actuableto give access to orto dispense a dose of the product and means for measuring lapse of time which co-operates with said mechan ism in such a way as to impede actuation of the mechanism until a predetermined time interval has elapsed.

In accordance with another aspect of the present invention there is provided a dose monitoring device for medicinal use, the device comprising a container for a medicinal product, the container comprising a mechanism actuable to give access to or to dispense a dose of the product, said mechanism being controlled by a time-measuring means which permits the actuation of said mechanism only at a predetermined time or times.

The mechanism may comprise a lock for the container which is unlocked by the time-measuring means to allow the container to be opened by manual operation of said mechanism.

Alternatively, the mechanism may be under the control of an electrical circuit which can be cam pleted to open the container only during predetermined time periods established by the setting of said time-measuring means.

The container preferably comprises means for producing a visible or audible signal connected to said timing means in such a way as to indicate when said mechanism may be actuated, or may be actuated without impedence.

Said timing means preferably comprises a clock and means for producing a signal to influence said mechanism at one or more instants in the twentyfour hour cycle of the clock.

The said-producing means preferably comprises a second time-measuring means additional to the clock and a counter arranged to control the number of times, within a given cycle of the clock, that the timer will operate, the counter being responsive to a signal received from the clock.

The clock preferably displays current time exteriorly of the container and means is preferably provided actuable exteriorly of the container for temporarily exchanging for the current time display a display of the time setting of said signal-producing means.

In accordance with yet another aspect of the present invention there is a dose monitoring device for medicinal use, the device comprising a clock, audible or visible signal generating means, a counter and a second timer, the arrangement being such that within a predetermined part of the twenty-four hour cycle of the clock the second timer is activated a number of times selected by the counter, the signal generating means being activated in response to the timing out of the second timer, the counter and/or the second timer re-settable independently of setting means for the clock.

Said time measuring means or clock preferably comprises a twenty-four hour alarm clock microprocessor module with a liquid crystal display.

Afeedback loop incorporating a pulse shaper adapted automatically to reset the alarm module after each "alarm" signal of the clock is preferably provided.

In one embodiment of the invention in which a container is provided a solenoid is arranged to be actuated by a signal produced by said timemeasuring means thereby to permit manual actua tion of said mechanism to open the container. A lid of the container is adapted normally to be held closed by a spring-loaded bolt accessible from outside the container to displace the bolt against its spring bias to release the lid, and the solenoid is arranged, when energised, to release a latch which normally prevents movement of the bolt in the lid-releasing direction.

In another embodiment of the invention in which a container is provided the container has a lid adapted normally to be held closed by a spring-loaded latch, the latch being displaceable against its spring bias to release the lid when a solenoid associated with the latch is energised, the electrical circuit of the solenoid including a switch and being under the control of said timing means in such a way that actuation of the switch will cause energisation of th solenoid to release the lid only at a time or times controlled by said time-measuring means.

Embodiments of the invention will now be described by way of example, with reference to the accompanying diagrammatic drawings, in which: Figure 1 is a perspective view of a container in accordance with the invention with its lid open, Figure 2 is a side elevation of a mounting panel indicated at II in Figure 1 when removed from the container, Figure 3 is a partial view on an enlarged scale taken generally on the line Ill-Ill of Figure 1, and with the lid of the container closed, Figure 4 is a circuit diagram of the electrical components mounted on the circuit board indicated at IV in Figure 2; Figure 5is a partial view similar to Figure 3 but illustrating a modification in which release of the lid is effected manually after electrical unlocking, and Figure 6 is a partial view, on an enlarged scale,; taken on the line VI-VI of Figure 5.

The container 10 of Figure 1 is in the form of a box which has a base (not shown), front and rear walls 11 and 12 and side walls 13 and 14. The open top of the box can be closed by pivoting downward a lid 15 about a hinge pin 16, and wound round the hinge pin is a wire spring 17 which reacts between the lid 15 and the rear wall 12 of the box to bias the lid to the open position shown. The lid 15 is flanged along its front and side edges, and releasably connected to the side flange 18 by screws 19 is an L-shaped member 20 providing an inwardly-projecting lip.

Inside the box there is removably mounted by screws (not shown) a mounting panel 21 which divides the interior of the box into a rear compartment available to be filled e.g. with capsules or tablets, or a bottle or package containing the same, and a forward compartment in which is accommodated a rechargeable battery 22, a solenoid 23 and a circuit board IV which carries, interalia, a micro switch 24 and a twenty-four hour alarm clock microprocessor unit 25 having an LCD display.When the circuit board IV is mounted in spaced relation to the panel 21 by screws 26, as shown in Figure 2, and the panel 21 is mounted in the box, components on the board IV will be in register with respective holes in the front wall 11 and the side wall 14 of the box, so that the LD display of the clock 25 will be visible, the micro switch 24 will be accessible, a lamp 27 on the circuit board will be visible and also sockets 28 and a button 29 will be accessible whether the lid 15 is open or closed. The clock 25, energised by the battery 22, will constantly display current time.

When the button 29 is pressed the LCD display will temporarily change to that of the "alarm" setting of the clock, enabling the user readily to ascertain when next the box can be opened. This alarm setting, as well as adjustment of the clock, is effected by plugging into the sockets 28 the male elements of a remote setting unit (not shown) which is provided as a separate item.

When the desired contents have been placed in the rear compartment of the box it is closed by depressing the lid 15. In the course of closing the lip 20 of the lid engages the chamfer 30 on the upper side of the leading end of a bolt member 31 (see Figure 3). This is mounted in a slide 32 fixed to the upper surface of a flange 33 of the panel 21 in such a way that the member 31 can be displaced to the left as viewed to allow the lip 20 to pass, and will then spring back the locking position as shown in Figure 3 under the influence of a compression spring 34. The lid is thus held closed. When the solenoid 23 is energised it draws the member 31 back to the left as viewed, against the action of the spring 34, enabling the lid 15to fly open under the action of the spring 17.Because, as hereafter explained, the action of the solenoid 23 is momentary a flexible pawl is provided to co-operate with a ramp 36 on top of the slide member 31. The pawl 35, which is suitably of a resilient plastics material, is fixed to the inner surface of the front flange of the lid 15 in such a position that it will engage the ramp 36 of the slide member 31 and hold the latter in the retracted position long enough (after the solenoid is deenergised) to allow the lid 15 to open. As soon as the lid 15 opens, of course, the pawl 35 releases the member 31 allowing it to return to the position shown under the influence of spring 34. The pawl 35 is so positioned that the reciprocative movement it undergoes when the lid 15 is closed is insufficient to cause pawl 35 to relatch the member 31.

The electrical components of the device mounted on the circuit board IV and the way in which they cooperate will now be described with reference to the circuit diagram of Figure 4: The control unit B (marked 25 in Figures 1 and 2) is a twenty-four alarm clock module with a liquid crystal display. The time of day and "alarm" setting can be changed by using a plug-in setting unit A.

At the required time the alarm output signal is fed via gate D to a latch E. This is indicated to the user by means of the flashing light J (27 in Figures 1 and 2).

The flasher circuit I causes the signal to operate with short bursts at a repetition rate of approximately once per second. This is done to conserve the power of the battery 22 and to make the signal more apparent.

Whilst in this condition, it is possible to activate the solenoid H (23 in Figures 1 - 3) by means of the push-button F (24) and a driver circuit G, thereby releasing latch 31.

In order to conserve battery power, a delay circuit K is incorporated in the feedback circuit which resets the latch E such that a single pulse only is fed to the solenoid H (23). Having operated the push-button F (24), the latch E is reset and awaits the end of the next time period.

When a signal appears at the alarm output, it also activates a pre-set counter L and a second timer M.

The purpose of these two units is for use of the box more than once in twenty-four hours, e.g. to obtain access to the box say three times in the course of a day. On being activated, pre-settimer M times out for the required interval (say four hours) and its output is fed via gate D to the latch E and the release mechanism as before. The counter L is advanced and timer M reset. The system repeats as often as necessary. Should only once per day operation be required, then elements Land M may be omitted from the device or a switch (not shown) may be provided to isolate their part of the circuit.

Afeedback loop with a pulse shaper N is provided so that the alarm module B (25) is re-set each time it is used.

The battery 0 (22) of appropriate voltage and capacity may be of either a primary or secondary type. Storage device C is included to prevent the settings being disturbed when the battery is exchanged. Test facilities can be provided on the remote setting unit A to check battery state.

The clock 25 is set for correct time using a remote setting unit (not shown in Figures 1 - 3) plugged into the socket 28. This is also used to provide the clock with a chosen "alarm" setting (corresponding with the time of day when it is next desired to gain access to the box 10) and in the meantime, while the box remains closed, the "alarm setting" of the clock can be checked at any time by pressing button 29. At the preselected moment the "alarm" of the clock 25 generates a signal which makes the lamp 27 commence to flash, indicating that the box 10 may now be opened by pressing the button of switch 24 (previously pressing the button of switch 24 will not cause the box 10 to open). If the button of switch 24 is pressed while the light 27 is illuminated the solenoid 23 will be energised and at the same time the lamp 27 will go out.The solenoid 23 causes the lid 15 of the box to open and it is up to the user whether and how soon to reclose it, although usually it will be reclosed as soon as a dose has been taken out of the box. If the circuit of the counter Land th second timer M are operative the system will be primed again as soon as the second timer M times out, and this will recur the number of times selected by the counter L. On conclusion of a cycle representing one day control reverts back to the clock module B or 25. Alternatively, if the circuit of counter L and second timer M are isolated or omitted the system is primed once a day by the "alarm" setting of the clock module B or 25.

The box 10 can thus be used for a variety of purposes. If used to contain sleeping tablets or capsules the circuit of the counter Land second timer M will be omitted or switched off. Once a day, e.g. at a suitable time in the evening, the "alarm" of the clock B or 25 will illuminate the lamp 27 indicating to the user that a dose may be taken if desired . After the box has been opened by pressing the button 24 and reclosed the lamp 27 will not light again until the same time on the following day and pressing the switch 24 will fail to open the box. This alerts the user to the fact that the box has already been opened within the previous twenty-four hours and therefore, presumptively, that a dose has already been taken.

In the alternative use of the box which utilises the circuit of the counter Land second timer M the light 27 will flash at chosen intervals, say four hours, throughout a given day (but not throughout the following night) advising that a dose is due. Illumination of the lamp and readiness of the box to open when the button 24 is pressed advises the user that a dose is due, or overdue, and has not yet been taken.

Conversely, non-illumination of the lamp and unwillingness of the box to open is evidence that a dose has been taken within the previous preselected time period.

The lip 20 is held onto the lid 15 by removable screws 19 in case of failure of the mechanism for any reason or to gain access to the box when it is not normally openable. By removing the screws 19 the lid 15 is released from the slide member 31 and will open.

If the pulse administered to the solenoid H or 23 were of sufficient duration the pawl 35 and cooperating latch formation 36 on the slide member 31 could be omitted. This would be feasible if, for example, the device were provided with a power source less exhaustible than the battery 0 or 22, for example if it were mains operated through a suitable transformer (not shown).

It will be appreciated that the lamp 27 is not essential ana may be omitted. Willingness of the box to open itself provides an indication that the requisite time period has elapsed. Nevertheless a signal such as is provided by the lamp demonstrates that the unit is functioning properly and, in the latter of the two types of use discussed, provides a warning that a dose should be taken. In suitable cases the lamp 27 would be replaced by an audible signal generator. This would be more useful for blind persons and if the unit were small enough to be carried in a pocket or handbag by sufferers who, while carrying on a normal life and travelling about, must take medicines at intervals throughout the day.

For the benefit primarily of such persons an embodiment of the invention is envisaged which lacks a container for medicinal products altogether.

This device is not illustrated but its circuitry would be generally as illustrated in Figure 4 except that the solenoid H or 23 and associated push button For 24 will be omitted and a pulsed visible or audible warning signal generating means will be directly under the control of the latch E. Means (not shown) is provided for de-activating the signal generating means when it has served its purpose in alerting the user, but is such that the signal generating means will be re-energised the next time the second timer M times out, or at the initial setting of the clock B or 25, whichever next occurs.

Lacking a container and any electrical/mechanical interface to control a mechanical lock or latch such a device could be made small and compact enough to be readily portable and the elimination of moving parts would lend itself to modern, low-cost mass production.

As thus described the "container-less" embodiment of the invention would resemble a microprocessor wrist watch and would have functions in common such as an "alarm" and a "lap counter" re-settable separately from the clock. It differs, however, in that the function corresponding to the "lap timer" is automatically re-set whenever it "times out" a number of times controlled by a counter, and whenever it "times out" it activates the "alarm". The resetting of a wrist watch alarm, say three times within the twelve-hour portion of a twenty-four hour clock corresponding to the day, is a laborious business which the average patientwill not trouble with, primarily because the "alarm setting" must be re-set each time the alarm has been triggered and the setting can be advanced, at the quickest, by hourly intervals.

By the device of the invention, by contrast, the second timer is separately adjustable to activate the "alarm" at the end of a selected period (say four hours) and the counter is separately adjustable to select the number of times (say three) that the second timer will time out following an initial signal from the clock corresponding to the beginning of the day. There is thus no need for the user to re-set any of the controls unless the clock itseld needs adjustment or there is a variation in the frequency of doses throughout the day. In the latter case only the second timer or the counter, or both, will be suitably re-set. A device according to this embodiment of the invention could be carried in a pocket or handbag, or indeed worn on the wrist either as well as or as a substitute for a wrist watch.

Figure 5 illustrates an embodiment of the invention which differs from that of Figures 1 - 3 in that the lid 15 of the box is released manually, rather than by the action of the solenoid 23. In most respects, however, this embodiment resembles the previous and common parts have been given the same reference numerals. In Figure 5 the slide member 31, under the control of the solenoid H or 23, is movable vertically and is mounted on the inside of the wall 14 of the box where its chamfered, leading end may engage in a corrspondingly-shaped notch 37 in a bolt 38. This is mounted in the box 10 to be movable to the left, as viewed, when a knob 39, accessible outside the closed box, is pressed.Movement of the bolt to the left against the action of a compression spring 40, which reacts against the wall 13 of the box, disengages a lug 41 of the bolt from the lip 20 of the lid 15, allowing the lid to open. It will be apparent that the bolt 38 cannot be moved in the lid-releasing direction as long as the slide member 31 is engaged in the notch 37. When the timer device (module B or 25 or M) causes the solenoid H or 23 to be energised the slide member 31 is withdrawn from the notch 37 and to prevent it from re-entering as soon as the solenoid H or 23 is de-energised a compression spring 42, between wall 14 and the bolt 38, shifts the bolt 38 to the left, as viewed, a distance insufficient to release the lid 15 from the lug 41.This small movement of bolt 38, contrary to the spring 40, is possible because the spring 40 is connected to the bolt 38 by a pin 43 which is engaged in an elongated slot 44 in the bolt, and it suffices to ensure that when the solenoid H or 23 is de-energised the slide 31 will, when attempting return movement under the influence of spring 34, encounter not the notch 37 but a smooth part of the bolt 38 between the notch 37 and the knob 39. It is thus now possible, when desired, to move the bolt 38 to the left, as viewed, sufficiently to release the lid 15 from the lug 41, against the action of the spring 40.As the lid 15 is reclosed first the bolt 38 is momentarily moved to the left, as viewed, to allow the lug 41 to re-engage the lip 20 and then the bot 38 is moved to the right, as viewed, sufficiently to allow the slide member 31 to engage in the notch 37 by the co-operation of a cam extension 45 on the bolt 38 with a cam extension 46 on the underside of the lid 15. As well as re-engaging the slide member 31 in the member 3 in the notch 37 this rightward movement of the bolt 38 re-compresses the spring 42 ready to displace the bolt to the left when next the solenoid H or 23 is energised.

The circuit diagram for the embodiment of Figure 5 resembles that of Figure 4 except that the "push button F" is omitted because the box is opened by manual operation of the bolt 38 instead of electrically. The solenoid H or 23 does not open the box but only unlocks it, enabling the box to be opened at a chosen time after the solenoid has been energised by the time-measuring means B or M.

It will be apparent that many modifications of the invention are possible without departure from the overall concept as expressed by the appended claims. Other electrical and mechanical expedients may be adopted, within the competence of the relevant expert, both to adapt the invention to particular uses and to facilitate the mass production of an item which can be retailed at an acceptable price. In particular it is not intended that a container in accordance with the invention must have the form of an open-topped box with a pivoting lid, or that it should be usable exclusively for medicines in a solid form. Bottles or dispensers for medicines in liquid or vapour form - for example the inhalants used by asthma sufferers - could be kept in the container or it could be modified to serve perse as a dispenser for such medicines. The controlled (i.e. suitably timed) use of dispensers for such inhalants is believed to be of great importance. Fundamentally, however, the invention provides a device which serves either or both purposes of (a) warning that a dose has been taken within a given time period, and (b) reminding when a dose ought to be taken.

Claims (2)

1. A dose monitoring device for medicinal use, the device comprising a container for a medicinal product, the container comprising a mechanism actuable to give access to or to dispense a dose of the product and means for measuring lapse of time which co-operates with said mechanism in such a way as to impede actuation of the mechanism until a predetermined time interval has elapsed.

2. A dose monitoring device for medicinal use, the device comprising a container for a medicinal product, the container comprising a mechanism actuableto give access to or to dispense a dose of the product, a latch adapted to impede actuation of the mechanism and time measuring means which controls the latch, the arrangement being such that actuation of the mechanism is impeded by the latch only for a predetermined time period after the mechanism have previously been actuated.

2. A dose monitoring device for medicinal use, the device comprising a container for a medicinal product, the container comprising a mechanism actuable to give access to or to dispense a dose of the product, said mechanism being controlled by a time-measuring means which permits the actuation of said mechanism only at a predetermined time or times.

3. A device as claimed in either preceding claim, wherein the mechanism comprises a lock for the container which is unlocked by the time-measuring means to allow the container to be opened by manual operation of said mechanism.

4. A device as claimed in claim or claim 2, wherein the mechanism is under the control of an electrical circuit which can be completed to open the container only during predetermined time periods established by the setting of said time-measuring means.

5. A device as claimed in any one of the preceding claims and further comprising means for producing a visible or audible signal connected to said timing means in such a way as to indicate when said mechanism may be actuated, or may be actuated without impedence.

6. A device as claimed in any one of the preceding claims, wherein said timing means comprises a clock and means for producing a signal to influence said mechanism at one or more instants in the twenty-four hour cycle of the clock.

7. A device as claimed in claim 6, wherein said signal producing means comprises a second timemeasuring means additional to the clock and a counter arranged to control the number of times, within a given cycle of the clock, that the timer will operate, the counter being responsive to a signal received from the clock.

8. A device as claimed in claim 6 or claim 7, wherein the clock displays current time exteriorly of the container and wherein means actuable exteriorly of the container is provided for temporarily exchanging for the current time display a display of the time setting of said signal producing means.

9. A dose monitoring device for medicinal use, the device comprising a clock, audible or visible signal generating means, a counter and a second timer, the arrangement being such that within a predetermined part of the twenty-four cycle of the clock the second timer is activated a number of times selected by the counter, the signal generating means being activated in response to the timing out of the second timer, the counter and/or the second timer being resettable independently of setting means for the clock.

10. A device as claimed in any one of the preceding claims, wherein said time-measuring means or clock comprises a twenty-four hour alarm clock micro processor module with a liquid crystal display.

11. A device as claimed in claim 10 and comprising a feedback loop incorporating a pulse shaper adapted automatically to re-set the alarm module after each "alarm" signal of the clock.

12. A device as claimed in any one of claims 1 - 8, wherein a solenoid is arranged to be actuated by a signal produced by said time-measuring means thereby to permit manual actuation of said mechanism to open the container.

13. A device as claimed in claim 12, wherein the container has a lid adapted normally to be held closed by a spring loaded bolt accessible from outside the container to displace the bolt against its spring bias to release the lid, and wherein the solenoid is arranged, when energised, to release a latch which normally prevents movement of the bolt in the lid-releasing direction.

14. A device as claimed in any one of claims 1 - 8, wherein the container has a lid adapted normally to be held closed by a spring loaded latch, the latch being displaceable against its spring bias to release the lid when a solenoid associated with the latch is energised, the electrical circuit of the solenoid including a switch and being under the control of said timing means in such a way that actuation of the switch will cause energisation of the solenoid to release the lid only at a time or times controlled by said time-measuring means.

15. A device for monitoring the use of medicines substantially as hereinbefore described, with reference to and as shown in Figures 1 - 4 or Figure 5 of the accompanying drawings.

16. An electrical device for monitoring the use of medecines utilising a circuit substantially as hereinbefore described, with reference to and as shown in Figure 4 of the accompanying drawings.

Amendments to the claims have been filed, and have the following effect: *(a) Claims 1 and 2 above have been deleted or textually amended.

*(b) New or textually amended claims have been filed as follows: New Claims 1 and 2 were filed on 15/11/84 CLAIMS

1. A dose monitoring device for medicinal use, the device comprising a container for a medicinal product, the container comprising a mechanism which, whenever actuated, provides access to the container or dispenses a dose of the product therefrom, and means for measuring lapse of time which responds to actuation of the mechanism in such a way as to impede the re-actuation of the mechanism until a predetermined time interval has elapsed.