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Description  |
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FIELD OF THE INVENTION
The present invention relates to a medication reminder system, apparatus
and method for notifying patients of the correct times during the day for
taking a medicine. The system provides a portable module carried by the
patient that alerts the patient to the time that a medication should be
taken. The portable module is programmed by an operator at a programming
station to provide the specific times for taking the medication.
BACKGROUND OF THE INVENTION
When medications are prescribed, a patient frequently does not follow the
administration instructions included with the medication. A patient often
forgets the specific time of day that the medication should be taken or
miscalculates the interval between doses which results in the patient
either taking medication too frequently, too infrequently or not at all.
This can lead to a variety of pharmacological and/or toxicological
problems to the patient which, ultimately, may result in ineffective
treatment of a disease and/or harm to the patient.
When a drug is first administered, the desired concentration of the drug in
the body is established by the prescribing physician at a level to provide
the desired pharmacological effect. For example, in the case of an
antibiotic, when the antibiotic is first administered, the concentration
of the antibiotic in the body is established at a level deemed sufficient
by the prescribing physician to kill off a proportion of the infecting
organisms. Subsequent and regular doses of antibiotic provide the desired
concentration that enables the immune system to overcome the infection.
The organisms that remain after first administration of the antibiotic are
the ones more resistant to the antibiotic than the ones killed by the
first dose. If subsequent doses of antibiotic are not administered in a
timely fashion, the concentration of the antibiotic in the blood declines
and the organisms resume active growth. Typically, if normal growth
resumes, it is those organisms more resistant to the antibiotic that are
growing thereby reducing the effectiveness of the subsequent doses of the
antibiotic.
Alternatively, in the case of a drug which may have a toxic effect in the
body above a particular concentration, a patient who inadvertently takes
such a medication too frequently may be deleteriously affected.
Accordingly, it is very important that a patient is aware of when to take
the prescribed medication and actually takes the medication at the
recommended intervals.
Frequently, patients who may need to take several different medications
during the course of a day, become confused both with the frequency and
particular medication that needs to be taken at a particular time
resulting in the above problems. These problems manifest themselves when
the patient has impaired eyesight or is in a confused state of mind.
Whereas past systems have provided patient-programmable reminder systems,
these systems do not address the needs of those patients, who, through a
lack of manual dexterity, impaired eyesight or inability to follow written
or oral instructions are either incapable of or unwilling to use these
reminder devices. These reminder devices may also permit the patient to
attempt to program a device by themselves leading to inappropriate
reminders or frustration with the device due to the complexity of the
programming task whereby the device is disregarded and not used.
Furthermore, past devices may enable tampering by unauthorized individuals
which again may lead to inappropriate reminders.
In some situations, optimum prescription times are not necessarily evenly
spaced throughout the day but are sometimes related to metabolism rates.
This requires that the interval between adjacent medications may not
always be the same which precludes the use of simple "repeat cycle" timers
that will time the same period each time it is reset. Past timers may also
limit the duration of the alarm which turn themselves off within a certain
period, usually in order to preserve battery power.
Accordingly, there has been a need for a programmable reminder system for
medications where the prescribing pharmacist has the ability to program a
simple portable module carried by the patient that ensures the correct
information has been programmed and that also prohibits the patient's from
gaining access to the stored program. There is also a need for an alarm
timer that provides a "time-of-day" alarm which will continue until the
alarm is acknowledged by the patient in order to provide specific times of
an alarm and to help ensure compliance with the reminder. As well, there
has been a need for a programmable reminder system where alarm times in
the portable module remain set until de-programmed by the programming
station in order to provide a continuous series of alarms until the module
is returned to the pharmacist.
Furthermore, there has been a need for a programmable reminder system where
a single programming station can program a plurality of portable modules
in order to provide an efficient and cost-effective distribution of
programming stations and portable modules for use by a pharmacist to serve
numerous patients. There is also a need for a system where the cost of
portable modules is low to ensure that the end cost of a medication to a
user is not substantially increased by an overly expensive and/or complex
module and base station.
As well, there has been a need for a programmable reminder system where the
portable module can be quickly programmed by the pharmacist through the
programming station with a communication link that minimizes the
complexity and, hence, the cost of the portable module. It is also
desirable to have a programmable reminder system that provides a long
shelf-life for the batteries in the portable module where the module is
put in a "sleep" mode by turning off the clock in the module when the
module is not being used between patients.
As mentioned above, there are numerous programmable reminder systems that
provide an indication that a specific period of time has elapsed thereby
alerting a user that a specific task should be performed.
Canadian Patent 1,239,024 discloses a programmable service reminder
apparatus and method for use with automobiles. This patent is not
concerned with the problems of a programmable reminder system as outlined
above. In particular, this patent does not disclose a central programming
station and portable module programmed by the central station.
Canadian Patent 1,293,382 discloses an apparatus for alerting a patient to
take medication which includes a plurality of medication compartments.
This device does not disclose a separate programming station and alarm
module and, furthermore, enables the patient to conduct the programming of
the device.
U.S. Pat. No. 5,107,469 discloses a reflectance photometer instrument for
controlled administration of insulin in diabetes management. This patent
is concerned with the problems of providing a low power alarm clock
functions in a microprocessor-based reflectance photometer instruments.
This patent does not disclose a separate programming station and alarm
module, where the alarm module is programmable by the programming station
to provide time-of-day reminders. Rather this patent is concerned with a
user initiated and activated alarm system that has been internally
pre-programmed to notify a user to perform a specific task. This patent
does not teach downloading alarm instructions to a portable module to
provide an alarm which is acknowledged by a user.
U.S. Pat. No. 4,690,566 and U.S. Pat. No. 4,218,871 disclose a portable
programmable timing device and electronic timer, respectively. These
patents do not disclose a separate programming station that provides
programming signals to the portable device.
SUMMARY OF THE INVENTION
In accordance with the invention, a medication reminder system for
reminding patients to take medications is provided, the system comprising:
a portable module, the portable module having
module microprocessor for receiving and storing alarm instructions from a
programming station, the module microprocessor also for generating an
alarm signal corresponding to the alarm instructions and for receiving an
alarm silence signal;
alarm means responsive to the alarm signal for generating an alarm;
alarm silence means for signalling the module microprocessor to silence the
alarm means when the alarm means is active;
module communication interface for communication with the programming
station;
the programming station having
programming station communication interface for communication with the
module communication interface;
programming station microprocessor for programming and downloading alarm
instructions to said module microprocessor through the programming station
communication interface and module communication interface.
In a preferred embodiment of the invention, communication between the
module communication interface and programming station communication
interface is a two-way optical serial data communication link.
In a further embodiment of the invention, the portable module further
comprises battery means for powering the portable microprocessor wherein
the portable microprocessor further monitors battery usage by a battery
usage counter, the battery usage counter responsive to elapsed time of
operation of the module in a timing mode and alarm mode.
In a still further embodiment, the module further comprises a body having a
lid means for engagement with a medication container.
In accordance with a further embodiment of the invention, a portable module
is provided comprising:
module microprocessor for receiving and storing alarm instructions from a
programming station, the module microprocessor also for generating an
alarm signal corresponding to the alarm instructions and for receiving an
alarm silence signal;
auditory alarm means responsive to the alarm signal for generating an
auditory alarm;
visual alarm means responsive to the alarm signal for generating a visual
alarm;
alarm silence means for signalling the module microprocessor to silence the
auditory alarm means and visual alarm means when the auditory and visual
alarm means are active;
module communication interface for communication with the programming
station;
In a still further embodiment, a programming station for programming and
downloading alarm data to a portable module is provided, the portable
module having a module communication interface and module microprocessor
comprising:
programming station communication interface for communication with the
module communication interface;
programming station microprocessor for programming and downloading alarm
instructions to said module microprocessor through the programming station
communication interface and module communication interface.
The invention also provides a method of programming a programming station
comprising the steps of:
a) establishing a communication link between the programming station
communication interface and module communication interface;
b) setting a plurality of dosage times;
c) downloading said dosage times to the module microprocessor.
In a still further embodiment, the invention is directed to the use of the
a medication reminder system for notifying a patient of a preprogrammed
time for taking a medication.
In a more specific embodiment, the invention provides a medication reminder
system for reminding patients to take medications comprising:
a portable module, the portable module having
module microprocessor for receiving and storing alarm instructions from a
programming station, the module microprocessor also for generating an
alarm signal corresponding to the alarm instructions and for receiving an
alarm silence signal;
visual alarm means responsive to the alarm signal for generating a visual
alarm;
auditory alarm means responsive to the alarm signal for generating an
auditory alarm;
alarm silence means for signalling the module microprocessor to silence the
visual and auditory alarm means when the visual and auditory alarm means
are active;
module communication interface for communication with the programming
station;
the programming station having
programming station communication interface for communication with the
module communication interface;
programming station microprocessor for programming and downloading alarm
instructions to said module microprocessor through the programming station
communication interface and module communication interface.
In a specific embodiment of the invention, the invention provides a
medication reminder system for reminding patients to take medications
comprising:
a portable module, the portable module having
module microprocessor for receiving and storing alarm instructions from a
programming station, the module microprocessor also for generating an
alarm signal corresponding to the alarm instructions and for receiving an
alarm silence signal;
light emitting diode (LED) alarm responsive to the alarm signal for
generating a visual alarm, the LED also for communication with the
programming station via a two-way optical serial data communication link;
piezo alarm responsive to the alarm signal for generating an auditory
alarm;
push-button switch for signalling the module microprocessor to silence the
LED and piezo alarms when the LED and piezo alarms are active;
a battery for powering the portable microprocessor wherein the portable
microprocessor further monitors battery usage by a battery usage counter,
the battery usage counter responsive to elapsed time of operation of the
module in a timing mode and alarm mode;
the programming station having
programming station LED communication interface for communication with the
module LED alarm wherein the portable module is received within the
programming station to establish communication with the portable module;
programming station microprocessor for programming and downloading alarm
instructions to the module microprocessor through the programming station
communication interface and module communication interface;
display and keypad for inputting alarm instructions to the programming
station microprocessor.
BRIEF DESCRIPTION OF THE DRAWINGS
These and other features of the invention will be more apparent from the
following description in which reference is made to the appended drawings
wherein:
FIG. 1 is a plan view of the programming station;
FIG. 1a is an end elevation of the programming station showing the module
engaged;
FIG. 1b is a cross section of the programming station showing the module
engaged;
FIG. 2 is a front view of the module;
FIG. 2a is a front view of the module with the cover removed showing the
internal components;
FIG. 3 is a circuit diagram of the module;
FIG. 3a shows a common method of measuring the leakage current through a
diode;
FIG. 4a is a first part of a circuit diagram of the module;
FIG. 4b is a second part of a circuit diagram of the programming station;
FIG. 4c is a third part of a circuit diagram of the module;
FIG. 5 is a schematic diagram of an alternative embodiment of the module
where the module is attached to a lid of a medication container;
FIG. 6a is a flow chart of alarm module operation;
FIG. 6b is a flow chart of the programming station erase module mode;
FIG. 6c is flow chart of the programming station set prescription time
mode;
FIG. 6d is a flow chart of the programming station set prescription time
mode.
DETAILED DESCRIPTION OF THE INVENTION
A programming station 10 and portable module 12 are shown in FIGS. 1-5. The
programming station 10 is provided with a body 14 with front panel 16
having a display 18 and keypad 20. In one embodiment of the invention, the
display 18 is provided with a two-line, 16 character LCD display and the
keypad 20 has a 4 button keypad labelled "Menu" or "Mode" 22, "UP" 24,
"Down" 26 and "OK" 28, respectively. The front panel 16 is also provided
with a receptacle 30 for receiving a module 12 in order to program the
module 12 through the station 10.
With reference to FIGS. 2 and 2a, the module 12 is provided with a body 32
having a cover 31 with push button 34, light emitting diode 36, sound port
38 and hole 40. The body 32 of the module 12 is adapted to be received
within the receptacle 30 of the station 10. A communication link between
the module 12 and station 10 is through LED 36 on the body 32 and LED 44
within receptacle 30. Other communication links may be used between the
module 12 and station 10 such as, but not being limited to, optical,
fibre-optic, acoustic, magnetic, capacitative, radio frequency,
magnetic/capacitative, or electrical data transfer links.
A typical circuit diagram of the module 12 is shown in FIG. 3. A
microprocessor 46 is provided for receiving and storing alarm information
from the programming station 10 through LED 36, for providing visual and
auditory alarms signals to sound device 48 and LED 36 and for receiving an
alarm silence signal from push button 34. The microprocessor 46 is powered
by battery 47. In one embodiment of the invention, the sound device 48 is
a piezo crystal driven directly by the microprocessor 46. In another
embodiment of the invention, the alarm silence signal is generated by a
piezo crystal in place of the push button 34.
In one specific embodiment of the invention, the LED 36 on the module 12
and LED 44 on the programming station 10 provide a bi-directional
communication link between the station 10 and module 12. In this
embodiment, both LED's 36 and 44 serve as a transmitter and receiver
wherein light from one LED induces a current in corresponding LED, both
adapted to provide a coded bi-directional communication signal between the
respective circuitry of the module 12 and programming station 10. In this
embodiment of the invention, the principle of the leakage current across a
semiconductor junction being affected by incident light is utilized. A
light emitting diode which is normally used to produce light will also
operate as a light sensor if a circuit is made to measure the leakage
current through the diode. FIG. 3a shows a common method of measuring the
leakage current through a diode. A reverse bias voltage 47 is provided
across the diode 36 and a voltage is produced across a resistor 301 by the
leakage current. If the light incident on the light emitting diode is
modulated then a modulated voltage will appear on the resistor 301.
In a preferred embodiment of the invention, the diode 36 is reverse biased
by providing a positive voltage on a port pin 310 of the microprocessor 46
(Microchip Technology Inc., Part #PIC16C5X). Instead of providing a
resistor to detect the leakage current, a capacitor 302 is charged with
the leakage current. The microprocessor 46 used in the preferred
embodiment has the ability to have its port pins changed from outputs to
inputs via software commands. When the presence of incident light is to be
detected, the residual voltage on the capacitor can be discharged by
setting port pin 309 to an output and then setting its output level to a
logic low level. Port pin 309 is then changed to an input via software
control. The leakage current through the diode 36 causes the voltage on
the capacitor 302 to rise from zero volts toward the supply voltage 47 of
the microprocessor 46. The time required for the voltage on the capacitor
302 to reach the logic switching threshold level of the input pin 309 of
the microprocessor will depend on the level of the incident light. If the
incident light level produced by the LED 44 in the programming station 10
is modulated in an on-off fashion corresponding to a serial data stream of
digital information, then the corresponding serial data can be detected on
the input pin 309 of the microprocessor 46.
In order to provide two-way communication, the LED 36 in the module 12 can
be driven by the microprocessor 46 by setting port pin 309 to an output
with a logic high level and setting port pin 310 to an output with a logic
low level. The LED 36 is then forward biased and will produce light. The
microprocessor 46 can then transmit serial data back to the programming
station 10 by modulating the logic level on port pin 310 which will turn
the LED 36 on and off.
To receive data from the module 12, the LED 44 in the programming station
is used in a similar fashion to detect the serial data being sent by the
LED 36 in the module 12.
A typical circuit diagram of the programming station 10 is shown in FIGS.
4a, 4b and 4c. The programming station 10 is provided with a
microprocessor 60 for programming and downloading alarm instructions to
the module microprocessor 46 through the LED 44 and LED 36 interface. The
microprocessor 60 receives input signals from keys 22, 24, 26 and 28 and
provides display output to display 18. The microprocessor 60 is
continuously powered by a battery or power supply connected to a jack 62.
The microprocessor 60 operates continuously so as to provide a real-time
time-of-day clock function.
The physical configuration of the module 12 may be provided to further
enhance the convenience to the patient of using the module 12. In one
embodiment, the hole 40 in body 32 may be used to facilitate attachment of
the module 12 to a separate article which is regularly carried by the
patient, for example, a key ring.
Alternatively, the body of the module 12 may be further provided with a lid
means 70 to enable the module 12 to be attached directly to a medication
bottle 72 as shown in FIG. 5. It is contemplated that the lid means may
take numerous forms, such as, but not being limited to, screw or snap
lids. Alternatively, the module 12 may be adapted to attach to existing
medication container lids. When these embodiments are employed, the
patient actively taking several prescriptions may be provided with two or
more modules 12, each forming the lid of a different medication bottle. In
this situation, the patient may be alerted to the correct time for taking
a specific medicine by the visual and auditory alarm on a specific bottle.
The body of the module 12 may also be provided with a surface for placing
written instructions to the patient relevant to the particular medication.
It is also envisaged within the scope of the invention that alternative
embodiments of the alarm may be utilized. These may include but are not
limited to amplifiers, large flashing lights and/or vibrators for patients
with a visual and/or hearing impairment. Accordingly, it is contemplated
that the specific configuration of the module may be realized to provide
notification to the patient of the alarm. Similarly, alternative
embodiments of the alarm silence means are envisaged including, but not
limited to, vibration, light, impact or sound sensors.
In the preferred embodiment of the invention, the alarm is a combination of
a blinking light and buzzer.
Operation
In operation, the programming station 10 is located at a central
dispensary, for example with a pharmacist. The pharmacist, when filling a
patient's prescription and completing the written instructions would
initiate programming of the module according to the following illustrative
algorithm and as described in FIGS. 6a, 6b, 6c and 6d. It is understood
that other algorithms may be used without departing from the spirit and
scope of this invention.
Programming:
As indicated above, the programming station 10 has a real-time clock that
keeps track of hours and minutes in a 12-hour format with the display
"A/P" to indicate AM or PM. The "MENU" or "MODE" key is used to scroll
through the following modes of operation displayed on the first line of
the display 18:
______________________________________
1. ERASE MODULE (Standby Mode)
2. SET MODULE ALARM (Sets Alarms)
3. SET CLOCK (Sets Real-time Clock)
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A particular mode of operation is selected by depressing the "OK" key 28.
If the ERASE MODULE mode is selected, then the first line of the display
18 will instruct the pharmacist or operator to INSERT MODULE as shown on
the display 18.
The second line of the display 18 shows an instruction and the present time
of day in 12 hour format with AM or PM, such as,
PRESS OK 11:38 A
1. Erase Module Mode
If a module 12 is being returned by a patient at the end of their
prescription, the module alarm times need to be erased to cease the alarm
cycle.
In the ERASE MODULE mode, the two-line display shows:
INSERT MODULE
PRESS OK
signalling the pharmacist or operator to insert a module 12 into the
receptacle 30. When the operator inserts the module 12 correctly and the
OK button is pressed, the module 12 responds to the programming station 10
by sending a battery usage counter value.
The module microprocessor 46 retains a battery counter value that is a
measure of the state of charge of the battery 47.
The power consumed by the circuit in the module 12 depends on the state of
operation of the module. The module has 3 states of operation.
The first state is a "sleep" mode where the clock of the microprocessor is
stopped. This state uses very little power and the battery 47 would last
for several years if left in this inactive mode.
The second state is a timing mode where the microprocessor 46 is keeping
track of the time of day. This mode consumes power resulting in an
estimated battery life of about one year for continuous timekeeping.
The third state is the alarm mode where the audible alarm is driven and the
LED is being flashed. This mode consumes the most energy from the battery
47 and would operate for about one month if left alarming continuously.
In the microprocessor 46 there is a battery usage counter that is
incremented periodically whenever the microprocessor is in mode 2 or 3.
The counter is incremented much more frequently when in mode 3 because the
rate of power consumption is much higher. The resulting counter value is
representative of the energy consumed from the battery 47.
When the module 12 is inserted into the programming station 10, the module
12 reports the value of the battery usage counter. If the battery 47 has
been used so much that it may not reliably last for one more prescription
use, then the programming station 10 will provide a warning and refuse 16
program the module. When the battery 47 in the module 12 is replaced, the
battery usage counter in the microprocessor 46 is reset.
If the battery counter value indicates that there is not enough battery
power remaining for another use, the module 12 will no longer accept
further programming and the display will show:
REPLACE BATTERY
PRESS OK
If the module 12 is not inserted, inserted backwards, upside down, or in
such a way so that communication is not possible between the programming
station 10 and the module 12, the programming station 10 will retry
several times and then display the message:
NO RESPONSE
PRESS OK
After acknowledging this problem by pressing OK, the display returns to the
main menu and the operator can correct the problem and try again.
It is contemplated that in an alternative embodiment of the invention, the
module 12 and programming station 10 could be provided with an additional
feature which represents the number of days or number of doses that the
prescription will last. In this embodiment, the microprocessor 46 would
enter a "sleep" mode and no further alarms would be generated.
If communication between the programming station 10 and the module 12 was
successful, then the display 18 will read:
MODULE ERASED
PRESS OK
After acknowledging that the module 12 was erased and set back into the
"sleep mode", the programming station display 18 will return to the main
menu.
2. Operation of Programming Station for Setting Prescription Times
In the present embodiment, when the module 12 is inserted into the
programming station 10 and the OK button 28 is pressed, the programming
station 10 ash the module 12 to report the status of the battery usage
counter and the mode of operation.
If the module 12 contained a prescription program, then the programming
station will send a command to the module to erase the times and command
the module 12 to go into "sleep" mode. If the module was already in
"sleep" mode then the programming station assumes that the pharmacist or
operator wants to program a new set of prescription times into the module.
To program the alarm times, the programming station 10 will request the
number of doses per day. The display 18 will show the following message:
DOSES PER DAY 4
PRESS OK
The operator can press the UP 24 and DOWN 26 keys to change the default
value of doses to the desired number and then press the OK 28 button.
The programming station 10 will next ask the operator to confirm the time
of day for each of the doses. Default times for a standard regimen of 3,
4, 6, etc. doses per day can be offered. A typical message would be
displayed as follows:
FIRST TIME . . . 8:00a
PRESS OK
Again the operator can press the UP 24 and DOWN 26 keys to change the
default time to the desired time and then press the OK 28 button.
The next time would then be displayed with a request for confirmation.
After all of the alarm times have been reviewed, the programming station
then loads the information into the module via the communication link.
If the data is successfully sent to the module then the following message
is presented:
MODULE PROGRAMMED
PRESS OK
The module 12 is then removed from the programming station 10 and given to
the patient.
Pressing OK will return to the main menu. If the data is not sent
successfully, it is re-tried several times and then, if still
unsuccessful, the following message is displayed:
PROGRAMMING FAILED
PRESS OK
The operator could attempt to change the module 12, or insert it correctly
and then press OK to try to program it again. Pressing MENU will abort the
programming and return to the main menu.
3-SET TIME mode:
This mode is provided so that the real time clock in the programming
station microprocessor 60 can be adjusted to the current time-of-day. The
display 18 will show the following message and the UP and DOWN keys can be
used to change the current time of day.
SET TIME OF DAY
PRESS OK hh:mm A
Pressing OK will accept the time setting and return to the standby menu.
Data Sent to the Module
The data sent between the programming station 10 and the module 12 via the
optical serial data link using LED 44 and 36 can be formatted as a serial
data stream with commonly used one-wire asynchronous half duplex serial
communication using start bit(s), data bits and stop bit(s). The data
stream may contain synchronization preamble byte(s) and checksum byte(s)
as is commonly used with serial communication to ensure that the received
data is valid.
The content of the data sent to the module 12 from the programming station
10 is the current time of day and the specific times for each alarm.
The content of the data sent from the module 12 to the programming station
10 is the value of the battery usage counter and the number of alarm times
programmed. If the module has been erased and is in "sleep" mode, then the
number of alarm times will return to 0 value.
Confirmation that the module has received value data and has been
programmed is achieved by the module 12 responding to the programming
station 10 by sending back the value of the battery usage counter and the
number of alarm times programmed.
In another embodiment of the invention, the data could be encoded using a
compression algorithm to reduce the number of bytes of data being
transmitted.
In operation, when the module 12 is module is away from the Station 10, the
LED 36 provides a flashing visual alarm and the sound port 38 provides an
auditory alarm warning a patient that it is time to take the prescribed
medicine. Both alarms are silenced by push button 34.
The terms and expressions which have been employed in this specification
are used as terms of description and not of limitations, and there is no
intention in the use of such terms and expressions to exclude any
equivalents of the features shown and described or portions thereof, but
it is recognized that various modifications are possible within the scope
of the claims.
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