Note: Descriptions are shown in the official language in which they were submitted.
CA 02251234 1998-10-21
MEDICATION REMINDER DEVICE
The invention relates to devices which remind individuals to take
medication.
Recent studies show that there is a significant number of individuals
5 who, given a medication regiment, refuse or forget to comply with their
regiment The results include unnecessary visits to hospitals, visits to the
family doctor, and in severe cases, the outcome is death.
Timed medication dispensing systems are known in the prior art. United
States Patent no. 4,695,954 issued September 22, 1987 to R. J. Rose et aL
10 discloses medication dispensers for home and hospital use. One version of a
medication dispenser has an LCD display which can display a message such as
"TIME TO TAKE PILLS". A ph~rm~Cy proC~ g device encodes
prescription information onto a code card, and the prescription information on
the code card is read by a tr~nc~ cer on the medication dispenser. The
15 dispenser includes means for mol~iloli"g whether or not a user is complying
with a prescribed me~ic~tion schedule. A cont~iner having a number of
individual colll~ ents is filled at the ph~rm~ y with medications and is
transported to the dispenser.
In the medication dispensing system of United States Patent no.
4,504,153 issued March 12, 1985 to Thomas A Schollmeyer et al.. a
medication plolllpling device is incorporated into the locking cap of a
medication container. After the elapsing of a specified time interval, the
dispensing system alerts the user by an ~lt~rn0ting beeping signal and fl~ching
25 of a plol~ g light. Information regarding prescriptions can be programmed
into the medication ~.. olll~ g device by means of a pro~i.. i.. g device
located in a phannacy.
CA 022~1234 1998-10-21
U.S. patent 5,719,780 issued February 17, 1998 to Medi Innovations
Inc. describes a small me-lis~tion remin-ler device that has a liquid crystal
display and that is controlled by a preprogrammed electronic circuit to display
to the user the number of doses of selected i~lentified medications to be
5 consumed at the time of the display. This device will also display special
instructions. However, in the device that is worn there is no storage facility for
the pills to be taken. Instead, there is a much larger so-called medication
m~n~eer or conlailler for the medications to be taken, this container being
divided into a number of co~ lents, one of which can be used to store the
10 medicament regime control device.
One particular difficulty with this known remin~er device is that the
information displayed on the LCD display is in a codified format which may
be difficult for users of this device to understand. Because the LCD display of
15 this remin~r device must be quite small in order that the device can be worn
on the user's wrist, the information displayed must be in this codified form.
This form includes de~ign~ting the various me~licines by di~clclll letters and
by indicating the amount to be taken by means of an aligned number only.
A portable medication llisp~n~in.~ unit is taught in U.S. patent
4,473,884 issued September 25, 1984 and this unit has several co~ ents
for storing pills or other medicines. The unit is programed with a medication
schedule which causes visual and audio signals when it is time for the
medication to be consumed. Although this unit has an LCD time display, the
LCD display is not capable of providing remin~ler mess~es or information to
the user. What medication pill should be taken at a particular time is provided
by several small indicators at the top of the unit.
CA 02251234 1998-10-21
It is desirable to provide an improved mç~licatiQn remin~l~r device
which has the capability of displaying an easily read and understood mess~ge
concrrning the me-liç~tion to be taken and the amount thereof, with this
message being displayed on a display device such as an LCD screen and
5 provided by a program stored in the unit. Preferably the medication remin~l~r
device should also have con~ lents for storing the medication to be taken,
so that this medication is readily available to the user when a remin(ler
mess~ge is given.
It is also desirable to provide a medication reminder device that has the
capability of recording whether or not the user is complying with his or her
schedule for taking medication, prescription information for which has been
stored in the memory of the unit. Such illroll-lation, for ç~mrle, can be very
useful to the ph~rm~cist or doctor who is able to obtain this compliance
15 information from the unit after it is returned to the ph~rm~rict or the medical
facility. If the ph~rmacist or doctor should learn that a patient is not taking the
required pills or tablets at the specified times, then a~)plol,liate steps can
hopefully be taken to ensure that in the future the medication is taken at the
proper times, for ex~mrle, by e~ cating the patient on the need for taking his
20 or her pills at the required times in order to obtain ~e desired result of
medication compliance.
One embo~liment of the present invention provides a me~iic~tion
remin(ler device which alerts a user when it is time for him to take his
25 medication contained within the housing of the rçminder device. The means to
alert the user incl~1rles preferably an LCD display and an audible signal. The
LCD display provides mel1ic~tion data and mess~es- Means are also provided
to turn the audible signal off. The device preferably provides other useful
information, including whether or not a previous medication has been micse~l,
CA 022~1234 1998-10-21
a forewarning to the user that it is time to return to the ph~rm~cy for a
prescription refill, medication specific instructions such as "take on an empty
stomach", and an indication to the user that it is time for him to change the
batteries powering the device. Side-by-side displays of alphabetic letters and
5 numerals display the mess~ge on the LCD display.
According to one aspect of the invention, a medication reminder device
comprises a small portable housing and means for displaying ~lphAnl..ne, ;c
characters in at least one row, the display means being mounted in the
10 housing. The or each row has a number of side-by-side displays adapted to
selectively display individual alphabetic letters and numerals. The remin(ler
device also has means for alerting a user when a particular medication is to be
taken and a programmable electronic circuit mounted in the housing. The
circuit includes a clock and a microcontroller and is electrically connected to
15 the displaying device and the alerting means, and adapted to operate same.
There is also a mech~ni~m which m~ml~lly turns off the alerting signal and
termin~tes a displayed message on said displaying means. The electronic
circuit is programmable to display first and second alternating mess~es on the
displaying device so that the first message is displayed for a short period of
20 time before being replaced by the second mess~ge which is then displayed for
a short period of time before being replaced by the first mess~ge. At least the
first mess~ge provides an indication of a particular medication to be taken and
a dosage amount.
In a prere.led embodiment, the housing has a number of individually
labelled medication storage CO~ ~ t--lents.
CA 022~1234 1998-10-21
According to another aspect of the invention, there is provided a
portable medis~*on rçminder and compliance device that includes a small
portable housing for the device and a displaying device for displaying
~lph~nllmeric characters in one or more rows, this displaying device being
5 mounted in the housing and adapted to display me-lic~*on inform~*on to a
user. The informa*on includes an indica~*on of a medica*on to be taken.
There is also an audible device for alerting a user by means of an audible
sound when the particular medica*on is to be taken. A progr~.. ~ble
electronic circuit is mounted in the housing and in~llldes a clock, electronic
10 memory and a microprocessor, this circuit being electric~lly connected to thedisplaying device and the audible device and being adapted to operate same.
The electronic circuit includes means for recording in the electronic memory
that one or medica*ons, prescrip*on informa*on for which has been stored in
the memory, have not been taken on time as prescribed within a preselected
15 *me interval. The recording device records a non-compliance event when the
tnrning off device is not ~ctll~ted by the user within a preselected time interval
commencing when the audible sound is ini*~ted by the electronic circuit.
There is also provided a co~ )ul~l based system which programs the
20 rçmin(ler device. The system comprises a programmable col~uler, a
progl~ g unit and the remind~r device whose memory is progr~mmed A
colll~,uler operator can run the software and thereby control medica*ion and
patient information stored in the com~uler. The progl;~.. ing of informa*ion
and instruc*ons proceeds by signal tr~n~mi~sion from the co....~.-..-ica*ons
25 port of the colll~ul. r to the prog~ g unit. The il~ru....~tion and
instructions then allow the microcontroller of the progr~...".;l~g unit to
program the remind~r device by an electronic interface between the
progl~.. ;l-~ unit and the rçminder device.
CA 02251234 1998-10-21
Further fealules and advantages will become appd~enl from the
follouring detailed description of a prerelred embo~iimPnt taken in conjunction
with the accol-lp~ying drawings.
In the drawings,
Figure 1 is a front perspective view of a me~lic~tion remin~l~r and
compli~nce device constructed in accordance with the invention, this view
showing the lid in a closed position;
Figure 2 is ano~er front perspective view of the medication reminder
and cnmpli~nce device showing the lid in an open position;
Figure 3 is a front perspective view of the bottom half of the medication
remin~er and compliance device, the top half of the device being removed;
Figure 4 is a perspective view of the me~lic~tion remin~i~r and
compliance device, this view showing the bottom and front of the device;
Figure 5 is a rear view of a prog~ device used to program the
20 device of Figures 1, 2 and 4;
Figure 6 is a front view of the prog~ g device;
Figure 7 is a block diagram of the electronic circuit of the remin~ler
25 device;
Figure 7A is a transition diagram of the state -c1line imple-.lf .~te~ by
the reminder device;
CA 02251234 1998-10-21
Figure 8 is a block diagram of the electronic circuit ofthe progl; .~ g
unit;
Figure 9 is a block diagram of the sonwa~e and databases used in the
5 co~ uler based system provided for progr;1.."~ g the remin~Pr device;
Figure 10 is a circuit schem~tic represçntation of one possible
embodiment of the progr~l."..i~ unit;
Figure 1 1 is a circuit schematic representation of one possible
embodiment of the remin~lt?r device.
Figure 1 illustrates a ~l~fell~d form of medication remin~er and
compliance device 10. In the ~lerelled embo-liment the medication rçmin~l~r
15 and compliance device is a small portable unit which provides conl?~~ ents
for medication. The reminder device 10 has a lid or cover 12, which is shown
in a closed position. The remin~er and compliance device has a small, portable
housing 45 formed by an upper section 14 and a lower section 16. An upper
face 18 of the cover has a cut-away area 20 which allows a user to view an
20 LCD display 24 when the cover is closed. The display provides means for
displaying ~lph~nllmeric characters in at least one row and preferably in two
rows. An attached plastic covering on the LCD display itself protects the LCD
display from ~l~mage
The prerelled device 10 is made of plastic sturdy enough to resist
cracking in case of the device being drol)l)ed. In the prefelr~d embodiment the
device is pocket size or about the size of a cardboard cigarette pacl~age,
approxim~tely 1 l.5cm x 9cm by 2cm (4.5 x 3.5x 0.75 measured in inches). It
is therefore very easy for the user to carry almost all of the time.
CA 02251234 1998-10-21
Turning to Figure 2, the device is illustrated with pivoting cover 12 in
an open position, the cover being lifted so that the user can take his
mellic~tion. The rear portion of the device houses electronic componentc,
including a progr~mm~ble electronic circuit, LCD display 24 and a user input
5 interf~ce that includes a confirrn~tion button or key 26. The front portion ofthe device plerelably stores me-lic~tion in storage means 30 provided for this
purpose.
The LCD display device 24 having an area in one p,ere.lt;d
10 embo~lim~nt of a~l,roxi...~ely 8cm x 3cm displays ~lph~mlmeric character and
numerical formed messa~es in rows according to the p-ere.led embo~limpnt It
can also display gr~phic~l symbols, if desired. The display 24 is rigidly
mounted in a side of the housing 45, preferably in the top side as shown. The
~lerelled display device has two lines 92 and 94 of displays, each line
15 displaying a m~x;...~ . of 20 side-by-side characters, and each character is
allocated a 0.3cm x 0.5 cm area. The two rows are located one above the other
as shown in Figure 2. Electronic circuit means, described below, control the
LCD display to produce the mecs~ges The LCD display itself is of known
construction and can be found in such devices as graphical displaying
20 calculators. Although a two line display is pler~lled, it is also possible toconstruct the present remin~l~r device with a single line display or a display
having three or more lines.
Confirm~tion or turn off button 26 is connecte(l by a signal path to the
25 electronic circuit means. The button can be made of rubber or plastic.
Confirm~tion works on a "Timeout" based system. For a particular "Timeout"
period if the confirm~tion button is not pressed, an associated disabling or
registering action will occur. A first "Timeout" period begins when the beeper
sounds for a me~lic~tion alert. By pressing this button, the user of the device
CA 02251234 1998-10-21
_9 _
acknowledges that he has heard the alert. The first "Timeout" period could be
four, five or even fifteen .~in~ s~ depending on the embo-liment A second
"Timeout" period of four, five or fifteen min~ltes again depending on the
embo~iment begins after acknowledging the alert. The user is then required to
5 push the button each time an ~lt~rn~tin~ mess~ge pair is displayed
corresponding to a particular medication. Thus at a particular Medication
Time, every pressing of the con~irm~hon button following the first such
pressing corresponds to a user taking a particular medication.
In one ~,ler~led embo(limPnt the reminder and cnmpli~nce device is
powered by a single AA battery. When the battery needs to be çh~nge-l the
device will alert the user of this at medication time. A microcontroller of the
remin~r and com~ nce device will eventually be disabled when voltage
levels provided by the batteries fall to a pre~lele, ~li"ed level, and the remin-l~r
15 and compliance device will no longer be functional.
Medication storage region 28 is broken into four individual, labelled
medication compartments 30 by rectangular slats 32. Drug co~ lent
numbers 33 can be illlp~ ted on the rect~n~ r slats, the side walls of the
20 cavity and/or on the coll,p~ll,lent bottoms 34. Tncte~ll of printing on the device
itself, labels with numbers thereon can be applied to the device by the user.
Each colllpalll~,ent is preferably a~prox;ln~ely 4cm x 2.5cm x lcm. The
rect~n~ r slats can slide out of recesses 35 formed in the long sidewalls to
form larger co~ ...ent~, if desired. When lid 12 is closed, the lid helps to
25 keep the rect~n~ r slats in position. On the corner of two of the
compartments, screw receivers 37 protrude. Although four compartments are
illustrated, there can be fewer or more collll,~ l,llents in the device, as desired.
It is also possible to construct a remin-ier device with only one pill
COlllp&l ll"ent or even no COlllp~ Llllents at all. A user can, for instance, ca~y
CA 022~1234 1998-10-21
-10-
his required pills in separ~le containers or bottles.
As best seen in Figure 2, lid 12 is hinged at 38 to a rear ridge 40. When
the lid is closed, a projecting ridge 42 keeps the lid from opening
5 ~ e..~;onally. Grooves 44 on the housing ensure that lid edges 46 fit in a
close m~nner with the upper section of the housing 45.
Although only a single cover 12 is shown in the illustrated remindPr
device 10, it is also possible to construct the device so that each pill
10 col~LI~lent 30 has its own pivoting lid. With this arrAngement only the
colllp~llllent co~ g the medication scheduled to be taken need be opened
and the othèr COlll~)al l"~ents can remain closed.
With lefe,~l~ce to Figure 3, electronic circuit components that make up
15 an electronic circuit for controlling the operation of the remindPr device are
mounted on a circuit board 48 that is supported on top edges 52 and 56 of two
dividers 50. The board 48 also inçhldes a square housing 59 for confirmAtion
or turn offbutton 26. An edge stop 58 can be integrally formed on the bottom
section 16 of the housing to locate the side edge of the board 48 and a similar
20 stop (not shown) is provided at the opposite side edge of the board.
Bay 60 of lower section 16 of the device also has two integral sleeves
62 for receiving connecting screws which are inserted into holes 64 from the
bottom of the unit. In the upper left hand corner of the bay is mounted a
standard telephone jack 66 which connects to a docking pro~.. il-g unit
used in the progr~.. il-g of the device. It will be appreciated by those skilled
in the art that the signal tr~n~mi~sion means provided by the jack 66 could alsobe provided by an infrared link. At the rear and at the opposite corner from
the telephone jack is a standard buzer 67 outlined in dashed line only. The
CA 022~1234 1998-10-21
buzer 67 is a plerelled form of audible means for alerting a user of the device
by means of an audible signal when a particular medication is to be taken. The
buzer is electrically connected to the electronic circuit of the device and is
operated thereby.
In Figure 4 bottom face 68 of the remindçr device is illustrated. Battery
cover 70 can be opened to put in one AA battery in battery colll~ lllent 72
located in the housing. The electronic circwl~y the buzzer 67 and the display
device 24 can be powered by the battery. Battery cover 70 protrudes below
bottom face 68 as do two bulges 71,73 that extend from opposite ends of the
cover. The cover 70 is opened or closed by snap mech~nicm 74. The bottom
face of the device also includes rece~ses 76 to receive the heads of two screws
to hold bottom section 16 and upper section 14 together. Screw holes 64 open
into the recesses 76. It will be understood that the upper section of the housing
15 is formed with aligned threaded holes to receive these connecting screws.
With reference to Figures 5 and 6, the rçminder and compliance device
10 is configured to be progr~mmed through a software application running on
a personal colllpulel 83 that is connectable to the remindçr and compliance
device 10 by means of a docking progr......il~e interface unit 80. In the
prefelled embodiment of the colll~uler based system prog~ e
information for the reminder and compliance device 10 is conveyed through
serial tr~nsmi.csion on an RS-232 cable 82 from the co~u, ication port of
personal co~ ler 83 to the progl; .....il~~ unit 80. It will be appreciated by
those skilled in the art that co..l ~-ic~lions link provided by the RS-232 cable82 could also be provided by an infrared link. The progr~mming information is
supplied from medication software installed on the conll,ulel. The
prog~ g unit 80 has electronic circuit means which convert and process
the received signals to program the reminder and compliance device.
CA 02251234 1998-10-21
The back and front of the progr1.."..il-e unit 80 used in the CO~ ul~
based system is illustrated in Figures 5 and 6 respectively. The unit 80 is
capable of controlling the state of the reminder device 10 when the remin~l~r
device is being programmed by the personal col"~uler 83. RS-232 cable 82
plugs into port 84 on the progr~.. ~.;.. g device and a co.. l~"ication port 85 of
colllpul~l 83. The cable col~ ic~tes electric~l signal tr~ncmi.ccion between
the progli.. il-g device and the progralnable personal co~ ulel 83. A
power cord 86 from an AC/DC power adapter inserts into a plug 88, providing
DC power to the progl;1.. il-g device. When reminder device 10 is to be
10 programmed, a conventional phone extension cord 91 is connected between
phone jack 90 in the front of the progrA~ g unit 80 and phone jack 66 in
back of reminrler device 10 to allow signal trAncmicsion between the
progr~mmin~ unit and the remin~ler and compliAnce device. Thus there is a
physical connection between the progrAmming unit and the remindPr device in
15 this embo~iment In an embodiment incorporating infrared for signal
trAncmicsion there would be no physical connection. As will be explained in
greater detail below, the progrAmming unit 80 includes a microcontroller
capable of writing inform~tion and instructions into an electronic memory of
the remin-l~r device 10.
Figure 7 is a block diagram representation of the electronic circuit
indicated generally by 121, ofthe remin~er and compliAnce device 10. In its
~lerel,ed embo-limçnt the electronic circuit 121 of the rPminder device is
provided with EEPROM memory 122 which is programmed through the
25 progr~...l~.il-g unit 80. This type of memory is erasable, so that the reminder
and compliance device can be programmed more than once. The memory is
static so that information written to it during progl~.. i.~g will not be lost
during, for example, battery repl~cement
CA 022~1234 1998-10-21
The operation of the rçmin~l~r device 10 is controlled by a
microcontroller 124, which is conn~cte~l to memory 122. An electrical
connector, namely jack 66 which could also be an infrared link, is connected
to controller 124 and memory 122 to allow information to be e~ch~nged
5 between the prog~A~ E unit 80 and the electronic circuit 121 when desired.
During operation, the controller 124 reads inform~1ion and instructions from
the memory 122. The controller 124 is operatively connected to buzzer 67 and
a display unit 128 (which includes LCD display 24). When me-ss~ges are to be
displayed on the remin~ler device, the controller 124 sends messAge
information to display unit 128. The timing of controller 124 is controlled by
real time clock 130, which is pre~l~bly a 12 month real time data and time
clock. The clock 130 serves to time int~rn~l operations in the rçmin~er and
compliance device. A suitable setting for the clock is 4Hz. A power supply
132, which includes connection hardware for connecting to a AA battery, and
a step-up convertor to convert the 1.5 V output of the AA battery to 5 volts,
powers the electronic cilc~ y ofthe remin~l~r device. The circuit 121
includes a voltage detector 134 and if the voltage supplied by the power
supply 132 is below a certain level, voltage ~letector 134 provides an alerting
signal to the controller 124 to indicate the need for battery repl~cement
Confirm~tion button 26 is connected to controller 124 and allows user
acknowle~grnçnt of mess~ges and alerts. Confirm~fiion button 26 is preferably
implemente~ using a one-shot monostable so that repetitive keystrokes within
a short time period are considered as a single key stroke, and so the button will
only generate one key stroke signal when pressed, regardless of how long it is
pressed.
Wi~ reference to the transition diagram of Figure 7A, three modes of
operation are provided in the plefe.l. d embodiment of the remin~er device:
idle mode, alert mode and show mode. Idle mode is characterized by
CA 022~1234 1998-10-21
substantial inactivity of the controller 124. Average power consumption by the
reminder device is lowest in this mode as col"paled to other modes. This mode
is inlellupled periodically by the clock 130. In alert mode, the controller 124
of the remin(lçr and compliance device causes an audible alerting device
5 (bl~77er 67), to sound a periodic beep or other audible signal. If the alert mode
is not sooner termin~te~l by the user, then fifteen mimltes after alert mode is
entered, the remind~r and compli~nce times out and the periodic beep stops.
Also, the rçmin(ler and compliance device will register a missed medication
after a shorter preselected time interval, for example, four, five or fifteen
10 ...i..-~les after a take me~lic~tion alert is raised, if the confirm~tion button 26 is
not pressed. The purposes of the show mode are to provide an indication of
what medication has to be taken, and whether or not the last sçhç~nled
medication has been mi~se-l In this mode, the electronic cir~ ly 121 of the
device opel~les the display unit 128 in order to display this inform~tion on
15 LCD screen 24.
Figure 7A is a transition diagram of an eleven state state m~..hine
implemente-l by electronic circuit 121 ofthe remin~er device 10 according to
the preferred embo~liment In all states of the state m~chinç at each quarter
second the real time clock triggers controller 124 to check if the key 26 was
pressed, and update accordingly for the event~ Each mimlte, the controller 124
will decrement a time out counter and will test if time out occurred. At each
hour, the microcontroller 124 will check if it is Medication Time (MT).
The "Reset" state S 1 is entered when the remin~r device 10 is first
powered up (for example, when a new battery is installed), or after the
rçmin~er device 10 has been programmed. In the "Reset" state, the circuit 121
goes through an initi~li7~tion procedure and, in the event that the "Reset" state
is entered after power loss, also retrieves stored information from memory -
CA 022~1234 1998-10-21
.
-15-
122 which indicates the previous state that the circuit 121 was in before the
power loss occurred. As indicated in the transition diagram of Figure 7A, the
rem~ining ten states that electronic circuit 121 is progr~mmed to implement
are: "Idle" state S2; "Alert" state S3; "Show Time to Next Medication" state
5 S4; "Show Missed Medication" state S5; "Show Medication" state S6; "Show
Battery Alert" state S7; "Missed Medication" state S8; "Show Refill AlerP'
state S9; "Show Missed Medication Before Me~iic~tion" state S10; and
"Missed Medication Alert" state S 11. The operation of the remin~ler device 10
in each of these states, and the progression from state-to-state will now be
10 explained in greater detail.
From the "Reset" state S 1, the state maclline will proceed to the "Idle"
state S2 in the event that the previous state before the "Reset" state S 1 was
entered was the "Idle" state S2, the "Show Refill AlerP' state S9, the "Show
15 Battery Alert?' state S7, or the "Show Time To Next Medication" state S4. In
the event that the previous state was "Missed Me-lic~tion" state S4, or "Show
Missed Medication" state S5, the state m~rhine will proceed from the "Reset"
state S 1 to the "Missed Medication" state S8. In the event that the previous
state was the "Missed Medication Aler~' state was the "Missed Medication
20 Alert" state Sl 1, or the "Show Missed Medication Before Medication" state
S10, the state machine will proceed from the "Reset" state Sl to the "Missed
Medication Alert" state S 11. In the event that the previous state was the
"Alert" state S3, or the "Show Me-lic~tion" state S6, the state m~r.hine will
proceed from the "Reset" state S 1 to the "Alert" state S3.
Once in the "Idle" state S2, the state m~hine periodically checks to see
if a Medication Time (MT) has arrived and also checks to see if the key or
button 26 has been pressed. In the event that a Medication Time (MT) has
arrived, the state m~c1line will proceed from the "Idle" state S2 to the "Alert~'
CA 022~1234 1998-10-21
state S3.
By pressing the button 26 when the state --hine is in the "Idle" state
S2 (and a Medication Time has not occurred), a user can obtain status
5 information about the remin~lPr device 10. In particular, electronic circuit 121
tracks the amount of me~lic~til n co~ e~l in each of the co~ ents 30 and
notes when a refill is required. If the user presses the button 26 when the state
machine is in the "Idle" state S2, and a refill is required, the state m~- hine will
proceed from the "Idle" state to the "Show Refill Alert" state S9. Also, if the
10 voltage detector 134 detects a supply voltage that is below a pre~le~ ..,;..ed
threshold, a signal is sent to the controller 124, and if the button 26 is pressed
when in the "Idle" state S2 and a refill is not required, the state m~ ine will
proceed from the "Idle" state S2 to the "Show Battery Alert" state S7. In the
event that button 26 is pressed during the "Idle" state S2, and a refill is not
15 required, an MT has not arrived, and battery power is fine, the state m~c~ine will proceed to the "Show Time To Next Medication" state S4.
A Timeout counter is set each time a transition occurs from the "Idle"
state S2 to a dirrerelll state. From "Idle" state to "Alert" state, the Timeout
20 counter is set to 15 ~ les, and for any of the other possible transition from "Idle" state, the counter is set to 4 ~ ul~s.
W~en the "Alert" state S3 is entered, the buzzer 67 is sounded for 300
milliseconds followed by a shorter period of silence, and then these two
25 periods repeat for five intervals. Silence follows, and then the five intervals
repeat each m-inute. Entrance into the "Alert" state S3 bec~ e of an MT
causes the Timeout counter to be set to fifteen ...i.."les. The Timeout counter
is continuously decrem~nted and if a Timeout occur (i.e. the Timeout counter
gets to zero) then the state m~ ine increments an al)propliate Missed
CA 02251234 1998-10-21
Medication counter to record the non-compliance of the user, turns off LCD
24, and proceeds to the "Missed Medication" state S8. In the event that the
user presses the button 26 during the "Alert" state S3, the Timeout counter is
set to four ,~ les, the audible alarm is shut off, and the state m~~hine
5 proceeds to the "Show Medication" state S6.
In the "Show Me~ic~tion" state S6, controller 124 instructs display unit
128 to display infonn~tiQn previously stored in memory 122 about the
medication to be taken at the current mçdi~tion time. Plcrclably, inform~tion
10 such as dosage description, con,~ lent number and prescription specifics are
displayed on the two line LCD display 24, with dosage ~lescription and
COlllp~ ent number appe~ring on the top line 92, and prescriptions specifics
appearing on the second line 94. For example, the phrase "Take 1/2 pill from
4" could be displayed on top line 92, with the phrases "From col~ llent #4"
15 and another phrase being ~ltçrn~tively displayed on bottom line 94 every 4
seconds for 4 second intervals while the state m~clline is in "Show
Medication" state S6. The Timeout counter counts down during the "Show
Medication" state S6, and if a Timeout occur, the LCD display 24 is turned off
and the state m~c.hine will increment the apl)ro~liate Missed Medication
20 counters and proceed to Missed Medication state S8.
Depression of the button 26 during the "Show Medication" state S6 is
inlell~lcled by the state m~chinç as an in~lic~tion that the user has complied
with the displayed medication information and taken the correct dosage.
25 Accordingly, the controller 124 will decrement a dosage counter (stored in
memory 122) for the relevant con,~ ent 30, and check to see if the dosage
counter is less than a pre-stored refill threshold for the cull~nl colllpalLIllent
30, and if so, a Refill Flag is set for the con~ llent on.
CA 02251234 1998-10-21
.
As it is possible that more than one me~lic~tion must be taken at any
given Medication Time (MT), upon receiving notice by depression of the
confirm~ion button 26 that the user has taken the displayed me~lic~tion the
controller 124 will check to see if More Medication (MM) must be taken, and
S if so, go through the above routine for as many di~lenl medications as
required. If no more medications must be taken, after depression of button 26,
the state m~çlline will proceed to the "Show Refill Alert" state S9 if a refill is
required, or, if a refill is not required, to "Show Battery Alert" state S7 if the
battery voltage is below a pred~lf ....;I~ed threshold, or, if no refill is required
10 and the battery is fine, to "Show Time to Next Medication" state S4. Upon
transition from the "Show Me-lication" state S6 to either the "Show Refill
Alert", "Show Battery Alert", "Show Medication" or "Show Time to Next
Medication", the Timeout COUI~teliS set to 4 ~ "~eC
In the "Show Time to Next Medication" state S4, display unit 128
displays the time left to the next occurring medication time due in the cullenl
day. If there is no more me~ic~tion for that day, a message will be displayed tothat effect, along with instructions that the co~ llcnls should be refilled. If
an (MT) occurs while in state S4, the state m~G~ine will set the Timeout
20 counter to 15 ...il.llles and proceed to the "Alert" state S3. Otherwise the state
m~hine will shut down LCD 24 and proceed to "Idle" state S2 upon a
Timeout occurring or depression of button 26.
In "Show Refill Alert" state S9, controller 124 instructs display unit
2s 128 to display refill alert information that instructs the user which
COlllpal ~ ent needs to be filled with what. If an MT occurs during state S9, the
Timeout counter is set to 15 mimltec and a transition to "Alert" state S3
occurs. Otherwise, if a Timeout occurs during state S9, the display 24 is turnedoffand the "Idle" state S2 is enleled. If the button 26 is pressed during state
CA 022~1234 1998-10-21
-19-
S9, the state machine will proceed to "Show Battery Alert" state S7 if the
battery is below its predele~ ed voltage threshold, or if the battery is fine,
will proceed to "Show Time to Next Medication" state S4. Upon transition to
state S7 or state S4, the Timeout counter is set to 4 .~ "les
In "Show Battery Alert" state S7, a mess~ge is displayed on the display
24 to indicate to the user that the battery must be changed. If an MT occurs
during the "Show Battery Alert" state S7 the "Alert" state S3 will be c~llered
and the Timeout counter set to 15 ...;...~les Otherwise, if a Tirneout occurs
10 during state S7, the "Idle" state will be entered, or if button 26 is pressed,
transition to "Show Time To Next Medication" state S4 will occur and the
Timeout counter set to 4 ...il~l~les.
In the "Missed Medication" state S8, the circuit 121 waits either for the
15 button 26 to be pressed or for an MT to occur. If an MT occurs during the
"Missed Medication" state S8, the Timeout counter is set to 15 min~tes and
transition to "Missed Me~licfltion Alert" state S 11 occurs. Otherwise, if the
user presses button 26, transition to the "Show Missed Medication" state S5
occurs and the Timeout counter is set to 4 ...il.~les Upon this tr~nc~ition to
20 "Show Missed Medication" state S5, a mess~e such as, "misse~l medication
please call ph~rm~cy" appears on the LCD display, and the user is required to
press the confirm~tion button. Pressing the confirm~tion button a second time
causes a message such as, "medication is due in 60 min~tes" to appear. A third
pressing of the confirm~t on button causes this mess~e to be removed.
In the "Missed Medication Alert" state S 1 1, the buzzer 67 sounds in the
same manner as in the "Alert" state S3. If a Timeout occurs, the ap~rop~iate
Missed Medication counters are incr~m~nte~l and the "Missed Medication"
state S8 is entered. If the user presses button 26 before a Timeout occurs in
CA 022~1234 1998-10-21
-20-
state S 11, the Timeout counter is set to four ...i..-"es and the "Show Missed
Medication Before Medication" state S10 is entered.
In the "Show Missed Medication Before Medication" state S10 a
5 display is generated to in-lic~te to the user that the medication that was due to
be taken at the previous MT was micse-i is displayed. If the user presses the
key 26 in state S10 before a Timeout occurs, the "Show Medication" state 56
is entered and the Timeout counter set to 4 ~~ ules If a Timeout occurs in
state S10, the LCD display 24 is shut down, the a~p-ol";ate mi~se~l medication
10 counters are incretn~-nte~l and the "Missed Medication" state S8 is entered. In
"Show Missed Medication" state S5, the LCD display 24 displays the
medication that was mi~se~i If an MT occurs during state S5, the Timeout
counter is set to 15 ..,i~ es and the "Missed Medication Alert" state S11 is
entered. If a Timeout occurs before a Medication Time, the "Missed
15 Medication" state S8 is entered. As indicated in Figure 7A, each of states S4,
S7 and S9 can be entered from state S5 depending on the con~iition~ that exist
when button 26 is pressed in states S5. The Timeout counter is set to 4 mimltes
upon such transitions occuring.
As mentioned above, the electric circuit 121 has three modes of
operation: alert, idle and show. Idle mode corresponds with "Missed
Mediration" state S8 and "Idle" state S2. Alert mode corresponds to states
"Alert" S3 and "Missed Medication Alert". Show modes corresponds to states
S4,S5,S6,S7,S9andS10.
Figure 8 is a block diagram of circuil.~r of the pro~ unit 80.
Microcontroller 138 is provided for controlling the writing of information onto
the remin~er device 10 through telephone jack 90. Again the telephone jack 90
could also be an infrared link. Signal altering means 142 provides
CA 02251234 1998-10-21
progr~mming information from the RS-232 or infrared link to microcontroller
138. Power supply 144 powers the microcontroller 138, and clock 146
provides a clock signal for the intern~l operation of the microcontroller 138.
The plo~ g unit 80 is powered at 5V, which can be obtained by
plugging an AC/DC adaptor connected to the docking unit into a normal 120V
wall outlet. During pro~;~.. i.~g of the remin~er and compliance device, the
progr~....nil~g unit disables the microcontroller of the remin~r device. The
progli,....nil-g unit then performs the n~cess~ry read/write operations on the
10 remin(1er device through the I/O phone jacks or i~cd links provided on both
units.
Figure 10 shows an ex~mrl~ry circuit sch~m~tic of the pro~ ...;..g
unit 80 plug. A plug CNl connects to a 9 V DC wall transformer (not shown)
the 9 V DC being converted to 5 volts DC by a power transistor U1 which is a
- power tr~nsictor acting as a 5 volt re~ tor. The part nnmber for the power
transistor Ul is LM3408T-5.0 in the illustrated embo~liment Ul is
m~mlf?~ctured by National Semiconductor. The output of the power tr~ncictor
Ul supplies DC power to the prog~ unit. A tr~ncictor U3 can be a unit
m~n~lf~ctured by TelCom Semiconductor, Inc. with electronic component
identification TC54VN45 and this tr~n~ictor serves as a voltage detector.
When the prog~ g unit is turned off, a reset signal is sent to a
microcontroller U4. The microcontroller U4 can be a Motorolla
microcontroller serial no. 68HC705J18. A self-generating clock CRl of
3.6864 MHz is tied to two on-chip oscillators providing the on-chip clock.
Signals from a telephone jack CN2 are tied to the output lines of the
microcontroller, and the telephone jack tr~nemitc progr~.. il-g information to
the rerninder device 10.
CA 022~1234 1998-10-21
A divider U2 in the p,efelled embodiment is chip serial no. HIN232-
CB m~n~lf~ctured by Harris Semiconductor. The divider U2 provides a signal
interface between the four data pins of a divider U4 and a DB-9 connector
CN3. The DB-9 connector CN3 is on the RS-232 cable connected to the
5 col....,ll"ications port of the personal com~ulel. A suitable DB-9 connector is
sold as part no. HD20-F-9.
Figure 11 shows a circuit sch~-m~tic for the remind~r device 10. A first
contact CN2 and a second contact CN3 are battery contacts for the two AA
10 batteries which source power to the remin-l~r device according to this circuit
sçhem~tic. Although this illustrated circuit employs two such b~tt~ries, it is
also possible to power a remin~er device 10 with a single AA battery. As the
batteries provide a voltage level of 1.5 volts, a step-up convertor U3 is
required to provide Vcc of 5 volts. The convertor U3 can be one
m~nllf~ctured by Linear Technology with identifiç~tion no. LT1073CS8-5.
The converter U3 also serves as a voltage ~letector for the circuit. When the
input voltage provided to the converter U3 falls below 1.25 volts, the output
current provided by the converter U3 falls off sub~t~nli~lly, and when the
input voltage falls below 1.1 volts an alert signal to change the battery is
20 asserted. The circuit will cease to function when the input voltage to the
battery falls below 0.9 volts. A voltage detector U5 is the exact same transistor
as the convertor U3 in figure 10. When the input voltage to the voltage
detector U5 falls below 4.5 volts, the output for the voltage detector U5
provides a reset signal to a microcontroller U6 putting this rnicrocontroller in25 reset. The microcontroller U6 is the same electronic component as the
microcontroller U4 in figure 10. At an input voltage from the battery of l.OV
this type of behaviour could occur; however it is also possible that the circuitcould just cease to function.
CA 02251234 1998-10-21
-23-
A divider U4 tr~n~mit~ the real time clock signal to the micro~ oller
U6. The real time clock signal has a frequency of 4 Hz and is tied to the
illtellu~l request line of the microcontroller U6. The divider U4 produces the 4Hz signal from a much higher frequency signal of 32.668 kHz.
The microcontroller U6 implements the state m~ ine which controls
the behaviour of the circuit. The microcontroller U6 is also the central
controller of other electronic components in the remin~- device 10. These
components including an EEPROM memory U7, an LCD display Ul
10 corresponding to the LCD display 24, an audible alarm BZ 1 and a push button
switch SWl.
The EEPROM memory U7 can be chip serial number AT24C08
m~m-f~ctured by Atmel. The memory U7 is connected to a telephone jack
15 CNl, which is the same phone jack as the telephone jack CN2, in figure 10
and also to the microcontroller U6. Pro~i.. i~lg i~form~tion is read in from
the telephone jack CNl and written onto the memory U7. The _icrocontroller
U6 can then read prog,~ information stored in the memory U7 to
control the operation of the remin~er device.
The push button switch SWl can be m~mlf~ctured by C&K
Components, Inc having a component serial no. PTS125SM43. The push
button SWl serves as the cnnfirm~tion button 26 for the rçmin~ler device 10.
The audible alarm BZl takes the form of a periodic beep. The audible alarm
25 BZl can, for example, be m~mlfactured by Projects Unlimite~l with unit serialno. AI-175. The microcontroller U6 turns on the audible alarm BZl during
alert mode.
The LCD display Ul can be a display m~mlfactured by Rohm Co., Ltd.
CA 02251234 1998-10-21
.
-24-
with a unit serial no. LCD 16X2. Embedded in the LCD display Ul is a
controller/driver for the LCD display 24. The LCD display has 20 character by
two lines, and the dot construction is 5 x 7 dots. By modifying the values of
resistors Rl and R2, the int~n~ity of the dots on the display can be varied. TheS microcontroller U6 drives 4 lines on the LCD display Ul to control the
mess~ges on the LCD display 24. When the microcontroller U6 is in reset, all
of the pins of the microcontroller are configured as inputs. Accordingly, the
microcontroller embedded in the LCD display does not receive ground, and is
therefore not powered.
Figure 9 is a block diagram of the sonw~e and d~t~b~ces used in the
co,~ er based system provided for prog,~ ;..g the me/lic~tion r~min~r
device. Operating systems including Windows Version 3.1, NT, '95 and '98
on the personal COllli)Ull~ are acceptable for said software and d~t~b~ces7 and
15 the operating system controls the process for co...~ ication of the
prog~ ..nil-g inform~tion When medic~tion software 150 is l~lmche-l start
up and initi~li7~tion procedures 152 are run.
Preferably, the medication reminder and compliance sorlw~e will
20 detect the presence of the remind~r and compliance device (that is, that it is
attached to the docking unit) and will read the unit serial number. In addition,if the battery of the particular reminder device has to be çh~ngefl the so~lw~e
will display a wan~ing mess~e. If the unit serial number is in the intern~l
database, the personal information of the user and all the previous dispensed
25 prescription information will be loaded from the intçrn~l d~t~b~ce. If the
software has just been installed, the software will create a new ~l~t~b~ce with
the necessary tables. The software also asks the operator to identify himself,
for example, by his initi~l.c By doing so, any further inform~tion entered by
the operator can be attributed to him.
CA 02251234 1998-10-21
The software then enters a menu stage lS4 with a graphical interf~ce to
an operator of the coml)ulel allowing a number of sub-applic~tion groups to be
run. The operator must then choose what sub-application he wishes to run.
Functions of various sub-applications include retrieving compliance
5 information, providing drug information, supplying strength, frequency,
dosage and refill information, supplying specific instnlction~, warning label
and report generation, and col~t ,lent inform~tion elrc~neine Some of
these sub-applications are simply one or two procedules written in Visual
Basic. It will be appreciated however by those skilled in the art of
prog,;.. i~.~ that the sub-applications could also be written as C~ functions
in an equivalent C~ implement~hon of the medication software.
Sub-application groups include Display/Program Prescriptions 156,
Message Display/Program 158, Print/Display Warning Labels 160, Allergy
Provision 162, Com~ ent ~csie~m~nt 164, Report Genel~tion 166 and
Pro~ i..e of l~mind~r Device 168. Three reports which can be generated
include a compliance report which contains user compli~nce information, a
statistics report providing st~ti~tic~l use of the rçminder device, and a
progr~ e report providing medication and user information programmed
20 into the reminder device. In Allergy Provision 162, allergies of the user can be
added or removed by "checking" or "unchecking" corresponding boxes. In
Display/Program Prescriptions 156, çnterine of prescription dosages,
frequency of taking medication and refill threshold is possible. During
Pro~,1.. il~e of ~eminder Device 168, Co~ ications Port Drivers 169
25 control the tr~ncmittine of data over the co",~ ications port of the co",~ r.
Display Program Flesc"~lions 156 allows the operator to program into
and retrieve medication specific details from the remind~ and compliance
device. In terms of the number of dosages, the operator can dete- ..~ e how
CA 02251234 1998-10-21
-26-
many times the user has taken each prescribed. Each time the rçminder and
compliance device is progrAmme-l the clock of the device is synchronized
with the int~rn~l clock of the personal com~uler, as sometimes the real time
clock in the reminder device can be inaccurate after being turned off. By
entering a value into the a~p,opliate field during op~ or pro~S~.. ~i.. g the
number of times a medication should be taken can be specified. Another set of
fields allows the operator to specify the times and days a medication must be
taken. Automatic time sched~lling is generated based on the frequency at
which the medication must be taken. Finally, the operator can specify the refill10 threshold. This is the level at which the reminder and compliance device willbegin to alert the user that it is time for him to refill his meflic~tion.
Internal D~t~base 170 can provide or receive medication or user data
from 150. To update standard medication data in 170, Modem/Network Driver
15 172 can retrieve an eYecllt~ble file which can be çYecllted for this purpose.Standard prescription information is read from Commercial D~t~b~ce 174 and
used by 150 for progl~i.. i.. g of the remindçr device 10.
In the pr~relled embodimçnt the suitable commercial ~l~t~b~ce could be
20 any known ph~rm~cy d~t~b~ce application including: Kroll, ~lOr~lll, Zedoll,
Pharma-Plus and Wal-Mart. The software issues structure query l~n~-~ge calls
to the commercial ~l~t~b~ce to read standard prescription related information.
The software also has an intern~l d~t~b~ce which stores user provided
information in its various tables. When the rçmindçr device is being
25 programmed, the s~nware issues structure query l~n~l~e calls to the int~rn~l
d~tab~ce to extract the required medis~tion data. Standard medication data in
the intPrnal ~l~t~h~ce could be kept up-to-date via an operator download of an
executable or other file from, for example, a website. A downloaded
executable file could automatically update the int.~rn~l d~t~b~ce. This data
CA 02251234 1998-10-21
forms in part the information which the software instructs the co.. ~ ication
program of the operating system to transmit on the co.. l~i.ic~ionc port.
In the prcre~led embo~liment the int~rn~ at~bAce has four tables
5 including units, prescriptions, patient~, and drugs and mess~es. Both the
reminder and compliance device and the user are given mlmbers for distinction
and identification by the medication software. The pli~ y key for the units
table is the rçminder and compli~nce device serial number.
The units table contains the reminder and compliance device serial
number, the user identific~tion and the number of times the rçmindçr and
compliance device has been programmed. The remin~i~r and compliance
device serial number is the indeYine number for the device and is unique. The
field for number of times the remindçr and compliance device has been
15 programmed is incremented each time the reminder device is progr~ed.
The prescriptions table contains the attributes of the rçmindçr and
compliance device serial number, progra~ e data, col~ lent number,
drug identification number, prescription strength, mlmber of dosages, refill
20 threshold, displayed mess~ee, and the compliance data including date and
missed medicine counter value. The serial number is again the plil~l~y key for
the table, and a join path exists between the primary keys of the prescriptions
and units tables. Furthermore, a many-to-one relationship exists between the
primary key of the prescriptions and units table respectively. The
25 pro~ date attribute contains the date and time the unit has been
programmed. The colllp~llllent number contains the colllp~l,llent number that
is programmed and can be blank in the case of a virtual com~ llent. The
drug identification number is the drug identification number ~cci~ned to a
particular drug. The prescription strength is a quA~ d~ e value for the
CA 02251234 1998-10-21
strength of the ~,t;sc~ ion. The n~mber of dos~ges cont~ine the number of
times the prescription has to be taken. The refill threshold is the threshold for
dosages left which triggers the refill alert. The displayed mess~e cont~inc the
mess~ge that is displayed for that cu~ ent as pr~ ,ed. The
compliance date contains the next date and time the re-minder and compliance
device is to be progr~mmed The missed me~licine record is the number of
times the user has missed a particular prescription.
The p~h~nt~e table contains the attributes of the user identific~tion, user
name and date of birth. The user identification is the unique number
identifying each user. The user id~nhficahon is the primary key for the
patients table. The drugs table contains the records or attributes of drug
idenhfic~hion number and brand name of the drug. The primary key for the
drugs table is the drug identific~tion number.
The me~es~ges table contains the single attribute of message and
contains the text of the message to be displayed. A join path exists between
the message in the mess~es table and displayed messa&e in the prescriptions
table.
Three types of reports which can be gcne.aled are statistical,
progr~mming and compliance. The intern~l d~t~b~ee which will be described
later, has a prescription table. In generating a compli~nce report, if the
software detects m~trlling records in the prescriptions table of the int~rn~l
d~t~b~se the compliance i~ .ation will be retrieved from the medication
remindPr and compliance device. The compliance inform~tion is then
processed into the int~rn~ t~b~ee, and the compliance report will be
generated. A compliance report graph can also be generated showing mi~e~l
medication. Example I set out below is a sample of a compli~nce report that
can be produced by the software.
CA 02251234 1998-10-21
-29-
Example I
Med MinderT~I Compliance Report
Name S~rialNumber 2
Address Pro~ram Date S~p 17, 1998
~ ON, Re~d Date: Sep 22, 1998
Phone: Pharmacist
Drug ~ame: %CARBON DIOXIDE USPa'oCOMPRESSED Al:R USP ~I G .~I
D.I.~.: 2014416
R-~m~inina Dosaaes: 37 i7 I~Iissed Dosages: 8
The statistical report provides statistical use of the reminder and
compliance device based on the number of devices programmed and on the
age of the users. Graphs of statistical use can be generated, if desired. F~mrle15 II set out below is a sample of a statistical report that can be produced.
Example II
Med MinderT~I - Statistics Report
Aae Group linits A~er~ge Proarammed A~eraae ~lissed A-er:lae Proaram
Comp~rtments per ~ nit Dosaaes per ~ nit Tasl~s per ~ nit
~6 40 1 20 60 -
41 45 2 15 27
51 55 1 50 18
56 60 2 20 1 5
CA 02251234 1998-10-21
-30-
The pro~ g report provides all the medica~on and user
info~na~on programmed into the rernin~l~r and compliance device. A
progl~.. ;n~ report is generated a~er the remind~r and comrli~nce device has
been programmed and disconnected. Example m set out below is a sample of
S a prog~ report that can be produced.
FY~mrle m
Med MinderTM- Pro~ram Report
Name Senal Number: 13
Address ProgramDate: Sep25, 1998
~icSicc~l-~ ON, ph~
Phone:
. COMPART~IENT#l
Drug r~'ame: TYLENOL DROPS 80~1GIML INF~NTS
D.I.~'.: . 728519 ReorderPrescription:lOdosa~es
Days: All davs Total Dosages:
~ours: 8:00AM, 12:00PM, 4:00PM, 8:00PM
~lessages: T2ke l pill
From comp2rtment- ~ ~
CO~IPART~LE~T #2
Drug ~ame: CE?~RUM FORTE - TABLETS
D.I.r~.: 2166674 ReorderPrescription:5 dosaces
Days: All days Total Dosages: 100
Hours: 9:00Al~I
~Iessages: T2ke 1 pill
From comp2rtment ~ 2
CO~IPART~IE~rT#3
Drug ~ame: VITA~IN C 1000 MG - TABLET
D.I.:.~.: 2155168 Reorder Prescription: 5 dosa~es
Days: All da~s Total Dosages: 100
Hours: 8:00~ 00PM,6:00P.~, II:00P~
~lessages: 1I Tcke 2 pills Chew b~,ore s~cll~w
Fro~ compcrt.. -.c~t # 3 Or.l~ with wc.e_
CA 02251234 1998-10-21
-31-
It will be appreciated by those skilled in this art that various
modifications and changes to the described ~r.,.led embo~lim~nt can be made
without depar~ng from the spirit and scope of this invention. Accordingly all
such modifications and changes as fall within the scope of the appended
5 claims are intçn~e~ to be part of this invention.
