U.S. patent application number 09/798925 was filed with the patent office on 2001-07-26 for prescription compliance device and method of using device.
Invention is credited to Sekura, Carol M., Sekura, Ronald D..
Application Number | 20010009398 09/798925 |
Document ID | / |
Family ID | 26721335 |
Filed Date | 2001-07-26 |
United States Patent
Application |
20010009398 |
Kind Code |
A1 |
Sekura, Ronald D. ; et
al. |
July 26, 2001 |
Prescription compliance device and method of using device
Abstract
A prescription compliance device which aids patients in
complying with instructions given by a physician for taking
prescription medication. The device reminds a patient when the next
dose of medication is to he taken and indicates whether a specified
dose has been taken. The device includes a microcontroller, a
display, a program memory for storing pre-programmed
medication-taking regimens for single and multiple medications, a
real time clock, a selector for selecting one of the regimens and
for programming the device as to the time and day on which a first
dose of medication is to be taken, a display which alternately
displays the current time and a time at which a next dose of
medication is to be taken, and an alarm which alerts the patient at
times when a dose of medication is to be taken. The selector
includes an event switch which is activated by the patient after
taking a dose of medication so as to record the taking of the
medication and to cause the microcontroller to effect the display
of the next time at which a dose of medication is to be taken. A
memory may also be included to record the times at which a patient
takes doses of medication. The device is small enough to be
attached to medication containers, and includes a remote
programming feature via a wireless link.
Inventors: |
Sekura, Ronald D.; (Key
Largo, FL) ; Sekura, Carol M.; (Key Largo,
FL) |
Correspondence
Address: |
OBLON SPIVAK MCCLELLAND MAIER & NEUSTADT PC
FOURTH FLOOR
1755 JEFFERSON DAVIS HIGHWAY
ARLINGTON
VA
22202
US
|
Family ID: |
26721335 |
Appl. No.: |
09/798925 |
Filed: |
March 6, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09798925 |
Mar 6, 2001 |
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09425292 |
Oct 25, 1999 |
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6198383 |
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09425292 |
Oct 25, 1999 |
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08990811 |
Dec 15, 1997 |
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6018289 |
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08990811 |
Dec 15, 1997 |
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PCT/US96/09241 |
Jun 14, 1996 |
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60000232 |
Jun 15, 1995 |
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60044265 |
Apr 25, 1997 |
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Current U.S.
Class: |
340/573.1 ;
221/2; 221/3; 340/309.16; 340/531; 368/10; 705/3 |
Current CPC
Class: |
A61J 2200/30 20130101;
A61J 7/0481 20130101; G16H 20/10 20180101; G16H 20/13 20180101;
G04G 11/00 20130101; A61J 7/0454 20150501; G04G 13/026 20130101;
A61J 7/0418 20150501 |
Class at
Publication: |
340/573.1 ;
340/309.15; 340/531; 221/2; 221/3; 705/3; 368/10 |
International
Class: |
G08B 023/00 |
Claims
What is claimed as new and is desired to be secured by Letters
Patent of the United States is:
1. A prescription compliance device comprising: microcontroller; a
program memory storing data representing a plurality of
pre-programmed medication-taking regimens; a selector selecting one
of said regimens and programming said device in accordance
therewith; and a display, said selector including an event switch
which is activated by said patient after taking a dose of said
medication to record the taking of said medication, said event
switch causing said microcontroller to effect the display of the
time at which a next dose of said medication is scheduled to be
taken, in accordance with the regimen selected by said
selector.
2. The device according to claim 1, further comprising: an
attaching mechanism for attaching said device to a medication
container.
3. The device according to claim 1, further comprising: a
transmitter/receiver; and an external transmitter/receiver
configured to be connected to an input device, said external
transmitter/receiver communicating with said transmitter/receiver
via a wireless link to select one of said regimens and program said
device in accordance therewith from remote locations.
4. The device according to claim 3, wherein said input device is a
personal computer.
5. The device according to claim 3, wherein said wireless link is
an infrared link.
6. The device according to claim 1, fuirther comprising an alarm
circuit alerting said patient at times when said patient is
scheduled to take a dose of medication.
7. The device according to claim 1, wherein said event switch is
activated to scan through regimen and programming options, and
wherein said selector further includes: a reset button rendering
said device on and off; and a function button selecting an
appropriate regimen and programming options.
8. The device according to claim 7, wherein each of said regimens
dictates the times at which said medication is to be taken daily or
events during which said medication is to be taken, and wherein
said programming options include: a time of day at which the first
dose of medication is to be taken or designation of default times
in accordance with a selected regimen; and a day of the week on
which said first dose is to be taken.
9. A device according to claim 8, wherein said programming options
further include: said patient's specified times for said events;
and a number of doses in a prescription.
10. A device according to claim 1, wherein said display comprises:
a first display area displaying a number of the regimen selected by
said selector; a second display area displaying a day of the week
on which a next dose of said medication is to be taken; a third
display area displaying the time or event during which the next
dose of said medication is to be taken; a fourth display area
displaying AM or PM designations for the time at which a next dose
of said medication is to be taken; and a fifth display area
displaying an icon indicating the nature of the information
currently displayed in said first through fourth display areas.
11. The device according to claim 10, wherein said third display
area further displays the current time.
12. The device according to claim 11, wherein said third display
area further displays the number of doses remaining in a
prescription.
13. The device according to claim 1, wherein said display is a
liquid crystal display.
14. The device according to claim 6, wherein said alarm circuit is
activated if said patient takes a dose of said medication and
presses said event switch more than a predetermined time before or
after a time at which a next dose is scheduled to be taken.
15. The device according to claim 1, wherein said microcontroller
causes said display to display a low battery indication after a
predetermined number of days have elapsed.
16. The device according to claim 6, wherein said alarm circuit
alerts said patient by emitting an audible signal.
17. The device according to claim 6, wherein said alarm circuit
alerts said patient by emitting a visible signal.
18. The device according to claim 3, further comprising a
non-volatile memory recording times at which said patient takes
doses of medication when said event switch is activated, contents
of said memory being accessible via said wireless link.
19. The device according to claim 18, wherein said non-volatile
memory comprises an electrically erasable programmable read only
memory (EEPROM).
20. The device according to claim 1, wherein at least one of said
plurality of pre-programmed medication taking regimens corresponds
to a plurality of medications.
21. The device according to claim 20, wherein said event switch is
further activated to view prescription information based on said
pre-programmed medication-taking regimens.
22. The device according to claim 20, further comprising an alarm
circuit alerting said patient at times when said patient is
scheduled to take at least one of said plurality of
medications.
23. The device according to claim 20, wherein prescription
compliance information is generated based on said plurality of
pre-programmed medication-taking regimens and said prescription
compliance information is recorded.
24. The device according to claim 20, wherein at least one of said
plurality of pre-programmed medication-taking regimens calculates
times when said patient is scheduled to take at least one of said
plurality of medication based on predetermined time intervals and a
time a first dose of said medication is to be taken.
25. The device according to claim 1, further comprising an alarm
circuit providing at least one of an audio, voice and vibration
indication.
26. The device according to claim 1, further comprising: a
transmitter/receiver; and an external transmitter/receiver
configured to be connected to a secondary device, said
transmitter/receiver communication with said external
transmitter/receiver via a wireless link to activate said secondary
device to perform at least one of generating an alarm, dispensing
said medication, and transmitting prescription information based on
said pre-programmed medication-taking regimens to at least a third
device.
27. A prescription compliance device comprising: control means;
program memory means for storing data representing a plurality of
pre-programmed medication-taking regimens; select means for
selecting one of said regimens and programming said device in
accordance therewith; and display means, said select means
including an event switch which is activated by said patient after
taking a dose of said medication for recording the taking of said
medication, said event switch causing said control means to effect
the display of the time at which a next dose of said medication is
scheduled to be taken, in accordance with the regimen selected by
said select means.
28. The device according to claim 27, further comprising: attach
means for attaching said device to a medication container.
29. The device according to claim 27, further comprising:
transmitter/receiver means; and external transmitter/receiver means
configured to be connected to an input device, for communicating
with said transmitter/receiver means via a wireless link to select
one of said regimens and program said device in accordance
therewith from remote locations.
30. The device according to claim 29, wherein said wireless link is
an infrared link.
31. The device according to claim 29, wherein said input device is
a personal computer,
32. The device according to claim 29, further comprising
non-volatile memory means for recording times at which said patient
takes doses of said medication when said event switch is activated,
contents of said memory means being accessible via said wireless
link.
33. The device according to claim 32, wherein said non-volatile
memory means comprises an electrically erasable programmable read
only memory (EEPROM).
34. The device according to claim 27, wherein said event switch is
activated to scan through regimen and programming options, and
wherein said select means further includes: a reset button for
rendering said device on and off; and a function button for
selecting an appropriate regimen and programming options.
35. The device according to claim 28, wherein each of said regimens
dictates the times at which said medication is to be taken daily or
events during which said medication is to be taken, and wherein
said programming options include: a time of day at which the first
dose of medication is to be taken or designation of default times
in accordance with a selected regimen; and a day of the week on
which said first dose is to be taken.
36. A device according to claim 35, wherein said programming
options further include: said patient's specified times for said
events; and a number of doses in a prescription.
37. A device according to claim 27, wherein said display means
comprises: a first display area displaying a number of the regimen
selected by said selector; a second display area displaying a day
of the week on which a next dose of said medication is to be taken;
a third display area displaying the time or event during which the
next dose of said medication is to be taken; a fourth display area
displaying the time at which a next dose of said medication is to
be taken; and a fifth display area displaying an icon indicating
the nature of the information currently displayed in said first
through fourth display areas.
38. The device according to claim 37, wherein said third display
area further displays the current time.
39. The device according to claim 38, wherein said third display
area further displays the number of doses remaining in a
prescription.
40. The device according to claim 27, wherein said display means
comprises a liquid crystal display.
41. The device according to claim 27, further comprising alarm
means for alerting said patient at times when said patient is
scheduled to take a dose of said medication.
42. The device according to claim 41, wherein said alarm means is
activated if said patient takes a dose of said medication and
presses said event switch more than a predetermined time before or
after a time at which a next dose is scheduled to be taken.
43. The device according to claim 27, wherein said control means
causes said display means to display a low battery indication after
a predetermined number of days have elapsed.
44. The device according to claim 41, wherein said alarm means
alerts said patient by emitting an audible signal.
45. The device according to claim 41, wherein said alarm means
alerts said patient by emitting a visible signal.
46. A method of operating a prescription compliance device,
comprising the steps of: (a) switching said device to a setup
state; (b) programming the current time into said device; (c)
selecting one of a plurality of pre-programmed medication-taking
regimens; (d) programming a time of day or an event during which a
first dose of medication is to be taken, or designating default
times in accordance with the selected regimen; (e) programming a
day of the week on which said first dose of medication is to be
taken; (f) programming a number of doses in a prescription; (g)
switching said device from a setup state to an operation state; (h)
indicating to said device that a dose of medication has been taken;
and (i) switching said device from an operation state to an off
state after said prescription has been nearly exhausted.
47. The method according to claim 46, wherein said steps (a) and
(i) are executed by activating a reset button.
48. The method according to claim 46, wherein said step (b) is
executed by activating an event switch to scan through times as
displayed on a display, and activating a function button to select
an the current time when displayed.
49. The method according to claim 46, wherein said step (c) is
executed by activating an event switch to scan through said
pre-programmed regimens as displayed on a display, and activating a
function button to select an appropriate regimen when
displayed.
50. The method according to claim 46, wherein said step (d) is
executed by activating an event switch to scan through times or
events as displayed on a display, and activating a function button
to select an appropriate time or event when displayed, or
activating an event switch to designate pre-programmed default
times in accordance with a selected regimen.
51. The method according to claim 46, wherein said step (e) is
executed by activating an event switch to scan through days of the
week as displayed on a display, and activating a function button to
select an appropriate day when displayed.
52. The method according to claim 46, wherein said step (f) is
executed by activating an event switch to scan through numbers as
displayed on a display, and activating a function button to select
an appropriate number when displayed.
53. The method according to claim 46, wherein said step (g) is
executed by activating an event switch after one of said regimens
has been selected and said device has been programmed.
54. The method according to claim 46, wherein said step (h) is
executed by activating an event switch after a dose of medication
has been taken so as to cause said device to display a time at
which a next dose of said medication is to be taken.
55. The method according to claim 46, wherein said steps (a)-(i)
are executed by activating an input device which communicates with
said prescription compliance device.
56. The method according to claim 55, wherein said input device
communicates with said prescription compliance device via a
wireless link.
57. The method according to claim 56, wherein said wireless link is
an infrared link.
58. The method according to claim 56, further comprising the step
of recording times at which doses of medication are taken when said
event switch is activated.
59. The method according to claim 58, further comprising the step
of accessing the recorded times via said wireless link.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This is a Continuation-in-Part application of the
International Application Serial No. PCT/US96/09241 filed Jun. 14,
1996 which is incorporated herein by reference. In addition, full
benefit of the filing date of U.S. Provisional Application Serial
No. 60/000,232 filed Jun. 15, 1995, International Application
Serial No. PCT/US96/09241 filed Jun. 14, 1996, and U.S. Provisional
Application Serial No. 60/044,265 filed Apr. 25, 1997 are claimed
pursuant to the provisions of 35 U.S.C. .sctn.119(e), and are
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to an apparatus which aids patients
in complying with instructions given by a physician for taking
prescription medication, and more particularly, to a device which
is programmable in accordance with the physician's instructions or
desired regimen.
[0004] 2. Discussion of the Background Art
[0005] A variety of devices have been proposed for recording
intervals at which patients, especially those under the care of an
attendant, take medication at periodic intervals prescribed by a
physician. If the patient or his medical care provider ignores the
proper instructions and repeats the dose too frequently or fails to
administer or take medication at the proper time, the concentration
of medication in the patient's body may become too high or too low.
In order to ensure that medications are taken at the proper time, a
variety of devices, such as the one disclosed in U.S. Pat. No.
4,361,408, have been devised to generate audible and/or visible
prompting or alarm signals that remind a patient or his caretaker
to administer the correct dosages at the correct time. Such devices
have been complex and costly, inconvenient to program, and have not
been flexible enough in establishing varying time intervals at
which the medication needs to be administered.
SUMMARY OF THE INVENTION
[0006] Accordingly, one object of this invention is to provide a
low cost, easy to use prescription compliance device that has the
flexibility of operating in accordance with various different
medication-taking intervals.
[0007] Another object of this invention is to provide a
prescription compliance device which is easily programmable either
by activating a programmer on the device itself or by remotely
programming the device via a wireless link. Multiple programming
regimens which correspond to different medication-taking intervals
and medication-types may also be programmed into the device.
[0008] Yet another object of this invention is to provide a
prescription compliance device which records the event of taking a
dose of medication and displays the time at which the next dose of
medication is to be taken.
[0009] A still further object of this invention is to provide a
prescription compliance device having a timer which measures the
time that has elapsed since the patient last took a dose of the
medication and an alarm which is activated at times when the
patient is to take the next dose of medication.
[0010] A further object of this invention is to provide a
prescription compliance device that maintains a count of the number
of doses remaining in a patient's prescription and displays the
count so that a patient will know when to have the prescription
refilled.
[0011] Another object of this invention is to provide a
prescription compliance device that alerts a patient when the
patient has missed a scheduled dose of medication or has taken a
dose of medication at a non-scheduled time.
[0012] Yet another object of this invention is to provide a
prescription compliance device which records the times at which a
patient takes each dose of medication in a format that can be
easily accessed via a wireless interface.
[0013] These and other objects are accomplished by a prescription
compliance device which includes a microcontroller, a program
memory which stores data representing a plurality of pre-programmed
medication-taking regimens for single and multiple medications, an
oscillator which controls timing functions of the device, a
selector selecting one of the regimens and programming the device
in accordance with the selected regimen, a display which
alternately displays the current time, the time at which a next
dose of medication is to be taken in accordance with the regimen
selected by the selector, and the number of doses remaining in a
prescription, and an alarm which alerts the patient at times when
the patient is scheduled to take a dose of medication. The device
may also include a memory which records the times at which a
patient takes each dose of medication in a format that can be
easily accessed via a wireless interface.
[0014] The selector includes an event switch which is activated by
the patient after taking a dose of medication to record the taking
of the medication, the event switch causing the microcontroller to
effect the display of the next time at which a dose of the
medication is scheduled to be taken, in accordance with the regimen
selected by the selector.
[0015] The event switch and a function button are provided for
programming the regimens by which the medication is to be taken,
the day of the week on which the first dose is to be taken, the
time at which the first dose is to be taken or the designation of
meals during which the first dose is to be taken, and the number of
doses in a patient's prescription.
[0016] Programming may be done either directly by using the
function button and the event switch or remotely via a wireless
link. To program from a remote location, the device is provided
with a wireless transmitter/receiver and an external wireless
transmitter/receiver configured to be connected to an input device.
The external wireless transmitter/receiver communicates with the
wireless transmitter/receiver via a wireless link to select one of
the regimens and to program the device in accordance with the
selected regimen.
[0017] The display includes a first display area which displays a
number of the regimen selected by the selector, a second display
area which may alternately displays the current day of the week and
a day of the week on which a next dose of medication is to be
taken, a third display area which alternately displays the current
time, the time or meal at which the next dose of medication is to
be taken, and the number of doses remaining in a prescription, a
fourth display area which alternately displays AM or PM
designations for the current time and the time at which a next dose
of medication is to be taken, and a fifth display area which
displays an icon indicating the nature of the information currently
displayed in the first through fourth display areas.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] A more complete appreciation of the invention and many of
the attendant advantages thereof will be readily obtained as the
same becomes better understood by reference to the following
detailed description when considered in connection with the
accompanying drawings, wherein:
[0019] FIG. 1 is an illustration of a prescription compliance
device in accordance with a first embodiment of the present
invention;
[0020] FIG. 2 is a block diagram of a prescription compliance
device of FIG. 1;
[0021] FIGS. 3A-3E are flow diagrams illustrating the steps
followed when operating the prescription compliance device;
[0022] FIG. 4 is a table listing examples of common
medication-taking regimens which may be programmed into the
prescription compliance device;
[0023] FIG. 5 is an illustration of a prescription compliance
device in accordance with a second embodiment of the present
invention;
[0024] FIG. 6A is a flow diagram illustrating the menu choices
available to the user;
[0025] FIGS. 6B-6H are flow diagrams illustrating the steps
followed when operating the menu options shown in FIG. 6A;
[0026] FIG. 7 is a block diagram of a prescription compliance
device including a memory for recording the takings of medication
and wireless programming capabilities;
[0027] FIG. 8A illustrates the prescription compliance device
according to the present invention as a free standing device;
[0028] FIG. 8B illustrates a top view of the prescription
compliance device and attachment mechanism according to the present
invention;
[0029] FIG. 8C illustrates a cross-sectional view of the
prescription compliance device attached to a bottle according to
the present invention; and
[0030] FIG. 9 is another table listing examples of common
medication-taken regimens which may be programmed into the
prescription compliance device.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0031] Referring now to the drawings, wherein like reference
numerals designate identical or corresponding parts throughout the
several views, and more particularly to FIG. 1 thereof, a
prescription compliance device 1 according to a first embodiment of
the present invention includes a function button 2a, a reset button
2b, and an event switch 4 for programming the device, and a display
3 for displaying the programmed information. The event switch 4 is
activated by the patient upon the taking of a dose of
medication.
[0032] Prescription Compliance Device For Single Medications
[0033] FIG. 2 illustrates a block diagram of the prescription
compliance device according to the first embodiment of the
invention. The illustrated and described configuration is exemplary
and any desired hardware implementation can be used. An 8-bit
microcontroller 9 such as (microchip Part No. PIC 16C954, for
example) which controls the overall functions of the device
includes a program memory 20 for storing preprogrammed
medication-taking regimens. A 32 KHz crystal oscillator 7 controls
all timings of the device. The program memory 20 is preferably a
dedicated chip mask read only memory (ROM), although other
nonvolatile memories such as a flash memory or EEPROM may be used.
The specific parameters of the microcontroller, program memory, and
the oscillator are set forth here solely for illustrative purposes
and are not intended to limit the scope of the invention. The use
of equivalent elements is contemplated within the scope of this
invention.
[0034] The microcontroller receives inputs from the function and
reset buttons 2a, 2b and from the event switch 4 and controls the
device functions in accordance with the pre-programmed regimens
stored in program memory 20. The microcontroller 9 is connected via
an 8-bit bus 21 to display driver 11 which drives the display 3 to
display relevant information in display areas 31-35. The display 3
is preferably a liquid crystal display (LCD) and the display driver
11 an ASIC LCD driver. Battery 12 is preferably a 3 volt battery
and alarm circuit 8 may visually and/or audibly prompt the patient
to take medication. However, equivalents are also within the scope
of the invention.
[0035] The operation of the prescription compliance device
according to this embodiment of this invention will now be
described with reference to FIGS. 3A-3E. Patients who are under the
care of an attendant are instructed to take medication at periodic
intervals as prescribed by a physician. Upon receiving the
prescription, the patient or his medical care provider employs the
prescription compliance device to aid the patient in complying with
the instructions given by the physician.
[0036] First, the device must be switched from an OFF state to an
ON state by pressing the reset button (Step S1). A "SET" icon is
displayed in display area 35 to indicate that the device is in a
setup mode. The patient first sets the current time (Steps S2 and
S3) as follows.
[0037] The event switch 4 is pressed and the microcontroller 9
directs the display area 33 to blink hour digits "12". Hours "1"
through "12" are scanned through by pressing the event switch 4 and
the appropriate hour is selected by pressing the function button 2a
when that hour is displayed.
[0038] The minutes tenth digit then blinks "0" and the digits "0"
through "5" are scanned through by pressing the event switch 4. The
appropriate digit is selected by pressing the function button 2a
when that digit is displayed.
[0039] The minutes unit digit then blinks "0" and the digits "0"
through "9", are scanned through by pressing the event switch 4.
The appropriate digit is selected by pressing the function button
2a when that digit is displayed.
[0040] The display area 34 then blinks "A" and the patient selects
AM or PM time designations using the event switch 4 to toggle
between the two and the function button 2a to select. This
completes the setting of the current time.
[0041] The patient now selects the regimen by which the
prescription medication is to be taken. Upon depressing the event
switch 4, the display area 35 displays "RGMN" and the display area
31 blinks "0", prompting the patient to scan through and select a
desired regimen using the event switch 4 (Step S4). FIG. 4 lists
examples of common programming regimens which may be pre-programmed
into program memory 20. These regimens are listed only by way of
example and other regimens are possible.
[0042] In FIG. 4, regimens are provided for taking the medication
1, 2, 3, 4, or 6 times daily, taking the medication with breakfast
and dinner, with breakfast, lunch, and dinner, or with breakfast,
lunch, dinner, and at bedtime, and for taking the medication once
every 48 hours.
[0043] The patient presses the event switch 4 to advance through
the programming regimens. During scanning, regimen numbers appear
in display area 31 and descriptions of the regimens appear in
display area 35 so that the patient knows which regimen each number
corresponds to. For example, when "8" appears in display area 31,
"3:D" appears in display area 35 to indicate to the patient that
programming regimen 8 corresponds to taking medication three times
daily.
[0044] When the desired regimen is displayed, the function key 2a
is pressed (Step S5) and the display 3 prompts the patient to
choose between standard, pre-programmed default times corresponding
to the selected regimen or setting a specific time at which the
first dose is to be taken. If the default times for taking the
medication are acceptable, the patient presses the event switch 4
and is then prompted to enter the number of doses in the
prescription (Step S21).
[0045] If the patient instead wants to set the time at which the
first dose is to be taken, the microcontroller 9 directs the
display area 33 to blink hour digits "12". Unless the patient
selects one of the meal regimens, the time of day at which the
first dose of the medication is to be taken is next programmed
(Steps S6 and S7). Hours "1" through "12" are scanned through by
pressing the event switch 4 and the appropriate hour is selected by
pressing the function button 2a when that hour is displayed.
[0046] The minutes tenth digit then blinks "0" and the digits "0"
through "5" are scanned through by pressing the event switch 4. The
appropriate digit is selected by pressing the function button 2a
when that digit is displayed.
[0047] The minutes unit digit then blinks "0" and the digits "0"
through "9" are scanned through by pressing the event switch 4. The
appropriate digit is selected by pressing the function button 2a
when that digit is displayed.
[0048] The display area 34 then blinks "A" and the patient selects
AM or PM time designations using the event switch 4 to toggle
between the two and the function button 2a to select. This
completes the setting of the time at which a first dose of
medication is to be taken by the patient.
[0049] If one of the meal regimens is selected, the medication is
to be taken with meals the times of which will vary from person to
person. The program memory 20 has pre-programmed therein standard
meal times (breakfast, lunch, dinner) during which most persons
normally eat. However, the device is flexible enough to allow for
different meal times, as will now be explained.
[0050] After a meal regimen is selected, display area 33 blinks "D"
for default meal times. If the patient eats meals at the standard
times programmed into the program memory 20, then the function
button 2 a is pressed when "D" is displayed (Step S8). If the
patient eats at different times, then pressing the event switch 4
(Step S9) allows the patient to toggle between "D" and "S"
(indicating `set`). Pressing the function key 2a when "S" is
displayed (Step S10) allows the user to set his breakfast, lunch,
dinner, and bedtimes as follows. After the function key 2a is
pressed, "BRKF" appears in display area 35 and "12" blinks in
display area 33. The patient's breakfast time (hour, minute, AM/PM)
is entered as described above (Steps S11 and S12).
[0051] After programming the breakfast time, the operation varies
according to the specific regimen selected. For explanatory
purposes, regimens 1, 2, and 3 refer to the meal designations
listed in FIG. 4. If regimen 2 or 3 has been selected, "LNCH"
appears in display area 35 and the time setting process is repeated
to set the patient's lunch time (Steps S13 and S14). "DINR" then
appears in display area 35 under regimens 1, 2, and 3 and the
patient's dinner time is similarly set (Steps S15 and S16).
Finally, "BDTM" appears in display area 35 if regimen 3 is selected
and the patient's bedtime is set as described above (Steps S17 and
S18).
[0052] Once the time/meal designations have been programmed, the
display area 32 then blinks "SU", prompting the patient to program
the day of the week on which the first dose is to be taken. The
days "SU" through "SA" are scanned through by pressing the event
switch 4 (Step S19) and the appropriate day is selected by pressing
the function button 2a (Step S20).
[0053] The display area 35 then displays "CNT," prompting the
patient to enter the number of doses in the current prescription.
Display area 33 blinks "0" and the patient scans up using the event
switch 4 until the desired number is displayed (Step S21). The
function button 2a is then pressed to select this number (Step
S22).
[0054] The display area 35 then prompts the patient to enter the
number of days that the current prescription is scheduled to last.
Display area 33 blinks "0" and the patient can scan up using the
event switch 4 until the desired number is displayed (Step S23).
The function button 2a is then pressed to select this number (Step
S24).
[0055] This completes the setup process. Display area 35 next
displays "STRT" and display area 33 displays a question mark ("?").
When the user presses the event switch 4, the device is in an
operation mode (Step S25). The operation mode is defined a mode the
device resides in after the user has programmed the desired
options. Display 3 may alternately display the current time or the
time at which the next dose is to be taken. When the current time
is displayed, display area 35 displays "TIME," display area 31
displays the number of the regimen selected by the patient, display
areas 33 and 34 display the current time of day, and display area
32 displays the current day of the week. When the time of taking
the next dose of medication is displayed, display areas 33 and 34
display the time at which the next dose is to be taken, display
area 32 displays the day of the week on which the next dose is to
be taken, display area 31 continues to display the number of the
selected regimen, and display area 35 displays "NEXT."
[0056] After the device is programmed and the event switch 4 is
pressed to enter the operation mode, the patient is aware of the
day and time at which the first dose of the medication must be
taken. At the time for taking the first dose, the microcontroller 9
directs the alarm circuit 8 to emit an audible and/or visible
signal to alert the patient that the first dose must be taken at
this time (Step S26). The alerting signal continues to be emitted
intermittently until the patient takes the dose and presses the
event switch 4 or until a prescribed time has elapsed (Step S27).
During this time, display area 35 displays "TAKE" indicating that
it is time to take the next dose. If the patient takes the dose
more than a prescribed time before the scheduled time and presses
the event switch 4, the alarm circuit 8 is activated (Step S28) and
the display area 35 indicates "ERR" (Step S29) to indicate that the
patient has not properly followed the selected regimen.
[0057] If the patient fails to take the dose within a prescribed
time after the scheduled time while the alarm circuit 8 is
activated, display area 35 displays "MISS" (Step S34) indicating
that the patient has missed taking the scheduled dose. The display
then indicates the time that the missed dose was scheduled to be
taken (Step S35) and prompts the patient to direct the device as to
how to proceed (Step S36). At this point the patient may press the
event switch 4 to maintain the current regimen (Step 37) or may
select a new regimen (Step S38).
[0058] Upon taking the first dose, the patient presses the event
switch 4 which records the taking of the medication and causes the
microcontroller to automatically calculate the time/meal at which
the next dose of medication must be taken according to the selected
regimen and to effect the display of this time on the display 3
(Step S39). The microcontroller also subtracts the dose taken from
the total number of doses in the prescription to update the count
of remaining doses. This number is displayed in display area 33
while "LEFT" is displayed in display area 35 to indicate the number
of doses remaining (Step S40).
[0059] Likewise, at the end of each day the microcontroller
subtracts one from the total number of days in the prescription to
update the count of remaining days. This number is displayed in
display area 33 to indicate the number of days remaining (Step
S41).
[0060] These operating procedures are repeated for as long as the
patient's prescription is valid. When the number of doses in the
prescription has been nearly exhausted (i.e., six doses or less
remaining), the display indicates "FILL" and the alarm circuit is
activated (Step S42). If the patient has the prescription refilled
at the direction of a physician, the operating procedures are
resumed at Step S21. Otherwise, if the patient has completed his
prescription and needs no further medication, the device is turned
off by pressing the reset button 2b (Step S43).
[0061] Prescription Compliance Device for Multiple Medications
[0062] FIG. 5 illustrates a block diagram prescription compliance
device according to a second embodiment of the invention. In this
embodiment, the user may program the device and monitor the status
of multiple medications.
[0063] In addition to the central processor and supporting
circuitry shown in FIG. 2 for the first embodiment, the device 50
according to the second embodiment includes a display 51 and a key
pad 52. The display 51 includes eight character and/or graphical
display fields F1-F8 which display information to the user. This
information could also be presented using a dot matrix display
and/or a scrolling display. Exemplary manners of implementing the
display include using a liquid crystal display (LCD), a cathode ray
tube (CRT), or a plasma display.
[0064] Referring to FIG. 5, the field F1 informs the user if
multiple medications are to be taken, F2 informs the user of the
specific prescription regimen being used with the medicine
identified in F6 and F7, and F3 informs the user as to the status
of the alarm or vibrator. When the device 50 is in an "OPERATE"
mode, F4 informs the user whether or not to take a medication. If
the user is to take a medication, F4 displays the word "TAKE,"
otherwise F4 displays the word "NEXT." An "OPERATE" mode is defined
as a mode in which the device normally resides without an action on
the part of the user. During a menu scan operation, the field F4
informs the user of the various options available. The field F4
also provides other information necessary to inform user of the
nature or status of information that is being provided in the other
fields. The field F5 displays time information, such as the day of
the week, hour, minute, and AM or PM, and F6 is an optional
character field identifying a memory slot relating to a specific
medication F7 displays user programmed information identifying a
specific medication and F8 advises the user if a program for a
particular medication is operative or if it has been suspended.
[0065] As shown in FIG. 5, the device 50 also includes a keypad 52
with six keys: SELECT 53, MENU 54, UP 55, DOWN 56, SNOOZE 57 and
EVENT 58. Other keys such as a numeric keypad, an alpha-numeric key
pad, or a computer keyboard may be utilized, if desired. These keys
are used during programming and operation of the device. The UP 55
and DOWN 56 keys allow the user to scroll through the options under
the various menu items and the SELECT 53 key is used to select a
desired option. Failure to activate the SELECT 53 key within a
prescribed time interval returns the device to the OPERATE mode.
Successive activation of the MENU 54 key causes the field F4 to
display the menu choices shown in FIG. 6A. Pressing the SELECT 53
key while one of these options is displayed sets the device into
the specific operation mode selected. The keypad 52 may be combined
with the display 51, as illustrated in FIG. 5, or alternatively the
keypad 52 may be separate from the display 51.
[0066] The multi-medicine prescription compliance device also
includes a SNOOZE switch 57 and an EVENT switch 58. For the
medication that is displayed in the fields F6 and F7, pressing the
EVENT switch 58 causes the following events to occur. When the
field F4 displays the word TAKE, the current date, time, and
medication name is recorded, thus signifying the medication was
taken. Then the field F4 displays the word NEXT and the next time
to take the medication is displayed in the field F5. However, if
other medications have earlier take times, the field F4 displays
the appropriate NEXT or TAKE screen for that medication. When the
field F4 displays the word NEXT and the time to take the medication
is within a predetermined time range, the same sequence applies as
when the F4 displays the word TAKE. However, when the field F4
displays the word NEXT and the time to take the medication has
exceeded the predetermined time range, the current clock time and
day are identified with the medication and the event is recorded.
If the user fails to take the medication within the predetermined
time range, the device advances to the appropriate next take time
for that medication. In addition, the SNOOZE button 57 is used to
silence the alarm. The alarm will then skip one interval before
alerting the user again.
[0067] The operation of the prescription compliance device
according to the second embodiment of this invention will now be
described with reference to FIGS. 6A-6H. FIG. 6A illustrates the
choices available to the user which can be scrolled through by
pressing the MENU 54 key.
[0068] The menu choices shown in FIG. 6A include the options of
TIME (Step S50), VIEW (Step S60), MEDICATION (Step S70), ALARM
(Step S80), LOCK (Step S90), HELLO (Step S100) and RUN (Step S110)
which are explained below with respect to FIGS. 6B to 6H. The user
scrolls through the options by pressing the MENU 54 key and then
selects the desired option with the SELECT 53 key.
[0069] FIG. 6B illustrates the programming steps required to
display or edit the current time. After the TIME option is selected
(Step S50) in FIG. 6A, the user has a choice to display the current
time or edit the current time (Step S51). If the user chooses to
display the current time in Step S51 and executes the RUN option
(Step S53), the current time will be displayed in the field F6
(Step S54) and the device returns to the OPERATE mode. If the user
chooses to edit the current time in Step S51, the user scrolls
through the times (days, hours, minutes) and selects a desired time
(Step S52). After executing the RUN option (Step S53), the edited
time will be displayed in the filed F6 and the device returns to
the OPERATE mode.
[0070] FIG. 6C illustrates the programming steps to view the
different medications programmed into the device. After the VIEW
option is selected (Step S60) in FIG. 6A, the user scrolls through
the times that various medications are to be taken (Step S61). The
time the medication is to be taken is displayed in the field F5 and
the medicine identifiers are displayed in the fields F6 and F7. The
user then selects the RUN option (Step S62) to return the device to
the OPERATE mode.
[0071] FIG. 6D illustrates the programming steps to view, omit or
customize a specific medication. After the MEDICATION option is
selected (Step S70) in FIG. 6A, the user scrolls through and
selects one of the various medications (Step S71). Upon selecting a
medication, the user scrolls through and selects an option (Step
S72) including "LAST", "FUTURE", "OMIT" and "PROGRAM". The "LAST"
option (Step S73) informs the user the last time the medication was
taken. The "FUTURE" option (Step S74) allows the user to scroll
through the future times the medication is to be taken and the
"OMIT" option (Step S75) allows a user to temporarily turn off the
program for the selected medication. The ON/OFF status for the
medication is displayed in the field F8. The PROGRAM option (Step
S76) allows the user to set (customize) program parameters for the
selected medication. FIG. 6E illustrates the programming steps
required to set the program parameters.
[0072] After the PROGRAM option is selected (Step S76) in FIG. 6D,
the user enters customized information identifying the selected
medication (Step S77a) in FIG. 6E. The customized information is
displayed in the field F7. After Step S77a is performed, the user
selects among several regimen options including a daily regimen
(i.e., 1/Daily-once per day; 2/Daily-twice a day; 3/Daily-three
times a day; and 4/Daily-four times a day) (Step S77c), and an
hourly regimen in which the user selects hourly intervals to take
the medication (Step 77d). Also included are a CYCLICAL (monthly
cycle), MEAL (meal time), CUSTOMIZE (customized time intervals),
and RECORD (record time at which medication was taken) regimens.
Upon selecting the CYCLICAL option, the user enters the number of
days in the cycle they take the medication (Step S77e). Then, the
user enters the days in the month (Step 77f), the start date in the
month that the user wants to start taking medication (Step 77g),
and the current date of the month (Step S77h). The user also enters
the time the first dose is to be taken (Step 77m) for the DAILY,
HOURLY, and CYCLICAL regimens. After selecting the MEAL option, the
user has a choice to take the medication WITH, AFTER or BEFORE
meals (Step S77j). After selecting the CUSTOMIZE option, the user
enters a specific time interval (Step S77k). The RECORD option
(Step S77l) records the time the medication is taken. The user
selects the RUN option (Step S77n) to return the device to the
normal operating mode.
[0073] FIG. 6F illustrates the programming steps to program the
ALARM options. After the ALARM option (Step S80) is selected in
FIG. 6A, the user selects a low, high or vibrator ALARM (Step S81).
The user then selects the RUN option (Step S82) to return the
device to the normal operating mode.
[0074] FIG. 6G illustrates the programming steps required to
program the LOCK option. After the LOCK option (Step S90) is
selected in FIG. 6A, the user has the choice to lock or unlock the
programming features of the device (Step S91). If the user wants to
lock the programming features, the user enters a code in Step S93.
The code may include any combination of numeric or character
values. If the user chooses to unlock the programming features, the
user enters the code to unlock the device (Step S92). The user then
selects the RUN option (Step S94) to return to the device to the
OPERATE mode.
[0075] FIG. 6H illustrates the programming steps required to
program the HELLO option. After the HELLO option is selected (S100)
in FIG. 6A, the user may enter phone and name information or meal
time information (Step S101). If the user chooses to enter phone
and name information, the user enters the desired phone and name
information (Step S102) then has a choice to enter another name and
phone number (Step S104). If the user desires to enter another
phone and name number (Yes in Step S104), the programming procedure
returns to Step S102. If the user does not wish to enter any more
phone and name numbers (No in Step S104), the user selects the RUN
option (Step S105) and the device returns to the OPERATE mode. If
the user chooses to enter meal time information in Step S101, the
user enters the desired meal times for breakfast, lunch, and dinner
in Step S103. After the desired meal time information is entered,
the user selects the RUN option in Step S105 to return the device
to the OPERATE mode.
Wireless Output
[0076] FIG. 7 illustrates a third embodiment of the present
invention. Since the programming and operation of the prescription
compliance device according to this embodiment are identical in
most aspects to those of the first and second embodiments, a
description of the identical features will be omitted. Referring to
FIG. 7, the prescription compliance device fuirther includes a
wireless transmitter/receiver 40 (Microchip Part No. SFH485) which
communicates with an external wireless transmitter/receiver 41 via
a wireless link (not shown). The external wireless
transmitter/receiver 41 includes a wireless transmitter/receiver 42
and an interface 43 for connection to an input device, such as a
personal computer. The interface is preferably a standard RS-232
serial interface, and infrared technology is employed in the
preferred embodiment to transmit and receive information. The
personal computer runs software by which the device may be
programmed via the personal computer instead of directly
programming using the function buttons. The above-described
programming procedures for the first and second embodiments are
carried out in this embodiment on a personal computer. Programming
the device is thus made more convenient by simply inputting the
above-described parameters (time, meals, number of pills, etc.) via
a personal computer keyboard.
[0077] The information input by the patient or his medical care
provider via a personal computer is transmitted by the wireless
transmitter/receiver 42 and received by the wireless
transmitter/receiver 40 and processed just as if it were directly
input via the buttons described for the first and second
embodiments. The wireless transmitter/receiver 40 transmits back to
the external device the current status of the device and the
information displayed on the display 3,51.
[0078] The device of FIG. 7 also includes a non-volatile memory 10
which records the taking of each dose of medication by the patient
when the event switch 4,58 is pressed. Information as to which
doses have been taken is accessible via the wireless link so that a
physician can examine the patient's compliance in taking the
medication. The non-volatile memory 10 of the preferred embodiment
is an 8 KB serial EEPROM (Microchip Part No. 24LC08B), however
equivalent memories may be employed without departing from the
scope of this invention. After programming the device on a personal
computer, the patient's operation of the device is identical to
that described above for the first and second embodiments.
[0079] The wireless transmitter/receiver 40 preferably utilizes
Amplitude Shift Keying (ASK) modulation to transmit/receive
infrared energy to/from the external wireless transmitter/receiver.
Infrared technology has been disclosed merely for illustrative
purposes and other wireless technologies and modulation methods are
contemplated to be within the scope of the invention.
[0080] In addition, each prescription compliance device has a
unique identification number assigned thereto and stored in its
program memory 20 for the purpose of identifying a particular
device when programming from a remote location.
[0081] With regard to programming the device, parameters such as
the day, time of day, and other parameters may be set in a global
register, whereas medication specific parameters are programmed
within a unique register. An additional capacity may be included to
allow the user to review the information programmed into the device
for each of the registers and to review any other pertinent
information. This information may be reviewed at the level of the
device itself and/or through the wireless computer interface.
[0082] The activation of the event switch 4,58 will cause temporal
data to be stored in a non-volatile memory. In addition, such
temporal data will have associated with it an identifying character
so that a utilization of a specific medication or therapy can be
tracked.
[0083] In addition to or as an alternative to identifying the
individual registers by characters or symbols, the device may also
provide user-friendly information, such as information identifying
the specific medication associated with a register by name or
description (i.e. yellow pill, water pill, etc.). Additionally,
instructions may be provided in conjunction with an alarm providing
the user with useful information (i.e. take with food; avoid milk,
etc.). Both types of such additional information would be
accessible to each register to recall and display at appropriate
times in either voice or character formats as discussed below.
[0084] The wireless emissions of the device can also be used as
transducing the elements to activate secondary apparatuses. Thus,
the emission of a wireless signal in conjunction with an alarm can
be used as a signal to activate secondary alarms. The secondary
alarms can be used to alert individuals who are hearing or vision
impaired, to alert delivery systems to dispense medication to
individuals who are mentally or physically handicapped, or to
activate any of a variety of other types of apparatuses.
[0085] Within institutional settings, emissions from the
prescription compliance device which are triggered by the alarm
logic, may be used in conjunction with medication or therapy
dispensing stations, or similarly, to alert staff that the time has
arrived to provide a specific medication or therapy to a patient.
Thus, according to the present invention, scheduling and planning
of therapy regimens in the pharmacy, by the physician, or by any
other care provider, may be programmed into the prescription
compliance device. In this embodiment, the device can perform a
function of instructing staff to provide medication or therapy in a
prescribed manner and/or at prescribed times.
[0086] In the present invention, this prescription compliance
device is equipped with a capacity for wireless emissions that are
output in conjunction with activation of the event switch or
passively by opening the medicine bottle, etc. The wireless
emissions carry the unique unit specific signature and can be
collected by independent receivers. Therefore, collection of
emission data can be used to evaluate and monitor the appropriate
dispensing of medication and therapy, and to provide an alert/alarm
condition if serious omission or error occurs (e.g., a medication
was not dispensed properly).
[0087] Wireless emission output may also be used to effect
concurrent signal emission by another apparatus or device.
Concurrent wireless emission by the prescription compliance device
and other apparatuses could be received by an independent recorder
in very close time sequences, thus allowing temporal and proximity
relation of action and instruments to be established. For example,
the activation of the "Event Switch" on a prescription compliance
device would emit a signal that would be collected by the
independent receiver and would also cause an appropriate patient
identifying device to emit a signal. This signal would also be
collected by the receiver. Through correlation of the receiver
identity, prescription compliance device identity, and patient
identity, a data set can be generated establishing a relationship
between a specific action, a specific place, a specific medication,
and a particular patient.
Attachments
[0088] FIGS. 8A, 8B and 8C illustrate the prescription compliance
device attached to a variety of containers and surfaces that are
either flat or curved. FIG. 8A shows the prescription compliance
device as a free standing device which is housed in a plastic
casing that has an accommodation on the back surface to permit
attachment to a chain or loop that facilitates use as a key chain
or pendent (not shown). The device fits into a collar (A in FIGS.
8B and 8C) that are flexible and can bend to accommodate the shape
of curved containers or flat surfaces. The "wings" and back surface
of the collar are coated with adhesive which attaches the
attachment appliance to the surface or container (FIG. 8C). In
applications where a narrow construct is required, the "wings" may
be clipped off at points D (in FIG. 8B) and attachment to the
surface can be achieved solely through the adhesive on the back of
the collar C (in FIG. 8C)
[0089] Thus, the prescription compliance device according to this
invention may be attached to medication containers by adhesives,
straps, velcro, mechanical attachment, integration as a component
of the container itself, or by any other manner of attachment. The
device also operates freestanding, and need not be attached to a
medication container.
[0090] The device can be utilized in conjunction with or as a part
of a wide array of medicine delivery systems and free standing
units. Free standing units independent of the medical container
include use as, or as a part of a clock, pendent, key chain or
watch. Other free standing applications include configurations
similar to those used for beepers or cellular telephones or any
other similar configuration that can easily be carried by a person.
In addition to attaching the device to the medicine container or
integration as a part of the medicine container, the current
invention describes prescription compliance devices that can be
used with or are a part of blister packaging, medicine cabinets,
pill box or any other container intended for distributing
medication. Additionally, the device can be integrated with, or
used in conjunction with a cabinet, cart or other similar apparatus
that is used in conjunction with dispensing medicine or therapy in
an institutional setting.
Alarms
[0091] As discussed above, the device triggers circuits to alert
the patient when to take a dose of medication. These alarm
capabilities include, in addition to audio and visual signals,
tactile signaling, such as a vibrator or comparable mode of
signaling, voice signaling achieved through a recording or digital
generation, and the use of a wireless output as a transducing
element to activate a triggering of secondary devices (e.g.,
alarms, patient assistance equipment, etc.) or to alert medical
personnel or other personnel that some form of action should be
taken (e.g., providing medication or therapy). The avenue via which
the prescription compliance device communicates information to the
user includes tactile and visual and auditory signaling.
[0092] The use of tactile stimulation, such as the vibrator used in
a pager, or some similar stimulus will provide the user with a
discrete signal that can alert the user without alerting others in
his/her company. Operation of a tactile stimulation will occur in a
manner analogous to that described for the visual and auditory
stimuli.
[0093] The device according to the present invention also includes
the use of recorded signaling to provide the user with
identification and/or instructional information. In order for
prescription devices to achieve these capabilities, they may be
equipped with a microphone, speaker and solid state recording
device. In the recording mode, the user can provide vocal input
regarding identification of medication and/or proper usage.
Utilization of user (or medical care provider) recorded information
will occur per logic employed at the level of the device's
microprocessor(s) and may incorporate prerecorded information in
addition to that recorded by the user. Thus, with the
multi-medicine device described, the logic in a specific register
may be used to dictate playback of a recorded sequence such as "10
PM; Take Yellow Pills; Take with food." Such a sequence may combine
user recorded and prerecorded signaling to alert the user to
therapy identification, the time of utilization, special
instructions, and any other parameters that might be appropriate.
Such sequences are appropriately utilized within specific registers
in multi-medication devices, thus providing the user with the
proper timing and practical advice for the correct use of specific
medications.
[0094] In addition, a user initiated action may be required to
initiate the display of either visual or recorded identification
and instructional information. Thus, the prescription device may
first emit an audio, visual or tactile stimulus, and then an action
by the user will cause the device to display the appropriate audio
and/or visual information. Display of such audio or visual
information may be accomplished in a manner so as to preserve the
privacy of the user in hearing or viewing such information (e.g.,
an ear phone).
Dosing Schedules
[0095] TABLE 1 summarizes dosing time intervals for morning,
midday, afternoon, etc. Normally a patient is awake for 14 hours
and it is over this interval that a patient is most likely to take
medication prescribed in a given day. The 14 day is divided into a
series of time intervals desirable for the patient to take
medication. Alternatively, the dosing time intervals may correspond
to meal times (e.g., with, before, and after breakfast, lunch,
etc.).
1 TABLE 1 DOSAGE TIME INCREMENT TIME (example) 1st (Morning) 0 hr 8
AM (first dose of day) 2nd (Mid day) 4 hr 12 PM 3rd (Afternoon) 7
hr 3 PM 4th (Evening) 9 hr 5 PM 5th (Late evening) 12 hr 10 PM 6th
(Bedtime) 14 hr 10 pm
[0096] FIG. 9 illustrates additional programming regimes which
allow the user to easily adjust a mediation taken.
[0097] Utilization of the specific times generated in such a matrix
as shown in Table 1 allows simple definition of appropriate times
for the patient to take medication under the most common regimens
identified in FIG. 9 as Regimens 1, 2, 3 and 4. Medications not
prescribed by these straight forward regimens may be handled by
additional regimens. Regimen 0 is a fully custom regimen which
allows the patient to define up to, for example, 9 specific times
in a day when medication is to be taken. Regimen 5 is designed for
medications that must be taken at prescribed intervals and may
accommodate intervals of up to 99 hours. Regimen 6 operates to
define a specific interval after taking a dose of medication prior
to which another dose should not be taken. Regimen 7 defines a
monthly cycle for taking medication (i.e., the patient is advised
when to and when not to take medication over the course of a month
or other cycle). Regimen 8, 9, and 10 are for use with medications
that are to be taken in conjunction with meals. These regimen may
have default times of 8:00 AM, 12:30 PM, and 6:00 PM, but the
patient is able to set times appropriate for his own schedule.
Regimen 11 is a record only mode where only activation of the event
button is recorded.
[0098] Programming the regimens shown in FIG. 9 is similar to the
programming steps described in the first and second embodiments.
Briefly, to program one of the regimens in FIG. 9, the user sets
the current time of the day and selects a desired regimen number.
To program regimen 0, the times for T1-T9 are set. The chain of
times may be terminated by setting 0:00. For Regimens 1-4, the time
for the first dose to be taken is set and the take times are
automatically calculated as appropriate.
[0099] For Regimen 5, the time for the first dose to be taken and
the desired time interval is set. The time interval may be set as
any number between 0 and 100 or it may be selected from the
sequence 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96 hr. The
take times are automatically calculated by adding the interval time
to the first dose time or the previously calculated take time.
[0100] For Regimen 6, the time interval is set as any number
between 0 and 100 or it may be selected from the sequence 1, 2, 3,
4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96 hrs. The take times are
automatically calculated by adding the interval time to the time
the first time or the previously calculated take time.
[0101] For Regimen 7, the time for the first dose to be taken is
set. Then the days on (i.e., the number of consecutive days in
which the prescription should be taken) is set. The days in the
cycle (i.e., days in month or number of days), and the current date
or number of days in the cycle is set. The starting date in the
cycle is set and the take times are automatically calculated. The
device additionally advises the user on what days in the cycle
medication should be taken. When the user enters the first take
time in a new cycle, the device will prompt the user to enter a new
value for the day in the cycle. For example, assume the user wanted
to take medication from the 16th to the 25th of each month and
today is April 9th. In this case, Day ON=10, Days in Cycle=30,
Current Date=9, and Starting Date=16.
[0102] For Regimen 8, the user scans and selects a default time for
Breakfast (08:00 AM), Lunch (12:30 PM), and Dinner (6:00 PM) and
additionally the user has the ability to alter the default
time.
[0103] For Regimen 9, the user scans and selects a default time for
Breakfast (08:00 AM), Lunch (12:30 PM), and Dinner (6:00 PM) (and
may alter the default time) and the take times are automatically
calculated by adding 2 hours to the selected meal times.
[0104] For Regimen 10, the user scans default times for Breakfast
(08:00 AM), Lunch (12:30 PM), and Dinner (6:00 PM) (and may alter
the default time) and the take times are automatically calculated
by subtracting 1 hour from the selected meal times.
[0105] The event switch shown in the first and second embodiments
should be of a size such that activation by an elderly person would
not be difficult while at the same time safeguarding against
accidental activation. The reset button is of a size such that
activation thereof requires a thin, needle-shaped object so as to
safeguard against the accidental turning off of the device.
Accidental depression of the function button is harmless since this
button has no effect when the device is not in the setup mode
except to de-activate the alarm circuit.
[0106] Provision is also made for a low battery indication. After
the passage of a certain number of days from when the battery was
last replaced, the display displays "BAT" to indicate that the
battery should soon be replaced.
Electronic Configuration and Programming Parameters
[0107] This invention may be conveniently implemented using a
conventional general purpose digital computer or microprocessor
programmed according to the teachings of the present specification,
as will be apparent to those skilled in the computer art.
Appropriate software coding can readily be prepared by skilled
programmers based on the teachings of the present disclosure, as
will be apparent to those skilled in the software art. The
invention may also be implemented by the preparation of application
specific integrated circuits or by interconnecting an appropriate
network of conventional component circuits, as will be readily
apparent to those skilled in the art.
[0108] The present invention includes a computer program product
which is a storage medium including instructions which can be used
to program a computer to perform a process of the invention. The
storage medium can include, but is not limited to, any type of disk
including floppy disks, optical discs, CD-ROMs, and magneto-optical
disks, ROMs, RAMs, EPROMs, EEPROMs, magnetic or optical cards, or
any type of media suitable for storing electronic instructions.
[0109] Obviously, numerous modifications and variations of the
present invention are possible in light of the above teachings. The
specific parameters mentioned in conjunction with the description
of the invention have been set forth solely for illustrative
purposes and are not limiting of the scope of the invention in any
way. It is therefore to be understood that within the scope of
appended claims, the invention may be practiced otherwise than as
specifically described herein.
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