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Claims  |
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What is claimed is:
1. A medication compliance, co-ordination and dispensing system for
dispensing a plurality of medications in a medication regimen according to
a defined prescription schedule, comprising:
an upright, centrally located main housing containing a plurality of
electronic devices, a power supply, a main front panel for attaching a
plurality of output devices, and a control element, wherein
said control element is in communication with said plurality of electronic
devices, each said device being actuable by said control element and in
communication with said plurality of output devices, each device actuable
by said control element, said control element including memory means for
storing programs and data and a microprocessing means for processing a
program for generating a prescription schedule containing administration
times for each medication in the medication regimen;
clock means associated with said control element for indicating real time;
a plurality of secondary housing means positioned in two rows on opposite
sides of the main housing, each said secondary housing means engageable
with adjacent secondary housing means and/or the main housing;
storage means located inside each secondary housing means and dedicated to
storing a medication with defined administration times in accordance with
the program generated prescription schedule;
dispensing means located inside each secondary housing means and associated
with said storage means for dispensing said medication, wherein said
dispensing means is actuable by the control element when the clock means
indicates real time matching said defined administration times;
receiving means dedicated to each dispensing means and capable of receiving
medications delivered by the dispensing means;
compartment means dedicated to each receiver means and capable of
containing medication received by said receiver means until said
medication is removed by the patient; and
a plurality of first indicator means positioned on the outside of each
secondary housing means, said indicator means actuable by the control
element when real time equals said defined medication administration time
for the said medication.
2. The medication compliance, co-ordination and dispensing system of claim
1, wherein said plurality of first indicator means is an illuminated bulb.
3. The medication compliance, co-ordination and dispensing system of claim
1, wherein said plurality of first indicator means is an audible alarm.
4. The medication compliance, co-ordination and dispensing system of claim
1, wherein said secondary housing means includes a front surface panel for
embedding medication information in braille.
5. The medication compliance, co-ordination and dispensing system of claim
1, further comprising:
voice means located inside the main housing and actuable by the control
element; and
speaker means for broadcasting output of said voice means.
6. The medication compliance, co-ordination and dispensing system of claim
5, wherein said voice means is actuable by the control element to
selectively broadcast a predetermined message when real time equals said
defined medication administration time.
7. The medication compliance, co-ordination and dispensing system of claim
1, wherein said compartment means includes:
a hinged trap door for accessing the dispensed medication contained in the
compartment means; and
switch means associated with said hinged trap door and the control element
such that when the trap door is opened the switch means is closed.
8. The medication compliance, co-ordination and dispensing system of claim
7, further comprising:
display means located on the outside surface of each secondary housing
means, said display means actuable by the control element, wherein when
said switch means is closed, the control element causes said display means
to display a message.
9. The medication compliance, co-ordination and dispensing system of claim
1, further comprising:
a user-worn signal receiving device wherein the signal receiving device is
activated when real time equals said defined medication administration
time for a medication in the medication regimen.
10. The medication compliance, co-ordination and dispensing system of claim
9, further comprising:
signal transmission means associated with the control element for
communicating with said signal receiving device.
11. The medication compliance, co-ordination and dispensing system of claim
9, wherein the user-worn signal receiving device includes:
display means for communicating medication information to the patient; and
vibrating means for alerting the patient at the defined medication
administration time.
12. The medication compliance, co-ordination and dispensing system of claim
9, wherein the user-worn signal receiving device further includes sound
means for alerting the patient at the defined medication administration
time.
13. The medication compliance, co-ordination and dispensing system of claim
9, wherein the signal receiving device is a user-worn wristwatch.
14. The medication compliance, co-ordination and dispensing system of claim
13, wherein the user-worn wristwatch is programmable, said wristwatch
including vibrator means, and wherein the wristwatch is programmed in
conjunction with said prescription schedule such that when real time
equals said defined administration time the vibrator means is activated.
15. The medication compliance, co-ordination and dispensing system of claim
13, wherein the user-worn wristwatch further includes sound means, and
wherein the wristwatch is programmed in conjunction with the said
prescription schedule such that when real time equals medication
administration time, the sound means is activated.
16. The medication compliance, co-ordination and dispensing system of claim
7, further comprising:
a camera actuable by the control element when said switch means is closed.
17. The medication compliance, co-ordination and dispensing system of claim
7, further comprising:
a video camera, said video camera being capable of transmitting live
pictures to a remote location.
18. The medication compliance, co-ordination and dispensing system of claim
1, further comprising:
a second indicator means actuable by the control element, for alerting the
user of low supply status of a storage means.
19. The medication compliance, co-ordinating and dispensing system of claim
1, wherein one or more of the medication storage means is capable of
storing medication in the liquid form and one or more of the dispensing
means is capable of dispensing medication in the liquid form.
20. The medication compliance, co-ordination and dispensing system of claim
1, wherein the control element further report means for generating a
report on demand.
21. The medication compliance, co-ordination and dispensing system of claim
1, wherein the control element further includes means for communicating
with an external programming unit.
22. The medication compliance, co-ordination and dispensing system of claim
1, wherein the control element further includes means for communicating
via telephone modem.
23. A method of dispensing a first and second medication in a medication
regimen, comprising the steps of:
providing a control element including clock means for indicating real time,
memory means and microprocessor means;
providing a cabinet including a main housing, a plurality of storage means,
dispensing means associated with each storage means and actuable by the
control element, and compartment means associated with each dispensing
means and for receiving medication dispensed by said dispensing means;
selectively storing the first medication inside a first storage means and
the second medication inside a second storage means;
storing a schedule program in the memory means;
storing a user-defined medication administration criteria in the memory
means;
using the microprocessing means to process the schedule program such that
prescription schedules for each of the first and second medications are
generated in accordance with the medication administration criteria, said
prescription schedules including defined medication administration times;
using the control element to cause the first dispensing means to deliver a
predetermined amount of the first medication into the first compartment
means when real time equals the medication administration time for the
first medication; and,
using the control element to cause the second dispensing means to dispense
a predetermined amount of the second medication into the second
compartment means when real time equals the medication administration time
for the second medication.
24. The method of claim 23, wherein the compartment means further includes:
a hinged trap door for accessing said dispensed medication; and,
switch means associated with each trap door; and wherein there is further
included the step of:
using the opening of the trap door to close the switch means.
25. The method of claim 21, further comprising the steps of:
recording real time in the memory means whenever said switch means status
changes from open to closed;
incorporating said real time in the medication administration criteria; and
processing the schedule program to generate updated prescription schedules
for the first and second medications after each time the first or second
switch means is closed but before the first and second dispensing means is
actuated by the control element.
26. The method of claim 23, further comprising the steps of:
providing a first counter means associated with said first switch means and
a first indicator means associated with said first counter means;
initializing first counter means to a predetermined first value;
decrementing said first counter means each time said first switch means is
closed;
activating the first indicator means when the first counter means equals
the second threshold value;
refilling said first storage means with said first medication; and
deactivating first indicator means and re-initializing said first counter
means to first value. |
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Claims |
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Description |
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TECHNICAL FIELD
The present invention relates to systems for coordinating the
administration of medication regimens at, for example, home away from the
support system of a hospital or pharmacy, and without the day-to-day
supervision of medical personnel. More specifically, the present invention
is directed to improvements which allow the systems to be more accessible
to all types of patients, including, for example, the elderly, children,
the visually-impaired, and the hearing-impaired. The improvements include
new mechanisms and operating processes which protect the user from
overdosage and underdosage, and provide assurances of patient compliance.
The present invention also relates to a user-wearable, message receiving
or generated component, for example, a special wrist watch, of a
compliance, co-ordination and dispensing unit, remote from the main unit
of the coordinator but in communication with its safety and compliance
systems.
BACKGROUND ART
Medication compliance systems and associated medication dispensing devices,
and their equivalents, are known in the prior art. These systems are used
for overseeing and coordinating the administration of medication regimens.
Present systems function primarily to remind the patients when to take a
particular medication and to automatically dispense that medication in
accordance with a prescription schedule. Integration of CPU-based
microprocessors into the compliance, co-ordination and dispensing system
hardware has allowed the most recent systems to handle even more complex
regimens, often involving multiple medications and administration
criteria. These systems are particularly directed to coordinating and
administering a complex medication regimen at home, outside the support of
a hospital or pharmacy.
Critical to the effectiveness of a compliance, co-ordination and dispensing
system is a method of assuring the care-giver that a patient is complying
with the administration regimen. Moreover, the medication compliance and
dispensing system should provide some protection from overdosage and
underdosage. Generally speaking, prior art compliance and dispensing
systems are able to regulate dosage and frequency according to
administration criteria stored in the internal memory of the device's
control sub-system. These devices can often provide a record of the
administration history, which a care-giver can later review for patient
compliance or non-compliance. Some medical dispensers provide protection
by restricting patient access to medication only in accordance with a
prescription schedule.
As the health care industry continues to change, the importance of
self-administered medication regimens will also continue to increase. This
increase challenges the adequacy of existing compliance and dispensing
systems in meeting the demands of a wider variety of patient needs and
even more complex medication regimens.
It is now apparent that the compliance and dispensing systems in the prior
art are limited in use by certain members of the patient populations,
particularly those with special needs, such as children, the elderly, the
visually-impaired, the hearing-impaired and patients with failing memory.
With respect to these subpopulations, it is imperative to provide
compliance, co-ordination and dispensing systems and medical dispensers
which feature further assurances of compliance and greater protection from
overdosage and underdosage. The increased popularity has also created a
demand for compliance, co-ordination and dispensing systems which are more
convenient to use and more conducive to the lifestyle of any type of
patient.
Typical of present systems, U.S. Pat. No. 5,329,459, issued to Kaufman et
al, and U.S. Pat. No. 5,159,581 issued to Agans, disclose an interactive
medication dispenser capable of storing and dispensing a plurality of
medication, reminding the patient of administration times, and
discriminating between the different categories of medication stored, as
well as the different schedules of medication administration. These prior
art approaches include a housing for storage and dispensing of a plurality
of medication on demand from a programmable control element integrated
with the device. The CPU-based control element communicates with internal
memory containing medication administration criteria, a medication
delivery system and output devices which send audible or displayed
messages to the patient or care-giver, including a speech output means, a
visual display and other control signal devices.
The approach disclosed in U.S. Pat. No. 5,291,191, issued to Moore, is
intended to improve access by the visually-impaired to such a medical
dispenser. The Moore approach dispenses medication according to a
prescription schedule. When a medication is dispensed, the device
selectively broadcasts an audible description of the specified medication.
The invention includes a housing, an saudible broadcast means, and switch
means for regulating access to a predetermined storage compartment and
causing a sound playback means to broadcast a message associated with that
compartment.
Moore also teaches designing the cabinet of the housing such that the
compartments slide downwardly from the closed position to an open
position, and whereby gravity defines the urging means. When individual
switches are closed or opened via a control system, in accordance with a
prescribed schedule, access to the compartment containing the subject
medication is allowed. When the compartment is actually opened, e.g. by
the patient, another switch causes the control element to broadcast or
display a specific message associated with that medication.
A first problem recognized in the above-described prior art is that the
dispensing devices eject medication automatically according to a timed
sequence or schedule, but do not provide assurances that the medication
was taken, and, if taken, when the medication was taken. In this regard,
the devices do not provide adequate protection against both underdosage
and underdosage. If the patient fails to take the medication according to
schedule, the system continues to dispense medication at set intervals
under the false assumption or premise that the patient took previous
medications accordingly. Such a situation greatly enhances the risk of
underdosage--the patient takes less than is prescribed. An equally
critical situation arises if the patient takes the medication not
according to schedule, but long after it is dispensed. If the patient
takes the medication too close to the time for taking the subsequent
medication, the patient is in danger of overdosage.
An attempt to provide some of the protection and assurances lacking in the
prior art is evidenced in U.S. Pat. No. 5,392,952 issued to Bowden. Bowden
'952 is another medication dispensing system for providing specific doses
of medication in accordance with a pre-determined schedule. The device is
specifically targeted for use by the elderly, the visually-impaired, the
hearing-impaired and the disabled, and for prevention of overdosage. The
system provides information regarding the medication regimens of the
patient and specific instructions associated with each medication,
including dosage, whether to take with water or food, and whether it is
necessary to refill any of the medication supplies. The Bowden system also
monitors and records compliance, or non-compliance, by the patient, with
the compliance information then made available to a care-giver for review.
As with the previous devices, the Bowden approach includes a plurality of
compartments for storage and dispensing of medication and a control
element for receiving and storing medication administration criteria, e.g.
the time periods for dispensing medication and specific instructions
associated with each medication. The control element also actuates the
display and broadcast of messages to either the care-giver or the patient.
In Bowden '952, overdose protection is provided by a mechanism and
operation for retrieving pills which are delivered but not removed from
the dispenser within a specified time period. The previously dispensed
pills are restocked in the device's storage area.
One problem with Bowden '952, however, is that the prescribed medication
can be dispensed on demand, thereby allowing the patient to continue to
press a button for multiple dosage at the same time. This is especially a
problem for a patient with limited manual dexterity. Such a patient is
susceptible to inadvertently requesting multiple dosage at once, thereby
interrupting and thus invalidating the prescription schedule. In addition,
someone besides the patient could gain unrestricted access to the
medications as well.
Another deficiency in Bowden '952, and common to present pill dispensing
devices, is that the dispensing apparatus dispenses into a common drawer
or tray. When multiple medications are dispensed, or when multiple
medications have gathered in the tray, a patient is forced to discriminate
between the pills, for example, when administering instructions differ
between the pills. A visually-impaired patient finds this task difficult
if not impossible. When the pills are identical in color, shape or form,
as are many forms of medication, even a patient with some visual acuity
will find the task just as challenging.
Although Bowden '952 is specifically directed at providing a compliance
system and medical dispenser with improved protection from overdosage and
some assurances of patient compliance, existing systems are still lacking.
However, the present invention, in contrast, provides a compliance,
co-ordination and dispensing system embodying the desirable aspects of
recent technology, but introduces new mechanisms and operations which
provide additional assurances of patient compliance and greater protection
from overdosage and underdosage. The improvements are necessary in order
for these health care devices to effectively service the elderly, the
visually-impaired, the hearing-impaired, the mentally ill, and others with
handicaps.
Because of the increased complexity of medical regimens, it is also
desirable for a compliance and dispensing system to provide more extensive
and more accessible information on the medications and their
administration. The Moore '191 and Bowden '952 devices give limited
information regarding dosage, dosage times, how to take the medication and
supply status to the patient.
However, the present invention preferably provides administering
instructions, information on side effects, precautionary measures,
symptoms to watch and when the patient should call a doctor. Moreover,
such information is be accessible, in one form or other, to the variety of
patients to which the present invention is directed. The present
invention's compliance, co-ordination and dispensing system preferably
also provide means for communicating the information to the care-giver,
and to the patient when he/she is not in the vicinity of the device.
There is also a need to provide compliance systems which are more
convenient to use in the home and more conducive to the lifestyle of the
patient. Although it is known in the prior art to provide a portable
medical dispenser, such systems remain heavy and bulky, and are
impractical to carry around with the patient, as that patient goes about
in his/her normal routine. For the compliance and dispensing system to be
effective, the patient must be in the near vicinity to hear or see the
alarms. This, of course, is burdensome, since the patient will need to
leave the home or frequent other parts of the home far from the device.
Finally, despite recent developments in medical dispensing devices for the
home, prior art systems are further limited in that they are not capable
of dispensing medication in liquid form. Regardless of complexity, it is
common, if not essential, for medication regimens to include liquid
medication. Thus, a system for coordinating and administering complex
medical regimens in the home, provided with assurances of compliance and
protection from overdosage and underdosage, would not be complete without
liquid dispensing capability. It is one object of the present invention to
preferably provide such a capability in a compliance, co-ordination and
dispensing system.
A list of prior patents which may be of interest is provided below:
______________________________________
U.S. Pat. No. Inventor(s) Issue Date
______________________________________
5,400,301 Rackley 03/21/95
5,392,952 Bowden 02/28/95
5,367,505 Tsuchiya et al
11/22/94
5,329,459 Kaufman et al
07/12/94
5,291,191 Moore 03/01/94
5,159,581 Agans 10/27/92
4,785,981 Rodman 11/22/88
4,462,696 Yung et al 07/31/84
4,147,021 Kondo 04/03/79
______________________________________
It is noted that some of the above patents are directed to wristwatches
that include an alarm of one type or another for, for example, reminding
the wearer to take medication, noting for example, the Rackley '301
patent; and one watch which includes a vibration based alarm, noting, for
example, the Tsuchiya et al '505 patent. However, there is suggested no
co-ordination of such a watch with a separate medication compliance,
co-ordination and dispensing system.
GENERAL, SUMMARY DISCUSSION OF INVENTION
The present invention is directed to curing specific deficiencies in prior
art medication compliance systems and/or medication dispensing systems.
More specifically, the invention is directed to providing a compliance,
co-ordination and dispensing system which provides greater assurances of
patient compliance and protection from overdosage and underdosage. The
invention provides improvements necessary in order for these home health
care systems to effectively service all patients, but particularly those
with special needs, such as children, the elderly, the visually-impaired,
the hearing-impaired and patients with failing memory or other handicaps.
Finally, the present invention is also directed to providing a compliance,
co-ordination and dispensing system which is more convenient to use in the
home environment and more conducive to the normal lifestyle of any
patient.
As will become readily apparent, there are significant structural and
operational differences between the compliance, co-ordination and
dispensing system of the present invention and the compliance dispensers
of the prior art.
Structurally, the present invention comprises a cabinet preferably defining
a centrally located, free-standing main housing unit and two rows of
smaller individual units arranged on two opposite sides of the main unit
and engageable with the main unit. Each of the smaller individual units
function independently to store and dispense a medication and are referred
to as "dispensers."
The main unit houses the common components of the compliance, co-ordination
and dispensing system, including a control element primarily responsible
for operating the control system, a power supply, a computer-generated
voice means and a front panel. The front panel features a digital clock, a
speaker associated with the computer-generated voice means, an audio
alarm, a visual indicator and, in the preferred embodiment, the wide-angle
lens of a mini-camera or video recorder.
A typical dispenser comprises a substantially vertical, sometimes
cylindrical housing. A front surface is provided with a flat panel for
containing a digital display means, a visual indicator, i.e. a visual
alarm indicator such as a flashing bulb or the like, and a dedicated
surface for attaching typed instructions or, in an alternative embodiment,
for embedding braille instructions. Physically engageable with adjacent
dispensers and/or the main housing, each dispenser is electronically
connected to the control element.
In a preferred embodiment of the invention, the dispenser is dedicated to
storing and dispensing one type of medication in the pill form. The pills
are stored in an upper storage area. Upon actuation by the control
element, a dispensing mechanism delivers the required number of pills into
a receiver located below the storage area by way of urging means or by
gravity. The delivered pill passes through the receiver and into a chute,
which guides the pill to a small compartment area near the chute's bottom
point or end. There, the pill rests against the inside of a hinged trap
door, awaiting removal by the patient.
The patient gains access to the dispensed pill by opening the hinged trap
door to the pill compartment. Switch means are associated with each trap
door such that, when the door is opened, the switch is closed and, when
the door is shut, the switch is open. Because the switch means is
electrically connected to the control element, the switch status is known
at all times, and any change is automatically recorded and stored in
internal memory. Thus, the compliance, co-ordination and dispensing system
is able to record not only the time when a particular medication is
dispensed, but also the time when the medication is removed from the
dispenser. The realization that the two events--dispensing of medication
and removal of the medication--may differ greatly in time and monitoring
and accounting and adjusting therefor is unique to the present invention.
In an alternative embodiment of the compliance, co-ordination and
dispensing system, one or more of the dispensers are modified for storage
and dispensing of medication in the liquid form. The liquid dispenser,
however, retains the same control and protection features associated with
pill-type dispensers.
The control element controls the dispensing function, activates alarms,
indicators and other electronic devices, and receives, processes and sends
information between patient and care-giver. In the preferred, exemplary
embodiment, physically, the control element communicates with an external
CPU, various input and output devices located on the main unit and on each
storage unit, and additional output devices including a printer, a
mini-camera or video recorder, and a user-worn message receiving device
such as a digital beeper or a specially-designed, vibrating wristwatch. It
may also communicate with a remote monitoring facility or care-giver via a
modem or other communication link.
The control element is equipped with programmable or variable, static,
internal memory which is used to store user-inputted medication
administration criteria, a program for generating prescription schedules
and a control logic program associated with operation of the control
system for the compliance, co-ordination and dispensing system. The
internal memory also stores medication information, administration
instructions, and patient compliance history.
An important feature of the invention is the control element's ability to
generate updated prescription schedules for each medication in the regimen
during use, without requiring additional user input and programming. The
control element automatically runs the schedule program in response to
updated information on patient compliance or non-compliance and actual
times for taking prescribed medication, i.e. removal of the medication
from the dispenser. The program runs checks on the frequency of
administration and patient compliance, compares it with the earlier
prescription schedule and compares administration history with the
individual medication administration schedules and criteria in the
regimen. The latter check ensures that the patient does not take a
combination of medications which may cause harm if taken too closely
together.
A basic function of the control element is to discriminate between the
individual dispensers and the different medication contained therein. The
control element actuates the individual dispensing mechanisms according to
the medication administration criteria, i.e. according to a constantly
updated prescription schedule.
The control element also operates the alarms and indicators of the
compliance, co-ordination and dispensing system. When it is time for the
patient to take a particular medication, the control element activates an
alarm or indicator via control signals.
In the preferred embodiment of the invention, bright, flashing indicators
or flashers located on each dispenser are activated. Alternatively, a
variety of audible alarms, for example, a beeper or the like, could
function with or in lieu of the visual indicators.
When the patient removes a pill from the pill compartment, the control
element causes the appropriate alarm to be deactivated and a computerized
voice message to be broadcasted. The message provides extended information
on the medication, including brand and dosage, as well as instructions
regarding what to take with the pill, possible side effects and
precautions, symptoms to watch for, and when to call the doctor.
Alternatively, the same message may be displayed on the digital display
means of the front panel of the appropriate dispenser.
The compliance, co-ordination and dispensing system can also alert the
patient or care-giver when refills of the dispensers are necessary. In the
preferred embodiment, a visual indicator located on the front panel of the
main housing is activated by the control element when a particular
dispenser has only, for example, five days supply of medication left. The
control element simultaneously activates another visual indicator, audible
alarm, or message display, at the appropriate storage unit to direct the
user.
A unique feature of the compliance, co-ordination and dispensing system is
an integrated mini-camera or video recorder. This feature provides
additional assurance of patient compliance by recording the patient
receiving and/or actually swallowing the medication. The camera is
activated by the control element at the time of administering medication
or when a dispenser trap door is opened. In the preferred embodiment, the
lens of the camera is located on the front panel. Alternatively, the
camera may be mounted remotely from the main unit, strategically
positioned so as to capture the patient self-administering the medication.
For example, the camera may be equipped with a wide angle lens and mounted
at the far end of the patient's kitchen, away from the main unit of the
compliance, co-ordination and dispensing system.
Another unique feature of the system is, inter alia, a user-wearable
message receiving device such as a digital beeper or a specially-designed,
programmable wristwatch, integrated into the system and in communication
with the control element. In the preferred embodiment the watch includes a
clock display, vibrating means, and audio alarm means. In either case, the
watch or beeper is programmed in conjunction with the control element. In
the case of a beeper, the control element may communicate with a
commercial transmission service by modem. Alternatively, the control
element is provided with transmission means for directly communicating
with the beeper or wristwatch by, for example, using a bar code type
display incorporating the requisite information on the dispenser unit with
a bar code reader in the wristwatch using known technology currently used
in personal computers with co-ordinated, informat | | |
