U.S. patent application number 09/237194 was filed with the patent office on 2001-08-02 for modular microprocessor-based health monitoring system.
Invention is credited to BROWN, STEPHEN JAMES.
Application Number | 20010011224 09/237194 |
Document ID | / |
Family ID | 42241352 |
Filed Date | 2001-08-02 |
United States Patent
Application |
20010011224 |
Kind Code |
A1 |
BROWN, STEPHEN JAMES |
August 2, 2001 |
MODULAR MICROPROCESSOR-BASED HEALTH MONITORING SYSTEM
Abstract
A modular self-care health monitoring system which employs a
compact microprocessor-based unit such as a video game system of
the type that includes switches for controlling device operation
and a program cartridge. In accordance with the invention, the
program cartridge adapts the microprocessor-based unit for
operation with a glucose monitor (or, another type of health
monitor). The microprocessor-based unit processes data supplied by
the glucose monitor to supply signals for displaying relevant
information on a display unit that may be included in the
microprocessor-based unit or may be a separate unit such as a
television or video display monitor. The system provides for
transmission of signals to a remote clearinghouse or a healthcare
facility via telephone lines or other transmission media. The
clearinghouse includes signal processing capability for
transmission of reports to a remotely located healthcare
professional via facsimile transmission.
Inventors: |
BROWN, STEPHEN JAMES; (PALO
ALTO, CA) |
Correspondence
Address: |
BLACK LOWE & GRAHAM
816 SECOND AVE.
SEATTLE
WA
98104
US
|
Family ID: |
42241352 |
Appl. No.: |
09/237194 |
Filed: |
January 26, 1999 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09237194 |
Jan 26, 1999 |
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08481925 |
Jun 7, 1995 |
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5899855 |
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Current U.S.
Class: |
705/4 ; 600/309;
600/481; 705/3 |
Current CPC
Class: |
G16H 40/67 20180101;
G06Q 40/12 20131203; G06F 15/025 20130101; Y10S 128/903 20130101;
A61B 2560/0443 20130101; G16H 10/60 20180101; G16H 15/00 20180101;
G16H 20/17 20180101; G06Q 40/08 20130101; A61B 5/0022 20130101;
A61B 5/087 20130101; G16H 40/40 20180101; G16H 50/20 20180101; A61B
5/6896 20130101; A61B 5/0205 20130101; G06Q 10/10 20130101; G01N
33/48792 20130101; A61B 5/743 20130101; A61B 5/14532 20130101; G16H
40/63 20180101 |
Class at
Publication: |
705/4 ; 705/3;
600/481; 600/309 |
International
Class: |
G06F 017/60 |
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. A health monitoring system comprising: a programmable
microprocessor-based unit, said programmable microprocessor-based
unit including a plurality of switches and a receptacle for the
temporary insertion of an external memory unit that includes memory
medium having stored therein program instructions for controlling
the operation of said programmable microprocessor-based unit said
microprocessor-based unit also including circuit means for
generating a video signal for causing display of information on a
video display unit; monitoring means operable for monitoring a
condition indicative of a person's physical well-being and for
producing digitally encoded signals representative of said
monitored condition; and a signal interface connectable in signal
communication with said programmable microprocessor-based unit and
said monitoring means, said signal interface for coupling said
digitally encoded signals that are supplied by said monitoring
means and are representative of said monitored condition to said
programmable microprocessor-based unit; said microprocessor-based
unit being programmed for supplying a video signal for displaying
information based upon said signal supplied by said monitoring
means.
2. The health monitoring system of claim 1 wherein said monitoring
means is a blood glucose monitor that produces digitally encoded
signals representative of a user's blood glucose level.
3. The health monitoring system of claim 1 wherein said
programmable microprocessor-based unit is a video game system.
4. The health monitoring system of claim 3 wherein said program
instructions of said external memory unit include instructions for
causing said programmable microprocessor-based unit to store
signals representative of said monitored condition in said memory
medium of said external memory unit for subsequent access by a
health care professional.
5. The health monitoring system of claim 4 wherein said monitoring
means is a blood glucose monitor that produces digitally encoded
signals representative of a user's blood glucose level.
6. The health monitoring system of claim 1 wherein said
programmable microprocessor-based unit is responsive to program
instructions stored in said memory medium of said external memory
unit for supplying encoded signals representative of said monitored
condition of physical well being, said encoded signals being
established to allow transmission to a remote location; and wherein
said health monitoring system further comprises signal transmission
means for supplying said encoded signals representative of said
monitored condition of physical well being to a medium that allows
transmission of said encoded signals to a desired remote
location.
7. The health monitoring system of claim 6 wherein said monitoring
means is a blood glucose monitor that produces digitally encoded
signals representative of a user's blood glucose level.
8. The health monitoring system of claim 7 wherein said
programmable microprocessor-based unit is a video game system.
9. The health monitoring system of claim 6 wherein said desired
remote location is a clearinghouse facility for receiving said
encoded signals representative of said monitored condition of
physical well being, said clearinghouse facility including signal
processing means for converting said encoded signals representative
of said monitored condition of physical well being into a report
that provides information relating to said monitored condition of
physical well being.
10. The health monitoring system of claim 9 wherein said
programmable microprocessor-based unit is a video game system.
11. The health monitoring system of claim 9 wherein said signal
processing means of said clearinghouse facility further includes
means for electronically transmitting said report to a remotely
located health care professional.
12. The health monitoring system of claim 3 wherein said monitoring
means is a blood glucose monitor that produces digitally encoded
signals representative of a user's blood glucose level.
13. The health monitoring system of claim 2 wherein said program
instructions included in said external memory unit of said
programmable microprocessor-based unit cause said circuit means of
said programmable microprocessor-based unit to generate a video
signal for display of one or more menus and further operation of
said one or more switches of said plurality of switches allows the
user of said self-care health monitoring system to control the
operation of said programmable microprocessor-based unit by
selecting an item included in at least one of said one or more
menus, said operation controlled by said user with said one or more
switches including the processing of said digitally encoded signals
representative of said monitored condition, and the generation of a
video signal by said circuit means of said programmable
microprocessor-based unit.
14. The health monitoring system of claim 13 wherein said one or
more menus and further operation of said one or more switches
allows the user of said self-care health monitoring system to cause
the generation of a video signal by said circuit means for the
display of graphic and alphanumeric information that is based upon
said signals representative of said monitored condition.
15. The health monitoring system of claim 13 wherein said
programmable microprocessor-based unit is a video game system.
16. The self-care health monitoring system of claim 1 wherein said
signal interface is a microprocessor-based data management unit
programmed for encoding said digitally encoded signals that are
supplied by said monitoring means and are representative of said
sensed condition for transmission to a remotely located healthcare
professional and wherein said self-care health monitoring system
further comprises means for supplying said encoded signals to a
medium that provides transmission to a remote location.
17. The self-care health monitoring system of claim 16 further
comprising a clearinghouse facility for receiving said signals
supplied via said medium of transmission, said clearinghouse
facility being remotely located from said microprocessor-based unit
and including signal processing means for converting said encoded
signals supplied via said medium of transmission into a report that
relates to said condition sensed by said monitoring means.
18. The self-care health monitoring system of claim 17 wherein said
signal processing means of said clearinghouse facility includes
means for transmitting a signal representative of said report to
said remotely located healthcare professional.
19. A self-care health monitoring system comprising: a programmable
microprocessor-based unit, said programmable microprocessor-based
unit including a display screen and a plurality of switches, said
microprocessor-based unit including a receptacle for temporarily
receiving an external memory unit that includes a memory medium
having stored therein program instructions for controlling the
operation of said programmable microprocessor-based unit;
monitoring means operable for sensing a condition indicative of a
person's physical well-being and for producing digitally encoded
signals representative of said monitored condition; and a signal
interface connectable in signal communication with said
programmable microprocessor-based unit and said monitoring means,
said signal interface for coupling said digitally encoded signals
that are supplied by said monitoring means and are representative
of said sensed condition to said programmable microprocessor-based
unit; said microprocessor-based unit being programmed for supplying
a video signal for displaying information based upon said signal
supplied by said monitoring means.
20. The self-care health monitoring system of claim 19 wherein said
programmable microprocessor-based unit is a video game system.
21. The self-care health monitoring system of claim 19 wherein said
microprocessor-based unit is further programmed for supplying
signals encoded for transmission to a remotely located health care
professional and said self-care health monitoring system further
comprises means for supplying said encoded signals to a medium that
provides transmission to a remote location.
22. The self-care health monitoring system of claim 21 further
comprising a clearinghouse facility for receiving said encoded
signals supplied via said medium of transmission, said
clearinghouse facility being remotely located from said
microprocessor-based unit and including signal processing means for
converting said encoded signals supplied via said medium of
transmission into a report that relates to said condition sensed by
said monitoring means.
23. The self-care health monitoring system of claim 22 wherein said
signal processing means of said clearinghouse facility includes
means for transmitting a signal representative of said report to
said remotely located healthcare professional.
24. The self-care health monitoring system of claim 20 wherein said
monitoring means is a blood glucose monitor that produces digitally
encoded signals representative of a user's blood glucose level.
Description
RELATED APPLICATIONS
[0001] This is a continuation-in-part of application Ser. No.
07/977,323, filed Nov. 17, 1992
FIELD OF THE INVENTION
[0002] This invention relates to self-care health monitoring
arrangements that enable a patient or other user to gather data
important to a health management program and, if appropriate,
provide that data to a healthcare professional.
Background of the Invention
[0003] Controlling or curing conditions of ill health generally
involves both establishing a therapeutic program and monitoring the
progress of the afflicted person. Based on that progress, decisions
can be made as to altering therapy to achieve a cure or maintain
the affliction or condition at a controlled level. Successfully
treating certain health conditions calls for rather frequent
monitoring and a relatively high degree of patient participation.
For example, in order to establish and maintain a regimen for
successful diabetes care, a diabetic should monitor his or her
blood glucose level and record that information along with the date
and time at which the monitoring took place. Since diet, exercise,
and medication all affect blood glucose levels, a diabetic often
must record data relating to those items of information along with
blood glucose level so that the diabetic may more closely monitor
his or her condition and, in addition, can provide information of
value to the healthcare provider in determining both progress of
the patient and detecting any need to change the patient's therapy
program.
[0004] Advances in the field of electronics over the past several
years have brought about significant changes in medical diagnostic
and monitoring equipment, including arrangements for self-care
monitoring of various chronic conditions. With respect to the
control and monitoring of diabetes, relatively inexpensive and
relatively easy-to-use blood glucose monitoring systems have become
available that provide reliable information that allows a diabetic
and his or her healthcare professional to establish, monitor and
adjust a treatment plan (diet, exercise, and medication). More
specifically, microprocessor-based blood glucose monitoring systems
are being marketed which sense the glucose level of a blood sample
that is applied to a reagent-impregnated region of a test strip
that is inserted in the glucose monitor. When the monitoring
sequence is complete, the blood glucose level is displayed by, for
example, a liquid crystal display (LCD) unit.
[0005] Typically, currently available self-care blood glucose
monitoring units include a calendar/clock circuit and a memory
circuit that allows a number of blood glucose test results to be
stored along with the date and time at which the monitoring
occurred. The stored test results (blood glucose level and
associated time and date) can be sequentially recalled for review
by the blood glucose monitor user or a health professional by
sequentially actuating a push button or other control provided on
the monitor. In some commercially available devices, the average of
the blood glucose results that are stored in the monitor (or the
average of the results for a predetermined period of time, e.g.,
fourteen days) also is displayed during the recall sequence.
Further, some self-care blood glucose monitors allow the user to
tag the test result with an "event code" that can be used to
organize the test results into categories. For example, a user
might use a specific event code to identify test results obtained
at particular times of the day, a different event code to identify
a blood glucose reading obtained after a period of exercise, two
additional event codes to identify blood glucose readings taken
during hypoglycemia symptoms and hyperglycemia symptoms, etc. When
event codes are provided and used, the event code typically is
displayed with each recalled blood glucose test result.
[0006] Microprocessor-based blood glucose monitoring systems have
advantages other than the capability of obtaining reliable blood
glucose test results and storing a number of the results for later
recall and review. By using low power microprocessor and memory
circuits and powering the units with small, high capacity batteries
(e.g., a single alkaline battery), extremely compact and light
designs have been achieved that allow taking the blood glucose
monitoring system to work, school, or anywhere else the user might
go with people encountered by the user not becoming aware of the
monitoring system. In addition, most microprocessor-based self-care
blood glucose monitoring systems have a memory capacity that allows
the system to be programmed by the manufacturer so that the monitor
displays a sequence of instructions during any necessary
calibration or system tests and during the blood glucose test
sequence itself. In addition, the system monitors various system
conditions during a blood glucose test (e.g., whether a test strip
is properly inserted in the monitor and whether a sufficient amount
of blood has been applied to the reagent impregnated portion of the
strip) and if an error is detected generates an appropriate display
(e.g., "retest"). A data port may be provided that allows test
results stored in the memory of the microprocessor-based blood
glucose monitoring system to be transferred to a data port (e.g.,
RS-232 connection) of a personal computer or other such device for
subsequent analysis.
[0007] Microprocessor-based blood glucose monitoring systems are a
significant advance over previously available self-care systems
such as those requiring a diabetic to apply a blood sample to
reagent activated portions of a test strip; wipe the blood sample
from the test strip after a predetermined period of time; and,
after a second predetermined period of time, determine blood
glucose level by comparing the color of the reagent activated
regions of the test strip with a color chart supplied by the test
strip manufacturer. Despite what has been achieved, numerous
drawbacks and disadvantages still exist. For example, establishing
and maintaining diabetic healthcare often requires the diabetic to
record additional data pertaining to medication, food intake, and
exercise. However, the event codes of currently available
microprocessor blood glucose monitoring systems provide only
limited capability for tagging and tracking blood glucose test
results according to food intake and other relevant factors. For
example, the event codes of currently available monitoring systems
only allow the user to classify stored blood glucose readings in a
manner that indicates blood glucose tests taken immediately after a
heavy, light or normal meal. This method of recording information
not only requires subjective judgment by the system user, but will
not suffice in a situation in which successfully controlling the
user's diabetes requires the recording and tracking of relatively
accurate information relating to food intake, exercise, or
medication (e.g., insulin dosage). An otherwise significant
advantage of currently available blood glucose monitoring systems
is lost when blood glucose test results must be recorded and
tracked with quantitative information relating to medication, food
intake, or exercise. Specifically, the system user must record the
required information along with a time and date tagged blood
glucose test result by, for example, writing the information in a
log book.
[0008] The use of event codes to establish subcategories of blood
glucose test results has an additional disadvantage or drawback. In
particular, although alphanumeric display devices are typically
used in currently available microprocessor-based blood glucose
monitoring systems, the display units are limited to a single line
of information having on the order of six characters. Moreover,
since the systems include no provision for the user to enter
alphanumeric information, any event codes that are used must be
indicated on the display in a generic manner, e.g., displayed as
"EVENT 1", "EVENT 2", etc. This limitation makes the system more
difficult to use because the diabetic must either memorize his or
her assignment of event codes or maintain a list that defines the
event codes. The limited amount of data that can be displayed at
any one time presents additional drawbacks and disadvantages.
First, instructions and diagnostics that are displayed to the user
when calibrating the system and using the system to obtain a blood
glucose reading must be displayed a line at a time and in many
cases, the information must be displayed in a cryptic manner.
[0009] The above-discussed display limitations and other aspects of
currently available blood glucose monitoring systems is
disadvantageous in yet another way. Little statistical information
can be made available to the user. For example, in diabetic
healthcare maintenance, changes or fluctuations that occur in blood
glucose levels during a day, a week, or longer period can provide
valuable information to a diabetic and/or his or her healthcare
professional. As previously mentioned, currently available systems
do not allow associating blood glucose test results with attendant
quantitative information relating to medication, food intake, or
other factors such as exercise that affect a person's blood glucose
level at any particular point in time. Thus, currently available
blood glucose monitoring systems have little or no capability for
the generating and display of trend information that may be of
significant value to a diabetic or the diabetic's healthcare
professional.
[0010] Some currently available blood glucose monitoring systems
provide a data port that can be interconnected with and transfer
data to a personal computer (e.g., via an RS-232 connection). With
such a system and a suitable programmed computer, the user can
generate and display trend information or other data that may be
useful in administering his or her treatment plan. Moreover, in
such systems, data also can be transferred from the blood glucose
monitoring system to a healthcare professional's computer either
directly or remotely by telephone if both the blood glucose
monitoring system (or computer) to which the data has been
downloaded and the healthcare professional's computer are equipped
with modems. Although such a data transfer provision allows a
healthcare professional to analyze blood glucose data collected by
a diabetic, this aspect of currently available blood glucose
monitoring systems has not found widespread application. First, the
downloading and subsequent analysis feature can only be used by
system users that have ready access to a computer that is
programmed with appropriate software and, in addition, have both
the knowledge required to use the software (and the inclination to
do so). This same problem exists with respect to data transfer to
(and subsequent analysis by) a healthcare professional. Moreover,
various manufacturers of systems that currently provide a data
transfer feature do not use the same data format. Therefore, if a
healthcare professional wishes to analyze data supplied by a number
of different blood glucose monitoring systems, he or she must
possess software for each of the systems and must learn to conduct
the desired analyses with each software system.
[0011] The above-discussed disadvantages and drawbacks of
microprocessor-based self-care health monitoring systems take on
even greater significance with respect to children afflicted with
diabetes, asthma and other chronic illnesses. In particular, a
child's need for medication and other therapy changes as the child
grows. Current microprocessor-based self-care health monitoring
systems generally do not provide information that is timely and
complete enough for a healthcare professional to recognize and
avert problems before relatively severe symptoms develop. Too
often, a need for a change in medication and/or other changes in
therapeutic regimen is not detected until the child's condition
worsens to the point that emergency room care is required.
[0012] Further, currently available microprocessor-based health
monitoring systems have not been designed with children in mind. As
previously mentioned, such devices are not configured for
sufficient ease of use in situations in which it is desirable or
necessary to record and track quantitative information that affects
the physical condition of the system user (e.g., medication dosage
administered by a diabetic and food intake). Children above the age
at which they are generally capable of obtaining blood samples and
administering insulin or other medication generally can learn to
use at least the basic blood glucose monitoring features of
currently available microprocessor-based blood glucose monitoring
systems. However, the currently available monitoring systems
provide nothing in the way of motivation for a child to use the
device and, in addition, include little or nothing that educates
the child about his or her condition or treatment progress.
[0013] The lack of provision for the entering of alphanumeric data
also can be a disadvantage. For example, currently available blood
glucose monitoring systems do not allow the user or the healthcare
professional to enter information into the system such as
medication dosage and other instructions or data that is relevant
to the user's self-care health program.
[0014] The above-discussed disadvantages and drawbacks of currently
available microprocessor-based blood glucose monitoring systems
also have been impediments to adopting the basic technology of the
system for other healthcare situations in which establishing and
maintaining an effective regimen for cure or control is dependent
upon (or at least facilitated by) periodically monitoring a
condition and recording that condition along with time and date
tags and other information necessary or helpful in establishing and
maintaining a healthcare program.
SUMMARY OF THE INVENTION
[0015] This invention provides a new and useful system for
healthcare maintenance in which the invention either serves as a
peripheral device to (or incorporates) a small handheld
microprocessor-based unit of the type that includes a display
screen, buttons or keys that allow a user to control the operation
of the device and a program cartridge or other arrangement that can
be inserted in the device to adapt the device to a particular
application or function. The invention in effect converts the
handheld microprocessor device into a healthcare monitoring system
that has significant advantages over systems such as the currently
available blood glucose monitoring systems. To perform this
conversion, the invention includes a microprocessor-based
healthcare data management unit, a program cartridge and a
monitoring unit. When inserted in the handheld microprocessor unit,
the program cartridge provides the software necessary (program
instructions) to program the handheld microprocessor unit for
operation with the microprocessor-based data management unit.
Signal communication between the data management unit and the
handheld microprocessor unit is established by an interface cable.
A second interface cable can be used to establish signal
communication between the data management unit and the monitoring
unit or, alternatively, the monitoring unit can be constructed as a
plug-in unit having an electrical connector that mates with a
connector mounted within a region that is configured for receiving
the monitoring unit.
[0016] In operation, the control buttons or keys of the handheld
microprocessor-based unit are used to select the operating mode for
both the data management unit and the handheld microprocessor-based
unit. In response to signals generated by the control buttons or
keys, the data management unit generates signals that are coupled
to the handheld microprocessor unit and, under control of the
program instructions contained in the program cartridge, establish
an appropriate screen display on the handheld microprocessor-based
unit display. In selecting system operating mode and other
operations, the control buttons are used to position a cursor or
other indicator in a manner that allows the system user to easily
select a desired operating mode or function and provide any other
required operator input. In the disclosed detailed embodiment of
the invention several modes of operation are made available.
[0017] In the currently preferred embodiments of the invention, the
handheld microprocessor unit is a compact video game system such as
the system manufactured by Nintendo of America Inc. under the
trademark "GAME BOY." Use of a compact video game system has
several general advantages, including the widespread availability
and low cost of such systems. Further, such systems include switch
arrangements that are easily adapted for use in the invention and
the display units of such systems are of a size and resolution that
can advantageously be employed in the practice of the invention. In
addition, such systems allow educational or motivational material
to be displayed to the system user, with the material being
included in the program cartridge that provides the monitor system
software or, alternatively, in a separate program cartridge.
[0018] The use of a compact video game system for the handheld
microprocessor-based unit of the invention is especially
advantageous with respect to children. Specifically, the compact
video game systems of the type that can be employed in the practice
of the invention are well known and well accepted by children. Such
devices are easily operated by a child and most children are well
accustomed to using the devices in the context of playing video
games. Motivational and educational material relating to the use of
the invention can be presented in game-like or animated format to
further enhance acceptance and use of the invention by children
that require self-care health monitoring.
[0019] A microprocessor-based health monitoring system that is
configured in accordance with the invention provides additional
advantages for both the user and a healthcare professional. In
accordance with one aspect of the invention, standardized reports
are provided to a physician or other healthcare provider by means
of facsimile transmission. To accomplish this, the data management
unit of the currently preferred embodiments of the invention
include a modem which allows test results and other data stored in
system memory to be transmitted to a remote clearinghouse via a
telephone connection. Data processing arrangements included in the
clearinghouse perform any required additional data processing;
format the standardized reports; and, transmit the reports to the
facsimile machine of the appropriate healthcare professional.
[0020] The clearinghouse also can fill an additional communication
need, allowing information such as changes in medication dosage or
other information such as modification in the user's monitoring
schedule to be electronically sent to a system user. In
arrangements that incorporate this particular aspect of the
invention, information can be sent to the user via a telephone
connection and the data management unit modem when a specific
inquiry is initiated by the user, or when the user establishes a
telephone connection with the clearinghouse for other purposes such
as providing data for standardized reports.
[0021] The clearinghouse-facsimile aspect of the invention is
important because it allows a healthcare professional to receive
timely information about patient condition and progress without
requiring a visit by the patient (system user) and without
requiring analysis or processing of test data by the healthcare
professional. In this regard, the healthcare professional need not
possess or even know how to use a computer and/or the software
conventionally employed for analysis of blood glucose and other
health monitoring data and information.
[0022] The invention also includes provision for data analysis and
memory storage of information provided by the user and/or the
healthcare professional. In particular, the data management units
of the currently preferred embodiments of the invention include a
data port such as an RS-232 connection that allows the system user
or healthcare professional to establish signal communication
between the data management unit and a personal computer or other
data processing arrangement. Blood glucose test data or other
information can then be downloaded for analysis and record keeping
purposes. Alternatively, information such as changes in the user's
treatment and monitoring regimen can be entered into system memory.
Moreover, if desired, remote communication between the data
management unit and the healthcare professional's computer can be
established using the clearinghouse as an element of the
communications link. That is, in the currently preferred
arrangements of the invention a healthcare professional has the
option of using a personal computer that communicates with the
clearinghouse via a modem and telephone line for purposes of
transmitting instructions and information to a selected user of the
system and/or obtaining user test data and information for
subsequent analysis.
[0023] The invention can be embodied in forms other than those
described above. For example, although small handheld
microprocessor-based units such as a handheld video game system or
handheld microprocessor-based units of the type often referred to
as "palm-top" computers provide many advantages, there are
situations in which other compact microprocessor-based units can
advantageously be used. Among the various types of units that can
be employed are using compact video game systems of the type that
employ a program cartridge, but uses a television set or video
monitor instead of a display unit that is integrated into the
previously described handheld microprocessor-based units.
[0024] Those skilled in the art also will recognize that the
above-described microprocessor-implemented functions and operations
can be apportioned between one or more microprocessors in a manner
that differs from the above-described arrangement. For example, in
some situations, the programmable microprocessor-based unit and the
program cartridge used in practicing the invention may provide
memory and signal processing capability that is sufficient for
practicing the invention. In such situations, the microprocessor of
the microprocessor-based data management unit of the
above-described embodiments in effect is moved into the video game
system, palm-top, computer or programmable microprocessor device.
In such an arrangement, the data management unit can be realized as
a relatively simple interface unit that includes little or no
signal processing capability. Depending upon the situation at hand,
the interface unit may or may not include a telephone modem and/or
an RS-232 connection (or other data port) for interconnecting the
healthcare system with a computer or other equipment. In other
situations, the functions and operations associated with processing
of the monitored health care data may be performed by a
microprocessor that is added to or already present in the
monitoring device that is used to monitor blood glucose or other
condition.
[0025] Because the invention can be embodied to establish systems
having different levels of complexity, the invention satisfies a
wide range of self-care health monitoring applications. The
arrangements that include a modem (or other signal transmission
facility) and sufficient signal processing capability can be
employed in situations in which reports are electronically
transmitted to a healthcare professional either in hard copy
(facsimile) form or in a signal format that can be received by and
stored in the healthcare professional's computer. On the other
hand, less complex (and, hence, less costly) embodiments of the
invention are available for use in which transfer of system
information need not be made by means of telephonic data transfer
or other remote transmission methods. In these less complex
embodiments, transfer of data to a healthcare professional can
still be accomplished. Specifically, if the program cartridge
includes a battery and suitable program instructions, monitored
healthcare data can be stored in the program cartridge during use
of the system as a healthcare monitor. The data cartridge can then
be provided to the healthcare professional and inserted in a
programmable microprocessor-based unit that is the same as or
similar to that which was used in the healthcare monitoring system.
The healthcare professional can then review the data, and record it
for later use, and/or can use the data in performing various
analyses. If desired, the microprocessor-based unit used by the
healthcare professional can be programmed and arranged to allow
information to be stored in the cartridge for return to and
retrieval by the user of the healthcare monitoring system. The
stored information can include messages (e.g., instructions for
changes in medication dosage) and/or program instructions for
reconfiguring the program included in the cartridge so as to effect
changes in the treatment regimen, the analyses or reports to be
generated by the healthcare monitoring system, or less important
aspects such as graphical presentation presented during the
operation of the healthcare system.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] The foregoing aspects and many of the attendant advantages
of this invention will become more readily appreciated as the same
becomes better understood by reference to the following detailed
description, when taken in conjunction with the accompanying
drawings, wherein:
[0027] FIG. 1 is a block diagram that illustrates a healthcare
monitoring system arranged in accordance with the invention;
[0028] FIG. 2 diagrammatically illustrates monitoring systems
constructed in accordance with the invention connected in signal
communication with a remotely located computing facility which
includes provision for making the data supplied by the monitoring
system of the invention available to a designated healthcare
professional and/or for providing data and instructions to the
system user;
[0029] FIG. 3 is a block diagram diagrammatically depicting the
structural arrangement of the system data management unit and its
interconnection with other components of the system shown in FIG.
1;
[0030] FIGS. 4-10 depict typical system screen displays of data and
information that can be provided by the arrangements shown in FIGS.
1-3; and
[0031] FIG. 11 diagrammatically illustrates an alternative
healthcare monitoring system that is arranged in accordance with
the invention.
DETAILED DESCRIPTION
[0032] FIG. 1 depicts a self-care health monitoring system arranged
in accordance with the invention. In the arrangement shown in FIG.
1, a data management unit 10 is electrically interconnected with a
handheld microprocessor-based unit 12 via a cable 14. In the
depicted arrangement, data management unit 10 also is electrically
interconnected with a blood glucose monitor 16 of the type capable
of sensing blood glucose level and producing an electrical signal
representative thereof Although FIG. 1 illustrates blood glucose
monitor 16 as being connected to data management unit 10 by a cable
18, it may be preferable to construct blood glucose monitor 16 as a
plug-in unit that is placed in a recess or other suitable opening
or slot in data management unit 10. Regardless of the manner in
which blood glucose monitor 16 is interconnected with data
management unit 10, both that interconnection and cable 14 are
configured for serial data communication between the interconnected
devices.
[0033] Also shown in FIG. 1 are two additional monitoring devices
20 and 22, which are electrically connected for serial data
communication with data management unit 10 via cables 24 and 26,
respectively. Monitoring units 20 and 22 of FIG. 1 represent
devices other than blood glucose monitor 16 that can be used to
configure the invention for self-care health monitoring
applications other than (or in addition to) diabetes care. For
example, as is indicated in FIG. 1, the monitoring device 20 can be
a peak-flow meter that provides a digital signal representative of
the airflow that results when a person suffering from asthma or
another chronic respiratory affliction expels a breath of air
through the meter. As is indicated by monitor 22 of FIG. 1, various
other devices can be provided for monitoring conditions such as
blood pressure, pulse, and body temperature to thereby realize
systems for self-care monitoring and control of conditions such as
hypertension, certain heart conditions and various other
afflictions and physical conditions. Upon understanding the
hereinafter discussed aspects and features of the invention it will
be recognized that the invention is easily implemented for these
and other types of healthcare monitoring. In particular, monitors
used in the practice of the invention can be arranged in a variety
of ways as long as the data to be recorded or otherwise employed by
handheld microprocessor unit 12 and/or data management unit 10 is
provided in serial format in synchronization with clock signals
provided by data management unit 10. As is the case with blood
glucose monitor 16, the additional monitors can be configured as
plug-in units that are directly received by data management unit
10, or can be connected to data management unit 10 with cables (as
shown in FIG. 1).
[0034] As is shown in FIG. 1, handheld microprocessor unit 12
includes a display screen 28 and a plurality of switches or keys
(30, 32, 34, 36, and 38 in FIG. 1), which are mounted on a housing
40. Located in the interior of housing 40, but not shown in FIG. 1,
are a microprocessor, memory circuits, and circuitry that
interfaces switches 30, 32, 34, 36 and 38 with the microprocessor.
Stored in the memory of program handheld microprocessor unit 12 is
a set of program instructions that establishes a data protocol that
allows handheld microprocessor unit 12 to perform digital data
signal processing and generate desired data or graphics for display
on display unit 28 when a program cartridge 42 is inserted in a
slot or other receptacle in housing 40. That is, program cartridge
42 of FIG. 1 includes read-only memory units (or other memory means
such as battery-powered random access memory) which store program
instructions and data that adapt handheld microprocessor 12 for
operation in a blood glucose monitoring system. More specifically,
when the instructions and data of program cartridge 42 are combined
with program instructions and data included in the internal memory
circuits of handheld microprocessor unit 12, handheld
microprocessor unit 12 is programmed for processing and displaying
blood glucose information in the manner described below and
additional monitors 22 to provide health monitoring for asthma and
various other previously mentioned chronic conditions. In each
case, the plurality of switches or keys (30, 32, 34, 36, and 38 in
FIG. 1) are selectively operated to provide signals that result in
pictorial and/or alphanumeric information being displayed by
display unit 42.
[0035] Various devices are known that meet the above-set forth
description of handheld microprocessor unit 12. For example,
compact devices are available in which the plurality of keys allows
alphanumeric entry and internal memory is provided for storing
information such as names, addresses, phone numbers, and an
appointment calendar. Small program cartridges or cards can be
inserted in these devices to program the device for various
purposes such as the playing of games, spreadsheet application, and
foreign language translation sufficient for use in travel. More
recently, less compact products that have more extensive
computational capability and are generally called "palm top
computers" have been introduced into the marketplace. These devices
also can include provision for programming the device by means of
an insertable program card or cartridge.
[0036] The currently preferred embodiments of the invention are
configured and arranged to operate in conjunction with yet another
type of handheld microprocessor unit. Specifically, in the
currently preferred embodiments of the invention, program cartridge
42 is electrically and physically compatible with commercially
available compact video game systems, such as the system
manufactured by Nintendo of America Inc. under the trademark "GAME
BOY." Configuring data management unit 10 and program cartridge 42
for operation with a handheld video game system has several
advantages. For example, the display unit of such a device provides
display resolution that allows the invention to display both
multi-line alphanumeric information and graphical data. In this
regard, the 160.times.144 pixel dot matrix-type liquid crystal
display screen currently used in the above-referenced compact video
game systems provides sufficient resolution for at least six lines
of alphanumeric text, as well as allowing graphical representation
of statistical data such as graphical representation of blood
glucose test results for a day, a week, or longer.
[0037] Another advantage of realizing handheld microprocessor unit
12 in the form of a compact video game system is the relatively
simple, yet versatile arrangement of switches that is provided by
such a device. For example, as is indicated in FIG. 1, a compact
video game system includes a control pad 30 that allows an object
displayed on display unit 42 to be moved in a selected direction
(i.e., up-down or left-right). As also is indicated in FIG. 1,
compact video game systems typically provide two pair of
distinctly-shaped push button switches. In the arrangement shown in
FIG. 1, a pair of spaced-apart circular push button switches (36
and 38) and a pair of elongate switches (32 and 34) are provided.
The functions performed by the two pairs of switches is dependent
upon the program instructions contained in each program cartridge
42.
[0038] Yet another advantage of utilizing a compact video game
system for handheld microprocessor-based unit 12 of FIG. 1 is the
widespread popularity and low cost of such units. In this regard,
manufacture and sale of a data management unit 10, blood glucose
monitor 16 and program cartridge 42 that operate in conjunction
with a compact microprocessor-based video allows the self-care
health monitoring system of FIG. 1 to be manufactured and sold at a
lower cost than could be realized in an arrangement in which
handheld unit 12 is designed and manufactured solely for use in the
system of FIG. 1.
[0039] An even further advantage of using a compact video game
system for handheld microprocessor 12 is that such video game
systems include means for easily establishing the electrical
interconnection provided by cable 14 in FIG. 1. In particular, such
compact video game systems include a connector mounted to the game
unit housing (40 in FIG. 1) and a cable that can be connected
between the connectors of two video game units to allow interactive
operation of the two interconnected units (i.e., to allow
contemporaneous game play by two players or competition between
players as they individually play identical but separate games). In
the preferred embodiments of the invention, the "two-player" cable
supplied with the compact video game unit being used as handheld
microprocessor unit 12 is used as cable 14 to establish serial data
communication between the handheld microprocessor unit 12 (compact
video game system) and data management unit 10. In these preferred
embodiments, the program instructions stored on the memory of data
management unit 10 and program cartridge 42 respectively program
data management unit 10 and the compact video game system (i.e.,
handheld microprocessor unit 12) for interactive operation in which
switches 30, 32, 34, 36 and 38 are used to control the operation of
data management unit 10 (e.g., to select a particular operational
mode such as performance of a blood glucose test or the display of
statistical test data and, in addition, to control operation such
as selection of an option during operation of the system in a
particular operational mode). In each operational mode, data
management unit 10 processes data in accordance with program
instructions stored in the memory circuits of data management unit
10. Depending upon the operational mode selected by the user, data
is supplied to data management unit 10 by blood glucose monitor 16,
by additional monitors (20 and 22 in FIG. 1) or any interconnected
computers or data processing facility (such as the hereinafter
described user's computer 48 and clearinghouse 54 of FIG. 1).
During such operation, mode switches 30, 32, 34, 36 and 38 are
selectively activated so that signals are selectively coupled to
the video game system (handheld microprocessor unit 12) and
processed in accordance with program instructions stored in program
cartridge 42. The signal processing performed by handheld
microprocessor unit 12 results in the display of alphanumeric,
symbolic, or graphic information on the video game display screen
(i.e., display unit 28 in FIG. 1), which allow the user to control
system operation and obtain desired test results and other
information.
[0040] Although the above-discussed advantages apply to use of the
invention by all age groups, employing a compact video game system
in the practice of the invention is of special significance in
monitoring a child's blood glucose or other health parameters.
Children and young adults are familiar with compact video game
systems. Thus, children will accept a health monitoring system
incorporating a compact video game system more readily than a
traditional system, even an embodiment of the invention that uses a
different type of handheld microprocessor unit. Moreover, an
embodiment of the invention that functions in conjunction with a
compact video game system can be arranged to motivate children to
monitor themselves more closely than they might otherwise by
incorporating game-like features and/or animation in system
instruction and test result displays. Similarly, the program
instructions can be included in program cartridges 41, 42 and 43
(or additional cartridges) that allow children to select game-like
displays that help educate the child about his or her condition and
the need for monitoring.
[0041] With continued reference to FIG. 1, data management unit 10
of the currently preferred embodiments of the invention includes a
data port 44 that allows communication between data management unit
10 and a personal computer 48 (or other programmable data
processor). In the currently preferred embodiments of the
invention, data port 44 is an RS-232 connection that allows serial
data communication between data management unit 10 and personal
computer 48. In the practice of the invention, personal computer 48
can be used to supplement data management unit 10 by, for example,
performing more complex analyses of blood glucose and other data
that has been supplied to and stored in the memory circuits of data
management unit 10. With respect to embodiments of the invention
configured for use by a child, personal computer 48 can be used by
a parent or guardian to review and analyze the child's progress and
to produce printed records for subsequent review by a healthcare
professional. Alternatively, personal computer 48 can be used to
supply data to data management unit 10 that is not conveniently
supplied by using handheld microprocessor switches 30, 32, 34, 36
and 38 as an operator interface to the system shown in FIG. 1. For
example, some embodiments of the invention may employ a substantial
amount of alphanumeric information that must be entered by the
system user. Although it is possible to enter such data by using
switches 30, 32, 34, 36 and 38 in conjunction with menus and
selection screens displayed on display screen 28 of FIG. 1, it may
be more advantageous to use a device such as personal computer 48
for entry of such data. However, if personal computer 48 is used in
this manner, some trade-off of system features may be required
because data management unit 10 must be temporarily interconnected
with personal computer 48 during these operations. That is, some
loss of system mobility might result because a suitably programmed
personal computer would be needed at each location at which data
entry or analysis is to occur.
[0042] As is indicated in FIG. 1, data management unit 10 of the
currently preferred embodiments of the invention also includes a
modem that allows data communication between data management unit
10 and a remote computing facility identified in FIG. I as
clearinghouse 54 via a conventional telephone line (indicated by
reference numeral 50 in FIG. 1) and a modem 52 that interconnects
clearinghouse 54 and telephone line 50. As shall be described in
more detail, clearinghouse computing facility 54 facilitates
communication between a user of the system shown in FIG. 1 and his
or her healthcare professional and can provide additional services
such as updating system software. As is indicated by facsimile
machine 55 of FIG. 1, a primary function of clearinghouse 54 is
providing the healthcare professional with standardized reports 56,
which indicate both the current condition and condition trends of
the system user. Although a single facsimile machine 55 is shown in
FIG. 1, it will be recognized that numerous healthcare
professionals (and hence facsimile machine 55) can be connected in
signal communication with a clearinghouse 54.
[0043] Regardless of whether a compact video game system, another
type of commercially available handheld microprocessor-based unit,
or a specially designed unit is used, the preferred embodiments of
FIG. 1 provide a self-care blood glucose monitoring system in which
program cartridge 42: (a) adapts handheld microprocessor unit 12
for displaying instructions for performing the blood glucose test
sequence and associated calibration and test procedures; (b) adapts
handheld microprocessor unit 12 for displaying (graphically or
alphanumerically) statistical data such as blood glucose test
results taken during a specific period of time (e.g., a day, week,
etc.); (c) adapts handheld microprocessor unit 12 for supplying
control signals and signals representative of food intake or other
useful information to data management unit 10; (d) adapts handheld
microprocessor unit 12 for simultaneous graphical display of blood
glucose levels with information such as food intake; and, (e)
adapts handheld microprocessor unit 12 for displaying information
or instructions from a healthcare professional that are coupled to
data management unit 10 from a clearinghouse 54. The manner in
which the arrangement of FIG. 1 implements the above-mentioned
functions and others can be better understood with reference to
FIGS. 2 and 3.
[0044] Referring first to FIG. 2, clearinghouse 54 receives data
from a plurality of self-care microprocessor-based healthcare
systems of the type shown in FIG. 1, with the individual self-care
health monitoring systems being indicated in FIG. 2 by reference
numeral 58. Preferably, the data supplied to clearinghouse 54 by
each individual self-care health monitoring system 58 consists of
"raw data," i.e., test results and related data that was stored in
memory circuits of data management unit 10, without further
processing by data management unit 10. For example, with respect to
the arrangement shown in FIG. 1, blood glucose test results and
associated data such as food intake information, medication dosage
and other such conditions are transmitted to clearinghouse 54 and
stored with a digitally encoded signal that identifies both the
source of the information (i.e., the system user or patient) and
those having access to the stored information (i.e., the system
user's doctor or other healthcare professional).
[0045] As shall be recognized upon understanding the manner in
which it operates, clearinghouse 54 can be considered to be a
central server for the various system users (58 in FIG. 2) and each
healthcare professional 60. In that regard, clearinghouse 54
includes conventionally arranged and interconnected digital
processing equipment (represented in FIG. 2 by digital signal
processor 57) which receives digitally encoded information from a
user 58 or healthcare professional 60; processes the information as
required; stores the information (processed or unprocessed) in
memory if necessary; and, transmits the information to an intended
recipient (i.e., user 58 or healthcare professional 60).
[0046] In FIG. 2, rectangular outline 60 represents one of numerous
remotely located healthcare professionals who can utilize
clearinghouse 54 and the arrangement described relative to FIG. 1
in monitoring and controlling patient healthcare programs. Shown
within outline 60 is a computer 62 (e.g., personal computer), which
is coupled to clearinghouse 54 by means of a modem (not shown in
FIG. 2) and a telephone line 64. Also shown in FIG. 2 is the
previously mentioned facsimile machine 55, which is coupled to
clearinghouse 54 by means of a second telephone line 68. Using the
interface unit of computer 62 (e.g., a keyboard or pointing device
such as a mouse), the healthcare professional can establish data
communication between computer 62 and clearinghouse 54 via
telephone line 64. Once data communication is established between
computer 62 and clearinghouse 54, patient information can be
obtained from clearinghouse 54 in a manner similar to the manner in
which subscribers to various database services access and obtain
information. In particular, the healthcare professional can
transmit an authorization code to clearinghouse 54 that identifies
the healthcare professional as an authorized user of the
clearinghouse and, in addition, can transmit a signal representing
the patient for which healthcare information is being sought. As is
the case with conventional database services and other
arrangements, the identifying data is keyed into computer 62 by
means of a conventional keyboard (not shown in FIG. 2) in response
to prompts that are generated at clearinghouse 54 for display by
the display unit of computer 62 (not shown in FIG. 2).
[0047] Depending upon the hardware and software arrangement of
clearinghouse 54 and selections made by the healthcare professional
via computer 62, patient information can be provided to the
healthcare professional in different ways. For example, computer 62
can be operated to access data in the form that it is stored in the
memory circuits of clearinghouse 54 (i.e., raw data that has not
been processed or altered by the computational or data processing
arrangements of clearinghouse 54). Such data can be processed,
analyzed, printed and/or displayed by computer 62 using
commercially available or custom software. On the other hand,
various types of analyses may be performed by clearinghouse 54 with
the results of the analyses being transmitted to the remotely
located healthcare professional 60. For example, clearinghouse 54
can process and analyze data in a manner identical to the
processing and analysis provided by the self-care monitoring system
of FIG. 1. With respect to such processing and any other analysis
and processing provided by clearinghouse 54, results expressed in
alphanumeric format can be sent to computer 62 via telephone line
64 and the modem associated with computer 62, with conventional
techniques being used for displaying and/or printing the
alphanumeric material for subsequent reference.
[0048] The arrangement of FIG. 2 also allows the healthcare
professional to send messages and/or instructions to each patient
via computer 62, telephone line 64, and clearinghouse 54. In
particular, clearinghouse 54 can be programmed to generate a menu
that is displayed by computer 62 and allows the healthcare
professional to select a mode of operation in which information is
to be sent to clearinghouse 54 for subsequent transmission to a
user of the system described relative to FIG. 1. This same menu (or
related submenus) can be used by the healthcare professional to
select one or more modes of operation of the above-described type
in which either unmodified patient data or the results of data that
has been analyzed by clearinghouse 54 is provided to the healthcare
provider via computer 62 and/or facsimile machine 55.
[0049] In the currently contemplated arrangements, operation of the
arrangement of FIG. 2 to provide the user of the invention with
messages or instructions such as changes in medication or other
aspects of the healthcare program is similar to the operation that
allows the healthcare professional to access data sent by a
patient, i.e., transmitted to clearinghouse 54 by a data management
unit 10 of FIG. 1. The process differs in that the healthcare
professional enters the desired message or instruction via the
keyboard or other interface unit of computer 62. Once the data is
entered and transmitted to clearinghouse 54, it is stored for
subsequent transmission to the user for whom the information or
instruction is intended.
[0050] With respect to transmitting stored messages or instructions
to a user of the invention, at least two techniques are available.
The first technique is based upon the manner in which operational
modes are selected in the practice of the invention. Specifically,
in the currently preferred embodiments of the invention, program
instructions that are stored in data management unit 10 and program
cartridge 42 cause the system of FIG. 1 to generate menu screens
which are displayed by display unit 28 of handheld microprocessor
unit 12. The menu screens allow the system user to select the basic
mode in which the system of FIG. 1 is to operate and, in addition,
allow the user to select operational subcategories within the
selected mode of operation. Various techniques are known to those
skilled in the art for displaying and selecting menu items. For
example, in the practice of this invention, one or more main menus
can be generated and displayed which allow the system user to
select operational modes that may include: (a) a monitor mode
(e.g., monitoring of blood glucose level); (b) a display mode
(e.g., displaying previously obtained blood glucose test results or
other relevant information), (c) an input mode (e.g., a mode for
entering data such as providing information that relates to the
healthcare regimen, medication dosage, food intake, etc.); and, (d)
a communications mode (for establishing a communication link
between data management unit 10 and personal computer 48 of FIG. 1;
or between data management unit 10 and a remote computing facility
such as clearinghouse 54 of FIG. 2).
[0051] In embodiments of the invention that employ a compact video
game system for handheld microprocessor unit 12, the selection of
menu screens and the selection of menu screen items preferably is
accomplished in substantially the same manner as menu screens and
menu items are selected during the playing of a video game. For
example, the program instructions stored in data management unit 10
and program cartridge 42 of the arrangement of FIG. 1 can be
established so that a predetermined one of the compact video game
switches (e.g., switch 32 in FIG. 1) allows the system user to
select a desired main menu in the event that multiple main menus
are employed. When the desired main menu is displayed, operation by
the user of control pad 30 allows a cursor or other indicator that
is displayed on the menu to be positioned adjacent to or over the
menu item to be selected. Activation of a switch (e.g., switch 36
of the depicted handheld microprocessor unit 12) causes the
handheld microprocessor unit 12 and/or data management unit 10 to
initiate the selected operational mode or, if selection of
operational submodes is required, causes handheld microprocessor
unit 12 to display a submenu.
[0052] In view of the above-described manner in which menus and
submenus are selected and displayed, it can be recognized that the
arrangement of FIG. 1 can be configured and arranged to display a
menu or submenu item that allows the user to obtain and display
messages or instructions that have been provided by a healthcare
professional and stored in clearinghouse 54. For example, a submenu
that is generated upon selection of the previously mentioned
communications mode can include submenu items that allow the user
to select various communication modes, including a mode in which
serial data communication is established between data management
unit 10 and clearinghouse 54 and data management unit 10 transmits
a message status request to clearinghouse 54. When this technique
is used, the data processing system of clearinghouse 54 is
programmed to search the clearinghouse memory to determine whether
a message exists for the user making the request. Any messages
stored in memory for that user are then transmitted to the user and
processed for display on display unit 28 of handheld microprocessor
unit 12. If no messages exist, clearinghouse 54 transmits a signal
that causes display unit 28 to indicate "no messages." In this
arrangement, clearinghouse 54 preferably is programmed to store a
signal indicating that a stored message has been transmitted to the
intended recipient (user). Storing such a signal allows the
healthcare professional to determine that messages sent to
clearinghouse 54 for forwarding to a patient have been transmitted
to that patient. In addition, the program instructions stored in
data management unit 10 of FIG. 1 preferably allow the system user
to designate whether received messages and instructions are to be
stored in the memory of data management unit 10 for subsequent
retrieval or review. In addition, in some instances it may be
desirable to program clearinghouse 54 and data management unit 10
so that the healthcare professional can designate (i.e., flag)
information such as changes in medication that will be prominently
displayed to the user (e.g., accompanied by a blinking indicator)
and stored in the memory of data management unit 10 regardless of
whether the system user designates the information for storage.
[0053] A second technique that can be used for forwarding messages
or instructions to a user does not require the system user to
select a menu item requesting transmission by clearinghouse 54 of
messages that have been stored for forwarding to that user. In
particular, clearinghouse 54 can be programmed to operate in a
manner that either automatically transmits stored messages for that
user when the user operates the system of FIG. 1 to send
information to the clearinghouse or programmed to operate in a
manner that informs the user that messages are available and allows
the user to access the messages when he or she chooses to do
so.
[0054] Practicing the invention in an environment in which the
healthcare professional uses a personal computer in some or all of
the above-discussed ways can be very advantageous. On the other
hand, the invention also provides healthcare professionals timely
information about system users without the need for a computer (62
in FIG. 2) or any equipment other than a conventional facsimile
machine (55 in FIGS. 1 and 2). Specifically, information provided
to clearinghouse 54 by a system user 58 can be sent to a healthcare
professional 60 via telephone line 68 and facsimile machine 55,
with the information being formatted as a standardized graphic or
textual report (56 in FIG. 1). Formatting a standardized report 56
(i.e., analyzing and processing data supplied by blood glucose
monitor 16 or other system monitor or sensor) can be effected
either by data management unit 10 or within the clearinghouse
facility 54. Moreover, various standardized reports can be provided
(e.g., the textual and graphic displays discussed below relating to
FIGS. 6-10). Preferably, the signal processing arrangement included
in clearinghouse 54 allows each healthcare professional 60 to
select which of several standardized reports will be routinely
transmitted to the healthcare professionals' facsimile machine 55,
and, to do so on a patient-by-patient (user-by-user) basis.
[0055] FIG. 3 illustrates the manner in which data management unit
10 is arranged and interconnected with other system components for
effecting the above-described operational aspects of the invention
and additional aspects that are described relative to FIGS. 4-10.
As is symbolically indicated in FIG. 3, handheld microprocessor
unit 12 and blood glucose monitor 16 are connected to a dual
universal asynchronous receiver transmitter 70 (e.g., by cables 14
and 18 of FIG. 1, respectively). As also is indicated in FIG. 3
when a system user connects a personal computer 48 (or other
programmable digital signal processor) to data port 44, signal
communication is established between personal computer 48 and a
second dual universal asynchronous receiver transmitter 72 of data
management unit 10. Additionally, dual universal asynchronous
receiver transmitter 72 is coupled to modem 46 so that data
communication can be established between data management unit 10
and a remote clearinghouse 54 of FIGS. 1 and 2.
[0056] Currently preferred embodiments of data management unit 10
include a plurality of signal sensors 74, with an individual signal
sensor being associated with each device that is (or may be)
interconnected with data management unit 10. As previously
discussed and as is indicated in FIG. 3, these devices include
handheld microprocessor unit 12, blood glucose monitor 16, personal
computer 48, remote computing facility 54 and, in addition,
peak-flow meter 20 or other additional monitoring devices 22. Each
signal sensor 74 that is included in data management unit 10 is
electrically connected for receiving a signal that will be present
when the device with which that particular signal sensor is
associated is connected to data management unit 10 and, in
addition, is energized (e.g., turned on). For example, in
previously mentioned embodiments of the invention in which data
port 44 is an RS-232 connection, the signal sensor 74 that is
associated with personal computer 48 can be connected to an RS-232
terminal that is supplied power when a personal computer is
connected to data port 44 and the personal computer is turned on.
In a similar manner, the signal sensor 74 that is associated with
clearinghouse 54 can be connected to modem 46 so that the signal
sensor 74 receives an electrical signal when modem 46 is
interconnected to a remote computing facility (e.g., clearinghouse
54 of FIG. 2) via a telephone line 50.
[0057] In the arrangement of FIG. 3, each signal sensor 74 is a low
power switch circuit (e.g., a metal-oxide semiconductor
field-effect transistor circuit), which automatically energizes
data management unit 10 whenever any one (or more) of the devices
associated with signal sensors 74 is connected to data management
unit 10 and is energized. Thus, as is indicated in FIG. 3 by signal
path 76, each signal sensor 74 is interconnected with power supply
78, which supplies operating current to the circuitry of data
management unit 10 and typically consists of one or more small
batteries (e.g., three AAA alkaline cells).
[0058] The microprocessor and other conventional circuitry that
enables data management unit 10 to process system signals in
accordance with stored program instructions is indicated in FIG. 3
by central processing unit (CPU) 80. As is indicated in FIG. 3 by
interconnection 82 between CPU 80 and battery 78, CPU 80 receives
operating current from power supply 78, with power being provided
only when one or more of the signal sensors 74 are activated in the
previously described manner. A clock/calendar circuit 84 is
connected to CPU 80 (via signal path 86 in FIG. 3) to allow time
and date tagging of blood glucose tests and other information.
Although not specifically shown in FIG. 3, operating power is
supplied to clock/calendar 84 at all times.
[0059] In operation, CPU 80 receives and sends signals via a data
bus (indicated by signal path 88 in FIG. 3) which interconnects CPU
80 with dual universal asynchronous receiver transmitters 70 and
72. The data bus 88 also interconnects CPU 80 with memory circuits
which, in the depicted embodiment, include a system read-only
memory (ROM) 90, a program random access memory (RAM) 92, and an
electronically erasable read-only memory (EEROM) 94. System ROM 90
stores program instructions and any data required in order to
program data management unit 10 so that data management unit 10 and
a handheld microprocessor unit 12 that is programmed with a
suitable program cartridge 72 provide the previously discussed
system operation and, in addition, system operation of the type
described relative to FIGS. 4-10. During operation of the system,
program RAM 92 provides memory space that allows CPU 80 to carry
out various operations that are required for sequencing and
controlling the operation of the system of FIG. 1. In addition, RAM
92 can provide memory space that allows external programs (e.g.,
programs provided by clearinghouse 54) to be stored and executed.
EEROM 94 allows blood glucose test results and other data
information to be stored and preserved until the information is no
longer needed (i.e., until purposely erased by operating the system
to provide an appropriate erase signal to EEROM 94).
[0060] FIGS. 4-10 illustrate typical screen displays that are
generated by the arrangement of the invention described relative to
FIGS. 1-3. Reference will first be made to FIGS. 4 and 5, which
exemplify screen displays that are associated with operation of the
invention in the blood glucose monitoring mode. Specifically, in
the currently preferred embodiments of the invention, blood glucose
monitor 16 operates in conjunction with data management unit 10 and
handheld microprocessor unit 12 to: (a) perform a test or
calibration sequence in which tests are performed to confirm that
the system is operating properly; and, (b) perform the blood
glucose test sequence in which blood glucose meter 16 senses the
user's blood glucose level. Suitable calibration procedures for
blood glucose monitors are known in the art. For example, blood
glucose monitors often are supplied with a "code strip," that is
inserted in the monitor and results in a predetermined value being
displayed and stored in memory at the conclusion of the code strip
calibration procedure. When such a code strip calibration procedure
is used in the practice of the invention, the procedure is selected
from one of the system menus. For example, if the system main menu
includes a "monitor" menu item, a submenu displaying system
calibration options and an option for initiating the blood glucose
test may be displayed when the monitor menu item is selected. When
a code strip option is available and selected, a sequence of
instructions is generated and displayed by display screen 28 of
handheld microprocessor unit 12 to prompt the user to insert the
code strip and perform all other required operations. At the
conclusion of the code strip calibration sequence, display unit 28
of handheld microprocessor unit 12 displays a message indicating
whether or not the calibration procedure has been successfully
completed. For example, FIG. 4 illustrates a screen display that
informs the system user that the calibration procedure was not
successful and that the code strip should be inserted again (i.e.,
the calibration procedure is to be repeated). As is indicated in
FIG. 4, display screens that indicate a potential malfunction of
the system include a prominent message such as the "Attention"
notation included in the screen display of FIG. 4.
[0061] As previously indicated, the blood glucose test sequence
that is employed in the currently preferred embodiment of the
invention is of the type in which a test strip is inserted in a
receptacle that is formed in the blood glucose monitor. A drop of
the user's blood is then applied to the test strip and a blood
glucose sensing sequence is initiated. When the blood glucose
sensing sequence is complete, the user's blood glucose level is
displayed.
[0062] In the practice of the invention, program instructions
stored in data management unit 10 (e.g., system ROM 90 of FIG. 3)
and program instructions stored in program cartridge 42 of handheld
microprocessor unit 12 cause the system to display step-by-step
monitoring instructions to the system user and, in addition,
preferably result in display of diagnostic messages if the test
sequence does not proceed in a normal fashion. Although currently
available self-contained microprocessor-based blood glucose
monitors also display test instruction and diagnostic messages, the
invention provides greater message capacity and allows multi-line
instructions and diagnostic messages that are displayed in easily
understood language rather than cryptic error codes and abbreviated
phraseology that is displayed one line or less at a time. For
example, as is shown in FIG. 5, the complete results of a blood
glucose test (date, time of day, and blood glucose level in
milligrams per deciliter) can be concurrently displayed by display
screen 28 of handheld microprocessor unit 12 along with an
instruction to remove the test strip from blood glucose monitor 16.
As previously mentioned, when the blood glucose test is complete,
the time and date tagged blood glucose test result is stored in the
memory circuits of data management unit 10 (e.g., stored in EEPROM
94 of FIG. 3).
[0063] The arrangement shown and described relative to FIGS. 1-3
also is advantageous in that data relating to food intake,
concurrent medication dosage and other conditions easily can be
entered into the system and stored with the time and date tagged
blood glucose test result for later review and analysis by the user
and/or his or her healthcare professional. Specifically, a menu
generated by the system at the beginning or end of the blood
glucose monitoring sequence can include items such as
"hypoglycemic" and "hyperglycemic," which can be selected using the
switches of handheld microprocessor unit 12 (e.g., operation of
control pad 30 and switch 36 in FIG. 1) to indicate the user was
experiencing hypoglycemic or hyperglycemic symptoms at the time of
monitoring blood glucose level. Food intake can be quantitatively
entered in terms of "Bread Exchange" units or other suitable terms
by, for example, selecting a food intake menu item and using a
submenu display and the switches of handheld microprocessor 12 to
select and enter the appropriate information. A similar menu
item--submenu selection process also can be used to enter
medication data such as the type of insulin used at the time of the
glucose monitoring sequence and the dosage.
[0064] As was previously mentioned, program instructions stored in
data management unit 10 and program instructions stored in program
cartridge 42 of handheld microprocessor unit 12 enable the system
to display statistical and trend information either in a graphic or
alphanumeric format. As is the case relative to controlling other
operational aspects of the system, menu screens are provided that
allow the system user to select the information that is to be
displayed. For example, in the previously discussed embodiments in
which a system menu includes a "display" menu item, selection of
the menu item results in the display of one or more submenus that
list available display options. For example, in the currently
preferred embodiments, the user can select graphic display of blood
glucose test results over a specific period of time, such as one
day, or a particular week. Such selection results in displays of
the type shown in FIGS. 6 and 7, respectively. When blood glucose
test results for a single day are displayed (FIG. 6), the day of
the week and date can be displayed along with a graphic
representation of changes in blood glucose level between the times
at which test results were obtained. In the display of FIG. 6,
small icons identify points on the graphic representation that
correspond to the blood glucose test results (actual samples).
Although not shown in FIG. 6, coordinate values for blood glucose
level and time of day can be displayed if desired. When the user
chooses to display a weekly trend graph (FIG. 7), the display
generated by the system is similar to the display of a daily graph,
having the time period displayed in conjunction with a graph that
consists of lines interconnecting points that correspond to the
blood glucose test results.
[0065] The screen display shown in FIG. 8 is representative of
statistical data that can be determined by the system of FIG. 1
(using conventional computation techniques) and displayed in
alphanumeric format. As previously mentioned, such statistical data
and information in various other textual and graphic formats can be
provided to a healthcare professional (60 in FIG. 2) in the form of
a standardized report 56 (FIG. 1) that is sent by clearinghouse 54
to facsimile machine 55. In the exemplary screen display of FIG. 8,
statistical data for blood glucose levels over a period of time
(e.g., one week) or, alternatively, for a specified number of
monitoring tests is provided. In the exemplary display of FIG. 8,
the system (data management unit 10 or clearinghouse 54) also
calculates and displays (or prints) the average blood glucose level
and the standard deviation. Displayed also is the number of blood
glucose test results that were analyzed to obtain the average and
the standard deviation; the number of test results under a
predetermined level (50 milligrams per deciliter in FIG. 8); and
the number of blood glucose tests that were conducted while the
user was experiencing hypoglycemic symptoms. As previously noted,
in the preferred embodiments of the invention, a screen display
that is generated during the blood glucose monitoring sequence
allows the user to identify the blood sample being tested as one
taken while experiencing hyperglycemic or hypoglycemic symptoms
and, in addition, allows the user to specify other relevant
information such as food intake and medication information.
[0066] The currently preferred embodiments of the invention also
allow the user to select a display menu item that enables the user
to sequentially address, in chronological order, the record of each
blood glucose test. As is indicated in FIG. 9, each record
presented to the system user includes the date and time at which
the test was conducted, the blood glucose level, and any other
information that the user provided. For example, the screen display
of FIG. 9 indicates that the user employed handheld microprocessor
unit 12 as an interface to enter data indicating use of 12.5 units
of regular insulin; 13.2 units of "NPH" insulin; food intake of one
bread exchange unit; and pre-meal hypoglycemic symptoms.
[0067] Use of data management unit 10 in conjunction with handheld
microprocessor unit 12 also allows display (or subsequent
generation of a standardized report 56) showing blood glucose test
results along with food intake and/or medication information. For
example, shown in FIG. 10 is a daily graph in which blood glucose
level is displayed in the manner described relative to FIG. 6.
Related food intake and medication dosage is indicated directly
below contemporaneous blood glucose levels by vertical bar
graphs.
[0068] It will be recognized by those skilled in the art that the
above-described screen displays and system operation can readily be
attained with conventional programming techniques of the type
typically used in programming microprocessor arrangements. It also
will be recognized by those skilled in the art that various other
types of screen displays can be generated and, in addition, that
numerous other changes can be made in the embodiments described
herein without departing from the scope and the spirit of the
invention.
[0069] It will also be recognized by those skilled in the art that
the invention can be embodied in forms other than the embodiments
described relative to FIGS. 1-10. For example, the invention can
employ compact video game systems that are configured differently
than the previously discussed handheld video game systems and
palm-top computers. More specifically, as is shown in FIG. 11, a
self-care health monitoring system arranged in accordance with the
invention can employ a compact video game system of the type that
includes one or more controllers 100 that are interconnected to a
game console 102 via cable 104. As is indicated in FIG. 11, game
console 102 is connected to a video monitor or television 106 by
means of a cable 108. Although differing in physical configuration,
controller 100, game console 102 and the television or video
monitor 106 collectively function in the same manner as the
handheld microprocessor 12 of FIG. 1. In that regard, a program
cartridge 42 is inserted into a receptacle contained in game
console 102, with program cartridge 42 including stored program
instructions for controlling microprocessor circuitry that is
located inside game console 102. Controller 100 includes a control
pad or other device functionally equivalent to control pad 30 of
FIG. 1 and switches that functionally correspond to switches 32-38
of FIG. 1.
[0070] Regardless of whether the invention is embodied with a
handheld microprocessor unit (FIG. 1) or an arrangement such as the
compact video game system (FIG. 11), in some cases it is both
possible and advantageous to apportion the signal processing
functions and operations differently than was described relative to
FIGS. 1-10. For example, in some situations, the
microprocessor-based unit that is programmed by a card or cartridge
(e.g., handheld unit 12 of FIG. 1 or compact video game console 102
of FIG. 11) includes memory and signal processing capability that
allows the microprocessor to perform all or most of the functions
and operations attributed to data management unit 10 of the
embodiments discussed relative to FIGS. 1-10. That is, the
digitally encoded signal supplied by blood glucose monitor 16 (or
one of the other monitors 20 and 22 of FIG. 1) can be directly
coupled to the microprocessor included in game console 102 of FIG.
11 or handheld microprocessor 12 of FIG. 1. In such an arrangement,
the data management unit is a relatively simple signal interface
(e.g., interface unit 110 of FIG. 11), the primary purpose of which
is carrying signals between the blood glucose monitor 16 (or other
monitor) and the microprocessor of game console 102 (FIG. 11) or
handheld unit 12 (FIG. 1). In some situations, the interface unit
may consist primarily or entirely of a conventional cable
arrangement such as a cable for interconnection between RS-232 data
ports or other conventional connection arrangements. On the other
hand, as is shown in FIG. 11, signal interface 110 can either
internally include or be connected to a modem 52, which receives
and transmits signals via a telephone line 50 in the manner
described relative to FIGS. 1 and 2.
[0071] It also should be noted that all or a portion of the
functions and operations attributed to data management unit 10 of
FIG. 1 can be performed by microprocessor circuitry located in
blood glucose monitor 16 (or other monitor that is used with the
system). For example, a number of commercially available blood
glucose monitors include a clock/calendar circuit of the type
described relative to FIG. 3 and, in addition, include
microprocessor circuitry for generating visual display signals and
signals representative of both current and past values of monitored
blood glucose level. Conventional programming and design techniques
can be employed to adapt such commercially available units for the
performance of the various functions and operations attributed in
the above discussion of FIGS. 1-11 to data management unit 10
and/or the microprocessors of handheld unit 12 and compact video
console 102. In arrangements in which the blood glucose monitor (or
other system monitor) includes a microprocessor that is programmed
to provide signal processing in the above-described manner, the
invention can use a signal interface unit 110 of the
above-described type. That is, depending upon the amount of signal
processing effected by the monitoring unit (e.g., blood glucose
monitor 16) and the amount of signal processing performed by the
microprocessor of video game console 102 (or handheld unit 12), the
signal interface required ranges from a conventional cable (e.g.,
interconnection of RS232 ports) to an arrangement in which signal
interface 110 is arranged for signal communication with an internal
or external modem (e.g., modem 52 of FIG. 11) or an arrangement in
which signal interface 110 provides only a portion of the signal
processing described relative to FIGS. 1-10.
[0072] The invention also is capable of transmitting information to
a remote location (e.g., clearinghouse 54 and/or a remotely located
healthcare professional) by means other than conventional telephone
lines. For example, a modem (52 in FIGS. 1 and 11) that is
configured for use with a cellular telephone system can be employed
to transmit the signals provided by the healthcare monitoring
system to a remote location via modulated RF transmission.
Moreover, the invention can be employed with various digital
networks such as recently developed interactive voice, video and
data systems such as television systems in which a television and
user interface apparatus is interactively coupled to a remote
location via coaxial or fiberoptic cable and other transmission
media (indicated in FIG. 11 by cable 112, which is connected to
television or video monitor 106). In such an arrangement, compact
video game controller 100 and the microprocessor of video game
console 102 can be programmed to provide the user interface
functions required for transmission and reception of signals via
the interactive system. Alternatively, the signals provided by
video game console 102 (or handheld unit 12 if FIG. 1) can be
supplied to the user interface of the interactive system (not shown
in FIG. 11) in a format that is compatible with the interactive
system and allows the system user interface to be used to control
signal transmission between the healthcare system and a remote
facility such as clearinghouse 54, FIGS. 1 and 2.
* * * * *