U.S. patent application number 14/222340 was filed with the patent office on 2014-07-24 for method and system for transferring analyte test data.
This patent application is currently assigned to Abbott Laboratories. The applicant listed for this patent is Abbott Laboratories. Invention is credited to Brian Edmond Connolly, Marc R. Lai, Chad Harold Mace.
Application Number | 20140207384 14/222340 |
Document ID | / |
Family ID | 33158509 |
Filed Date | 2014-07-24 |
United States Patent
Application |
20140207384 |
Kind Code |
A1 |
Connolly; Brian Edmond ; et
al. |
July 24, 2014 |
Method and System for Transferring Analyte Test Data
Abstract
A system for transferring data includes an analyte test
instrument (ATI) adapted to store data, a wirelessly enabled data
management device (DMD) for comprehensively analyzing data, and an
adaptor removably connected to the ATI for transferring data stored
on the ATI to the DMD. The adaptor includes a data communication
device capable of removable connection with the ATI, a
microprocessor electrically connected to the data communication
device, a wireless controller electrically connected to the
microprocessor and a wireless transceiver electrically connected to
the wireless controller. In use, data transfer is executed between
the ATI and the DMD by electrically and mechanically connecting the
adaptor to the ATI. Data stored on the ATI is then automatically
downloaded into adaptor memory. Upon completion of the download,
the user activates an externally accessible input device on the
adaptor which, in turn, wirelessly transmits data from the adaptor
memory to the DMD.
Inventors: |
Connolly; Brian Edmond;
(Reading, MA) ; Mace; Chad Harold; (Hudson,
NH) ; Lai; Marc R.; (Dover, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Abbott Laboratories |
Abbott Park |
IL |
US |
|
|
Assignee: |
Abbott Laboratories
Abbott Park
IL
|
Family ID: |
33158509 |
Appl. No.: |
14/222340 |
Filed: |
March 21, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12549296 |
Aug 27, 2009 |
8682598 |
|
|
14222340 |
|
|
|
|
10407695 |
Apr 4, 2003 |
7587287 |
|
|
12549296 |
|
|
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|
Current U.S.
Class: |
702/19 |
Current CPC
Class: |
A61B 5/14532 20130101;
A61B 2562/0295 20130101; G06F 19/00 20130101; G16H 10/40 20180101;
G16H 40/40 20180101; A61B 5/0002 20130101; A61B 2560/0456
20130101 |
Class at
Publication: |
702/19 |
International
Class: |
G06F 19/00 20060101
G06F019/00 |
Claims
1. A system, comprising: a monitor configured to store analyte
related data having a first data communication component, the first
data communication component including an analyte test port
configured for receiving an analyte test strip; a data management
device in data communication with the monitor over a second data
communication channel; and a device configured for data
communication with the monitor via a first data communication
channel, the device comprising a second data communication
component wherein a portion of the second data communication
component is configured to be removably received in the analyte
test port of the first data communication component to establish
the first data communication channel between the device and the
monitor.
2. The system of claim 1, wherein the device further comprises a
power source.
3. The system of claim 1, wherein the analyte test strip includes a
blood glucose test strip.
4. The system of claim 1, wherein the second data communication
component is adapted to be electrically or mechanically coupled to
the first data communication component of the monitor.
5. The system of claim 1, wherein the first data communication
component includes at least one contact strip and is adapted to
electrically or mechanically receive at least the portion of the
second data communication component.
6. The system of claim 1, wherein one or more of the first data
communication channel or the second data communication channel is
configured to support one or more of radio frequency (RF)
communication protocol, Bluetooth communication protocol, Zigbee
communication protocol, or infrared communication protocol.
7. A system, comprising: a monitor configured to store analyte
related data and having a first data communication component, the
first data communication component including an analyte test port
configured for receiving an analyte test strip; a data management
device in data communication with the monitor over a second data
communication channel; and a device configured for data
communication with the monitor via a first data communication
channel, wherein the device operatively coupled to the monitor to
establish the first data communication channel between the device
and the monitor.
8. The system of claim 7, wherein at least a portion of the device
is configured to be removably received in the analyte test port of
the first data communication component to establish the first data
communication channel between the device and the monitor.
9. The system of claim 7, wherein the analyte test strip includes a
blood glucose test strip.
10. The system of claim 7, wherein a second data communication
component is adapted to be electrically or mechanically coupled to
the first data communication component of the monitor.
11. The system of claim 7, wherein the first data communication
component includes at least one contact strip and is adapted to
electrically or mechanically receive at least a portion of a second
data communication component.
12. The system of claim 7, wherein one or more of the first data
communication channel or the second data communication channel is
configured to support one or more of radio frequency (RF)
communication protocol, Bluetooth communication protocol, Zigbee
communication protocol, or infrared communication protocol.
13. A method, comprising: providing a first data communication
component to a monitor to configure the monitor to store analyte
related data; providing an analyte test port to the first data
communication component to receive an analyte test strip; providing
a data management device in data communication with the monitor
over a second data communication channel; and configuring a device
for data communication with the monitor via a first data
communication channel, wherein configuring the device includes
providing a second data communication component such that a portion
of the second data communication component is configured to be
removably received in the analyte test port of the first data
communication component to establish the first data communication
channel between the device and the monitor.
14. The method of claim 13, wherein the analyte test strip includes
a blood glucose test strip.
15. The method of claim 13, electrically or mechanically coupling
the second data communication component to the first data
communication component of the monitor.
16. The method of claim 13, further including providing at least
one contact strip to the first data communication component,
wherein the one contract strip is adapted to electrically or
mechanically receive at least the portion of the second data
communication component.
17. The method of claim 13, further including configuring one or
more of the first data communication channel or the second data
communication channel to support one or more of radio frequency
(RF) communication protocol, Bluetooth communication protocol,
Zigbee communication protocol, or infrared communication protocol.
Description
RELATED APPLICATIONS
[0001] This application is a Continuation of U.S. patent
application Ser. No. 12/549,296 filed Aug. 27, 2009, now U.S. Pat.
No. 8,682,598, which is a Continuation of U.S. patent application
Ser. No. 10/407,695 filed Apr. 4, 2003, issued as U.S. Pat. No.
7,587,287, entitled "Method and System for Transferring Analyte
Test Data", the disclosures of each of which are incorporated
herein by reference for all purposes.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to the field of
analyte test instrument systems which can be used to perform
electrochemical assays on biological samples. More particularly,
the present invention relates to analyte test instrument systems
which include an adaptor for transferring data stored on an analyte
test instrument (e.g., a blood glucose monitor) to a data
management device (e.g., a computer).
[0003] For many patients, the concentration of a particular analyte
in blood must be routinely measured. The results of an analyte
concentration measurement may, in turn, necessitate the patient to
undertake a particular course of action in response thereto (e.g.,
requiring the patient to partake in a particular drug
treatment).
[0004] Diabetes is a disease which typically requires a patient to
routinely monitor the concentration of glucose in his/her blood. In
particular, a patient suffering from diabetes is often required to
measure the concentration of glucose in his/her blood multiple
times each day. Based upon the results of each blood glucose
measurement, the patient may require a particular drug treatment
(e.g., an injection of insulin) in order to regulate that the blood
glucose level of the patient remains within a specified range.
Exceeding the upper limit of said range (hyperglycemia) or dropping
beneath the lower limit of said range (hypoglycemia) should be
avoided with as much diligence as possible to prevent the patient
from experiencing serious medical complications which include,
inter alia, retinopathy, nephropathy, and neuropathy.
[0005] Analyte test instrument systems are well known and are
widely used in the art to perform routine electrochemical assays on
biological samples. A blood glucose monitoring system is one
well-known type of analyte test instrument system which is used to
perform routine glucose concentration tests on blood samples.
[0006] One type of blood glucose monitoring system which is well
known and widely used in the art comprises at least one disposable
test strip which electrochemically reacts in response to the
deposition of a blood sample thereon. The test strip is designed
for use with a corresponding blood glucose monitor which calculates
the concentration of blood glucose in the blood sample based upon
the electrochemical reaction between the test strip and the blood
sample. Examples of blood glucose monitoring systems of the type
described above are manufactured and sold by Abbott Laboratories,
Medisense Products of Bedford, Mass. under the PRECISION line of
blood glucose monitoring systems.
[0007] A disposable, blood glucose monitoring test strip typically
comprises a thin base, or substrate, layer which is generally
rectangular in shape. A plurality of electrical contacts, or
strips, are deposited along substantially the entire length of the
base layer in a spaced apart, parallel relationship. One end of the
electrical contacts is positioned within the reaction area of the
test strip. In the reaction area of the test strip, an enzyme is
deposited which is capable of reacting with the glucose in a blood
sample to produce a measurable electrical response. The other end
of the electrical contacts is disposed to electrically contact
associated conductors located in the blood glucose monitor, as will
be described further below.
[0008] A blood glucose monitor is typically modular and portable in
construction to facilitate its frequent handling by the patient. A
blood glucose monitor often comprises a multi-function test port
which is adapted to receive the test strip in such a manner so that
an electrical communication path is established therebetween. As
such, an electrical reaction created by depositing a blood sample
onto the reaction area of the test strip travels along at least one
of the conductors of the test strip and into the test port of the
blood glucose monitor. Within the housing of the monitor, the test
port is electrically connected to a microprocessor which controls
the basic operations of the monitor. The microprocessor, in turn,
is electrically connected to a memory device which is capable of
storing a multiplicity of blood glucose test results.
[0009] In use, a blood glucose monitor of the type described above
can be used in the following manner to measure the glucose level of
a blood sample and, in turn, store the result of said measurement
into memory as test data. Specifically, a disposable test strip is
inserted into the test port of the monitor. With the test strip
properly inserted into the monitor, there is established a direct
electrical contact between the conductors on the test strip and the
conductors contained within the test port, thereby establishing an
electrical communication path between the test strip and the
monitor through which electrical signals can travel. Having
properly disposed the test strip into the test port, the monitor
typically displays a "ready" indication on its display.
[0010] The user is then required to deposit a blood sample onto the
reaction area of the test strip, the acquisition of the blood
sample typically being accomplished by pricking the fingertip of
the patient with a lancing device. When a sufficient quantity of
blood is deposited on the reaction area of the test strip, an
electrochemical reaction occurs between the blood sample and the
enzyme present in the reaction area which, in turn, produces an
electrical current which decays exponentially over time.
[0011] The decaying electrical current created through the chemical
reaction between the enzyme and the glucose molecules in the blood
sample, in turn, travels along the electrically conductive path
established between the test strip and the monitor and is measured
by the microprocessor of the monitor. The microprocessor of the
monitor, in turn, correlates the declining current to a standard
numerical glucose value. The numerical glucose value calculated by
the monitor is then shown on the monitor display for the patient to
observe. In addition, the data associated with the particular blood
glucose measurement is stored into the memory for the monitor.
[0012] It should be noted that blood glucose monitors of the type
described above often include a memory device which is capable of
storing a number of different events, wherein examples of some
possible events include, but are not limited to, a blood glucose
measurement, a calibration function, and a date/time change for the
monitor. In fact, some blood glucose monitors are capable of
storing in memory as many as 400 events at a single time.
[0013] In order to effectively monitor the blood glucose level
patterns of a patient, a clinician and/or physician for a diabetes
patient often downloads a series of blood glucose monitoring events
onto a data management device, such as a computer, which is loaded
with comprehensive data management system (DMS) software (e.g., the
PRECISION LINK data management system software which is
manufactured and sold by Abbott Laboratories, MediSense Products of
Bedford, Mass.) capable of retrieving, managing and analyzing the
data stored on the monitor. In particular, a clinical analyst
and/or a physician for a diabetes patient is often interested in
tracking the blood glucose levels of a patient over a fixed period
of time (e.g., 1 month).
[0014] In order to effectively track the blood glucose levels of a
patient over a fixed time, a clinical analyst and/or a physician is
required to periodically meet with the patient and download all of
the data stored in the blood glucose monitor into the data
management device for comprehensive analysis. Analyzing the test
results in this manner, the clinician and/or physician is able to
assess how effectively the patient is able to regulate his/her
blood glucose level.
[0015] Traditionally, the data stored on a blood glucose monitor is
downloaded onto a data management device using a hardwire
communication link. A hardwire communication link typically
comprises a communication cable which, at one end, is provided with
a test strip-shaped communication interface which can be removably
inserted into the strip port of the blood glucose monitor and, at
the other end, is provided with a connector which is adapted to
removably connect with the serial port of a conventional
computer.
[0016] As can be appreciated, a diabetes patient is somewhat
limited in the frequency in which he/she can visit a clinician
and/or physician to track glucose test results. As a result,
diabetes patients are encouraged to frequently download the data
stored on the blood glucose monitor onto his/her own computer for
comprehensive analysis. In this manner, a diabetes patient can
monitor his/her test results as frequently as desired (e.g., daily,
weekly, etc.).
[0017] However, the process of electrically connecting a blood
glucose monitor to a computer using a hardwire communication link
has been found by some diabetes patients to be cumbersome,
complicated, and time consuming. Overwhelmed by the connection
process, some patients download their blood glucose levels onto a
computer for further analysis less frequently than is desired,
thereby increasing the patient's risk of experiencing a serious
diabetes related medical complication, which is highly
undesirable.
SUMMARY OF THE INVENTION
[0018] It is an object of the present invention to provide a method
and system for wirelessly transferring analyte test data stored on
an analyte test instrument, such as a blood glucose monitor, to a
data management device, such as a computer.
[0019] It is another object of the present invention to provide a
method and system for transferring analyte test data stored on an
analyte test instrument to a data management device via an
adaptor.
[0020] It is yet another object of the present invention to provide
a method and system as described above wherein the adaptor can be
removably connected to the analyte test instrument.
[0021] It is yet still another object of the present invention to
provide a method and system as described above which has a limited
number of parts, which is inexpensive to manufacture and which is
easy to use.
[0022] Therefore, according to one feature of the present
invention, there is provided a system for transferring data
comprising an analyte test instrument which is adapted to store
data, an adaptor removably connected to said analyte test
instrument, said adaptor being in data communication with said
analyte test instrument through a first data communication channel,
and a data management device in data communication with said
adaptor through a second data communication channel, said second
communication channel being a wireless data communication
channel.
[0023] According to another feature of the present invention, there
is provided an adaptor for transferring data stored on an analyte
test instrument to a wirelessly enabled data management device,
said analyte test instrument comprising a data communication
device, said adaptor comprising a data communication device, said
data communication device for said adaptor being adapted to
removably connect with the data communication device of said
analyte test instrument so as to establish a first data
communication channel between said adaptor and said analyte test
instrument, a microcontroller in electrical connection with said
data communication device for said adaptor, a wireless controller
in electrical connection with said microcontroller; and a wireless
transceiver in electrical connection with said wireless controller,
said wireless transceiver being adapted to wirelessly communicate
with said data management device through a second data
communication channel.
[0024] According to another feature of the present invention, there
is provided a method for transferring data stored on an analyte
test instrument to a data management device via an adaptor, said
adaptor being independent from said analyte test instrument, said
method comprising the steps of removably connecting said adaptor to
said analyte test instrument so as to establish a first data
communication channel between said adaptor and said analyte test
instrument, transferring data stored on said analyte test
instrument to said adaptor through the first data communication
channel, and transmitting the transferred data from said adaptor to
said data management device through a second data communication
channel, the second data communication channel being a wireless
data communication channel.
[0025] Various other features and advantages will appear from the
description to follow. In the description, reference is made to the
accompanying drawings which form a part thereof, and in which is
shown by way of illustration, various embodiments for practicing
the invention. The embodiments will be described in sufficient
detail to enable those skilled in the art to practice the
invention, and it is to be understood that other embodiments may be
utilized and that structural changes may be made without departing
from the scope of the invention. The following detailed description
is therefore, not to be taken in a limiting sense, and the scope of
the present invention is best defined by the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] In the drawings wherein like reference numerals represent
like parts:
[0027] FIG. 1 is a perspective view of a first embodiment of a
system for transferring analyte test data, said system being
constructed according to the teachings of the present invention,
the adaptor being shown connected to the analyte test instrument,
the adaptor being shown in wireless communication with the data
management device;
[0028] FIG. 2 is a simplified block diagram of the system shown in
FIG. 1;
[0029] FIG. 3(a) is a front plan view of the analyte test
instrument and the adaptor shown in FIG. 1, the adaptor being shown
connected to the analyte test instrument;
[0030] FIG. 3(b) is a right side view of the analyte test
instrument and the adaptor shown in FIG. 1, the adaptor being shown
connected to the analyte test instrument;
[0031] FIG. 3(c) is a rear perspective view of the analyte test
instrument and the adaptor shown in FIG. 1, the adaptor being shown
connected to the analyte test instrument;
[0032] FIG. 4 is an enlarged front perspective view, broken away in
part, of the analyte test instrument shown in FIG. 1;
[0033] FIG. 5 is an enlarged front plan view of the display for the
analyte test instrument shown in FIG. 1;
[0034] FIG. 6(a) is an enlarged, front perspective view of the
adaptor shown in FIG. 1;
[0035] FIG. 6(b) is an enlarged, rear perspective view of the
adaptor shown in FIG. 1;
[0036] FIG. 6(c) is an enlarged, front plan view of the adaptor
shown in FIG. 1;
[0037] FIG. 6(d) is an enlarged, right side view, broken away in
part, of the adaptor shown in FIG. 1;
[0038] FIG. 7 is a flow chart depicting the method in which the
system shown in FIG. 1 transfers data from the analyte test
instrument to the adaptor;
[0039] FIG. 8 is a flow chart depicting the method in which the
system shown in FIG. 1 wirelessly transmits data from the adaptor
to the data management device;
[0040] FIG. 9 is a perspective view of a second embodiment of a
system for transferring analyte test data, said system being
constructed according to the teachings of the present invention,
the adaptor being shown connected to the analyte test instrument,
the adaptor being shown in wireless communication with the data
management device; and
[0041] FIG. 10 is an enlarged front perspective view of the analyte
test instrument and the adaptor shown in FIG. 9, the adaptor being
shown disconnected from the analyte test instrument.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0042] Referring now to FIGS. 1 and 2, there is shown a first
embodiment of a system for transferring data, said system being
constructed according to the teachings of the present invention and
identified generally by reference numeral 11.
[0043] System 11 comprises an analyte test instrument (ATI) 13, a
data management device (DMD) 15, and an adaptor 17. As will be
described further in detail below, analyte test data stored in ATI
13 can be wirelessly transmitted to DMD 15 via adaptor 17.
[0044] Analyte test instrument 13 represents a monitor which can be
used to measure the concentration of an analyte in a test sample.
As is shown herein, ATI 13 is in the form of a conventional blood
glucose monitor (e.g., an electrochemical or photometric blood
glucose monitor). As such, ATI 13 is capable of measuring glucose
concentrations of a blood sample and, in turn, storing the results
of each blood glucose measurement as data in memory. As an example,
ATI 13 may be of the type disclosed in U.S. Pat. No. 6,377,894 to
Deweese et al, which is incorporated herein by reference.
[0045] ATI 13 is a communication enabled device. In this respect,
ATI 13 is capable of serial data transfer with another device
(e.g., adaptor 17), as will be described further in detail
below.
[0046] Referring now to FIGS. 2-4, ATI 13 is a modular,
self-contained, and portable unit which comprises a protective
housing 19 constructed of a durable and inexpensive material, such
as plastic. Housing 19 includes a front casing 21 and a rear casing
23 which are secured together by means of a snap-fit
interconnection. With front casing 21 and rear casing 23 affixed
together, housing 19 is a substantially enclosed device which is
shaped to include an interior cavity 25 into which the electrical
and electronic components of ATI 13 are disposed, as will be
described further below.
[0047] ATI 13 comprises a data communication device 27 which is
disposed within interior cavity 25 of housing 19 and which is
accessible through a slot 29 formed into the top of housing 19.
Data communication device 27 is a current source sensing device
which is capable of transmitting and receiving serial data. In the
present embodiment, data communication device 27 is in the form of
a conventional multi-purpose test port which includes a slot shaped
to fittingly receive and electrically connect with, inter alia, a
test strip, a calibration strip, or the interface connector of a
hardwire communication link. Data communication device 27 comprises
six metal contact strips, which are identified as contact strips
Cont1 through Cont6 in FIG. 2.
[0048] It should be noted that data communication device 27 is not
limited to a conventional multi-purpose test port. Rather, it is to
be understood that data communication device 27 could be in the
form of any conventional communication device which is capable of
transmitting and receiving serial data without departing from the
spirit of the present invention. As one example, data communication
device 27 could alternatively be in the form of a wireless
transceiver without departing from the spirit of the present
invention. As another example, data communication device 27 could
alternatively be in the form of a phone jack receptacle without
departing from the spirit of the present invention, which will be
described further in detail below.
[0049] ATI 13 also comprises a user input device 31 which is
disposed within interior cavity 25 and which at least partially
projects through an opening formed in front casing 21 of housing
19. User input device 31 is shown herein as being in the form of a
button capable of being manually depressed. In use, input device 31
is for the manual regulation of a switch which, in turn, controls
operative functions for ATI 13. In particular, input device 31
enables the user to regulate the power state of ATI 13, to recall
information stored in memory, to respond to messages provided in
the display, to provide access to menus generated by software
contained within ATI 13, and to set some of the configuration
control parameters.
[0050] ATI 13 further comprises a display 33 which is disposed
within interior cavity 25 and which is viewable through a
transparent window formed in front casing 21 of housing 19. Display
33 is shown herein as being in the form of a screen designed to
provide the user with information in a visual form. As can be seen
most clearly in FIG. 5, display 33 is in the form of a liquid
crystal display (LCD) which is used to display, inter alia, test
results, user messages, and recalled information which is stored in
the memory of ATI 13. Display 33 includes a numerical display 35
which is capable of generating three, seven-segment digital
numbers. As can be appreciated, display 35 provides the user with a
means for visually indicating the numerical value associated with a
particular test result, display 35 including a pair of decimal
point indicators to allow for a wider range of possible output
values. Display 33 also comprises a plurality of icons 37 which
indicate the units of measurement of a test result (e.g., mg/dL or
mmol/l) and a low battery condition. Display 33 further comprises a
dot-matrix message line 39 which can be used to provide information
to the user, message line 39 being capable of generating up to 10
numerals or up to 9 characters at the same time. The information
displayed by message line 39 can include, among other things, time
and data information, user prompts (e.g., "apply blood"), error
messages (e.g., "expired strip"), and configuration control
settings (e.g., setting time or selecting a operating
language).
[0051] It should be noted that the information shown on display 33
is controlled by display driver software for ATI 13. The display
driver software provides display 33 with the ability to scroll a
long message, flash a message or a portion of a message, or display
alternating messages. In addition, the display driver software can
provide ATI 13 with the ability to flash icons 37. Furthermore, as
ATI 13 is powering up, the display driver software can support a
visual check of display 33 wherein the icons and pixels for display
33 are turned on for a brief period to enable the user to confirm
the entire display 33 is functioning properly.
[0052] ATI 13 preferably derives power from a power source (not
shown) disposed within interior cavity 25. The power source may be
in the form of one or more replaceable AA-type batteries which are
removably mounted into an associated battery compartment in
interior cavity 25 and which are accessible through a removable
cover formed into rear casing 23 of housing 19. However, it is to
be understood that any source of power capable of providing a
suitable direct (DC) voltage can be used to provide power to ATI
13.
[0053] As seen most clearly in FIG. 2, user input 31 and display 33
are connected to a processing circuit 41 which, in turn, is
connected to a microprocessor 43, memory 45, and instrument
software 47. In addition, data communication device 27 is connected
to processing circuit 41 through a test strip circuit 49.
[0054] Processing circuit 41 is an application specific integrated
circuit (ASIC) which enables a test strip to be inserted into
direct electrical connection with data communication device 27 to
communicate with microprocessor 43. For example, processing circuit
41 enables microprocessor 43 to send signals to data communication
device 27 to determine the identity of a strip which is disposed
into electrical connection therewith (i.e., to determine whether
the strip is a calibration strip, a test strip, or the strip-like
interface connector for a communication link). Microprocessor 43
may determine the identity of a strip disposed into electrical
connection with data communication device 27 by measuring the
impedance of said strip or by detecting the location of the
electrical contacts on said strip.
[0055] Microprocessor 43 is an application specific integrated
circuit (ASIC) that functions as the central processing unit for
ATI 13. As such, microprocessor 43 performs the principal
calculation and data management tasks for ATI 13.
[0056] Memory 45 is connected to microprocessor 43 and serves to
retain data processed by microprocessor 43, said data being
available for subsequent retrieval. Types of information that may
be stored in memory 45 include measurement delay times, sample
incubation times, number of measurements to be taken during an
assay, thresholds against which voltage levels can be compared,
values of excitation voltage levels applied to a test strip during
assay, analyte value conversion factors, failsafe assay threshold
values, and configurations of circuitry of analyte test instrument
13. It should be noted that memory 45 has the capacity to store a
multiplicity of assay results. Specifically, each assay result is
typically stored into memory 45 as a data bundle referred to herein
as "an event". As can be appreciated, memory 45 is preferably of
the type which can store in excess of 400 events.
[0057] Instrument software 47 is provided for microprocessor 43,
software 47 functioning in response to information received at data
communication device 27 from a calibration strip. Specifically,
instrument software 47 uses the information received from a
calibration strip to control the operation of the ATI 13.
Instrument software 47 also controls operations of the ATI 13 that
are independent of information introduced or generated at data
communications device 27. For example, instrument software 47
enables the user to recall assay results and assay information, can
provide various warning, error, and prompting messages, can permit
setting of date and time, can control transmission of data to
external devices, can monitor power level or battery level or both,
and can provide indications to the user if power drops below a
specified level.
[0058] A test strip circuit 49 connects data communication device
27 to processing circuit 41. In operation, test strip circuit 49
enables data to pass between data communication device 27 and
processing circuit 41.
[0059] A pair of device circuits 51 are also connected to
processing circuit 41. Device circuits 51 can comprise analog,
digital, or mixed-signal circuits, application-specific integrated
circuits (ASICs), and passive and active electrical components.
Device circuits 51 can perform various electrical functions
required by ATI 13. Specifically, device circuits 51 carry
instructions from microprocessor 43 to various functional
components of ATI 13 so that these components can perform their
intended functions. As one example, device circuits 51 may serve to
drive the clock functions for microprocessor 43.
[0060] In use, ATI 13 can be used in the following manner to
measure and store analyte test data. Specifically, an analyte test
strip is inserted into data communication device 27 so that the
metal contacts on the test strip are in direct metal-to-metal
contact with the contacts CONT1 through CONT6 of data communication
device 27, thereby establishing a communication channel between the
test strip and ATI 13. Having inserted the test strip into data
communication device 27, instrument software 47 identifies the item
inserted into data communication device 27 as an analyte test
strip. At this time, microprocessor 43 executes software which
generates a message on display 33 that notifies the user to deposit
a sample onto the test strip. When a sample is deposited onto the
reaction area of the test strip, the sample reacts with enzymes in
the reaction area which, in turn, produces an electrical response
in the form of a decaying electrical current. Test strip circuit 49
converts the decaying current from an analog signal to a digital
signal and then passes the converted signal to processing circuit
41. The converted signal is then processed by microprocessor 43 to
determine the analyte test value that corresponds to the signal.
Microprocessor 43 then stores the analyte test data as an event in
memory 45 and simultaneously registers the analyte test value on
display 33 for the patient to read.
[0061] The aforementioned analyte testing process can be repeated
as desired. As noted briefly above, each test performed is
preferably stored into memory 45 as an event, memory 45 being
capable of storing a large quantity of events which can be
subsequently retrieved and analyzed by a personal computer using
sophisticated data management software.
[0062] Although ATI 13 is represented herein as being in the form
of a communication enabled, blood glucose monitor, it is to be
understood that ATI 13 represents any conventional communication
enabled device which can be used to measure the concentration of an
analyte in a sample. As an example, ATI 13 may represent any of the
PRECISION line of blood glucose monitors which are manufactured and
sold by Abbott Laboratories, MediSense Products of Bedford,
Mass.
[0063] Data management device (DMD) 15 is represented herein as
being in the form of a wirelessly enabled, laptop computer. As
such, DMD 15 is capable of serial data transfer with another device
(e.g., adaptor 17) through a wireless communication channel.
Preferably, DMD 15 is provided with comprehensive data analysis
software (e.g., the PRECISION LINK software manufactured and sold
by Abbott Laboratories, MediSense Products of Bedford, Mass.) which
allows for analyte test data stored on an analyte testing device
(e.g., ATI 13) to be downloaded, managed, and analyzed (e.g.,
charted) by DMD 15, thereby providing the patient with
sophisticated analyte test data monitoring and tracking
capabilities, which is highly desirable.
[0064] Although DMD 15 is represented herein as being in the form
of a wirelessly enabled, laptop computer, it is to be understood
that DMD 15 is not limited to a wirelessly enabled laptop computer.
Rather, DMD 15 could be in the form of other types of conventional,
wirelessly enabled data management devices (e.g., desktop computer,
personal data assistant (PDA), printer, etc.) without departing
from the spirit of the present invention.
[0065] Adaptor 17 is a modular, self-contained and portable unit
which can be removably connected to ATI 13, as seen most clearly in
FIGS. 3(a)-(c). As will be described further in detail below,
adaptor 17 is adapted to communicate with ATI 13 by means of a
first communication channel 53 and wirelessly communicate with DMD
15 by means of a second communication channel 55. In this capacity,
adaptor 17 can be used to retrieve data (e.g., analyte test data)
stored in memory 45 via first communication channel 53 and, in
turn, wirelessly transmit said data to DMD 15 via second
communication channel 55.
[0066] As seen most clearly in FIGS. 2 and 6(a)-(d), adaptor 17
comprises a protective housing 57 constructed of a durable and
inexpensive material, such as plastic. Housing 57 is a
substantially enclosed device which is shaped to define an interior
cavity 59 which is shaped to substantially receive the electrical
and electronic components of adaptor 17, as will be described
further below.
[0067] Adaptor 17 comprises a data communication device 61 disposed
within interior cavity 59 and which partially and fittingly
protrudes out through a narrow slot formed in the bottom of housing
57. Data communication device 61 is a communication device which is
capable of electrically connecting with data connection device 27
of ATI 13, so as to establish communication channel 53 between ATI
13 and adaptor 17 through which data can be transmitted and
received.
[0068] In the present embodiment, the portion of data communication
device 61 which extends out from housing 57 is in the form of a
rectangular strip 63 having the same approximate width and
thickness as a test strip used in conjunction with data
communication device 27. Six metal contact strips, which are
identified as contact strips Cont1 through Cont6 in FIGS. 2 and
6(a)-(c), are deposited along substantially the entire length of
strip 63 in a spaced apart, parallel relationship. As such, when
strip 63 of data communication device 61 is inserted into the test
port configuration of data communication device 27, each of the
contact strips, or leads, on data communication device 61 is
disposed in direct conductive contact with an associated contact
strip within the test port. In this manner, with data communication
device 61 properly inserted into the test port slot for data
communication device 27, communication channel 53 is established
between ATI 13 and adaptor 17 through which serial data is capable
of being transferred.
[0069] It should be noted that the particular construction of data
communication device 61 enables adaptor 17 to be removably
connected to ATI 13. As a result, adaptor 17 can be manufactured
and stored separately from ATI 13, adaptor 17 being connected to
ATI 13 to form communication channel 53 only when the user desires
to send data from ATI 13 to DMD 15.
[0070] As can be appreciated, the ability to removably connect
adaptor 17 to ATI 13 provides the user with a number of significant
advantages. As a first advantage, when the user only desires to
store data onto ATI 13 and is not interested in wirelessly
transmitting said data to DMD 15, adaptor 17 can be separated from
ATI 13, thereby reducing the overall size and weight of the unit,
which is highly desirable. As a second advantage, the particular
construction of data communication device 61 enables adaptor 17 to
be used in conjunction with many types of pre-existing types of
analyte test instruments. As a result, a patient who owns a
pre-existing ATI which is compatible with adaptor 17 can wirelessly
transmit data stored on said pre-existing ATI to a data management
device, such as a computer, simply by purchasing adaptor 17, which
is highly desirable.
[0071] It should be noted that data communication device 61 is not
limited to the test strip-type configuration shown herein. Rather,
it is to be understood that data communication device 61 could be
in the form of alternative types of conventional communication
devices which are capable of transmitting and receiving serial data
without departing from the spirit of the present invention.
Specifically, data communication device 27 and data communication
device 61 represent any compatible means for establishing a
communication channel (e.g., wireless, hardwire) therebetween. As
will be described further in detail below, data communication
device 61 may be in the form of a male, phone jack and data
communication device 27 may be in the form of a female, phone jack
receptacle without departing from the spirit of the present
invention.
[0072] Data communication device 61 is electrically connected to a
microcontroller 65 via universal asynchronous receiver transmitter
(UART) communication bus 67, microcontroller 65 being disposed
within interior cavity 59 of housing 57. Microcontroller 65 is an
application specific integrated circuit (ASIC) which functions as
the central processing unit for adaptor 17. As such,
microcontroller 65 is responsible for, inter alia, the processing
and managing of data which is retrieved from ATI 13 and wirelessly
transmitted to DMD 15, as will be described further in detail
below.
[0073] For purposes of the present specification and claims, the
term microcontroller shall mean microcontroller or microprocessor
unless otherwise specified.
[0074] Memory 69 is disposed within interior cavity 59 of housing
57 and is electrically connected to microcontroller 65 through a
communication bus 71. As will be described further below, memory 69
serves two principal functions. As a first function, memory 69
stores the application code software for adaptor 17. As a second
function, memory 69 temporarily stores (i.e., buffers) the data
retrieved from ATI 13 prior to its transmission to DMD 15. It
should be noted that memory 69 preferably includes two separate
memory devices, one of said memory devices being responsible for
storing the application code software for adaptor 17 and the other
of said memory device being responsible for temporarily storing the
data retrieved from ATI 13 prior to its transmission to DMD 15.
[0075] A wireless controller 73 is disposed within interior cavity
59 of housing 57 and is electrically connected to microcontroller
65 via universal asynchronous receiver transmitter (UART)
communication bus 75. As will be described further in detail below,
in response to commands sent by microcontroller 65, wireless
controller 73 serves to regulate the operation of a wireless
transceiver 75.
[0076] For purposes of the present specification and claims,
wireless controller 73 represents both a component which is
physically separate from microcontroller 65 as well as a component
which is physically incorporated into microcontroller 65 to form an
integrated device unless otherwise specified.
[0077] Wireless transceiver 75 is disposed within interior cavity
59 of housing 57 and is electrically is connected to wireless
controller 73 via a transmitter line TxD and a receiver line RxD,
electrical signals passing from controller 73 to transceiver 75
traveling via transmitter line TxD and electrical signals passing
from transceiver 75 to controller 73 traveling via receiver line
RxD. As will be described further in detail below, wireless
transceiver 75 serves to transmit electrical signals to DMD 15 and
receive electrical signals from DMD 15. Preferably, wireless
transceiver 75 is disposed within interior cavity 59 in close
proximity to a window 77 formed into the top of housing 57 through
which signals are capable of traveling.
[0078] It should be noted that wireless transceiver 75 represents
any conventional transceiver which is capable of two-way
communication with a communication enabled device. As a result,
wireless communication channel 55 represents any conventional
two-way wireless communication channel (e.g., infrared (IR), such
as infrared data (IrDA), or radio frequency (RF), such as
Bluetooth.RTM., 802.11, Zigbee.RTM.).
[0079] A power source 79 is disposed within interior cavity 59 of
housing 57 and is electrically connected to microcontroller 65,
memory 69, wireless controller 73 and wireless transceiver 75.
Power source 79 is preferably in the form of a replaceable 3 volt,
coin cell lithium battery which is accessible through a door 81
which is slidably mounted onto housing 57. However, it is to be
understood that power source 79 is not limited to a 3 volt, coin
cell lithium battery. Rather, it is to be understood that power
source 79 could be in the form of additional types of conventional
power sources (e.g., a solar battery cell) without departing from
the spirit of the present invention. In addition, it is to be
understood that power source 79 could be eliminated entirely from
adaptor 17 without departing from the spirit of the present
invention. Specifically, if power source 79 were to be removed from
adaptor 17, power could alternatively be supplied to adaptor 17
from the power source of ATI 13.
[0080] A user input device 83 is disposed within interior cavity 59
and is sized and shaped to fittingly project through a
corresponding opening formed in the front of housing 57. User input
device 83 is preferably in the form of a circular button which can
be manually depressed so as to selectively close a switch which is
electrically connected to microcontroller 65. As will be described
further below, input device 83 serves as a finger actuable means
for triggering the execution of the data transfer from adaptor 17
to DMD 15.
[0081] An indicator 85 is disposed within interior cavity 59 and is
sized and shaped to fittingly project through a corresponding
opening formed in the front of housing 57. Indicator 85 is
preferably in the form of a green light emitting diode (LED) which
is electrically connected to microcontroller 65. As will be
described further in detail below, indicator 85 serves as a means
for providing the user with a visual indication of the operating
state of indicator 85 (e.g., whether indicator 85 is transferring
data to DMD 15).
[0082] As noted above, system 11 is capable of transferring data
stored in memory 45 of ATI 13 to DMD 15 via adaptor 17. As will be
described further below, system 11 transfers data stored on ATI 13
to DMD 15 via adaptor 17 by means of a two-step process. In the
first step of the two step process, data stored in memory 45 of ATI
13 is transferred into buffer memory 69 of adaptor 17. In the
second step of the two step process, data transferred into buffer
memory 69 of adaptor 17 is, in turn, wirelessly transmitted to DMD
15. Each of the two aforementioned steps will be discussed further
in detail below.
[0083] FIG. 7 is a flow chart illustrating the method in which
system 11 transfers data from ATI 13 to adaptor 17, said method
being represented generally by reference numeral 101. Method 101
commences once data communication channel 53 is established between
ATI 13 and adaptor 17, said step being represented by reference
numeral 103. It should be noted that, for system 11, data
communication channel 53 is established between ATI 13 and adaptor
17 by inserting strip 63 of data communication device 61 into the
corresponding test port slot of data communication device 27,
wherein the electrical conductors on data communication device 61
are disposed in direct electrical contact against the electrical
conductors within data communication device 27.
[0084] Having established data communication channel 53 between ATI
13 and adaptor 17 in step 103, adaptor microcontroller 65 becomes
active, or "wakes up", in anticipation of the transfer of data
between ATI 13 and adaptor 17, said step being represented by
reference numeral 105. Specifically, once data communication
channel 53 has been established between ATI 13 and adaptor 17, the
protocol for ATI 13 is to send out a signal to determine the type
of device (e.g., adaptor, analyte test strip, calibration test
strip) connected to data communication device 27. It is this signal
sent by ATI 13 to determine the type of device connected to data
communication device 27 which, in turn, serves to activate adaptor
microcontroller 65. Once adaptor microcontroller 65 becomes active,
adaptor microcontroller 65 then sends a signal to activate, or
"wake up", microprocessor 43 for ATI 13 in anticipation of data
transfer between ATI 13 and adaptor 17, said step being represented
by reference numeral 107.
[0085] With adaptor microcontroller 65 and ATI microprocessor 43
having been activated in steps 105 and 107, adaptor microcontroller
65 receives a first bundle of data stored in memory 45 of ATI 13,
said step being represented by reference numeral 109. It should be
noted that adaptor microcontroller 65 is programmed to understand
the protocol of ATI 13 (e.g., ASTM 1381 protocol) and, as a result,
can recognize the particular bundles, or packets, of data stored in
memory 45 of ATI 13. Having received the first bundle of data in
step 109, adaptor microcontroller 65 processes (i.e., reformats and
sorts) the first bundle of data in order to render said bundle in
compliance with the data receiving protocol for DMD 15, said step
being represented by reference numeral 111. In step 113, the first
bundle of processed data in microcontroller 65 is then buffered
into memory 69.
[0086] Having completed the transfer of the first bundle of data
from memory 45 of ATI 13 to buffer memory 69 of adaptor 17,
microcontroller 65 then sends a signal to microprocessor 43 to
determine whether additional bundles of data remain in memory 45
for ATI 13 that need to be retrieved by adaptor 17, said step being
represented by reference numeral 115. If there are no additional
bundles of data located in memory 45 of ATI 13, the data transfer
process between ATI 13 and adaptor 17 ends, as represented by
reference numeral 117.
[0087] However, if additional bundles of data are located in memory
45 of ATI 13, adaptor microcontroller 65 receives the next
sequential bundle of data stored in memory 45 of ATI 13, said step
being represented by reference numeral 119. Having received the
next sequential bundle of data in step 119, adaptor microcontroller
65 processes said bundle of data in step 121. In step 123, said
bundle of processed data in microcontroller 65 is then buffered
into memory 69.
[0088] Having completed the transfer of the next sequential bundle
of data from ATI 13 to adaptor 17, microcontroller 65 then sends an
additional signal to microprocessor 43 to determine whether more
bundles of data remain in memory 45 of ATI 13 that need to be
retrieved by adaptor 17, said step being represented by reference
numeral 125. If there are no additional bundles of data located in
memory 45, method 101 proceeds to step 117. However, if additional
bundles of data are located in memory 45 of ATI 13, method 101
returns to step 119. As such, method 101 continues until all the
bundles of data in memory 45 for ATI 13 are properly transferred
into memory 69 for adaptor 17.
[0089] Having completed the first step of the two-step process for
transferring data from ATI 13 to DMD 15 via adaptor 17, system 11
is now prepared to execute the second step of the two-step process
for transferring data from ATI 13 to DMD 15 via adaptor 17. More
specifically, system 11 is now prepared to wirelessly transmit the
data buffered into memory 69 of adaptor 17 to wirelessly enabled
DMD 15. FIG. 8 is a flow chart illustrating the method by which
system 11 transfers data from memory 69 of adaptor 17 to DMD 15,
said method being represented generally by reference numeral
201.
[0090] Method 201 commences once user input device 83 on adaptor 17
is activated (i.e., depressed), said step being represented by
reference numeral 203. The activation of user input device 83 in
step 203, causes adaptor microcontroller 65 to become active, or
"wake up", in anticipation of data transfer between adaptor 17 and
DMD 15, said step being represented by reference numeral 205.
[0091] Once activated, adaptor microcontroller 65 instructs
wireless controller 73 to have wireless transceiver 75 send out a
signal through window 77 in order to establish a data communication
channel 55 between adaptor 17 and DMD 15, said step being
represented by reference numeral 207. It should be noted that
during step 207, adaptor microcontroller 65 simultaneously
instructs indicator 85 to provide a signal (e.g., a flashing green
light) to notify the user of the attempt by adaptor 17 to establish
a data communication channel 55 with DMD 15. If compatible, adaptor
17 and DMD 15 will be able to establish data communication channel
55, said step being represented by reference numeral 209. It should
be noted that, upon establishing data communication channel 55
between adaptor 17 and DMD 15, adaptor microcontroller 65
simultaneously instructs indicator 85 to provide a signal (e.g., a
solid, non-flashing green light) to notify the user of the
established data communication channel.
[0092] With data communication channel 55 having been established
between adaptor 17 and DMD 15, adaptor microcontroller 65 retrieves
a first bundle of data from adaptor memory 69 and, in turn, sends
said first bundle of data to wireless controller 73, as represented
by reference numeral 211. It should be noted that the size of the
first data bundle retrieved from adaptor memory 69 is dependent
upon the transfer protocol established between adaptor 17 and DMD
15. In step 213, wireless controller 73 converts the first bundle
of received data into a format suitable for wireless transmission.
The converted first bundle of data is then sent from wireless
controller 73 to wireless transceiver 75 through transmission line
TxD, said step being represented by reference numeral 215. In step
217, the converted first bundle of data is wirelessly transmitted
from wireless transceiver 75 to DMD 15.
[0093] Having completed the transfer of the first bundle of data
from adaptor 17 to DMD 15, microcontroller 65 then sends out a
signal to determine whether additional data bundles remain in
adaptor memory 69, said step being represented by reference numeral
219. If there are no additional bundles of data located in memory
69, the data transfer process between adaptor 17 and DMD 15
terminates, as represented by reference numeral 221. It should be
noted that once method 201 reaches step 221, adaptor
microcontroller 65 simultaneously turns off indicator 85 to notify
the user that the transfer of data between adaptor 17 and DMD 15
has completed.
[0094] However, if additional bundles of data are located in memory
69, adaptor microcontroller 65 retrieves the next sequential bundle
of data from adaptor memory 69 and, in turn, forwards said bundle
to wireless controller 73, as represented by reference numeral 223.
In step 225, wireless controller 73 converts the next sequential
bundle of received data into a format suitable for wireless
transmission. The converted bundle of data is then sent from
wireless controller 73 to wireless transceiver 75 through
transmission line TxD, said step being represented by reference
numeral 227. In step 229, the converted bundle of data is
wirelessly transmitted from wireless transceiver 75 to wireless
enabled DMD 15.
[0095] Having completed the transfer of the next sequential bundle
of data from adaptor 17 to DMD 15, microcontroller 65 then sends an
additional signal to determine whether more bundles of data remain
in memory 69 for adaptor 17, said step being represented by
reference numeral 231. If there are no additional bundles located
in adaptor memory 69, method 201 proceeds to step 221. However, if
additional bundles of data are located in adaptor memory 69, method
201 returns to step 223. As such, method 201 continues until all of
the bundles of data stored in adaptor memory 69 are wirelessly
transmitted to DMD 15.
[0096] As noted above, data communication device 61 of adaptor 17
is preferably in the form of a strip-type connective interface
which includes multiple metal contacts and communication device 27
is preferably in the form of a slotted, multi-purpose test port
which includes multiple metal contacts. Preferably, the strip-type
connective interface of device 61 is sized and shaped to be
fittingly inserted into the slot of the multi-purpose test port of
device 27 so that the metal contacts of device 61 are disposed in
direct electrical contact with the metal contacts within device 27.
In this manner, data communication channel 53 is established
between ATI 13 and adaptor 17.
[0097] However, it is to be understood that system 11 is not
limited to the particular type of electrical interconnection
between ATI 13 and adaptor 17 as described above. In particular,
system 11 is not limited to data communication device 61 being in
the form of a strip-type connective interface with multiple metal
contacts and data communication device 27 being in the form of a
multi-purpose test port with multiple metal contacts. Rather, it is
to be understood that data communication devices 27 and 61 are
meant to represent any complementary pair of connectors which can
be removably interconnected so as to establish a serial data
communication channel therebetween.
[0098] As an example, referring now to FIG. 9, there is shown a
second embodiment of a system for transferring data, said system
being constructed according to the teachings of the present
invention and identified generally by reference numeral 311.
[0099] System 311 is similar to system 11 in that system 311
comprises an analyte test instrument (ATI) 313, a data management
device (DMD) 315 and an adaptor 317, wherein analyte test data
stored in ATI 313 can be wirelessly transmitted to DMD 315 via
adaptor 317.
[0100] The principal distinction between system 311 and system 11
lies in the fact that adaptor 317 releasably interconnects with ATI
313 in a different manner in which adaptor 17 releasably
interconnects with ATI 13. Specifically, as shown in FIG. 10, ATI
313 comprises a data communication device 327 which is in the form
of a conventional, female-type, conductive phone jack receptacle
and adaptor 317 comprises a data communication device 361 which is
in the form of conventional, male-type, conductive phone jack.
Preferably, the phone jack receptacle of device 327 is sized and
shaped to fittingly and releasably receive the phone jack of device
361, with device 361 being disposed in direct electrical contact
with device 327. As such, a serial data communication path can be
established between adaptor 317 and ATI 313, which is highly
desirable.
[0101] It should be noted that the adaptors of the present
invention which were described in detail above can be used in
conjunction with various types of analyte test instruments. By
providing adaptors which can be used with different types of
analyte test instruments, the present invention serves to create a
standardized means for wirelessly transmitting data of any format
from any type of analyte test instrument to a common data
management device, which is highly desirable.
[0102] The embodiments shown in the present invention are intended
to be merely exemplary and those skilled in the art shall be able
to make numerous variations and modifications to it without
departing from the spirit of the present invention. All such
variations and modifications are intended to be within the scope of
the present invention as defined in the appended claims.
* * * * *