U.S. patent application number 12/889395 was filed with the patent office on 2011-01-20 for analyte monitoring and management system and methods therefor.
This patent application is currently assigned to Abbott Diabetes Care Inc.. Invention is credited to Thomas Peyser.
Application Number | 20110015508 12/889395 |
Document ID | / |
Family ID | 40455308 |
Filed Date | 2011-01-20 |
United States Patent
Application |
20110015508 |
Kind Code |
A1 |
Peyser; Thomas |
January 20, 2011 |
Analyte Monitoring and Management System and Methods Therefor
Abstract
Method and apparatus for providing multiple data receiver units
in a data monitoring and management system such as analyte
monitoring system where a first data receiver includes all of the
functionalities for the data monitoring and management system
receiver unit, and a second data receiver unit is configured with a
limited functions to provide application specific convenience to
the user or patient is disclosed.
Inventors: |
Peyser; Thomas; (Menlo Park,
CA) |
Correspondence
Address: |
JACKSON & CO., LLP
6114 LA SALLE AVENUE, #507
OAKLAND
CA
94611-2802
US
|
Assignee: |
Abbott Diabetes Care Inc.
Alameda
CA
|
Family ID: |
40455308 |
Appl. No.: |
12/889395 |
Filed: |
September 23, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12606890 |
Oct 27, 2009 |
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12889395 |
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11396181 |
Mar 31, 2006 |
7801582 |
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12606890 |
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Current U.S.
Class: |
600/347 |
Current CPC
Class: |
A61B 5/0004 20130101;
A61B 5/0026 20130101; A61B 5/002 20130101; G16H 40/67 20180101;
A61B 5/14546 20130101; A61B 5/1473 20130101; A61B 5/14532
20130101 |
Class at
Publication: |
600/347 |
International
Class: |
A61B 5/05 20060101
A61B005/05 |
Claims
1. (canceled)
2. A system for continuous measurement of an analyte in a host, the
system comprising: a continuous analyte sensor configured to
measure a concentration of an analyte in a host; and a sensor
electronics module physically connected to the continuous analyte
sensor during operation of the continuous analyte sensor, wherein
the sensor electronics module is configured to process a data
stream associated with an analyte concentration measured by the
continuous analyte sensor and to generate displayable sensor
information based on at least some sensor data of the data stream,
wherein the sensor electronics module comprises: a storage device
configured to store at least some of the displayable sensor
information; and a telemetry module configured to wirelessly
transmit a first portion of the displayable sensor information to a
first display device, wherein the first portion of displayable
sensor information is formatted for display on the first display
device, and to wirelessly transmit a second portion of the
displayable sensor information to a second display device, wherein
the second portion of displayable sensor information is formatted
for display on the second display device.
3. The system of claim 2, wherein the first and second portions of
the displayable sensor information each comprise a common subset of
the displayable sensor information and the first portion also
includes an additional subset of the displayable sensor information
that is not included in the second portion.
4. The system of claim 2, wherein the telemetry module is further
configured to wirelessly transmit a third portion of the
displayable sensor information to a third display device, wherein
the third portion of displayable sensor information is formatted
for display on the third display device.
5. The system of claim 2, wherein the sensor electronics module is
configured to communicate simultaneously with the first and second
display devices.
6. The system of claim 2, wherein the first portion of the
displayable sensor information is transmitted via a data network
and the second portion of the displayable sensor information is
transmitted via at least a cellular telephone network.
7. The system of claim 6, wherein the second portion of the
displayable sensor information comprises at least one message for
display.
8. The system of claim 2, wherein the first portion of displayable
sensor information is selected based at least on a type of the
first display device.
9. The system of claim 4, wherein display devices types include one
or more of hand-held display devices, mobile devices, mobile
phones, single point analyte monitor, drug delivery device, medical
device, smart phones, laptop computer, and desktop computers.
10. The system of claim 2, wherein the sensor electronics module is
further configured to determine if one or more sets of alert
conditions are satisfied by the sensor data.
11. The system of claim 10, wherein each set of alert conditions is
associated with one or more delivery actions, wherein each delivery
action indicates at least one display device to at least a portion
of the displayable sensor information is to be transmitted.
12. The system of claim 11, wherein the telemetry module transmits
the first portion of the displayable sensor information in response
to the sensor electronics module determining that a first set of
alert conditions are satisfied by the sensor data.
13. The system of claim 11, wherein a first set of alert conditions
are associated with a hypoglycemic alert, wherein satisfaction of
the alert conditions of the first set indicates that the host is in
a hypoglycemic state.
14. The system of claim 13, wherein a second set of alert
conditions are associated with a hyperglycemic alert, wherein
satisfaction of the alert conditions of the second set indicates
that the host is in a hyperglycemic state.
15. The system of claim 2, further comprising another sensor that
senses one or more characteristics associated with the host.
16. The system of claim 15, wherein the another sensor is a
temperature sensor.
17. The system of claim 2, wherein the displayable sensor
information further comprises one or more calibrated analyte
concentration values, rate of change information, trend
information, alarm information, sensor diagnostic information
and/or calibration information.
18. The system of claim 2, wherein the sensor electronics module is
configured to determine the first portion of displayable sensor
information to transmit to the first display device based at least
on a query received from the first display device.
19. The system of claim 2, wherein the at least some of the sensor
information is automatically readable by a network system upon
entry into a hospital or other medical complex.
20. A computerized method for customizing displayable sensor
information that is transmitted to display devices, the method
comprising: determining analyte concentration data associated with
a host based at least on sensor data from a continuous analyte
sensor associated with the host; generating displayable sensor
information based on at least some of the analyte concentration
data; storing at least some of the displayable sensor information
on a storage device; wirelessly transmitting a first portion of the
displayable sensor information to a first display device, wherein
the first portion of displayable sensor information is formatted
for display on the first display device; and wirelessly
transmitting a second portion of the displayable sensor information
to a second display device, wherein the second portion of
displayable sensor information is formatted for display on the
second display device.
21. The computerized method of claim 20, further comprising:
wirelessly transmitting to the first and second display devices in
response to determining that one or more sets of alert conditions
are satisfied by the analyte concentration data.
22. A computer readable medium storing software code thereon, the
software code configured for execution by one or more processors of
a sensor electronics module configured for coupling to an analyte
sensor that is attached to a host, wherein the software code, if
executed by the one or more processors, causes the sensor
electronics module to perform a method comprising: determining
analyte concentration data associated with a host based at least on
sensor data from a continuous analyte sensor associated with the
host; generating displayable sensor information based on at least
some of the analyte concentration data; storing at least some of
the displayable sensor information on a storage device; wirelessly
transmitting a first portion of the displayable sensor information
to a first display device, wherein the first portion of displayable
sensor information is formatted for display on the first display
device; and wirelessly transmitting a second portion of the
displayable sensor information to a second display device, wherein
the second portion of displayable sensor information is formatted
for display on the second display device.
Description
RELATED APPLICATIONS
[0001] The present application is a continuation of pending U.S.
patent application Ser. No. 12/606,890 filed Oct. 27, 2009, which
is a continuation of U.S. patent application Ser. No. 11/396,181
filed Mar. 31, 2006, now U.S. Pat. No. 7,801,582, the disclosures
of each of which are incorporated herein by reference for all
purposes.
BACKGROUND
[0002] Analyte, e.g., glucose monitoring systems including
continuous and discrete monitoring systems generally include a
small, lightweight battery powered and microprocessor controlled
system which is configured to detect signals proportional to the
corresponding measured glucose levels using an electrometer, and RF
signals to transmit the collected data. One aspect of certain
analyte monitoring systems include a transcutaneous or subcutaneous
analyte sensor configuration which is, for example, partially
mounted on the skin of a subject whose analyte level is to be
monitored. The sensor cell may use a two or three-electrode (work,
reference and counter electrodes) configuration driven by a
controlled potential (potentiostat) analog circuit connected
through a contact system.
[0003] The analyte sensor may be configured so that a portion
thereof is placed under the skin of the patient so as to detect the
analyte levels of the patient, and another portion of segment of
the analyte sensor that is in communication with the transmitter
unit. The transmitter unit is configured to transmit the analyte
levels detected by the sensor over a wireless communication link
such as an RF (radio frequency) communication link to a
receiver/monitor unit. The receiver/monitor unit performs data
analysis, among others on the received analyte levels to generate
information pertaining to the monitored analyte levels.
[0004] The receiver/monitor units generally include sophisticated
functionalities and features, while providing robust data
management system, also provide a steep learning curve and
challenge to the initial users of such devices. In addition, due to
its sophistication and robust functionality, the reduction in the
size of the receiver/monitor unit can be limited. For diabetic
children that use the analyte monitoring system, for example,
having a complex device such as the receiver/monitor unit may pose
a health risk in addition to its intended benefit. Indeed, the
receiver/monitor unit may be misprogrammed, or otherwise, its
settings and/or features modified by the user and thus not operate
properly.
[0005] In addition, due to its size, it is cumbersome to engage in
physical activities such as exercise while carrying the
receiver/monitor unit so as to be in signal range with the on-body
transmitter unit.
[0006] In view of the foregoing, it would be desirable to have a
system which includes a receiver/monitor unit for use with the data
monitoring and management system which is compact in size and that
has limited set of primary features that is less cumbersome to
transport and which is easy to manipulate and use by children, for
example.
SUMMARY OF THE INVENTION
[0007] In view of the foregoing, in accordance with the various
embodiments of the present invention, there is provided a method
and system for providing a secondary receiver/monitor unit in a
data monitoring and management system which is configured for data
communication with the primary receiver/monitor unit, and further,
where the secondary receiver/monitor unit can replace the
functionalities of the primary receiver/monitor unit during a
predetermined time periods such as exercise periods, sleeping
periods, travel periods, or any other periods during which access
to the full functionality of the primary receiver/monitor unit is
not needed.
[0008] These and other objects, features and advantages of the
present invention will become more fully apparent from the
following detailed description of the embodiments, the appended
claims and the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 illustrates a block diagram of a data monitoring and
management system for practicing one embodiment of the present
invention;
[0010] FIG. 2 is a block diagram of the transmitter unit of the
data monitoring and management system shown in FIG. 1 in accordance
with one embodiment of the present invention;
[0011] FIG. 3 is a block diagram of the receiver/monitor unit of
the data monitoring and management system shown in FIG. 1 in
accordance with one embodiment of the present invention;
[0012] FIG. 4 is a flowchart illustrating data synchronization
procedure between the primary receiver unit and the secondary
receiver unit of the analyte monitoring system in accordance with
one embodiment of the present invention; and
[0013] FIG. 5 is a flowchart illustrating data synchronization
procedure between the primary receiver unit and the secondary
receiver unit of the analyte monitoring system in accordance with
another embodiment of the present invention.
DETAILED DESCRIPTION
[0014] FIG. 1 illustrates a data monitoring and management system
such as, for example, analyte (e.g., glucose) monitoring system 100
in accordance with one embodiment of the present invention. The
subject invention is further described primarily with respect to a
glucose monitoring system for convenience and such description is
in no way intended to limit the scope of the invention. It is to be
understood that the analyte monitoring system may be configured to
monitor a variety of analytes, e.g., lactate, and the like.
[0015] Analytes that may be monitored include, for example, acetyl
choline, amylase, bilirubin, cholesterol, chorionic gonadotropin,
creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine,
glucose, glutamine, growth hormones, hormones, ketones, lactate,
peroxide, prostate-specific antigen, prothrombin, RNA, thyroid
stimulating hormone, and troponin. The concentration of drugs, such
as, for example, antibiotics (e.g., gentamicin, vancomycin, and the
like), digitoxin, digoxin, drugs of abuse, theophylline, and
warfarin, may also be monitored.
[0016] The analyte monitoring system 100 includes a sensor 101, a
transmitter unit 102 coupled to the sensor 101, and a primary
receiver unit 104 which is configured to communicate with the
transmitter unit 102 via a communication link 103. The primary
receiver unit 104 may be further configured to transmit data to a
data processing terminal 105 for evaluating the data received by
the primary receiver unit 104. Moreover, the data processing
terminal in one embodiment may be configured to receive data
directly from the transmitter unit 102 via a communication link 103
which may optionally be configured for bi-directional
communication.
[0017] Also shown in FIG. 1 is a secondary receiver unit 106 which
is operatively coupled to the communication link and configured to
receive data transmitted from the transmitter unit 102. Moreover,
as shown in the Figure, the secondary receiver unit 106 is
configured to communicate with the primary receiver unit 104 as
well as the data processing terminal 105. Indeed, the secondary
receiver unit 106 may be configured for bi-directional wireless
communication with each of the primary receiver unit 104 and the
data processing terminal 105. As discussed in further detail below,
in one embodiment of the present invention, the secondary receiver
unit 106 may be configured to include a limited number of functions
and features as compared with the primary receiver unit 104. As
such, the secondary receiver unit 106 may be configured
substantially in a smaller compact housing or embodied in a device
such as a wrist watch, for example. Alternatively, the secondary
receiver unit 106 may be configured with the same or substantially
similar functionality as the primary receiver unit 104, and may be
configured to be used in conjunction with a docking cradle unit for
placement by bedside, for night time monitoring, and/or
bi-directional communication device.
[0018] Only one sensor 101, transmitter unit 102, communication
link 103, and data processing terminal 105 are shown in the
embodiment of the analyte monitoring system 100 illustrated in FIG.
1. However, it will be appreciated by one of ordinary skill in the
art that the analyte monitoring system 100 may include one or more
sensor 101, transmitter unit 102, communication link 103, and data
processing terminal 105. Moreover, within the scope of the present
invention, the analyte monitoring system 100 may be a continuous
monitoring system, or semi-continuous, or a discrete monitoring
system. In a multi-component environment, each device is configured
to be uniquely identified by each of the other devices in the
system so that communication conflict is readily resolved between
the various components within the analyte monitoring system
100.
[0019] In one embodiment of the present invention, the sensor 101
is physically positioned in or on the body of a user whose analyte
level is being monitored. The sensor 101 may be configured to
continuously sample the analyte level of the user and convert the
sampled analyte level into a corresponding data signal for
transmission by the transmitter unit 102. In one embodiment, the
transmitter unit 102 is mounted on the sensor 101 so that both
devices are positioned on the user's body. The transmitter unit 102
performs data processing such as filtering and encoding on data
signals, each of which corresponds to a sampled analyte level of
the user, for transmission to the primary receiver unit 104 via the
communication link 103.
[0020] In one embodiment, the analyte monitoring system 100 is
configured as a one-way RF communication path from the transmitter
unit 102 to the primary receiver unit 104. In such embodiment, the
transmitter unit 102 transmits the sampled data signals received
from the sensor 101 without acknowledgement from the primary
receiver unit 104 that the transmitted sampled data signals have
been received. For example, the transmitter unit 102 may be
configured to transmit the encoded sampled data signals at a fixed
rate (e.g., at one minute intervals) after the completion of the
initial power on procedure. Likewise, the primary receiver unit 104
may be configured to detect such transmitted encoded sampled data
signals at predetermined time intervals. Alternatively, the analyte
monitoring system 100 may be configured with a bi-directional RF
(or otherwise) communication between the transmitter unit 102 and
the primary receiver unit 104.
[0021] Additionally, in one aspect, the primary receiver unit 104
may include two sections. The first section is an analog interface
section that is configured to communicate with the transmitter unit
102 via the communication link 103. In one embodiment, the analog
interface section may include an RF receiver and an antenna for
receiving and amplifying the data signals from the transmitter unit
102, which are thereafter, demodulated with a local oscillator and
filtered through a band-pass filter. The second section of the
primary receiver unit 104 is a data processing section which is
configured to process the data signals received from the
transmitter unit 102 such as by performing data decoding, error
detection and correction, data clock generation, and data bit
recovery.
[0022] In operation, upon completing the power-on procedure, the
primary receiver unit 104 is configured to detect the presence of
the transmitter unit 102 within its range based on, for example,
the strength of the detected data signals received from the
transmitter unit 102 or a predetermined transmitter identification
information. Upon successful synchronization with the corresponding
transmitter unit 102, the primary receiver unit 104 is configured
to begin receiving from the transmitter unit 102 data signals
corresponding to the user's detected analyte level. More
specifically, the primary receiver unit 104 in one embodiment is
configured to perform synchronized time hopping with the
corresponding synchronized transmitter unit 102 via the
communication link 103 to obtain the user's detected analyte
level.
[0023] Referring again to FIG. 1, the data processing terminal 105
may include a personal computer, a portable computer such as a
laptop or a handheld device (e.g., personal digital assistants
(PDAs)), and the like, each of which may be configured for data
communication with the receiver via a wired or a wireless
connection. Additionally, the data processing terminal 105 may
further be connected to a data network (not shown) for storing,
retrieving and updating data corresponding to the detected analyte
level of the user.
[0024] Within the scope of the present invention, the data
processing terminal 105 may include an infusion device such as an
insulin infusion pump or the like, which may be configured to
administer insulin to patients, and which may be configured to
communicate with the receiver unit 104 for receiving, among others,
the measured analyte level. Alternatively, the receiver unit 104
may be configured to integrate an infusion device therein so that
the receiver unit 104 is configured to administer insulin therapy
to patients, for example, for administering and modifying basal
profiles, as well as for determining appropriate boluses for
administration based on, among others, the detected analyte levels
received from the transmitter unit 102.
[0025] Additionally, the transmitter unit 102, the primary receiver
unit 104 and the data processing terminal 105 may each be
configured for bi-directional wireless communication such that each
of the transmitter unit 102, the primary receiver unit 104 and the
data processing terminal 105 may be configured to communicate (that
is, transmit data to and receive data from) with each other via the
wireless communication link 103. More specifically, the data
processing terminal 105 may in one embodiment be configured to
receive data directly from the transmitter unit 102 via the
communication link 103, where the communication link 103, as
described above, may be configured for bi-directional
communication.
[0026] In this embodiment, the data processing terminal 105 which
may include an insulin pump, may be configured to receive the
analyte signals from the transmitter unit 102, and thus,
incorporate the functions of the receiver 103 including data
processing for managing the patient's insulin therapy and analyte
monitoring. In one embodiment, the communication link 103 may
include one or more of an RF communication protocol, an infrared
communication protocol, a Bluetooth enabled communication protocol,
an 802.11x wireless communication protocol, or an equivalent
wireless communication protocol which would allow secure, wireless
communication of several units (for example, per HIPPA
requirements) while avoiding potential data collision and
interference.
[0027] FIG. 2 is a block diagram of the transmitter of the data
monitoring and detection system shown in FIG. 1 in accordance with
one embodiment of the present invention. Referring to the Figure,
the transmitter unit 102 in one embodiment includes an analog
interface 201 configured to communicate with the sensor 101 (FIG.
1), a user input 202, and a temperature detection section 203, each
of which is operatively coupled to a transmitter processor 204 such
as a central processing unit (CPU). As can be seen from FIG. 2,
there are provided four contacts, three of which are
electrodes--work electrode (W) 210, guard contact (G) 211,
reference electrode (R) 212, and counter electrode (C) 213, each
operatively coupled to the analog interface 201 of the transmitter
unit 102 for connection to the sensor unit 201 (FIG. 1). In one
embodiment, each of the work electrode (W) 210, guard contact (G)
211, reference electrode (R) 212, and counter electrode (C) 213 may
be made using a conductive material that is either printed or
etched, for example, such as carbon which may be printed, or metal
foil (e.g., gold) which may be etched.
[0028] Further shown in FIG. 2 are a transmitter serial
communication section 205 and an RF transmitter 206, each of which
is also operatively coupled to the transmitter processor 204.
Moreover, a power supply 207 such as a battery is also provided in
the transmitter unit 102 to provide the necessary power for the
transmitter unit 102. Additionally, as can be seen from the Figure,
clock 208 is provided to, among others, supply real time
information to the transmitter processor 204.
[0029] In one embodiment, a unidirectional input path is
established from the sensor 101 (FIG. 1) and/or manufacturing and
testing equipment to the analog interface 201 of the transmitter
unit 102, while a unidirectional output is established from the
output of the RF transmitter 206 of the transmitter unit 102 for
transmission to the primary receiver unit 104. In this manner, a
data path is shown in FIG. 2 between the aforementioned
unidirectional input and output via a dedicated link 209 from the
analog interface 201 to serial communication section 205,
thereafter to the processor 204, and then to the RF transmitter
206. As such, in one embodiment, via the data path described above,
the transmitter unit 102 is configured to transmit to the primary
receiver unit 104 (FIG. 1), via the communication link 103 (FIG.
1), processed and encoded data signals received from the sensor 101
(FIG. 1). Additionally, the unidirectional communication data path
between the analog interface 201 and the RF transmitter 206
discussed above allows for the configuration of the transmitter
unit 102 for operation upon completion of the manufacturing process
as well as for direct communication for diagnostic and testing
purposes.
[0030] As discussed above, the transmitter processor 204 is
configured to transmit control signals to the various sections of
the transmitter unit 102 during the operation of the transmitter
unit 102. In one embodiment, the transmitter processor 204 also
includes a memory (not shown) for storing data such as the
identification information for the transmitter unit 102, as well as
the data signals received from the sensor 101. The stored
information may be retrieved and processed for transmission to the
primary receiver unit 104 under the control of the transmitter
processor 204. Furthermore, the power supply 207 may include a
commercially available battery.
[0031] The transmitter unit 102 is also configured such that the
power supply section 207 is capable of providing power to the
transmitter for a minimum of about three months of continuous
operation after having been stored for about eighteen months in a
low-power (non-operating) mode. In one embodiment, this may be
achieved by the transmitter processor 204 operating in low power
modes in the non-operating state, for example, drawing no more than
approximately 1 .mu.A of current. Indeed, in one embodiment, the
final step during the manufacturing process of the transmitter unit
102 may place the transmitter unit 102 in the lower power,
non-operating state (i.e., post-manufacture sleep mode). In this
manner, the shelf life of the transmitter unit 102 may be
significantly improved. Moreover, as shown in FIG. 2, while the
power supply unit 207 is shown as coupled to the processor 204, and
as such, the processor 204 is configured to provide control of the
power supply unit 207, it should be noted that within the scope of
the present invention, the power supply unit 207 is configured to
provide the necessary power to each of the components of the
transmitter unit 102 shown in FIG. 2.
[0032] Referring back to FIG. 2, the power supply section 207 of
the transmitter unit 102 in one embodiment may include a
rechargeable battery unit that may be recharged by a separate power
supply recharging unit (for example, provided in the receiver unit
104) so that the transmitter unit 102 may be powered for a longer
period of usage time. Moreover, in one embodiment, the transmitter
unit 102 may be configured without a battery in the power supply
section 207, in which case the transmitter unit 102 may be
configured to receive power from an external power supply source
(for example, a battery) as discussed in further detail below.
[0033] Referring yet again to FIG. 2, the temperature detection
section 203 of the transmitter unit 102 is configured to monitor
the temperature of the skin near the sensor insertion site. The
temperature reading is used to adjust the analyte readings obtained
from the analog interface 201. The RF transmitter 206 of the
transmitter unit 102 may be configured for operation in the
frequency band of 315 MHz to 322 MHz, for example, in the United
States. Further, in one embodiment, the RF transmitter 206 is
configured to modulate the carrier frequency by performing
Frequency Shift Keying and Manchester encoding. In one embodiment,
the data transmission rate is 19,200 symbols per second, with a
minimum transmission range for communication with the primary
receiver unit 104.
[0034] Referring yet again to FIG. 2, also shown is a leak
detection circuit 214 coupled to the guard electrode (G) 211 and
the processor 204 in the transmitter unit 102 of the data
monitoring and management system 100. The leak detection circuit
214 in accordance with one embodiment of the present invention may
be configured to detect leakage current in the sensor 101 to
determine whether the measured sensor data are corrupt or whether
the measured data from the sensor 101 is accurate.
[0035] Additional detailed description of the continuous analyte
monitoring system, its various components including the functional
descriptions of the transmitter are provided in U.S. Pat. No.
6,175,752 issued Jan. 16, 2001 entitled "Analyte Monitoring Device
and Methods of Use", and in application Ser. No. 10/745,878 filed
Dec. 26, 2003 entitled "Continuous Glucose Monitoring System and
Methods of Use", each assigned to the Assignee of the present
application, and the disclosures of each of which are incorporated
herein by reference for all purposes.
[0036] FIG. 3 is a block diagram of the receiver/monitor unit of
the data monitoring and management system shown in FIG. 1 in
accordance with one embodiment of the present invention. Referring
to FIG. 3, the primary receiver unit 104 includes a blood glucose
test strip interface 301, an RF receiver 302, an input 303, a
temperature detection section 304, and a clock 305, each of which
is operatively coupled to a receiver processor 307. As can be
further seen from the Figure, the primary receiver unit 104 also
includes a power supply 306 operatively coupled to a power
conversion and monitoring section 308. Further, the power
conversion and monitoring section 308 is also coupled to the
receiver processor 307. Moreover, also shown are a receiver serial
communication section 309, and an output 310, each operatively
coupled to the receiver processor 307.
[0037] In one embodiment, the test strip interface 301 includes a
glucose level testing portion to receive a manual insertion of a
glucose test strip, and thereby determine and display the glucose
level of the test strip on the output 310 of the primary receiver
unit 104. This manual testing of glucose can be used to calibrate
sensor 101. The RF receiver 302 is configured to communicate, via
the communication link 103 (FIG. 1) with the RF transmitter 206 of
the transmitter unit 102, to receive encoded data signals from the
transmitter unit 102 for, among others, signal mixing,
demodulation, and other data processing. The input 303 of the
primary receiver unit 104 is configured to allow the user to enter
information into the primary receiver unit 104 as needed. In one
aspect, the input 303 may include one or more keys of a keypad, a
touch-sensitive screen, or a voice-activated input command unit.
The temperature detection section 304 is configured to provide
temperature information of the primary receiver unit 104 to the
receiver processor 307, while the clock 305 provides, among others,
real time information to the receiver processor 307.
[0038] Each of the various components of the primary receiver unit
104 shown in FIG. 3 is powered by the power supply 306 which, in
one embodiment, includes a battery. Furthermore, the power
conversion and monitoring section 308 is configured to monitor the
power usage by the various components in the primary receiver unit
104 for effective power management and to alert the user, for
example, in the event of power usage which renders the primary
receiver unit 104 in sub-optimal operating conditions. An example
of such sub-optimal operating condition may include, for example,
operating the vibration output mode (as discussed below) for a
period of time thus substantially draining the power supply 306
while the processor 307 (thus, the primary receiver unit 104) is
turned on. Moreover, the power conversion and monitoring section
308 may additionally be configured to include a reverse polarity
protection circuit such as a field effect transistor (FET)
configured as a battery activated switch.
[0039] The serial communication section 309 in the primary receiver
unit 104 is configured to provide a bi-directional communication
path from the testing and/or manufacturing equipment for, among
others, initialization, testing, and configuration of the primary
receiver unit 104. Serial communication section 104 can also be
used to upload data to a computer, such as time-stamped blood
glucose data. The communication link with an external device (not
shown) can be made, for example, by cable, infrared (IR) or RF
link. The output 310 of the primary receiver unit 104 is configured
to provide, among others, a graphical user interface (GUI) such as
a liquid crystal display (LCD) for displaying information.
Additionally, the output 310 may also include an integrated speaker
for outputting audible signals as well as to provide vibration
output as commonly found in handheld electronic devices, such as
mobile telephones presently available. In a further embodiment, the
primary receiver unit 104 also includes an electro-luminescent lamp
configured to provide backlighting to the output 310 for output
visual display in dark ambient surroundings.
[0040] Referring back to FIG. 3, the primary receiver unit 104 in
one embodiment may also include a storage section such as a
programmable, non-volatile memory device as part of the processor
307, or provided separately in the primary receiver unit 104,
operatively coupled to the processor 307. The processor 307 is
further configured to perform Manchester decoding as well as error
detection and correction upon the encoded data signals received
from the transmitter unit 102 via the communication link 103.
[0041] Referring back to FIGS. 1 and 3, in one embodiment of the
present invention, the secondary receiver unit 106 may be
configured substantially in the manner described in conjunction
with FIG. 3. Alternatively, in another embodiment of the present
invention, the secondary receiver unit 106 may be configured to
include a limited number of functionalities as compared with the
primary receiver unit 104 described in detail in conjunction with
FIG. 3.
[0042] For example, in one embodiment of the present invention, the
secondary receiver unit 106 may be substantially incorporated into
a wrist watch worn by the user of the analyte monitoring system.
Accordingly, in addition to keeping accurate time, the secondary
receiver unit 106 is configured to receive the transmitted signals
from the transmitter unit 102 worn by the user. In one embodiment,
the wrist watch/secondary receiver unit 106 configuration includes
a display section that, in addition to displaying the time and date
information, displays the monitored analyte levels substantially in
real time received from the transmitter unit 102. This
configuration is also programmable to store the received analyte
data from the transmitter unit 102 which can later be transferred
to the primary receiver unit 102. Other features of the receiver
unit display such as trend information or graphical representation
of the trend data, may not be displayed in this configuration given
the limited display area size on the wrist watch.
[0043] In one embodiment, the communication link between the
primary receiver unit 104 and the secondary receiver unit 106 may
be established using Bluetooth communication protocol, and each
device is configured to periodically transmit data such that the
information stored in the primary receiver unit 104 and the
secondary receiver unit 106 are maintained substantially up to date
and in synchronization with each other. In addition, each of the
primary receiver unit 104 and the secondary receiver unit 106 may
be configured to uniquely identify the transmitter unit 102 such
that both primary receiver unit 104 and the secondary receiver unit
106 are configured to receive data transmission from the
transmitter unit 102 without interruption, and to store the same in
the respective storage sections of the receiver units.
[0044] In this manner, in one embodiment of the present invention,
the user or patient may conveniently interchange the use between
the primary receiver unit 104 and the secondary receiver unit 106
without any interruption in the analyte monitoring system 100, and
importantly, without losing data transmitted from the transmitter
unit 102. For example, a diabetic child using the analyte
monitoring system 100 may carry the primary receiver unit 104 in
her backpack during the course of the day, and wear the secondary
receiver unit 106 which is configured as a wrist watch. During the
time period when the backpack containing the primary receiver unit
104 is in close proximity to the transmitter unit 102 attached to
the body of the diabetic child, the primary receiver unit 104 is
configured to receive the transmitted data from the transmitter
unit 102 corresponding to the monitored analyte levels of the
diabetic child. During recess at school or any other time period
during which the backpack containing the primary receiver unit 104
is not in signal range of the transmitter unit 102, the secondary
receiver unit 106 is configured to receive the signals from the
transmitter unit 104. Periodically during the day or at a
preprogrammed time during a 24 hour period, the primary receiver
unit 104 may be configured to synchronize with the secondary
receiver unit 106 such that all of the transmitted signals from the
transmitter unit 102 is stored in the primary receiver unit
104.
[0045] Such multiple receiver unit implementation of the analyte
monitoring system may be additionally beneficial in other
circumstances. For example, the secondary receiver unit 106 may be
used during the time period that the user or patient is engaged in
physical activities such as sports or other types of activities
where carrying an electronic device such as the primary receiver
unit 104 may be cumbersome.
[0046] In addition, the secondary receiver unit 106 may be
configured to operate in a low power transmission state such as
that complying with Class B transmission regulated by the Federal
Aviation Authority (FAA) which mandate electronic transmission
devices to be turned off during airplane take off and landing
procedures. In such cases, the primary receiver unit 104 may be
powered down completely while the Class-B compliant secondary
receiver unit 106 may be configured to continue receiving the
signals from the transmitter unit 102. Thereafter, at a later time
period when the primary receiver unit 104 may be turned on, the
primary receiver unit 104 is configured to synchronize data with
the secondary receiver unit 106 so that the transmitted signals
from the transmitter unit 102 during the time that the primary
receiver unit 104 was turned off can be captured and stored in the
primary receiver unit 104.
[0047] FIG. 4 is a flowchart illustrating data synchronization
procedure between the primary receiver unit and the secondary
receiver unit of the analyte monitoring system in accordance with
one embodiment of the present invention. Referring to FIG. 4, at
step 410 in one embodiment of the present invention, the secondary
receiver unit 106 (FIG. 1) is configured to receive and store the
signals received from the transmitter unit 102 that are associated
with the monitored analyte levels. Thereafter at step 420, the
secondary receiver unit 106 determined whether the primary receiver
unit 104 is back in the power on state. In one embodiment, the
primary receiver unit 104 may be configured to broadcast a power on
state signal as soon as it is powered on. Alternatively, in another
embodiment, the secondary receiver unit 106 is configured to
periodically transmit a signal to the primary receiver unit 104,
and when a return acknowledgement signal is received by the
secondary receiver unit 106 as originating from the primary
receiver unit 104, it is determined that the primary receiver unit
104 is in the powered on state.
[0048] Referring back to FIG. 4, if it is determined at step 420
that the primary receiver unit 104 is not in the power on state,
then the secondary receiver unit 106 returns to step 410 where the
transmitter unit 102 signals are continuously received and stored.
If however it is determined at step 420 that the primary receiver
unit 104 is in the power on state, then at step 430, the secondary
receiver unit 106 is configured to retrieve the stored data
received from the transmitter unit 102, and at step 440, the
secondary receiver unit 106 is configured to transmit the retrieved
data corresponding to data received from the transmitter unit 102
to the primary receiver unit 104. Thereafter, optionally, the
secondary receiver unit 106 may be configured to enter a powered
down or hibernate mode to conserve its power supply. In the
hibernate mode, the secondary receiver unit 106 may be configured
to not accept data transmitted from the transmitter unit 102.
[0049] In an alternate embodiment, the secondary receiver unit 106
may be configured to continue to receive the transmitted data from
the transmitter unit 102 even when the primary receiver unit 104 is
in the power on state and receiving data from the transmitter unit
102. In this manner, transmitter unit 102 data redundancy may be
achieved.
[0050] FIG. 5 is a flowchart illustrating data synchronization
procedure between the primary receiver unit and the secondary
receiver unit of the analyte monitoring system in accordance with
another embodiment of the present invention. Referring to FIG. 5,
at step 510, the primary receiver unit 104 (FIG. 1) entered the
power on state by, for example, the user or patient powering on the
primary receiver unit 104. Thereafter at step 520, the primary
receiver unit 520 is configured to retrieve the time information
associated with the power off state duration. For example, in one
embodiment, the primary receiver unit 104 is configured to retrieve
the time stamp information (as may be provided by its internal
clock 305 (FIG. 3) of the beginning of the power off state, and the
time stamp information of the beginning of the power on state.
[0051] Referring to FIG. 5, the retrieved time information
associated with the power off duration is transmitted to the
secondary receiver unit 106 at step 530. Thereafter, at step 540,
the primary receiver unit 104 is configured to receive transmitter
unit 102 data from the secondary receiver unit 104 that correspond
to the time information associated with the power off duration.
That is, since during the power off state the primary receiver unit
104 did not receive any data from the transmitter unit 102 which
are associated with the monitored analyte level, the primary
receiver unit 104 may be configured in one embodiment to receive
this data from the secondary receiver unit 106.
[0052] In addition, within the scope of the present invention, the
primary receiver unit 104 and the secondary receiver unit 106 may
be configured as a bedside monitor system where, the secondary
receiver unit 106 (or interchangeably the primary receiver unit
104) may be placed at or near the bedside of the child or patient
wearing the transmitter unit 102. The primary receiver unit 104 (or
interchangeably the secondary receiver unit 106) may be placed at
another location within the house (or hospital or any other
location within communication range with the secondary receiver
unit 106. In this manner, even though the RF communication link 103
between the transmitter unit 102 and the remotely located primary
receiver unit 104 may not be enabled due to distance, the secondary
receiver unit 106 which is in signal communication with the
transmitter unit 102 may be configured as a relay device to
retransmit the received transmitter unit 102 signals to the primary
receiver unit 104. In this manner, parents of diabetic children
wearing a transmitter unit 102 to monitor the children's glucose
levels, or patients in hospitals may conveniently and remotely
monitor the analyte levels substantially in real time.
[0053] Accordingly, a system for providing analyte monitoring in
one embodiment of the present invention includes a sensor
configured for subcutaneous placement for detecting a plurality of
analyte levels, a transmitter unit configured for electrical
communication with the sensor; the transmitter unit configured to
transmit a plurality of signals each associated with a respective
one or more of the detected plurality of analyte levels, a first
receiver unit configured to receive a first portion of the
transmitted plurality of signals from the transmitter unit, a
second receiver unit configured to receive a second portion of the
transmitted signals from the transmitter unit.
[0054] In one embodiment, each of the plurality of signals
transmitted by the transmitter unit may be associated with a
corresponding detection time information, where each detection time
information may substantially correspond to the detection time of
the corresponding associated analyte level by the sensor.
[0055] The second receiver unit may be configured to transmit the
received second portion of the signals to the first receiver unit,
where the first portion of the plurality of signals and the second
portion of the plurality of signals may be substantially
non-overlapping.
[0056] Further, the first receiver unit may include a storage unit
for storing the first and second portions of the plurality of the
signals.
[0057] In addition, the first receiver unit may include an output
unit for outputting one or more of a visual indication, an audible
indication or a vibratory indication associated with the received
one or more of the plurality of signals.
[0058] In a further aspect, the second receiver unit may include a
housing substantially configured as one of a wrist watch, a bed
side monitor unit, a two way radio communication unit, a mobile
telephone, a pager, or a personal digital assistant.
[0059] The first receiver unit and the second receiver unit in yet
another aspect may be configured to communicate over a
communication link which may include one or more of an infrared
communication link, an RF communication link, a Bluetooth
communication link, or a cable connection.
[0060] In yet another aspect, each of the first and second receiver
units may be configured for bi-directional communication.
[0061] A method of analyte monitoring in accordance with another
embodiment of the present invention includes transmitting a
plurality of signals associated with detected analyte levels,
receiving a first portion of the plurality of signals at a first
remote location, receiving a second portion of the plurality of
signals at a second remote location, wherein the first and second
portions of the plurality of signals are substantially
non-overlapping.
[0062] The method may further include the step of transmitting the
second portion of the plurality of signals from the second remote
location to the first remote location.
[0063] In another aspect, the method may also include one or more
steps of storing the plurality of signals, or displaying at least a
portion of the plurality of signals.
[0064] A method of analyte monitoring in accordance with still
another embodiment of the present invention includes receiving one
or more signals associated with a respective one or more analyte
levels being monitored, storing the received one or more signals,
detecting an active state of a receiver unit, and transmitting the
stored one or more signals to the receiver unit.
[0065] In another aspect, the method may also include the steps of
detecting the one or more analyte levels, and transmitting the one
or more signals each corresponding to the detected one or more
analyte levels substantially in real time.
[0066] A method of analyte monitoring in still yet another
embodiment of the present invention includes retrieving a time
information associated with an inactive state, transmitting the
retrieved time information, and receiving one or more signals each
associated with a monitored analyte level corresponding to the time
information.
[0067] The time information may include a beginning time and an end
time of the inactive state.
[0068] In a further aspect, the method may also include the step of
storing the received one or more signals.
[0069] Various other modifications and alterations in the structure
and method of operation of this invention will be apparent to those
skilled in the art without departing from the scope and spirit of
the invention. Although the invention has been described in
connection with specific preferred embodiments, it should be
understood that the invention as claimed should not be unduly
limited to such specific embodiments. It is intended that the
following claims define the scope of the present invention and that
structures and methods within the scope of these claims and their
equivalents be covered thereby.
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