U.S. patent application number 12/786428 was filed with the patent office on 2010-09-16 for glucose measuring device integrated into a holster for a personal area network device.
This patent application is currently assigned to Abbott Diabetes Care Inc.. Invention is credited to Timothy T. Goodnow.
Application Number | 20100235439 12/786428 |
Document ID | / |
Family ID | 39168478 |
Filed Date | 2010-09-16 |
United States Patent
Application |
20100235439 |
Kind Code |
A1 |
Goodnow; Timothy T. |
September 16, 2010 |
Glucose Measuring Device Integrated Into A Holster For A Personal
Area Network Device
Abstract
A glucose meter module integrated into a holster device that can
securely accommodate another device such as a portable server
device or an insulin pump is described. The glucose measuring
module and the health device communicate with each other by a short
range wireless modality. In the case in which the accommodated
device is a server, such as personal digital assistant or cell
phone, the device stores data in a memory, displays data on a
visual display, and can wirelessly transmit such data to other
devices within a personal area network. In the case where the
accommodated device is a cell phone, the phone can further transmit
data to remote sites. In the case where the accommodated device is
an insulin pump, wirelessly received data are stored in a memory,
are available for visual display on the insulin pump, and can be
incorporated into the electronic processes that regulate the
performance of the pump.
Inventors: |
Goodnow; Timothy T.;
(Pleasanton, 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: |
39168478 |
Appl. No.: |
12/786428 |
Filed: |
May 24, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10891327 |
Jul 14, 2004 |
7722536 |
|
|
12786428 |
|
|
|
|
60487808 |
Jul 15, 2003 |
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Current U.S.
Class: |
709/203 ;
340/539.12; 600/365; 604/151 |
Current CPC
Class: |
A61B 5/0024 20130101;
G16H 40/63 20180101; G16H 40/67 20180101; A61B 5/0022 20130101;
A61B 2560/0431 20130101; A61B 5/0002 20130101; G16H 20/17 20180101;
A61B 5/14532 20130101; A61B 2560/06 20130101; A61B 2560/0456
20130101; G16H 10/40 20180101 |
Class at
Publication: |
709/203 ;
600/365; 604/151; 340/539.12 |
International
Class: |
G06F 15/16 20060101
G06F015/16; A61B 5/00 20060101 A61B005/00; A61M 5/142 20060101
A61M005/142; G08B 1/08 20060101 G08B001/08 |
Claims
1. A system comprising: a client device configured for wireless
data communication in a personal area network, the client device
having at least one user interface component and configured to
receive a medical component with an analyte sample, the client
device including a security code to access the information in the
client device; and a server device configured to detachably couple
to the client device and configured to wirelessly communicate with
the client device in the personal area network; wherein the client
device is configured to transmit one or more health related data to
the server device over the personal area network; and wherein the
server device is configured to generate one or more health
management signals based on the received one or more health related
data.
2. The system of claim 1, wherein server device is configured to
request an analyte level value prior to activating a device at
least partially controlled by the server device.
3. The system of claim 1, wherein the client device includes a
client device wireless communication port for the wireless data
communication, and wherein the server device includes a server
device wireless communication port for data communication.
4. The system of claim 3, wherein each of the client device
wireless communication port and the server device wireless
communication port includes one of an infrared port, a radio
frequency enabled port, and a Wi-Fi communication port.
5. The system of claim 1, wherein the client device includes a
blood glucose meter, and further, wherein the health related data
includes a blood glucose level.
6. The system of claim 5, wherein the server device includes a
blood glucose monitoring device configured to generate the one or
more health management signals based on the blood glucose level
data received from the blood glucose meter.
7. The system of claim 6, wherein the one or more health management
signals includes one or more of an audio alert signal, a vibration
alert signal, and a graphical display signal.
8. The system of claim 6, wherein the blood glucose monitoring
device is configured to generate an alert signal for output when
the received blood glucose level data is determined to be beyond a
predetermined range.
9. The system of claim 8, wherein the predetermined range
substantially establishes an impending hyperglycemic state and an
impending hypoglycemic state.
10. The system of claim 1, wherein the server device includes one
or more of a personal digital assistant, a cell phone, a portable
gaming unit, an insulin pump, or one or more combinations
thereof.
11. The system of claim 1, wherein the at least one user interface
component is at least one of a liquid crystal display, a light
emitting diode, or an electroluminescent strip.
12. The system of claim 1, wherein the port includes a strip port
and wherein the medical component includes an in vitro blood
glucose test strip.
13. The system of claim 1, wherein the server device includes an
output unit to output the generated one or more health management
signals.
14. The system of claim 13, wherein the output unit of the server
device is configured to output the generated one or more health
management signals substantially in real time when the one or more
health related data is received from the client device.
15. The system of claim 1, wherein the server device includes one
or more of a personal digital assistant, a cell phone, a portable
gaming unit, an insulin pump, or one or more combinations
thereof.
16. The system of claim 1, wherein the at least one user interface
component is at least one of a liquid crystal display, a light
emitting diode, or an electroluminescent strip.
Description
RELATED APPLICATIONS
[0001] This is a continuation application of pending U.S. patent
application Ser. No. 10/891,327 filed Jul. 14, 2004, which claims
priority to U.S. Provisional Patent Application No. 60/487,808
filed Jul. 15, 2003, the disclosures of each of which is
incorporated herein by reference in their entirety for all
purposes.
FIELD OF THE INVENTION
[0002] The present invention relates to glucose monitoring devices.
More particularly, the present invention relates to a glucose
sensor module integrated into a holster that can accommodate
another device, and further, to a method by which the glucose
sensor module and the accommodated device wirelessly communicate
with each other.
BACKGROUND
[0003] The number of diagnosed cases of diabetes continues to
increase in the U.S. and throughout the world, creating enormous
economic and public health consequences. One area in which recently
developed technologies have been able to improve the standard of
care has been in the maintenance of tight control over the blood
glucose levels. It is well known that if a diabetic patient's blood
glucose values are maintained within the normal range of from about
80 milligrams per deciliter (mg/dL) to about 120 mg/dL, the
physiologically damaging consequences of unchecked diabetes can be
minimized.
[0004] Recent technological and commercial development in the two
areas of glucose monitoring and of insulin administration have each
contributed significantly to improving the ability of diabetic
people to maintain better control over their blood glucose level,
and thereby enhance their quality of life.
[0005] With better blood glucose information, diabetic patients can
better exercise tight control of their blood glucose level through
a variety of means, including diet, exercise, and medication. A
common type of glucose measuring device is represented by hand-held
electronic meters which receive blood samples via enzyme-based
"test strips". In using these systems, the patient lances a finger
or alternate body site to obtain a blood sample, the sample is
applied to the strip, the strip is inserted into a port in the
meter housing where it engages the meter's internal electronics,
and the electronics convert a current generated by the enzymatic
reaction in the test strip to a blood glucose value. The glucose
value is then typically displayed on the meter's liquid crystal
display (LCD), which is generally relatively large in size in order
to accommodate the eyesight capability of older adults and diabetic
people, who often have deteriorating vision.
[0006] Some diabetic patients require insulin administration in
order to maintain tight control of their glucose level. Insulin
administration to these insulin-dependent patients has
traditionally been by self-injection, but a more recently available
technology is represented by insulin pumps. These pump devices
offer significant therapeutic value over self injection, as the
pumps deliver insulin in a more physiological manner, with measured
doses of insulin being infused slowly, over an extended period of
time. Further, the rate at which insulin is delivered can be
programmed to follow standard or individually-modified protocols,
to give the user even better glucose control over the course of a
day. Insulin pumps have commercially evolved to become small in
size, which offers easier portability and unobtrusiveness, and with
electronic advances, they have evolved to become more
fully-featured, and thus capable of enhanced and individualized
performance. These various advantages in terms of health care
quality and user convenience have supported the growth of the
insulin pump market.
[0007] It has been recognized that combining the newer technologies
of insulin administration with the newer technologies of glucose
measurement could significantly improve user convenience, resulting
in a greater ability to comply with frequent testing, and greater
ability to effect individually appropriate schedules of insulin
administration. Such an integrated combination of a glucose
measuring device and insulin pump is shown in U.S. Pat. No.
5,665,065, which teaches the inclusion of a mechanism for measuring
blood glucose within the housing of an insulin pump. While the
advantages of such a glucose measuring/insulin pump combinations
has been known for many years, in fact, no such device has become
commercially available. Various practical and market-based factors
may contribute to the absence of a combination device in the
market. Insulin pumps, though expensive, have become well
established and stabilized in the market; and pump users tend to
remain with their initial choice. Glucose meters, in contrast, are
presently evolving more quickly and are inexpensive for users;
indeed they are often provided to users by manufacturers without
charge, as a loss leader in an overall business strategy. At least
in part as a consequence of the low price, glucose meter users have
lower brand loyalty, and will switch among brands. As another
consequence, there is intense manufacturing cost pressure on
glucose meters, which, in turn, encourages efficient product design
by the meter manufacturers. From the perspective of a pump
manufacturer in designing such a physically integrated combination
device, the manufacturer would need to commit to a particular blood
glucose measuring technology in the face of the concern that such
technology could become less competitive or even obsolete during
the normal life of the pump product.
[0008] It is known that hand-held glucose meters can advantageously
be manufactured to include short range wireless communication
capability, through which data from the glucose sensor can be
transmitted to another health device, such as a computer, cell
phone, or a personal digital assistant (PDA); such wireless
communication between two portable devices is shown in the PCT
publication WO-03/005891A1. This wireless data transfer relieves
the glucose sensor user of the need to record such data by hand,
and allows for accumulation of data points within a larger database
for longer term health monitoring and intervention. In spite of the
benefits of wireless communication, the inconvenience of handling
separate devices to achieve the patient's singular goal of
maintaining glucose control remains unsolved by wireless
communication alone.
[0009] Devices that provide for secure personal portability of
various communication and health-related electronic devices, and
ease of use while being carried are also well known. Holsters and
cases for electronic devices that attach to belts or other articles
of clothing are never far from where mobile telephones are being
sold, and are described in U.S. Pat. Nos. 5,664,292 and 5,833,100,
and 6,081,695. Similarly, U.S. Pat. No. 5,472,317 describes an
apparatus that provides for a belt-clip mounting for a medication
infusion pump.
[0010] In view of these various problematic factors associated with
the actual physical integration of a glucose measuring device with
an insulin pump, it would be desirable to provide an insulin pump
user the benefits and performance of functionally combined glucose
measuring device and insulin pump. Such a combined device would
desirably be in a portable configuration that, in fact, maintains
physical distinctness of the devices, gets past the market-based
barriers that accompany physical integration, and yet offers a
combination which for all practical purposes is used as a single
integrated device. It would be further desirable for this
functionally integrated device to be fully enabled to interact with
other devices within a personal area network.
SUMMARY OF THE INVENTION
[0011] In view of the foregoing, in accordance with one embodiment
of the present invention, there is provided a glucose monitoring
device housing, comprising a holster unit, a glucose sensing module
integrally disposed on the holster unit, where the holster unit is
configured to substantially receive a server device, the server
device configured to wirelessly communicate with the glucose
sensing module.
[0012] The server device may include a blood glucose monitoring
device. Alternatively, the server device may include one or more of
an insulin pump, a personal digital assistant, a mobile telephone,
and a portable gaming unit.
[0013] The server device may be configured to receive one or more
data from the glucose sensing module, the one or more data
including one or more data related to a detected blood glucose
level.
[0014] The glucose sensing module may include a test strip port
configured to receive a test strip.
[0015] The glucose sensing module may be shaped substantially
elongate.
[0016] In one embodiment, the glucose sensing module may be
configured to transmit data to the server device when the server
device is substantially positioned within the holster unit.
[0017] The holster unit may include in one embodiment a belt clip
portion, and a device clasping portion mechanically coupled to the
belt clip portion.
[0018] The belt clip portion may be mechanically coupled to the
device clasping portion by a spring biased connector unit.
[0019] Further, the glucose sensing module may be integrally
disposed on one of the belt clip portion and the device clasping
portion.
[0020] The glucose sensing module may include a test strip port
configured to receive a test strip.
[0021] The device clasping portion of the holster unit may be
configured to receive the server device such that the server device
is in physical contact with the device clasping portion. Moreover,
the server device may be securely positioned substantially within
the device clasping portion of the holster unit.
[0022] Additionally, in one embodiment, each of the glucose sensing
module and the server device may include a communication port for
data communication.
[0023] Indeed, the glucose sending module communication port and
the server device communication port each may include one of an
infrared port, a Bluetooth enabled communication port, and a Wi-Fi
enabled communication port.
[0024] The server device may include in one embodiment one or more
of an output unit, and an input unit, where the output unit may
include one or more of a display unit and an audio output unit.
[0025] The display unit in this case may include one of a liquid
crystal display (LCD) unit, a plasma display unit, and a
touch-sensitive display unit, and further, wherein the audio output
unit includes an output speaker.
[0026] Also, the input unit may include one or more of an input
button, and a touch-sensitive input unit integrated with the output
unit.
[0027] Additionally, the output unit may be configured to output
one or more of an image data, a video data, and an audio signal, in
response to a predetermined event.
[0028] The predetermined event in one embodiment may include one or
more of an input command generated by the input unit and a
detection of a glucose sensing module signal.
[0029] A method of providing a glucose monitoring device housing in
accordance with another embodiment of the present invention
includes the steps of providing a holster unit, integrally
disposing a glucose sensing module on the holster unit, configuring
the holster unit to substantially receive a server device, and
configuring the server device to wirelessly communicate with the
glucose sensing module.
[0030] In a further embodiment, the server device may include one
or more of a blood glucose monitoring device, an insulin pump, a
personal digital assistant, a mobile telephone, and a portable
gaming unit.
[0031] The method may further include the step of configuring the
server device to receive one or more data from the glucose sensing
module, the one or more data including one or more data related to
a detected blood glucose level.
[0032] Also, the method may additionally include the step of
providing a test strip port on the glucose sensing module, the test
strip port configured to receive a test strip.
[0033] Indeed, the method may also include the step of configuring
the glucose sensing module to transmit data to the server device
when the server device is substantially positioned within the
holster unit.
[0034] A data management system for managing health related data in
accordance with still another embodiment of the present invention
includes a personal area network, a client device configured for
data communication in the personal area network, and a server
device configured to communicate with the client device in the
personal area network, where the client device is configured to
transmit one or more health related data to the server device over
the personal area network, and the server device is configured to
generate one or more health management signals based on the
received one or more health related data.
[0035] The client device may include a client device wireless
communication port for data communication, and the server device
includes a server device wireless communication port for data
communication.
[0036] Further, each of the client device wireless communication
port and the server device wireless communication port may include
one of an infrared port, a Bluetooth enabled port, and a Wi-Fi
communication port.
[0037] Moreover, the client device may include a blood glucose
meter, and further, where the health related data includes a blood
glucose level data.
[0038] The server device may include a blood glucose monitoring
device configured to generate the one or more health management
signals based on the blood glucose level data received from the
blood glucose meter, where the health management signals includes
one or more of an audio alert signal, a vibration alert signal, and
a graphical display signal.
[0039] The blood glucose monitoring device may in one embodiment be
configured to generate an alert signal for output when the received
blood glucose level data is determined to be beyond a predetermined
range.
[0040] Also, the predetermined range may substantially establish an
impending hyperglycemic state and an impending hypoglycemic
state.
[0041] In the manner described above, in accordance with one
embodiment of the present invention, there is provided a glucose
monitoring and response system that includes a glucose meter
module, operating within a personal area network as a client
device, integrated into a holster apparatus typically clipped or
loop-attached to a belt or other article of clothing worn by a
diabetic person, the holster being configured so as to be able to
securely accommodate another health device such as a portable
server device or an insulin pump. Communication between the glucose
measuring module and the responding health device may be performed
by a wireless modality, for example using infrared (IR), Bluetooth,
or Wi-Fi (801.11g, 801.11b, or 801.11a) protocols.
[0042] In one embodiment, the accommodated device may include a
server, such as a personal digital assistant or cell phone, where
the accommodated device may be configured to store data in a
memory, display data on a visual display, and may wirelessly
transmit such data to other devices within a personal area network
(PAN), as well as send data to remote sites via the global system
for mobile communications (GSM). In another embodiment where the
health device includes an insulin pump, the wirelessly received
data may be stored in a memory, and may be available for visual
display on the insulin pump, as well as incorporating into the
selection of appropriate protocols that regulate the performance of
the pump.
[0043] The glucose measuring module in one embodiment of the
present invention may include glucose measuring circuitry for
enzymatic electrochemical detection of glucose in a blood sample.
The module, by including a holster accommodation for a device with
which it wirelessly communicates, may be configured to establish a
functional system integration in spite of physical distinctness of
the two major system components. Cost and size of the
holster-integrated glucose meter may be minimized by reliance on
the fully meter-functional display and controls present on the
holster-accommodated device, and the absence of the redundant
visual display and redundant control buttons on the glucose
meter.
[0044] More particularly, in accordance with one embodiment of the
present invention, there is provided a glucose sensing and insulin
delivery system which includes a glucose sensor module, an insulin
pump including a visual display, a holster apparatus into which the
glucose sensor module is integrated and which holster is configured
to hold the insulin pump, and a wireless data communication system
for transmitting data between the glucose sensor module and the
insulin pump.
[0045] In another embodiment, the holster apparatus may include a
belt-clip portion and a device clasping portion. Moreover, the
glucose sensor module may be integrated into the device-clasping
portion of the holster apparatus. Alternatively, the glucose sensor
module may be integrated into the belt-clip portion of the holster
apparatus.
[0046] The wireless data communication system may include an
infrared transceiver in the glucose sensor module and an infrared
transceiver in said insulin pump. Additionally, the wireless data
communication system may include a Bluetooth-enabled transceiver in
the glucose sensor module and a Bluetooth-enabled transceiver in
the insulin pump.
[0047] Furthermore, the glucose sensing and insulin delivery system
may include a single visual display. Alternatively, the glucose
sensor module may not include a visual display.
[0048] In addition, the insulin pump may include a housing, where
the housing includes control buttons mounted in the housing.
[0049] Also, control unit may be provided for controlling the
operation of the glucose module, where the control unit may include
control buttons mounted on the insulin pump.
[0050] In accordance with another embodiment of the present
invention, there is provided a glucose sensing system comprising a
glucose sensor module enabled to wirelessly communicate within a
personal area network, a second personal area network
communication-enabled device including a visual display, and a
holster apparatus into which the glucose sensor module is
integrated and which holster is configured to hold the second
personal area network device.
[0051] The second personal area network communication-enabled
device may include an insulin pump. Alternatively, the second
personal area network communication-enabled device may include a
cell phone.
[0052] These and other features and advantages of the present
invention will be understood upon consideration of the following
detailed description of the invention and the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0053] The invention will now be described by reference to the
figures, wherein like reference numerals and names indicate
corresponding structure throughout the several views.
[0054] FIG. 1A illustrates a glucose measuring module integrated
into the device-clasping portion in accordance with one embodiment
of the present invention;
[0055] FIG. 1B illustrates a belt-clasping portion with a glucose
measuring module integrated thereto in accordance with another
embodiment of the present invention;
[0056] FIG. 2A illustrates a glucose measuring module integrated
into the device-clasping portion in accordance with another
embodiment of the present invention;
[0057] FIG. 2B illustrates the belt-clasping portion with a glucose
measuring module integrated therewith in accordance with another
embodiment of the present invention;
[0058] FIG. 3 illustrates a cut away perspective view where the IR
transceiver ports of the glucose measuring module and the held
device, respectively, are aligned for transmission of IR data in
accordance with one embodiment of the present invention;
[0059] FIG. 4 illustrates an exploded view of a swivel-enabled and
detachable holster apparatus, a holding button, a device carrying
case, and a held server device in accordance with one embodiment of
the present invention;
[0060] FIG. 5 is a block diagram illustrating data signal flow
between devices of a wireless system in accordance with one
embodiment of the present invention;
[0061] FIG. 6 is a block diagram of a glucose meter client device
as shown in FIG. 3 in accordance with one embodiment of the present
invention;
[0062] FIG. 7 is a block diagram of a server device such as an
insulin pump, as shown in FIG. 3 in accordance with one embodiment
of the present invention; and
[0063] FIG. 8 is a pictorial view showing a client device and
server devices within a personal area network in accordance with
one embodiment of the present invention.
DETAILED DESCRIPTION
[0064] FIG. 1A illustrates a glucose measuring module integrated
into the device-clasping portion in accordance with one embodiment
of the present invention. Referring to the Figure, there are shown
two main components of the holster apparatus, a belt-clip portion
101 and device-clasping portion 103, which includes a glucose
sensing module 102, a client device within the larger context of
networked devices to be further described below. The
glucose-sensing module is generally elongate and pen-shaped, as has
been described in U.S. patent application entitled Glucose
Measuring Device for Use in Personal Area Network filed Jun. 4,
2004, assigned to Abbott Diabetes Care Inc., of Alameda Calif., the
assignee of the present invention, and the disclosure of which is
incorporated herein by reference for all purposes. More
specifically, as shown in the Figure, the glucose sensing module
102 may be integrally molded into the larger contours of the device
clasping portion of the holster apparatus, and situated vertically
on the outer aspect of one of the two clasping arms 104 of device
clasping portion 103.
[0065] At the base of the glucose sensing module 102 is located a
test strip port 105, wherein test strips are inserted after having
been contacted with a blood sample. Alternatively, glucose sensing
module 102 can be configured to accept test strips before they have
been contacted with a blood sample. Other configurations for the
placement of the glucose sensing module within the clasping portion
of the holster are possible that would meet the basic requirement
that the module, and more particularly the test strip port 105
within the module, be readily accessible to the user. The two
holster mechanical components, the belt-clip portion 101 and the
device-clasping portion 103, may be joined by a spring-biased
connector (not shown) which causes the belt-clip to press toward
the device-clasping portion, in order to grip a belt or article of
clothing worn by a user, and thus to secure the apparatus.
[0066] FIG. 1B illustrates a belt-clasping portion with a glucose
measuring module integrated thereto in accordance with another
embodiment of the present invention. Referring to the Figure, there
is shown a perspective view of a belt-clip portion of another
embodiment of the holster apparatus into which the glucose sensing
module 102 has been integrated. As noted in the description above
in conjunction with FIG. 1A, the glucose-sensing module 102 is
generally elongate and pen-shaped, but in this embodiment it has
been molded into the larger contours of the belt-clip portion 101
of the holster apparatus, and is situated horizontally across the
top of the upper aspect thereof. Other configurations for the
placement of the glucose sensing module are possible that would
meet the basic desire that the module, and more particularly the
test strip port 105 within the module be readily accessible to the
user.
[0067] Because of the constraints of the generally elongate profile
of the glucose sensing module 102 as a whole, as well as the
elongate profiles of test strips and the test strip port 105, the
test strip port 105 in one embodiment of the present invention is
preferably located at one of the two ends of the glucose sensing
module 102 (see FIGS. 1A-1B and 2A-2B.). The analog "front end"
circuitry associated with measuring the small electrochemical
currents from test strips 101 is located near the strip port 105,
and is sensitive to electrical interference. It is advisable,
therefore, to situate the wireless link antenna of the glucose
sensing module 102 at a such a distance from the strip port end
that such wireless transmission interference does not occur. In
operation, in accordance with one embodiment, the holster apparatus
may either be worn by the user while the test strip is inserted
into the test strip port 105, or alternatively, the holster
apparatus may be removed from the user's belt, for example, when
inserting the test strip into the test strip port 105 and
conducting a glucose measurement.
[0068] FIG. 2A illustrates a glucose measuring module integrated
into the device-clasping portion in accordance with another
embodiment of the present invention. Referring to the Figure, there
are shown the two main components of the holster apparatus, a
belt-clip portion 201 and device-clasping portion 203, which
includes a glucose sensing module 202, a client device within the
larger context of networked devices as described in further detail
below. This embodiment illustrates features that provide both for
swiveling of the held device with respect to the relatively fixed
orientation of the holster when secured to a belt, as well as an
ability to quickly engage and disengage the held server device (see
FIG. 4) from the holster. The feature providing these forms of
functionality is a button-holding box 206, which includes a
U-shaped slot 205. Fitting into this U-shaped slot 205 is a
complementary broadened holding button 407 (see FIG. 4) that is
attached to the back of the held server device 411 (see FIG. 4),
thereby securing the held server device 411 to the holster.
[0069] Referring back to FIG. 2A, the glucose-sensing module 202,
generally elongate and pen-shaped, may be molded into the larger
contours of the device clasping portion 203 of the holster
apparatus, and may be situated vertically on the outer aspect of
one of the two sides of the clasping portion 203 of the holster, or
on one of the sides of the button-holding box 206. Located at the
base of the glucose sensing module 202 may be a test strip port
204, into which test strips are inserted before or after having
been contacted with a blood sample. Other configurations for the
placement of the glucose sensing module within the clasping portion
of the holster are possible that would meet the basic requirement
that the module, and more particularly the test strip port 204
within the module be readily accessible to the user. The two major
mechanical components of the holster, the belt-clip portion 201 and
the device-clasping portion 203, are typically joined by a
spring-biased connector (not shown) which causes the belt-clip to
press toward the device-clasping portion 203, in order to grip a
belt or an article of clothing worn by a user, and thus to secure
the apparatus.
[0070] FIG. 2B illustrates the belt-clasping portion with a glucose
measuring module integrated therewith in accordance with another
embodiment of the present invention. Referring to the Figure, there
is shown a perspective view of a belt-clip portion 201 of another
embodiment of the same general type of holster apparatus as seen in
FIG. 2A, into which the glucose sensing module 102 has been
integrated. As discussed above in conjunction with FIG. 2A, the
glucose-sensing module 102 is generally elongate and pen-shaped,
but has been molded into the larger contours of the belt-clip
portion 201 of the holster apparatus, and situated horizontally
across the top of the upper aspect of the belt-clip portion 201 of
the holster apparatus. Within the scope of the present invention,
other configurations for the placement of the glucose sensing
module are possible that would meet the basic desire that the
module, and more particularly the test strip port 204 within the
module be readily accessible to the user.
[0071] Moreover, other forms of the belt-clip portion of the
holster may be compatible with the various embodiments shown herein
and within the scope of the above-described and illustrated
embodiments of the present invention. The clip, for example, may be
made of bent metal or molded plastic, the clasping pressure of the
spring, as described above, in these alternative embodiments being
instead provided by the spring bias inherent in the bent metal or
molded plastic. Metal clips may also be covered with fabric and/or
padding material. Alternatively, the belt-clip portion could also
be fabricated as a loop, constructed from various materials
(fabric, synthetics, leather), into which the belt of the user is
threaded, and the loop could also make use of Velcro.RTM.-type hook
and loop connections.
[0072] FIG. 3 illustrates a cut away perspective view where the IR
transceiver ports of the glucose measuring module and the held
device, respectively, are aligned for transmission of IR data in
accordance with one embodiment of the present invention. Referring
to the Figure, the infrared (IR) modality is shown as being used to
transmit data between a client device and the server device 409
(FIG. 4). Successful transmission by the IR may be facilitated by a
physical alignment of the transmitting and receiving data ports, as
shown herein. In this exploded and partially cutaway figure, the
inner aspect of a clasping arm 104 of the clasping portion 103 of a
holster is shown. From this inside-looking-out and transparent
perspective, the outline of the client device, or glucose sensing
module 102 on the outer aspect of the clasping arm 104 is seen.
Within that outline of the glucose sensing module can also be seen
the wireless transceiver port 301 of the glucose sensing module,
which faces inward, toward the accommodated server device 411.
[0073] Exploded rightward for visibility is the server device 411,
or insulin pump in this depiction, that may be held by the holster
apparatus. On the front aspect of the housing of this device, the
LCD 409 and interface control keys 410 can be seen. The front
aspect housing of the device 411 is for purpose of illustration
rendered as partially transparent so as to make visible the
transceiver port 302 of the device, located on a side wall of the
housing, facing outward toward the clasping arm 104, and more
specifically, toward transceiver 301 of the glucose monitor 102. It
can thus be seen that when the insulin pump or portable server
device 411 is contained within the holster, the two transceiver
ports 301 (of the client device) and 302 (of the server device),
are directly aligned together, a configuration that assures
successful transmission of data by IR.
[0074] FIG. 4 illustrates an exploded view of a swivel-enabled and
detachable holster apparatus, a holding button, a device carrying
case, and a held server device in accordance with one embodiment of
the present invention. Referring to the Figure, there is shown on
the left side of the figure is a holster device, swivel-enabled and
detachable, as in FIG. 3. Moving rightward, a holding button 407 is
depicted. The holder button 407 is attached to the back of device
carrying case 408. The button 407 is seen in this embodiment to
include two basic elements (a round insertion piece and a square
backing nut), connected by a spacer bar (not shown). The round
insertion piece slips into the U-shaped slot of the button holder
box, and secures the device carrying case 408 to the holster.
[0075] The server device in the illustrated case includes an
insulin pump with an LCD display 409 and control interface keys
410. The carrying case 408 is a component of holster devices and
which allows for the secure holding of a device, the device itself
being unencumbered by specific attachment elements. A carrying case
can be combined with the herein described holster apparatus,
whether it is of the variety depicted in FIG. 1, or in FIG. 2
(swivel-enabled, detachable), as well as other variations of
holsters based on two basic mechanical elements, a belt-clip
portion and a device-clasping portion within the scope of the
present invention. In the variations containing a case, the
device-clasping portion actually secures the case, and the case, in
turn, secures the held device. The case itself generally
constructed from one or more types of fabric, such as cloth,
plastic, or leather, and is custom fitted to the contours of the
held device.
[0076] FIG. 5 is a block diagram illustrating data signal flow
between devices of a wireless system in accordance with one
embodiment of the present invention. Referring to the Figure, a
wireless system 500 for moving data among devices in the context of
a personal area network and constructed according to one embodiment
of the present invention is shown. In one embodiment, the test
strip 501 electrically communicates with client device 502, which
wirelessly communicates with server device 504, such as by two-way
radio frequency (RF) contact, infrared (IR) contact, or other known
wireless connections 503. Optionally, server device 504 may also
communicate with other devices such as data processing terminal 505
by direct electronic contact, via RF, IR, or other wireless
connections.
[0077] Test strip/sensor unit 501 is an electrochemical analyte
test strip, such as the blood glucose test strip described in U.S.
patent application Ser. No. 09/434,026 filed Nov. 4, 1999 entitled
"Small Volume In Vitro Analyte Sensor and Methods", assigned to
Abbott Diabetes Care Inc., of Alameda, Calif., the assignee of the
present invention, and the disclosure of which is incorporated
herein by reference for all purposes. The test strip 501 is
mechanically received in a test strip port 105, 204, 404 (of the
embodiments shown in FIGS. 1, 2, and 4, respectively) of a client
device 502, similar to a hand-held blood glucose meter as described
in the aforementioned patent application entitled Small Volume In
Vitro Analyte Sensor and Methods. In one embodiment, client device
502 is constructed without a user interface or display to keep the
size and cost of device 502 to a minimum. Client device 502 can be
powered by a single AA or AAA size battery, and can take a pen-like
form that is integrally molded into the larger configuration of a
holster, as shown in FIGS. 1 and 2.
[0078] Referring back to FIG. 5, the client device 502 wirelessly
communicates with server device 504, preferably using a common
standard such as 802.11 or Bluetooth RF protocol, or an IrDA
infrared protocol. The server device 504 may include another
portable device, such as a Personal Digital Assistant (PDA), a cell
phone, a pump for a medication such as insulin, and a portable
gaming unit, for example, (and as shown by some of the examples in
FIG. 8). In one embodiment, the server device 504 includes a
display, such as a liquid crystal display (LCD), as well as an
input device, such as control buttons, a keyboard, mouse or
touch-screen. With this configuration, the user can control client
device 502 via interaction with the user interface(s) of server
device 504, which in turn interacts with client device 102 across
wireless link 503.
[0079] The server device 504 may also communicate with a data
processing terminal 505, such as for sending glucose data from
devices 502 and 504, and/or receiving instructions or an insulin
pump protocol from a health care provider via the data processing
terminal 505. Examples of such communication include a PDA 504
synchronizing data with a personal computer (PC) 505, a mobile
phone 504 communicating over a cellular network with a computer 505
at the other end, or an insulin pump 504 communicating with a
computer system 505 at a physician's office.
[0080] FIG. 6 is a block diagram of a glucose meter client device
as shown in FIG. 3 in accordance with one embodiment of the present
invention. Referring to FIG. 6, internal components of the client
device 502 such as a blood glucose meter of one embodiment is
shown. User input 602 of data or instructions, via keys or control
buttons is shown as an option, but can also be eliminated to reduce
size and cost of client device 502. In this case, data or
instructional input can be provided via the server device 504 held
in the holster (see FIG. 7 and description below). The glucose
meter housing may contain any glucose sensing system of the type
well known in the art that can be configured to fit into a small
profile. Such a system can include, for example, the
electrochemical glucose strip and meter sensing system sold by
Abbott Diabetes Care Inc. of Alameda, Calif. under the
Freestyle.RTM. brand, or other strip and meter glucose measuring
systems. The housing may thus encompass the sensor electronics and
a strip connector, which connector is accessed via a test strip
port opening in the housing. The housing will typically also
include one or more batteries.
[0081] FIG. 7 is a block diagram of a server device such as an
insulin pump, as shown in FIG. 3 in accordance with one embodiment
of the present invention. Referring to FIG. 7, internal components
of server device 504 of one embodiment are shown. Note that a
redundant test strip interface 701 can be provided if desired for
receiving test strips 501. Server device 504 can be a proprietary
unit designed specifically for use with blood glucose meters, or
can be a generic, multipurpose device such as a standard PDA. An
example of a similar device designed for blood glucose testing is
disclosed in U.S. Pat. No. 6,560,471 issued May 6, 2003 to the
Abbott Diabetes Care Inc. of Alameda, Calif., the assignee of the
present invention, entitled "Analyte Monitoring Device and Methods
of Use", the disclosure of which is incorporated herein by
reference for all purposes. Note also the presence of user input
703, which would occur through user manipulation of buttons or
keys. There is two-way data flow between devices 502 and 504, and
thus data or instructional input applied through the held device
504 can be seamlessly applied to controlling the operation of a
client device (a glucose meter, for a specific example).
[0082] As noted in the discussion above of the client device in
conjunction with FIG. 6, one embodiment of the present invention
include the "displayless" glucose meter unit on the display of a
separate device in order to minimize the complexity and cost of the
meter unit. The glucose meter user "reads" and interacts with the
meter via the larger display units within his or her personal area
network, all of which can be synchronized as they interact and
communicate with the wireless enabled meter. When the glucose meter
is used, the sequences through which the user must "step" to
complete the test are readily viewed on the larger display units
(for example, by entering the calibration code, prompting
application of the sample). At the same time the meter unit is
simplified, smaller and less expensive to manufacture.
[0083] Additionally, control buttons that are found on typical
glucose meters can be eliminated, saving additional size and cost,
since the user can rely on the user in out features of the server
device instead. It is expected that the simplified, wireless
enabled meters integrated into a device holster, as described
herein, may ultimately become inexpensive enough to make them
disposable after a specified number of uses, permitting the
producer to routinely upgrade as appropriate.
[0084] Further, the system permits the user to include security
coding at any time the meter unit accesses a display device, so
that the user's data are secure, such that, when the "client" meter
of one embodiment of the present invention is used, the system
requires the user to enter an identity code in order to verify that
the person handling the meter is indeed an authorized user. In an
alternate embodiment, it is possible for the system to permit more
than one user if the meter owner so desires.
[0085] While the glucose sensing module does not include a large or
expensive display, it may nevertheless be advantageous to include
some ability to advise the user of a glucose level which is
determined when the module is used as a "stand-alone" unit. For
example, the module could include a very low cost, small three
digit LCD display. Alternatively, the module could include light
emitting diode (LED) indicator lights (for example, red for out of
desired range, green for within desired range). Other possibilities
include a red LED for below range, a green LED for within range,
and a yellow LED for above range, or a column of LEDs or an
electroluminescent strip (similar to those used on common batteries
to indicate battery life) to indicate approximate or relative
glucose levels.
[0086] FIG. 8 is a pictorial view showing a client device and
server devices within a personal area network in accordance with
one embodiment of the present invention. More specifically, FIG. 8
shows examples of the devices to and from which the meter (client
device 801) of one embodiment of the present invention can
communicate. Such devices may be a part of an individual's personal
area network and each device is enabled to communicate via short
range wireless communication link with every other device. Laptop
computers 803 and handheld computers 802, as well as printers 804
can be so enabled and will provide displays and printouts valuable
as records for the diabetic. Telephones such as cellular telephones
805 and regular land-line telephones 808 will also be enabled in
this fashion and can be used for displaying glucose data as well as
further enabled to transmit the data over larger networks via GSM
protocols (as for the cellular telephones 805). Many of these
devices can assist the diabetic by responding to glucose levels by
providing alarms, or suggesting that action be taken to correct a
hypoglycemic or hyperglycemic condition, or by summoning necessary
medical assistance.
[0087] Diabetics are well aware of the risks involved in driving
when glucose levels are out of range and particularly when they are
too low. Thus, for example, the navigation computer in the
diabetic's vehicle 806 could become part of the personal area
network and would download glucose data from the meter when the
diabetic enters the vehicle 806. For the sake of safety, the car
computer system could be programmed to require that the diabetic
perform a glucose test before driving, and more specifically the
car could be disabled until the diabetic performs a blood glucose
test and the result is in an appropriate range. Other possible
devices for communication with the client device 801 may include a
television 807, a gaming device 809, and a refrigerator 810.
[0088] In this manner, in accordance with the embodiments of the
present invention, there is provided a glucose monitoring system
resulting from the functional combination of a holster-integrated
glucose measuring device and a second device accommodated within
the holster. The holster itself includes a belt-clip portion and a
device-clasping portion; the glucose monitor can be integrated into
either portion. Various embodiments provide for an ability for the
belt-clip and device-clasping portions to swivel with respect to
each other, and to detach from each other. In the embodiments where
the belt-clip portion and clasping portion do not detach, the
clasping portion provides for a quick attachment/detachment of the
held server device.
[0089] 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.
* * * * *