U.S. patent application number 12/698124 was filed with the patent office on 2010-08-05 for compact on-body physiological monitoring devices and methods thereof.
This patent application is currently assigned to Abbott Diabetes Care Inc.. Invention is credited to Martin J. Fennell, Lei He, Udo Hoss, Michael Love, Christopher Allen Thomas, Phillip Yee.
Application Number | 20100198034 12/698124 |
Document ID | / |
Family ID | 42398266 |
Filed Date | 2010-08-05 |
United States Patent
Application |
20100198034 |
Kind Code |
A1 |
Thomas; Christopher Allen ;
et al. |
August 5, 2010 |
Compact On-Body Physiological Monitoring Devices and Methods
Thereof
Abstract
Methods and devices to monitor an analyte in body fluid are
provided. Embodiments include continuous or discrete acquisition of
analyte related data from a transcutaneously positioned analyte
sensor automatically or on demand upon request from a user.
Inventors: |
Thomas; Christopher Allen;
(San Leandro, CA) ; Hoss; Udo; (Castro Valley,
CA) ; Fennell; Martin J.; (Concord, CA) ; He;
Lei; (Moraga, CA) ; Love; Michael;
(Pleasanton, CA) ; Yee; Phillip; (San Francisco,
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: |
42398266 |
Appl. No.: |
12/698124 |
Filed: |
February 1, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61149639 |
Feb 3, 2009 |
|
|
|
Current U.S.
Class: |
600/365 |
Current CPC
Class: |
A61B 2560/0487 20130101;
A61B 5/6898 20130101; A61B 2560/0475 20130101; A61M 2205/33
20130101; A61B 5/14532 20130101; A61B 5/6849 20130101; H04L 67/12
20130101; A61M 5/3286 20130101; A61M 2230/201 20130101; A61B
5/02055 20130101; A61B 5/7425 20130101; A61M 5/158 20130101; A61M
5/1723 20130101; A61B 5/7455 20130101; A61B 2560/0214 20130101;
A61B 5/0022 20130101; A61B 2562/0295 20130101; A61M 2005/1726
20130101; A61B 5/0004 20130101; A61B 5/7405 20130101; A61M 2205/502
20130101; A61B 5/742 20130101; C12Q 1/001 20130101; C12Q 1/006
20130101; A61B 5/002 20130101; A61B 5/72 20130101; A61M 2205/3584
20130101; G06K 7/10366 20130101; A61B 5/0024 20130101; A61B 5/14865
20130101; A61B 2560/0412 20130101; A61B 5/14503 20130101 |
Class at
Publication: |
600/365 |
International
Class: |
A61B 5/145 20060101
A61B005/145 |
Claims
1. An integrated analyte monitoring device assembly, comprising: an
analyte sensor for transcutaneous positioning through a skin layer
and maintained in fluid contact with an interstitial fluid under
the skin layer during a predetermined time period, the analyte
sensor having a proximal portion and a distal portion; and sensor
electronics coupled to the analyte sensor, the sensor electronics
comprising: a circuit board having a conductive layer and a sensor
antenna disposed on the conductive layer; one or more electrical
contacts provided on the circuit board and coupled with the
proximal portion of the analyte sensor to maintain continuous
electrical communication; and a data processing component provided
on the circuit board and in signal communication with the analyte
sensor, the data processing component configured to execute one or
more routines for processing signals received from the analyte
sensor, the data processing component configured to control the
transmission of data associated with the processed signals received
from the analyte sensor to a remote location using the sensor
antenna in response to a request signal received from the remote
location.
2. The assembly of claim 1 wherein the proximal portion of the
analyte sensor and the circuit board are encapsulated.
3. The assembly of claim 2 wherein the proximal portion of the
analyte sensor and the circuit board are encapsulated with a
potting material.
4. The assembly of claim 1 wherein the circuit board includes an
upper layer and a lower layer, where the conductive layer is
disposed between the upper layer and the lower layer.
5. The assembly of claim 1 wherein the antenna includes a loop
antenna or a dipole antenna.
6. The assembly of claim 1 wherein the antenna is printed on the
conductive layer.
7. The assembly of claim 1 further including a plurality of
inductive components coupled to the sensor antenna on the
conductive layer of the circuit board.
8. The assembly of claim 7 wherein the plurality of inductive
components are coupled in series to the sensor antenna.
9. The assembly of claim 7 wherein the plurality of inductive
components are positioned substantially around an outer edge of the
circuit board.
10. The assembly of claim 9 wherein the circuit board is
substantially circular, and the plurality of components are
positioned around the outer circumference of the circular circuit
board.
11. The assembly of claim 7 wherein each of the plurality of the
inductive components are positioned substantially equidistant to
each other on the circuit board.
12. The assembly of claim 1 including a power supply to provide
power to the sensor electronics.
13. The assembly of claim 1 wherein the data processing component
includes an application specific integrated circuit (ASIC) disposed
on the circuit board and configured to process signals from the
analyte sensor.
14. The assembly of claim 1 wherein the data processing component
includes a state machine.
15. The assembly of claim 14 wherein the state machine is
configured to execute one or more programmed or programmable logic
for processing the signals received from the analyte sensor.
16. The assembly of claim 1 wherein the analyte sensor includes a
glucose sensor.
17. An analyte data acquisition device, comprising: a control unit
configured to generate a control command based on a carrier signal;
an antenna section coupled to the control unit to transmit the
control command with the carrier signal and to receive a
backscatter response data packet using the carrier signal; and a
receiver section coupled to the antenna section and the control
unit to process the received backscatter response data packet and
to generate an output glucose data.
18. The device of claim 17 wherein the control unit includes a
signal resonator coupled to an oscillator, and configured to
generate RF power.
19. The device of claim 18 wherein the signal resonator includes a
surface acoustic wave resonator.
20. The device of claim 18 wherein the generated RF power and the
control command are transmitted with the carrier signal.
21. The device of claim 17 wherein the control command includes an
RF control command transmitted with the carrier signal to a remote
location.
22. The device of claim 21 wherein the backscatter response data
packet is received from the remote location when the antenna is
positioned no more than approximately ten inches from the remote
location.
23. The device of claim 22 wherein the antenna is positioned about
five inches or less from the remote location.
24. The device of claim 17 wherein the antenna section includes one
or more of a loop antenna, or a dipole antenna.
25. The device of claim 17 wherein the control unit is configured
to generate the carrier signal.
26. The device of claim 17 wherein the receiver section includes a
filter to filter the received backscatter response data packet.
27. The device of claim 17 including an output unit operatively
coupled to the control unit to output an indication corresponding
to the generated glucose data.
28. The device of claim 27 wherein the outputted indication
includes one or more of a visual output, an audible output, a
vibratory output, or one or more combinations thereof.
29. The device of claim 17 wherein the control unit generates a
receipt confirmation signal upon successful receipt of the
backscatter response data packet.
30. The device of claim 29 wherein the generated receipt
confirmation signal is output to the user.
31. The device of claim 17 further including a storage device
coupled to the control unit to store the generated control command,
carrier signal, the received backscatter response data packet, the
generated output glucose data, or one or more combinations
thereof.
32. The device of claim 31 wherein the storage device includes a
nonvolatile memory device.
33. The device of claim 17 wherein the control unit includes a
microprocessor.
34. The device of claim 17 wherein the control unit includes an
application specific integrated circuit.
35. The device of claim 17 further including a strip port for
receiving an in vitro blood glucose test strip, the strip port
including an electrical connection in signal communication with the
control unit.
36. The device of claim 35 wherein the control unit is configured
to process a sample on the test strip to determine a corresponding
blood glucose level.
37. An integrated analyte monitoring device, comprising: a sensor
electronics assembly including: an analyte sensor; a power supply;
an activation switch operatively coupled to the power supply and
the analyte sensor; a controller unit in electrical contact with
the analyte sensor and the activation switch having one or more
programming instructions stored therein for execution, the
controller unit configured to process one or more signals received
from the analyte sensor when the activation switch is triggered;
and an insertion device including: a housing; an introducer coupled
to the housing configured to move between a first position and a
second position; and a bias mechanism operatively coupled to the
housing configured to automatically retract the introducer from the
second position to the first position.
38. The device of claim 37 wherein the sensor electronics assembly
is retained entirely within the housing of the insertion device
prior to the introducer movement from the first position to the
second position.
39. The device of claim 37 wherein the activation switch is not
triggered until the introducer has reached the second position.
40. The device of claim 37 wherein the analyte sensor includes a
glucose sensor.
41. The device of claim 37 wherein the activation switch is
triggered after the introducer has reached the second position, and
prior to the introducer refraction from the second position to the
first position.
42. The device of claim 37 wherein the introducer engages with the
analyte sensor during its movement from the first position to the
second position, and further, wherein the introducer disengages
from the analyte sensor during its movement from the second
position to the first position.
43. The device of claim 37 wherein the movement of the introducer
from the first position to the second position is in response to a
manual force applied on the housing.
44. The device of claim 37 wherein the bias mechanism includes a
spring.
45. The device of claim 37 including an adhesive layer provided on
a bottom surface of the housing for placement on a skin layer.
46. The device of claim 45 wherein the adhesive layer is configured
to retain the sensor electronics assembly on the skin layer for a
predetermined time period.
47. The device of claim 37 wherein the power supply includes a
single use disposable battery.
48. The device of claim 37 wherein the active operational life of
the power supply exceeds the active operational life of the analyte
sensor.
49. The device of claim 37 including a cap configured to mate with
an open end of the housing of the insertion device.
50. The device of claim 49 wherein when the cap is coupled to the
housing, the interior space of the housing is maintained in a
substantially contaminant free environment.
51. The device of claim 37 wherein the sensor electronics assembly
includes a printed circuit board including a portion of the analyte
sensor permanently connected thereto.
52. The device of claim 37 wherein the controller unit includes an
application specific integrated circuit (ASIC).
53. The device of claim 37 wherein the movement of the introducer
between the first position and the second position is at an angle
at approximately 90 degrees or less from a skin surface.
54. The device of claim 37 wherein the sensor electronics assembly
includes a housing having a height of less than approximately 4 mm.
Description
RELATED APPLICATIONS
[0001] The present application claims priority under 35 U.S.C.
.sctn.119(e) to U.S. provisional application No. 61/149,639 filed
Feb. 3, 2009 entitled "Compact On-Body Physiological Monitoring
Devices and Methods Thereof", the disclosure of which is
incorporated by reference for all purposes. The present application
is further related to US patent Application entitled "Analyte
Sensor and Apparatus for Insertion of the Sensor (Attorney Docket
No. 031312-06099) filed concurrently on Feb. 1, 2010, and the
disclosure of which is incorporated by reference for all
purposes.
BACKGROUND
[0002] The detection of the level of glucose or other analytes,
such as lactate, oxygen or the like, in certain individuals is
vitally important to their health. For example, the monitoring of
glucose is particularly important to individuals with diabetes.
Diabetics may need to monitor glucose levels to determine when
insulin is needed to reduce glucose levels in their bodies or when
additional glucose is needed to raise the level of glucose in their
bodies.
[0003] Devices have been developed for continuous or automatic
monitoring of analytes, such as glucose, in bodily fluid such as in
the blood stream or in interstitial fluid. Some of these analyte
measuring devices are configured so that at least a portion of the
devices are positioned below a skin surface of a user, e.g., in a
blood vessel or in the subcutaneous tissue of a user.
[0004] Ease of insertion and use, including minimal user
intervention and on-body size and height (or thickness) of such
transcutaneous or percutaneous medical devices that are worn on the
body are important in usability, wearability, and comfort during
the device usage. Moreover, for many of such medical devices that
require a battery or a similar power source to perform the device
specific operations, power management as well as shelf life is
important.
SUMMARY
[0005] Embodiments of the subject disclosure include devices and
methods and kits for providing sensor electronics assembly
including an analyte sensor for monitoring of analyte levels such
as glucose levels over a sensing time period. Sensing time period
may be determined by the analyte sensor life, for example,
including, but not limited to about three days or more, about five
days or more, or about seven days or more, or about fourteen days
or more.
[0006] Embodiments include methods, devices and systems for
monitoring glucose levels and obtaining glucose measurements that
are discreet, automated, minimally invasive and with reduced pain
and repetition of glucose testing procedures to obtain multiple
discrete measurements over the sensing time period. Also provided
are kits.
[0007] Embodiments further include a control unit, a control
command generator coupled to the control unit to receive a control
signal and to generate a control command based on a carrier signal,
an antenna section coupled to the control command generator to
transmit the control command with the carrier signal and to receive
a backscatter response data packet using the carrier signal, and a
receiver section coupled to the antenna section to process the
received backscatter response data packet and to generate an output
glucose data.
[0008] Embodiments also include real time discrete glucose
measurement data acquisition on-demand, as desired by the user or
upon request, based on, for example, RFID data communication
techniques for data transmission and acquisition from the analyte
sensor/electronics assembly or the on-body patch device including
the analyte sensor and the data processing and communication
components provided in a compact, low profile housing and placed on
the skin surface of the user. The analyte sensor in certain
embodiments includes a portion that is transcutaneously positioned
and maintained in fluid contact with an interstitial fluid under
the skin surface continuously during the sensing time period as
discussed above, for example.
[0009] These and other features, objects and advantages of the
present disclosure will become apparent to those persons skilled in
the art upon reading the details of the present disclosure as more
fully described below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 shows a data monitoring and management system such
as, for example, an analyte (e.g., glucose) monitoring system in
accordance with certain embodiments of the present disclosure;
[0011] FIG. 2 illustrates a data monitoring and management system
for real time glucose measurement data acquisition and processing
in one aspect of the present disclosure;
[0012] FIG. 3 is a block diagram of a receiver/monitor unit such as
that shown in FIG. 1 in accordance with certain embodiments;
[0013] FIG. 4 is a block diagram of a reader device/receiver unit
such as that shown in FIG. 2 in one aspect of the present
disclosure;
[0014] FIG. 5 is an exemplary schematic of an on-body patch device
including an integrated sensor and sensor electronics assembly for
use in the monitoring systems of FIGS. 1 and 2 in one aspect of the
present disclosure;
[0015] FIG. 6 is a block diagram of the integrated sensor and
sensor electronics assembly for use in the monitoring systems of
FIGS. 1 and 2 in another aspect of the present disclosure;
[0016] FIG. 7 is a schematic of the reader device/receiver unit for
use in the monitoring systems of FIGS. 1 and 2 in accordance with
one aspect of the present disclosure;
[0017] FIGS. 8A and 8B illustrate a top view and a side view,
respectively, of antenna and electronic circuit layout of the
on-body patch device including an sensor and sensor electronics
assembly for use in the monitoring systems of FIGS. 1 and 2 in one
aspect of the present disclosure;
[0018] FIG. 9 illustrates an exemplary circuit schematic of the
on-body patch device including an sensor and sensor electronics
assembly in accordance with aspects of the present disclosure;
[0019] FIG. 10A is a perspective view of the components of the
on-body patch device including sensor and sensor electronics
assembly in accordance with one aspect of the present
disclosure;
[0020] FIG. 10B is another perspective view of the components of
the on-body patch device including sensor and sensor electronics
assembly in accordance with one aspect of the present
disclosure;
[0021] FIG. 10C is another perspective view of the assembled
on-body patch device including sensor and sensor electronics
assembly in accordance with one aspect of the present
disclosure;
[0022] FIGS. 11A-11C illustrate circuit layouts for the sensor
electronics assembly in the on-body patch device including sensor
and sensor electronics assembly in accordance with embodiments of
the present disclosure;
[0023] FIGS. 12A-12B illustrate pre-deployment and post insertion
configurations of the insertion device for positioning the on-body
patch device including sensor and sensor electronics assembly in
accordance with embodiments of the present disclosure;
[0024] FIGS. 12C-12G illustrate cross sectional perspective views
of the operation of the insertion device for deploying the on-body
patch device including sensor and sensor electronics assembly in
accordance with embodiments of the present disclosure;
[0025] FIGS. 13A-13B illustrate embodiments of a power supply
switch mechanism including conductive plugs of the on-body patch
device including sensor and sensor electronics assembly in
accordance with embodiments of the present disclosure;
[0026] FIGS. 13C-13E illustrate another configuration of the power
supply switch mechanism including conductive pads of the on-body
patch device including sensor and sensor electronics assembly in
accordance with embodiments of the present disclosure;
[0027] FIG. 14 illustrates a power supply switch mechanism
including an internal switch with a push rod activation of the
on-body patch device including sensor and sensor electronics
assembly in accordance with embodiments of the present
disclosure;
[0028] FIG. 15 illustrates a power supply switch mechanism
including introducer retraction trigger activation of the on-body
patch device including sensor and sensor electronics assembly in
accordance with embodiments of the present disclosure;
[0029] FIG. 16 illustrates a power supply switch mechanism with a
contact switch of the on-body patch device including sensor and
sensor electronics assembly in accordance with embodiments of the
present disclosure;
[0030] FIGS. 17A-17B illustrate a power supply switch mechanism
with a battery contact locking mechanism of the on-body patch
device including sensor and sensor electronics assembly in
accordance with embodiments of the present disclosure; and
[0031] FIGS. 18A-18B illustrate a power supply switch mechanism
with a bi-modal dome switch of the on-body patch device including
sensor and sensor electronics assembly in accordance with
embodiments of the present disclosure.
INCORPORATION BY REFERENCE
[0032] The following patents, applications and/or publications are
incorporated herein by reference for all purposes: U.S. Pat. Nos.
4,545,382; 4,711,245; 5,262,035; 5,262,305; 5,264,104; 5,320,715;
5,509,410; 5,543,326; 5,593,852; 5,601,435; 5,628,890; 5,820,551;
5,822,715; 5,899,855; 5,918,603; 6,071,391; 6,103,033; 6,120,676;
6,121,009; 6,134,461; 6,143,164; 6,144,837; 6,161,095; 6,175,752;
6,270,455; 6,284,478; 6,299,757; 6,338,790; 6,377,894; 6,461,496;
6,503,381; 6,514,460; 6,514,718; 6,540,891; 6,560,471; 6,579,690;
6,591,125; 6,592,745; 6,600,997; 6,605,200; 6,605,201; 6,616,819;
6,618,934; 6,650,471; 6,654,625; 6,676,816; 6,730,200; 6,736,957;
6,746,582; 6,749,740; 6,764,581; 6,773,671; 6,881,551; 6,893,545;
6,932,892; 6,932,894; 6,942,518; 7,167,818; and 7,299,082; U.S.
Published Application Nos. 2004/0186365; 2005/0182306;
2007/0056858; 2007/0068807; 2007/0227911; 2007/0233013;
2008/0081977; 2008/0161666; and 2009/0054748; U.S. patent
application Ser. Nos. 12/131,012; 12/242,823; and 12/363,712; and
U.S. Provisional Application Ser. Nos. 61/149,639; 61/155,889;
61/155,891; 61/155,893; 61/165,499; 61/230,686; 61/227,967 and
61/238,461.
DETAILED DESCRIPTION
[0033] Within the scope of the present disclosure, there are
provided devices, systems, kits and methods for providing compact,
low profile, on-body physiological parameter monitoring device
(physiological parameters such as for example, but not limited to
analyte levels, temperature levels, heart rate, etc), configured
for single or multiple use over a predetermined time period, which
provide a low profile geometry, effective power management,
improved shelf life, and ease and comfort of use including device
positioning, and activation. Embodiments include an on-body
assembly including a transcutaneously positioned analyte sensor and
sensor electronics in a compact, low profile integrated assembly
and coupled to an insertion device for deployment.
[0034] Embodiments include continuous glucose monitoring (CGM)
system or routines or functions for execution operations to
continuously or semi-continuously monitor an analyte level such as
glucose level with the transcutaneously positioned analyte sensor,
where the real time analyte measurements are provided to a data
receiver unit, a reader device, a data repeater or relay device
such as data processing module, a data processing terminal or a
remote terminal for data processing automatically upon data
sampling at predetermined time intervals or based on programmed or
programmable data transmission schedule. Data processing may
include display, storage, execution of related alarm or
notification functions, and analysis such as generating charts or
graphs based on, for example, the monitored analyte levels received
from the sensor/sensor electronics assembly.
[0035] Embodiments further include analyte data acquisition in real
time where the analyte level detected by the transcutaneously
positioned analyte sensor is stored either permanently or
temporarily in a memory or storage unit of a data processing unit
or an integrated sensor and data processing unit assembly, such as
an on-body patch device (stored for example, for about one day or
less, or for about 10 hours or less, or for about 5 hours or less,
or for about 3 hours or less, or for about one hour or less). In
such embodiments, the receiver unit or the reader device may be
used to acquire the detected analyte level in real time, and/or
on-demand or upon request using, for example, RFID communication
protocol or other suitable data communication protocols. Sampled
analyte related data in certain embodiments are received by the
receiver unit or the reader device upon activation or initiation by
the user or the patient, for example, of a switch or other
initiation mechanism to initiate the data transfer or provide data
request command. Such activation switch or mechanism may be
provided or included in the user interface of the reader device or
the receiver unit.
[0036] Embodiments of the present disclosure relate to methods and
devices for detecting at least one analyte such as glucose in body
fluid. Embodiments include glucose measurements by an on-body patch
device that includes a transcutaneously positioned analyte sensor
in fluid contact with the body fluid such as interstitial fluid,
and sensor electronics in signal communication with the analyte
sensor, where the on-body patch device is configured to transmit
one or more signals or data packets associated with a monitored
analyte level upon detection of a reader device or the receiver
unit of the analyte monitoring system within a predetermined
proximity for a period of time (for example, about 10 seconds or
less, or preferably about 5 seconds or less, or preferably about 2
seconds or less, or until a confirmation, such as an audible
notification, is output on the reader device/receiver unit
indicating successful acquisition of the analyte related signal
from the on-body patch device).
[0037] For example, in one aspect, when a reader device/receiver
unit is positioned within approximately 5 inches or less (or about
10 inches or less, for example) to the on-body patch device that is
adhesively placed or mounted on the skin surface of a patient (with
the analyte sensor transcutaneously positioned in fluid contact
under the skin surface and in signal communication with the sensor
electronics of the on-body patch device), a radio frequency source
within the reader device/receiver unit may be configured to provide
RF power to the on-body patch device. In response, the on-body
patch device in one embodiment may be configured to generate an
output signal (e.g., an RF signal) and transmit it to the reader
device/receiver unit which includes, among others data indicating
the glucose measurement. In one aspect the signal communication
and/or RF power transmission may initiate automatically upon
detection of the reader device/receiver unit within a predetermined
proximity to the on-demand patch device, or alternatively the
reader device/receiver unit may require a user activation or
confirmation prior to initiating signal communication and/or RF
power transmission with the on-body patch device as discussed
above.
[0038] In a further aspect, the transmitted data from the on-body
patch device to the reader device/receiver unit may include glucose
trend information that was stored in the on-body patch device for a
predetermined time period, since the initialization of the sensor
and positioning it in fluid contact with the interstitial fluid, or
since the last transmission of data to the reader device, or any
one or more combinations of the above. For example, the trend
information may indicate the variation in the monitored glucose
level over the particular time period based on signals received
from the analyte sensor and stored in the on-body patch device.
[0039] As described in further detail below, the on-body patch
device may optionally include an output component such as a
speaker, a light indicator (for example, an LED indicator), or the
like to provide one or more indications associated with its
functions such as a successful transmission of data to the reader
device or the receiver unit, alarm or alert conditions associated
with its internal components, or a detection of the RF power
received from the reader device or the receiver unit, for example.
By way of a non-limiting example, one or more exemplary output
indication may include an audible sound (including for example, a
short tone, a changing tone, multi-tone, one or more programmed
ringtones or one or more combinations thereof), a visual indication
such as a blinking light of the LED indicator, a solid light on the
LED indicator maintained at a predetermined or programmed or
programmable time period (for example, 5 seconds), each of which
may be pre-programmed in the on-body patch device, or alternatively
programmable by the user through the user interface of the reader
device/receiver unit when in communication with the on-body patch
device.
[0040] In a further aspect, when an alarm or alert condition is
detected (for example, a detected glucose level monitored by the
analyte sensor that is outside a predetermined acceptable range
indicating a physiological condition which requires attention or
intervention for medical treatment or analysis (for example, a
hypoglycemic condition, a hyperglycemic condition, an impending
hyperglycemic condition or an impending hypoglycemic condition)),
the one or more output indications may be generated in the on-body
patch device and presented to the patient or the user so that
corrective action may be timely taken. Alternatively, the output
indications may be additionally or alternatively presented or
output on the reader device/receiver unit when, for example, the
reader device/receiver unit is within range of the on-body patch
device
[0041] In certain aspects, future or anticipated analyte levels may
be predicted based on information obtained, e.g., the current
analyte level, the rate of change of the analyte level and analyte
trend information. Predictive alarms may be programmed or
programmable in the reader device/receiver unit, or the on-body
patch device, or both, and may be configured to notify the user of
a predicted analyte levels that may be of concern in advance of the
user's analyte level reaching the future level. This provides the
user an opportunity to take corrective action.
[0042] Before the present disclosure is described in additional
detail, it is to be understood that this disclosure is not limited
to particular embodiments described, as such may, of course, vary.
It is also to be understood that the terminology used herein is for
the purpose of describing particular embodiments only, and is not
intended to be limiting, since the scope of the present disclosure
will be limited only by the appended claims.
[0043] Where a range of values is provided, it is understood that
each intervening value, to the tenth of the unit of the lower limit
unless the context clearly dictates otherwise, between the upper
and lower limit of that range and any other stated or intervening
value in that stated range, is encompassed within the disclosure.
The upper and lower limits of these smaller ranges may
independently be included in the smaller ranges is also encompassed
within the disclosure, subject to any specifically excluded limit
in the stated range. Where the stated range includes one or both of
the limits, ranges excluding either or both of those included
limits are also included in the disclosure.
[0044] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this disclosure belongs.
Although any methods and materials similar or equivalent to those
described herein can also be used in the practice or testing of the
present disclosure, the preferred methods and materials are now
described. All publications mentioned herein are incorporated
herein by reference to disclose and describe the methods and/or
materials in connection with which the publications are cited.
[0045] It must be noted that as used herein and in the appended
claims, the singular forms "a", "an", and "the" include plural
referents unless the context clearly dictates otherwise.
[0046] The publications discussed herein are provided solely for
their disclosure prior to the filing date of the present
application. Nothing herein is to be construed as an admission that
the present disclosure is not entitled to antedate such publication
by virtue of prior disclosure. Further, the dates of publication
provided may be different from the actual publication dates which
may need to be independently confirmed.
[0047] As will be apparent to those of skill in the art upon
reading this disclosure, each of the individual embodiments
described and illustrated herein has discrete components and
features which may be readily separated from or combined with the
features of any of the other several embodiments without departing
from the scope or spirit of the present disclosure.
[0048] The figures shown herein are not necessarily drawn to scale,
with some components and features being exaggerated for
clarity.
[0049] Generally, embodiments of the present disclosure relate to
methods and devices for detecting at least one analyte such as
glucose in body fluid. In certain embodiments, the present
disclosure relates to the continuous and/or automatic in vivo
monitoring of the level of an analyte using an analyte sensor.
[0050] Accordingly, embodiments include analyte monitoring devices
and systems that include an analyte sensor--at least a portion of
which is positionable beneath the skin of the user--for the in vivo
detection, of an analyte, such as glucose, lactate, and the like,
in a body fluid. Embodiments include wholly implantable analyte
sensors and analyte sensors in which only a portion of the sensor
is positioned under the skin and a portion of the sensor resides
above the skin, e.g., for contact to a transmitter, receiver,
transceiver, processor, etc. The sensor may be, for example,
subcutaneously positionable in a patient for the continuous or
periodic monitoring of a level of an analyte in a patient's
interstitial fluid.
[0051] For the purposes of this description, continuous monitoring
and periodic monitoring will be used interchangeably, unless noted
otherwise. Discrete monitoring as used herein includes the
acquisition or reception of monitored analyte data where real time
monitored analyte level information is received or acquired on
demand or in response to a request to the on-body patch device
including sensor and sensor electronics. That is, embodiments
include analyte sensors and sensor electronics which sample and
process analyte related information based on a programmed or
programmable schedule such as every minute, every five minutes and
so on. Such analyte monitoring routines may be reported or
transmitted in real time to the receiver unit/reader device at the
time of data sampling and processing. Alternatively, as discussed,
the continuously sampled analyte data and processed analyte related
signals may be stored and transmitted to a remote location such as
the receiver unit, data processing module, the data processing
terminal, the reader device or the remote terminal in response to a
request for such information from the remote location. The analyte
level may be correlated and/or converted to analyte levels in blood
or other fluids. In certain embodiments, an analyte sensor may be
positioned in contact with interstitial fluid to detect the level
of glucose, which detected glucose may be used to infer the glucose
level in the patient's bloodstream. Analyte sensors may be
insertable into a vein, artery, or other portion of the body
containing fluid. Embodiments of the analyte sensors of the subject
disclosure may be configured for monitoring the level of the
analyte over a time period which may range from minutes, hours,
days, weeks, or longer.
[0052] Of interest are analyte sensors, such as glucose sensors,
that are capable of in vivo detection of an analyte for about one
hour or more, e.g., about a few hours or more, e.g., about a few
days of more, e.g., about three or more days, e.g., about five days
or more, e.g., about seven days or more, e.g., about several weeks
or at least one month. Future analyte levels may be predicted based
on information obtained, e.g., the current analyte level at time
t.sub.0, the rate of change of the analyte, etc. Predictive alarms
may notify the user of predicted analyte levels that may be of
concern prior in advance of the analyte level reaching the future
level. This enables the user an opportunity to take corrective
action. Embodiments include transmission of the acquired real time
analyte information on-demand from the user (using for example, the
reader device/receiver unit positioned in close proximity to the
low profile on-body patch device), storage of the acquired real
time analyte information, and subsequent transmission based on
retrieval from the storage device (such as a memory device).
[0053] FIG. 1 shows a data monitoring and management system such
as, for example, an analyte (e.g., glucose) monitoring system in
accordance with certain embodiments of the present disclosure.
Embodiments of the subject disclosure are described primarily with
respect to glucose monitoring devices and systems, and methods of
glucose detection, for convenience only and such description is in
no way intended to limit the scope of the disclosure. It is to be
understood that the analyte monitoring system may be configured to
monitor a variety of analytes at the same time or at different
times.
[0054] Analytes that may be monitored include, but are not limited
to, 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. In those
embodiments that monitor more than one analyte, the analytes may be
monitored at the same or different times.
[0055] Referring to FIG. 1, the analyte monitoring system 100
includes a sensor 101, a data processing unit (e.g., sensor
electronics) 102 connectable to the sensor 101, and a primary
receiver unit 104 which is configured to communicate with the data
processing unit 102 via a communication link 103. In aspects of the
present disclosure, the sensor 101 and the data processing unit
(sensor electronics) 102 may be configured as a single integrated
assembly 110. In certain embodiments, the integrated sensor and
sensor electronics assembly 110 may be configured as an on-body
patch device. In such embodiments, the on-body patch device may be
configured for, for example, RFID or RF communication with a reader
device/receiver unit.
[0056] In certain embodiments, the primary receiver unit 104 may be
further configured to transmit data to a data processing terminal
105 to evaluate or otherwise process or format data received by the
primary receiver unit 104. The data processing terminal 105 may be
configured to receive data directly from the data processing unit
102 via a communication link which may optionally be configured for
bi-directional communication. Further, the data processing unit 102
may include a transmitter or a transceiver to transmit and/or
receive data to and/or from the primary receiver unit 104, the data
processing terminal 105 or optionally the secondary receiver unit
106.
[0057] Also shown in FIG. 1 is an optional secondary receiver unit
106 which is operatively coupled to the communication link and
configured to receive data transmitted from the data processing
unit 102. The secondary receiver unit 106 may be configured to
communicate with the primary receiver unit 104, as well as the data
processing terminal 105. 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 certain embodiments the
secondary receiver unit 106 may be a de-featured receiver as
compared to the primary receiver unit 104, i.e., the secondary
receiver unit 106 may include a limited or minimal number of
functions and features as compared with the primary receiver unit
104. As such, the secondary receiver unit 106 may include a smaller
(in one or more, including all, dimensions), compact housing or
embodied in a device such as a wrist watch, arm band, etc., for
example. Alternatively, the secondary receiver unit 106 may be
configured with the same or substantially similar functions and
features as the primary receiver unit 104. The secondary receiver
unit 106 may include a docking portion to be mated with a docking
cradle unit for placement by, e.g., the bedside for night time
monitoring, and/or bi-directional communication device.
[0058] Only one sensor 101, data processing unit 102 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 more than one sensor 101 and/or
more than one data processing unit 102, and/or more than one data
processing terminal 105. Multiple sensors may be positioned in a
patient for analyte monitoring at the same or different times. In
certain embodiments, analyte information obtained by a first
positioned sensor may be employed as a comparison to analyte
information obtained by a second sensor. This may be useful to
confirm or validate analyte information obtained from one or both
of the sensors. Such redundancy may be useful if analyte
information is contemplated in critical therapy-related decisions.
In certain embodiments, a first sensor may be used to calibrate a
second sensor.
[0059] 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 component may be
configured to be uniquely identified by one or more of the other
components in the system so that communication conflict may be
readily resolved between the various components within the analyte
monitoring system 100. For example, unique IDs, communication
channels, and the like, may be used.
[0060] In certain embodiments, 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 at least
periodically sample the analyte level of the user and convert the
sampled analyte level into a corresponding signal for transmission
by the data processing unit 102.
[0061] The data processing unit 102 is coupleable to the sensor 101
so that both devices are positioned in or on the user's body, with
at least a portion of the analyte sensor 101 positioned
transcutaneously. The data processing unit 102 in certain
embodiments may include a portion of the sensor 101 (proximal
section of the sensor in electrical communication with the data
processing unit 102) which is encapsulated within or on the printed
circuit board of the data processing unit 102 with, for example,
potting material or other protective material. The data processing
unit 102 performs data processing functions, where such functions
may include but are not limited to, filtering and encoding of 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. In one embodiment, the sensor 101 or the
data processing unit 102 or a combined sensor/data processing unit
may be wholly implantable under the skin layer of the user.
[0062] In one aspect, the primary receiver unit 104 may include an
analog interface section including an RF receiver and an antenna
that is configured to communicate with the data processing unit 102
via the communication link 103, and a data processing section for
processing the received data from the data processing unit 102 such
as data decoding, error detection and correction, data clock
generation, and/or data bit recovery.
[0063] In operation, the primary receiver unit 104 in certain
embodiments is configured to synchronize with the data processing
unit 102 to uniquely identify the data processing unit 102, based
on, for example, an identification information of the data
processing unit 102, and thereafter, to periodically receive
signals transmitted from the data processing unit 102 associated
with the monitored analyte levels detected by the sensor 101. That
is, when operating in the CGM mode, the receiver unit 104 in
certain embodiments is configured to automatically receive time
spaced analyte related data packets from the analyte sensor/sensor
electronics when the communication link (e.g., RF range) is
maintained between these components.
[0064] Referring again to FIG. 1, the data processing terminal 105
may include a personal computer, a portable data processing devices
or computers such as a laptop computer or a handheld device (e.g.,
personal digital assistants (PDAs), communication devices such as a
cellular phone (e.g., a multimedia and Internet-enabled mobile
phone such as an iPhone, a Blackberry device, a Palm device such as
Palm Pre, Treo, or similar phone), mp3 player, pager, and the
like), drug delivery device, 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, updating, and/or analyzing data corresponding to the
detected analyte level of the user.
[0065] 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 primary receiver unit 104 for
receiving, among others, the measured analyte level. Alternatively,
the primary receiver unit 104 may be configured to integrate an
infusion device therein so that the primary receiver unit 104 is
configured to administer insulin (or other appropriate drug)
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 data processing unit 102. An infusion device may
be an external device or an internal device (wholly implantable in
a user).
[0066] In particular embodiments, the data processing terminal 105,
which may include an insulin pump, may be configured to receive the
analyte signals from the data processing unit 102, and thus,
incorporate the functions of the primary receiver unit 104
including data processing for managing the patient's insulin
therapy and analyte monitoring. In certain embodiments, the
communication link 103 as well as one or more of the other
communication interfaces shown in FIG. 1 may use 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.
[0067] As described in aspects of the present disclosure, the
analyte monitoring system may include an on-body patch device with
a thin profile that can be worn on the arm or other locations on
the body (and under clothing worn by the user or the patient), the
on-body patch device including an analyte sensor and circuitry and
components for operating the sensor and processing and storing
signals received from the sensor as well as for communication with
the reader device. For example, one aspect of the on-body patch
device may include electronics to sample the voltage signal
received from the analyte sensor in fluid contact with the body
fluid, and to process the sampled voltage signals into the
corresponding glucose values and/or store the sampled voltage
signal as raw data.
[0068] In certain embodiments, the on-body patch device includes an
antenna such as a loop antenna to receive RF power from the an
external device such as the reader device/receiver unit described
above, electronics to convert the RF power received via the antenna
into DC (direct current) power for the on-body patch device
circuitry, communication module or electronics to detect commands
received from the reader device, and communication component to
transmit data to the reader device, a low capacity battery for
providing power to sensor sampling circuitry (for example, the
analog front end circuitry of the on-body patch device in signal
communication with the analyte sensor), one or more non-volatile
memory or storage device to store data including raw signals from
the sensor or processed data based on the raw sensor signals. More
specifically, in the on operation demand mode, the on body patch
device in certain embodiments is configured to transmit real time
analyte related data and/or stored historical analyte related data
when within the RF power range of the reader device. As such, when
the reader device is removed of positioned out of range relative to
the on body patch device, the on body patch device may no longer
transmit the analyte related data.
[0069] In certain embodiments, a data processing module/terminal
may be provided in the analyte monitoring system that is configured
to operate as a data logger, interacting or communicating with the
on-body patch device by, for example, transmitting requests for
analyte level information to the on-body patch device, and storing
the responsive analyte level information received from the on-body
patch device in one or more memory components of the data
processing module. Further, data processing module may be
configured as a compact on-body relay device to relay or retransmit
the received analyte level information from the on-body patch
device to the reader device/receiver unit or the remote terminal or
both. The data processing module in one aspect may be physically
coupled to the on-body patch device, for example, on a single
adhesive patch on the skin surface of the patient. Alternatively,
the data processing module may be positioned close to but not in
contact with the on-body patch device. For example, when the
on-body patch device is positioned on the abdomen of the patient,
the data processing module may be worn on a belt of the patient or
the user, such that the desired close proximity or predetermined
distance of approximately 1-5 inches (or about 1-10 inches, for
example, or more) between the on-body patch device and the data
processing module may be maintained.
[0070] The various processes described above including the
processes operating in the software application execution
environment in the analyte monitoring system including the on-body
patch device, the reader device, data processing module and/or the
remote terminal performing one or more routines described above may
be embodied as computer programs developed using an object oriented
language that allows the modeling of complex systems with modular
objects to create abstractions that are representative of real
world, physical objects and their interrelationships. The software
required to carry out the inventive process, which may be stored in
a memory or storage device of the storage unit of the various
components of the analyte monitoring system described above in
conjunction to the Figures including the on-body patch device, the
reader device, the data processing module, various described
communication devices, or the remote terminal may be developed by a
person of ordinary skill in the art and may include one or more
computer program products.
[0071] In one embodiment, an apparatus for bi-directional
communication with an analyte monitoring system may comprise a
storage device having stored therein one or more routines, a
processing unit operatively coupled to the storage device and
configured to retrieve the stored one or more routines for
execution, a data transmission component operatively coupled to the
processing unit and configured to transmit data based at least in
part on the one or more routines executed by the processing unit,
and a data reception component operatively coupled to the
processing unit and configured to receive analyte related data from
a remote location and to store the received analyte related data in
the storage device for retransmission, wherein the data
transmission component is programmed to transmit a query to a
remote location, and further wherein the data reception component
receives the analyte related data from the remote location in
response to the transmitted query when one or more electronics in
the remote location transitions from an inactive state to an active
state upon detection of the query from the data transmission
component.
[0072] FIG. 2 illustrates a data monitoring and management system
for real time glucose measurement data acquisition and processing
in one aspect of the present disclosure. More specifically, as
shown in FIG. 2, the on-body patch device 211 including sensor
electronics coupled to an analyte sensor 250 is positioned on a
skin surface 210 of a patient or a user. In one aspect, an
introducer mechanism may be provided, as discussed in further
detail below in conjunction with FIGS. 12A-12G, for the
transcutaneous placement of the analyte sensor 250 such that when
the on-body patch device 211 is positioned on the skin surface, a
portion of the sensor 250 is inserted through the skin surface and
in fluid contact with a body fluid of the patient or the user under
the skin layer 210.
[0073] The introducer mechanism may be fully or partially
automated, for example with a trigger mechanism, or may be fully or
partially manual such that the sensor 250 is positioned
transcutaneously by a manual operation of the user. That is, in one
aspect, the on-body patch device 211 may include an introducer
needle and/or lumen (and/or catheter) which may guide the sensor
250 during the insertion process through the skin layer 210. In a
further aspect, the placement of the on-body patch device 211 on
the skin layer 210 includes the initial piercing of the skin layer
210 with a force applied on the on-body patch device 211 in
conjunction with the on-body patch device 211 placement on the skin
layer 210, effectively driving the sensor 250 (and/or the
introducer) through the skin layer 210. Within the scope of the
present disclosure, a mechanism (such as a spring, for example) may
be provided within the on-body patch device 211 or alternatively,
in the introducer in cooperation with the on-body patch device 211,
to withdraw the introducer needle after the sensor 250 has been
positioned in fluid contact with the body fluid. In certain other
embodiments, a lumen may be provided, with the analyte sensor 250
provided within the hollow cavity of the lumen for insertion, and
maintained in position with the on-body patch device 211 during the
time period that the on-body patch device 211 is worn on the skin
layer 210.
[0074] Referring back to FIG. 2, as shown, when the reader
device/receiver unit 220 is positioned or placed in close proximity
and within a predetermined range of the on-body patch device 211,
the RF power supply in the reader device/receiver unit 220 may be
configured to provide the necessary power to operate the
electronics in the on-body patch device 211, and the on-body patch
device 211 may be configured to, upon detection or the RF power
from the reader device/receiver unit 220, perform preprogrammed
routines including, for example, transmitting one or more signals
240 to the reader device/receiver unit 220 indicative of the
sampled analyte level measured by the analyte sensor 250.
[0075] In certain embodiments, the reader device/receiver unit 220
may include an RF power switch that is user activatable or
activated upon positioning within a predetermined distance from the
on body patch device 211 to turn on the analyte sensor in the on
body patch device 211. That is, using the RF signal, the analyte
sensor coupled to the sensor electronics in the on-body patch
device 211 may be initialized or activated. In another embodiment,
a passive RFID function may be provided or programmed such that
upon receiving a "turn on" signal which, when authenticated, will
turn on the electronic power switch that activates the on-body
patch device 211. That is, the passive RFID configuration may
include drawing energy from the RF field radiated from the reader
device/receiver unit 220 so as to prompt for and/or detect the
"turn on" signal which, upon authentication, activates the on body
patch device 211.
[0076] In one embodiment, communication and/or RF power transfer
between the reader device/receiver unit 220 and the on-body patch
device 211 may be automatically initiated when the reader
device/receiver unit 220 is placed in close proximity to the
on-body patch device 211 as discussed above. Alternatively, the
reader device/receiver unit 220 may be configured such that user
activation, such as data request initiation and subsequent
confirmation by the user using, for example, the display 222 and/or
input components 221 of the reader device/receiver unit 220, may be
required prior to the initiation of communication and/or RF power
transfer between the reader device/receiver unit 220 and the
on-body patch device 211. In a further embodiment, the reader
device/receiver unit 220 may be user configurable between multiple
modes, such that the user may choose whether the communication
between the reader device/receiver unit 220 and on-body patch
device 211 is performed automatically or requires a user activation
and/or confirmation.
[0077] As further shown in FIG. 2, the reader device/receiver unit
220 may include display 222 or output component to provide output
indication to the user or the patient, including, for example, the
corresponding glucose level measurement. The display 222 of the
reader device/receiver unit 220 may be additionally configured to
provide the functionalities of a user interface to present other
information such as alarm or alert notification to the user. In one
aspect, the reader device/receiver unit 220 may include other
output components such as a speaker, vibratory output component and
the like to provide audible and/or vibratory output indication to
the user in addition to the visual output indication provided on
the display 222. Moreover, the reader device/receiver unit 220 may
also include one or more input components 221 (such as, for
example, push buttons, switches, capacitive sliders, jog wheels,
etc.) for receiving input commands or information from the user or
the patient by operation of the input components 221. In one
embodiment, the display 222 and the input component 221 may be
integrated into a single component, for example as a touch screen
display. In such an embodiment, the user may be able to manipulate
the reader device/receiver unit 220 by utilizing a set of
pre-programmed motion commands, including, but not limited to,
single or double tapping the display, dragging a finger or
instrument across the display, motioning multiple fingers toward
one another, motioning multiple fingers away from one another, etc.
Other embodiments include the use of "soft buttons", whereby the
input components 221 correspond to dynamic menus on the display 222
to control features and operation of the reader device/receiver
unit 220. In yet another embodiment, the input component 221 may
include a microphone and the reader device/receiver unit 220 may
include software configured to analyze audio input received from
the microphone, such that functions and operation of the reader
device/receiver unit 220 may be controlled audibly by the user or
patient.
[0078] As discussed, some or all of the electronics in the on-body
patch device 211 in one embodiment may be configured to rely on the
RF power received from the reader device/receiver unit 220 to
perform analyte data processing and/or transmission of the
processed analyte information to the reader device/receiver unit
220. That is, the on-body patch device 211 may be discreetly worn
on the body of the user or the patient, and under clothing, for
example, and when desired, by positioning the reader
device/receiver unit 220 within a predetermined distance from the
on-body patch device 211, real time glucose level information may
be received by the reader device/receiver unit 220. This routine
may be repeated as desired by the patient (or on-demand, for
example) to determine glucose levels at any time during the time
period that the on-body patch device 211 is worn by the user or the
patient.
[0079] Referring still to FIG. 2, also shown are a data processing
module/terminal 260 and a remote terminal 270. In one aspect, data
processing module 260 may include a stand alone device configured
for bi-directional communication to communicate with the on-body
patch device 211, the reader device/receiver unit 220 and/or the
remote terminal 270. More specifically, data processing module 260
may include one or more microprocessors or similar data processing
components configured to execute one or more software routines for
communication, as well as data storage and retrieval to and from
one or more memory components provided in the housing of the data
processing module 260.
[0080] The data processing module 260 in one embodiment may be
configured to communicate with the on-body patch device 211 in a
similar manner as the reader device/receiver unit 220 and may
include communication components such as antenna, power supply and
memory, among others, for example, to allow provision of RF power
to the on-body patch device 211 or to request or prompt the on-body
patch device 211 to send the current analyte related data and
optionally other stored analyte related data. The data processing
module 260 may be configured to interact with the on-body patch
device 211 in a similar manner as the reader device/receiver unit
220 such that the data processing module 260 may be positioned
within a predetermined distance from the on-body patch device 211
for communication with the on-body patch device 211.
[0081] In one aspect, the on-body patch device 211 and the data
processing module 260 may be positioned on the skin surface of the
user or the patient within the predetermined distance of each other
(for example, within approximately 5 inches or less) such that the
communication between the on-body patch device 211 and the data
processing module 260 is maintained. In a further aspect, the
housing of the data processing module 260 may be configured to
couple to or cooperate with the housing of the on-body patch device
211 such that the two devices are combined or integrated as a
single assembly and positioned on the skin surface.
[0082] Referring again to FIG. 2, the data processing module 260
may be configured or programmed to prompt or ping the on-body patch
device 211 at a predetermined time interval such as once every
minute, or once every five minutes or once every 30 minutes or any
other suitable or desired programmable time interval to request
analyte related data from the on-body patch device 211 which is
received and is stored in one or more memory devices or components
of the data processing module 260. In another embodiment, the data
processing module 260 is configured to prompt or ping the on-body
patch device 211 when desired by the patient or the user on-demand,
and not based on a predetermined time interval. In yet another
embodiment, the data processing module 260 is configured to prompt
or ping the on-body patch device 211 when desired by the patient or
the user upon request only after a programmable time interval has
elapsed. For example, in certain embodiments, if the user does not
initiate communication within a programmed time period, such as,
for example 5 hours from last communication (or 10 hours from the
last communication), the data processing module 260 may by
programmed to automatically ping or prompt the on-body patch device
211 or alternatively, initiate an alarm function to notify the user
that an extended period of time has elapsed since the last
communication between the data processing module 260 and the
on-body patch device 211. In this manner, users, healthcare
providers, or the patient may program or configure the data
processing module 260 to provide certain compliance with analyte
monitoring regimen, so that frequent determination of analyte
levels is maintained or performed by the user. Similar
functionalities may be provided or programmed in the receiver unit
or the reader device in certain embodiments.
[0083] As further shown in FIG. 2, the data processing module 260
in one aspect may be configured to transmit the stored data
received from the on-body patch device 211 to the reader
device/receiver unit 220 when communication between the data
processing module 260 and the reader device/receiver unit 220 is
established. More specifically, in addition to RF antenna and RF
communication components described above, data processing module
260 may include components to communicate using one or more
wireless communication protocols such as, for example, but not
limited to, infrared (IR) protocol, Bluetooth protocol, Zigbee
protocol, and 802.11 wireless LAN protocol. Additional description
of communication protocols including those based on Bluetooth
protocol and/or Zigbee protocol can be found in U.S. Patent
Publication No. 2006/0193375 incorporated herein by reference for
all purposes. The data processing module 260 may further include
communication ports, drivers or connectors to establish wired
communication with one or more of the reader device/receiver unit
220, on-body patch device 211, or the remote terminal 270
including, for example, but not limited to USB connector and/or USB
port, Ethernet connector and/or port, FireWire connector and/or
port, or RS-232 port and/or connector.
[0084] In one aspect, the data processing module 260 may be
configured to operate as a data logger configured or programmed to
periodically request or prompt the on-body patch device 211 to
transmit the analyte related information, and to store the received
information for later retrieval or subsequent transmission to the
reader device/receiver unit 220 or to the remote terminal 270 or
both, for further processing and analysis. Further, the memory or
storage component in the data processing module 260 may be
sufficiently large to store or retain analyte level information
over an extended time period, for example, coinciding with the
usage life of the analyte sensor 250 in the on-body patch device
211. In this manner, the analyte monitoring system described above
in conjunction with FIGS. 1 and 2 may be configured to operate in a
CGM (continuous glucose monitoring) mode such that a continuous,
time spaced monitored analyte level may be received from the
on-body patch device 211 and stored in the data processing module
260. The stored data in the data processing module 260 may be
subsequently provided to or transmitted to the reader
device/receiver unit 220, the remote terminal 270 or the like for
further analysis such as identifying frequency of periods of
glycemic level excursions over the monitored time period to improve
or enhance therapy related decisions. Using this information, the
doctor, healthcare provider or the patient may adjust or recommend
modification to the diet, daily habits and routines such as
exercise, and the like.
[0085] In a further aspect, the functionalities of the data
processing module 260 may be configured or incorporated into a
memory device such as an SD card, microSD card, compact flash card,
XD card, Memory Stick card, Memory Stick Duo card, or USB memory
stick/device including software programming resident in such
devices to execute upon connection to the respective one or more of
the on-body patch device 211, the remote terminal 270 or the reader
device/receiver unit 220. In a further aspect, the functionalities
of the data processing module 260, including executable software
and programming, may be provided to a communication device such as
a mobile telephone including, for example, iPhone, iTouch,
Blackberry device, Palm based device (such as Palm Pre, Treo, Treo
Pro, Centro), personal digital assistants (PDAs) or any other
communication enabled operating system (such as Windows or Android
operating systems) based mobile telephones as a downloadable
application for execution by the downloading communication device.
To this end, the remote terminal 270 as shown in FIG. 2 may include
a personal computer, or a server terminal that is configured to
provide the executable application software to the one or more of
the communication devices described above when communication
between the remote terminal 270 and the devices are established. In
still a further aspect, the executable downloadable application may
be provided over-the-air (OTA) as an OTA download such that wired
connection to the remote terminal 270 is not necessary. In this
configuration, the executable application may be automatically
downloaded as an available download to the communication device,
and depending upon the configuration of the communication device,
installed on the device for use automatically, or based on user
confirmation or acknowledgement on the communication device to
execute the installation of the application.
[0086] Depending upon the user setting or configuration on the
communication device, the downloaded application may be programmed
or customized using the user interface of the respective
communication device (screen, keypad, and the like) to establish or
program the desired settings such as hyperglycemia alarm,
hypoglycemia alarm, sensor replacement alarm, sensor calibration
alarm, or any other alarm or alert conditions as may be desired by
the user. Moreover, the programmed notification settings on the
communication device may be output using the output components of
the respective communication devices, such as speaker, vibratory
output component, or visual output/display. As a further example,
the communication device may be provided with programming and
application software to communicate with the on-body patch device
211 such that a frequency or periodicity of data acquisition is
established. In this manner, the communication device may be
configured to conveniently receive analyte level information from
the on-body patch device 211 at predetermined time periods such as,
for example, but not limited to once every minute, once every five
minutes, or once every 10 or 15 minutes, and store the received
information, as well as to provide real time display of the
monitored or received analyte level information and other related
output display such as trend indication of the analyte level (for
example, based on the received analyte level information),
projection of future analyte levels based on the analyte trend, and
any other desired or appropriate warning indication or notification
to the user or the patient.
[0087] Information, such as trend information, for example, may be
output on one or more of the reader device/receiver unit 220, data
processing module 260, remote terminal 270, or any other connected
device with output capabilities. Trend, and other, information may
be output on a display unit of a device, for example the display
222 of the reader device/receiver unit 220. Trend information may
be displayed as, for example, a graph (such as a line graph) to
indicate to the user or patient the current, historical, and
predicted future analyte levels as measured and predicted by the
analyte monitoring system. Trend information may also be displayed
as trend arrows, indicating whether the analyte level is increasing
or decreasing as well as the acceleration or deceleration of the
increase or decrease in analyte level. This information may be
utilized by the user or patient to determine any necessary
corrective actions to ensure the analyte level remains within an
acceptable and/or clinically safe range. Other visual indicators,
including colors, flashing, fading, etc., as well as audio
indicators including a change in pitch, volume, or tone of an audio
output and/or vibratory or other tactile indicators may also be
incorporated into the display of trend data as means of notifying
the user or patient of the current level and/or direction and/or
rate of change of the level of the monitored analyte.
[0088] Additionally, when integrated with the functionalities of
the data processing module 260, the communication devices described
above may be programmed to operate in the optional CGM mode to
receive the time spaced monitored analyte level information from
the on-body patch device 211.
[0089] Referring back to the remote terminal 270 of FIG. 2, in one
aspect, software updates such as software patches, firmware updates
or driver upgrades, among others, to the reader device/receiver
unit 220, on-body patch device 211 or the data processing module
260 may be provided by the remote terminal 270 when communication
between the remote terminal 270 and the reader device/receiver unit
220 and/or the data processing module 260 is established. In still
another aspect, software upgrades, programming changes or
modification to the on-body patch device 211 may be received from
the remote terminal 270 by one or more of the reader
device/receiver unit 220 or the data processing module 260, and
thereafter, provided to the on-body patch device 211 by the reader
device/receiver unit 220 or the data processing module 260.
[0090] FIG. 3 is a block diagram of a receiver/monitor unit such as
that shown in FIG. 1 in accordance with certain embodiments. The
primary receiver unit 104 (FIG. 1) includes one or more of: 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 processing and storage section 307. 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 processing and storage unit 307.
The receiver may include user input and/or interface components or
may be free of user input and/or interface components.
[0091] In certain embodiments, the test strip interface 301
includes a glucose level testing portion to receive a blood (or
other body fluid sample) glucose test or information related
thereto. For example, the interface may include a test strip port
to receive a glucose test strip. The device may determine the
glucose level of the test strip, and optionally display (or
otherwise notice) the glucose level on the output 310 of the
primary receiver unit 104. Any suitable test strip may be employed,
e.g., test strips that only require a very small amount (e.g., one
microliter or less, e.g., about 0.5 microliter or less, e.g., about
0.1 microliter or less), of applied sample to the strip in order to
obtain accurate glucose information, e.g. FreeStyle.RTM. or
Precision.RTM. blood glucose test strips and systems from Abbott
Diabetes Care Inc. Glucose information obtained by the in vitro
glucose testing device may be used for a variety of purposes,
computations, etc. For example, the information may be used to
calibrate sensor 101, confirm results of the sensor 101 to increase
the confidence thereof (e.g., in instances in which information
obtained by sensor 101 is employed in therapy related decisions),
etc.
[0092] In one aspect, the RF receiver 302 is configured to
communicate, via the communication link 103 (FIG. 1) with the data
processing unit (sensor electronics) 102, to receive encoded data
from the data processing 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 keys of a keypad, a
touch-sensitive screen, and/or a voice-activated input command
unit, and the like. The temperature monitor section 304 may be
configured to provide temperature information of the primary
receiver unit 104 to the processing and control section 307, while
the clock 305 provides, among others, real time or clock
information to the processing and storage section 307.
[0093] Each of the various components of the primary receiver unit
104 shown in FIG. 3 is powered by the power supply 306 (or other
power supply) which, in certain embodiments, 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
may alert the user, for example, in the event of power usage which
renders the primary receiver unit 104 in sub-optimal operating
conditions. 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.
[0094] 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 (such as USB or serial cable), infrared (IR)
or RF link. The output/display 310 of the primary receiver unit 104
is configured to provide, among others, a graphical user interface
(GUI), and may include a liquid crystal display (LCD) for
displaying information. Additionally, the output/display 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, pagers,
etc. In certain embodiments, 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.
[0095] Referring back to FIG. 3, the primary receiver unit 104 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 may be configured to perform
Manchester decoding (or other protocol(s)) as well as error
detection and correction upon the encoded data received from the
data processing unit 102 via the communication link 103.
[0096] In further embodiments, the data processing unit 102 and/or
the primary receiver unit 104 and/or the secondary receiver unit
105, and/or the data processing terminal/infusion section 105 may
be configured to receive the blood glucose value wirelessly over a
communication link from, for example, a blood glucose meter. In
further embodiments, a user manipulating or using the analyte
monitoring system 100 (FIG. 1) may manually input the blood glucose
value using, for example, a user interface (for example, a
keyboard, keypad, voice commands, and the like) incorporated in the
one or more of the data processing unit 102, the primary receiver
unit 104, secondary receiver unit 105, or the data processing
terminal/infusion section 105.
[0097] Additional detailed descriptions are provided in U.S. Pat.
Nos. 5,262,035; 5,264,104; 5,262,305; 5,320,715; 5,593,852;
6,175,752; 6,650,471; 6,746,582, 6,284,478, 7,299,082, and in
application Ser. No. 10/745,878 filed Dec. 26, 2003 titled
"Continuous Glucose Monitoring System and Methods of Use", and in
application Ser. No. 11/060,365 filed Feb. 16, 2005 titled "Method
and System for Providing Data Communication in Continuous Glucose
Monitoring And Management System" each of which is incorporated
herein by reference.
[0098] FIG. 4 is a block diagram of a reader device/receiver unit
such as that shown in FIG. 2 in one aspect of the present
disclosure. Referring to FIG. 4, in one aspect the reader
device/receiver unit includes a control unit 410, such as one or
more microprocessors, operatively coupled to a display 430 and a
user interface 420. The reader device/receiver unit may also
include one or more data communication ports such as USB port (or
connector) 470 or RS-232 port 450 (or any other wired communication
ports) for data communication with other devices such as a personal
computer, a server, a mobile computing device, a mobile telephone,
a pager, or other handheld data processing devices including smart
phones such as Blackberry, iPhone and Palm based mobile devices,
with data communication and processing capabilities including data
storage and output.
[0099] Referring to FIG. 4, a power supply 440, such as one or more
batteries, is also provided and operatively coupled to the control
unit 410 and configured to provide the necessary power to the
reader device/receiver unit for operation. In addition, referring
still again to FIG. 4, the reader device/receiver unit may include
a loop antenna 481 such as a 433 MHz (or other equivalent) loop
antenna coupled to a receiver processor 480 (which may include a
433 MHz receiver chip, for example) for wireless communication with
the sensor electronics in the on-body patch device/sensor data
processing unit. Additionally, a primary inductive loop antenna 491
is provided and coupled to a squarewave driver 490 which is
operatively coupled to the control unit 410.
[0100] Referring still to FIG. 4, the reader device/receiver unit
of the analyte monitoring system may include a strip port 460
configured to receive an in vitro test strip, the strip port 460
coupled to the control unit 410, and further, where the control
unit 410 includes programming to process the sample on the in vitro
test strip which is received in the strip port 460. Furthermore,
within the scope of the present disclosure some of the components
of the reader device/receiver unit shown in FIG. 4 may be
integrated as a single component such as the user interface 420 and
the display 430 may be configured as a single touch sensitive
display which may be configured to include soft buttons of the
display itself, operable by the user or the patient for providing
input commands or information to the reader device.
[0101] In one aspect, the reader device/receiver unit of the
analyte monitoring system described herein may be configured to
include a compact form factor, similar to a USB memory device,
where the USB port 470 may be configured as a USB connector for
insertion or connection to a USB port on another device such as a
personal computing device or the like. Such compact form factor may
include some or all of the components of the reader device/receiver
unit described above.
[0102] FIG. 5 is an exemplary schematic of an on-body patch device
including an integrated sensor and sensor electronics assembly for
use in the analyte monitoring systems of FIGS. 1 and 2 in one
aspect of the present disclosure. As shown in FIG. 5, the
integrated sensor and sensor electronics assembly/on-body patch
device of the analyte monitoring system, in one aspect, may include
a loop antenna 520 for transmitting the analyte related data to the
reader device/receiver unit and further, an inductive power loop
antenna 530 for processing the RF power from the reader
device/receiver unit, and including converting the RF power to
corresponding DC power for the operation of the electronics of the
on-body patch device. In this manner, in one aspect of the present
disclosure, the on-body patch device may be configured to operate
as a passive data transmitter, adopting inductive coupling power
without a separate power supply or battery for data transmission.
Furthermore, the on-body patch device in one aspect does not
require a mechanism to turn the device in operational mode nor to
deactivate or turn off the on-body patch device. That is, the
on-body patch device may be configured to enter an active or
operational mode when it detects the RF power from the reader
device. Further shown in FIG. 5 is a plurality of super capacitors
C1, C2 coupled to the inductive power loop antenna 530 and the
controller 510. Referring still to FIG. 5, the controller 510 may
be provided on a printed circuit board assembly including the loop
antenna 520, thermistor (not shown), analyte sensor contact pads
for coupling to the electrodes of the sensor 540, one or more
storage devices such as non-volatile memory (not shown), and other
discrete components. In certain aspects, the printed circuit board
assembly may be partially or fully encapsulated with, for example,
potting material.
[0103] FIG. 6 is a block diagram of the integrated sensor and
sensor electronics assembly for use in the analyte monitoring
systems of FIGS. 1 and 2 in another aspect of the present
disclosure. Referring to FIG. 6, in certain aspects of the present
disclosure, the on-body patch device includes a control unit 610
(such as, for example but not limited to, one or more
microprocessors, and/or application specific integrated circuits
(ASICs)), operatively coupled to analog front end circuitry 670 to
process signals such as raw voltage or current signals received
from the sensor 680. Also shown in FIG. 6 is a memory 620
operatively coupled to the control unit 610 for storing data and/or
software routines for execution by the control unit 610. That is,
the control unit 610 may be configured to access the data or
routines stored in the memory 620 to update, store or replace
information in the memory 620, in addition to retrieving one or
more stored routines for execution. Also shown in FIG. 6 is a power
supply 660 which, in certain embodiments, provides power to the
electronics of the on-body patch device for operation, under the
control of the control unit 610, to process signals from the sensor
680 and to store the processed sensor data for subsequent
transmission to the reader device/receiver unit when prompted or
pinged by the reader device/receiver unit for transmission of the
stored data in addition to the real time analyte level data. As
discussed above, in certain embodiments, the on-body patch device
does not include the power supply 660 and is configured to rely
upon the RF power from the reader device.
[0104] Additionally, an optional output unit 650 is provided to the
on-body patch device as shown in FIG. 6. In certain embodiments,
the output unit 650 may include an LED indicator, for example, to
alert the user or the patient of one or more predetermined
conditions associated with the operation of the on-body patch
device and/or the determined analyte level. For example, in one
aspect, the on-body patch device may be programmed or configured to
provide a visual indication to notify the user of one or more
predetermined operational conditions of the on-body patch device.
The one or more predetermined operational conditions may be
configured by the user or the patient or the healthcare provider,
so that certain conditions are associated with an output indication
on the on-body patch device. By way of nonlimiting example, the
on-body patch device may be programmed to assert a notification
using the LED indicator on the on-body patch device when signals
from the sensor 680 are indicated to be beyond a programmed
acceptable range (based on one sampled sensor data point, or
multiple sensor data points), potentially indicating a health risk
condition such as hyperglycemia or hypoglycemia, or the onset of
such conditions. With such prompt or indication, the user or the
patient may be timely informed of such potential condition, and
using the reader device, acquire the glucose level information from
the on-body patch device to confirm the presence of such conditions
so that timely corrective actions may be taken.
[0105] In certain embodiments, the on-body patch device may include
a speaker or an audible output component instead of or in addition
to the LED indicator to provide an audible indication of one or
more such conditions described above. The type of audible output
may be programmed or programmable in the on-body patch device, for
example, via the reader device, and may include a standard audible
tone (monotone or multi tone), or include one or more ring tones
provided to the on-body patch device. In certain embodiments,
different conditions may be associated with a different type of
audible output/alert such that the patient or the user may easily
recognize the underlying detected condition based on the type of
audible notification. For example, different levels of audible
tones may be associated (programmed by the user or the patient, or
pre-programmed in the on-body patch device) with different
conditions such that when asserted, each outputted tone may be
easily recognized by the user or the patient as an indication of
the particular associated condition. That is, the detected onset of
hyperglycemic condition based on the signal from the analyte sensor
may be associated with a first predetermined loudness and/or tone,
while the detected onset of hypoglycemic condition based on the
signal from the analyte sensor may be associated with a second
predetermined loudness and/or tone. Alternatively, the programmed
or programmable audible alerts may include one or more sequence of
audible outputs that are output based on a temporally spaced
sequence or a sequence indicating an increase or decrease in the
level of loudness (using the same tone, or gradually
increasing/decreasing tones).
[0106] Furthermore, in aspects of the present disclosure the
audible output indication may be asserted in conjunction with the
visual output indicator, simultaneously or alternatingly, as may be
customized or programmable in the on-body patch device or
pre-programmed.
[0107] Referring again to FIG. 6, the antenna 630 and the
communication module 640 operatively coupled to the control unit
610 may be configured to detect and process the RF power when in
predetermined proximity to the reader device/receiver unit
providing the RF power, and further, in response, to transmit the
analyte level information and optionally analyte trend information
based on stored analyte level data, to the reader device. In
certain aspects, the trend information may includes a plurality of
analyte level information over a predetermined time period that are
stored in the memory 620 of the on-body patch device and provided
to the reader device/receiver unit with the real time analyte level
information. For example, the trend information may include a
series of time spaced analyte level data for the time period since
the last transmission of the analyte level information to the
reader device. Alternatively, the trend information may include
analyte level data for the prior 30 minutes or one hour that are
stored in memory 620 and retrieved under the control of the control
unit 610 for transmission to the reader device.
[0108] Referring back to the Figures, in one aspect the on-body
patch device and the reader device/receiver unit may be configured
to communicate using RFID (radio frequency identification)
techniques where the reader device/receiver unit is configured to
interrogate the on-body patch device (associated with an RFID tag)
over an RF communication link, such that the on-body patch device,
in response to the RF interrogation signal from the reader device,
transmits an RF response signal including, for example, data
associated with the sampled analyte level from the sensor.
Additional information regarding the operation of RFID
communication can be found in U.S. Patent Publication No.
2009/0108992 and U.S. Pat. No. 7,545,272, the disclosure of which
are incorporated herein by reference.
[0109] For example, in one embodiment, the reader device/receiver
unit may include a backscatter RFID reader configured to transmit
an RF field such that when the on-body patch device is within the
transmitted RF field, its antenna is tuned and in turn provides a
reflected or response signal (for example, a backscatter signal) to
the reader device. The reflected or response signal may include
sampled analyte level data from the analyte sensor.
[0110] In one aspect, the reader device/receiver unit may be
configured such that when the reader device/receiver unit is
positioned in close proximity to the on-body patch device and
receives the response signal from the on-body patch device, the
reader device/receiver unit is configured to output an indication
(audible, visual or otherwise) to confirm the analyte level
measurement acquisition. That is, during the course of the 5 to 10
days of wearing the on-body patch device on the body, the user or
the patient may at any time position the reader device/receiver
unit within a predetermined distance (for example, approximately
1-5 inches) from the on-body patch device, and after waiting a few
seconds, output an audible indication confirming the receipt of the
real time analyte level information. The received analyte
information may be output to the display 430 (FIG. 4) of the reader
device/receiver unit for presentation to the user or the
patient.
[0111] As shown above, the on-body patch device is configured to be
worn over a predetermined time period on the body of the user or
the patient. Accordingly, certain embodiments described below
include configurations of the on-body patch device to provide for a
compact configuration which is configured to remain adhered to the
skin surface for the predetermined wear time period comfortably and
without detaching from the skin surface. For example, in one
aspect, the on-body patch device may include a single integrated
housing or body assembly that includes the analyte sensor,
electronics and an adhesive path. Such configuration provides for
fewer parts that require manipulation by the patient or the user,
leading to improved ease of use, and further, with an overmolded
assembly, may be configured to provide the desired water tight seal
during the course of the wear, preventing moisture or other
contaminants from entering into the on-body patch device housing.
Such single body configurations may additionally provide ease of
manufacturing with the fewer components that require assembly.
[0112] In a further aspect, the on-body patch device may include a
two part assembly including a reusable electronics component mated
or coupled (detachably or fixedly) to a disposable component
including the analyte sensor, a base or mount for the electronics
component, and the adhesive patch.
[0113] FIG. 7 is a schematic of the reader device/receiver unit for
use in the analyte monitoring systems of FIGS. 1 and 2 in
accordance with one aspect of the present disclosure. Referring to
the Figure, the reader device/receiver unit 220 (FIG. 2) or the
handheld controller in accordance with one aspect of the present
disclosure, includes a surface acoustic wave (SAW) resonator 701
which may includes a resonator that generates the RF signal
operating in conjunction with an oscillator (OSC) 702. The
oscillator 702 is the active RF transistor component, and in
conjunction with the SAW resonator 701, is configured to send out
control commands (the ping signals), transmit the RF power to
receive the backscatter signal from the on-body patch unit, and
generate local oscillation signal to the mixer 703, as described in
further detail below.
[0114] More specifically, in one aspect of the present disclosure,
in operation, the transmit data (TX data) as shown is the control
signal received from the control unit 410 of the reader
device/receiver unit (see e.g., FIG. 4) and received from the power
amplifier (PA) 706 is the RF control command to be transmitted to
the on-body patch device. The SAW resonator 701 in one embodiment
is configured to provide the carrier signal for the control
commands (ping signals). The control signal from the control unit
410 in one embodiment include data packets that are to be
transmitted to the on-body patch device to ping it to return a
response signal back to the reader device.
[0115] In one embodiment, before the control signal is sent, a turn
on signal from the control unit 410 is received at the TX enable
line (as shown in FIG. 7) and provided to the oscillator 702. After
the control signal from the control unit 410 is provided to the
oscillator 702 and the SAW resonator 701, the carrier signal which
is used to carry the control signal is maintained. The same carrier
signal in one embodiment may be used to receive the response data
packet from the on-body patch device. When the RF control signal is
provided to the on-body patch device using the loop antenna and
over the carrier signal, the RF power is provided at the same time
(radiation energy) where the RF power is generated by the
oscillator 702 in conjunction with the SAW resonator 701. In
certain aspects, because the carrier signal is maintained during
transmit/receive time periods between the reader device/receiver
unit and the on-body patch device, the RF power is provided during
the ping (or control signal) request transmission of the RF control
signal and also during the time period when the backscatter
response is received from the on-body patch device. In certain
aspects, the reader device/receiver unit loop antenna 708 uses the
same carrier signal to transmit the RF power and the RF control
signal to the on-body patch device.
[0116] Referring back to FIG. 7, further shown is an LC power
splitter 704 which his configured in one aspect of the present
disclosure, to split the power two ways to the buffer 705 and to
the power amplifier (PA) 706. The buffer 705 in one embodiment is
configured to boost the RF signal received from LC power splitter
704. Output of the power amplifier 706 is the control command that
is provided to a second LC power splitter 707 which splits the
antenna signal (from the loop antenna into transmit signal (the
control signal) and the receive signal (backscatter signal from the
on-body patch device)). That is, in one embodiment, the second LC
power splitter 707 may be configured to manage the transmit/receive
signals using one loop antenna 708. Referring again to FIG. 7, a
balun 709 provided between the loop antenna 708 and the second LC
power splitter 707 is used in one embodiment to match the balanced
signal from the loop antenna 708 to the unbalanced signal from the
power splitter 707 (as most circuit components are unbalanced
relative to ground terminal). The balun 709 includes, in one
embodiment, an electrical transformer that can convert electrical
signals that are balanced about ground (differential) to signals
that are unbalanced (single-ended), and vice versa, using
electromagnetic coupling for operation.
[0117] Referring still to FIG. 7, the loop antenna 708 transmits
the RF control signal (the ping signal) and in response, receives a
backscatter signal from the on-body patch device. In one aspect,
the received backscatter response signal by the loop antenna is
passed through the balun 709, and to the power splitter 707 to the
SAW filter 711. SAW filter 711 in one aspect includes a bandpass
filter configured to remove noise or interference components in the
received backscatter signal, for example. The output of the SAW
filter 711 is passed through ASK receiver 720. In one aspect, the
ASK receiver 720 includes a low noise amplifier (LNA) 721 whose
output is sent to mixer 703 which mixes the low noise amplified
signal output from the LNA 721 with the RF carrier signal from the
buffer 705.
[0118] The output of the mixer 703 is passed to the high pass
filter (HPF) 712 that filters out the DC component and low
frequency components of the signal, and then the output of the HPF
712 is sent to the intermediate frequency amplifier (IF amplifier)
713 which is configured to amplify the received signal. The
amplified output signal from the IF amplifier 713 is provided to
the low pass filter (LPF) 722 of the ASK receiver 720, and the
output low pass filtered signal from LPF 722 is provided to another
intermediate frequency amplifier 723 of the ASK receiver 720 which
is configured to amplify the low pass filtered signal output from
the LPF 722. As shown in FIG. 7, the IF amplifier 723 of the ASK
receiver 720 is provided between the LPF 722 and the ASK
demodulator 724.
[0119] Referring yet still to FIG. 7, the gain controller signal
from IF amplifier 723 of the ASK receiver 720 controls the low
noise amplifier (LNA) 721 that receives the filtered backscatter
signal. The gain controller signal in one embodiment switches
between high gain and low gain state of the LNA 721. For example,
if IF amplifier 723 has high gain, then the gain controller signal
to the LNA 721 switches the LNA 721 to low gain operation, and vice
versa. As discussed above, the output of the IF amplifier 723 of
the ASK receiver 720 is provided to the ASK demodulator 724 of the
ASK receiver 720 which is configured to demodulate (or recover the
data) the output signal from the IF amplifier 723.
[0120] That is, as shown in FIG. 7, the RX enable line to the ASK
receiver 720 is configured to turn on after the TX enable line
where the turn on signal from the control unit 410 (FIG. 4) is
received in the reader device/receiver unit such that with the
receive enable signal from the control unit 410, the data out line
(i.e., the output of the ASK demodulator 724) of the ASK receiver
720 provides the data or signal associated with the monitored
glucose level based on the raw current signals from the glucose
sensor.
[0121] Referring back to the Figures and as described above, in one
aspect, the on-body patch device may include a power supply to
power the electronic components as well as the sensor, or
alternatively, the on-body patch device may not includes a separate
dedicated power supply and rather, include a self-powered sensor as
described in further detail in U.S. patent application Ser. No.
12/393,921 filed Feb. 27, 2009 and incorporated by reference herein
for all purposes. In certain aspects, for configurations of the
on-body patch device that includes a power supply, the on-body
patch device may be configured to listen for the RF control command
(ping signal) from the reader device. More specifically, an On/Off
Key (OOK) detector may be provided in the on-body patch device
which is turned on and powered by the battery to listen for the RF
control command or the ping signal from the reader device.
Additional details if the OOK detector are provided in U.S. Patent
Publication No. 2008/0278333, the disclosure of which is
incorporated by reference for all purposes. In certain aspects,
when the RF control command is detected, on-body patch device
determines what response packet is necessary, and generates the
response packet for transmission back to the reader device. In this
embodiment, the sensor is always turned on and configured to
continuously receive power from the power supply or the battery of
the on-body patch device. However, the sampled current signal from
the sensor may not be transmitted out to the reader device/receiver
unit until the on-body patch device receives the RF power (from the
reader device/receiver unit) to enable the transmission of the data
to the reader device. In one embodiment, the battery may be a
rechargeable battery configured to be charged when the on-body
patch device received the RF power (from the reader device/receiver
unit).
[0122] In certain embodiments, the on-body patch device does not
include an RF communication chip, nor any other dedicated
communication chip to allow for wireless transmission separate from
being powered on based on the RF power received from the reader
device/receiver unit and transmitting the backscatter response
packet to the reader device.
[0123] Referring again to FIG. 7, in a further embodiment of the
present disclosure, an RF transmitter chip or an ASK transmitter
may be provided to the reader device/receiver unit 220 (FIG. 2) to
replace the SAW resonator 701, the oscillator 702, the mixer 703,
the LC power splitter 704, the buffer 705, the power amplifier 706,
the high pass filter (HPF) 712, and the IF amplifier 713 shown in
FIG. 7. More specifically, in this embodiment of the reader device,
the RF transmitter chip may be coupled to a crystal which provides
the frequency reference base for generating the RF carrier signal
to receive the backscatter from the on-body patch device, and also
to send the control commands (ping signals) to the on-body patch
device.
[0124] In the embodiment discussed above, in aspects of the present
disclosure, the RF transmitter chip or unit may be coupled to the
LC power splitter, a balun and the loop antenna similar to the LC
power splitter 707, the balun 709, and the loop antenna 708 shown
in FIG. 7, in addition to a SAW filter and ASK receiver similar to
the SAW filter 711 and ASK receiver 720 shown in FIG. 7. However,
in contrast to the configuration shown in FIG. 7, in the alternate
embodiment, another crystal may be coupled to the ASK receiver to
provide the frequency reference base for receiving the backscatter
signal from the on-body patch device.
[0125] FIGS. 8A and 8B illustrate a top view and a side view,
respectively, of antenna and electronic circuit layout of the
on-body patch device including an sensor and sensor electronics
assembly for use in the analyte monitoring systems of FIGS. 1 and 2
in one aspect of the present disclosure. Referring to FIGS. 8A and
8B, the loop antenna and circuit layout of the on-body patch device
in one embodiment includes a conductive layer 801, such as a PCB
copper trace, provided on a substrate 802, and further includes, a
plurality of inductors 803a-803e disposed on the substrate and
electrically connected to the conductive layer 801 in a loop
configuration. In one aspect, the inductors 803a-803e are spaced
equidistantly from each other around the loop configuration. In a
further aspect, the inductors 803a-803e may not be equidistantly
spaced apart from each other in the loop configuration. Also shown
in FIGS. 8A and 8B is a data processor or controller 804 in
electrical communication with the conductive layer 801 for
processing signals from the sensor (not shown) and interfacing with
the sensor in addition to processing the control commands from the
reader device/receiver unit and generating and/or transmitting the
backscatter response data packet to the reader device.
[0126] Accordingly, in aspects of the present disclosure, loop
antenna configurations are provided for a passive glucose sensor
and a low power glucose reader device/receiver unit at Ultra High
Frequency (UHF) frequency bands, providing an on-demand glucose
data acquisition system that includes the reader device/receiver
unit which is configured to generate a strong near electromagnetic
field to power the passive glucose sensor, and further provide a
weak far electromagnetic field such that the strength of the
generated magnetic field at a far distance, such as approximately 3
meters away from the on-body patch device, including the sensor is
in compliance with the regulated radiation level.
[0127] In certain embodiments, the on-body patch device antenna may
be printed as an internal conductive layer of a printed circuit
board surrounded by the ground plane on the top and bottom layers.
That is, in one aspect, the top and bottom conductive layers may be
separated by layers of dielectrics and a conductive layer of loop
antenna disposed therebetween. Further, the antenna for the on-body
patch device may be printed on the top conductive layer of the
printed circuit in series with a plurality of inductors chips, such
as, for example, but not limited to, five inductor elements.
[0128] FIG. 9 illustrates an exemplary circuit schematic of the
on-body patch device including an sensor and sensor electronics
assembly in accordance with aspects of the present disclosure.
Referring to the Figure, in one embodiment the sensor contacts 910
are provided to establish contact with the various electrodes of
the sensor including working electrode, reference electrode and
counter electrode. Also shown is an RF transmission antenna 920
operatively coupled to the control unit 950. In certain
embodiments, the control unit 950 may be implemented as application
specific integrated circuits (ASICs), or include microprocessors or
both. An activation switch 930, described in further detail below,
is also shown in FIG. 9 along the electrical path from the power
supply 940 for switching on or turning on the sensor electronics of
the on-body patch device.
[0129] Referring still to FIG. 9, also shown in analog front end
circuitry/components 970 coupled to the sensor contacts 910 for
processing the raw current signals generated by the analyte sensor
and detected at the sensor contacts 910. Additional passive storage
capacitors 960 coupled to the power supply such as a battery is
shown. In addition, crystal oscillators 980, 990 are provided as
shown in FIG. 9, where in certain embodiments, crystal oscillator
980 is configured to provide clock signals for the state machine in
the ASIC 950, while crystal oscillator 990 may be configured to
provide frequency reference for the RF communication components
within the ASIC 950.
[0130] FIG. 10A is a perspective view of the components of the an
on-body patch device including sensor and sensor electronics
assembly in accordance with one aspect of the present disclosure.
Referring to FIG. 10A, an integrated sensor and sensor electronics
assembly/on-body patch device 110 of FIG. 1 in one embodiment is
shown. As can be seen, the housing 1010 in one embodiment is
substantially shaped such that the height profile is minimized (for
example, to less than or equal to approximately 10 mm, e.g., about
4 mm or less). For example, as shown in the figures, the housing of
the integrated assembly may have a dome-like shape, or otherwise
tapered shape. A height dimension may be at most about 4 mm, and
may taper (gradually or step wise) to heights less than about 4 mm,
e.g., 3 mm or less, e.g., 2 mm or less, e.g., 1 mm or less.
[0131] Referring back to FIG. 10A, in one embodiment, the analyte
sensor 1020 is assembled (e.g., provided to the user) with the
sensor electronics 1030 and provided within the housing 1010.
Furthermore an adhesive (single sided or two sided) layer 1040
(FIG. 10C) may be provided on a lower surface of the housing 1010
to provide secure positioning of the housing 1010 on the skin
surface during and after sensor deployment. As discussed in further
detail below, the integrated sensor and sensor electronics
assembly/on-body patch device 110 may be positioned (e.g., during
manufacture to provide to the user) within the housing of an
insertion device, avoiding the need for a user to align, position,
or otherwise connect or couple the sensor and sensor electronics to
the insertion device prior to the insertion of the sensor and
turning on the sensor electronics. Accordingly, potential misuse,
misalignment of the sensor relative to the introducer of the
insertion device, or errors and difficulties in use of the
integrated assembly by the user may be avoided.
[0132] FIG. 10B is another perspective view of the components of
the on-body patch device including sensor and sensor electronics
assembly in accordance with one aspect of the present disclosure.
As shown in the Figure, each component of the integrated assembly
is separated to illustrate the relative position of each component,
in one embodiment. As discussed in further detail below, it can be
seen in one embodiment that the sensor 1020 includes a bent
configuration, whereby at least a portion of the body of the sensor
is maintained in a direction substantially planar to the surface of
the skin. In one aspect, this configuration allows for the low
profile dimension of the housing 1010 that includes the sensor 1020
such that the protrusion of the housing 1010, when positioned on
the skin surface of the user, is minimized. Accordingly, the sensor
1020 may be bent, or may be bendable, from about 1 degree to about
90 degrees or more.
[0133] FIG. 10C is another perspective view of the assembled
on-body patch device including sensor and sensor electronics
assembly in accordance with one aspect of the present disclosure.
As shown in FIG. 10C, after positioning the integrated sensor and
sensor electronics assembly, the adhesive layer 1040 may be
configured to substantially fixedly retain the integrated assembly
110 on the skin surface such that movement of the sensor 1020
during the course of wearing the device is minimized. In one
aspect, the adhesive layer 1040 may be configured to provide a
substantially water tight seal between the integrated assembly 110
and the skin surface during the predetermined time period of wear
such that the likelihood of the integrated assembly 110 detaching
from the skin surface is minimized.
[0134] FIGS. 11A-11C illustrate circuit layouts for the sensor
electronics assembly in the on-body patch device including sensor
and sensor electronics assembly in accordance with embodiments of
the present disclosure. Referring to FIGS. 11A-11C, embodiments of
the sensor electronics of the integrated assembly includes
dimensions that are optimized for reduction and thus maximized for
comfort in use and wear. For example, embodiments of the sensor
electronics shown in FIGS. 11A-11C may include a diameter of
approximately 25 mm or less (typical size of a quarter coin, for
example), e.g., 20 mm or less, or 15 mm or less. As shown, for
example, the control unit including an application specific
integrated circuit (ASIC) 1110 is provided in electrical contact
with a plurality of RF communication transmission capacitors 1130
positioned, for example, substantially around the outer periphery
of the flexible circuit board. Depending upon the size of the
circuit board and/or RF transmission requirement, RF transmission
capacitors 1130 of different capacitance may be provided. For
example, FIG. 11A illustrates RF transmission capacitors 1130 of
600 .mu.F, while the FIGS. 11B and 11C illustrate RF transmission
capacitors 1130 having approximately 610 .mu.F and 240 .mu.F,
respectively.
[0135] Referring back to the Figures, also shown is a battery 1120
configured to provide the necessary power for the operation of the
sensor electronics, and may include a single use coin-cell type
battery that is disposable after single use, but which is
sufficient to provide the necessary power to operate the integrated
sensor and sensor electronics assembly 110 (FIG. 1) during the
desired time period (for example, such as 5 days or 7 days or
longer). Additionally, further shown in FIGS. 11A-11C are RF
antennas 1140 that are positioned, in one embodiment substantially
around the circumference of a portion of the flexible circuit
board.
[0136] Accordingly, in aspects of the present disclosure, the
circuit layout of the sensor electronics may be optimized to
minimize the surface area of the circuit board (and thus the
overall size of the integrated assembly), by positioning the
various components in the manner as shown in FIGS. 11A-11C.
[0137] FIGS. 12A-12B illustrate pre-deployment and post insertion
configurations of the insertion device for positioning the on-body
patch device including sensor and sensor electronics assembly in
accordance with embodiments of the present disclosure. Referring to
FIG. 12A, insertion device 1200 in one embodiment includes a
housing or body 1210 and a cap 1220 which is configured to provide
closure or seal on the open end of the insertion device. As shown,
the insertion device 1200 may be configured for sensor insertion
and sensor electronics assembly positioning in a direction
substantially perpendicular to the skin surface.
[0138] Referring to FIG. 12B, when a force, e.g., a manual force,
is applied upon the top end of the housing 1210 in the direction as
shown by arrow 1240, and with the open end of the housing on the
skin surface 1230, the integrated sensor and sensor electronics
assembly provided within the housing (not shown) is configured to
come into contact with the skin surface 1230. Furthermore, the
force applied as discussed above also may be configured to move the
introducer (not shown) within the housing in the same direction as
shown by arrow 1240 to pierce the skin surface 1230 and position
the sensor in fluid contact with an analyte of the user.
[0139] Further details of the mechanism associated with the
insertion device for sensor insertion and sensor electronics
assembly positioning is shown and described below in conjunction
with FIGS. 12C-12G which illustrate cross sectional perspective
views of the operation of the insertion device for deploying the
on-body integrated sensor and sensor electronics assembly in
accordance with embodiments of the present disclosure.
[0140] As shown in these figures, in response to the force applied
on the insertion device housing 1210, the introducer 1260 is driven
in a direction substantially perpendicular to the skin surface
1230, and along with the movement of the introducer 1260, the
sensor 1280 and the sensor electronics assembly 1270 are moved in
the same direction. When the bottom surface of the sensor
electronics assembly 1270 comes into contact with the skin surface
1230, the bottom surface is maintained in an adhered relationship
with the skin surface 1230 by, for example, the adhesive layer 1290
(FIG. 12G). Moreover, also shown in the Figures is a bias spring
1250 which, in one embodiment, is configured to retract the
introducer needle from the insertion position to a retracted
position which is an opposite direction from the direction
indicated by arrow 1240 (FIG. 12B).
[0141] Referring back to the Figure, it can be seen that the
introducer needle 1260 is substantially and entirely retained
within the insertion device housing 1210 after sensor insertion,
and thereafter, when the insertion device 1200 is removed from the
skin surface 1230, the sensor electronics assembly 1270 is retained
on the skin surface 1230, while the position of the sensor 1280 is
maintained in fluid contact with the analyte of the user under the
skin layer 1230.
[0142] Prior to activation of the integrated sensor and sensor
electronics assembly for use, there may be a period of time from
the manufacturing that the assembly may be in sleep or idle mode.
With a power supply such as a battery integrated within the
assembly, for reasons including cost optimization and prolonging
shelf life, embodiments of the present disclosure include systems
that are activated merely by positioning the sensor and electronics
unit on a skin surface as described above, i.e., no additional
action need be required of the user other than applying a force to
housing 1210. As such, insertion of the sensor causes activation of
the electronics unit. In certain embodiments, activation switch
configurations are included which may be configured to be
triggered, for example, by the insertion device activation, thereby
turning on the integrated sensor and sensor electronics assembly
into an active mode.
[0143] For example, FIGS. 13A-13B illustrate embodiments of a power
supply switch mechanism including conductive plugs of the on-body
patch device including sensor and sensor electronics assembly in
accordance with embodiments of the present disclosure. As shown,
the sensor electronics assembly circuit board 1310 may be provided
with a physical gap 1350 that breaks the electrical circuit between
the power supply (e.g., battery) and the other circuitry of the
sensor electronics assembly.
[0144] In one embodiment, when the predetermined force is applied
on the insertion device as discussed above, a conductive portion
1320 provided within the housing of the sensor electronics may be
moved in a direction as shown by arrow 1330 such that electrical
contact is established in the physical gap 1350 on the circuit
board, by for example, the conductive portion 1320 coming into
physical contact with the conductive portions 1360 of the circuit
board. In this manner, in one embodiment, the electrical path from
the power supply and the remaining circuitry on the circuit board
of the sensor electronics is completed, thereby powering the sensor
electronics.
[0145] By way of another example, referring to FIG. 13B, the
conductive portions 1360 of the circuit board are provided on the
board itself, and the conductive plug 1340, for example, when
pushed into the cavity 1350, establishes electrical contact between
the conductive portions 1360 of the circuit board.
[0146] In one embodiment, as discussed above, the actuation of the
insertion device to position the sensor and sensor electronics
assembly triggers the switch mechanism shown in FIGS. 13A and 13B
by also moving the conductive portion 1320 or the conductive plug
1360 in the direction complimentary to the direction of the
introducer movement, and thereby switching on the sensor
electronics. Within the scope of the present disclosure, the
activation of the sensor electronics by moving the conductive
portion 1320 or the conductive plug may include a separate
procedure, where after positioning the sensor and the sensor
electronics assembly on the skin surface, a predetermined force is
applied on the housing of the integrated sensor and sensor
electronics assembly such that the desired movement of the
conductive portion 1320 or the conductive plug 1360 may be
achieved.
[0147] FIGS. 13C-13E illustrate another configuration of the power
supply switch mechanism including conductive pads of the on-body
patch device including sensor and sensor electronics assembly in
accordance with embodiments of the present disclosure. Referring to
FIG. 13C, an exposed conductive ring 1371 may be provided and
configured to contact the surface of the circuit board in the
sensor electronics such that, the insertion device activation
positions the conductive ring 1371 on the surface of the circuit
board so as to complete the electrical contact of the sensor
electronics assembly (by for example, manual force applied on the
insertion device placing the conductive ring in contact with the
circuit board of the sensor electronics).
[0148] Referring to FIG. 13D, in another aspect, electrical contact
pads 1372, 1373 may be provided to the circuit board in the sensor
electronics assembly such that the mating of the contact pads with
the conductive ring 1371 switches on the sensor electronics device
to provide power to the device from its power source. FIG. 13E
shows yet another configuration of the switch activation mechanism
in accordance with the present disclosure, where a portion of the
conductive ring 1374 is selectively positioned and provided to
establish electrical contact in the device.
[0149] As discussed, each of the activation configuration described
above includes a break in the circuitry from the power source such
that the power supply is not drained when the device is not in use,
and upon activation, the break in the electrical contact is
completed, thereby powering the device and activating it for
operation.
[0150] FIG. 14 illustrates a power supply switch mechanism
including an internal switch with a push rod activation of the
on-body patch device including sensor and sensor electronics
assembly in accordance with embodiments of the present disclosure.
As shown, in one embodiment, push rod 1410 may be provided and
positioned in the sensor electronics such that when a force is
applied in the direction as shown by arrow 1430, the push rod 1410
is displaced in the same direction, and completes the electrical
contact between the two contacts 1420, 1421. In one aspect, the
push rod 1410 may be provided within a seal 1440 such as an O-ring
or similar components.
[0151] FIG. 15 illustrates a power supply switch mechanism
including introducer retraction trigger activation of the on-body
integrated sensor and sensor electronics assembly in accordance
with embodiments of the present disclosure. As shown, a
nonconducting needle or device 1510 is provided to physically
separate two electrical contacts 1520, 1521. Each of the electrical
contacts 1520, 1521 is biased or spring loaded to be urged towards
each other, physically separated by the nonconducting needle 1510.
Accordingly, when the nonconducting needle 1510 is retracted or
pulled away from the sensor electronics assembly in the direction
as shown by arrow 1530, the two electrical contacts 1520, 1521 are
configured to contact each other, thereby completing the break in
the circuit and establishing electrical connection to activate the
sensor electronics assembly.
[0152] In one aspect, the nonconducting device or needle 1510 may
include, for example, but not limited to, glass, plastic or any
other material suitable to separate two electrical contacts and
provide insulation therebetween.
[0153] FIG. 16 illustrates a power supply switch mechanism with a
contact switch of the on-body patch device including sensor and
sensor electronics assembly in accordance with embodiments of the
present disclosure. As shown, in a further aspect, there is
provided an electronic switch 1601 (that is configured to draw an
insubstantial amount of power from the sensor electronics power
supply), and when triggered, completes the break between the
contacts 1610, 1611 by physically contacting the two contacts 1610,
1611 with the activation component 1602 that completes the circuit
in the sensor electronics from its power supply such as battery to
activate the device for operation.
[0154] FIGS. 17A-17B illustrate a power supply switch mechanism
with a battery contact locking mechanism of the on-body patch
device including sensor and sensor electronics assembly in
accordance with embodiments of the present disclosure. Referring to
the Figures, in still another aspect, the battery contact of the
sensor electronics may be provided with a barbed tab 1710. In post
manufacturing shelf mode when the device is nonoperational, the tab
1710 is positioned within the sensor electronics housing in the
position as shown in FIG. 17A so that it is not in contact with the
conductive contact 1720 of the sensor electronics circuit board.
When in use as shown in FIG. 17B, the tab 1710 may be biased such
that it physically contacts the conductive contact 1720 on the
circuit board, thereby closing the circuit to/from the
battery/power source and thus activating or switching on the sensor
electronics. As shown in the Figures, the tab 1710 may be
configured that upon biasing to establish contact with the
conductive contact 1720, it locks or latches with the conductive
contact 1620 and the circuit board so as to maintain the electrical
connection.
[0155] FIGS. 18A-18B illustrate a power supply switch mechanism
with a bi-modal dome switch of the on-body patch device including
sensor and sensor electronics assembly in accordance with
embodiments of the present disclosure. Yet in another embodiment, a
bi-modal dome shaped switch 1810 is provided on the circuit board
of the sensor electronics assembly such that, when pressed down (as
shown in FIG. 18B), the dome shaped layer 1810 (which may include,
for example, a thin sheet metal dome) may be configured to retain
the concave shape as shown in FIG. 18B and effectively closing the
circuit on the circuit board at the contact point 1820. In one
aspect, the dome shaped layer 1810 may be configured to shunt to
short two or more electrical contacts at the contact point 1820 of
the circuit board. Alternatively, the dome shaped layer 1810 may be
connected to the circuit board such that one end of the dome shaped
layer 1810 is in contact with one of the two or more open
electrical contacts, and the depression of the dome shaped layer
1810 closes the circuit on the circuit board by physically
contacting the other one or more of the open electrical
contacts.
[0156] In the manner described above, in accordance with various
embodiments of the present disclosure, sensor electronics
activation switch configurations are provided that may be triggered
or activated automatically or semi-automatically in response to the
activation of the insertion device described above, or
alternatively, may be separately activated by the user by, for
example, depressing upon a portion of the housing or switch
provided on the housing of the sensor electronics. Accordingly,
power consumption may be optimized for the sensor electronics
assembly while improving post manufacturing shelf life of the
device prior to use or activation.
[0157] As described above, in certain aspects of the present
disclosure, discrete glucose measurement data may be acquired
on-demand or upon request from the reader device, where the glucose
measurement is obtained from an in vivo glucose sensor
transcutaneously positioned under the skin layer of a patient or a
subject, and further having a portion of the sensor maintained in
fluid contact with the interstitial fluid under the skin layer.
Accordingly, in aspects of the present disclosure, the patient or
the user of the analyte monitoring system may conveniently
determine real time glucose information at any time, using the RFID
communication protocol as described above.
[0158] In the manner described above, in accordance with various
embodiments of the present disclosure, discrete glucose
measurements may be obtained within the need for lancing or
performing fingerprick test for access to blood sample each time a
measurement is desired. The analyte monitoring system described in
further aspects may be configured to log or store glucose data
monitored by the analyte sensor continuously over a predetermined
or programmable time period, or over the life of the sensor without
user intervention, and which data may be retrieved at a later time
as desired. Furthermore, output indications such as audible, visual
or vibratory alerts may be provided to inform the user of a
predetermined condition or when the monitored glucose level
deviates from a predefined acceptable range (for example, as
warning indication of low glucose or high glucose level).
[0159] The various processes described above including the
processes operating in the software application execution
environment in the analyte monitoring system including the on-body
patch device, sensor electronics, the reader device, the receiver
unit, data processing module and/or the remote terminal performing
one or more routines described above may be embodied as computer
programs developed using an object oriented language that allows
the modeling of complex systems with modular objects to create
abstractions that are representative of real world, physical
objects and their interrelationships. The software required to
carry out the inventive process, which may be stored in a memory or
storage device of the storage unit of the various components of the
analyte monitoring system described above in conjunction to the
Figures including the on-body patch device, the reader device, the
data processing module, various described communication devices, or
the remote terminal may be developed by a person of ordinary skill
in the art and may include one or more computer program
products.
[0160] In still another aspect, the methods, devices and systems
described above may be configured to log and store (for example,
with an appropriate time stamp and other relevant information such
as, for example, contemporaneous temperature reading)) the real
time analyte data received from the analyte sensor, and may be
configured to provide the real time analyte data on-demand by
using, for example a device such as a blood glucose meter or a
controller discussed above that is configured for communication
with the on-body integrated sensor and sensor electronics
assembly.
[0161] That is, in one embodiment, real time data associated with
the analyte being monitored is continuously or intermittently
measured and stored in the integrated on-body sensor and sensor
electronics assembly, and upon request from another device such as
the receiver unit or the reader device/receiver unit (operated by
the user, for example) or any other communication enabled device
such as a cellular telephone, a personal digital assistant, an
iPhone, a Blackberry device, a Palm device such as Palm Treo, Pro,
Pre, Centro), or any other suitable communication enabled device
which may be used to receive the desired analyte data from the
on-body integrated sensor and sensor electronics assembly while
being worn and used by the user. In one aspect, such communication
enabled device may be positioned within a predetermined proximity
to the integrated on-body sensor and sensor electronics assembly,
and when the communication enabled device is positioned within the
predetermined proximity, the data from the integrated on-body
sensor and sensor electronics assembly may be transmitted to the
communication enabled device. In one aspect, such data
communication may include inductive coupling using, for example,
electromagnetic fields, Zigbee protocol based communication, or any
other suitable proximity based communication techniques. In this
manner, glucose on-demand mode may be provided such that the
information associated with contemporaneously monitored analyte
level information is provided to the user on-demand from the
user.
[0162] In this manner, in embodiments of the present disclosure,
the size and dimension of the on-body sensor electronics may be
optimized for reduction by, for example, flexible or rigid potted
or low pressure/low temperature overmolded circuitry that uses
passive and active surface mount devices for securely positioning
and adhering to the skin surface of the user. When flexible
circuitry is with or in the overmold, the sensor electronics may
includes the analyte sensor and/or other physiological condition
detection sensor on the flex circuit. Furthermore in embodiments of
the present disclosure, one or more printed RF antenna may be
provided within the sensor electronics circuitry for RF
communication with one or more remote devices, and further, the
device operation and/or functionalities may be programmed or
controlled using one or more a microprocessors, or application
specific integrated circuits (ASIC) to reduce the number of
internal components.
[0163] Embodiments of the present disclosure include one or more
low pressure molding materials that directly encapsulate the
integrated circuits or the sensor electronic components. The
thermal process entailed in the encapsulation using the low
pressure molding materials may be configured to shield temperature
sensitive components such as, for example, the analyte sensor or
other components of the sensor electronics from the heat generated
during the thermal overmolding process. Other techniques such as
injection molding and/or potting may be used.
[0164] In another aspect, the sensor electronics may be molded
using optical techniques such as with a UV cured material, for
example, or using two photon absorption materials, which may also
be used to reduce the dead or unused volume surrounding the sensor
electronics within the housing of the device such that the
reduction of its size and dimension may be achieved. Moreover, the
sensor electronics may be configured to reduce the number of
components used, for example, by the inclusion of an application
specific integrated circuit (ASIC) that may be configured to
perform the one or more functions of discrete components such as a
potentiostat, data processing/storage, thermocouple/thermister, RF
communication data packet generator, and the like. Additionally, a
field programmable gate array (FPGA) or any other suitable devices
may be used in addition to the ASIC in the sensor electronics to
reduce the on-body device dimension.
[0165] Also, embodiments of the present disclosure includes analyte
sensors that may be fabricated from flex circuits and integrated
with the sensor electronics within the device housing, as a single
integrated device. Example of flex circuits may include evaporated
or sputtered gold on polyester layer, single or multi-layer copper
or gold on polymide flex circuit. When the sensor fabricated from a
copper or gold polymide flex circuit, gold or other inert material
may be selectively plated on the implantable portion of the circuit
to minimize the corrosion of the copper. In aspects of the present
disclosure, the flex circuit may be die or laser cut, or
alternatively chemically milled to define the sensor from the flex
circuit roll.
[0166] A further configuration of embodiments of the present
disclosure includes RF communication module provided on the flex
circuit instead of as a separate component in the sensor
electronics. For example, the RF antenna may be provided directly
on the flex circuit by, such as surrounding the sensor electronics
components within the housing on the flex circuit, or folded over
the components, and encapsulated with the electronic components
within the housing of the device.
[0167] In accordance with embodiments of the present disclosure,
the integrated sensor and sensor electronics assembly may be
positioned on the skin surface of the user using an insertion
device. For example, automated or semi-automated, spring biased
and/or manual insertion device may be provided to deploy the sensor
and the sensor electronics such that the implantable portion of the
sensor is positioned in fluid contact with the analyte of the user
such as the interstitial fluid, while the housing of the sensor
electronics is securely positioned and adhered to the skin surface.
In embodiments of the present disclosure, the sensor electronics
device (for example, a transmitter unit of an analyte monitoring
system) may be switched to an operational state or condition (from
an inactive, shelf mode) upon deployment of the integrated assembly
by the insertion device.
[0168] In one aspect, integrated sensor and sensor electronics
assembly may be pre-loaded or otherwise pre-assembled within the
insertion device, such that, when in use, the user may, by a single
operation of the insertion device, deploy the integrated sensor and
sensor electronics assembly, without the need to couple the
integrated assembly with the insertion device prior to
deployment.
[0169] In one aspect, the integrated sensor and sensor electronics
assembly and the insertion device may be sterilized and packaged as
one single device and provided to the user. Furthermore, during
manufacturing, the insertion device assembly may be terminal
packaged providing cost savings and avoiding the use of, for
example, costly thermoformed tray or foil seal. In addition, the
inserter device may include an end cap that is rotatably coupled to
the insertion device body, and which provides a safe and sterile
environment (and avoid the use of desiccants for the sensor) for
the sensor provided within the insertion device along with the
integrated assembly. Also, the insertion device sealed with the end
cap may be configured to retain the sensor within the housing from
significant movement during shipping such that the sensor position
relative to the integrated assembly and the insertion device is
maintained from manufacturing, assembly and shipping, until the
device is ready for use by the user.
[0170] Moreover, as discussed above, the insertion device in
embodiments of the present disclosure includes a sharp needle or
introducer for aiding the transcutaneous insertion of the sensor
through the skin layer of the user. The sharp needle or the
introducer may be configured to be retracted within the insertion
device housing after deployment to permit movement, such as tilting
or angled movement, to position the adhesive on the housing of the
sensor electronics onto the skin surface of the user without the
introducer interfering such movement. Also, by retaining the
introducer within the insertion device housing after insertion, the
disposal of the used introducer may be safer, without presenting
possible biohazard concerns.
[0171] Also, in embodiments of the present disclosure the sharp
needle or the introducer is not visible to the user prior to,
during and after the use of the insertion device to position the
sensor and the sensor electronics. As such, potential for perceived
pain associated with when the sharp needle is visible is
minimized.
[0172] In a further embodiment, the insertion device may be
configured for manual deployment with spring biased or automatic
refraction of the introducer. That is, sensor insertion, the user
may apply a predetermined amount of pressure upon the housing of
the insertion device to insert the introducer and the sensor, the
applied pressure sufficient to pierce through the skin layer of the
user, and the device housing configured such that the applied
pressure or the distance traveled by the introducer is
predetermined (for example, by the use of a stopper or a protrusion
within the inner wall of the insertion device that effectively
stops of blocks further downward movement of the introducer towards
the skin piercing direction after the introducer has reached a
predetermined distance. In one aspect, the applied pressure may be
configured to also press down upon a spring or a bias mechanism
provided within the housing of the insertion device such that, when
the applied pressure is released, the introducer is automatically
retracted to its original pre-deployment position within the
housing of the insertion device, by the return force from the
spring or bias mechanism.
[0173] In this manner, consistent and repeatable insertion depth
for the placement of the analyte sensor may be achieved.
Furthermore, the insertion device housing (for example, a plastic
or a combination of plastic and metal housing) may not be under the
stress of spring tension since the bias spring provided for
refraction of the introducer is, in the predeployment state,
unbiased and in a relaxed state.
[0174] In a further embodiment, two sided adhesive layer may be
provided along the other periphery of the insertion device that is
positioned to be in contact with the skin surface of the user such
that, proper alignment and positioning of the introducer, the
sensor and the sensor electronics assembly may be provided before
and during the sensor positioning process, in addition to increased
comfort and breathability of the material once adhered to the skin
layer of the user.
[0175] In one embodiment, an integrated analyte monitoring device
assembly may comprise an analyte sensor for transcutaneous
positioning through a skin layer and maintained in fluid contact
with an interstitial fluid under the skin layer during a
predetermined time period, the analyte sensor having a proximal
portion and a distal portion, and sensor electronics coupled to the
analyte sensor, the sensor electronics comprising a circuit board
having a conductive layer and a sensor antenna disposed on the
conductive layer, one or more electrical contacts provided on the
circuit board and coupled with the proximal portion of the analyte
sensor to maintain continuous electrical communication, and a data
processing component provided on the circuit board and in signal
communication with the analyte sensor, the data processing
component configured to execute one or more routines for processing
signals received from the analyte sensor, the data processing
component configured to control the transmission of data associated
with the processed signals received from the analyte sensor to a
remote location using the sensor antenna in response to a request
signal received from the remote location.
[0176] The proximal portion of the analyte sensor and the circuit
board may be encapsulated.
[0177] The proximal portion of the analyte sensor and the circuit
board may be encapsulated with a potting material.
[0178] The circuit board may include an upper layer and a lower
layer, where the conductive layer is disposed between the upper
layer and the lower layer.
[0179] The antenna may include a loop antenna or a dipole
antenna.
[0180] The antenna may be printed on the conductive layer.
[0181] In one aspect, the assembly may include a plurality of
inductive components coupled to the sensor antenna on the
conductive layer of the circuit board.
[0182] The plurality of inductive components may be coupled in
series to the sensor antenna.
[0183] The plurality of inductive components may be positioned
substantially around an outer edge of the circuit board.
[0184] The circuit board may be substantially circular, and the
plurality of components may be positioned around the outer
circumference of the circular circuit board.
[0185] Each of the plurality of the inductive components may be
positioned substantially equidistant to each other on the circuit
board.
[0186] Moreover, the assembly may include a power supply to provide
power to the sensor electronics.
[0187] The data processing component may include an application
specific integrated circuit (ASIC) disposed on the circuit board
and configured to process signals from the analyte sensor.
[0188] The data processing component may include a state
machine.
[0189] The state machine may be configured to execute one or more
programmed or programmable logic for processing the signals
received from the analyte sensor.
[0190] The analyte sensor may include a glucose sensor.
[0191] In another embodiment, an analyte data acquisition device
may comprise a control unit configured to generate a control
command based on a carrier signal, an antenna section coupled to
the control unit to transmit the control command with the carrier
signal and to receive a backscatter response data packet using the
carrier signal, and a receiver section coupled to the antenna
section and the control unit to process the received backscatter
response data packet and to generate an output glucose data.
[0192] The control unit may include a signal resonator coupled to
an oscillator, and configured to generate RF power.
[0193] The signal resonator may include a surface acoustic wave
resonator.
[0194] The generated RF power and the control command may be
transmitted with the carrier signal.
[0195] The control command may include an RF control command
transmitted with the carrier signal to a remote location.
[0196] The backscatter response data packet may be received from
the remote location when the antenna is positioned no more than
approximately ten inches from the remote location.
[0197] The antenna may be positioned about five inches or less from
the remote location.
[0198] The antenna section may include one or more of a loop
antenna, or a dipole antenna.
[0199] The control unit may be configured to generate the carrier
signal.
[0200] The receiver section may include a filter to filter the
received backscatter response data packet.
[0201] A further aspect may include an output unit operatively
coupled to the control unit to output an indication corresponding
to the generated glucose data.
[0202] The outputted indication may include one or more of a visual
output, an audible output, a vibratory output, or one or more
combinations thereof.
[0203] The control unit may generate a receipt confirmation signal
upon successful receipt of the backscatter response data
packet.
[0204] The generated receipt confirmation signal may be output to
the user.
[0205] In another aspect, the device may further include a storage
device coupled to the control unit to store the generated control
command, carrier signal, the received backscatter response data
packet, the generated output glucose data, or one or more
combinations thereof.
[0206] The storage device may include a nonvolatile memory
device.
[0207] The control unit may include a microprocessor.
[0208] The control unit may include an application specific
integrated circuit.
[0209] Yet another aspect may include a strip port for receiving an
in vitro blood glucose test strip, the strip port including an
electrical connection in signal communication with the control
unit.
[0210] The control unit may be configured to process a sample on
the test strip to determine a corresponding blood glucose
level.
[0211] In another embodiment, an integrated analyte monitoring
device may comprise a sensor electronics assembly including an
analyte sensor, a power supply, an activation switch operatively
coupled to the power supply and the analyte sensor, a controller
unit in electrical contact with the analyte sensor and the
activation switch having one or more programming instructions
stored therein for execution, the controller unit configured to
process one or more signals received from the analyte sensor when
the activation switch is triggered, and an insertion device
including a housing, an introducer coupled to the housing
configured to move between a first position and a second position,
and a bias mechanism operatively coupled to the housing configured
to automatically retract the introducer from the second position to
the first position.
[0212] The sensor electronics assembly may be retained entirely
within the housing of the insertion device prior to the introducer
movement from the first position to the second position.
[0213] The activation switch may be not triggered until the
introducer has reached the second position.
[0214] The analyte sensor may include a glucose sensor.
[0215] The activation switch may be triggered after the introducer
has reached the second position, and prior to the introducer
retraction from the second position to the first position.
[0216] The introducer may engage with the analyte sensor during its
movement from the first position to the second position, and
further, wherein the introducer disengages from the analyte sensor
during its movement from the second position to the first
position.
[0217] The movement of the introducer from the first position to
the second position may be in response to a manual force applied on
the housing.
[0218] The bias mechanism may include a spring.
[0219] A further aspect may include an adhesive layer provided on a
bottom surface of the housing for placement on a skin layer.
[0220] The adhesive layer may be configured to retain the sensor
electronics assembly on the skin layer for a predetermined time
period.
[0221] The power supply may include a single use disposable
battery.
[0222] The active operational life of the power supply may exceed
the active operational life of the analyte sensor.
[0223] Moreover, one aspect may include a cap configured to mate
with an open end of the housing of the insertion device.
[0224] When the cap is coupled to the housing, the interior space
of the housing may be maintained in a substantially contaminant
free environment.
[0225] The sensor electronics assembly may include a printed
circuit board including a portion of the analyte sensor permanently
connected thereto.
[0226] The controller unit may include an application specific
integrated circuit (ASIC).
[0227] The movement of the introducer between the first position
and the second position may be at an angle at approximately 90
degrees or less from a skin surface.
[0228] The sensor electronics assembly may include a housing having
a height of less than approximately 4 mm.
[0229] Various other modifications and alterations in the structure
and method of operation of this disclosure will be apparent to
those skilled in the art without departing from the scope and
spirit of the embodiments of the present disclosure. Although the
present disclosure has been described in connection with particular
embodiments, it should be understood that the present disclosure as
claimed should not be unduly limited to such particular
embodiments. It is intended that the following claims define the
scope of the present disclosure and that structures and methods
within the scope of these claims and their equivalents be covered
thereby.
* * * * *