METHODS AND SYSTEMS FOR EARLY SIGNAL ATTENUATION DETECTION
`
`Docket No. A0130.0090.C3
`9368USC3
`
`AND PROCESSING
`
`RELATED APPLICATIONS
`
`[0001] The present application is a continuation of U.S. Patent Application No. 15/061,774,filed
`
`March4, 2016, which is a continuation of U.S. Patent Application No. 13/925,694,filed June 24,
`
`2013, now U.S. Patent No. 9,310,230,which is a continuation of U.S. Patent Application No.
`
`12/769,635, filed April 28, 2010, now U:S. Patent No. 8,483,967, which claims the benefit of
`
`U.S. Provisional Patent Application No. 61/173,600, filed April 29, 2009, the disclosuresofall
`
`of which are incorporated herein by reference in their entireties for all purposes.
`
`BACKGROUND
`
`[0002] Analyte, e.g., glucose monitoring systems including continuous and discrete monitoring
`
`systems generally include a small, lightweight battery powered and microprocessor controlled
`
`system which is configured to detect signals proportional to the corresponding measured glucose
`
`levels using an electrometer. RF signals may be used to transmit the collected data. One aspect of
`
`certain analyte monitoring systems include a transcutaneous or subcutaneousanalyte sensor
`
`configuration which is, for example, at least partially positioned through the skin layer of a
`
`subject whoseanalyte level is to be monitored. The sensor may use a twoorthree-electrode
`
`(work, reference and counter electrodes) configuration driven by a controlled potential
`
`(potentiostat) analog circuit connected through a contact system.
`
`[0003] An analyte sensor may be configured so that a portion thereof is placed under the skin of
`
`the patient so as to contact analyte of the patient, and another portion or segmentof the analyte
`
`sensor may be in communication with the transmitter unit. The transmitter unit may be
`
`configured to transmit the analyte levels detected by the sensor over a wireless communication
`
`link such as an RF (radio frequency) communication link to a receiver/monitor unit. The
`
`receiver/monitor unit may perform data analysis, among other functions, on the received analyte
`
`levels to generate information pertaining to the monitored analyte levels.
`
`-l-|exci02|
`
`Page 1| of 37
`
`

`

`
`
`Docket No. A0130.0090.C3
`
`
`
`SUMMARY
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0004] Devices and methods for analyte monitoring, e.g., glucose monitoring, and/or therapy
`
`
`
`
`
`
`
`
`
`
`
`
`
`management system including, for example, medication infusion device are provided.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Embodiments include transmitting information from a first location to a second,e.g., using a
`
`
`
`
`
`
`
`
`
`
`
`
`telemetry system such as RF telemetry. Systems herein include continuous analyte monitoring
`
`
`
`
`
`
`
`
`
`
`
`systems, discrete analyte monitoring system, and therapy management systems.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0005] Embodiments include receiving sensor data from an analyte sensor of a sensor
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`monitoring system, processing the received sensor data with time corresponding calibration data,
`
`
`
`
`
`
`
`
`
`
`
`
`
`outputting the processed sensor data, detecting one or more adverse conditions associated with
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the sensor monitoring system, disabling the output of the sensor data during a adverse condition
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`time period, determining that the one or more detected adverse conditions is no longer present in
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the sensor monitoring system, retrieving the sensor data during the adverse condition time
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`period, processing the retrieved sensor data during the adverse condition time period, and
`
`
`
`
`
`
`
`
`
`outputting the processed retrieved sensordata.
`
`
`
`
`
`
`
`
`
`
`
`
`[0006] Embodiments include detecting a condition unsuitable for calibration of an analyte sensor
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`for a predetermined time period, disabling output of information associated with the analyte
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`sensor, determining a successful calibration of the analyte sensor, retrieving one or more
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`parameters associated with the successful calibration, processing sensor data during the time
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`period of disabled output of information with the one or more parameters associated with the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`successful calibration, and displaying the processed sensor data for the time period of disabled
`
`
`
`
`information output.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0007] Embodiments include an interface configured to receive sensor data, a first memory
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`configured to store the received sensor data, a processor coupled to the memory and configured
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`to process the stored sensor data, a second memory coupled to the processor and configured to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`store the processed sensor data, and a display unit coupled to the second memory and configured
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`to display the processed sensor data, where the processoris further configured to detect a
`
`
`
`
`
`
`
`
`
`
`
`
`condition unsuitable for calibration of a sensor for a predetermined time period, disable display
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`of processed sensor data, determinea successful calibration of the sensor, retrieve one or more
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`parameters associated with the successful calibration, process the sensor data during the time
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`period of disabled display of sensor data with the one or more parameters associated with the
`
`5.
`
`Page 2 of 37
`Page 2 of 37
`
`

`

`
`
`Docket No. A0130.0090.C3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`successful calibration, and display the processed sensor data for the time period of disabled
`
`
`
`
`information output.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0008] These and other objects, features and advantagesof the present disclosure will become
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`morefully apparent from the following detailed description of the embodiments, the appended
`
`
`
`
`
`
`
`
`claims and the accompanying drawings.
`
`
`
`INCORPORATION BY REFERENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0009] The following patents, applications and/or publications are incorporated herein by
`
`
`
`
`
`
`
`
`
`
`
`
`
`referenceforall purposes: U.S. Patent 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 Nos. 11/831,866; 11/831,881; 11/831,895; 12/102,839; 12/102,844; 12/102,847;
`
`
`
`
`
`
`
`
`
`12/102,855; 12/102,856; 12/152,636; 12/152,648; 12/152,650; 12/152,652; 12/152,657;
`
`
`
`
`
`
`
`
`
`
`12/152,662; 12/152,670; 12/152,673; 12/363,712; 12/131,012; 12/242,823; 12/363,712;
`
`
`
`
`
`
`
`
`
`
`
`12/393,921: 12/495,709; 12/698,124: 12/699,653: 12/699,844: 12/714,439; 12/761,372; and
`
`
`
`
`
`
`
`
`
`
`
`12/761,387 and U.S. Provisional Application Nos. 61/230,686 and 61/227,967.
`
`
`
`
`
`
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0010] FIG. 1 illustrates a block diagram of a data monitoring and management system for
`
`
`
`
`
`
`
`
`
`practicing one or more embodimentsof the present disclosure;
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`FIG. 2 is a block diagram of the transmitter unit of the data monitoring and management system
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`shownin FIG. | in accordance with one embodimentof the present disclosure;
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0012] FIG. 3 is a block diagram ofthe receiver/monitor unit of the data monitoring and
`
`
`
`
`
`management system shown in FIG.
`
`
`
`
`
`
`
`
`
`
`
`| in accordance with one embodimentofthe present
`
`
`
`
`disclosure;
`
`Be
`
`Page 3 of 37
`Page 3 of 37
`
`

`

`
`
`Docket No. A0130.0090.C3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0013] FIG. 4 illustrates analyte sensor data processing in accordance with one embodimentof
`
`
`
`
`
`
`the present disclosure;
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0014] FIG. 5 illustrates analyte sensor data processing in accordance with one embodimentof
`
`
`
`
`
`
`the present disclosure;
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0015] FIG.6 illustrates backfilling gaps in sensor data in one embodimentof the present
`
`
`
`
`disclosure; and
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0016] FIGS. 7A and 7Billustrate backfill of gaps of a period of uncalibrated sensor data in one
`
`embodiment.
`
`
`
`
`DETAILED DESCRIPTION
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0017] 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 appendedclaims.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0018] Where a range of values is provided, it is understood that each intervening value, to the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`tenth of the unit of the lowerlimit unless the context clearly dictates otherwise, between the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`upper and lowerlimit of that range and any other stated or intervening value in that stated range,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`is encompassed within the disclosure. The upper and lowerlimits 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. Wherethe stated range includes one
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`or both of the limits, ranges excluding either or both of those included limits are also included in
`
`
`
`
`the disclosure.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0019] Unless defined otherwise,all technical and scientific terms used herein have the same
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`meaning as commonly understood by oneof 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.
`
`
`
`"oY
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0020] It must be noted that as used herein and in the appendedclaims, the singular forms "a",
`
`Page 4 of 37
`Page 4 of 37
`
`

`

`
`
`Docket No. A0130.0090.C3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`“an”, and “the” include plural referents unless the context clearly dictates otherwise.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0021] 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 disclosureis 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 mayneedto be independently confirmed.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0022] As will be apparent to those of skill in the art upon reading this disclosure, each of the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`individual embodiments described andillustrated 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 orspirit of the present disclosure.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0023] The figures shownherein are not necessarily drawn to scale, with some components and
`
`
`
`
`
`
`
`features being exaggeratedforclarity.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0024] As described in further detail below, in accordance with the various embodiments of the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`present disclosure, there is provided a method and system for positioning a controller unit within
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`a transmission range for close proximity communication, transmitting one or more predefined
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`close proximity commands, and receiving a response packet in response to the transmitted one or
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`morepredefined close proximity commands. For example, in one aspect, close proximity
`
`
`
`
`
`
`
`
`
`
`communication includes short range wireless communication between communication
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`components or devices, where the communication rangeis limited to about 10 inchesorless,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`about 5 inchesor less, or about 2 inchesorless, or other suitable, short range or distance between
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the devices. The close proximity wireless communication in certain embodiments includesa bi-
`
`
`
`
`
`
`
`
`
`directional communication where a command sending communication device, when positioned
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`within the short communication range or in close proximity to the command receiving
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`communication device, is configured to transmit one or more commandsto the command
`
`
`
`
`
`
`
`
`
`
`
`
`
`receiving communication device (for example, when a user activates or actuates a transmit
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`command button or switch). In response, the command receiving communication device may be
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`configured to perform one or more routines associated with the received command, and/or return
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`or send back a response data packetor signal to the command sending communication device.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Example of such functions and or commands may include, but not limited to activation of certain
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`functions or routines such as analyte related data processing, and thelike.
`
`
`
`
`[0025] FIG.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`| illustrates a data monitoring and management system such as, for example, analyte
`
`
`
`5-
`
`Page 5 of 37
`Page 5 of 37
`
`

`

`
`
`Docket No. A0130.0090.C3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`(e.g., glucose) monitoring system 100 in accordance with one embodimentofthe present
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`disclosure. The subject invention is further described primarily with respect to a glucose
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`monitoring system for convenience and such description is in no way intendedto limit the scope
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`of the invention. It is to be understood that the analyte monitoring system may be configured to
`
`
`
`
`
`
`
`
`
`
`
`monitor a variety of analytes, e.g., lactate, and thelike.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0026] Analytes that may be monitored include, for example, acetyl choline, amylase, bilirubin,
`
`
`
`
`
`
`
`
`
`
`
`cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA,
`
`
`
`
`
`
`
`
`
`
`
`fructosamine, glucose, glutamine, growth hormones, hormones, ketones, lactate, peroxide,
`
`
`
`
`
`
`
`
`
`
`
`
`
`prostate-specific antigen, prothrombin, RNA,thyroid stimulating hormone, and troponin. The
`
`
`
`
`
`
`
`
`
`
`
`
`
`concentration of drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`like), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may also be monitored.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Morethan one analyte may be monitored by a single system, e.g. a single analyte sensor.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0027] The analyte monitoring system 100 includes a sensor unit 101, a data processing and
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`transmitter unit 102 coupleable to the sensor unit 101, and a primary receiver unit 104 which is
`
`
`
`
`
`
`
`
`
`
`
`
`
`configured to communicate with the data processing and transmitter unit 102 via a bi-directional
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`communication link 103. The primary receiver unit 104 maybe further configured to transmit
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`data to a data processing terminal 105 for evaluating the data received by the primary receiver
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`unit 104. Moreover, the data processing terminal 105 in one embodiment may be configured to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`receive data directly from the data processing and transmitter unit 102 via a communication link
`
`
`
`
`
`
`
`
`
`
`
`
`which may optionally be configured for bi-directional communication. Accordingly, data
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`processing and transmitter unit 102 and/or receiver unit 104 may include a transceiver.
`
`
`
`
`
`
`
`[0028] Also shownin FIG.
`
`
`
`
`
`
`
`
`
`
`
`
`
`| 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 and transmitter unit 102. Moreover, as shownin the Figure, the secondary receiver
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`unit 106 is configured to communicate with the primary receiver unit 104 as well as the data
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`processing terminal 105. Indeed, the secondary receiver unit 106 may be configured forbi-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`directional wireless communication with each or one of the primary receiver unit 104 and the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`data processing terminal 105. As discussed in further detail below, in one embodiment of the
`
`
`
`
`
`
`
`
`
`
`
`
`
`present disclosure, the secondary receiver unit 106 may be configured to include a limited
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`numberof functions and features as compared with the primary receiver unit 104. As such, the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`secondary receiver unit 106 may be configured substantially in a smaller compact housing or
`
`
`
`-6-
`
`Page 6 of 37
`Page 6 of 37
`
`

`

`
`
`Docket No. A0130.0090.C3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`embodied in a device such as a wrist watch, pager, mobile phone, PDA, for example.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Alternatively, the secondary receiver unit 106 may be configured with the sameor substantially
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`similar functionality as the primary receiver unit 104. The receiver unit may be configured to be
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`used in conjunction with a docking cradle unit, for example for one or more of the following or
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`other functions: placement by bedside, for re-charging, for data management, for night time
`
`
`
`
`
`
`
`
`monitoring, and/or bi-directional communication device.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0029] In one aspect sensor unit 101 may include two or more sensors, each configured to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`communicate with data processing and transmitter unit 102. Furthermore, while only one, data
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`processing and transmitter unit 102, communication link 103, and data processing terminal 105
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`are shownin the embodimentof the analyte monitoring system 100illustrated in FIG. 1.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`However, it will be appreciated by one of ordinary skill in the art that the analyte monitoring
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`system 100 may include one or more sensors, multiple transmitter units 102, communication
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`links 103, and data processing terminals 105. Moreover, within the scope of the present
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`disclosure, 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 deviceis
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`configured to be uniquely identified by each of the other devices in the system so that
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`communication conflict is readily resolved between the various components within the analyte
`
`
`
`
`
`monitoring system 100.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0030] In one embodimentof the present disclosure, the sensor unit 101 is physically positioned
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`in or on the body of a user whose analyte level is being monitored. The sensor unit 101 may be
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`configured to continuously sample the analyte level of the user and convert the sampled analyte
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`level into a corresponding data signal for transmission by the data processing and transmitter unit
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`102. In certain embodiments, the data processing and transmitter unit 102 may be physically
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`coupled to the sensor unit 101 so that both devices are integrated in a single housing and
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`positioned on the user's body. The data processing and transmitter unit 102 may perform data
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`processing suchasfiltering and encoding on data signals and/or other functions, each of which
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`correspondsto a sampled analyte level of the user, and in any event data processing and
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`transmitter unit 102 transmits analyte information to the primary receiver unit 104 via the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`communication link 103. Examples of such integrated sensor and transmitter units can be found
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`in, among others, U.S. Patent Application No. 12/698,124, incorporated herein by reference.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0031] In one embodiment, the analyte monitoring system 100 is configured as a one-way RF
`
`
`
`7
`
`Page 7 of 37
`Page 7 of 37
`
`

`

`
`
`Docket No. A0130.0090.C3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`communication path from the data processing and transmitter unit 102 to the primary receiver
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`unit 104. In such embodiment, the data processing and transmitter unit 102 transmits the sampled
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`data signals received from the sensor unit 101 without acknowledgementfrom the primary
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`receiver unit 104 that the transmitted sampled data signals have been received. For example, the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`data processing and transmitter unit 102 may be configured to transmit the encoded sampled data
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`signals at a fixed rate (e.g., at one minute intervals) after the completion of the initial power on
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`procedure. Likewise, the primary receiver unit 104 may be configured to detect such transmitted
`
`
`
`
`
`
`
`
`
`
`
`
`
`encoded sampled data signals at predetermined time intervals. Alternatively, the analyte
`
`
`
`
`
`
`
`
`
`
`
`
`
`monitoring system 100 may be configured with a bi-directional RF (or otherwise)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`communication between the data processing and transmitter unit 102 and the primary receiver
`
`
`
`
`
`unit 104.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0032] Additionally, in one aspect, the primary receiver unit 104 may include twosections. The
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`first section is an analog interface section that is configured to communicate with the data
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`processing and transmitter unit 102 via the communication link 103. In one embodiment, the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`analog interface section may include an RF receiver and an antenna for receiving and amplifying
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the data signals from the data processing and transmitter unit 102, whichare thereafter,
`
`
`
`
`
`
`
`
`
`
`
`
`
`demodulated with a local oscillator and filtered through a band-passfilter. The second section of
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the primary receiver unit 104 is a data processing section which is configured to process the data
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`signals received from the data processing and transmitter unit 102 such as by performing data
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`decoding, error detection and correction, data clock generation, and data bit recovery.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0033] In operation, upon completing the power-on procedure, the primary receiver unit 104 is
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`configured to detect the presence of the data processing and transmitter unit 102 within its range
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`based on, for example, the strength of the detected data signals received from the data processing
`
`
`
`
`
`
`
`
`
`
`
`
`and transmitter unit 102 and/or a predetermined transmitter identification information. Upon
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`successful synchronization with the corresponding data processing and transmitter unit 102, the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`primary receiver unit 104 is configured to begin receiving from the data processing and
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`transmitter unit 102 data signals correspondingto the user's detected analyte level. More
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`specifically, the primary receiver unit 104 in one embodimentis configured to perform
`
`
`
`
`
`
`
`
`
`
`
`
`
`synchronized time hopping with the corresponding synchronized data processing and transmitter
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`unit 102 via the communication link 103 to obtain the user's detected analyte level.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0034] Referring again to FIG. 1, the data processing terminal 105 may include a personal
`
`
`
`-8-
`
`Page 8 of 37
`Page 8 of 37
`
`

`

`
`
`Docket No. A0130.0090.C3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`computer, a portable computer such as a laptop or a handheld device (e.g., personal digital
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`assistants (PDAs)), and the like, each of which may be configured for data communication with
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the receiver via a wired or a wireless connection. Additionally, the data processing terminal 105
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`may further be connected to a data network (not shown)for storing, retrieving and updating data
`
`
`
`
`
`
`
`
`
`
`
`
`corresponding to the detected analyte level of the user.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0035] Within the scope of the present disclosure, the data processing terminal 105 may include
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`an infusion device such as an insulin infusion pump (external or implantable) or the like, which
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`may be configured to administer insulin to patients, and which may be configured to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`communicate with the receiver unit 104 for receiving, among others, the measured analytelevel.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Alternatively, the receiver unit 104 may be configured to integrate or otherwise couple to an
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`infusion device therein so that the receiver unit 104 is configured to administer insulin therapy to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`patients, for example, for administering and modifying basal profiles, as well as for determining
`
`
`
`
`
`
`
`
`
`
`
`
`
`appropriate boluses for administration based on, amongothers, the detected analyte levels
`
`
`
`
`
`
`
`
`
`received from the data processing and transmitter unit 102.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0036] Additionally, the data processing and transmitter unit 102, the primary receiver unit 104
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`and the data processing terminal 105 may each be configured for bi-directional wireless
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`communication such that each of the data processing and transmitter unit 102, the primary
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`receiver unit 104 and the data processing terminal 105 may be configured to communicate(that
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`is, transmit data to and receive data from) with each other via the wireless communication link
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`103. Morespecifically, the data processing terminal 105 may in one embodiment be configured
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`to receive data directly from the data processing and transmitter unit 102 via the communication
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`link 103, where the communication link 103, as described above, may be configured forbi-
`
`
`directional communication.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0037] In this embodiment, the data processing terminal 105 which may include an insulin pump,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`may be configured to receive the analyte signals from the data processing and transmitter unit
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`102, and thus, incorporate the functions of the receiver 104 including data processing for
`
`
`
`
`
`
`
`
`
`
`
`
`managing the patient's insulin therapy and analyte monitoring. In one embodiment, the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`communication link 103 may include one or more of an RF communication protocol, an infrared
`
`
`
`
`
`
`
`
`
`
`
`
`
`communication protocol, a Bluetooth® enabled communication protocol, an 802.11x wireless
`
`
`
`
`
`
`
`
`
`
`
`
`
`communication protocol, or an equivalent wireless communication protocol which would allow
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`secure, wireless communication of several units (for example, per HIPPA requirements) while
`
`
`
`-9-
`
`Page 9 of 37
`Page 9 of 37
`
`

`

`
`
`Docket No. A0130.0090.C3
`
`
`
`
`
`
`
`
`avoiding potential data collision and interference.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0038] FIG. 2 is a block diagram ofthe transmitter of the data monitoring and detection system
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`shownin FIG. | in accordance with one embodimentofthe present disclosure. Referring to the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Figure, the data processing and transmitter unit 102 in one embodimentincludes an analog
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`interface 201 configured to communicate with the sensor unit 101 (FIG. 1), a user input 202, and
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`a temperature measurement section 203, each of whichis operatively coupled to a transmitter
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`processor 204 such as a central processing unit (CPU). As can be seen from FIG.2, there are
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`provided four contacts, three of which are electrodes--work electrode (W) 210, guard contact (G)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`211, reference electrode (R) 212, and counter electrode (C) 213, each operatively coupled to the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`analog interface 201 of the data processing and transmitter unit 102 for connection to the sensor
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`unit 101 (FIG. 1). In one embodiment, each of the work electrode (W) 210, guard contact (G)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`211, reference electrode (R) 212, and counter electrode (C) 213 may be made using a conductive
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`material that is either printed or etched or ablated, for example, such as carbon which may be
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`printed, or a metal such as a metal foil (e.g., gold) or the like, which may be etched or ablated or
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`otherwise processed to provide one or more electrodes. Fewer or greater electrodes and/or
`
`
`
`
`
`
`
`
`
`contact may be provided in certain embodiments.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0039] Further shownin FIG. 2 are a transmitter serial communication section 205 and an RF
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`transmitter 206, each of whichis also operatively coupled to the transmitter processor 204.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Moreover, a power supply 207 such as a battery is also providedin the data processing and
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`transmitte