`
`
`
`US 20140176338A1633
`
`as) United States
`a2) Patent Application Publication (10) Pub. No.: US 2014/0176338 Al
`Heetal.
`(43) Pub. Date:
`Jun. 26, 2014
`
`(54) WIRELESS COMMUNICATION
`AUTHENTICATION FOR MEDICAL
`MONITORING DEVICE
`
`(52) U.S.Cl.
`CPG.
`sroncanorsasnnosnasnntasnersgscanannesis GO8C17/02 (2013.01)
`USPC stcassarsancsaciearee 340/870.02
`
`(71) Applicant: ABBOTT DIABETES CAREINC.,
`Alameda, CA (US)
`Inventors: Lei Lawrence He, Moraga, CA (US);
`Mare B. Taub, Mountain View, CA (US)
`
`(72)
`
`(73) Assignee: ABBOTT DIABETES CAREINC.,
`Alameda, CA (US)
`
`(21) Appl. No.: 13/722,223
`
`(22)
`
`Filed:
`
`Dee. 20, 2012
`
`Publication Classification
`
`(51)
`
`Int. Cl.
`GO08C17/02
`
`(2006.01)
`
`(57)
`ABSTRACT
`Methods, systems, and devices for short-range low-power
`wireless communication ofanalyte informationare provided.
`In some implementations, short-range low-power wireless
`communicationof analyte information mayinclude receiving
`an electromagnetic wireless communication signal and har-
`vesting energy fromthe electromagnetic wireless communi-
`cation signal. In some implementations, short-range low-
`powerwireless communication of analyte information may
`include enabling capabilities associated with anexternal sen-
`sor in response to detecting the external sensor. In some
`implementations, short-range low-powerwireless communi-
`cation ofanalyte information mayinclude detecting an ana-
`lyte sample: determining an analyte concentration associated
`with the detected analyte sample; and transmitting an indica-
`tionofthe analyte concentration to an external device.
`
`110
`
`120
`
`152
`
`130 DATA
`
`140
`
`PROCESSING
`UNIT
`
`158
`
`100
`
`
`
`Page 1 of 17
`
`

`

`
`
`
`
`
`
`
`
`
`Patent Application Publication
`Jun. 26,2014 Sheet 1 of 6
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`US 2014/0176338 Al
`
`
`
`
`
`
`
`
`
`bOC
`
`
`
`
`
`
`
`
`
`
`
`
`
`orl
`
`
`
`02c
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Or
`
`
`
`
`
`
`
`
`
`
`
`
`
`¢Old
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`wisn
`
`
`
`JOVIMLINI
`
`
`
`YOSNAS
`
`
`
`JOVAUTINI
`
`
`
`
`
`
`
`
`
`C0
`
`
`
`
`
`Osc
`
`
`
`YOSNAS
`
`Page 2 of 17
`Page 2 of 17
`
`
`

`

`
`
`Patent Application Publication
`
`
`
`
`
`
`
`
`Jun. 26, 2014 Sheet 2 of 6
`
`
`
`US 2014/0176338 Al
`
`
`
`310
`
`FIG.3
`
`
`
`
`
`
`
`
`
`
`
`320
`
`
`
`
`
`
`
`
`
`
`
`320
`320390 aC »
`320 Ly
`
`320
`
`\
`
`
`
`
`
`
`
`
`
`
`
`Page 3 of 17
`Page 3 of 17
`
`

`

`
`
`Patent Application Publication
`
`
`
`
`
`
`
`
`Jun. 26, 2014 Sheet 3 of 6
`
`
`
`US 2014/0176338 Al
`
`
`
`e
`QS
`om
`
`
`=
`S
`se
`
`
`
`FIG.4
`
`
`
`
`
`
`Page 4 of 17
`Page 4 of 17
`
`

`

`Patent Application Publication
`
`Jun. 26,2014 Sheet 4 of 6
`
`US 2014/0176338 Al
`
`SCAVENGING
`
`UNIT
`
` ENERGY
`
`550
`
`FIG.5
`
`Page 5 of 17
`
`

`

`
`
`Patent Application Publication
`
`
`
`
`
`
`
`
`Jun. 26, 2014 Sheet 5 of 6
`
`
`
`US 2014/0176338 Al
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`FIG. 7
`
`
`
`
`
`
`
`
`
`
`
`
`709
`
`
`
`
`
`
`
`
`
`
`
`
`77
`
`Page 6 of 17
`Page 6 of 17
`
`

`

`
`
`Patent Application Publication
`
`
`
`
`
`
`
`
`Jun. 26, 2014 Sheet 6 of 6
`
`
`
`US 2014/0176338 Al
`
`
`
`
`
`POWER ON
`
`
`
`SEARCH FOR SENSOR
`
`
`
`
`
`
`ENABLE SENSOR CAPABILITIES
`
`
`
`DETECT SAMPLE
`
`
`
`ANALYZE SAMPLE
`
`
`
`
`DETERMINE ANALYTE CONCENTRATION
`
`
`
`
`STORE ANALYTE INFORMATION
`
`
`
`
`
`TRANSMIT ANALYTE INFORMATION
`
`
`FIG.8
`
`
`
`
`810
`
`
`820
`
`
`830
`
`
`840
`
`
`850
`
`
`860
`
`
`870
`
`
`880
`
`Page 7 of 17
`Page 7 of 17
`
`

`

`
`
`US 2014/0176338 Al
`
`
`
`Jun. 26, 2014
`
`
`
`
`
`WIRELESS COMMUNICATION
`
`
`AUTHENTICATION FOR MEDICAL
`
`
`MONITORING DEVICE
`
`
`
`
`
`TECHNICAL FIELD
`
`
`
`
`
`
`
`
`
`
`
`
`
`to a
`[0001] The embodiments herein relate in general
`
`
`
`
`
`
`
`
`device and method for determining and reporting glucose
`
`
`
`
`readings using wireless communication.
`
`BACKGROUND
`
`
`
`
`
`
`
`
`
`
`[0002] Analyte monitoring systems, such as glucose moni-
`
`
`
`
`
`
`
`toring systems, including continuous and discrete monitoring
`
`
`
`
`
`
`
`systems, may include a battery powered and microprocessor
`
`
`
`
`
`
`
`
`controlled system whichis configured to detect signals pro-
`
`
`
`
`
`
`
`
`portional to the corresponding measured glucoselevels using
`an electrometer, and transmit the collected data, such as via
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`radio frequency (RF) transmission. In some implementations,
`
`
`
`
`
`
`
`glucose monitoring systems may include a transcutaneous or
`subcutaneous analyte sensor configuration which maybe, for
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`example, partially mounted on the skin of a subject whose
`
`
`
`
`
`
`
`
`
`
`
`
`glucoselevel is to be monitored. The sensor may use a two or
`
`
`
`
`
`
`
`three electrode (work, reference, and counter electrodes) con-
`
`
`
`
`
`
`figuration driven by a controlled potential (potentiostat) ana-
`
`
`
`
`
`
`log circuit connected through a contact system.
`
`
`
`
`
`
`
`
`
`
`[0003]
`In view of the foregoing, it would be desirable to
`
`
`
`
`
`
`
`provide a short-range low-energy communication unit in a
`
`
`
`
`
`data monitoring and managementsystem.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`analyte sample using the external sensor interface, determine
`
`
`
`
`
`
`
`an analyte concentration associated withthe detected analyte
`
`
`
`
`
`
`
`
`sample, and transmit an indication of the analyte concentra-
`tion to an external device.
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0008]
`Ina fourth aspect, the present disclosure provides a
`
`
`
`
`
`
`
`method including enabling an external sensor interface,
`
`
`
`
`
`
`
`
`
`
`wherein the external sensorinterface is one of a plurality of
`
`
`
`
`
`
`
`
`capabilities associated with an external sensor, wherein each
`
`
`
`
`
`
`
`
`
`capability in the plurality of capabilities associated with the
`
`
`
`
`
`
`
`
`
`external sensoris disabled, searching for the external sensor,
`
`
`
`
`
`
`
`
`
`in response to detecting the external sensor, enabling each
`
`
`
`
`
`
`
`
`
`capability in the plurality of capabilities associated with the
`
`
`
`
`
`
`
`
`external sensor, detecting an analyte sample using the exter-
`
`
`
`
`
`
`nal sensor interface, determining an analyte concentration
`
`
`
`
`
`
`
`associated with the detected analyte sample, andtransmitting
`
`
`
`
`
`
`
`
`an indication of the analyte concentration to an external
`device.
`
`
`It should be noted that two or more of the embodi-
`[0009]
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ments described herein, including those described above,
`
`
`
`
`
`
`
`
`
`may be combined to produce one or more additional embodi-
`ments whichinclude the combined features ofthe individual
`
`
`
`
`
`
`
`
`embodiments.
`
`
`
`
`
`
`
`
`
`
`
`[0010] These and other objects, features, and advantages of
`
`
`
`
`
`
`
`
`
`the present disclosure will become more fully apparent from
`
`
`
`
`
`
`
`
`the following detailed description of the embodiments, the
`
`
`
`
`
`
`appendedclaims and the accompanying drawings.
`
`
`
`
`
`
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`
`
`
`
`
`
`BRIEF SUMMARY
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`FIG. 1 shows a block diagram of an analyte data
`[0011]
`
`
`
`
`
`
`monitoring and management system in accordance with
`
`
`
`
`
`
`
`
`
`In accordance with the various embodiments of the
`[0004]
`
`
`
`
`
`embodiments of the present disclosure;
`
`
`
`
`
`
`
`
`present disclosure, there are provided methods, devices, and
`
`
`
`
`
`
`[0012] FIG.2 shows a diagramofa health monitor device in
`
`
`
`
`
`accordance with embodiments ofthis disclosure;
`systemsfor providing a short-range low-energy communica-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`tion unit in a data monitoring and management system.
`
`
`
`
`
`
`
`
`
`
`FIG. 3 shows examples ofa health monitor device in
`[0013]
`communication with external devices in accordance with
`
`
`
`
`
`
`
`
`
`
`[0005] Inafirst aspect, the present disclosure provides a
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`device, including a housing, a processor coupled to the hous-
`embodiments ofthis disclosure;
`
`
`
`
`
`
`
`
`
`
`
`
`
`ing, a memory unit configured to store computer executable
`
`
`
`
`
`
`
`
`FIG. 4 shows a perspective view diagramofa health
`[0014]
`
`
`
`
`
`
`
`
`
`instructions, an antenna, an energy scavenging unit, and a
`monitor device in accordance with embodiments of this dis-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`processor configured to execute the computer executable
`closure.
`
`
`
`
`
`
`
`
`
`
`instructions stored in the memory to contro] the energy scav-
`
`
`
`
`
`
`
`
`FIG. 5 shows a block diagram ofa wirelessly pow-
`[0015]
`
`
`
`
`
`
`
`
`
`enging unit to harvest energy from an electromagneticsignal
`ered health monitor device in accordance with embodiments
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`received by the antenna, detect an analyte sample, determine
`of this disclosure;
`
`
`
`
`
`
`
`
`
`
`
`an analyte concentration associated with the detected analyte
`
`
`
`
`
`
`
`
`[0016]
`FIG. 6 shows a perspective viewdiagramof a wire-
`
`
`
`
`
`
`
`
`sample, and transmit an indication of the analyte concentra-
`
`
`
`
`
`
`
`
`lessly powered health monitor device and external device in
`
`
`
`
`
`
`
`
`
`tion to an external device using the harvested energy.
`accordance with embodiments of this disclosure;
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0006]
`Inasecond aspect, the present disclosure provides a
`
`
`
`
`
`
`
`
`FIG. 7 shows an example of wirelessly powered
`[0017]
`
`
`
`
`
`
`method including receiving an electromagnetic wireless
`
`
`
`
`
`
`
`wireless communication of analyte data in accordance with
`
`
`
`
`
`
`communication signal, harvesting energy from the electro-
`embodiments ofthis disclosure; and
`
`
`
`
`
`
`
`
`
`
`
`magnetic wireless communication signal, detecting an ana-
`
`
`
`
`
`
`
`
`
`FIG. 8 is an example ofenabling suppressed capa-
`[0018]
`
`
`
`
`
`
`lyte sample, determining an analyte concentration associated
`bilities in accordance with embodimentsofthis disclosure.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`with the detected analyte sample, and transmitting an indica-
`
`
`
`
`
`
`
`
`
`
`tion of the analyte concentration to an external device using
`
`
`
`the harvested energy.
`
`
`
`
`
`
`
`
`[0007]
`In a third aspect, the present disclosure provides a
`
`
`
`
`
`
`
`
`device, including a housing, a memory unit configured to
`
`
`
`
`
`
`
`store computer executable instructions, a transceiver, a plu-
`
`
`
`
`
`
`
`
`rality of capabilities associated with an external sensor,
`
`
`
`
`
`
`
`
`wherein each capability in the plurality of capabilities asso-
`
`
`
`
`
`
`
`
`
`ciated with the external sensor is disabled, and a processor
`
`
`
`
`
`
`
`configured to execute the computer executable instructions
`
`
`
`
`
`
`
`
`
`
`stored in the memory to enable an external sensor interface,
`
`
`
`
`
`
`
`
`
`
`search for the external sensor, in response to detecting the
`
`
`
`
`
`
`
`
`
`external sensor, enable each capability in the plurality of
`
`
`
`
`
`
`
`
`capabilities associated with the external sensor, detect an
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`DETAILED DESCRIPTION
`
`
`
`
`
`
`
`[0019] As described in accordance with the various
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`embodiments of the present disclosure below,there are pro-
`
`
`
`
`
`
`
`vided methods and systems for utilizing short-range low-
`
`
`
`
`
`
`
`
`energy wireless communicationsin anelectronic device used
`
`
`
`
`
`
`
`
`
`in analyte monitoring and management systems, such as ina
`
`
`
`
`
`glucose monitoring and management systems.
`
`
`
`
`
`
`
`
`
`[0020] Although FIGS.1-8 are described with reference to
`
`
`
`
`
`
`
`glucose monitoring, any data monitoring and management
`
`
`
`
`
`
`
`
`
`system may be used. For example, an analyte monitoring
`
`
`
`
`
`
`
`
`
`
`system may monitor a variety of analytes, such as, lactate,
`
`
`
`
`
`
`ketones, acetyl choline, amylase, bilirubin, cholesterol,
`Page 8 of 17
`Page 8 of 17
`
`

`

`
`
`US 2014/0176338 Al
`
`
`
`Jun. 26, 2014
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`In another
`as a continuous analyte monitoring device.
`chorionic gonadotropin, creatine kinase (e.g., CK-MB), cre-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`example,
`the transmitter unit 120 may be configured to
`atine, DNA, fructosamine, glucose, glutamine, growth hor-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`receive a fluid sample transported bya test strip and to receive
`mones, hormones, ketones, lactate, peroxide, prostate-spe-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`analyte data from an external monitoring device. In some
`cific antigen, prothrombin, RNA,
`thyroid stimulating
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`embodiments, the transmitter unit 120 may be configured to
`hormone, and troponin. In some implementations, the con-
`control the sensor unit 110.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`centration of drugs, such as, for example, antibiotics (e.g.,
`
`
`
`
`
`
`
`gentamicin, vancomycin, and the like), digitoxin, digoxin,
`
`
`
`
`
`
`
`
`
`[0027] The transmitter unit 120 may be configured to com-
`municate withthe receiver unit 130 via a communicationlink
`
`
`
`
`
`
`
`
`drugs of abuse, theophylline, and warfarin, may be moni-
`
`
`
`
`
`
`
`
`tored.
`
`
`
`
`
`
`
`
`
`
`154. Insome embodiments,the transmitter device 120 may be
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`configured without a user interface or display to minimize the
`FIG. 1 shows a block diagram of an analyte data
`[0021]
`size and cost of the transmitter device 120. In some embodi-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`monitoring and management system 100, such as a glucose
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ments, the transmitter unit 120 may be mounted on the sensor
`monitoring system, in accordance with embodiments of the
`unit 110, or the sensor unit 110 and the transmitter unit 120
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`present disclosure. The analyte data monitoring and manage-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`may be configured as a combined unit, and both units may be
`ment system 100 may include a sensor unit 110, a transmitter
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`positioned on a user’s body. The transmitter unit 120 may
`unit 120, a receiver unit 130, a data processing unit 140, orany
`combination thereof.
`
`
`
`
`
`
`
`
`
`
`
`
`perform data processing suchas filtering and encoding ofdata
`
`
`
`
`
`
`
`
`
`signals, each of which may correspond to a sampled glucose
`
`
`
`
`
`
`
`
`
`
`In some implementations, one or more of the sensor
`[0022]
`
`level of the user, for transmission to the receiver unit 130 via
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`unit 110, the transmitter unit 120, the receiver unit 130, or the
`
`
`
`
`
`
`
`
`
`the communication link 154.
`
`
`
`
`
`
`
`
`
`
`
`
`
`data processing unit 140 may be configured to communicate
`via a wiredor Wireless communicationlink 152/154/156/158.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0028]
`Insome embodiments, the communication link 154
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`may be unidirectional from the transmitter unit 120 to the
`For example, communicating via a wireless communication
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`receiver unit 130. The transmitter unit 120 may transmit
`link may include using one or more of an radio frequency
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`sampled data signals received fromthe sensor unit 110 with-
`(RF) communication protocol, a near field communication
`
`
`
`
`
`
`
`
`
`
`
`
`
`out acknowledgement
`from the receiver unit 130. For
`(NFC) protocol, a radio frequency identification (RFID) pro-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`example, the transmitter unit 120 may be configured to trans-
`tocol, an infrared communication protocol, a Bluetooth®
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`mit encoded sampled data signals at a fixed rate (e.g., at one
`communication protocol, an 802.11x wireless communica-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`minute intervals) after the completionof an initial power on
`tion protocol, or an equivalent wireless communicationpro-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`procedure. The receiver unit 130 may be configured to detect
`tocol which may provide secure, wireless communication
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`transmitted encoded sampled data signals at predetermined
`with one or more units while avoiding data collision and
`time intervals.
`interference.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0029] The receiver unit 130 may be configured to receive
`[0023] The sensor unit 110 may communicate with the
`data from the transmitter unit 120 via communication link
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`transmitter unit 120 to provide monitored or detected analyte
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`154 and to transmit data to the data processing unit 140 for
`information. The sensor unit 110 may communicate the ana-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`evaluation via communication link 156. In some implemen-
`lyte information in response to manual interaction, based on
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`tations, the receiver unit 130 may include an analog interface
`a transmission schedule, or in response to a request from the
`transmitter unit 120.
`
`
`
`
`
`
`
`
`
`
`
`
`unit, which may be configured to communicate withthe trans-
`mitter unit 120 via the communication link 154, and a data
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`In some implementations, the sensor unit 110 may
`[0024]
`
`
`
`
`
`
`
`
`processing unit, which may be configured to process data
`
`
`
`
`
`
`
`
`
`
`be a test strip, which may be an electrochemical analyte test
`
`
`
`
`
`
`
`
`signals received fromthe transmitter unit 120, by performing,
`
`
`
`
`
`
`
`
`
`
`
`
`strip, such as a blood glucose test strip or other fluid sample
`
`
`
`
`
`
`
`for example, data decoding, error detection and correction,
`
`
`
`
`
`
`
`
`
`
`receptionunit. The test strip may be mechanically received in
`
`
`
`
`
`
`
`
`
`data clock generation, or data bit recovery. In some embodi-
`
`
`
`
`
`
`
`
`
`
`
`
`a test strip port of the transmitter unit 120, which may be a
`
`
`
`
`
`
`
`
`ments, the analog interface section may include or wireless
`
`
`
`
`hand-held blood glucose meter.
`
`
`
`
`
`
`
`communication receiver and an antenna for receiving and
`
`
`
`
`
`
`
`
`In some implementations, the sensor unit 110 may
`[0025]
`
`
`
`
`
`
`
`
`
`amplifying the data signals fromthe transmitter unit 120. The
`
`
`
`
`
`
`
`
`
`be an external monitoring device, such as a continuous ana-
`
`
`
`
`
`
`
`
`
`signals may be processed at
`the receiver unit 130. For
`
`
`
`
`
`
`
`
`
`
`lyte monitoring device. For example, the sensor unit 110 may
`
`
`
`
`
`
`
`
`example, the signals may be demodulated with a local oscil-
`
`
`
`
`
`
`
`
`
`
`
`be physically positioned in or on the body of a user whose
`
`
`
`
`
`
`lator and filtered througha band-passfilter.
`
`
`
`
`
`
`
`
`
`
`
`glucose level is being monitored, and the sensor unit 110 may
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0030]
`Insome implementations, the receiver unit 130 may
`continually or substantially continually measure an analyte
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`be configured to detect the presence of the transmitter unit
`concentration of a bodily fluid. In some embodiments, the
`
`
`
`
`
`
`
`
`
`
`120 within a range based on, for example, the strength ofthe
`
`
`
`
`
`
`
`
`
`
`
`sensor unit 120 may be configured as a compact, lowprofile
`
`
`
`
`
`
`
`
`
`detected data signals received fromthe transmitter unit 120 or
`
`
`
`
`
`
`
`on-body patch device assembled ina single integrated hous-
`
`
`
`
`
`based on predetermined transmitter identification informa-
`
`
`
`
`
`
`
`
`
`
`
`ing and positioned on a skin surface of the user or the patient
`
`
`
`
`
`
`
`
`
`
`tion. The receiver unit 130 and the transmitter unit 120 may
`
`
`
`
`
`
`
`
`
`with a portion ofthe analyte sensor maintained in fluid con-
`
`
`
`
`
`
`
`
`
`synchronize and the receiver unit 130 may receive data sig-
`
`
`
`
`
`
`
`
`
`
`tact with a bodily fluid such as an interstitial fluid. The sensor
`
`
`
`
`
`
`
`
`
`nals corresponding to the user’s detected glucose level from
`
`
`
`
`
`
`
`
`unit 110 may be configured to continuously sample the glu-
`
`
`
`
`
`
`
`
`
`the transmitter unit 120. For example, the receiver unit 130
`
`
`
`
`
`
`
`
`
`
`cose level of the user and convert the sampled glucose level
`
`
`
`
`
`
`
`may be configured to perform synchronized time hopping
`
`
`
`
`
`
`
`
`into a correspondingdata signal for transmissionby the trans-
`mitter unit 120.
`
`
`
`
`
`
`
`with the corresponding synchronized transmitter unit 120 via
`
`
`
`the communication link 154 to obtain the user’s detected
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0026] The transmitter unit 120 may be configured to
`
`
`glucose level.
`
`
`
`
`
`
`
`
`
`receive analyte information from the sensor unit 110. For
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`In some embodiments, the receiver unit 130 may
`[0031]
`example,
`the transmitter unit 120 may be configured to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`receive a fluid sample transported byatest strip. In another include a PDA or smartphone, which may synchronize data
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`example,
`the transmitter unit 120 may be configured to
`with the data processing unit 140, which may be a personal
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`receive analyte data froman external monitoring device, such
`computer (PC). In another embodiment, the receiver unit 130
`Page 9 of 17
`Page 9 of 17
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`
`
`US 2014/0176338 Al
`
`
`
`Jun. 26, 2014
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`may include a mobile phone, which may communicate via a
`as the transmitter unit 120 shownin FIG. 1, a server device.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`such as the receiver unit 130 shown in FIG. 1, or both. The
`cellular network with the data processing unit 140, which
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`health monitor device 200 may be used for determining a
`may be a computer system at, for example, a physician's
`office.
`
`
`
`
`
`
`
`
`
`
`
`concentration ofan analyte in blood orinterstitial fluid. For
`
`
`
`
`
`
`
`
`
`
`
`example, the health monitor device 200 may be ananalyte test
`
`
`
`
`
`
`
`
`
`
`[0032] The data processing unit 140 may be configured to
`evaluate data received from the receiver unit 130. In some
`
`
`
`
`
`
`
`
`
`
`
`
`meter, such as a glucose test meter that may be used for
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`determining an analyte concentration, suchas a blood glucose
`
`
`
`
`
`
`
`
`implementations, the data processing unit 140 may be con-
`
`
`
`
`
`
`
`concentration, of a sample for determination ofa blood glu-
`
`
`
`
`
`
`
`
`
`figured to communicate directly with the transmitter unit 120
`
`
`
`
`
`
`
`
`
`
`cose level of a patient, such as a patient with Type-1 or Type-2
`
`
`
`
`
`
`
`
`via communicationlink 158. In some implementations, the
`diabetes. In some embodiments, the health monitor device
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`receiver unit 130 may be configured to include the functions
`
`
`
`
`
`
`
`
`
`
`200 may be a blood glucose meter, a continuous monitor, an
`
`
`
`
`
`
`
`
`
`
`
`
`of the data processing unit 140 such that the receiver unit 130
`
`
`
`
`
`
`
`
`
`
`
`insulin pump, a blood pressure meter, a heart rate monitor, a
`
`
`
`
`
`
`
`
`
`
`may be configured to receive and evaluate data from the
`transmitter unit 120.
`thermometer, or any other health monitor device capable of
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`measuring, monitoring, or storing raw or analyzed medical
`
`
`
`
`
`
`
`
`In some implementations, the data processing unit
`[0033]
`
`
`data electronically.
`
`
`
`
`
`
`
`
`
`140 may include a personal computer, a portable computer
`
`
`
`
`
`
`
`
`
`
`such as a laptop or a handheld device(e.g., a personal digital
`
`
`
`
`
`
`
`
`
`[0038] The health monitor device 200 may communicate in
`
`
`
`
`
`
`
`
`
`
`assistant (PDA) or smartphone), and the like, and may be
`
`
`
`
`
`
`
`
`
`a wireless communicationsystem, such as the system shown
`
`
`
`
`
`
`
`
`
`configured for data communication with the receiver unit 130
`
`
`
`
`
`
`
`
`
`
`
`in FIG. 1. For example, the health monitor device 200 may
`via a wired or a wireless communication link.
`In some
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`receive fluid samples, or sample data, from a sensor device
`
`
`
`
`
`
`
`
`
`embodiments, the data processing unit 140 may be connected
`
`
`
`
`
`
`
`
`
`
`
`
`
`202, such as the sensor unit 110 shown in FIG. 1, and may
`
`
`
`
`
`
`
`
`
`
`to a data network (not shown) for storing, retrieving and
`
`
`
`
`
`
`
`
`
`
`
`wirelessly transmit data to an external device 204, such as the
`
`
`
`
`
`
`
`
`
`updating data corresponding to the detected glucose level of
`
`
`
`
`
`
`
`
`
`
`
`receiver unit 130 or the data processing unit 140 shownin
`the user.
`
`
`
`
`
`
`
`
`
`
`
`
`FIG. 1. The health monitor device 200 may include a housing
`
`
`
`
`
`
`
`In some implementations, the data processing unit
`[0034]
`
`
`
`
`
`
`
`
`
`
`210, a processor 220, a sensor interface 230, a user interface
`
`
`
`
`
`
`
`
`
`
`140 may include an infusion device such as an insulin infu-
`
`
`
`
`
`
`
`
`
`
`240, a clock 250, a data storage unit 260, a power supply 270,
`
`
`
`
`
`
`
`
`
`
`sion pumporthe like, which may be configured to administer
`a communicationinterface 280, or a combination thereof.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`insulin to patients, and which may be configured to commu-
`
`
`
`
`
`
`
`
`
`[0039] The housing 210 may physically enclose one or
`
`
`
`
`
`
`
`
`
`
`nicate with the receiver unit 130 for receiving, for example,
`
`
`
`
`
`
`
`
`
`
`
`more of the processor 220, the sensor interlace 230, the user
`
`
`
`
`
`
`
`glucose level measurements.
`In some embodiments,
`the
`
`
`
`
`
`
`
`
`
`
`
`interface 240, the clock 250, the data storage unit 260, the
`
`
`
`
`
`
`
`
`
`
`receiver unit 130 may be integrated with an infusion device
`
`
`
`
`
`
`
`
`
`powersupply 270, or the communicationinterface 280, and
`
`
`
`
`
`
`
`
`
`
`and the receiver unit 130 may be configured to administer
`
`
`
`
`
`
`
`
`
`
`
`may be configured tofit into a small profile. Although the
`
`
`
`
`
`
`
`
`
`insulin therapy to patients, for example, for administering and
`
`
`
`
`
`
`
`
`
`
`housing 210 is shownasingle physical unit, the housing 210
`
`
`
`
`
`
`
`
`modifying basal profiles, as well as for determining appro-
`
`
`
`
`
`
`
`
`
`
`
`may be implemented as one or more physical units that may
`
`
`
`
`
`
`
`
`
`priate boluses for administration based on, for example, the
`
`
`
`
`
`
`
`be physically or electronically connected. Although not
`
`
`
`
`
`
`
`
`detected glucose levels recerved from the transmitter unit
`
`
`
`
`
`
`
`
`
`
`
`
`shownin FIG, 2, the housing 210 may include one or more
`120.
`
`
`
`
`
`
`
`
`
`
`
`ports, such asatest strip port, a powerport, an audio connec-
`
`
`
`
`
`
`
`
`[0035]
`In some implementations, the data processing unit
`
`
`
`
`
`
`
`
`
`
`tionport, or a data connectionport. For example, the housing
`
`
`
`
`
`
`
`
`
`140 may be configured to receive signals including glucose
`
`
`
`
`
`
`
`
`
`
`
`210 mayincludea test strip port configured to receiveatest
`
`
`
`
`
`
`
`
`information from the transmitter unit 120, and may incorpo-
`
`
`
`
`
`
`
`
`
`
`strip, which may include a fluid sample, and may be con-
`
`
`
`
`
`
`
`
`
`
`rate functions ofthe receiver unit 130, which may include
`nected to the sensorinterface 230.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`data processing for managing the patient’s insulin therapy
`
`
`
`
`
`
`
`
`
`[0040] The processor 220 may include any device capable
`
`
`
`and glucose monitoring.
`
`
`
`
`
`
`
`
`of manipulating or processing a signal or other information,
`
`
`
`
`
`
`
`
`
`
`[0036] Although FIG. 1 shows a sensor unit 110, a trans-
`
`
`
`
`
`
`
`
`including an optical processor, a quantum processor, a
`
`
`
`
`
`
`
`
`
`
`mitter unit 120, a receiver unit 130, and a data processing unit
`
`
`
`
`
`
`
`molecular processor, or a combination thereof. For example,
`
`
`
`
`
`
`
`
`140, the glucose monitoring communication system 100 may
`
`
`
`
`
`
`
`
`the processor 220 may include a general purpose processor, a
`
`
`
`
`
`
`include multiple sensors, multiple transmitters, multiple
`
`
`
`
`
`
`
`central processing unit (CPU), a special purpose processor,a
`
`
`
`
`
`
`
`communication links, multiple receivers, or multiple data
`
`
`
`
`
`
`
`plurality of microprocessors, a controller, a microcontroller,
`
`
`
`
`
`
`
`processing units.
`In some implementations,
`the glucose
`
`
`
`
`
`
`
`
`an Application Specific Integrated Circuit (ASIC), a Field
`
`
`
`
`
`
`
`monitoring communication system 100 may be a continuous
`
`
`
`
`
`
`
`Programmable Gate Array (FPGA), a programmable logic
`
`
`
`
`
`
`monitoring system, a semi-continuous monitoring system, or
`
`
`
`
`
`
`array, programmable logic controller, microcode, firmware,
`
`
`
`
`
`
`
`
`
`a discrete monitoring system. For example, the sensor unit
`
`
`
`
`
`
`
`
`
`
`
`any type of integrated circuit (IC), a state machine, or any
`
`
`
`
`
`
`
`
`
`
`
`
`110 may be configured asa test strip, the transmitter unit 120
`
`
`
`
`
`
`
`
`combination thereof. As used herein, the term “processor”
`
`
`
`
`
`
`
`
`
`may be configured as a hand-held blood glucose monitor, and
`
`
`
`
`
`
`
`
`includes a single processor or multiple processors. The pro-
`
`
`
`
`
`
`
`
`
`
`
`
`the receiver unit 130 and the data processing unit 140 may be
`
`
`
`
`
`
`
`
`
`cessor 220 may be operatively coupled tothe sensorinterface
`
`
`
`
`
`
`
`
`
`
`omitted. In another example, the sensor unit 110 may be
`
`
`
`
`
`
`
`
`
`
`
`230, the user interlace 240, the clock 250, the data storage unit
`
`
`
`
`
`
`
`
`configured as an external monitoring device, the transmitter
`
`
`
`
`
`
`
`
`260, the power supply 270, or the communication interface
`
`
`
`
`
`
`
`
`
`
`
`unit 120 may be configured as small device without a user
`280.
`
`interface to receive information from and control the sensor
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`unit 110, and the receiver unit 130 may be configured to
`
`
`
`
`
`
`
`
`
`Insome embodiments, the sensorinterface 230 may
`[0041]
`receive information fromand control the transmitter unit 120
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`receive a fluid sample. For example, the sensor 202 may be a
`
`
`
`
`
`
`
`
`and to provide a user interface for the system.
`
`
`
`
`
`
`
`
`
`
`
`test strip and the sensor interface 230 may receive a fluid
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0037]
`FIG. 2 shows a diagram ofa health monitor device
`sample transported via a test strip. The processor 220 may
`200 in accordance with embodiments of this disclosure. The
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`control the sensor interface 230 to analyze the fluid sample to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`health monitor device 200 may include a client device, such
`determine anassociated analyte level.
`
`
`
`
`
`Page 10 of 17
`Page 10 of 17
`
`

`

`
`
`US 2014/0176338 Al
`
`
`
`Jun. 26, 2014
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[0046] The power supply 270 may be any suitable device
`Insome embodiments, the sensorinterface 230 may
`[0042]
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`for powering the health monitor device 200, or any portion
`receive raw or analyzed data indicating an analyte level asso-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`thereof. For example, the power supply 270 may include a
`ciated with a fluid sample analyzed at an external measure-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`wired power source; one or more dry cell batteries, such as
`ment device, such as a continuous analyte monitoring device,
`
`
`
`
`
`
`
`
`via a wireless communication medium, such as radio fre-
`
`
`
`
`
`
`nickel-cadmium (NiCd), nickel-zinc (NiZn), nickel metal
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`hydride (NiMH), lithium-ion (Li-ion); solar cells; fuel cells;
`quency identification (RFID). For example, the continuous
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`or any other device capable of powering the health monitor
`analyte monitoring device may include a transcutaneously
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`device 200. The processor 220, the sensorinterface 230, the
`implanted sensor, such as an implantable glucose sensor, that
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`user interface 240, the clock 250, the data storage unit 260, or
`may continually or substantially continually measure an ana-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the communication interface 280, may be operatively
`lyte concentration of a bodily fluid. In some embodiments,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`coupled to the power supply 270.
`the sensor interface 230 mayreceive analyte related data from
`
`
`
`
`
`
`
`
`the external measurement device periodically, based on a
`
`
`
`
`
`
`[0047] The communication interface 280 may communi-
`cate with an external device 204, suchas the receiver unit 130
`transmission schedule, or may requestthe data fromtheexter-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`nal measurementdevice.
`
`
`
`
`
`
`
`
`
`
`
`shownin FIG, 1. For example, the communication interface
`
`
`
`
`
`
`