throbber
(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2009/0076360 A1
`Brister et al.
`(43) Pub. Date:
`Mar. 19, 2009
`
`US 2009.0076360A1
`
`(54) TRANSCUTANEOUSANALYTE SENSOR
`
`(21) Appl. No.:
`
`11/855,101
`
`(75) Inventors:
`
`Mark Brister, Encinitas, CA (US);
`Jack Pryor, San Diego, CA (US);
`James R. Petisce, San Diego, CA
`(US); John Nolting, Poway, CA
`(US); Jacob S. Leach, Carlsbad,
`CA (US); Luis Pestana, San Diego,
`CA (US); Nelson Quintana, San
`Diego, CA (US); Vance Swanson,
`San Diego, CA (US)
`Correspondence Address:
`KNOBBE, MARTENS, OLSEN & BEAR, LLP
`2040 MAINSTREET, FOURTEENTH FLOOR
`IRVINE, CA 92.614 (US)
`(73) Assignee:
`DexCom, Inc., San Diego, CA (US)
`
`
`
`(22) Filed:
`
`Sep. 13, 2007
`
`Publication Classification
`
`(51) Int. Cl.
`A6IB 5/145
`GOIN 27/327
`
`(2006.01)
`(2006.01)
`
`(52) U.S. Cl. .................................... 600/365; 204/403.01
`
`ABSTRACT
`(57)
`The present invention relates generally to systems and meth
`ods for measuring an analyte in a host. More particularly, the
`present invention relates to systems and methods for transcu
`taneous measurement of glucose in a host.
`
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`FIG. 4B
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`FIG, 4C
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`FIG. 11 A
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`US 2009/0076360 A1
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`SENSOR
`SYSTEM
`
`RECEIVER
`-/6(7
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`USER INTERFACE
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`f7f
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`FIG. 15A
`
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`US 2009/0076360 A1
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`FIG. 15D
`
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`
`
`
`
`
`
`
`
`
`
`INITIAL CALIBRATION
`
`2622
`
`RECEIVE SENSOR DATA FROM
`CONTINUOUSANALYTE SENSOR
`
`222
`
`RECEIVE REFERENCE DATA FROM
`REFERENCEANALYTE SOURCE
`
`MATCHTIME CORRESPONDING
`SENSOR DATA AND REFERENCE
`DATATO PROVIDE MATCHED
`DATA PARS
`
`FORMA CALIBRATION SET FROM
`MATCHEDPAIR(S)
`
`CALCULATE CONVERSION
`FUNCTIONUSING CALIBRATION SET
`
`2/7
`
`2/2
`
`2/4
`
`CONVERT SENSOR DATAUSING
`CONVERSIONFUNCTION
`
`PROVIDE OUTPUT TO USER
`
`FIG. 16A
`
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`
`{[9] 'OIH
`
`(SunOO) eleO eSOOn JOSueS
`
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`EVALUATEACCEPTABILITY OF
`REFERENCE AND SENSOR DATA
`
`227
`
`RECEIVE REFERENCE DATA FROM
`REFERENCE ANALYTE SOURCE
`
`22
`
`EVALUATEACCEPTABILITY OF
`REFERENCE DATA TO SUBSTANTIALLY
`TIME CORRESPONDING CALIBRATED
`SENSOR DATA
`(NEWMATCHED DATAPAIR)
`
`224
`
`
`
`
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`
`
`22A
`
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`ACCEPTABLE
`?
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`YES
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`NO
`
`-25
`RE-CALCULATE CONVERSION
`FUNCTION WITH NEWMATCHED
`PARADDED TO CALIBRATION SET
`
`
`
`--
`
`CONTINUOUSLY CONVERT SENSOR
`DATAUSING CONVERSION
`FUNCTION
`
`CONTINUOUSLY DISPLAY
`CONVERTED SENSOR DATAON
`USER INTERFACE
`
`
`
`
`
`-254
`
`ADJUST THE CALIBRATION SET
`
`-256
`RE-CALCULATE CONVERSION
`FUNCTION
`
`-24
`RE-EVALUATEACCEPTABILITY OF
`REFERENCE DATA TO RE
`CALCULATED SUBSTANTIALLY
`TIME CORRESPONDING SENSOR
`DATA (NEWMATCHED DATAPAIR)
`
`
`
`
`
`
`
`YES
`
`
`
`ACCEPTABLE
`
`FIG. 17
`
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`Mar. 19, 2009 Sheet 28 of 33
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`US 2009/0076360 A1
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`EVALUATE CALIBRATED SENSOR
`DATA FOR ABERRANT WALUES
`
`
`
`262
`
`
`
`
`
`
`
`
`
`RECEIVE NEW SENSOR DATA FROM
`CONTINUOUS GLUCOSE SENSOR
`
`25?
`
`CONVERTNEW SENSOR DATAUSING
`CONVERSION FUNCTION
`
`24
`
`COMPARENEW CALIBRATED
`SENSOR DATAWITH PREVIOUS
`CALIBRATED SENSOR DATA
`
`
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`AERT
`2
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`
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`NO
`
`SUSPEND CALIBRATION
`AND DISPLAY OF
`SENSOR GLUCOSE DATA
`
`
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`a?
`
`CONVERT SENSOR DATAUSING
`CONVERSION FUNCTION
`
`232
`
`FIG. 18
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`
`
`SELF-DAGNOSTIC OF SENSOR
`DATA
`
`RECEIVE SENSOR DATA FROM
`CONTINUOUS GLUCOSE SENSOR
`
`CONVERT SENSOR DATAUSING
`CONVERSION FUNCTION
`
`PERFORM SELF-DAGNOSTICS
`
`SET MODE OF OPERATION
`
`23.7
`
`FIG. 19
`
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`US 2009/0076360 A1
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`Page 31 of 81
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`Page 32 of 81
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`US 2009/0076360 A1
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`Page 33 of 81
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`US 2009/0076360 A1
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`Mar. 19, 2009
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`TRANSCUTANEOUSANALYTE SENSOR
`
`FIELD OF THE INVENTION
`0001. The present invention relates generally to systems
`and methods for measuring an analyte in a host. More par
`ticularly, the present invention relates to Systems and methods
`for transcutaneous measurement of glucose in a host.
`
`BACKGROUND OF THE INVENTION
`0002 Diabetes mellitus is a disorder in which the pancreas
`cannot create Sufficient insulin (Type I or insulin dependent)
`and/or in which insulin is not effective (Type 2 or non-insulin
`dependent). In the diabetic state, the victim suffers from high
`blood Sugar, which can cause an array of physiological
`derangements associated with the deterioration of Small
`blood vessels, for example, kidney failure, skin ulcers, or
`bleeding into the vitreous of the eye. A hypoglycemic reac
`tion (low blood Sugar) can be induced by an inadvertent
`overdose of insulin, or after a normal dose of insulin or
`glucose-lowering agent accompanied by extraordinary exer
`cise or insufficient food intake.
`0003 Conventionally, a person with diabetes carries a
`self-monitoring blood glucose (SMBG) monitor, which typi
`cally requires uncomfortable fingerpricking methods. Due to
`the lack of comfort and convenience, a person with diabetes
`normally only measures his or her glucose levels two to four
`times per day. Unfortunately, such time intervals are so far
`spread apart that the person with diabetes likely finds out too
`late of a hyperglycemic or hypoglycemic condition, some
`times incurring dangerous side effects. It is not only unlikely
`that a person with diabetes will take a timely SMBG value, it
`is also likely that he or she will not know if his or her blood
`glucose value is going up (higher) or down (lower) based on
`conventional method. This inhibits the ability to make edu
`cated insulin therapy decisions.
`
`SUMMARY OF THE INVENTION
`0004. In a first aspect, a sensor System for measuring an
`analyte concentration in a host is provided, the system com
`prising a sensor configured to continuously measure an ana
`lyte concentration in a host; a housing configured to receive
`the sensor, wherein the housing is adapted for placement
`adjacent to the host's skin; an electronics unit releasably
`attached to the housing, wherein the electronics unit is opera
`tively connected to the sensor and comprises a processor
`module configured to provide a signal associated with the
`analyte concentration in the host, and wherein the processor
`module is further configured to assemble a data packet for
`transmission; and an antenna configured for radiating or
`receiving a radio frequency transmission, wherein the
`antenna is located remote from the electronics unit.
`0005. In an embodiment of the first aspect, the system
`further comprises an adhesive layer disposed on the housing
`and configured to adhere the housing to the host's skin,
`wherein the antenna is located in the adhesive layer or on the
`adhesive layer.
`0006. In an embodiment of the first aspect, the adhesive
`layer is configured for use with only one sensor and the
`electronics unit is configured for reuse with more than one
`SSO.
`0007. In an embodiment of the first aspect, the antenna is
`located in the housing or on the housing.
`
`0008. In an embodiment of the first aspect, the housing is
`configured for use with only one sensor and the electronics
`unit is configured for reuse with more than one sensor.
`0009. In an embodiment of the first aspect, the antenna
`extends Substantially around a periphery of the housing.
`0010. In an embodiment of the first aspect, the system
`further comprises a power source configured and arranged to
`power at least one of the sensor and the electronics unit.
`0011. In an embodiment of the first aspect, the system
`further comprises an adhesive layer disposed on the housing
`and configured to adhere the housing to the host's skin,
`wherein the power source is located in the adhesive or on the
`adhesive.
`0012. In an embodiment of the first aspect, the adhesive
`layer is configured for use with only one sensor and the
`electronics unit is configured for reuse with more than one
`SSO.
`0013. In an embodiment of the first aspect, the power
`source comprises a thin and flexible battery.
`0014. In an embodiment of the first aspect, the power
`Source is located in the housing or on the housing.
`0015. In an embodiment of the first aspect, the housing is
`configured for use with only one sensor and the electronics
`unit is configured for reuse with more than one sensor.
`0016. In an embodiment of the first aspect, a height of the
`electronics unit is no more than about 0.250 inches in its
`Smallest dimension.
`0017. In an embodiment of the first aspect, an overall
`height of the system is no more than about 0.250 inches in its
`Smallest dimension.
`0018. In an embodiment of the first aspect, the sensor is
`configured for insertion into the host's tissue.
`0019. In a second aspect, a sensor System for measuring an
`analyte concentration in a host is provided, the system com
`prising a sensor configured for insertion into a host's tissue,
`wherein the sensor is configured to continuously measure an
`analyte concentration in a host; a housing configured to
`receive the sensor, wherein the housing is adapted for place
`ment adjacent to the host's skin; and an electronics unit
`releasably attached to the housing, wherein the electronics
`unit is operatively connected to the sensor and comprises a
`processor module configured to provide a signal associated
`with the analyte concentration in the host.
`0020. In an embodiment of the second aspect, the housing
`comprises a flexible material, and wherein the electronics unit
`and housing are configured and arranged such that the elec
`tronics unit is released from the housing by a flexing of the
`housing.
`0021. In an embodiment of the second aspect, the housing
`is configured for use with only one sensor and the electronics
`unit is configured for reuse with more than one sensor, and
`wherein the housing and electronics unit are configured Such
`that the housing physically breaks upon release of the elec
`tronics unit.
`0022. In an embodiment of the second aspect, the system
`further comprises a tool configured and arranged to assist a
`user in releasing the electronics unit from the housing.
`0023. In an embodiment of the second aspect, the system
`further comprises an antenna configured for radiating or
`receiving a radio frequency transmission, wherein the
`antenna is located remote from the electronics unit.
`0024. In a third aspect, a sensor system for measuring an
`analyte concentration in a host is provided, the system com
`prising a sensor configured to continuously measure an ana
`
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`Mar. 19, 2009
`
`lyte concentration in a host; a housing configured to receive
`the sensor, wherein the housing is adapted for placement
`adjacent to the host's skin; an electronics module associated
`with the housing, wherein the electronics module is config
`ured to provide a signal associated with the analyte concen
`tration in the host; and a power source configured to power at
`least one of the sensor and the electronics module.
`0025. In an embodiment of the third aspect, the system
`further comprises an adhesive layer disposed on the housing
`and configured to adhere the housing to the host's skin,
`wherein the power source located in the adhesive layer or on
`the adhesive layer.
`0026. In an embodiment of the third aspect, the power
`Source located in the housing or on the housing.
`0027. In an embodiment of the third aspect, the power
`Source comprises a thin battery.
`0028. In an embodiment of the third aspect, the battery has
`a height of no more than about 0.125 inches in its smallest
`dimension.
`0029. In an embodiment of the third aspect, the battery is
`flexible.
`0030. In an embodiment of the third aspect, the electronics
`module is housed within an electronics unit, wherein the
`electronics unit is attachable to and detachable from the hous
`ing, and wherein the power source is configured to turn on
`when the electronics unit is attached to the housing.
`0031. In an embodiment of the third aspect, the system
`further comprises a Switch selected from the group consisting
`of a bi-stable magnetic reed Switch, a proximity switch, and a
`motion-activated Switch, wherein the Switch is configured to
`turn the power source on when the electronics unit is attached
`to the housing.
`0032. In an embodiment of the third aspect, the power
`Source is configured to turn off when the electronics unit is
`detached from the housing.
`0033. In an embodiment of the third aspect, the power
`Source is a motion-driven power source.
`0034. In an embodiment of the third aspect, the power
`Source is a glucose consumption-driven power source.
`0035. In an embodiment of the third aspect, an overall
`height of the system is no more than about 0.350 inches in its
`Smallest dimension.
`0036. In an embodiment of the third aspect, the sensor is
`configured for insertion into the host's tissue.
`0037. In a fourth aspect, a sensor for measurement of an
`analyte concentration in a host is provided, the sensor com
`prising a first wire electrode and a second wire electrode; a
`membrane system disposed on an electroactive portion of the
`first wire electrode, wherein the second wire electrode is
`coiled around the first wire electrode at least up to an edge of
`the electroactive portion of the first wire electrode.
`0038. In an embodiment of the fourth aspect, the second
`wire electrode is coiled around the first wire electrode over at
`least a portion of the electroactive portion of the first wire
`electrode
`0039. In an embodiment of the fourth aspect, the first wire
`electrode is a working electrode and wherein the second wire
`electrode is at least one of a reference electrode and a counter
`electrode.
`0040. In a fifth aspect, a sensor system for measuring an
`analyte concentration in a host is provided, the system com
`prising a sensor configured to continuously measure an ana
`lyte concentration in a host; a laminate housing configured to
`receive the sensor, wherein the laminate housing is adapted
`
`for placement adjacent to the host's skin, and wherein the
`laminate housing comprises electronics operatively con
`nected to the sensor and comprising a processor module con
`figured to provide a signal associated with the analyte con
`centration in the host; a power source configured to power at
`least one of the sensor and the electronics; an antenna con
`figured for radiating or receiving a radio frequency transmis
`sion; and an adhesive layer configured to adhere the housing
`to the host's skin.
`0041. In an embodiment of the fifth aspect, the system is
`configured for single-use.
`0042. In an embodiment of the fifth aspect, an overall
`height of the laminate housing is no more than about 0.250
`inches in its smallest dimension.
`0043. In an embodiment of the fifth aspect, an aspect ratio
`of the laminate housing is at least about 10:1.
`0044. In an embodiment of the fifth aspect, the sensor
`comprises a first electrode and a second electrode, wherein
`the first electrode comprises a working electrode, wherein the
`second electrode comprises at least one of a reference elec
`trode and a counter electrode, and wherein the second elec
`trode is located on the adhesive layer.
`0045. In an embodiment of the fifth aspect, the electronics
`comprise a flexible circuit board.
`0046. In an embodiment of the fifth aspect, the flexible
`circuit board is at least one of disposed in the adhesive layer,
`disposed on the adhesive layer, and laminated to the adhesive
`layer.
`0047. In an embodiment of the fifth aspect, the flexible
`circuitboard is no more thanabout 0.200 inches in its smallest
`dimension.
`0048. In an embodiment of the fifth aspect, the power
`source comprises a flexible battery.
`0049. In an embodiment of the fifth aspect, the flexible
`battery is at least one of disposed in the adhesive layer and
`laminated to the adhesive layer.
`0050. In an embodiment of the fifth aspect, the flexible
`battery is no more than about 0.200 inches in its smallest
`dimension.
`0051. In an embodiment of the fifth aspect, the antenna is
`at least one of disposed in the adhesive layer, disposed on the
`adhesive layer, and laminated to the adhesive layer.
`0052. In an embodiment of the fifth aspect, the laminate
`housing is water resistant.
`0053. In an embodiment of the fifth aspect, the laminate
`housing is waterproof
`0054. In an embodiment of the fifth aspect, the laminate
`housing is hermetically sealed.
`0055. In an embodiment of the fifth aspect, the electronics
`further comprise a conductive material that only conducts in
`the Z-axis.
`0056. In an embodiment of the fifth aspect, the system
`further comprises a cannula layer configured to receive the
`sensor, wherein the cannula layer is configured to be released
`from the system after sensor insertion.
`0057. In an embodiment of the fifth aspect, the sensor is
`configured for insertion into the host's tissue.
`0058. In a sixth aspect, a sensor system for measuring an
`analyte concentration in a host is provided, the system com
`prising a sensor configured for insertion into the host's tissue,
`wherein the sensor is configured to continuously measure an
`analyte concentration in a host; a thin and flexible housing
`formed from a plurality of layers and configured to receive the
`sensor, wherein the thin and flexible housing is adapted for
`
`Page 36 of 81
`
`

`

`US 2009/0076360 A1
`
`Mar. 19, 2009
`
`placement adjacent to the host's skin, wherein the thin and
`flexible housing comprises electronics operatively connected
`to the sensor and comprising a processor module configured
`to provide a signal associated with the analyte concentration
`in the host, wherein the electronics are located on a thin and
`flexible Substrate; a power source configured to power at least
`one of the sensor and the electronics, wherein the power
`Source is located on the thin and flexible Substrate; an antenna
`configured for radiating or receiving a radio frequency trans
`mission, wherein the antenna is located on the thin and flex
`ible substrate; and an adhesive layer configured to adhere the
`housing to the host's skin.
`0059. In an embodiment of the sixth aspect, the system is
`configured for single-use.
`0060. In an embodiment of the sixth aspect, an overall
`height of the laminate housing is no more than about 0.250 in
`its Smallest dimension.
`0061. In an embodiment of the sixth aspect, an aspect ratio
`of the laminate housing is at least about 10:1.
`0062. In an embodiment of the sixth aspect, the laminate
`housing is water resistant.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0063 FIG. 1 is a perspective view of a transcutaneous
`analyte sensor system, including an applicator, a mounting
`unit, and an electronics unit.
`0064 FIG. 2 is a perspective view of a mounting unit,
`including the electronics unit in its functional position.
`0065 FIG. 3 is an exploded perspective view of a mount
`ing unit, showing its individual components.
`0066 FIG. 4A is an exploded perspective view of a contact
`Subassembly, showing its individual components.
`0067 FIG. 4B is a perspective view of an alternative con
`tact configuration.
`0068 FIG. 4C is a perspective view of another alternative
`contact configuration.
`0069 FIG. 5A is an expanded cutaway view of a proximal
`portion of a sensor.
`0070 FIG. 5B is an expanded cutaway view of a distal
`portion of a sensor.
`0071 FIG.5C is a cross-sectional view through the sensor
`of FIG. 5B on line C-C, showing an exposed electroactive
`Surface of a working electrode Surrounded by a membrane
`system.
`0072 FIG. 6 is an exploded side view of an applicator,
`showing the components that facilitate sensor insertion and
`Subsequent needle retraction.
`0073 FIGS. 7A to 7D are schematic side cross-sectional
`views that illustrate applicator components and their cooper
`ating relationships.
`0074 FIG. 8A is a perspective view of an applicator and
`mounting unit in one embodiment including a safety latch
`mechanism.
`0075 FIG. 8B is a side view of an applicator matingly
`engaged to a mounting unit in one embodiment, prior to
`sensor insertion.
`0076 FIG. 8C is a side view of a mounting unit and appli
`cator depicted in the embodiment of FIG. 8B, after the
`plunger Subassembly has been pushed, extending the needle
`and sensor from the mounting unit.
`0077 FIG.8D is a side view of a mounting unit and appli
`cator depicted in the embodiment of FIG. 8B, after the guide
`tube subassembly has been retracted, retracting the needle
`back into the applicator.
`
`0078 FIG. 8E is a perspective view of an applicator, in an
`alternative embodiment, matingly engaged to the mounting
`unit after to sensor insertion.
`(0079 FIG. 8F is a perspective view of the mounting unit
`and applicator, as depicted in the alternative embodiment of
`FIG.8E, matingly engaged while the electronics unit is slid
`ingly inserted into the mounting unit.
`0080 FIG.8G is a perspective view of the electronics unit,
`as depicted in the alternative embodiment of FIG. 8E, mat
`ingly engaged to the mounting unit after the applicator has
`been released.
`I0081
`FIGS. 8H and 8I are comparative top views of the
`sensor System shown in the alternative embodiment illus
`trated in FIGS. 8E to 8G as compared to the embodiments
`illustrated in FIGS. 8B to 8D.
`I0082 FIG. 8J is a perspective view of a sensor system
`showing the electronics unit releasably attached to the hous
`ing and the safety latch mechanism in one embodiment.
`I0083 FIG. 8K is a perspective view of the sensor system
`of FIG. 8J showing the electronics unit releasably attached to
`the housing and the safety latch mechanism engaging the
`electronics unit/housing Subassembly.
`I0084 FIGS. 9A to 9C are side views of an applicator and
`mounting unit, showing stages of sensor insertion.
`I0085 FIGS. 10A and 10B are perspective and side cross
`sectional views, respectively, of a sensor system showing the
`mounting unit immediately following sensor insertion and
`release of the applicator from the mounting unit.
`I0086 FIGS. 11A and 11B are perspective and side cross
`sectional views, respectively, of a sensor system showing the
`mounting unit after pivoting the contact Subassembly to its
`functional position.
`I0087 FIGS. 12A to 12C are perspective and side views,
`respectively, of the sensor System showing the sensor, mount
`ing unit, and electronics unit in their functional positions.
`I0088 FIG. 13 is a block diagram that illustrates electron
`ics associated with a sensor System.
`I0089
`FIG. 14 is a perspective view of a sensor system
`wirelessly communicating with a receiver.
`0090 FIG. 15A is a block diagram that illustrates a con
`figuration of a medical device including a continuous analyte
`sensor, a receiver, and an external device.
`(0091
`FIGS. 15B to 15D are illustrations of receiver liquid
`crystal displays showing embodiments of Screen displays.
`0092 FIG. 16A is a flow chart that illustrates the initial
`calibration and data output of sensor data.
`0093 FIG. 16B is a graph that illustrates one example of
`using prior information for slope and baseline.
`0094 FIG. 17 is a flow chart that illustrates evaluation of
`reference and/or sensor data for statistical, clinical, and/or
`physiological acceptability.
`0095 FIG. 18 is a flow chart that illustrates evaluation of
`calibrated sensor data for aberrant values.
`0096 FIG. 19 is a flow chart that illustrates self-diagnos
`tics of sensor data.
`(0097 FIGS. 20A and 20B are graphical representations of
`glucose sensor data in a human obtained over approximately
`three days.
`0.098
`FIG. 21 is a graphical representation of glucose
`sensor data in a human obtained over approximately seven
`days.
`0099 FIG. 22A is a perspective view of a sensor system
`including a disposable thin laminate sensor housing in one
`embodiment.
`
`Page 37 of 81
`
`

`

`US 2009/0076360 A1
`
`Mar. 19, 2009
`
`0100 FIGS. 22B and 22C are cut-away side cross-sec
`tional views of the thin, laminate, flexible sensor system in
`one embodiment.
`
`DETAILED DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`0101 The following description and examples illustrate
`Some exemplary embodiments of the disclosed invention in
`detail. Those of skill in the art will recognize that there are
`numerous variations and modifications of this invention that
`are encompassed by its scope. Accordingly, the description of
`a certain exemplary embodiment should not be deemed to
`limit the scope of the present invention.
`
`DEFINITIONS
`0102. In order to facilitate an understanding of the pre
`ferred embodiments, a number of terms are defined below.
`0103) The term “analyte' as used herein is a broad term,
`and is to be given its ordinary and customary meaning to a
`person of ordinary skill in the art (and is not to be limited to a
`special or customized meaning), and refers without limitation
`to a substance or chemical constituentina biological fluid (for
`example, blood, interstitial fluid, cerebral spinal fluid, lymph
`fluid or urine) that can be analyzed. Analytes can include
`naturally occurring Substances, artificial Substances, metabo
`lites, and/or reaction products. In some embodiments, the
`analyte for measurement by the sensing regions, devices, and
`methods is glucose. However, other analytes are contem
`plated as well, including but not limited to acarboxypro
`thrombin; acylcarnitine; adenine phosphoribosyltransferase;
`adenosine deaminase, albumin; alpha-fetoprotein; amino
`acid profiles (arginine (Krebs cycle), histidine/urocanic acid,
`homocysteine,
`phenylalanine?tyrosine,
`tryptophan);
`andrenostenedione; antipyrine; arabinitol enantiomers; argi
`nase; benzoylecgonine (cocaine); biotinidase; biopterin;
`c-reactive protein; carnitine; carnosinase; CD4; ceruloplas
`min; chenodeoxycholic acid; chloroquine; cholesterol, cho
`linesterase; conjugated 1-3 hydroxy-cholic acid; cortisol;
`creatine kinase; creatine kinase MM isoenzyme; cyclosporin
`A; d-penicillamine; de-ethylchloroquine; dehydroepiandros
`terone sulfate; DNA (acetylator polymorphism, alcohol
`dehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duch
`enne/Becker muscular dystrophy, glucose-6-phosphate dehy
`drogenase, hemoglobin A, hemoglobin S, hemoglobin C,
`hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab,
`beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1,
`Leber hereditary optic neuropathy, MCAD, RNA, PKU.
`Plasmodium vivax, sexual differentiation, 21-deoxycortisol);
`desbutylhalofantrine; dihydropteridine reductase; diptheria/
`tetanus antitoxin; erythrocyte arginase; erythrocyte protopor
`phyrin, esterase D; fatty acids/acylglycines; free B-human
`chorionic gonadotropin; free erythrocyte porphyrin; free thy
`roxine (FT4); free tri-iodothyronine (FT3); fumarylacetoac
`etase; galactose/gal-1-phosphate; galactose-1-phosphate
`uridyltransferase; gentamicin; glucose-6-phosphate dehy
`drogenase; glutathione; glutathione perioxidase; glycocholic
`acid; glycosylated hemoglobin; halofantrine; hemoglobin
`variants; hexosaminidase A.; human erythrocyte carbonic
`anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine
`phosphoribosyltransferase; immunoreactive trypsin, lactate;
`lead; lipoproteins ((a), B/A-1, B); lysozyme; mefloquine;
`netilmicin; phenobarbitone; phenyloin, phytanic/pristanic
`acid; progesterone; prolactin; prolidase; purine nucleoside
`
`phosphorylase; quinine; reverse tri-iodothyronine (rT3);
`Selenium; serum pancreatic lipase; Sissomicin; Somatomedin
`C; specific antibodies (adenovirus, anti-nuclear antibody,
`anti-Zeta antibody, arbovirus, Aujeszky's disease virus, den
`gue virus, Dracunculus medimensis, Echinococcus granulo
`sus, Entamoeba histolytica, enterovirus, Giardia duodenal
`isa, Helicobacter pylori, hepatitis B virus, herpesvirus, HIV
`1, IgE (atopic disease), influenza virus, Leishmania
`donovani, leptospira, measles/mumps/rubella, Mycobacte
`rium leprae, Mycoplasma pneumoniae, Myoglobin,
`Onchocerca volvulus, parainfluenza virus, Plasmodium fall
`ciparum, poliovirus, Pseudomonas aeruginosa, respiratory
`syncytial virus, rickettsia (Scrub typhus), Schistosoma man
`soni, Toxoplasma gondii, Trepenoma pallidium, Trypano
`Soma Cruzi/rangeli, Vesicular stomatis virus, Wuchereria
`bancrofti, yellow fever virus); specific antigens (hepatitis B
`virus, HIV-1); succinylacetone; sulfadoxine; theophylline;
`thyrotropin (TSH); thyroxine (T4); thyroxine-binding globu
`lin; trace elements; transferrin; UDP-galactose-4-epimerase;
`urea; uroporphyrinogen I synthase; vitamin A; white blood
`cells; and Zinc protoporphyrin. Salts, Sugar, protein, fat, Vita
`mins, a

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