THE TWO TORTOITU MNAWN TO THE MOUNTAIN
`US 20180235520A1
`( 19 ) United States
`( 12 ) Patent Application Publication ( 10 ) Pub . No . : US 2018 / 0235520 A1
`( 43 ) Pub . Date :
`Aug . 23 , 2018
`Rao et al .
`
`( 54 ) SYSTEMS , DEVICES AND METHODS FOR
`ANALYTE SENSOR INSERTION
`( 71 ) Applicant : ABBOTT DIABETES CARE INC . ,
`Alameda , CA ( US )
`( 72 ) Inventors : Vivek S . Rao , Alameda , CA ( US ) ;
`Louis G . Pace , San Carlos , CA ( US ) ;
`Hyun Cho , Berkeley , CA ( US ) ;
`Benjamin Jay Feldman , Berkeley , CA
`( US ) ; Yi Wang , San Ramon , CA ( US ) ;
`Tuan Nguyen , Dublin , CA ( US )
`
`( 21 ) Appl . No . : 15 / 877 , 331
`
`( 22 ) Filed :
`
`Jan . 22 , 2018
`
`Related U . S . Application Data
`( 60 ) Provisional application No . 62 / 449 , 570 , filed on Jan .
`23 , 2017
`
`Publication Classification
`
`( 51 ) Int . Ci .
`A61B 5 / 145
`( 2006 . 01 )
`( 2006 . 01 )
`A61B 1734
`( 2006 . 01 )
`A61B 5 / 00
`( 52 ) U . S . CI .
`CPC . . . . . . A61B 5 / 14503 ( 2013 . 01 ) ; A61B 173468
`( 2013 . 01 ) ; A61B 2017 / 347 ( 2013 . 01 ) ; A61B
`5 / 6849 ( 2013 . 01 ) ; A61B 2560 / 063 ( 2013 . 01 ) ;
`A61B 5 / 0004 ( 2013 . 01 )
`ABSTRACT
`( 57 )
`Systems , devices and methods are provided for inserting at
`least a portion of an in vivo analyte sensor , such as a dermal
`sensor , for sensing an analyte level in a bodily fluid of a
`subject . An applicator is positioned against a skin surface
`and a force is applied to the applicator causing at least a
`portion of a sharp and an in vivo analyte sensor to be
`positioned in the body of the subject . In particular , disclosed
`herein are embodiments of applicators designed to prevent
`premature sharp withdrawal and / or reduce the likelihood of
`improper sensor insertion . Also disclosed are embodiments
`of applicators including sharp modules having an angled
`sharp which can be configured to create an insertion path for
`a sensor .
`
`100
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`Local
`Computer
`System
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`Abbott Ex. 1012 - 1/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 1 of 42
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`US 2018 / 0235520 A1
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`144
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`FIG . 1
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`Abbott Ex. 1012 - 2/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 2 of 42
`12
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`II US 2018 / 0235520 A1
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`234
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`Multi - Functional ( WiFi ) ( NFC ) ( Bluetooth , BTLE ) ( GPS ) 232
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`Power Supply 226
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`RF Transceiver 228
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`Abbott Ex. 1012 - 3/62
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`

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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 3 of 42
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`US 2018 / 0235520 A1
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`FIG . 2B
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`Power Source 170
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`Sensor Electronics 160
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`Sensor Control Device
`102
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`Mgmt . Circuitry 164
`Power
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`Processor 166
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`ASIC 161
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`AFE 162
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`Circuitry 168
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`Communication
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`Memory 163
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`Analyte Sensor 104
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`V
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`171
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`FIG . 2C
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`Power Source 170
`
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`Mgmt . Circuitry 164
`Power
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`Processor 166
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`Memory 165
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`= Communication Circuitry 168
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`Sensor Electronics 160 - 160
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`Chip 174
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`gerinimummmmmmmmmmmmmmm
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`Memory 163
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`AFE 162
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`173
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`ASIC 161
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`Analyte Sensor 104
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`Sensor Control Device
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`102
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`Abbott Ex. 1012 - 4/62
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`

`

`9027
`
`FIG . 3 F
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`FIG . 3 E
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`FIG . 3D
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`FIG . 3C
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`FIG . 3B
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 4 of 42
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`US 2018 / 0235520 A1
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`102
`704
`150
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`704
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`150 50
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`702
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`702
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`810
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`FIG . 3A
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`Abbott Ex. 1012 - 5/62
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`Patent Application Publication
`OST
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`Aug . 23 , 2018 Sheet 5 of 42
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`US 2018 / 0235520 A1
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`CCOO
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`702
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`704
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`0
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`706mm
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`7107
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`FIG . 4C
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`FIG . 4B
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`702
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`708
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`150
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`FIG . 4A
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`Abbott Ex. 1012 - 6/62
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`Patent Application Publication
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`Aug 23 , 2018 Sheet 6 of 42
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`US 2018 / 023s520 A1
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`08
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`FIG . 6A
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`812
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`FIG . 5
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`810
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`Abbott Ex. 1012 - 7/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 7 of 42
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`US 2018 / 0235520 A1
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`504 504
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`2300
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`FIG . 6B
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`1834
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`2500
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`920
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`Transition features
`1938
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`2200
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`Abbott Ex. 1012 - 8/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 8 of 42
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`US 2018 / 0235520 A1
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`1318 Grip overhang
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`1316 Side grip zone
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`1314 Tamper ring protector
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`1314 Tamper ring protector
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`Facilitibioti
`Free
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`1320 Shark tooth
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`- impianti
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`FIG . 7A
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`702
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`A
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`Housing orienting feature 1302
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`ring retainer 1306 Tamper ring groove 1304 Tamper
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`Housing threads 1310 wami
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`Abbott Ex. 1012 - 9/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 9 of 42
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`US 2018 / 0235520 A1
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`702
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`- 1340 Locking rib
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`1320 Shark tooth
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`guide rib 1321 Insertion hard stop 1322mm Housing
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`Guide edge 1326
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`Carrier interface post 1327 -
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`FIG . 7B
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`Sensor electronics carrier interface 1328
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`Abbott Ex. 1012 - 10/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 10 of 42
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`US 2018 / 0235520 A1
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`1336 Final lockout recess
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`1338 Sheath stopping ramp
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`1334 Unlocked groove
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`FIG . 70
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`1328 Sensor electronics carrier 1 interface
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`1340 Locking rib
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`7027
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`Insertion hard stop 1322 -
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`Housing guide rib 1321
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`Sheath guide rail 1326
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`Abbott Ex. 1012 - 11/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 11 of 42 US 2018 / 0235520 A1
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`702 702
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`Proximal
`
`FIG . 7D
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`1336
`
`1340
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`1338
`1337
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`1334
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`1330
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`FIG . 7E
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`1336
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`1330
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`Distal
`
`702
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`Proximal
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`1404
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`mais ou
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`menos son som
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`1346
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`1404
`1402
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`704
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`Distal
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`1346
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`Abbott Ex. 1012 - 12/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 12 of 42
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`US 2018 / 0235520 A1
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`2702
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`Proximal
`
`FIG . 7F
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`2340
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`2336
`2338
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`2340
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`2335 -
`2344 . -
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`1346
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`Distal
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`4
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`Abbott Ex. 1012 - 13/62
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`US 2018 / 0235520 A1
`1346
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`FIG . 71
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`1346
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`1
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`FIG . 7H
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 13 of 42
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`- 6404
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`- 6402
`- 6704
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`7702
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`7336
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`7338
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`7340
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`6336 6338
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`6332
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`6334
`6340
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`Abbott Ex. 1012 - 14/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 14 of 42
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`US 2018 / 0235520 A1
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`Detent snap 1402 -
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`Detent clearance 1410
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`1418 Guide rail
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`1416 Lock arm interface
`1414 Lock arm strengthening rib
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`704
`
`FIG . 8A
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`1412 Lock arms
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`704
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`Sensor electronics carrier
`travel limiter face 1420 -
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`Detent base 1436 anomenada
`
`Detent snap
`stiffening feature 1422 .
`Alignment notch 1424
`Stiffening ribs 1426 1
`
`1434 Tilt reducing ribs
`1428 Housing guide rail clearance
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`FIG . 8B
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`Abbott Ex. 1012 - 15/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 15 of 42
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`US 2018 / 0235520 A1
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`704
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`women 704
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`FIG . 8D
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`FIG . 8C
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`
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`Detent snap Rounds 1404
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`
`
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`Detent snap 1402
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`
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`1406 Detent snap flat
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`Detent snap bridge 1408
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`Abbott Ex. 1012 - 16/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 16 of 42
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`US 2018 / 0235520 A1
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`
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`rotation limiter
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`
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`1448 Sheath
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`away
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`mest
`watan water
`
`FIG . 8E
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`704
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`
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`Backwall for guide rails 1446 mm
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`Abbott Ex. 1012 - 17/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 17 of 42
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`US 2018 / 0235520 A1
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`6702
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`6702
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`po 6519
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`6704
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`FIG . 8G
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`FIG . 8H
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`6425
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`6710
`
`706
`
`6425
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`6404
`
`6402
`
`6704
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`FIG . 8F
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`6425
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`Abbott Ex. 1012 - 18/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 18 of 42
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`US 2018 / 0235520 A1
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`Sharp carrier lock arms Caritas 1526 Sharp carrier retention feature 1524
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`1520 Sensor electronics retention feature
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`1518 Sensor electronics retention spring arm
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`1516 Spring alignment ridge
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`FIG . 9A
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`
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`1510 Aperture
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`
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`
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`shock lock 1534 Sensor electronics carrier
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`
`
`
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`Rotation limiter 1506
`
`1
`
`1
`
`win
`
`ingin
`
`bohatstbieteti
`intentcontent
`
`710
`
`* * *
`
`*
`
`potendopenátomát semmistie
`
`
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`
`
`Lock interface 1502 mm
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`Abbott Ex. 1012 - 19/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 19 of 42
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`US 2018 / 0235520 A1
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`710
`
`1519 Retention
`detent
`
`6710
`
`. 1518 Sensor electronics
`retention spring arm
`
`- .
`
`6519
`
`FIG . 9B
`
`FIG . 9C
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`Abbott Ex. 1012 - 20/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 20 of 42
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`US 2018 / 0235520 A1
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`2332 1404
`
`2340
`
`3321 3702
`
`1510
`1513
`
`1333
`1339
`
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`2710
`
`FIG . 9D
`
`4321
`4321
`
`1510
`1510
`
`1513
`
`1513
`
`4702
`
`2710
`
`1329
`1331
`FIG . 9E
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`Abbott Ex. 1012 - 21/62
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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 21 of 42
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`US 2018 / 0235520 A1
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`1
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`wordenador
`
`FIG . 10A
`
`that
`
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`minimo 1608 Anti - rotation slot
`
`the
`
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`
`Sharp retention clip 1620
`
`Sharp hub contact face 1622
`
`FIG . 10B
`
`Abbott Ex. 1012 - 22/62
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`

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`Patent Application Publication
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`Aug . 23 , 2018 Sheet 22 of 42
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`2702
`704
`
`3152
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`1104
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`FIG . 100
`
`Abbott Ex. 1012 - 23/62
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`

`

`Patent Application Publication
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`Aug . 23 , 2018 Sheet 23 of 42 US 2018 / 0235520 A1
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`4162
`
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`
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`Abbott Ex. 1012 - 24/62
`
`

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`Patent Application Publication Aug . 23 , 2018 Sheet 24 of 42
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`US 2018 / 0235520 A1
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`5102
`
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`
`Abbott Ex. 1012 - 25/62
`
`

`

`Patent Application Publication
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`Aug . 23 , 2018 Sheet 25 of 42
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`US 2018 / 0235520 A1
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`1524
`
`1526
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`
`8704
`
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`
`Abbott Ex. 1012 - 26/62
`
`

`

`Patent Application Publication
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`Aug . 23 , 2018 Sheet 26 of 42
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`US 2018 / 0235520 A1
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`
`
`
`
`2514 hub snap pawl locating cylinder
`
`
`
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`FIG . 11A
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`
`Abbott Ex. 1012 - 27/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 27 of 42
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`US 2018 / 0235520 A1
`
`2550
`
`2545
`
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`FIG . 11B
`
`Abbott Ex. 1012 - 28/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 28 of 42
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`US 2018 / 0235520 A1
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`. 2558
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`Abbott Ex. 1012 - 29/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 29 of 42
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`US 2018 / 0235520 A1
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`2302
`
`2300
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`FIG . 117
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`Abbott Ex. 1012 - 30/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 30 of 42
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`US 2018 / 0235520 A1
`
`2603
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`Abbott Ex. 1012 - 31/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 31 of 42
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`US 2018 / 0235520 A1
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`2300 104
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`Abbott Ex. 1012 - 32/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 32 of 42
`
`US 2018 / 0235520 A1
`
`2702
`
`150
`
`2702
`proximal
`
`150 150
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`FIG . 12B
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`distal
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`FIG . 12A
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`
`1
`
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`3102
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`
`Abbott Ex. 1012 - 33/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 33 of 42
`
`US 2018 / 0235520 A1
`
`3110
`
`3160
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`FIG . 12D
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`104
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`
`FIG . 120
`
`1106
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`1104 3102
`
`Abbott Ex. 1012 - 34/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 34 of 42
`
`US 2018 / 0235520 A1
`
`3702
`
`151
`
`3702
`proximal
`
`151
`
`1106
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`3102
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`L
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`
`FIG . 13B
`
`704 2710
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`1524
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`1339
`
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`distal
`
`FIG . 13A
`
`2710
`
`704
`
`Abbott Ex. 1012 - 35/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 35 of 42
`
`US 2018 / 0235520 A1
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`3702
`
`151
`
`3702
`proximal
`
`151
`
`3152
`
`2552
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`1404
`
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`
`1104 ?
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`3152
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`3321
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`1333
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`3102 ?
`
`FIG . 13D
`
`FIG . 13C
`
`104 104 … … …
`2710
`2710
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`704
`
`1339
`1339
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`1513
`
`104 … … … …
`
`2552
`
`2710
`704
`
`Abbott Ex. 1012 - 36/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 36 of 42
`
`US 2018 / 0235520 A1
`
`1513
`
`7702
`
`Call - out 14A - 2 1510
`
`OCEL
`6710
`6710
`
`-
`
`104 2252
`distal
`
`FIG . 14A
`
`102
`6710
`
`6704
`
`7702
`proximal
`
`152
`
`1404 7336
`
`7338
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`1102
`1102
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`
`Call - out 14A - 1
`
`6415
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`
`6524
`
`Abbott Ex. 1012 - 37/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 37 of 42
`
`US 2018 / 0235520 A1
`
`1331 1331
`
`1513
`
`7702
`
`Call - out 14B - 2
`
`6704
`
`7702
`proximal
`
`152
`
`Call - out 14B - 1
`
`6415
`
`1329
`6710
`
`distal
`distal
`
`FIG . 14B
`
`102
`6710
`
`6524
`
`Abbott Ex. 1012 - 38/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 38 of 42
`
`US 2018 / 0235520 A1
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`1
`
`1329
`6710
`
`2252 104
`distal
`
`FIG . 14C
`
`102
`
`6710
`
`1513
`
`7702
`
`
`
`Call - out 140 - 2
`
`1104
`
`1102
`
`6524
`
`6704
`
`1102 1104
`
`7702
`proximal
`proximal
`
`152 152
`
`Call - out 14C - 2
`
`6415
`
`Abbott Ex. 1012 - 39/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 39 of 42
`
`US 2018 / 0235520 A1
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`6415
`
`6524
`
`1102
`
`1513
`
`1329
`
`6702
`
`6704
`
`153
`
`6702
`proximal
`
`153
`
`Din
`6720 6720
`
`6331
`
`1404
`
`16336
`
`63406338
`
`1102
`
`> 1104
`
`6704
`
`104 104
`
`FIG . 15B
`
`2552
`
`671072552
`
`6710 102
`
`104 2552
`
`distal
`
`FIG . 15A
`
`1404
`
`6340 16332 -
`( 6338
`
`6425
`
`6710 102
`
`Abbott Ex. 1012 - 40/62
`
`

`

`Patent Application Publication
`
`8102
`
`702
`
`Aug . 23 , 2018 Sheet 40 of 42
`1104
`
`US 2018 / 0235520 A1
`
`2552 104
`
`FIG . 16C
`
`1404 1336 1338 1524
`
`154
`
`702
`
`8102
`
`- 1104
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`8704 710
`2552 104
`
`* *
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`
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`
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`
`FIG . 16B
`
`$ 320 * * * * *
`
`154
`
`702
`
`proximal
`
`154
`
`h
`
`710
`
`8104 "
`
`8704
`
`1524
`
`8706
`
`104 2552
`
`distal
`
`FIG . 16A
`
`8704
`
`710
`
`Abbott Ex. 1012 - 41/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 41 of 42
`
`US 2018 / 0235520 A1
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`1
`
`??
`
`7702
`
`Call - out 17 - 1
`
`1331
`
`1329
`
`8102
`
`6710
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`viwand
`
`6524
`
`8104
`
`8706
`
`8704
`
`6710 102
`
`7702
`proximal
`
`155
`
`FIG . 17
`
`104 2552
`
`distal
`
`Abbott Ex. 1012 - 42/62
`
`

`

`Patent Application Publication
`
`Aug . 23 , 2018 Sheet 42 of 42
`
`US 2018 / 0235520 A1
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`1339
`
`W
`
`3702
`
`104
`2552
`
`FIG . 18
`
`156
`
`2710
`
`ZOT
`
`Abbott Ex. 1012 - 43/62
`
`

`

`US 2018 / 0235520 A1
`
`Aug . 23 , 2018
`
`SYSTEMS , DEVICES AND METHODS FOR
`ANALYTE SENSOR INSERTION
`CROSS - REFERENCE TO RELATED
`APPLICATIONS
`[ 0001 ] The present application claims priority to and the
`benefit of U . S . Provisional Patent Application Ser . No .
`62 / 449 , 570 , filed Jan . 23 , 2017 , which is incorporated by
`reference herein in its entirety for all purposes .
`FIELD
`[ 0002 ] The subject matter described herein relates gener
`ally to systems , devices , and methods for using an applicator
`and a sensor control unit in an in vivo analyte monitoring
`system .
`
`BACKGROUND
`[ 0003 ] The detection and / or monitoring of analyte levels ,
`such as glucose , ketones , lactate , oxygen , hemoglobin A1C ,
`or the like , can be vitally important to the health of an
`individual having diabetes . Patients suffering from diabetes
`mellitus can experience complications including loss of
`consciousness , cardiovascular disease , retinopathy , neuropa
`thy , and nephropathy . Diabetics are generally required to
`monitor their glucose levels to ensure that they are being
`maintained within a clinically safe range , and may also use
`this information to determine if and / or when insulin is
`needed to reduce glucose levels in their bodies , or when
`additional glucose is needed to raise the level of glucose in
`their bodies .
`[ 0004 ] Growing clinical data demonstrates a strong cor
`relation between the frequency of glucose monitoring and
`glycemic control . Despite such correlation , however , many
`individuals diagnosed with a diabetic condition do not
`monitor their glucose levels as frequently as they should due
`to a combination of factors including convenience , testing
`discretion , pain associated with glucose testing , and cost .
`[ 0005 ] To increase patient adherence to a plan of frequent
`glucose monitoring , in vivo analyte monitoring systems can
`be utilized , in which a sensor control device may be worn on
`the body of an individual who requires analyte monitoring .
`To increase comfort and convenience for the individual , the
`sensor control device may have a small form - factor , and can
`be assembled and applied by the individual with a sensor
`applicator . The application process includes inserting a
`sensor , such as a dermal sensor that senses a user ' s analyte
`level in a bodily fluid located in the dermal layer of the
`human body , using an applicator or insertion mechanism ,
`such that the sensor comes into contact with a bodily fluid .
`The sensor control device may also be configured to transmit
`analyte data to another device , from which the individual or
`her health care provider ( “ HCP ” ) can review the data and
`make therapy decisions .
`[ 0006 ] While current sensors can be convenient for users ,
`they are also susceptible to malfunctions due to improper
`insertion . These malfunctions can be caused by user error ,
`lack of proper training , poor user coordination , overly
`complicated procedures , and other issues . This can be par
`ticularly true for analyte monitoring systems having dermal
`sensors , which are typically of smaller scale relative to
`sensors used to measure an analyte level in an interstitial
`fluid ( “ ISF ” ) , and which are inserted using sharps ( also
`known as “ introducers ” or “ needles ” ) that are shorter than
`
`those used for ISF sensors . Some prior art systems , for
`example , may rely too much on the precision assembly and
`deployment of a sensor control device and an applicator by
`the individual user . Other prior art systems may utilize sharp
`insertion and retraction mechanisms that are susceptible to
`premature withdrawal before the sensor can be properly
`implanted . In addition , with respect to dermal sensors , some
`prior art systems may utilize sharps that are not optimally
`configured to create an insertion path in the dermal layer
`without creating trauma to surrounding tissue . These chal
`lenges and others described herein can lead to improperly
`inserted or damaged sensors , and consequently , a failure to
`properly monitor the patient ' s analyte level .
`[ 0007 ] Thus , a need exists for more reliable sensor inser
`tion devices , systems and methods , particularly for use in
`conjunction with dermal sensors , that are easy to use by the
`patient and less prone to error .
`SUMMARY
`[ 0008 ] Provided herein are example embodiments of sys
`tems , devices and methods for the assembly and use of an
`applicator and a sensor control device of an in vivo analyte
`monitoring system , and in particular , where dermal sensors
`are utilized . An applicator can be provided to the user in a
`sterile package with an electronics housing of the sensor
`control device contained therein . A structure separate from
`the applicator , such as a container , can also be provided to
`the user as a sterile package with a sensor module and a
`sharp module contained therein . The user can couple the
`sensor module to the electronics housing , and can couple the
`sharp to the applicator with an assembly process that
`involves the insertion of the applicator into the container in
`a specified manner . After assembly , the applicator can be
`used to position the sensor control device on a human body
`with a sensor in contact with the wearer ' s bodily fluid ( e . g . ,
`dermal fluid ) . The embodiments provided herein are
`improvements to prevent or reduce the likelihood that a
`sensor is improperly inserted or damaged . Other improve
`ments and advantages are provided as well . The various
`configurations of these devices are described in detail by
`way of the embodiments which are only examples .
`[ 0009 ] Other systems , devices , methods , features and
`advantages of the subject matter described herein will be or
`will become apparent to one with skill in the art upon
`examination of the following figures and detailed descrip
`tion . It is intended that all such additional systems , devices ,
`methods , features , and advantages be included within this
`description , be within the scope of the subject matter
`described herein , and be protected by the accompanying
`claims . In no way should the features of the example
`embodiments be construed as limiting the appended claims ,
`absent express recitation of those features in the claims .
`BRIEF DESCRIPTION OF THE FIGURES
`[ 0010 ] . The details of the subject matter set forth herein ,
`both as to its structure and operation , may be apparent by
`study of the accompanying figures , in which like reference
`numerals refer to like parts . The components in the figures
`are not necessarily to scale , emphasis instead being placed
`upon illustrating the principles of the subject matter . More
`over , all illustrations are intended to convey concepts , where
`relative sizes , shapes and other detailed attributes may be
`illustrated schematically rather than literally or precisely .
`
`Abbott Ex. 1012 - 44/62
`
`

`

`US 2018 / 0235520 A1
`
`Aug . 23 , 2018
`
`FIG . 1 is a system overview of a sensor applicator ,
`10011 ]
`reader device , monitoring system , network , and remote
`system .
`[ 0012 ] FIG . 2A is a block diagram depicting an example
`embodiment of a reader device .
`[ 0013 ] FIGS . 2B and 2C are block diagrams depicting
`example embodiments of sensor control devices .
`[ 0014 ]
`FIG . 3A is a proximal perspective view depicting
`an example embodiment of a user preparing a tray for an
`assembly .
`[ 0015 ] FIG . 3B is a side view depicting an example
`embodiment of a user preparing an applicator device for an
`assembly .
`[ 0016 ] FIG . 3C is a proximal perspective view depicting
`an example embodiment of a user inserting an applicator
`device into a tray during an assembly .
`[ 0017 ]
`FIG . 3D is a proximal perspective view depicting
`an example embodiment of a user removing an applicator
`device from a tray during an assembly .
`[ 0018 ] FIG . 3E is a proximal perspective view depicting
`an example embodiment of a patient applying a sensor using
`an applicator device .
`[ 0019 ] FIG . 3F is a proximal perspective view depicting
`an example embodiment of a patient with an applied sensor
`and a used applicator device .
`[ 0020 ]
`FIG . 4A is a side view depicting an example
`embodiment of an applicator device coupled with a cap .
`[ 0021 ] FIG . 4B is a side perspective view depicting an
`example embodiment of an applicator device and cap
`decoupled .
`[ 0022 ]
`FIG . 4C is a perspective view depicting an example
`embodiment of a distal end of an applicator device and
`electronics housing .
`[ 0023 ] FIG . 5 is a proximal perspective view depicting an
`example embodiment of a tray with sterilization lid coupled .
`[ 0024 ] FIG . 6A is a proximal perspective cutaway view
`depicting an example embodiment of a tray with sensor
`delivery components .
`[ 0025 ] FIG . 6B is a proximal perspective view depicting
`sensor delivery components .
`[ 0026 ] FIG . 7A is side view depicting an example embodi
`ment of a housing .
`[ 0027 ]
`FIG . 7B is a perspective view depicting an example
`embodiment of a distal end of a housing .
`[ 0028 ]
`FIG . 7C is a side cross - sectional view depicting an
`example embodiment of a housing .
`[ 0029 ] FIGS . 7D and 7E are side cross - sectional views
`depicting a locking rib portion of an example embodiment of
`a housing with a portion of a sheath .
`[ 0030 ] FIGS . 7F and 7G
`are side cross - sectional views
`depicting a locking rib portion of another example embodi
`ment of a housing and a portion of a sheath .
`[ 0031 ] FIG . 7H is a side cross - sectional view depicting a
`locking rib portion of another example embodiment of a
`housing and a portion of a sheath .
`[ 0032 ]
`FIG . 71 is a side cross - sectional view depicting a
`locking rib portion of another example embodiment of a
`housing and a portion of a sheath .
`[ 0033 ] FIG . 8A is a side view depicting an example
`embodiment of a sheath .
`[ 0034 ] FIG . 8B is a perspective view depicting an example
`embodiment of a proximal end of a sheath .
`
`( 0035 ] FIG . 8C is a close - up perspective view depicting an
`example embodiment of a distal side of a detent snap of a
`sheath .
`[ 0036 ] FIG . 8D is a side view depicting an example
`embodiment of features of a sheath .
`[ 0037 ] FIG . 8E is an end view of an example embodiment
`of a proximal end of a sheath .
`10038 ] FIGS . 8F to 8H are perspective views depicting
`another example embodiment of a sheath in various stages
`of assembly with other applicator components .
`[ 0039 ] FIG . 9A is a proximal perspective view depicting
`an example embodiment of a sensor electronics carrier .
`[ 0040 ] FIG . 9B is a distal perspective view depicting an
`example embodiment of a sensor electronics carrier .
`[ 0041 ] FIG . 9C is a distal perspective view depicting
`another example embodiment of a sensor electronics carrier .
`[ 0042 ] FIG . 9D is a side cross - sectional view depicting
`another example embodiment of a sensor electronics carrier
`along with housing and sheath .
`( 0043 ]
`FIG . 9E is a close - up side cross - sectional view
`depicting another example embodiment of a sensor elec
`tronics carrier along with housing .
`( 0044 )
`FIG . 10A is a proximal perspective view of an
`example embodiment of a sharp carrier .
`[ 0045 ] FIG . 10B is a side cross - section depicting an
`example embodiment of a sharp carrier .
`[ 0046 ]
`FIG . 10C is a side cross - sectional view depicting
`another example embodiment of a sharp carrier assembly
`within an applicator .
`[ 0047 ]
`FIG . 10D is a side cross - sectional view with a
`call - out depicting another example embodiment of a sharp
`carrier assembly along with a portion of a sensor electronics
`carrier .
`[ 0048 ]
`FIG . 10E is a side cross - sectional view depicting
`another example embodiment of a sharp carrier assembly
`along with a portion of a sensor electronics carrier .
`[ 0049 ] FIG . 10F is a side cross - sectional view depicting
`another example embodiment of a sharp carrier assembly
`and sheath within an applicator .
`[ 0050 ]
`FIG . 11A is a perspective view depicting an
`example embodiment of a sharp module .
`[ 0051 ]
`FIG . 11B is a perspective view of another example
`embodiment of a sharp module .
`[ 0052 ] FIGS . 11C and 11D are schematic views depicting
`the sharp module of FIG . 11B .
`[ 0053 ] FIGS . 11E and 11F are a side schematic view and
`a top - down schematic view , respectively , of the sharp mod
`ule of FIG . 11B , as assembled with a sensor module .
`[ 0054 ] FIG . 116 is a perspective view of another example
`embodiment of a sharp module .
`[ 0055 ]
`FIG . 11H is a side schematic view depicting the
`sharp module of FIG . 11G .
`100561 . FIGS . 111 and 11J are a side cross - sectional view
`and a side view , respectively , of the sharp module of FIG .
`11G , as assembled with a sensor module .
`[ 0057 ] FIGS . 12A to 12D are side cross - sectional views
`depicting an example embodiment of an applicator device
`during various stages of deployment .
`10058 ] FIGS . 13A to 13D are side cross - sectional views
`depicting another example embodiment of an applicator
`device during various stages of deployment .
`[ 0059 ] FIGS . 14A to 14C are side cross - sectional views
`depicting another example embodiment of an applicator
`device during various stages of deployment .
`
`Abbott Ex. 1012 - 45/62
`
`

`

`US 2018 / 0235520 A1
`
`Aug . 23 , 2018
`
`[ 0060 ] FIGS . 15A and 15B are side cross - sectional views
`depicting another example embodiment of an applicator
`device during various stages of deployment .
`[ 0