I lllll llllllll II llllll lllll lllll lllll lllll lllll lllll lllll 111111111111111111111111111111111
`US 20080177126Al
`
`c19) United States
`c12) Patent Application Publication
`Tate et al.
`
`c10) Pub. No.: US 2008/0177126 Al
`Jul. 24, 2008
`(43) Pub. Date:
`
`(54) RAD IO PHARMACEUTICAL
`ADMINISTRATION METHODS, FLUID
`DELIVERY SYSTEMS AND COMPONENTS
`THEREOF
`
`Publication Classification
`
`(51)
`
`Int. Cl.
`A61M 36108
`
`(2006.01)
`
`(76)
`
`Inventors:
`
`Leon J. Tate, Cranberry Township,
`PA (US); James H. Shigeno,
`Pittsburgh, PA (US); Steven C.
`Rygg, Irwin, PA (US); Jared E.
`Neff, New Kensington, PA (US);
`Scott R. Griffith, Delmont, PA
`(US); Joseph E. Bisegna,
`Cheswick, PA (US); Edward
`Ilgenfritz, Pittsburgh, PA (US);
`Paul J. Miller, Pittsburgh, PA (US);
`Scott Yanke, Dousman, WI (US)
`
`Correspondence Address:
`GREGORY L BRADLEY
`MEDRADINC
`ONE MEDRAD DRIVE
`INDIANOLA, PA 15051
`
`(21) Appl. No.:
`
`11/981,429
`
`(22) Filed:
`
`Oct. 31, 2007
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/979,541, filed on Oct.
`12, 2007, provisional application No. 60/878,304,
`filed on Jan. 1, 2007.
`
`(52) U.S. Cl. .................................. 600/5; 600/4; 6041526
`
`(57)
`
`ABSTRACT
`
`A fluid path set for a fluid delivery system includes a tube coil
`that is designed to optimally position one or more volumes of
`a pharmaceutical within an ionization chamber to optimally
`measure and prepare a pharmaceutical dose for administra(cid:173)
`tion to a patient. The tube coil may be maintained in a desired
`dimensional geometry by means of a core structure around
`which the tube coil is positioned. Novel developments in
`radiopharmaceutical administration methods and systems
`include, but are not limited to, the configuration and layout of
`a fluid path set for use in a fluid delivery system, arrangements
`for piercing and drawing fluid from a pharmaceutical con(cid:173)
`tainer (such as a vial), arrangements for optimizing the posi(cid:173)
`tioning of a tube coil within an ionization chamber, a handling
`system for transporting vial shields that maintain an opera(cid:173)
`tor's hand and fingers at a safe distance from a pharmaceutical
`vial, a method for calibrating a radiopharmaceutical delivery
`system in which the difference between the expected and
`measured activities of two radioisotopes are used to calculate
`an estimated error in the measured activity of a third radio(cid:173)
`isotope and a vial access system that ensures an optimal draw
`of fluid from a radiopharmaceutical container.
`
`JUBILANT EXHIBIT 1022
`Jubilant v. Bracco, IPR2018-01449
`
`

`

`Patent Application Publication
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`Jul. 24, 2008 Sheet 1 of 87
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`US 2008/0177126 Al
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`1 1
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`16
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`Jul. 24, 2008 Sheet 2 of 87
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`Jul. 24, 2008 Sheet 3 of 87
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`Patent Application Publication
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`Jul. 24, 2008 Sheet 4 of 87
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`Jul. 24, 2008 Sheet 6 of 87
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`Jul. 24, 2008 Sheet 7 0f 87
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`Jul. 24, 2008 Sheet 8 0f 87
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`Patent Application Publication
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`Jul. 24, 2008 Sheet 9 of 87
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`Patent Application Publication
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`Jul. 24, 2008 Sheet 11 0f 87
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`US 2008/0177126 A1
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`Patent Application Publication
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`Jul. 24, 2008 Sheet 12 0f 87
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`US 2008/0177126 A1
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`Patent Application Publication
`
`Jul. 24, 2008 Sheet 13 of 87
`
`US 2008/0177126 Al
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`Patent Application Publication
`
`Jul. 24, 2008 Sheet 14 of 87
`
`US 2008/0177126 Al
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`Patent AppJicatJon Publication
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`Patent Application Publication
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`Jul. 24, 2008 Sheet 16 of 87
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`Patent Application Publication
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`Jul. 24, 2008 Sheet 17 0f 87
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`Patent Application Publication
`
`Jul. 24, 2008 Sheet 18 0f 87
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`Jul. 24, 2008 Sheet 19 of 87
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`Patent Application Publication
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`Jul. 24, 2008 Sheet 20 of 87
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`

`Patent Application Publication
`
`Jul. 24, 2008 Sheet 21 of 87
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`US 2008/0177126 Al
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`FIG. 7
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`FOG
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`
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`
`Setup Guide
`
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`
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`
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`
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`
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`
`FIG. 8
`
`Edit
`
`1042
`
`Activity (mCi):
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`Time:
`Date:
`Lot Number:
`Assay Information
`
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`
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`
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`Volume
`
`FOG
`
`1040
`
`System Preparation
`
`

`

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`
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`
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`
`Purge Air
`
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`
`Setup Guide
`
`Daily QC
`
`Lower PIG into well
`
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`
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`
`Be sure that patient is disconnected.
`
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`
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`
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`
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`
`1060
`
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`FIG. 1 0
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`Cancel
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`
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`
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`000043218765
`
`Date
`
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`Lot Number
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`System Preparation
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`
`FIG. 11
`
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`
`1042
`
`Activity (mCi): 700.0
`30.0
`Volume (ml):
`7:1 SAM
`Time:
`20 July 2006
`Date:
`00004321 8765
`Lot Number:
`Assay Information
`
`(mCi): 700
`Total Activity
`
`(ml): 30
`Volume
`
`c__ __ _,
`
`mCi
`700
`
`FOG
`
`1040
`
`1038
`
`System Preparation
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`

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`1030
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`
`FIG. 1 2A
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`
`30.0
`7:15 AM
`20 July 2006
`000043218765
`
`Activity (mCi): 700.0
`Volume (ml):
`Time:
`Date:
`Lot Number:
`Assay Information
`
`(mCi): 700
`Total Activity
`
`(ml): 30
`Volume
`
`mCi
`700
`
`FOG
`
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`
`~
`
`1040
`
`System Preparation
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`

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`I
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`(mCi): 700
`Total Activity
`
`(ml): 30
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`700
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`
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`I Edit
`
`7:15 AM
`20 July 2006
`000043218765
`
`Activity (mCi): 700.0
`Volume (ml):
`Time:
`Date:
`Lot Number:
`Assay Information
`
`

`

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`FIG. 1 3
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`
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`
`Range 1-1 000 ml
`
`500
`
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`
`Volume ~ 1 1 1 2
`
`I Saline Source
`
`I
`
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`
`Activity (mCi): 7
`3
`Volume (ml):
`7
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`0
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`Assay Information
`
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`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1014a
`
`1012a
`
`1000
`
`1038
`
`1052
`
`1030
`
`Purge Air
`
`Summary
`
`Setup Guide
`
`Daily QC
`
`(mCi): 1 5
`Activity
`
`ml
`20
`
`Waste __,r1050
`
`Activity (mCi): 2
`MPDS Tubing
`
`Replace
`
`1044
`
`ml
`485
`
`Saline
`
`FIG. 14
`
`Edit
`
`1042
`
`30.0
`7: 1 S AM
`20 July 2006
`000043218765
`
`Activity (mCi): 700.0
`Volume (ml):
`Time:
`Date:
`Lot Number:
`Assay Information
`
`(mCi): 415
`Total Activity
`
`(ml): 1 5
`Volume
`
`mCi
`374
`
`FDG
`
`1040
`
`System Preparation
`
`

`

`FIG. 1 5
`
`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`~
`
`i._...-1 000
`
`I~ 1052
`v--1030
`v-1032
`v 1034
`
`-L-.---
`
`l---
`
`'---
`
`'--
`
`i..--1 036
`
`OK):[/
`
`®@
`
`Purge Air
`
`Summary
`
`Setup Guide
`
`l ~ Daily QC
`
`t'-...
`
`System Preparation
`
`}-rl 134
`y1130
`
`.
`
`Previous Test
`
`y112a
`
`y-1126
`
`y-1124
`
`y-1122
`
`1132~1 Start
`I D Battery Measure·ment
`I D Constancy/ Accuracy Test
`I D Background Check
`I D Bias Adjustment
`I D Zero Check
`Be su,. that th.,e ;5 no act;v;:y ~n:;~ the ;on;zatc;;;;;;;;~r.1 2
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`___...---1000
`
`~
`
`®@
`
`I
`
`I
`
`~I Yes
`
`1137
`
`1136
`
`ionization chamber?
`Is there activity inside the
`
`FIG. 1 6A
`
`D Battery~
`
`D Constanc
`D Backgrou
`
`D Bias Adju
`
`D Zero Chee
`
`v 1034
`
`,____
`
`>---1036
`
`/ OK)
`
`-
`
`-
`
`Daily QC
`
`Be sure that there is no activity inside the ionization chamber.
`
`System Preparation
`
`

`

`____,,..... 1000
`
`~
`
`®@
`
`y1130
`
`y1128
`
`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`_/ 1034
`
`.___
`
`~ 1036
`
`OK J/
`
`Daily QC
`
`y-1124
`
`y-1126
`r 1122
`
`Be sure that there is no activity inside the ionization chamber. <
`
`FIG. 1 6B
`
`I D Battery Measurement
`I D Constancy/Accuracy Test
`I D Background Check
`I D Bias Adjustment
`I ~Zero Check
`
`System Preparation
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`..----1000
`
`~
`
`_/ 1034
`
`..___
`
`-1036
`
`/
`
`OK J
`
`-
`
`-
`
`®@
`
`\ 1126a
`
`FIG. 1 7
`
`Daily QC
`
`<
`
`Be sure that there is no activity inside the ionization chamber.
`
`1120
`
`System Preparation
`
`v 1130
`v 1128
`I V 1126
`
`y-1124
`
`_y-1122
`
`t~~ 20%
`
`'\
`
`D Battery Measurement
`D Constancy/ Accuracy Test )
`D Background Check
`I ~ Bias Adjustment
`I ~Zero Check
`
`I
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`®@
`
`~ 1000
`
`~
`
`\. 1 144 "11 46
`I
`Edit
`
`)
`OK
`
`~
`
`\ 1142
`)
`
`Skip
`
`7:15 AM
`28 April 2006
`000251698
`Cs-1 37
`
`• Activity (mCi): 0.231
`•Time:
`• Date:
`•Lot#
`• Isotope
`
`Place source in ionization chamber.
`
`FIG. 1 8
`
`D Ba
`
`Oco
`
`~Ba
`
`~Bia
`
`~Ze1
`
`v 1034
`--1036
`
`.___
`
`/
`
`OK J
`
`-
`
`-
`
`RC
`
`/
`
`1140
`
`Be sure that
`
`1120
`
`System Preparation
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`®@
`
`1000
`
`~
`l...--""'
`
`I
`
`~ 15%
`
`D Battery Measurement
`
`FIG. 1 9
`
`Remove source from ionization chamber.
`
`01149
`
`K
`
`1148
`
`0 Constancy
`
`0 Backgroun
`
`~Bias Adjus
`
`~Zero Chee
`
`,__ v 1034
`OK>/ --1036
`
`Daily QC
`
`Be sure that there is no activity inside the ionization chamber.
`
`1120
`
`System Preparation
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1034
`
`1036
`
`v
`v -
`
`-
`
`OK J
`
`-
`
`Daily QC
`
`<
`
`y112a
`
`v1126
`
`v1124
`
`y-1122
`
`Be sure that there is no activity inside the ionization chamber.
`
`1120
`
`System Preparation
`
`1000
`
`l..---
`
`~
`
`®@
`
`f 1130
`
`~1130a
`'
`'.$":;
`~~-.... -8-4o/c ~~ I
`
`0:.
`
`FIG. 20
`
`D Battery Measurement
`I 0 Constancy I Accuracy Test
`I 0 Background Check
`I ~ Bias Adjustment
`I ~Zero Check
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`~
`
`_...........--1 000
`
`,,,...--1 052
`v-1030
`v-1 032
`v 1034
`
`1....--
`
`-
`
`-
`
`-l---"""'
`
`i--l 036
`
`OK >/
`
`®@
`
`Purge Air
`
`Summary
`
`New Test
`
`Print
`
`f 1154
`
`1152(
`
`FIG. 21
`
`1150
`
`Voltage:#
`
`~ Battery
`
`Constancy Deviation (0-5%): 2%
`Accuracy Deviation (0-10%): 8%
`Reference Time: OS January 2003 09:15
`Reference Activity: 50 mCi
`Measured Activity: 20 mCi
`Isotope: Cs-137
`
`~ Constancy I Accuracy Test
`
`Bias Current (0.05-0.15 pA): 0.12 pA
`Activity: 20 mCi
`Isotope: F-1 B
`
`~ Background Check
`
`Setup Guide
`
`Daily QC
`
`<
`
`Bias Value (1-99): 51
`Bias Current (0.05-0. l 5 pA): 0.12 pA
`
`~ Bias Adjustment
`
`ltoUb: #
`Preamp Gain: 3500
`
`~ Zero Check
`
`Chamber Serial # Software Version
`
`Summary: 24 October 2006 07:00
`
`System Preparation
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`......--1 000
`
`~
`
`v---1052
`v 1030
`v--1 032
`
`1034
`
`---
`
`I--'"
`
`-
`
`-
`
`-1 036
`
`OK ):V
`
`®@
`
`New Test
`
`Print
`
`FIG. 22
`
`Purge Air
`
`Summary
`
`Setup Guide
`
`< Daily QC
`
`f 1154
`
`1150A
`
`D Constancy/Accuracy Test
`
`Skipped
`
`1152 (
`
`Voltage:#
`
`~ Battery
`
`Bias Current (0.05-0.1 5 pA): 0.12 pA
`Activity: 20 mCi
`Isotope: F-1 8
`
`~ Background Check
`
`Bias Value ( 1-99): 51
`Bias Current (0.05-0.15 pA): 0.1 2 pA
`
`~ Bias Adjustment
`
`ltoUb: #
`Preamp Gain: 3500
`
`~ Zero Check
`
`Chamber Serial # Software Version
`Summary: 24 October 2006 07:00
`
`System Preparation
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1021 1 022 1 023
`
`1020
`
`FIG. 23
`
`1000
`
`1208
`
`1206
`
`1020
`
`'-8
`rE\
`
`1202b
`
`1202a
`
`Case ID: --
`
`Calculate by Weight
`
`mCi 15.0
`
`mCi
`700
`
`FOG
`
`ml
`500
`
`Saline
`
`1004
`
`1008
`
`1002
`
`System Preparation
`
`Desired Activity
`
`Available
`
`1006
`
`System is Ready
`
`Medrad Alchemy
`
`

`

`~ ...
`~ = :--
`.... 0 =
`O" -....
`.... 0 = ""O =
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`> ....
`....
`0 ....
`..._
`QO
`0
`0
`N
`1J1
`c
`
`O'I
`N
`-....J
`-....J
`
`..... ... ....
`1J1 =- ('D
`
`('D
`
`-....J
`QO
`0 .....
`
`QO
`0
`0
`N
`
`N
`
`1000
`
`No
`
`Calculate by Weight
`
`mo 15.0
`
`FIG. 24A
`
`mCi
`700
`
`FOG
`
`ml
`500
`
`Saline
`
`1004
`
`1008
`
`1002
`
`1 204
`
`Range: S-2SmCi
`
`,
`
`I. . '
`
`Available
`
`• • •
`
`Entered desired activity
`
`Medrad Alchemy
`
`

`

`~ ...
`~ = :--
`0 =
`....
`~ .....
`O" -....
`""O =
`.... 0 =
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`(')
`
`~ .....
`
`(')
`
`> ....
`....
`0 ....
`..._
`QO
`0
`0
`N
`1J1
`c
`
`O'I
`N
`-....J
`-....J
`
`-....J
`QO
`0 .....
`
`... N
`.....
`=- ('D
`
`1J1
`
`('D
`
`QO
`0
`0
`N
`
`N
`
`1000
`
`I Cancel II Enter I
`I
`l§J
`~00
`00G
`0~0
`
`0
`
`1205
`
`Range: 1-999 lb
`
`1003
`
`lb --
`
`Patient Weight
`
`0.1 mCi I lb
`
`--
`
`1006
`
`FIG. 248
`
`1202a
`
`mCi
`700
`
`FOG
`
`ml
`500
`
`Saline
`
`Desired Activity
`
`Available
`
`Enter Patient Weight
`
`Medrad Alchemy
`
`

`

`~ ...
`2' :-
`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`> ....
`....
`0 ....
`..._
`QO
`0
`0
`N
`1J1
`c
`
`O'I
`N
`-....J
`-....J
`
`-....J
`QO
`0 .....
`..... ...
`1J1 =- ('D
`
`(.H
`
`('D
`
`QO
`0
`0
`N
`
`N
`
`1013
`
`0.07 mCi /lb
`Pediatric
`
`0.13 mCi /lb
`Melanoma
`
`0.1 mCi /lb
`Standard
`
`®@0@
`
`lb 135
`
`Patient Weight
`
`Yes
`
`Calculate by Weight
`
`I mCi 13.s I
`
`FIG. 24C
`
`mCi
`700
`
`FDG
`
`ml
`500
`
`Saline
`
`Desired Activity
`
`Available
`
`1006
`
`Select formula
`
`Medrad Alchemy
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1023
`
`1oz1
`
`1020
`
`FIG. 240
`
`1000
`
`1208
`
`1206
`
`1020
`
`'&'
`18
`
`lb 135
`
`Patient Weight
`
`0.1 mCi I lb
`
`Yes
`
`Case ID: --
`
`Calculate by Weight
`
`mCi
`700
`
`FOG
`
`ml
`500
`
`Saline
`
`System Preparation
`
`Desired Activity
`
`Available
`
`1006
`
`System is ready
`
`Medrad Alchemy
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1023
`
`1021
`
`1020
`
`FIG. 24E
`
`1208
`
`1206
`
`1020
`
`Edit
`
`Case ID: --
`
`System Preparation
`
`5
`
`lb
`
`Patient Weight
`
`0.1 mCi I lb
`
`Yes
`
`Calculate by Weight
`
`_j_ 10.0
`
`mCi
`
`mCi
`700
`
`FDG
`
`ml
`500
`
`Saline
`
`Available
`
`1006
`
`1006a
`
`System is ready
`
`Medrad Alchemy
`
`

`

`~ ...
`~ = :--
`.... 0 =
`O" -....
`.... 0 = ""O =
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`> ....
`....
`0 ....
`..._
`QO
`0
`0
`N
`1J1
`c
`
`O'I
`N
`-....J
`-....J
`
`-....J
`QO
`0 .....
`
`..... ... O'I
`1J1 =- ('D
`
`('D
`
`QO
`0
`0
`N
`
`N
`
`1023
`
`1021
`
`1020
`
`FIG. 24F
`
`®
`
`(R)
`
`®@0@
`
`999
`
`lb
`
`Patient Weight
`
`1208
`
`1206
`
`1022a
`
`1020
`
`Case ID: --
`
`Yes
`
`Calculate by Weight
`
`mCi 17.5
`
`System Preparation
`
`1006
`
`mCi
`700
`
`FDG
`
`ml
`500
`
`Saline
`
`Available
`
`System is ready
`
`Medrad Alchemy
`
`

`

`~ ...
`~ = :--
`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`> ....
`....
`0 ....
`..._
`QO
`0
`0
`N
`1J1
`c
`
`O'I
`N
`-....J
`-....J
`
`-....J
`QO
`0 .....
`-....J
`..... ...
`1J1 =- ('D
`
`('D
`
`QO
`0
`0
`N
`
`N
`
`1023
`
`1021 1022
`
`1020
`
`FIG. 25A
`
`\51
`IB
`
`®@0©
`
`1217h
`
`121 ?f
`
`1217d
`
`Right Antecubital
`
`121 7b __,.--,.--.._
`
`1217
`
`Case Information
`
`5
`
`Sa
`
`Ava
`
`Medrad Alchemy
`
`

`

`~ ...
`~ = :--
`.... 0 =
`""O = O" -....
`.... 0 =
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`> ....
`....
`0 ....
`..._
`QO
`0
`0
`N
`1J1
`c
`
`O'I
`N
`-....J
`-....J
`
`-....J
`QO
`0 .....
`..... ... QO
`=- ('D
`
`1J1
`
`('D
`
`QO
`0
`0
`N
`
`N
`
`1023
`
`1020
`
`FIG. ZSB
`
`1212
`
`1210
`
`1208
`
`1206
`
`1022a
`
`1020
`
`lb 135
`
`Patient Weight
`
`Prime
`
`0.1 mCi I lb
`
`Patient Preparation
`
`Edit
`
`Right Antecubital
`CaselD:000043218765
`
`Yes
`
`Calculate by Weight
`
`I mCi 13.s I
`
`mCi
`700
`
`FOG
`
`ml
`500
`
`Saline
`
`System Preparation
`
`Desired Activity
`
`Available
`
`System is ready
`
`Medrad Alchemy
`
`

`

`/1000
`
`lb 135
`
`Patient Weight
`
`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1210
`
`1206
`
`1020
`
`1213
`
`Patient Preparation
`
`Right Antecubital
`CaselD:000043218765
`
`mCi 13.5]
`
`System Preparation
`
`Desired Activity
`
`Available
`
`17%
`
`»»:
`
`Priming
`
`Medrad Alchemy
`
`FIG. 26A
`
`mCi
`700
`
`FOG
`
`ml
`500
`
`Saline
`
`1004
`
`1008
`
`1002
`
`

`

`pa ration
`
`bi ta I
`043218765
`
`Has all air been expelled from disposible set?
`
`-
`
`I'---
`
`1008 -'"'
`
`ml
`500
`
`t21s
`
`"
`
`®@0@
`
`I 1b 1351
`
`Patient Weight
`
`FIG. 268
`
`mCi
`700
`
`FOG
`
`I"-
`
`[\
`
`-
`
`1004
`
`Yes
`
`~\~
`/~ c6iS6215b
`
`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`System Preparation
`
`I
`
`I
`Desired Activity
`
`r---Saline
`
`1002 -i\
`
`Available
`
`I
`
`System is ready
`
`I
`
`Medrad Alchemy
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1000
`
`1212d
`
`lb 135
`
`Patient Weight
`
`®@0©
`
`1210
`
`1206
`
`1020
`
`1213A
`
`Pause
`
`Patient Preparation
`
`0.1 mCi I lb
`
`Right Antecubital
`CaselD:000043218765
`
`System Preparation
`
`mCi 1a.s I
`
`Desired Activity
`
`FIG. 27 A
`
`mCi
`700
`
`FOG
`
`1004
`
`ml
`500
`
`Saline
`
`Available
`
`1008
`
`1002
`
`Test Injecting
`
`Medrad Alchemy
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1212c
`
`lb 135
`
`Patient Weight
`
`0.1 mCi I lb
`
`Patient Preparation
`
`Right Antecubital
`Case ID:000043218765
`
`System Preparation
`
`mCi 1a.s I
`
`Desired Activity
`
`FIG. 278
`
`mCi
`700
`
`FDG
`
`ml
`500
`
`Saline
`
`Available
`
`Paused
`
`Medrad Alchemy
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1023
`
`1021
`
`1020
`
`FIG. 28A
`
`1218
`
`1216
`
`1212
`1212a
`1210
`
`1208
`
`1206
`
`1020
`
`\&'
`tE'I
`
`®@0@
`
`lb 135
`
`Patient Weight
`
`FDG Dose
`
`0.1 mCi I lb
`
`Yes
`
`Right Antecubital
`
`Calculate by Weight
`
`mCi
`700
`
`FOG
`
`ml
`500
`
`Saline
`
`System Preparation
`
`Desired Activity
`
`Available
`
`System is ready
`
`Medrad Alchemy
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1000
`
`1216
`
`1210
`
`1206
`
`1020
`
`1214A
`
`lb 135
`
`Patient Weight
`
`FDG Dose
`
`0.1 mCi I lb
`
`Patient Preparation
`
`Right Antecubital
`Case ID: 000043218765
`
`System Preparation
`
`mCi 1a.s I
`
`Desired Activity
`
`FIG. 288
`
`mCi
`700
`
`FOG
`
`ml
`500
`
`Saline
`
`Available
`
`1004
`
`1008
`
`1002
`
`Measuring Dose
`
`Medrad Alchemy
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1000
`
`1220
`
`Inject
`
`lb 135
`
`Patient Weight
`
`FOG Dose
`
`0.1 mCi I lb
`
`FIG. 29
`
`mCi
`700
`
`FOG
`
`1210
`
`1206
`
`1020
`
`Patient Preparation
`
`Right Antecubital
`Case 10:000043218765
`
`<l DDDDDDDDDD q_ DDDDDDDDDD ~
`I mCi 13.s I
`
`l 1224a
`
`1224
`
`ml
`500
`
`Saline
`
`System Preparation
`
`Calibrated activity
`
`Available
`
`1006a
`
`Ready to Inject
`
`Medrad Alchemy
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`FIG. 30A
`
`I 1b 1351 I
`
`®@0©
`
`I
`
`Patient Weight
`
`eparation
`
`cub ital
`b0043218765
`
`881b
`
`No
`
`Discard the extracted dose?
`
`mCi
`700
`
`FOG
`
`~\~
`n /i.--
`
`ml
`500
`
`Saline
`
`System Preparation
`
`I
`
`)
`\
`/'1231
`
`I
`
`I
`
`Calibrated activity
`
`Available
`
`Ready to Inject
`
`Medrad Alchemy
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1216
`
`1210
`
`1206
`
`1020
`
`1233
`
`®@0@
`
`lb 135
`
`Patient Weight
`
`FOG Dose
`
`0.1 mCi/lb
`
`Patient Preparation
`
`Right Antecubital
`Case 10:000043218765
`
`System Preparation
`
`mCi 1a.s I
`
`Desired Activity
`
`FIG. 308
`
`mCi
`700
`
`FDG
`
`ml
`500
`
`Saline
`
`Available
`
`Discarding
`
`1004
`
`1008
`
`1002
`
`Medrad Alchemy
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1230
`
`1216
`
`1210
`
`1206
`
`1020
`
`1233
`
`Pause
`
`FOG Dose
`
`Patient Preparation
`
`Right Antecubital
`CaselD:000043218765
`
`System Preparation
`
`27%
`
`®@0@
`
`lb 135
`
`Patient Weight
`
`0.1 mCi I lb
`
`mCi 1a.s I
`
`Calibrated Activity
`
`FIG. 31
`
`mCi
`700
`
`FDG
`
`ml
`500
`
`Saline
`
`Available
`
`Injecting
`
`1004
`
`1008
`
`1002
`
`Medrad Alchemy
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1230a
`
`1216
`
`1210
`
`1206
`
`1020
`
`lb 135
`
`Patient Weight
`
`FOG Dose
`
`0. 1 mCi I lb
`
`Patient Preparation
`
`Right Antecubital
`Case 10:000043218765
`
`System Preparation
`
`mCi 1a.s I
`
`Calibrated Activity
`
`FIG. 3 2A
`
`mCi
`700
`
`FDG
`
`ml
`500
`
`Saline
`
`Available
`
`Paused
`
`Medrad Alchemy
`
`

`

`I
`
`J
`(1244
`
`Print
`
`I
`
`Right Antecubital
`IV Site:
`
`1234-56
`FOG Lot#:
`
`000043218765
`Patient ID:
`
`
`-~
`
`)
`
`I
`
`I
`
`1242
`
`,,
`I
`I
`
`I 1240
`
`FIG. 32B
`
`35.0]
`
`[ml
`
`Total Fluid Delivered
`
`5.0]
`[ml
`[mci 15.1]
`
`FOG Delivered
`
`mCi
`700
`
`FOG
`
`~\
`
`/
`
`ml
`470
`
`Saline
`
`Injection Complete
`
`Available
`
`Medrad Alchemy
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`Patent Application Publication
`
`Jul. 24, 2008 Sheet 61 0f 87
`
`US 2008/0177126 A1
`
`1308
`
`1302
`
`1000
`
`
`
`1306
`
`v0m
`
`33 8
`
`3'.
`
`2‘N
`
`EE
`
`5-:
`
`2
`8‘.
`
`<
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`m
`
`9
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`
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`0
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`
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`
`”
`'5
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`
`

`

`~ ...
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`.... 0 =
`""O = O" -....
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`('D = .....
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`
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`
`(')
`
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`(')
`
`.....
`
`> ....
`....
`0 ....
`..._
`QO
`0
`0
`N
`1J1
`c
`
`O'I
`N
`-....J
`-....J
`
`-....J
`QO
`0 .....
`N
`O'I
`.....
`1J1 =-
`
`('D
`('D
`
`QO
`0
`0
`N
`
`N
`
`I
`
`ays
`
`I
`
`I
`
`1334
`
`~
`
`~
`
`Print
`
`27 labels will be printed.
`
`1302A
`
`v .--
`
`__./
`
`FIG. 33B
`
`®
`
`.
`.
`.
`
`-
`
`~ 7
`
`Print October 2006
`
`lnjecth
`
`~ c-l 332
`1336
`
`\_ 1330
`
`'
`
`I Range
`
`All Days
`
`<
`
`

`

`~ ...
`= :--
`.... 0 =
`.... 0 = -= = O" -....
`'e -....
`~
`('D = .....
`-= ~ .....
`
`~ .....
`
`(')
`
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`
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`
`QO
`0
`0
`N
`
`N
`
`~
`
`1302b
`
`v-
`
`I/
`
`-----
`
`r--1332b
`
`31 -~
`
`r--1332a
`
`""
`~ ,_ 1 332
`
`1
`
`'
`
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`
`> ....
`....
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`0
`0
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`1J1
`c
`
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`N
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`
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`.....
`0
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`.....
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`
`('D
`
`l
`
`ays
`
`11
`
`I
`
`l...-/ 1334
`
`~i---
`
`Print
`
`27 labels will be printed.
`
`~Done)-
`
`~
`
`1336
`
`Print October 2006
`
`lnjectic
`
`All Days
`
`/From
`
`1330-L/
`<
`
`Day
`
`To
`
`Day
`
`FIG. 33C
`
`®
`
`'-
`
`...
`
`..
`..
`
`

`

`~ 1306a
`\
`
`Print Day
`
`I
`
`~1320
`\
`I
`
`Month View
`
`FIG. 34A
`®
`
`---1314
`---
`
`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`,....-314
`-1
`
`--1310
`
`~ 1351
`
`~ 1308
`
`~
`
`j)J
`j)J
`j)J ~-
`j)J -_/
`/
`j)J -__,,,. ,,,..-
`j)J'
`
`__..,
`/
`
`/
`
`> -L./
`~~l-/
`
`.,.,__......
`
`mCi
`
`Time Delivered
`
`Case ID
`
`15.0
`
`5.0
`
`20.0
`
`10.5
`
`10.0
`
`5.0
`
`00:00 PM
`
`00:00 PM
`
`00:00 PM
`
`00:00 PM
`
`OO:OOAM
`
`00000000000000
`
`00000000000000
`
`00000000000000
`
`00000000000000
`
`00000000000000
`
`OO:OOAM
`
`00000000000000
`
`-
`-
`
`00000000000000
`
`~
`
`;::::: ---
`-r---... '-~
`"" r-....._
`
`1312
`
`1318
`
`:......
`
`1312
`
`,\ ' 00000000000000
`1316 -
`1312 --~\ Lot Number
`
`-
`
`I\.
`
`10 October 2006 (Tuesday)
`
`7
`
`)
`\
`(1310a
`
`<
`
`"----
`
`1350 -r-...
`
`Injection History
`
`

`

`.... 0
`~ .....
`...
`~ 'e
`('D = .....
`~ .....
`""O
`
`-.
`
`(')
`
`~ ....
`2' :--
`.... 0 =
`= ""O = O" -....
`
`> ....
`....
`0 ....
`..._
`QO
`0
`0
`N
`1J1
`c
`
`O'I
`N
`-....J
`-....J
`
`-....J
`QO
`0 .....
`Ul
`O'I
`.....
`1J1 =- ('D
`
`('D
`
`QO
`0
`0
`N
`
`N
`
`~ .....
`
`(')
`
`
`
`1360
`
`-
`
`~ -
`
`Done)-
`
`-
`
`)
`
`\
`
`(, 362
`
`>
`
`-
`-
`
`·JI
`I
`
`-
`
`0
`
`-
`
`
`
`-0
`
`0
`0
`0
`
`-p
`
`-
`
`-
`
`-
`
`1
`
`.
`f 1363
`
`Print
`
`I
`
`-
`
`Right Antecubital
`IV Site:
`
`1234-56
`FOG Lot#:
`
`000043218765
`Patient ID:
`
`I
`
`FIG. 348
`I
`
`®
`
`~ [mci 35.0]
`
`..._
`
`Total Fluid Delivered
`
`5.ol
`[mci
`[mci 15.1]
`
`,
`
`FDG Delivered
`
`Injection Details
`
`-
`
`-
`
`-
`
`..._
`
`-
`
`<
`
`Injection History
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`FIG. 3 5
`
`1000
`
`1400a
`
`1414
`
`1418
`
`Language 10
`
`Language 9
`
`Language 8
`
`Language 7
`
`Language 6
`
`1420
`
`Audio
`
`Units
`
`Date I Time
`
`Languages
`
`1 41 2
`
`1 41 6
`
`1410
`
`1 408
`
`Select Language
`
`Configuration
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1000
`
`1400a
`
`1414
`
`1418
`
`1422d
`
`1422c
`
`1422b
`
`1422a
`
`1422
`
`Edit
`
`12 hour
`Time Format:
`
`10:00 AM
`Current Time:
`
`dd Month yyy
`
`10 August 2006
`
`Current Date
`
`Audio
`
`Units
`
`Date I Time
`
`Languages
`
`FIG. 36
`®
`
`Maintenance
`
`1406
`
`Treatment
`
`1404
`
`System
`
`1402
`
`1412
`
`1410
`
`1408
`
`Configuration
`
`

`

`~ ...
`~ =
`=
`.... 0
`~ .....
`O" -....
`=
`= '"=
`.... 0
`~ .....
`~ 'e -....
`('D = .....
`'"= ~ .....
`
`(')
`
`(')
`
`> ....
`....
`0 ....
`..._
`QO
`0
`0
`N
`1J1
`c
`
`O'I
`N
`-....J
`-....J
`
`-....J
`QO
`0 .....
`
`QO
`O'I
`.....
`=- ('D
`
`1J1
`
`('D
`
`QO
`0
`0
`N
`
`N
`:--
`
`1000
`
`1400a
`
`11.----B-ec+-, q-u-er-el---,1
`
`Curie
`
`Activity ~ 1428a ~ 1428b
`
`~1426b
`
`~1426a
`
`Weight
`
`I lr---K-il-1-og-r-am-s-----.1
`
`Pounds
`
`FIG. 37
`
`Maintenance
`
`Treatment
`
`System
`
`1406
`
`1404
`
`1402
`
`1414
`
`Audio
`
`1418
`
`1424
`Units
`
`1412
`1416
`
`Date I Time
`
`Languages
`
`1410
`
`1408
`
`Configuration
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1000
`
`1400a
`
`1444c~'-~~-L-ow~~--'
`
`1444bl~ [~~~~~~
`
`Normal
`
`L
`
`1444al._ [~~~~~--'
`
`High
`
`"i
`
`FIG. 3 8
`
`Maintenance
`
`Treatment
`
`System
`
`1406
`
`1404
`
`1402
`
`1414
`
`Audio
`
`Units
`
`Date I Time
`
`Languages
`
`1444
`
`1412
`1 41 6
`
`1410
`
`1408
`
`Conflguration
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`FIG. 39A
`
`lOOO
`
`1400b
`
`1466
`
`Edit Formulas
`
`1464b
`
`Off
`
`1464a
`
`Default Programming View
`
`Weight Based Dosing
`
`1460a
`
`r1462
`
`15.0
`
`1460
`
`mCi
`
`Default Activity
`
`Maintenance
`
`Treatment
`
`System
`
`1406
`
`1404
`
`1402
`
`1456
`
`Printing
`
`Case
`
`Saline
`
`FOG
`
`1454
`1416
`
`1452
`
`1450
`
`Configuration
`
`

`

`L-~~1476~~~~~====================
`
`FIG. 398
`
`QO
`0
`0
`N
`
`1000
`
`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`""O a ('D = .....
`
`~ .....
`
`(')
`
`~ .....
`
`(')
`
`1470
`
`478a
`
`___ ,
`
`J...-
`
`Edit Name
`
`1474
`
`1478e
`
`,L--I----'
`
`1478d
`
`1478
`
`1
`478c
`
`-
`
`20.0 v~
`
`~
`
`l
`
`0.0
`
`478b
`
`_-1
`
`0.1 ,-
`
`Delete
`
`New Formula
`
`1476b
`
`mCi/ib
`
`Maximum
`
`1476b
`
`New Formula
`
`mCi/ib
`
`Minimum
`
`mCi/ib
`
`I
`
`Multiplier
`
`1476a \
`
`-
`
`0.07 mCi/lb
`Pediatric
`
`0.13 mCi/lb
`Melanoma
`
`0.10 mCi/lb
`Standard
`
`Edit Formulas
`
`

`

`.... 0 =
`.... 0 = ""O = O" -....
`~ 'e -....
`('D = .....
`~ .....
`""O
`
`~ .....
`
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`
`~ .....
`
`(')
`
`1000
`
`1400b
`
`1456
`
`1418
`
`30
`
`ml
`
`Test Inject Volume
`
`1486
`
`Range: 1-1 000 ml
`
`1488
`
`1480
`
`Printing
`
`Case
`
`Saline
`
`1482
`
`FOG
`
`FIG. 40
`
`Maintenance
`
`Treatment
`
`System
`
`1406
`
`1404
`
`1402
`
`1454
`
`1416
`
`1