I lllll llllllll Ill lllll lllll lllll lllll lllll 111111111111111111111111111111111
`US009299467B2
`
`c12) United States Patent
`Hidem et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 9,299,467 B2
`Mar.29,2016
`
`(54)
`
`(72)
`
`A61N 5/1048; A61N 5/1071; A61N 5/1075;
`A61K 51/1282; A61M 5/007; G21G 4/04;
`G21G 4/06; G21G 4/08
`USPC ............................................. 60014, 5; 378/65
`See application file for complete search history.
`References Cited
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`(56)
`
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`
`FOREIGN PATENT DOCUMENTS
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`CN
`EP
`
`1968653
`5/2007
`3/1984
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`(Continued)
`OTHER PUBLICATIONS
`
`"Precision Control of Eluted Activity from a Sr/Rb Generator for
`Cardiac Positron Emission Technology" by R. Klein, A. Adler, R.S.
`Beanlands, R.A. deKemp (Proceedings of the 26th Annual Interna(cid:173)
`tional Conference of the IEEE EMBS, San Francisco, CA, USA, Sep.
`1-5, 2004, pp. 1393-1396.*
`(Continued)
`
`(57)
`
`Primary Examiner - Charles A Marmor, II
`Assistant Examiner - Carrie R Dama
`(74) Attorney, Agent, or Firm - Fredrikson & Byron, P.A.
`ABSTRACT
`Methods for setting up, maintaining and operating a radiop(cid:173)
`harmaceutical infusion system, that includes a radioisotope
`generator, are facilitated by a computer of the system. The
`computer includes pre-programmed instructions and a com(cid:173)
`puter interface, for interaction with a user of the system, for
`example, in order to track contained volumes of eluant and/or
`eluate, and/or to track time from completion of an elution
`performed by the system, and/or to calculate one or more
`system and/or injection parameters for quality control, and/or
`to perform purges of the system, and/or to facilitate diagnos(cid:173)
`tic imaging.
`
`22 Claims, 27 Drawing Sheets
`
`INFUSION SYSTEM WITH RADIOISOTOPE
`DETECTOR
`(71) Applicant: Bracco Diagnostics Inc., Monroe
`Township, NJ (US)
`Inventors: Stephen E. Hidem, Plymouth, MN
`(US); Aaron M. Fontaine, Fridley, MN
`(US); Janet L. Gelbach, New Albany,
`IN (US); Patrick M. McDonald,
`Omaha, NE (US); Kathryn M. Hunter,
`Knoxville, TN (US); Rolf E. Swenson,
`Silver Spring, MD (US); Julius P.
`Zodda, Mercerville, NJ (US)
`Assignee: Bracco Diagnostics Inc., Monroe
`Township, NJ (US)
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`Appl. No.: 14/455,623
`Aug. 8, 2014
`Filed:
`Prior Publication Data
`
`(73)
`
`( *)
`
`Notice:
`
`(21)
`(22)
`(65)
`
`US 2014/0374614 Al
`
`Dec. 25, 2014
`
`Related U.S. Application Data
`
`(63)
`
`Continuation of application No. 12/808,467, filed as
`application No. PCT/US2009/047031 on Jun. 11,
`
`(Continued)
`
`(51)
`
`Int. Cl.
`G21G4/08
`A61N5/10
`
`(2006.01)
`(2006.01)
`(Continued)
`
`(52) U.S. Cl.
`CPC G21G 4108 (2013.01); A61B 61107 (2013.01);
`A61B 61481 (2013.01); A61B 19154 (2013.01);
`(Continued)
`
`( 58) Field of Classification Search
`CPC .............. A61N 2005/1021; A61N 2005/1022;
`A61N 5/10; A61N 5/1007; A61N 5/1001;
`A61N 5/1002; A61N 5/1014; A61N 5/1015;
`A61N 5/1016; A61N 5/1017; A61N 5/1027;
`
`JUBILANT EXHIBIT 1001
`Jubilant v. Bracco, IPR2018-01449
`
`

`

`US 9,299,467 B2
`Page 2
`
`Related U.S. Application Data
`
`2009, which is a continuation of application No.
`12/137,356, filed on Jun. 11, 2008, now Pat. No. 8,317,
`674, and a continuationofapplicationNo. 12/137,363,
`filed on Jun. 11, 2008, now Pat. No. 7,862,534, and a
`continuation of application No. 12/137,364, filed on
`Jun. 11, 2008, and a continuation of application No.
`12/137,377, filed on Jun. 11, 2008, now Pat. No. 8,708,
`352.
`
`(51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61M5/14
`G21F 7100
`G21Gl/OO
`A61B 6110
`A61B 19100
`A61M5/00
`A61M5/142
`G21F 3100
`A61K51/00
`A61B 6100
`A61B 6103
`(52) U.S. Cl.
`CPC ................ A61K 51100 (2013.01); A61M 51007
`(2013.01); A61M 5114 (2013.01); A61M 51142
`(2013.01); A61N 511001 (2013.01); G21F 3100
`(2013.01); G21F 7100 (2013.01); G21G 110005
`(2013.01); A61B 61037 (2013.01); A61B 61507
`(2013.01); A61B 20191542 (2013.01); A61N
`200511021 (2013.01)
`
`(56)
`
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`......................... 60015
`
`

`

`US 9,299,467 B2
`Page 3
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`* cited by examiner
`
`

`

`V.s. Patent
`
`Mar. 29, 2016
`
`Sheet 1 0£27
`
`Us 9,299,467 B2
`
`Fig. 1A
`
`172
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`
`

`

`U.S. Patent
`
`Mar.29,2016
`
`Sheet 2of27
`
`US 9,299,467 B2
`
`Fig. 18
`
`117
`
`118
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`
`

`

`U.S. Patent
`
`Mar.29,2016
`
`Sheet 3of27
`
`US 9,299,467 B2
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`Fig. 1C
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`U.S. Patent
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`Mar.29,2016
`
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`US 9,299,467 B2
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`

`

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`Mar.29,2016
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`Mar. 29, 2016
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`

`Logout
`
`Breakthrough Results
`
`Data Operations
`
`Calibration
`
`System Settings
`
`Breakthrough Test
`
`Generator Setup
`
`[ Generator Column Wash
`
`Purge Operations
`
`Empty Waste Bottle
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`
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`Fig. 4
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`I
`I
`
`Logout
`
`Data Operations
`
`System Settings
`
`Generator Setup
`
`Purge Operations
`
`I Automatic Infusion
`
`l>
`
`Calibration
`
`Empty Waste Bottle
`
`3-__./
`
`57
`
`I Breakthrough Results
`I
`I Breakthrough Test
`I Generator Column Wash
`l/f Replace Saline Bag
`
`Fig. SA
`
`

`

`Yes
`
`No
`
`Do you wish to change it now?
`
`Saline bag is empty.
`
`Warning
`
`(578
`
`OK
`
`Refill
`
`Do not draw air!
`
`draw any remaining saline. Push OK when finished.
`
`Push and hold refill button to manually
`
`Saline bag is low.
`
`577
`
`Fig. 58
`
`

`

`I Done I
`
`I Cancel I
`
`your site specific radiation safety procedures.
`
`Dispose of contents in accordance with
`
`Empty or replace waste bottle
`
`Empty Waste Bottle
`
`•
`
`"
`
`584---.._
`
`Fig. 5C
`
`I
`I
`I
`I
`I
`I
`
`I
`I Data Operations
`I System Settings
`I
`I Purge Operations
`I Automatic Infusion
`
`Generator Setup
`
`Logout
`
`I
`
`I Breakthrough Results I
`I
`I
`I Breakthrough Test
`I
`I
`I Generator Column Wash
`I Replace Saline Bag
`
`Calibration
`
`-v
`
`583
`
`~ Empty Waste Bottle
`
`Main Menu
`
`~
`
`I
`
`470
`
`

`

`I Done I
`
`9 Min 50 Sec
`
`Time until next elution:
`
`Generator column wash is complete.
`
`Generator Column Wash
`
`0
`
`~
`
`677 ~
`
`I
`
`I Done I
`
`Generator column wash in progress.
`
`•
`
`Generator Column Wash
`
`676
`
`I
`,,....-
`
`I
`I
`I
`I
`I
`I
`
`I
`I Data Operations
`I
`I
`I Purge Operations
`I Automatic Infusion
`
`System Settings
`
`Generator Setup
`
`Logout
`
`Main Menu
`
`I Breakthrough Results I
`I
`I
`I
`I
`I Empty Waste Bottle I
`I Replace Saline Bag I
`
`Calibration
`
`Breakthrough Test
`
`L---1 Generator Column Wash
`
`5-v
`
`67
`
`L.-
`
`470 _/
`v
`Fig. 6
`
`

`

`I Done I
`
`I
`
`Abort
`
`I
`
`I Quit
`
`I
`
`•
`
`I Back I
`
`I Quit I
`
`Start Elution
`
`Breakthrough elution in progress.
`Breakthrough Test
`
`Press start button to begin breakthrough test.
`
`Breakthrough Test
`
`~776
`
`I Next I
`
`I
`
`I
`
`I Quit
`
`Insert new qc vial into elution vial shield.
`
`Press next to continue.
`
`Breakthrough Test
`
`470
`
`Logout
`
`Data Operations
`
`I
`
`(
`
`I System Settings
`I Generator Setup
`I Purge Operations
`
`Automatic Infusion
`
`(
`
`Main Menu
`
`775--,
`
`C I Breakthrough Test
`
`I Generator Column Wash I
`I Empty Waste Bottle
`I Replace Saline Bag
`
`1--~~~~~~~~~~~~~~---1-1\__ 774-----~~~~~~~~~~~~~~~~---1
`
`Fig. 7A
`
`

`

`I Done I
`
`I
`
`I Next
`
`I
`
`. . .
`
`-['\._ 779
`
`Press done to return to main menu.
`
`Breakthrough elution complete.
`
`Breakthrough Test
`
`i
`
`I Quit I
`
`I
`
`I Next
`
`I Quit I
`
`778
`
`-i---,,_
`
`I
`I
`
`Enter time since end of elution
`
`Time I
`
`mCI I
`
`Enter rb-82 reading from dose calibrator
`
`Breakthrough elution complete.
`Breakthrough Test
`
`_____...
`
`8 Min 50 Sec
`
`Time from end of elution:
`
`Breakthrough elution complete.
`
`Breakthrough Test
`
`___.v .....
`
`777
`
`Fig. 78
`
`

`

`Done
`
`11
`
`Back
`
`Sr-85/Rb-82 < 0.02 uCi I mCi
`Sr-82/rb-82 < 0.02 uCi I mCi
`
`Results should not exceed allowable limits:
`
`Sr-85/Rb-82 = 0.11 uC I mCi
`Sr-82/Rb-82 = 0.0005 uCi I mCi
`
`Breakthrough test complete.
`
`Results:
`
`Breakthrough Test
`
`Time 53 Min 20 Sec I Next
`
`Enter background radiation reading
`
`Quit
`
`uCi
`
`uCi
`
`• • •
`
`Enter breakthrough reading at 60 min
`
`Time 2 Min3Q Sec
`
`mCi 54 .5
`
`Breakthrough elution complete.
`Breakthrough Test
`
`(782
`
`/781
`
`Fig. 7C
`
`

`

`I Back I
`
`I Quit I
`
`I
`
`I
`
`Start
`
`_____..
`
`Press start button to begin calibration.
`
`Infusion System Calibration
`
`876\
`
`I
`
`11 Next I
`
`I Back
`
`I
`
`I Quit
`
`I Next I
`
`I
`I
`I
`I
`I
`
`199 ml (DEFAULT)
`11.0 mCi/sec (DEFAULT)
`150 mUmin (DEFAULT)
`150 ml
`160 mCi
`
`I
`
`I Quit
`
`Elution Volume
`
`Threshold
`Dose Rate
`
`Flow Rate
`
`Patient Volume
`
`Patient Dose
`
`Infusion System Calibration
`
`""-
`
`87 5-...._
`
`873 ---HJ
`
`Press next to continue.
`
`Insert new qc vial into elution vial sheild.
`
`_____..
`
`Infusion System Calibration
`
`I
`\
`
`-...._,.
`
`874
`
`I
`I
`I
`I
`I
`I
`
`Logout
`
`I Breakthrough Results I
`
`Data Operations
`
`Calibration
`
`System Settings
`
`Generator Setup
`
`Purge Operations
`
`Automatic Infusion
`
`I
`I Breakthrough Test
`I Generator Column Wash I
`I
`I Empty Waste Bottle
`I
`I Replace Saline Bag
`
`Main Menu
`
`~
`
`4 70_)
`A
`
`Fig. 8
`
`

`

`I Accept I
`
`I Reject I
`
`Daily calibration should be within 0.9 to 1.1
`
`New generator calibration should be within 0.95 to 1.05
`
`Calibration Ratio= 0.96
`
`Result:
`
`Calibration elution complete.
`
`Infusion System Calibration
`
`"'
`
`880~
`
`I
`
`I Next I
`
`I
`
`I Quit
`
`8 Min 50 Sec
`
`Time from end of elution:
`
`Calibration elution complete
`
`Infusion System Calibration
`
`_____.
`
`-
`
`878__/
`
`Enter rb-82 reading from dose calibrator
`
`Calibration elution complete.
`
`Infusion System Calibration
`
`"
`
`879 -""
`
`I Done I
`I
`
`I
`I
`
`I Quit
`
`Abort
`
`Infusion System Calibration
`
`lfl-------
`
`Calibration elution progress
`
`-
`
`Fig. BB
`
`_/
`
`887
`
`_____.
`
`I Next I
`I
`I
`
`I
`
`Enter time since end of elution
`
`I Quit
`Time I
`mCi I
`
`

`

`I Next I
`
`I
`
`199 ml (DEFAULT)
`11.0 mCi/sec (DEFAULT)
`I so ml/min (DEFAULT)
`lso ml
`160 mCi
`
`I Quit I
`
`Elution Volume
`
`Threshold
`Dose Rate
`
`Flow Rate
`
`Patient Volume
`
`Patient Dose
`
`Automatic Infusion
`
`I
`
`974~
`
`I
`
`I Next I
`
`I Quit I
`
`Next I
`
`11
`
`I Back
`
`I Quit I
`
`_____.
`
`Line
`
`Purge Patient
`
`Attach New Patient Line
`Automatic Infusion
`
`' r
`
`I\
`
`973 ---...._,
`
`I
`
`I
`
`Press next to continue.
`
`Enter patient id.
`
`Automatic Infusion
`
`-971
`
`972_/
`
`_____.
`
`I
`I
`~
`
`I Breakthrough Results
`I
`I Breakthrough Test
`I Generator Setup
`I Generator Column Wash
`I Purge Operations
`I Empty Waste Bottle
`I Replace Saline Bag I c I Automatic Infusion
`
`I System Settings v -995
`
`I
`
`I
`I Data Operations
`
`Logout
`
`Calibration
`
`Main Menu
`
`470 _f -
`Fig. 9A
`
`

`

`U.S. Patent
`
`Mar.29,2016
`
`Sheet 22 of 27
`
`US 9,299,467 B2
`
`N
`0
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`I Done I
`
`I Next I
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`Press done to return to main menu.
`
`Elution Volume 28 ml
`14 ml
`Patient Volume
`52 mCi
`Patient Dose
`
`Infusion Summary.
`
`Automatic Infusion
`
`_____.
`
`I Done I
`I
`
`I
`
`Abort
`
`978\
`
`I Quit I
`I
`
`lfl-------
`
`Infusion in progress. Patient id: d430b
`
`Automatic Infusion
`
`_____.
`
`976_/c-
`
`8 Min 50Sec
`
`Time from end of infusion:
`
`Infusion complete.
`
`Automatic Infusion
`
`1'
`
`__..../
`
`9 77
`
`I Back I
`
`I Quit I
`
`Infusion
`
`Start Patient
`
`Patient id: d430b
`
`Automatic Infusion
`
`_/
`9C
`
`Fig.
`
`975
`
`

`

`11 Next I
`
`I Back
`
`I Quit I
`
`I Back 11 Next I
`
`I Quit I
`
`I
`
`I
`
`Start Purge
`
`Purge with Air
`
`_____,..
`
`if you intend to continue using it.
`
`Warning: You must bypass the generator
`
`Purge with Air
`
`985\
`I
`
`I Next I
`
`I Quit I
`
`Attach elution test vial to patient line.
`
`Remove saline bag.
`
`Purge with Air
`
`I
`I
`I
`
`_____,..
`
`',
`
`'\
`98 4-,
`
`Logout
`
`Calibration
`
`I Breakthrough Results I I
`I I Data Operations
`I
`I I System Settings
`I Breakthrough Test
`(Generator Column Wash I Cl Generator Setup
`I Empty Waste Bottle I CJ
`I Replace Saline Bag I
`
`983----
`
`Main Menu
`
`..---981
`
`I Automatic Infusion I/
`
`Purge Operations v ,......-991
`
`"
`
`__/
`0
`Fig. 1
`
`470
`
`

`

`0.2
`
`4.48 GBq
`120.95 mCi
`
`TRANSPORT INDEX:
`TOTAL Sr-82/Sr-85 ACTIVITY:
`TOTAL Sr-82/Sr-85 ACTIVITY:
`
`SUMMARY
`
`SURFACE WIPE: 1278 dpm (MUST BE < 2200 dpm/100 cm2)
`1 METER:
`SURFACE:
`
`0.2 mrem/hr (MUST BE < 1 mrem/hr)
`5.6 mrem/hr MUST BE < 50 mrem/hr)
`RETURN SURVEY
`
`3.47 GBq
`93.77 mCi
`0.6011
`
`156 mCi
`
`REMAINING Sr-85 IN GBq
`REMAINING Sr-85 IN mCi:
`DECAY FACTOR:
`INITIAL Sr-85 ACTIVITY:
`
`Sr-85 RETURN CALCULATIONS
`
`1.01 GBq
`27.18 mCi
`0.2718
`
`100 mCi
`
`REMAINING Sr-82 IN GBq
`REMAINING Sr-82 IN mCi:
`DECAY FACTOR:
`INITIAL Sr-82 ACTIVITY:
`
`Sr-82 RETURN CALCULATIONS
`
`I 12/27/2008
`
`GENERATOR RETURN
`
`47
`
`DAYS SINCE CALIBRATION DATE: I
`DATE OF RETURN:
`
`SURFACE WIPE: 1599 dpm (MUST BE < 2200 dpm/100 cm2)
`1 METER:
`SURFACE:
`
`0.6 mrem/hr (MUST BE < 1 mrem/hr)
`10.0 mrem/hr MUST BE < 50 mrem/hr)
`
`RECEIPT SURVEY
`
`156 mCi
`256 mCi
`100 mCi
`
`11/10/2008
`11/9/2008
`
`Sr-85 ACTIVITY:
`TOTAL ACTIVITY:
`Sr-82 ACTIVITY:
`LOT NUMBER:
`DATE OF CALIBRATION:
`DATE OF DELIVERY:
`
`GENERATOR RECEIPT
`
`CARDIOGEN-82 GENERATOR MONTHLY RECEIPT/RETURN WORKSHEET
`
`Fig. 11
`
`

`

`U.S. Patent
`
`Mar.29,2016
`
`Sheet 26 of 27
`
`US 9,299,467 B2
`
`Fig. 12A
`
`1335
`
`~1300A
`
`35WP
`305P
`
`15
`
`1334
`
`35BG
`
`37
`
`33
`
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`
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`
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`
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`
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`
`37
`
`33
`
`l
`
`23
`
`1350
`
`------------------
`
`

`

`U.S. Patent
`
`Mar.29,2016
`
`Sheet 27 of 27
`
`US 9,299,467 B2
`
`Fig. 12C
`
`/1200A
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`
`TIME(S)
`
`

`

`US 9,299,467 B2
`
`1
`INFUSION SYSTEM WITH RADIOISOTOPE
`DETECTOR
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`This application is a continuation of U.S. patent applica(cid:173)
`tion Ser. No. 12/808,467, filed Jun. 16, 2010, which is a 371
`National Stage oflnternational Application No. PCT/US09/
`4 7031, filed Jun. 11, 2009, which in turn claims priority to the
`following four patent applications: U.S. patent application
`Ser. No. 12/137,356, filed Jun. 11, 2008, now U.S. Pat. No.
`8,317,674, issued Nov. 27, 2012; U.S. patent application Ser.
`No. 12/137,363, filed Jun. 11, 2008, now U.S. Pat. No. 7,862,
`534, issued Jan. 4, 2011; U.S. patent application Ser. No. 15
`12/137,364, filed Jun. 11, 2008; and U.S. patent application
`Ser. No. 12/137,377, filed Jun. 11, 2008, now U.S. Pat. No.
`8,708,352, issued Apr. 29, 2014. The entire contents of all of
`these applications are incorporated herein by reference.
`
`10
`
`TECHNICAL FIELD
`
`The present invention pertains to systems that generate and
`infuse radiopharmaceuticals, and, more particularly, to sys(cid:173)
`tems including computer-facilitated maintenance and/or 25
`operation.
`
`2
`FIG. lA is a first perspective view of an infusion system,
`according to some embodiments of the present invention.
`FIG. lB is another perspective view of a portion of a
`cabinet structure of the system shown in FIG. lA, according
`to some embodiments.
`FIG. lC is a second perspective view of the system shown
`in FIG. lA, according to some embodiments.
`FIG. lD is a schematic of an infusion circuit, according to
`some embodiments of the present invention.
`FIG. lE is a perspective view of exemplary sample vial
`shielding that may be employed in conjunction with the infu(cid:173)
`sion system of FIG. lA.
`FIG. 2A is a perspective view of a shielding assembly for
`an infusion system, such as that shown in FIGS. lA-C,
`according to some embodiments of the present invention.
`FIG. 2B is a perspective view ofa framework of the system,
`according to some embodiments, and FIG. 2B-1 is an
`enlarged detailed view of a component of the system, accord(cid:173)
`ing to some embodiments.
`FIG. 3A is another perspective view of the shielding
`20 assembly shown in FIG. 2A.
`FIG. 3B is a perspective view of the infusion circuit, shown
`in FIG. lC, configured and routed, according to some
`embodiments.
`FIG. 3C is a perspective view of a disposable infusion
`circuit subassembly, according to some embodiments.
`FIG. 3D is a frame for the subassembly shown in FIG. 3C,
`according to some embodiments.
`FIG. 4 is a main menu screen shot from an interface of a
`computer, which may be included in systems of the present
`invention, according to some embodiments.
`FIG. SA is a schematic showing a first group of successive
`screen shots from the computer interface, according to some
`embodiments.
`FIG. SB is a pair of screen shots from the computer inter(cid:173)
`face, which provide indications related to eluant volume lev(cid:173)
`els in a reservoir of the system, according to some embodi(cid:173)
`ments.
`FIG. SC is a schematic showing a second group of succes(cid:173)
`sive screen shots from the computer interface, according to
`some embodiments.
`FIG. 6 is a schematic showing a third group of successive
`screen shots from the computer interface, according to some
`embodiments.
`FIGS. 7A-C are schematics showing a fourth group of
`successive screen shots from the computer interface, accord(cid:173)
`ing to some embodiments.
`FIGS. SA-B are schematics showing a fifth group of suc(cid:173)
`cessive screen shots from the computer interface, according
`to some embodiments.
`FIGS. 9A-C are schematics showing a sixth group of suc(cid:173)
`cessive screen shots from the computer interface, according
`to some embodiments.
`FIG.10 is a schematic showing a seventh group of succes(cid:173)
`sive screen shots from the computer interface, according to
`some embodiments.
`FIG. 11 is an exemplary report which may be generated by
`the computer included in infusion systems, according to some
`embodiments.
`FIGS. 12A-B are schematics of alternative infusion cir(cid:173)
`cuits that may be employed by embodiments of the present
`invention.
`FIG. 12C is a schematic illustrating exemplary activity
`profiles of injected doses of a radiopharmaceutical.
`
`BACKGROUND
`
`30
`
`Nuclear medicine employs radioactive material for therapy
`and diagnostic imaging. Positron emission tomography
`(PET) is one type of diagnostic imaging, which utilizes doses
`of radiopharmaceuticals, for example, generated by elution
`within a radioisotope generator, that are injected, or infused
`into a patient. The infused dose of radiopharmaceutical is 35
`absorbed by cells of a target organ, of the patient, and emits
`radiation, which is detected by a PET seamier, in order to
`generate an image of the organ. An example of a radioactive
`isotope, which may be used for PET, is Rubidium-82 (pro(cid:173)
`duced by the decay of Strontium-82); and an example of a 40
`radioisotope generator, which yields a saline solution of
`Rubidium-82, via elution, is the CardioGen-82® available
`from Bracco Diagnostics Inc. (Princeton, N.J.). A PET scan(cid:173)
`ner in combination with infused doses ofradiopharmaceuti(cid:173)
`cals may also be employed to quantify blood flow rate, for 45
`example, through the coronary arteries of a patient.
`Set up, maintenance and operational procedures for infu(cid:173)
`sion systems that both generate and inject doses of radiophar(cid:173)
`maceuticals are relatively involved in order to assure the
`safety and efficacy of each injected dose for the patient. 50
`Efficiency in carrying out these procedures is highly desirable
`for technical personnel, who work with these systems on a
`routine basis and would like to avoid unnecessarily prolonged
`exposure to radioactive radiation. Thus there is a need for new
`system configurations that facilitate more efficient set up, 55
`maintenance and operation.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The following drawings are illustrative of particular 60
`embodiments of the present invention and therefore do not
`limit the scope of the invention. The drawings are not to scale
`(unless so stated) and are intended for use in conjunction with
`the explanations in the following detailed description.
`Embodiments of the present invention will hereinafter be 65
`described in conjunction with the appended drawings,
`wherein like numerals denote like elements.
`
`DETAILED DESCRIPTION
`
`The following detailed description is exemplary in nature
`and is not intended to limit the scope, applicability, or con-
`
`

`

`US 9,299,467 B2
`
`3
`figuration of the invention in any way. Rather, the following
`description provides practical illustrations for implementing
`exemplary embodiments. Utilizing the teaching provided
`herein, those skilled in the art will recognize that many of the
`examples have suitable alternatives that can be utilized.
`FIG. IA is a first perspective view of an infusion system 10,
`according to some embodiments of the present invention,
`wherein system IO is shown supported by a cabinet structure,
`which includes a platform 113 (seen better in FIG. 2B) and a
`shell 13; shell 13 extends upward from a skirt 11, that sur(cid:173)
`rounds platform 113, to surround an interior space in which a
`portion of infusion system IO is contained (seen in FIG. IC).
`Shell 13 may be formed from panels of injection-molded
`polyurethane fitted together according to methods known to
`those skilled in the art. FIG. IA illustrates the cabinet struc(cid:173)
`ture of system I 0 including a grip or handle I4, which extends
`laterally from shell 13, in proximity to an upper surface 13I
`thereof, and a post I42, which extends upward from shell 13,
`and to which a work surface, or tray I6 anda computer I7 are,
`preferably, attached, via an ergonomic, positionable mount.
`According to some embodiments, computer I 7 is coupled to
`a controller of system IO, which is mounted within the inte(cid:173)
`rior space surrounded by shell 13; and, a monitor I 72 of
`computer I 7 not only displays indications of system opera- 25
`ti on for a user of system I 0, but also serves as a device for user
`input (e.g. touch screen input). However, according to alter(cid:173)
`nate embodiments, another type of user input device, known
`to those skilled in the art, may be employed by computer I 7.
`Other types of user input devices may be included, for 30
`example, a keyboard, a series of control buttons or levers, a
`bar code reader (or other reader of encoded information), a
`scanner, a computer readable medium containing pertinent
`data, etc. The user input device may be mounted on the
`cabinet structure of system 10, as shown, or may