US0098 14826B2
`
`a2) United States Patent
`US 9,814,826 B2
`(0) Patent No.:
`*Nov. 14, 2017
`(45) Date of Patent:
`Hidem et al.
`
`(54)
`
`INTEGRATED STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION SYSTEMS
`
`(71) Applicant: Bracco Diagnostics Inc., Monroe
`Township, NJ (US)
`
`(72)
`
`Inventors: Stephen E. Hidem, Edina, MN (US);
`Aaron M.Fontaine, Minneapolis, MN
`(US); Janet L. Gelbach, Schaumburg,
`IL (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)
`
`(58) Field of Classification Search
`CPC .. A61M 5/007; A61M 5/1001; A61M 5/1002;
`A61M 5/1007;
`
`(Continued)
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`3,483,867 A
`3,535,085 A
`
`12/1969 Markovitz
`10/1970 Shumate
`
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`(73) Assignee: Bracco Diagnostics Inc., Monroe
`Township, NJ (US)
`
`CA
`CN
`
`(*) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
`(21) Appl. No.: 15/620,320
`
`(22)
`
`Filed:
`
`Jun. 12, 2017
`
`(65)
`
`Prior Publication Data
`
`US 2017/0274138 Al
`
`Sep. 28, 2017
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 15/389,200, filed on
`Dec. 22, 2016, now Pat. No. 9,750,869, which is a
`(Continued)
`
`(51)
`
`Int. Cl.
`AGIM 5/00
`AGIM 5/14
`
`(2006.01)
`(2006.01)
`(Continued)
`
`(52) U.S. Cl.
`CPC wees A6IM 5/007 (2013.01); A61B 6/037
`(2013.01); A6IB 6/107 (2013.01), A6IB 6/481
`(2013.01);
`
`2913373 Al
`1968653 A
`
`4/2008
`5/2007
`
`(Continued)
`
`OTHER PUBLICATIONS
`
`Alvarez-Diezetal. “Manufacture of strontium-82/rubidium-82 gen-
`erators and quality control of rubidium-82 chloride for myocardial
`perfusion imaging in patients using positron emission tomography,”
`Applied Radiation and Isotopes, 1999, pp. 1015-1023.
`(Continued)
`
`Primary Examiner — Charles A Marmor, II
`Assistant Examiner — Carrie R Dorna
`
`(74) Attorney, Agent, or Firm — Fredrikson & Byron,
`PA.
`
`ABSTRACT
`(57)
`Methods for setting up, maintaining and operating a radio-
`pharmaceutical infusion system,that includes a radioisotope
`generator, are facilitated by a computer of the system. The
`computer may include pre-programmed instructions and a
`computer 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
`diagnostic imaging.
`
`(Continued)
`
`30 Claims, 27 Drawing Sheets
`
`
`
`JUBILANT EXHIBIT 1036
`Jubilant v. Bracco, IPR2018-01449
`
`JUBILANT EXHIBIT 1036
`Jubilant v. Bracco, IPR2018-01449
`
`

`

`US 9,814,826 B2
`
`Page 2
`
`PPPPPEEPSEEEPEPEEEEESPPEESPPEEEEEPSEPPEEEPPEPrPPEPEPPS
`
`Related U.S. Application Data
`
`(56)
`
`continuation of application No. 12/808,467, filed as
`application No. PCT/US2009/047031 on Jun. 11,
`2009, now Pat. No. 9,607,722, which is a continu-
`ation of application No. 12/137,377, filed on Jun. 11,
`2008, now Pat. No. 8,708,352, and a continuation of
`application No. 12/137,363, filed on Jun. 11, 2008,
`now Pat. No. 7,862,534, and a continuation of appli-
`cation No. 12/137,356, filed on Jun. 11, 2008, now
`Pat. No. 8,317,674, and a continuation of application
`No. 12/137,364, filed on Jun. 11, 2008, now Pat. No.
`9,597,053.
`
`(51)
`
`(2016.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2016.01)
`(2006.01)
`(2006.01)
`(2013.01)
`(2006.01)
`(2016.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A6IB 90/00
`AGIM 5/145
`G21F 3/00
`AGIM 5/158
`G21F 7/00
`AGIM 5/168
`G21G 1/00
`AGIB 6/00
`AGIB 6/03
`G21G 4/08
`AGIB 50/13
`AGIM 5/142
`A6IK 51/00
`GO6F 21/31
`AGIB 6/10
`A6IB 50/10
`AGIN 5/10
`B62B 3/00
`(52) U.S. Cl
`CPC veeceecceseee A6IB 6/507 (2013.01); A6IB 50/13
`(2016.02); A6IB 90/39 (2016.02); A6LK 51/00
`(2013.01); A6IM 5/14 (2013.01); A61M 5/142
`(2013.01); A61M 5/1409 (2013.01); A6IM
`5/1452 (2013.01); A61M 5/158 (2013.01);
`A6IM 5/16854 (2013.01); A6IM 5/16881
`(2013.01); A6IN 5/1001 (2013.01); A6IN
`5/1007 (2013.01); A6LN 5/1075 (2013.01);
`GO6F 21/31 (2013.01); G2LF 3/00 (2013.01);
`G21F 7/00 (2013.01); G21G 1/001 (2013.01);
`G21G 1/0005 (2013.01); G21G 4/08
`(2013.01); A61B 2050/105 (2016.02); A6IB
`2090/392 (2016.02); A6IM 2005/1403
`(2013.01); A61M 2205/18 (2013.01); A61M
`2205/276 (2013.01); A6IM 2205/50 (2013.01);
`A61M 2205/505 (2013.01); A61M 2205/52
`(2013.01); A61M 2209/084 (2013.01); AGIN
`2005/1021 (2013.01); AGIN 2005/1022
`(2013.01); A6IN 2005/1074 (2013.01); A6IN
`2005/1094 (2013.01); B62B 3/005 (2013.01);
`G21G 2001/0031 (2013.01)
`(58) Field of Classification Search
`CPC A61M 5/1014—-5/1017; A61M 5/1027; A61M
`5/1028; A61M 5/1071; A61M 5/14;
`A61M 5/142; A61M 2005/1021; G21G
`4/08; G21G 1/0005; GO6F 19/3468;
`A61B 2050/105
`
`See application file for complete search history.
`
`3,543,752
`3,565,376
`3,576,998
`3,710,118
`3,714,429
`3,774,036
`3,847,138
`3,861,380
`3,953,567
`3,991,960
`3,997,784
`4,096,859
`4,160,910
`4,212,303
`4,241,728
`4,286,169
`4,336,036
`4,406,877
`4,466,888
`4,562,829
`4,585,009
`4,585,941
`4,597,951
`4,623,102
`4,625,118
`4,656,697
`4,674,403
`4,679,142
`4,755,679
`4,759,345
`4,769,008
`4,853,546
`4,994,056
`5,039,863
`5,092,834
`5,166,526
`5,254,328
`5,258,906
`5,274,239
`5,395,320
`5,468,355
`5,475,232
`5,485,831
`5,580,541
`5,590,648
`5,674,404
`5,681,285
`5,702,115
`5,739,508
`5,765,842
`5,827,429
`5,840,026
`5,885,216
`6,058,718
`6,157,036
`6,220,554
`6,267,717
`6,269,810
`6,327,895
`6,347,711
`6,442,418
`6,450,936
`6,454,460
`6,558,125
`6,626,862
`6,639,237
`6,758,975
`6,767,319
`6,773,686
`6,870,175
`6,901,283
`6,908,598
`6,931,327
`7,091,494
`7,125,166
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`12/1970
`2/1971
`5/1971
`1/1973
`1/1973
`11/1973
`11/1974
`1/1975
`4/1976
`11/1976
`12/1976
`6/1978
`TN9T9
`7/1980
`12/1980
`8/1981
`6/1982
`9/1983
`8/1984
`1/1986
`4/1986
`4/1986
`T1986
`11/1986
`11/1986
`4/1987
`6/1987
`TN987
`TN988
`TN988
`9/1988
`8/1989
`2/1991
`8/1991
`3/1992
`11/1992
`10/1993
`11/1993
`12/1993
`3/1995
`11/1995
`12/1995
`1/1996
`12/1996
`1/1997
`10/1997
`10/1997
`12/1997
`4/1998
`6/1998
`10/1998
`11/1998
`3/1999
`5/2000
`12/2000
`4/2001
`7/2001
`8/2001
`12/2001
`2/2002
`8/2002
`9/2002
`9/2002
`5/2003
`9/2003
`10/2003
`7/2004
`7/2004
`8/2004
`3/2005
`5/2005
`6/2005
`8/2005
`8/2006
`10/2006
`
`Hesseet al.
`Viers
`Deutsch etal.
`Holgate et al.
`McAfeeetal.
`Gerhart
`Gollub
`Chassagneetal.
`Grant et al.
`Tanaka
`Picunkoetal.
`Agarwalet al.
`Thornton etal.
`Nolan
`Mirell
`Rossem
`Leekeetal.
`Neirinckx etal.
`Verkaart
`Bergner
`Barker et al.
`Bergner
`Gennaroet al.
`Houghetal.
`Kriwetz et al.
`Naslund
`Bryantet al.
`Lee
`Wong
`Mistry
`Hessel
`Abeet al.
`Ikeda
`Matsunoetal.
`Bradshawetal.
`Dietzel
`Herscheid
`Kroll et al.
`Laneetal.
`Padda etal.
`Sheferet al.
`Powerset al.
`Holdsworth et al.
`Wells et al.
`Mitchell et al.
`Kenley et al.
`Fordet al.
`Poolet al.
`Uberet al.
`Phaneuf
`Ruschkeet al.
`Uber, ITI et al.
`Evans,III et al.
`Forsberg et al.
`Whiting et al.
`Daoud.
`Stoll et al.
`Brookeretal.
`Jeppsson et al.
`Goebel etal.
`Evans,III et al.
`Smith, II et al.
`Ramanathan et al.
`Futterknecht
`Duchonetal.
`Pedersen et al.
`Peabodyet al.
`Reilly et al.
`Herscheid et al.
`Dell
`Evans,III et al.
`Sylvester
`Goodeetal.
`Weisneretal.
`Ecket al.
`
`

`

`US 9,814,826 B2
`Page 3
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2012/0310031 Al
`2012/0312980 Al
`2013/0300109 Al
`2014/0084187 Al
`2014/0175959 Al
`2014/0343418 Al
`2014/0374614 Al
`2014/0374615 Al
`2015/0260855 Al
`
`12/2012 Quiricoet al.
`12/2012 Whitehouse
`11/2013 Balestracci et al.
`3/2014 Quirico et al.
`6/2014 Quirico et al.
`11/2014 Quirico et al.
`12/2014 Hidem etal.
`12/2014 Hidem etal.
`9/2015 McQuaid etal.
`
`B2
`Graveset al.
`1/2007
`7,163,031
`B2
`Duchonetal.
`1/2007
`7,169,135
`B2
`4/2007
`7,204,797
`Reilly et al.
`B2
`Staehr et al.
`8/2007
`7,256,888
`B2
`10/2007
`7,286,867
`Schlyeret al.
`B2
`Ortenzi
`8/2008
`7,413,123
`B2
`Moller etal.
`1/2009
`7,476,377
`B2
`Balestracci et al.
`3/2009
`7,504,646
`B2
`4/2009
`7,522,952
`3/1984
`102121 Al
`EP
`Krieg et al.
`B2
`Mourtadaet al.
`9/2009
`7,586,102
`4/1989
`310148 A2
`EP
`B2
`Sonnenholet al.
`10/2009
`7,605,384
`5/1989
`317114 Al
`EP
`B2
`Lambetal.
`10/2009
`7,608,831
`2/1991
`160303 A2
`EP
`B2
`Clark etal.
`11/2009
`7,612,999
`2/1994
`319148 A2
`EP
`B2
`5/2010
`7,712,491
`5/2004
`1421960 Al
`EP
`Tochon-Danguyet al.
`B2
`Dhawaleetal.
`6/2010
`7,734,331
`1/2005
`919249 Al
`EP
`B2
`Casale et al.
`6/2010
`7,737,AIS
`4/2007
`1772157 Al
`EP
`B2
`Fox et al.
`8/2010
`7,780,352
`8/2007
`1820730 Al
`EP
`B2
`10/2010
`7,813,841
`1/2009
`2011126 A2
`EP
`deKempetal.
`B2
`11/2010
`7,825,372
`8/2012
`2492920 A2
`EP
`Allberg
`B2
`1/2011
`7,862,534
`9/2005
`2867084 Al
`FR
`Quirico et al.
`B2
`Telischak et al.
`8/2011
`7,996,068
`12/2000
`2000350783 A
`JP
`B2
`Balestracci et al.
`11/2011
`8,058,632
`7/2003
`2003520780 A
`JP
`B2
`12/2011
`8,071,959
`12/2006
`2006325826 A
`JP
`deKemp
`B2
`Boutonet al.
`6/2012
`8,198,599
`3/1996
`960003726 Bl
`KR
`B2
`Balestracci
`7/2012
`8,216,181
`6/1999
`2131273 Cl
`RU
`B2
`Balestracci
`7/2012
`8,216,184
`
`RU 2288755 Cl—12/2006
`B2
`10/2012
`Shimchuk etal.
`8,295,916
`SU
`244513 Al
`12/1969
`B2
`11/2012
`8,317,674
`WO
`9615337 Al
`5/1996
`Quirico et al.
`B2
`4/2013
`Hortonetal.
`8,431,909
`WO
`9956117 Al
`11/1999
`B2
`Lemer
`5/2013
`8,439,815
`WO
`02096335 A2
`12/2002
`B2
`5/2013
`Chenetal.
`8,442,803
`WO
`03034444 Al
`4/2003
`B2
`4/2014
`8,708,352
`WO
`2004004787 A2
`1/2004
`Quirico et al.
`Al
`2002/0128594
`9/2002
`Daset al.
`WO
`2004059661 Al
`7/2004
`Al
`2002/0129471
`9/2002
`WO
`2004080523 A2
`9/2004
`Wang
`Al
`2003/0139640
`7/2003
`Whittacre et al.
`WO
`2005002971 Al
`1/2005
`Al
`2003/0194894
`10/2003
`Wariar etal.
`WO
`2006007750 Al
`1/2006
`Al
`2004/00543 19
`3/2004
`WO
`2006026603 A2
`3/2006
`Langley et al.
`Al
`2004/0104160
`6/2004
`WO
`2006074473 A2
`7/2006
`Scagliarini et al.
`Al
`2004/0260143
`12/2004
`WO 2006129301 A2=12/2006
`
`Reilly et al.
`Al
`2005/0085682
`4/2005
`Sasaki et al.
`WO
`2006135374 A2
`12/2006
`Al
`2005/0187515
`8/2005
`Varrichio et al.
`WO
`2007016170 Al
`2/2007
`Al
`2005/0277833
`12/2005
`Williams
`WO
`2007016173 Al
`2/2007
`Al
`2005/0278066
`12/2005
`Graveset al.
`WO
`2007030249 A2
`3/2007
`Al
`2006/00 15056
`1/2006
`WO
`2007041017 Al
`4/2007
`Ellingboeetal.
`Al
`2006/015 1048
`7/2006
`WO
`2007071022 Al
`6/2007
`Tochon-Danguyet al.
`Al
`2006/0164093
`7/2006
`Ooeet al.
`WO
`2007082093 A2
`7/2007
`Al
`2006/0173419
`8/2006
`Malcolm
`WO
`2007104133 Al
`9/2007
`Al
`2007/0080223
`4/2007
`WO 2007149108 A2=12/2007
`
`Japuntich
`Al
`2007/0140958
`6/2007
`WO
`2008028165 A2
`3/2008
`deKemp
`Al
`2007/0226175
`9/2007
`Resnic et al.
`WO
`2008037939 A2
`4/2008
`Al
`2007/0232980
`10/2007
`Felt et al.
`WO
`2008066586 A2
`6/2008
`Al
`2007/02602 13
`11/2007
`Williamsetal.
`WO
`2008082966 A2
`7/2008
`Al
`2007/0282263
`12/2007
`Kalafutet al.
`WO 2008140351 Al=11/2008
`
`Al
`2008/0015794
`1/2008
`Eiler et al.
`WO 2009152320 A2=12/2009
`
`Al
`2008/007 1219
`3/2008
`Rhinehart et al.
`WO
`2010020596 Al
`2/2010
`Al
`2008/0093564
`4/2008
`WO 2011126522 A2=10/2011
`
`Tartaglia et al.
`Al
`2008/0166292
`7/2008
`Levin etal.
`Al
`2008/0177126
`7/2008
`Tate et al.
`Al
`2008/0191148
`8/2008
`Gibson
`Al
`2008/0200747
`8/2008
`Wagneretal.
`Al
`2008/02033 18
`8/2008
`Wagneretal.
`Al
`2008/0237502
`10/2008
`Fago
`Al
`2008/02429 15
`10/2008
`Jacksonetal.
`Al
`2008/0260580
`10/2008
`Helle et al.
`Al
`2009/0112478
`4/2009
`Mueller, Jr. et al.
`Al
`2009/0155167
`6/2009
`Powell et al.
`Al
`2009/0224171
`9/2009
`Verbokkem
`Al
`2009/03 12630
`12/2009
`Hidemetal.
`Al
`2010/03 12039
`12/2010
`Quirico et al.
`2011/0071392
`3/2011
`Quirico et al.
`2011/0172524
`7/2011
`Hidemetal.
`2011/0178359
`7/2011
`Hirschman etal.
`2011/0209764
`9/2011
`Uberet al.
`2012/0098671
`4/2012
`Wieczoreket al.
`2012/0305730
`12/2012
`Balestracci
`
`Brochure, “IV and Liquid Filters: Speedflow Adult 0.2 um Posi-
`tive”,
`http://www.gvs.it/flex/FixedPages/UK/LiquidFilters.php/L/
`UK/ID/Speedflow%20Adjust% .. . Retrieved from URL on Nov.
`11, 2008.
`“Rubidium 82 Infusion System, Easy to
`Bracco Brochure,
`Operate ... Automated . .. Complete”, © Bracco Diagnostics, Inc.,
`0605-002NA,Jun. 2001, (2 pages).
`“CardioGen-82 Infusion System User’s Guide,” Medical Product
`Service GmbH,Jul. 3, 2007, 53 pages.
`Imaging Technology News, web exclusive: “FDG-PET Injector
`Thrusts New Life into Molecular Imaging”, Apr. 2008, 2 pages.
`Neil J. Epstein, “A Rb82 infusion system for quantitative perfusion
`imaging with 3D PET” Applied Radiation and Isotopes, vol. 60,
`
`FOREIGN PATENT DOCUMENTS
`
`OTHER PUBLICATIONS
`
`

`

`US 9,814,826 B2
`Page 4
`
`(56)
`
`References Cited
`OTHER PUBLICATIONS
`
`Feb. 9, 2004, pp. 921-927, XP002557544 DOI: 10, 1016). apradiso.
`2004.02.002.
`R. Klein, “Precision controlled elution of a Sr82/Rb82 generator for
`cardiac perfusion imaging with positron emission tomography”
`Physics in Medicine and Biology, vol. 52, Jan. 11, 2007, pp.
`659-673, XP002557545 DOI:10, 1088/003 1-9155/52/3/009.
`International Search Report and Written Opinion for International
`Patent Application No. PCT/US2009/047030, dated Feb. 25, 2010,
`22 pages.
`International Search Report and Written Opinion for International
`Patent Application No. PCT/US2009/047030, dated Feb. 17, 2010,
`17 pages.
`International Search Report and Written Opinion for International
`Patent Application No. PCT/US2009/047031, dated Mar. 1, 2010,
`20 pages.
`International Search Report and Written Opinion for International
`Patent Application No. PCT/US2009/047034, dated Feb. 25, 2010,
`15 pages.
`International Search Report and Written Opinion for International
`Patent Application No. PCT/US2009/063788, dated Apr. 1, 2010,
`13 pages.
`LEMERPAX, POSIJET® Integrated FDG dispensing and infusion
`system, www.lemerpax.com (copyright date May 2008).
`
`R. Klein, “Precise 82RB infusion system for cardiac perfusion
`measurement using 3D positron emission tomography”, Ottawa-
`Carleton Institute for Electrical and Computer Engineering School
`of Information Technology and Engineering (Electrical & Computer
`Engineering), Feb. 2005, 147 pages.
`R. Klein, “Precision control of eluted Activity from a S1/Rb gen-
`erator for cardiac positron emission tomography”, Proceedings of
`the 26th Annual International Conference of the IEEE EMBS San
`Francisco, CA, USA, Sep. 1-5, 2004, 4 pages.
`Machinetranslation of abstract of RU2307378 published Sep. 27,
`2007.
`in Point-of-Care Testing,”
`Kost, “Preventing Medical Errors
`Archives of Pathology & Laboratory Medicine, vol. 125, No. 10,
`Oct. 2001, pp. 1307-1315.
`Leveson, “Medical Devices: The Therac-25*,” Appendix of:
`Safeware: System Safety and Computers, 1995, 49 pages.
`“Medfusion 3000 Series Technical Service Manual,” Smiths Medi-
`cal, 2010, 184 pages.
`“BodyGuard 323 Infusion Pump System Operator Manual,”
`Caesarea Medical Electronics Ltd, Mar. 2009, 81 pages.
`“Alaris GH Syringe Pump Directions for Use,” Cardinal Health,
`Oct. 2005, 34 pages.
`“Auto Syringe AS40A: Model AS40A Infusion Pump Operation
`Manual,” Baxter, Aug. 1993, 84 pages.
`“CardioGen-82 Rubidium Rb 82 Generator for Elution of Rubidium
`Chloride Rb 82 Injection,” Bracco Diagnostics, May 2000, 13
`pages.
`
`

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`U.S. Patent
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`Nov. 14, 2017
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`Nov. 14, 2017
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`Nov. 14, 2017
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`U.S. Patent
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`Nov. 14, 2017
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`Nov. 14, 2017
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`U.S. Patent
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`Nov. 14, 2017
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`Nov. 14, 2017
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`Nov. 14, 2017
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`U.S. Patent
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`Nov. 14, 2017
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`Sheet 21 of 27
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`U.S. Patent
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`Nov. 14, 2017
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`Nov. 14, 2017
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`Nov. 14, 2017
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`Nov. 14, 2017
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`Sheet 27 of 27
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`

`1
`INTEGRATED STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION SYSTEMS
`
`US 9,814,826 B2
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`FIG. 1A isafirst perspective view of an infusion system,
`according to some embodiments of the present invention.
`This application is a continuation of U.S. patent applica-
`FIG. 1B is another perspective view of a portion of a
`tion Ser. No. 15/389,200, filed Dec. 22, 2016, which is a
`cabinet structure of the system shownin FIG. 1A, according
`continuation of U.S. patent application Ser. No. 12/808,467,
`to some embodiments.
`filed Jun. 16, 2010, now U.S. Pat. No. 9,607,722, issued
`Mar. 28, 2017, which is a 371 National Stage of Interna-
`tional Application No. PCT/US09/47031,
`filed Jun. 11,
`2009, which in turn is a continuation of 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. 12/137,364, filed
`Jun. 11, 2008, now U.S. Pat. No. 9,597,053, issued Mar. 21,
`2017; 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.
`
`2
`scale (unless so stated) and are intended for use in conjunc-
`tion with the explanationsin the following detailed descrip-
`tion. Embodiments of the present invention will hereinafter
`be described in conjunction with the appended drawings,
`wherein like numerals denote like elements.
`
`FIG. 1C is a second perspective view of the system shown
`in FIG. 1A, according to some embodiments.
`FIG. 1D is a schematic of an infusion circuit, according to
`some embodiments of the present invention.
`FIG. 1Eis a perspective view of exemplary sample vial
`shielding that may be employed in conjunction with the
`infusion system of FIG. 1A.
`FIG.2A is a perspective view of a shielding assembly for
`an infusion system, such as that shown in FIGS. 1A-C,
`according to some embodiments of the present invention.
`FIG. 2B is a perspective view of a framework of the
`system, according to some embodiments, and FIG. 2B-1 is
`an enlarged detailed view of a component of the system,
`according to some embodiments.
`FIG. 3A is another perspective view of the shielding
`assembly shown in FIG. 2A.
`FIG. 3B is a perspective view of the infusion circuit,
`shown in FIG. 1C, 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 shownin 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 systemsof the present
`invention, according to some embodiments.
`FIG. 5A is a schematic showinga first group of successive
`screen shots from the computerinterface, according to some
`embodiments.
`FIG. 5B is a pair of screen shots from the computer
`interface, which provide indicationsrelated to eluant volume
`levels in a reservoir of the system, according to some
`embodiments.
`
`FIG. 5C is a schematic showing a second group of
`successive screen shots from the computer interface, accord-
`ing to some embodiments.
`FIG.6 is a schematic showing a third group of successive
`screen shots from the computerinterface, according to some
`embodiments.
`
`FIGS. 7A-C are schematics showing a fourth group of
`successive screen shots from the computer interface, accord-
`ing to some embodiments.
`FIGS. 8A-B are schematics showing a fifth group of
`successive screen shots from the computer interface, accord-
`ing to some embodiments.
`FIGS. 9A-C are schematics showing a sixth group of
`successive screen shots from the computer interface, accord-
`ing to some embodiments.
`FIG. 10 is a schematic showing a seventh group of
`successive screen shots from the computer interface, accord-
`ing 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-
`cuits that may be employed by embodiments of the present
`invention.
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`TECHNICAL FIELD
`
`The present invention pertains to systems that generate
`and infuse radiopharmaceuticals, and, more particularly, to
`systems including computer-facilitated maintenance and/or
`operation.
`
`BACKGROUND
`
`for
`radioactive material
`Nuclear medicine employs
`therapy and diagnostic imaging. Positron emission tomog-
`raphy (PET)
`is one type of diagnostic imaging, which
`utilizes doses of radiopharmaceuticals, for example, gener-
`ated by elution within a radioisotope generator, that are
`injected, or infused into a patient. The infused dose of
`radiopharmaceuticalis absorbed by cells of a target organ, of
`the patient, and emits radiation, which is detected by a PET
`scanner, in order to generate an image of the organ. An
`example of a radioactive isotope, which may be used for
`PET, is Rubidium-82 (produced by the decay of Strontium-
`82); and an example of a 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 scanner in combination with
`infused doses of
`radiopharmaceuticals may also be
`employed to quantify blood flow rate, for example, through
`the coronary arteries of a patient.
`Set up, maintenance and operational procedures for infu-
`sion systems that both generate and inject doses of radiop-
`harmaceuticals are relatively involved in order to assure the
`safety and efficacy of each injected dose for the patient.
`Efficiency in carrying out these procedures is highly desir-
`able 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, maintenance and operation.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The following drawings are illustrative of particular
`embodiments of the present invention and therefore do not
`limit the scope of the invention. The drawings are not to
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`US 9,814,826 B2
`
`3
`FIG. 12C is a schematic illustrating exemplary activity
`profiles of injected doses of a radiopharmaceutical.
`
`DETAILED DESCRIPTION
`
`The following detailed description is exemplary in nature
`and is not
`intended to limit the scope, applicability, or
`configuration of the invention in any way. Rather,
`the
`following description provides practical
`illustrations for
`implementing exemplary embodiments. Utilizing the teach-
`ing provided herein, those skilled in the art will recognize
`that manyof the examples have suitable alternatives that can
`be utilized.
`FIG. 1A is a first perspective view of an infusion system
`10, according to some embodiments of the present inven-
`tion, wherein system 10 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 surrounds platform 113, to surround an interior space in
`which a portion of infusion system 10 is contained (seen in
`FIG. 1C). Shell 13 may be formed from panels of injection-
`molded polyurethane fitted together according to methods
`known to those skilled in the art. FIG. 1A illustrates the
`
`cabinet structure of system 10 including a grip or handle 14,
`which extends laterally from shell 13, in proximity to an
`upper surface 131 thereof, and a post 142, which extends
`upward from shell 13, and to which a work surface, or tray
`16 and a computer 17 are, preferably, attached, via an
`ergonomic, positionable mount. According to some embodi-
`ments, computer 17 is coupled to a controller of system 10,
`which is mounted within the interior space surrounded by
`shell 13; and, a monitor 172 of computer 17 not only
`displays indications of system operation for a user of system
`10, but also serves as a device for user input (e.g. touch
`screen input). However, according to alternate embodi-
`ments, another type of user input device, known to those
`skilled in the art, may be employed by computer 17. Other
`types of user input devices may be included, for 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 maybetethered thereto;
`alternatively the user input device may be remote from
`system 10, for example, located in a separate control room.
`According to some additional embodiments, another user
`input device, for example, in addition to a touch screen of
`computer 17, may be remote from system 10 and used to
`start and stop infusions, as well as to monitor system
`operation both during quality control infusions and during
`patient infusions. Operation of system 10, which is facili-
`tated by computer 17, will be described below, in conjunc-
`tion with FIGS. 4-9C.
`FIG. 1A further illustrates two pairs of wheels 121, 122,
`mounted to an underside of platform 113, to make system 10
`mobile; handle 14 is shown located at an elevation suitable
`for a person to grasp in order to maneuver system 10, from
`one location to another, upon pairs of wheels 121, 122.
`According to some preferred embodiments, one or both
`pairs of wheels 121, 122, are casters, allowing for rotation
`in a horizontal plane (swivel), in order to provide additional
`flexibility for maneuvering system 10 in relatively tight
`spaces.
`FIG.1B is a perspective view of a portion of system 10,
`on a side 111 of the cabinet structure, which is in proximity
`to wheels 121, 122. FIG. 1B illustrates a lever or pedal 125,
`whichis located for activation by a foot of the person, who
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`In a neutral
`grasps handle 14 to maneuver system 10.
`position, pedal 125 allows wheels 121, 122 to rotate, and,if
`embodied as casters, to swivel freely. Pedal 125 may be
`depressed to a first position which prevents a swiveling of
`wheels 121, 122, according to those embodiments in which
`wheels 121, 122 are casters, and may be further depressed to
`brake wheels 121, 122 from rolling and swiveling, upon
`reaching a desired location. According to some embodi-
`ments, braking may be designed to slow system 10, for
`example, when rolling down an incline, and, according to
`yet further embodiments, system 10 may include a motorto
`power movementthereof.
`FIG. 1B further illustrates: a rear access panel 174 ofshell
`13, for example, providing access to circuit boards of the
`aforementioned controller contained within the interior
`space that is surrounded by shell 13; an optional lock 184,
`to secure panel 174; a power jack 118, for connecting system
`10 to a power source; and a printer 117 for providing
`documentation of each patient infusion carried out by sys-
`tem 10, and of system quality control test results. In some
`embodiments, system