AU2015200752A1 - Infusion systems including computer-facilitated maintenance and/or operation - Google Patents

Abstract

INFUSION SYSTEMS INCLUDING COMPUTER-FACILITATED MAINTENANCE AND/OR OPERATION Methods for setting up, maintaining and operating a radiopharmaceutical infusion system, that includes a radioisotope generator, are facilitated by a computer of the system. The computer includes 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 10 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. 15 Figure ID 6202596_1 (GHMatters) P85620.AU.1 JMEAD

Description

INEUSION STidS INCIJDINGi COMPU.TERT CIL!ITE~D MAiNENANEAnN D/ORP OP F ATIjON RELAD APPUC.KAONS 5 T~he present applicantr claims priority to the followingS. patent applictions: S patent application serial No. 1213T56. filed e 2008 S. aenpbeation serial No.y / 121 63 fied Kne 1, 2008: patenp e sethu Nos I 4(36 fieden lam 1 2008; and U.. atent application serial No. 0 37,-77, mied Ju e W , 2008. Theprestpplication is a divisional appication derived on parent application number 2.009257432 which is herein incorporated in its entirety by reference. TECA IN /AL FJIEWD is ~The present invention pertains to systems that generate and infse radiophamniaeutdcal s and, more particularlytosystemts inching computer fihi aed maintenance anr onperatioin BACKUROUN D 20 Nuclear medicine emnploys radioactive material for iherapy ad diagostic imaging. PosNron emission tomography(PET)is onie type' diagnostic imaging whichutilizesdoses of radopharnmacenica fr examp gnerated by nation wthin a radioisotope generatorh are I oeed infused ino abused dose Sanfatphacl~eutical is absorbed by cells of a targt organ, of ek pademi, and emits a, iaton which is detected by a PEI scanner orderto generate an intake ofthe organ An example of aradioactieisotope whih may be usedor PET s R idiun 82 (produced bythe decayof Strontianv2) and an example of a radioisotope generator which yields a aline solution of Rubidimn-82 via elato iso the Cardiodene 82@ available fom Braccc Diagnostics Inc. (Princeton A PE scanner in 30 combination wAh infused Aoses ofdiphrmacen deals may also be employed to qpiantit blood flow rvae. tbr 'nmp t igh the cornar> parties Wo apaten Set up, maintenance and operational prcdrsfrutso ytm hthoto fC~tlC ndijetdoss o Adipaaetci are reaievivlvd nodrt assur tnesaietv-; and effiacy. 01 ec n0 ce0ds0ottepain. fiiec1i 5 carnying out Thee procedurs is higU y desirable fOr technical personneL who work wt hcsstmso arotn ass and wudketo avod m ' io.we exposure to radioactiv radiatons. 'TUS thereo is' aI nedOr new% sy semCo'nut ln Nuv SUM AR OF 'H i IN VEllTION Fn naccordance 01th a Ais aspect of the present ineto, hr s poie a mmh' plav~sttri carryinir an houson tubing ciruit, an acivity detor, a ds.Calibrator. a compute, and a shielding asmbly coritinmga wtontlurnirubjiwri :25 raiistop geeao cotgrd to geanrae radI oaciec aevalui fa the Wrlsi'm t10in; cii rneludnz a tabint Kne connectd bautmv Te strOntIUndnhun radicosotpe Lenerator and teo dose.clbrtraKIcnigrdt 20 the acivity detector hiei g posiioed downstream of the stronim/rbdum rahisotope generaor and conheured to measue an actvtyo tetd octv eut floingthrughthe. intision tuin circuit. and coniured to execute autotnd nI S uait ontro testing usng the dosecabro. 25 ~In accordanc wiT a seond. aspect ofthprsniveiohres oved a oblrdoisotope geneator system comparing: a. shielding aseib ofgrdto contain astotntbiumrdioop AW:~~st tubinhiganWo ~g line eontieurc to onvey elsa tronm tAe mensk nesuia naciity of the eluate 1 o3wing thr-oghtelut men"ot eenit activity data from the means fon~esamn Te =ctivit or the eluat an! Als reciig hreakthroueh aciity dat-a ro'nathe mni,.,ns "'or rcrm eUate and cacltn rekhog civity and control a.We mobil rsdoisotooc 10 In accord a wi0th a thi rd aspect oI th preen invnto n thre apoie Aeno coinp siingtuin:o oai cat aindathereby anraiY radieti eat viaelaon measugitanatvtdecor carriedby the movable Cart. an activity ofwm VOQ elvUr;rnx a nrinp'" to a arrie 3'1CI11 U"V "na -- l i, fLine~l on the eeliateired to he ns the crnnrcarried W theldYing assemblv is ca nv ned to reciv th ativtydata Maon the dose calbraor and calculate breakthronen test 5 In accodance withi a fIfth aspect of the present invention, there is proid A gmerling "Wha ,r\4ThWAmAc generator c.ontained KI Ijthi a vdn asserubly, at radioatie eluate via eWton of an eMwnt tnesurn~i wiha dose Ca librato eWeTro~a c pe 0acnpt ae by !b te shielding assembly an activity olf the aiacieeuae determningwith the computer, a n activ,""iyol uitr-awti h BRIEF DECIi t'HON OFIII lFl DI{A WING Theibioing d wngsar ilustrative of pNatcu embodim n of the explanatons in tGe followi ng deals descript ion. Frabodmmens of the present Figue iK is a firs porspective Woew of an inbsiom sylm tOwdn u! smmC en idnenskoftepeetivnon M Figure i B iS anthe r ers Pective v iew VVo1 a px otin of a cabine stucur of te syse showing Figure 1A.acording to some embodiments. Figure i C is a second perspective view of the system shown in Figure I A, according to some cmbodimens Figure 1 D) is aschtenmatic of an infusion circuitiacording to some embodientsi ofthe present invention. Miac l. in a pen reeli of exemplary Sample vial shitingthait na be 1 employed in cornetdun wih the infusion synem of Figatie A, Figae 2A is a perspeey view otashielding assembly for an inision system uch as that shown in Figures A according to some embodinentsofthe present invention. s lagure B is a perspective view of a framework of the system accordingt some enibotdments. hi an enlargedetailed view of a component ofthe system according to son enbodinments 3A is another perspective ve of the shielding assembly shown in figure 2A, Figure 3 is a txspective view ofte infusion circuit shown inFigure iCeonfigured and rutied, adcordng to some emnbodimueiits Figure 3C is a perspective view of a disposable infusionircuitsubassembly according to some embodiments.

wo 20091152323 PTm2~h07 3 Fi re 3D isa rame for the ubassemblshown in Figare 3 accrcmg to somne enbodimnents, Figure 4 is a main menu screen shot from an intrfiace of a computer, which may be included in systems of the present invention, according g to some embodiments Figure 5A is a schematic showing a first group of successive screen shos from the computer nterfc, c to soe enbodiments. Figure SB is a pair of se shots from the computer interface, which provide indications related to eluant volume levels in a reservoir of the system, according to sOefli embodiments. 10 Rigure 5c is a schematte showing a seco.ig frm te computer interface, according to some ermbodiments. Figue fs schematics showing a third group of succesv sceeTho>t twn the coinriter interface accordmtot some embodiments. giures 74-C are scheaw's shown a tourth group of successive screen shots 1$ from he computer interfae according to some embodimnats. Figures 8At are schematics showing a finh group of successie screen shots from the computer intraeaccording to some enmbodinens gnures 9A& are schematics showing a sixth group of successive seenshots rons he computer interface, according to soie embxodiments. 20 Fig 0 s a scheaT showing a seven groupfsuecessive scren so fromthe computers nterface.aecordtng to some enbodents. arg.r is an exemplar report which may generated by the compete inclded i i fsion systms, according to some emnbocimets. Figures 2 A- are schematics of alternative intuston eireuts that msay be 24employed by embodinents of the presentinvention. Figure .12c is a schematieh lstrattg exemplaatvt profie snecte doses of adaiopharmaceuncai. DETMED DESRIPN hetiyo etae cd desri n os exempt innaMre and is not intended to limit the scope, applicabiliy ot conguration or the mnvennon tn any Wiy.x er. te following description pmv es pracrcal tiustrattons fr irplemnentng eemplary embodiments. Uilizing the teaching pouse skilhe pi recognize that many of the examples have suitable alternatives that can beuiliA. Figmre A is a first pepeve view of an infson system !0 aordng to someemodit ofthe prsn inetion. wherein system 1 is sh5~ow&n supported by ) a cabinet structure, which includes a platform 113 (sen better in Figure 3B% and a shell 13; shel 13 extends upward from a skirt 1 1 that surrounds platform 113, to surrounds an interior space in which a portion of infusion system 10 is confined ( seen in Figure Q2) Shell may be formed from panels of injectionmolded polyurethane fitted together according to methods known to those skilled in the art. Figure IA 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 compu er 17 are. preferably, attached, via an ergonomtc, ostionabe mount, Acording to some embodiments, computer 17 is coupled to a controller of system 15 which is moumted 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, hut also serves as a device for user input (e.g, touc screen input), However, according g to alternate embodiments, another type of user input device, known to those skilled in the art, may be employed by c e 17. Oter types of user input devices 20 may e included, fem example, a keyboard, a series of control buttons or levers, a bar code reader (or other reader of encoded information, a scanner, a conmputer readable miedim con 4 ~ctanion pertinent. data, etc, The user input device maybe mounted on the Wabetstructure of sstem 10, as shown or may betethered thereto; erntivelyte user input devie may be remote from system 10, for example, located n a separate 25 control room. According to sompe addiaonal embodimentsnother usr nptd for example, in addition to a touch screen o computer 1 7, may be remote frm system i10 and used to start and stop inf'asions, as well as to monitor system operation both durng quaity control infusions and during patient inrusions, Oeration of system 104 which is facilitated by compmer 17, will be described below, in conjunction with 30 Figres 9l Figure 1 A further lustrates two pairs 0f wheels 121 , 122 mounted to0 an underside ofptfom 11 to make system 10 mobe handle 14 shown oeated a an ~ee on sui fra persontogr p in order t maneuver system Q. Onne WV( 2(W9!15232 PCTUS209O {N 5 location for another uoon pairs of wheels 121, 122. Accorting to sorne preerred enmbodments, one or both pirs of wheels 121, 122 are casters, a2-owig for rotation in a horizontal plane (swivel) in order to provide additional flexibility for mnaneuvering system~: 10 in relatively tight spaces. Figure B is a perspecive view of a portion of system 10, on a snie of the cabinet structure, which is in proximity to wheels 121 .Figre 11B illustrates a lever or pedal 12j. which is located [hr activation by a [oot of the person, who grsps handle 14 to maneuver system 10. In a neutral position, pedal 125 allows wheels 121, 2 to rotate, and, if embodied as casters, to swivel freely. Pedal 12$ rmay be depressed to a tO first position which prevents a swiveling of whieels 122, according to those embodiments in which wheels 122 are casters, and may he further depressed to brake wheels 121, 12 f'ro rolling~ N~a nd swvlng, upnw rea"ching a desired location. According to sone enbod iments, braking may be designed to slow system 10, for example, when rolling down an incline, and, according. to vet further .bodiments, 1$ system 10 may include a motor to power movement thereof Figure 1. further illustrates: a rear access panel 174 of shell 13, [or example, providing access to circit boards of the aforementioned controller comained withn the inmernor space teat is surrounded by shell 13; an optional lock 18S4, to secure panet 174; a power jack 18, folr connecting system 10 to a power source; and a printer 117 20 [hr providing documentation of each Patient infusion carried out by t , f system quality control test results. In som embodiments, system 1 0 may rurtrher include a power strip by which auxiliary equipment may be powered, and one or more additional eletrical conn~.ectors, or ports (not shown), which are supported by platform l1 13 and may be integrated into shell 13, or example, in proximity to jack 25 1.8 or Printeri 17; these elCctrical connectors/ports anow system 10 to communicate with, other devices used [or nuclear imaging procedures, Ar example. a PET scanner/cearnera, and/or for coupling to an imtranet network, and/or to the internet, for example, to link up with software prorams for various types of data analysis. and/hr to lnk to computers of consultinv clinicians/physicians, and/or to link ito service 30 providers and/or component suppliers data bases for enhanced maintenance a inventory mnan agenrtenta Fire liA further illustrates rrpper surface 131 of sh ell 13 including several openings 133. 135, I'39 formed therein, Figure IC is a partially exploded perspective 6 view of system 10, wherein a removable access panei 132s shows as a contoured portin oft upper surface 13 , which, when exposed, by lifting away a bin 18, that mates therewithNl may be removed rm another opeing 13 7 tornmed in u~per srface 131, Figure 1C also provides a better view ot another panel 134 which may be lifted a m nthe iustcd embodiment, opeins 139 and 137 provide a user ot system 10 with independent access to seprat potions ot uosystem 10, which are contained within shell 13, for example, to set up and mainai system 10; and openings 133 and 135 provide passageways for tubing lines to pass through shelI 13. Figure 1C further illustrates an optional switch 102, which in 10 case of an emergency, may he activated to Abort function ofsystem 10, With reference to Figures lA and ?C, it may be appreciated that an arrangement of features formed in upper surfCe 131 of shell 13, in conjunction with bin 18, tray 16 and cornputer 17. providea relatively rgonomic and organized wo:rk area far technical Personnel who operate systemn10 15 urnng now to Figure 1D, a schematic of an infusion circuit 300, which may be icororatd b sysem 0, i shwnFigure ) illustrates cir'r c 300 enerally divided into a irst part 300A, which includes components mounted&outside sll 13, and a second part 300B, which includes components mounted within the interior space surroundd by he 13. (Parts 300A and 300B aedelinated by dotted lines in Figure ^0 i. Figure ID farther illustrates second part 300B of circuit 300 including a portion conined whi a shielding assembly 200, which is nested asa dashed line. Some enmbodiments of asheeidin~g assembly 200 will be described in gmaer etat i cnjuctin wthFigures 2A-13 and 3A-B. below. k~td'v OWNil in cJ"uctodwih, 25 reservoir 15, for example, a bag, bottle or other container, containing saline as the ciuant, which is sown hngng ro ap , or hangr 141 above upper surface f shell 13 iniFigure 1A; a syringe pump 33, for pumping the eluant rn reservoir 15, ard a pressures yringe 34 (or other device or sensor), ror monitoring pumping pressure: a filter 37, which may also serve as a bubble trap, for the pumped eluant; a 30 radioisotope geneaor 21, through which the filtered eluant is pumped to create a radioactive eluate, for example an eluate carrying Rubidium-82 that is generated by the decay of Strontiurm-82 via elation, within a column of generator 21; and an activity detector 25, for measuring the activity of the eluate discharged from generator 21, in order topovd eebc fo ietn hlow of the cluae, via ao divergenc valve 35WP, either to a waste bottle 23 or through a patient line 305p, tor example. to inject a dose oA the radiopharmaceutical cIuate into a patient. With refMene back to Figure 1A, Patent i 305p is shown etendin out fr3 5aistalt end there-of, wich, according to somc emnbodimnents, includes a filter. ?atient line 305p may be counled to another line that includes a patient injetion needle (not shown). Alternatively, patient line 305p may be coupled to another hie (not shown) which extends from a source of another active substance, for example, a stress agent; the other lne is coupled to the line that includes the patient inection needle, in order to 10 permit injecti on of the additional active substance. Figure i1D illustrates an eluant tubing line 302 coupled to reservoir 15 and to pump 33, and, with reference to Figures IA-B, it may be appreciated that opening 133 provides the passageway for tubing line 301% to enter the interior space surrounded byv shell 13, According to some preferred embodiments, opening 133 includes a 15 grommiet-ype seal that prevents leakage of cluant, which may spill fromreser 15, into the interior Spac tugh opening 133, while allowing a user to assernbe tubing line 301 through opening 133. Likewise opening 135, ich provides a passageway for patent line 305p, may include a grommet-rype seal. According to sone embodiments, shell 1 3 further supports holders to safely hold, for example, during 20 transport of system 10, portions of tubing lines that extend outward therefrom, tor example line 301 and or line 3 0 5p. Figure 1D) further illustrates another eluant tubing line 302 coupled to punmp 33 and a divergence valve 35BG, which may either direct pumped eluant through a tubing line 304, to generator 21, or direct the pumped cluant through a bypass tbing 2$ line 303. directly to patient line 305p. Divergence valve 35B, as well as divergec valve 35W, which directs euate from. an cluate tubing line 305 either to a waste line 305w or to patient line 305p, may each be auornaticaily operated by a corresponding servomnotor (not shown), coupled to the controller (not shown) of systern 10, wh ich con troiller receives feedback from activity detector 25. When system 10 is operatingr 30 for autornatc infusion, to deliver a dose of Tradopharmaeu~tical to a patient for example, Rubidium-82 for diagnostic imagmg, divergence valve 3$BG is initially set to di elam to generator 21 and divergence vabve 35WP is set to direct lunate imtn generator into waste bottle 23, until activity detector 25 detects the desi red actvityot the elutite, at wbich time the fedac ro ctvt deetr25cue tontrolle t direct the corsodn serv-motor to re-set valve 35WP for diverting> the~ flowyo eluiate into patient line 305p, Ac-cording to sonic embodiments, once a prescribed volum~te of the eiuaite has paissedi through patient line 305p, the controller diret the Scorresponding servomnotor to re-set divergence valve 3530 for divert the flow of ehiant through by-pass line 303 anid into patient line 305$p in order to flush, or puJsh any eluate remaining in patient line 3O5p inltO the patient, According to some embodime,~t' the ctolle m~ay als direc thecrepndnMevmto or-e divergence valve 35WP back toward waste bottle 23, prior to the flush through by-pass I 0 line 303, in order to prevent back flow of eluant, through line 305, toward generator 21, According to sonme preferred methods of operation, in certain situations, which will be described in gre-ater detail below, eluant is pumped through by-pass line 303 itntmediately following the flow of the prescribed volutne of chuite into patient Imne 305p, at a higher speed, in order to push the eduate in patient lire .305, therety 15 increasing a flow rate of the iecion of eluate our front patient line 305p and into patieat. For example, once the prescribed volume of ei uate has flowed into patient line 305p, and once divergence valve 35BG is set to divert flow through by-pass line 303, the speed of pump 33 may be adjusted to increase the flow rate of eluant to between apprximately 7OmL/min and approximately I100mkL/min. This method or increasing 20 the infection flow rate, is desirable, if a relatively high flow raeis desre fr aten ijection and. a flow rate through generator 21 is limited, for exicn, to below apporoximuately 7inEmnn maximum (typical flow rate may be approximately 50tmmin), in order to avoid an excessive back pressure created by the column of generator 21 in upstream portions of tubing circuit 300; the excessive back pressure 25 could damage filter 37 or otherwise impede flow through eluant tubin in 302 Although not shown in Figure JD, a numberr of sensors, for example, to measure pressure and/or flow velocity, may be incorporated into circuit 300. according to sonme aIt eraate embtodim'ents, in order to monitor for flow anomalies, tor example. related to occluio~npug in circuit 300 and/or leas, and/or to provide reedbeack tfor 30 control of an activity level of infused doses of radiopharmaceuticai, Suitable sensors for any of the above purposes are known to those skilled in the art. Ehxamplies of flow meters that may be~ inopoae into ci rcut 300, include the lnnova-onico Model 205 Transn'itime UitrasonoLiuid Flow Meter that employs digital signal processing4 wo Zti9!15Sm P(O'~i99/Q47*SI ava e fromn Serra instruments, ine) and the Flocat LA 10-C differential pressure flow m ieter m On example of a pressure sensor that may be to detect inuincircuit occlusions is the PRO / Pressure-Occiusion Detector (aa .al fro INTROTK@ of Edgewood, NY, a subsidiary of Magncerol of Downers Grove, L), which enmloys pulsetype utraSOund: this sensor detects s i cange in positive and negative air pressure and produces a corresponding passive resistive output i gnaa which may be roted& to the system controller and/or computer 17. On or more of this type of sensor may be ;icorporated into infu~sion circuit 300 by simply fitting the sensor around any of the uabing lines of infuson circuit 300;1i fact, the PRO / 10 Pressure-Occlusion Detector may bc a suitable alternative to pressure syringe 34 of circuit 300. Other types of pressure sensors, for example, similar to those known in the art for blood pressure monitoring, may be employed in infusion circuit 300. System 10 may further include sensors to detect fluid levels in eluant reservoir 15 and waste bottle 23. Some examples of such sensors, which also employ the 15 aforWmenioned pu - ultrasound, are the LSensra the CLD / Continuou Leve Detctor (both available fronm INTROTEKC); alternatively, tor example, ai HPQ- pipe ounted, sel-caids (available horn Yamatake Sensing Control, Ltd. or an SL-630 Non--nvasive Disposablc/Reusable Level Switch availablee from Cosense, inc, of Hauppauge, NY) 20 ma be eploeto dect te fld lves. Aeatly or in addition, system 10 can incudeaddtioalradiation arid/or moisture detection sensors, whichn deetlas With reference to Figure 91D. such sensors are preferably located in proximity to fittings 311, 312, 313, 314 and 315 that join portions of circuit 300 to one another. Some examples of leak detection sensors include, without limitaton, those in the APQ-Dtk detection sensor family, and the HiPDO40 fiberoptic leak detector (i. available from Yamatake Sensing Cotrol, Ltd.), System 10 may further include additional sensors to detect contaminants and/or air bubbles within the mbing lines ot circuit; examples of such sensors include the Point-air Detection (PAD) Sensor that "ploys pulse-type ultrasound for air bubble detection, and the Blood Compnent 30 Detector that empoys optical sensing technology to person Colorinetry-0sed fid4 detection or unwanted elements in the tubing lines (both av ailable from iNTROTEK®Y WO 2009/152323 P=/S2?0NN P$) According to those embodints that inAde any of the above sensors, the sensors are linked ito the controller of sstern 10 and/or computer 17, eithr of which may provide a signal to a user of systern 10. when a flow anomaly is detected. and/o~r information to the user, via monitor 172, concerning uid levels, pressure and/or low 5 through circuit 300, Computer 17 may be pre-programmed to display, for example, on moanitotr 172. a graphic of infusion circuit 300 wherein each zone of the circuit, where an anornaly has been ,sted, and/or to provide guidance, to the system user, tar correcting the anomaly. It should be noted that the aitemative infusion circuits illustrated in Figures 1 2A-B, which will he described below. may also 10 include any or all of these types of sensors, With further reference to Figure ID, it may be appreciated that shielding assembly 200 encose thos porto of circuit 300 from which radioactive radiation may emanate, with the exception of that portion of patient line 305p, which must extend out from shielding assembly 200 in order to he coupled to the patient tr 15 injection., or in order to be coupled to shielded sample vials, as will be described below. Thus, technical personnel, who operate system 10, are petram b shielding assembly 200. exept at those times when an Mnfusion is taking place. or when quchity control tests require collection of eluate into sampnle vtals. During ifusions and quality control test sample colecton, all technical personnel are 20 typically in another room, or otherwise distanced from system 10, in order to avoid exposure to radiation during thve infusion, and, according to some preferred embodimens or the present invention, system 10 includes at least one means for infonming technical personnel that an infusion is about to tke pace or king plae. With refereneback to Figures1 A and iCsystem 1is shown including alght 25 proeor 100mounted on post 142. Accordigt the illustrated cndboannent projector 100, projects a light stgnai upward, for maxium visibili ty, when pump 33 is pumping eiuam and elhtion is taking piace within generator 21, or at all times when punp 33 is pumping eluant. According to some embodiments, the light signal lashes on and off when the eluate is being diverted front generator 2 1 into waste bottle 23 30 and the light signal shines steadily when the cluate is being diverted though patient line 305p or visa versa. According to other embodiments, a proctor :00 shines a light having a nrst color, to indicate that eluate is bemg diverted to waste bottle 23. and then shines a light having a second, different color, to ndicate that euate is being dircted toatient line 30 5p for itusion. Lih qpoector 100 may further projet a more rapidl flashig ight, for example, for approxritely five seconds, once apeak bolus of radioacuvitv is detected in the ehuate. to provide further iformattin to techrnical pesone. Alternative means ofinfo rming technical personlC that an 5 ifion is taking place may also be incorporated by system 10, for example, ncin audibie alams or other types of visible or readable signals that are apparent at a di stance firom system,~ including in the control room, It should be noted that, according to alternate embodiments, system 10 includes an 'on hoard' dose calibrator for quality control tests, and circuit 300 is expanded to 10 include elements f an automated collection of eiuate samp les fr activity measurements. via the on board dose calibrator. A according to a first set ofithese alternate embodAments, a sample collection reservoir 1s integrated into circuit 30i, downstream of diverence vave 35TWP and in ca w i n inorder to receive quality control test samples of eluate, via tubing line 305P, and both 15 the reservoir and the dose calibrator are located in a separate shielded well According to a second set of these alternate embodiments, waste bottle 23 is configared to receive the quality control test samples of ehuate. via tubing ine305W, and a dose calibrator is integrd into shielding assembly 200, Quality control e w dcribed in gather deaielo i c ionjncton wih Figures 6-81. 20 When maintenance of system 10 requires the emptying waste bottle 2.3 relatively easy access to waste bottle 23 is provided through opening 139 n top surface 131 of shell 13. It should be noted that technical personne are preferably trained to empty waste bottle 23 at tzs when the equate, contaned in waste bote 23. has decayed sufficiently to ensure that the radioactivity thereof hasifallen beiow a 25 threshold to be safe. Opening 139 is preferably located at an elevation of between approximatoiv 2 fret and aproxiately 3 feet; tor example, Opening i 139 may be at an elevation of approximately 24 inches, with respect to a lower surace of piatfbnm 113, or at an elevaton of approximately 32 inches, with respect to a ground surface upon which wheels 121, 122 rest. According to the illustrated embodiment, opening 139 is accessed by living pane! 34 just wihi opening 139, a shielded id or doer 223 (Fugure 2A) may be lifted away ten a compartment ot sieidin assembly 200 that contain waste bottle 23. With further reference to Figure IC, it may be appreciated that opening 137 provides access to other portions of circuit 300 for additional ntenamce procedres o such as chasing out generate 1and/or othercompoents ot eireun 00, as wiul be described below F'or those embodiments ot system 1 0 in which automated quality control tests arc perfrm a.ndr whe s 1s employed for relatively high volume 5 operation, management of waste may become burdensome, even tough access to waste bottle 23 is greatly facilitated, as described above, Thus, in order to facilitate waste Ianaerment, some embodirnens of system 10 may employ a separation systern to separate saits, incdi reactive elements, rom water, or example, via evaporation or reverse osmosis. In an evaporation type system, the water component 10 of the waste is evaporated, while in a reverse osmosis type system the water is separated from the sats, and, then, once confirmed to be non-radioactive, via a radiation detector, is piped to a drain. According to some other embodiments, circuit 300 may be configured so that the waste may be used to purge air from the tubing lines thereof and/or to perform the byp ass flsh that was described above, preferably afer 1$ the radioactivity of the waste drops below a critical threshold. Figures A. and 1C further illustrate a pair of relatively shallow extemal recesses 190, which are termed in upper surface 131 of shelb 13, for example, in order to catch any spills from infusion system; one of r 9loc:n t ated in proximnty to o ns r hanger 141, which holds reservoir 15, and in proximity to 20 opening 133, through whic tubing line 301 passes. Another recess 192 is shown formed in upper surface 13 1; a width and depth of recess 192 may accommodate amyof techical documestimniewwdcwih storagn ftcncldcmnton asso .ciated with infusion system 10U, for example, a technical manual and/or maintenance records, or printouts from printer i 7 (Figure Ix With reference to Figure IC, upper surface 131 of shell 13 is shown to aiso 25 include additional recesses 01, which are each sized to hold a shielded test vial, which contains samples from infusion system 10, fOr example, for breakthrough testing and/or calibration, which will be described in greater detail, below. An exemplary test vial shield is shown in Figure I E, The test vial shield of Figure iEis preferably formed from Tungsten rather than lead, tot example, to red uce exposure to 30 lead, for improved sh wielding, and o reduce the weght of the shield. Figure I E illustrates the test vial shield including a handle to simplify manipulation thereof, but alterative configurations of test vial shields have no handle -for these a s nn. or strap, may be employed for handling, WO 24499/1523 ?CLL S209070. h o13 Additional receptacles 1 80 are shown formed in inf .18, on eihr side of handle 1 82, which facilitates removal of bin 18 away frmshell 13, Techrnicai personnel may,. thus. con veniently transport bin 1 8 to a storage area for a collection of supplies, for examipie, sharps, gloves, tubing hines, etc.., into one or mrte receptacles IS18 thereof, and/or to a at container where separate receptacles .180 of bin. 18 may' be emptied of waste, such as packaging for the aforementioned supplies, for example, deposited therein during infusion procedures, According to some enmbodimets, One or more additiona! receptacles are formed in one or more disposal containers, for example, to contain sharps and/or radioactive waste (other than that contained in waste 10 bottle 231 which may be integrated into bin 18, or otherwise titted into, or attached to shell 13. separa to rm bin I8. Fgr2A is a perspective view of shielding assembly 200, according to some embhodiments~ of the present invention, With reference to Figures IC and 2Ak, together, it may be appreciated that opening 137, in upper surface 131 of shell 13, provides 13 access to a lid or door 221 of a sidewall 201 of shielding assembly 200, which sidewali 2.01 encloses a compnartnment sized to contain a radio isotope generator of system 10, for example, generator 21.L previously introduced, it should be noted that, accordEng to alternate embodiments, the comipartmlenit enclosed by sidewall 201 is large enough to hold more than one generator> for example, to increase system operating efficency for 2.0 relatively higt volume operati on, In some of these alternate embodimnents. tuiig lines 304 and 305 are each. branched for parallel flow through the multiple generators, in which ease divergence valves may be employed to alternate the flow through the generators, one at a time. In others or. these alternte embodiuntms. re nutnpke generators are connected in series beteenrtubing lime 34andtuing lne 03 nr 25 addiina reservoirte accumulating equate may be included in circit300, downstream of te generators andustrem ofdvergence vave 35W~t incetlt.C~ wttha second pump, in some cases. Emnbodinments including multiple generators and/or aeuae reservoir and second pump can be employed to better manage an activity tevel of each dose. or painietin for example, as deseri ned below in 30 conjunction with Figures 12 B. According to the embod mntcnt dsrated mn tFigure opemage i ann oor 22 ax located at a lower elevation for example, withrespect to iaform 11.than are opening 139 and lid 223. hich provide access to the comopainent bengfne WO209.522 PCT/USAK94WB1 by a sdewal 203 of shieldng assemy 20 to contain waste bottle 2as previously descrd. When panel 132 is separate from shell 13, and door 221 oned, generate 21 may be Uie out rn an opening 231 (igre 3A) which mats door 221 0 sidewall 20 1. A weigh t of generator 21, which includes its own shieidig, may be 5 betwenaproximatly 23and approximately 25 pounds, ltus, according to some preferred em iments of the present invention, the elevation of each of openings 137 and 231, with respect to the owermnost portion of the cabinet structure. is between approximately 1 foot and approximately 2 feet, in order to facilitate an ergonomic stance for technical personnel to lift generator 2 lout fronm the comartment, 10 Accordin to an exemplary embodiment, when shielding assembly 2K0 s contained in the cabinet structure of Figure IA , openings 137 and 231. are located at an elevation of approximately 12 Inches, with respect to the lower surface of piatfonm 113, or at an elevation of approximately 19 inches. with respect to the gmund surface npon which wheels 121, 122 rest. Figure 1C further illustrates access panel 132 including a 15 security lock 138. which mates with a Ramework i9 of system 1 shown in Figure 2 B, in order to limit access to generator 21, Figures 1C and 2A further illustrate a lid or a door 225 of another sidewall 205 iure 3A) of shielding assembly 200, which encloses another compartment that is accessibe through opening 137 of shell 13, and which is located adjacent tle 20 compartment enclosed by sidewalN 201, Each of doors 221, 225 are shown bng attached by a corresponding hinge H, and another door 227 is shown attached to sidewa l 203 by anoW hinge H, Figure 2A illustrates each of lid 223 and doors 221, 225, 227 including a handle 23, 22, 2S2 and 272, respectively, for moving lid 223 and doors 221, 225, 227, n order to provide access to the corresponding 25 compartmIe.nts, which can be seen in Figures 3A-B. Figure 2A further illustrates optional thunb screws 20, one securing lid 223 to sidewall 203 and another securing door 221 to sidewa 201 or other means fbr securing the doors, which are knwn to those skilled in the orn may be incorporated. Each sidewall 201, 203. 205 and the corresponding lid/door 223, 221. 225. 227 thereof may be individually cast front 3% 30 antimnony lead, or from other known shielding materials, and then assemtied together according to methods known to those skil led in the art Ac"rjcing to the illustrated embodiment, doors 221. 225 are hinged to open in an Upward dcto per anows D and C, and, with reference back to Ftgure IC, a WO 2{ki~t 232 PCT/U20 07Efl !atch comonent 191 is provided to hold each of doors 221, 225 in an opened position, thereby, preventing doors 221, 225 from falling closed, which could in fCtt/Cru3sh fingers of technical personnel and/or tubing lines of circuit 300, when in the midst of a maintenance procedure, Figure 2B is a perspective view of framework 19 of the 5 cabinet structure of system 10, according to some embodiments, to which arch component 191 is mounted; Figure 2B includes an enlarged detailed view of latch orpIonent 191, according to some embodiments. Figre 21 illustrates latch component 191 ir 9 3 , corresponding to door 225, and ap second pi 19$, corresponding to door 221; each pin 193, 195 includes a lever end 193A, 1938, 10 respectively, and a holding end 193B, 195B, respectively, An edge of each door 221, 22-,on open ing of doors 221, 225. may push past the holding end i95B3 1933 of the correspondAing pin 195, 193, in a first direction, per arrow F, and then may rest against a respective side S95 and S93 of each end 195B, 19313, untl the corresponding lever end 195A, 93A is rotated in a counter-clockvise direction, per arrow cc, 15 thereby moving the corresponding holding end A 931, 195B to rake way for the closing of doors 221. 225 Doors 221, 225 being held by latch component 191 in an open p-osition may e seen in Fiar 3A With further reference to Figure 2A, according to some preferred emnbodiments of the present invention, an edge of door 225 overlaps door 221 to prrevem door 221 201 from being opened, per arrow D, if door 223 is not opened, per arrow C; and an edge of door 227 overlaps an edge of door 225 to prevent door 225 from being opened i door 2-27 is not opened, per arrow B; and an. edge of lid 223 overlaps door 222 to prevent door 227 from being opened if lid 223 is not opened, per arrow A .Thuas, access to the compartment enclosed by sidewall 201% and containing generator 21 isa 25 only systematically allowed through a sequential opening of lid 2 23 and doors 227, 225, 221, since. whe cn generator 21 is replaced it is typically desirable to also replace those portions of circuit 300 which are shielded behind lid 223 anid doors 222, 25, The routingp of these portions of circuit 300 will be described in conjtunction wit Figures 3A P -C, 30 Figure 3A is another perspective view of shielding assembly 200, according to some embodimnents of the presen t in vention, In Figure 3A, lid 223 and doors 221, 225, and 227 are opened to provide a view into openings 233,

.

f 235 and 21 of sidewalls 203, 205 and 201, respective y-, and into a passageway 207, which is fonined. in if, sidewall 203, opposite the compartment, whcch contains waste bt 23. Passageway 207 is shown extenaing vertically along sidewall 203 and having a grooved ex ension 213 frmed in a perimeter surface of opening 233. An optioa reanng mernber23 for example, formed frm a ongate strip of resilient pastic having a general c. tin' exarupie arloed faon an h -, 5 shap cros-~sction, is shown being moun tcd aiong a length of passageway 207 to hold lines 305w and 30$p in place within passageway 207. Figure 3A father illustrates a pair of passageways 251 b and 251g, which are Formed as grooves ma portion or sidewall 205 and another pair of passageways 215i and 21 o, which are forned as grooves in a portion of sidewall 201 A rotin g of porios of tubing' circuit 300 0 (Figure iD) through passageways 207, 25 b 251 c, 215i and 21 So is shown in Figure Figure 3Billustates tbing line 304 being routedthrough passageway 251g and2151 ate tubing le 303 being routed through pasaewY .2 S o, and both waste line 305w and p in o 305p bing routedkmg passagewaye27 waste lin 15 305w father extends through grooved extension 213 to waste bottle 23, and patient line 305p further extends outward from shielding assembly 200, for exampe., to extend our through opening 135 in upper surface 131 of shell 13 (Figure At Accornding to the illustrated embodiment, each passageway formed in shielding asseby 2, by being accessible aon ga eogh can facilitate relatively easy routn of the 29 corresponding tubing line therethrough, when the corresponrding lid/door is open, and a depth of each passageway prevents pinching and/or crushing of the corresponing tubing line routed therethrough, when the corresponding lid/door is closed down thereover. With further reference to Figures 3A-B, it may be appreciated that the compartment ferred by sidewall 201 may have a shape matching an exterior contour 2$ of generator 21 such that generator 21 is 'keyed' to the compartment, for example, to prevent installation of an improper generate into system 10, and/or to tfacilitate the proper orientatCon of generator 21 within the compartment fr the proper routing of tubing lines. Alteately, or in addition. according to alternate embodi ,ifsystem 10 incius a of eno inrmnaton in comm unicati w 3uique denfincation andor data associated with each generator may be provided for exarnple, in a bar code label or a radiofrequency identification (R ID) tag that is attached to each generator, so that the reader may transfer the information to computer 17, when a generator is installed, in order to either enable system operation or to w) 2W9/m52323 P 29/043 provide an~ indication to the user that an incorrect generator has been installed, Of course a user tof system 10 may aiternatewy manruall enter informnaton, that is provided ona a generator label or marking, into computer 17, in order tihreal system 0. or to receive feedback from computer 17 that the incorrect generator is 5 ins ailldi Figure 3A further illustrates sidewall 205 including a valve iactutor receptacle 253 into which divergence~vaive 35WP is mounted, to be controlled by one of the sermotors (not shown) of system 10, and an opening 325 for activity detector 25. Activity detector 25 is mounted in a shielded well 255 that extends downward from 10opening 32 (shown in Figure 3B), and, with reference to Figure 38, tubing line 305 passes over opening 325 so that detector 25 can detect an activity of theWelate, whic. passes therethrough. According to some embodiments, he positioning, within the compartmnent enclosed by sidewall 205, of the components of the portion of infusion circuit 300 which are shown routed therein, is faciltatedby providing the cooents IS mounted in a frame 39 as a disposable subassembly 390, an embodiment nof which is illustrated by Figcures 3C-D. Figure 3C is a pesTpedcve view of asubassemby 391k nd Figure 3D is a perspective view of frame 39. According to the embodiment illustrated by Figure 3D, s fored fr mti ays 39A, 3913 or example, Wone from a 20 theroformed plastic, which fit together to capture, therebetween, and hold, in fixed relation to a perimeter edg of frame 39, divergence valve 3 5WP and portions of e.iuan tubinli 304, b-ss tubing line 303, e t 2uingline35,wse line3 and patient tine 305p, Figure 3C illustrates the perimeter edge divided ito a first side 39la second side 392, opposite first side 391. a third side 393, extending between 25 first and second sides 391., 392, and a fourth side 394, opposite third side 393, Although Figur 31) shows trays 39A, 39B individually fonned for fitting together, according to aternate embodiments, mating trays of frame 39 may be parts of a continuous shet of plastic foided over on itself. Accorineng to the illustrated emrbodirment, anen~d 404 A, of eluant line 304, and 30 an end 4M3, of by-pass line 303 extnd from t rd side 393 of rane 39 to couple witrh divergence valve 35BG and an upstream section o eMunt tubing line 302. Figure 3C futnher illustrates an opposite end 404B of eluant line extending from first side 391 of frame 39, alongsideasiniiarly extending end 405 of eluate line 305, and ends 406 and WO( 2405152303 P171/ S20}9=0T35i 407 of patient line 305p and waste line 305w, respectively, extending frIo SeCond side 392 of frame 39. AithoIgh ends 406, 407 are shown extending upward frn tray 39a, as they would wthin shielding assembly 200, it should be appreciated that the tubing lines of circuit 300 are preferably flexible and would drop down under their own weight rather than extending upward, as shown, if not supported. Referring back to Figure 1D), in conjunction with Figure 3C, it can be seen that the aforementioned fittings are provided for coupling subassembly 390 into circuit 300: first fitting 311 couples the section of euant line 302 to fIlter 37; second fitting 312 couples cluant line 304 to an inlet port of generator 21; third fitting 313, which may incorporate a check 10 valve, couples elate line 305 to an outlet port of generator 21; fourth fitting 314 coIples waste line 305w to waste bottle 23; and fifth fitting 35 COupleS patiem line 305p to an extension thereof, which extends outside shell 13 (designated by the dotted line), Each of the fittings 311, 312, 313, 314, 315 maybe of the LWer type, may be a type suitable for' reaivlhg pressure appliceations, or rnay be any other suitable 5that is known those skild in the ar. As previously mention ed, when generator 21 is replaced, it is typically desirable to also repace those portions of circuit 300 which are shielded behind idJ 223 and doors 227, 225. and, in those instances wherein system 10 is moved to a new site each day, these portions may be replaced daily, Thus, according to the illustrated 20 emboiment, these portions are conveniently held together by n 5e 39, as subassembly 390, in order to facilitate relatively speedy removal and replacement while assuring a proper assembly orentatton, via registration with states tormed in sidewall 205 (Figure 3 A) tor example: registration of divergence valve 35W wi valve actuator receptacl 53, regstration of tubing iine ends 403 and 404A with 25 pa.sc'csageways 251b and 251g respecwely, registratnin of ting line ends 404B ano 405 wih passageways 2 1i and 21o, respectively, a! egitratmion of tubing line ends 406 and 407 with passageway 2. WVith ferther reference to Figure 3B3, other portions of tubing circuit 3.00 are shown, Figcure 3B3 illustrates e luant tubing line 301i extending fromn reservoir 15, 30 outside of shell 13 (Figure A), to ngepum 33, which is mounted to an actuanga platform 433. According to the illustrated embodiment, platform 433 is actuated by another servomotor (not shown) of system 10, which is controlled by the comroller and computer 1' of system 10, to cause a plunger of pump 33 to move, per arrow , so as to draw in eluant. from reservoir 1$, through tubing line 301, and ten to cause the plunger to nmoe in the opposite direction so as to pump the eluant, through tubig ine 302, to either generator 21 or to by-pass line 303. Although the illustrated embodment incus s e p , other suitable pumps, known to those skiled in :Wrw y~gepumip n. tauWT in the art, my be substituted for p:mp 33, in order to draw euant from5 and to pump the Mantthroughout circuit 300 Athough not shown, it should be appreciated that divergence valve 35BG is fitted into another valve actuating receptacle mounted within shell I3 and coupled to yet another servonotor (not hown) of system 10. 10 Figure 3B further illustrates a filter holder 317 that is mounted alongside an inor sucof shel 13 to hold fiber 37 Figure ID) of tubing line 302, Filer holder 317, like frame 39 for subassembly 390, may be formed from a thermotormed plastic sheet; holder 317 may have a clam-shell structure to enclose filter 37 in an interior space, yet allow tubing line 302. on either sde of fiter 37, to exwe out from 15 the interior spac, in between opposing sides of the clam-sheil structure. Holder 317 is shown including an appendage 307 for hanging holder 317 from a structure (not hown) insie shell13 Turning now to Figures 4-90C details conceding computerfacilitated operation of system 10 will be described, according to, soe embodmets of the present 20 invention As previously mentioned, and with reference back to Fgure iA, computer 17 of system 10 includes monitor 172, which, preferably, no only displays indications of system operation to inform a user of system 10, but is also configured as a touch screen to receive input Eom the user, it should be understood that computer 17 is coupled to the controller of system 10, which may be mount ed wi thin the interior 25 space surrounded by shell 13. Although Figure IA shows computer 17 mounted to post 142 of system 10, for direct hardwiring to the controller of system 10. according to some alternate embodiments, computer 17 is coupled to the controller via a flexible lead that allows computer 17 to be positioned somewhat rernotely f-rnm those portions of system 10. fronm which radioactive radiation may emanate; or, aecordinAg to soM 30 other embodiments, computer 17 is tirelessly coupled, fbr example, via two-way telemetry, to the controller of system 10, fbr even greater fexibilit) in positioning computer 1 7, o that the operation of system 10 may be monitor red and controlled remotely, away frontradioactive radiation.

wo() 2009/152323 PT / 7 Azcoordig to some preferred embodiments, computer 17 is pre-progranmmed to guide the user, via monitor 172, through procedures necessary to maintai system 10, Como! um m ymem 0. and i to pertorrn quality control tests on system 10In to operate system 10 for patient infusions, as well as to interact with the user, via the touch-screen capability of monitor 172, according to preferred embodiments, in order to track volumes ot eluant and Ciuate contained within system 10. to track a time rrom comlnion of each euttion perform ed by system 10, to calculate one or more system parameters for the quality control tests. and. to performi various data operations. Computer 17 may alsoi be pre progranmed to inmeraet with the controllAr of system 10 in order to keep a morning 0 tadly or count of elutons per unit trne, Or a gien generator employed by the system, andmay further categ~orizo each of the counted elutions, ror example, as bein gen rated either as a same, for qualy control testing, or as a dose, for patient injection. The elation count and categorization, along with measurements made on each sample or dose, for example, activity level, volume, flow rate, etc, may be .15 ratned in a stored record on computer 17 All or a portion of this stored information can be comnpved in a report, to be printed locally, and/or to be electrontically transferred to a remote location, for example, via an internet connection to technical support personnel, suppliers, service providers, etc, as previously described. Computer 17 may further interact with the user and/or a reader of encoded A' infrmnation, for example, a bar code reader or a radiofrequenc y identification (RFID? tag reader, to store and organlizC product information collected from a product labels/tages, thereby faceilitating inventory control, and/or con firming that the proper componentsjfr example, of trhe tubing cirruit aud/or accessones, andi/or solution$ are oeing usedin the system. 25 lIt should be understood that screen shots shown in Figures 4-9C are exemplary in nature anda are presented to provide an outline of some methods of the present inven tioni in wich computer 17~ facilitates the aforemenioned procedures, without limiting the scope of the invention to any particular computer irntertace tornat. Computer 1 7 may also include a pre-programmed user manual, which may be viewed 30 on monitor 172, either independent of system operation or in conjuncrton with system operation, tor exam~ple, via pop-up help screens,.lhog the Eih language is emnployed: in the screen shots of Figures 4-9C, it should be understood that, accor ding to sontcembodmnentscomputer 17is pre-pregriunned to ride gidance n nuip k hmguages. Figure 4 is a screen shot of a main menu 470, which is presented by computer 17 on monitor 172. according to some embodiments. Main menu 470 includes a sting of each computer-fcilitatcd operation that may be selected by tho user, once the user has logged on. to some m.uhi iga emodiments, computer 17 presents a list o f languages from which the user may select, prior to presenting minak menu 47(. Figues 5A is a schematic showing a series of screen shots which includes a lon in screen $70 According to some embodiments, when the user touchselects the data entry Pelds of screen 570 or 571, or of any of the other screens presented herein, below, a virtual keyboard is displayed for touch-select data entry into the selected data entry fel; alternately, computer 17 may be augmented with another type of device tor u e ples of which include, without limitation aripherai keyboard 15 device, a storae medium (e. disk) reader, a scanner, a bar cod rd (or othr reader of encoded inf t a hand control (i Q mouse, joy stick, etc ). Although not shown, according to some embodiments, screen 570Y may further include another data entry field in which the user is required to enter a license key related to the generator employed by system 10 in order to enable operation of system I0; the 20 key may be time senitine relat ed to generator contract tems. Of courseany number of log in requirements may be employed, according to various embodimeats,andcmay be presented on multiple sequentially appearing screens rather than on a single log in screen. Anter the user enters the appropriate information into data entry fields of log in 25 screen .570, computer 17 presents a request for the user to contirm the volume ot clnan that is within reservoir 15 (e.g, saline in saline bag), via a screen 571, and then brings up main menu 470. If the user determines that the vohume of eluant/salineis insufficient the user selects a menu item 573, to replace the saline ban if system 10 includes an encoded information reader, such as a bar code or RFID tag reader. 30 eonfirmation that the selected reservoir is proper, i. contains the proper saline solutred out by computer 17, prior to connecting the reservoir into circuit 300, by processing information read from a labeang attached to the reservoir, Alternatively, or in addition, tubing line 30 of ciri 300 may be provided with a Wi) 2(49/15323 PCGtS2099:04~Thi connector which only mates with the proper type of reservoir 15, According to some embodiments, system 10 nmay further inclu tde an osmnolarity or carge detector, which is located lust downstrean of reservoir 15 and is linked to computer 17. so tat an error message may be prtesemed onmnoittor 172 stating that the wrong osmolarity or enhare is detected in the cluant supplied by reservoir, indicating an improper solution. One example of a charge detector that may be employed by system 30 is the SciConM Conducti vi ty Sensor (available from SciLog, in-c, of Middleton, WI), Once the reservoir/saline bag is successfully replaced, computer 17 prompts the user to enter a quantity of saline contained by the new saline bag, via a screen 574. 10 Ahermately, if system 10 includes the aforementioned reader, and the saline bag includes a tag by wie volume information is provided, the reader may autoMatically transfer the quantity informnation to computer 1 7, Thus, computter 17 uses either the confirmed eluantsai-ne voluim, via screen 571, or the newly entered eWuant/salie volume as a baseline fron which to track depletion of reservoir volume, via activations 5 of pump 33, in the operation of system !I With reference to Figure 58, during the operation ot system 10, when computer 17 detcts that the cluant reservoir/saline has been depeted to a predetermined volume threshold, computer 17 wams the usr via a screen 577. If the user has disregarded screen 577 and continues to deplete the saline hag, conpuiter 17 detects when the saline bag is empty and prvid-es nation 20 of the same to the user, via a screen 578. To replenish the reseirvomirsaine bag, the user may either refill the reservoir/bag or replace the empty reservoidbag with a to reservoir'bag. Accordmg to some embodiments, system 10 automatcaiiy precludes any fLrter operation of the system until he resevoir is rnplenished. i should e noted tat as Previousl mentioned.ysten10 can inchA a fhid leelsensorcouped 25 to the elant reservoir in order to detect when the lNee ofline dops belw a certain i addition to tracking the volume of eluant in reservoir 1$) computer 17 also tracks a voltue of the euate which is discharged from generator 21 into waste ote 23, Vith reference to Figure 5C, an item 583 is provided in main menu 470, to he 0 selected by the user when the user empties waste bottle 23, When the user selects item 583, computer 17 presents a screen $84. by which the user may effectively command computer I7 to set a waste bottle level indicator to zero, once the user has empded waste bottle 23. Tyically, the user, when powering up~ system 10 libr operation, each day, wilt either empty waste bottle 23. or confirm that wateZ botlC 23 was emptied ma the end of operatiOn the previous day, and utilz screen 584 to set the waste bottle level cator to zero. hu, computer 17, can track the filling of waste bottle 23 via monitoring of the operation of purnp 33 and dnd p an indication to the user when waste bottle 23 needs to be emptied, fr xamp, via. presentation ot screen 584, in order to wam the user that 4 unless emptied, the waste bote will overflow. According to some embodimerts, systen 10 automatically precludes any further operation of the system until the waste bottle is emptied, According to some alternative embodiments, a fluid level sensor may be coupled to .0 waste bottle , or example, as mentioned above in conjunction with Figure 1 f, in order to automaticaly deWtect when waste bottle is filled to a predetermined level and to provide, via computer 17, an indiaon to the user that waste bottle 23 needs to be S/or to automatically preclude operation of system 10 until the waste bottle is enmptiec. 15 in addition to the above maintcnanee steps related to eluant and eltute volumes of system 10. the user of system 10 will typically perform qualty control tests each day, Prior to any patient infusions. With efe-rence to Figur" 6, according to preferred rnethods,5 prior to pertorming the quality control tests (outlined in conjunction with Figures 7A-C and 8A-B, the user may select an item 675 frm main menu 470, in 20 order to direct system 10 to wash the column of generator 2L During the generator eelurn wash, which is perfRrmed by pumping a predetermined volume of euant, or example, approximately 50 milliliters, throughgenerator2l and into waste bottle 23, computer 17 provides an indication, via a screen 676, that the wash is in progress. Also, during the generator column wash, the system ay provide a signal to indicate 25 that eluate i being diverted to waste bottle 23, f light projector 100 (Figure I)mayrjet a fashingligt igalas previousy described. Figure 6 further illustrates a screen 677, which is presented by computer 17 ipon completion of the column wash, and which provides an indication of a time iase since the completion of the wash. in terms of a time countdown, until a subsequent 30 elution process may be effectively carried out, Whilescreen 677 is displayed sem 10 may be refillingg, frnm reservoir 1$, pump 33, which has a capacity of approximate '55 milliliters, according to somie embodiments, According to sornec preferred emod imants of the present inventi on, computer 17 starts a timter onrce any W() M1)9152303P?72S~S073 24 ejution process is compoleted and infoms the user or the tine *apse eiher in terms oft the time rcoundo wn (screen 677 or in terms of a time from completion or the eation, or e e as will be described in cojunction with Figure 7B. According to an exemplaryemnbodiment, wherein generator 21 is the Cardio~en-2@ that yields a sadlne soluton of Rubidium- 2, produced by the decay of Strontium2, via the elution, a time required between two effective elutiOn processes is aproxirnatey 1t) Once the appropriate amount of time has lapsed, after the eiutionproces or generator column wash, a first quality control test may be perfted, With refeene 10 to Figure 7A, the user may select, from main menu 470t an item 773A, which directs computer 17 to begin a sequence for breakthrough testing. According to some embodiments, in conjunction with the selection of item 773A, the user attaches a needle to an end of patient line 30sp and inserts the neede into to a es vial, for the collection of an cuate sanple therefrom, and, according to Figure1 A, computer 17 15 presents a screen 774, which instructs the user to insert the test vial into a vial shield, which nma be held in. recess 10) i of shell 13 (Figure IC). Fthe illutrats- ai subsequent screen 7 by w computer 17 receives input, from the user, for system 10 to start the breakthrough e ution, followed by a screen 776, which provides both an indicaton that the el-ution is in progress and 20 ar option for t user to abort the eiution. As previously described, the system may provide a'signa to indicate that elation is in progress, for exam pie, light proiccior 100 (Figure WC may project a flashing light signal during that p-orion of the cutinon process when eluate is diverted from generator 21 through wastem line 3 -5 andino waste bottle 23, and then a steady light signal during that portion of the elAtion process 25 when the eiuate is diverted from generaor 21 through patient line 305p and into the test vial, fM example, once activity detector 25 detects a dose rate of approximately L-0 mCi/sec in the elate discharged from generator 21. Anoiter type of light signal, for exmplthe more ,rapidly f ight, as previously described, may be projected when a peak bolus of radioactivity is detected in the eluate. 30 Upon completion of the elution process for breakthrough testing, comIuter 17 presents a screen 777, shown in Figure 7, which, like screen 677, pwvides an indication of a. tie lapsc since the completion of the elation, but now in terms or a tine since completion of the breakthrough elation process. When the user traustere W O PrS12523200W .1 th vial contining the sample of ciauste wto a dose cahibraor.o mea' ' ta aty of te sample, the user may ake a note of thetime lapsenicated on screen 7 With further reference toigure 7$ once the user has received acvy masure fronm he dose calibrator, the user proceeds to a screen 775 wich incldes data itn n &elds foi e activity mese and the time between tat at whichthe dose caibrator measured the actietyo Mi tesample and tat at wMich the eluton was comphe The user ni nertnhe data ae touch -screen tArface monitor 172. or viaany 1 tfhe other aforementioned devicesfor user data entry According to some alternate embodmets, compute 17 may recevthe data, eketronically, from the dose 10 cabrator, either via wireless communication or a cable connection, After the data is entered by the user, computer 17 presents screen 779, from which the user moves back to main menu 470 to perform a system caibration, tor example, as will be described in conjunction with Figures 8A-B, although the breakthrough testing is not completed, With reference back to Figure 7A, an item 15 7733 is shown, somewhat Maded, in main menu 470; item 773B may only be effectively selected allowing the completion of steps for item 773A so as to perform a second stage of breakthrough testing, in the second stage, the breakthrough of the sample of ehate collected in the test vial for the breakthrough testing is mveasured,< at a time ofapproxitely v60 minute fro e ompleton if the eutio that produced the 20 sample, With reference to Figure 7C, after the user has selected item 773$ fron main menu 470, in order to direct computer 17 to provide breakthrough test results, a screen 781 is displayed. Screen 781 includes, for reference, the values previo usly entered by the user in screen 778, along with another pair of data entry fields into whic the user is instructed to enter the breakthrough reading of the sample at 60 minutes and the 25 background radiation reading, respectively. After the user enters this remanin information, as described above, computer 17 may calculate and ten display, on a screen 782. the breakthrough test results. A according to the illustrated embodiment, computer 17 also displays on screen 782 pre-programed allowable limits for the results, so that the user may verify that the bre-akthrough test results are in compliance 30 with acceptable hirnits, before moving on to a patient fsion. Accord ingto somne embodiments, system 10 will not allow an infusion if the results exceed the acceptable limits, and may present a screen explaining that the results are outside the acceptable WO2009I2aa PCTr/us2109/47031 26 limits; the screen may further direct the user to contact the generator supplier, for example, t order a replacement generator. With reference to Figure 8A, during the aforementioned 60 minute time period. wile waiting to comnpte the breakthrough testing, the user mray perform calibration A5e item 87 from a ain menu 4 Up1 on we ol ecion , cmunter17 presents a screen 874. wh i instructs the user to insert a new test vtal into an elation vial shield. In addition to pacing the vial in the shield, the user, preferably, replaces patient line 3 0 5 p with a new patient line, and then attaches a needle to the end of the new patient line fOr insertion into the test vial, in order to collect an elate sanpic 10 therefrom. After perfrming these steps, the user may move to screen 875, wherein a plurality data entry fields are presented; all or some of the fields may he filled in with pre-programmed defauht paramneters, which the user has an option to change, it necessary Once the user confirms entry of desired parameters for the calibration, the user naty enter a comrnand , via interaction with a subsequent screen 876, to start the S calibration elution. With reference to Figure 8$, after computer?17 starts the ci ution process, a screen 87 informs the user that the calibration elation is in progress and provides an option to abort the elution, As previously described, the system may provide an indication that solution is in progress, for example, ig'ht projector 100 (Figure I -C) tay 20 poca J ing ights during that portion of the elation process when equate is diverted from generator 21 through waste lno 30w and into waste bottle 23. and then steady light signal during that portion of the edition process when activity detector 25 has detected that a prescribed dose rate threshold is reached, for example, 1.0 mCi/sec, and the ejuate is being diverted from generator 21, through the new patient 25 line, and into the test vial. Another type of light signal, for example, the more rapidly flashing light, as previously described, tay bc projected when a "pealk ousof radioactivity is detected in the eluate. Upon completion of thW elution process for cair: ation, computer 17 presems a screen 87, ich provides an indication of a time lapse since the completion of the elAtion, in terms of a tMe sAnce completion oF the 30 calibration eluton process. When the user transfer the vial containing the sample of eluate into the ds cali

T

raor, to measure the activity of the sample, the user may make a note ox the time lapse indicated on screen 878. With further reference to Figure 83, once the user has received th"e vity measre fronm, the dose calibrator, the WI) ZnQ~I 52323 cTLS20OiW4O3 o user proceeds to a screent 9,chinudesdata ein de for the activity meaenna and te time, with respect he tteiion of cltin at whih the doe cibrat measured the activaty of the samrne. Once the data is iput by he users described above, computer caculates a liberation coeffiient or ratioad presents Uhe rato on S a scren 850 According o Figure B, screen 880 further provides an indication ofa desirab range fOr the calbraton ratio and presents anotionsor the user to recet the calculated ratio. in hich case, the usermay instruct computer torecalulae the As previously mentioned, some alternate emnbodirnents of the present in vention 10 incde an on board dose calibrator so that the entre sequence of sample collection and calculation steps, which are described above, in con junction with Figures 6~8B, tot the quality control procedures, mnay be automated. This automnate~d alternative preferably includes screen shots, smiar to some of those described above which provide a user of the system with information at various stages over the crse o the $ automated procedure and that provide the user with opporamities to modif, override and/or abort one or more steps in the procedure. Regardless of the Ymbodimet (I.e, whether system 10 employs an on hoard dose calibrator or not), compmer 17 may father codket all quiy control test parameters and results into a stored record and/or compile a report icuding all or sonic of the parameters and results for local prin out 20 and l eciron tranfe to a remote cadon. With referencto Figur9,upon compeoan of the abovedeseribed quaty cntroiteststhe user may select an item 971. from mainmnu 470norder to det system 1 0 to egna procedure for the generation and automatic fns ion or radophnamaceutal into a patient. As previously described system ninus te 25 parent wittheradiophamaceutical so that nuclediagnosticnaima g eotipment, fI example, a P'ET scanner, can create images of an organ of the patienthiabsorbs te radiphanVaceutica via detection o radioactive radiation therefom. Accordng to Figure9PA 4 pon selection of item 97 Icomputer 1 presentsascreen 922 wich incldes adata enterfeld. for a patient identification nmbner. This identfiusaions 3.0 nmber that is entered by thse is retained by cornnuter t nornunctionwth the pettinet systcn paranueters cated. . .dwih the patient'sinfusion. After te user enters the parent identicationnumner computer directs, per screen 973, tha user to attach a new patient lineandto purge the patientle of air Aubsequenseen wo 2O*9i52'm PCTUS 24.{9/44 h3. 974 presented 7y computer 7ides data entry fie bywhichhe us may estaois harametesor thautomticnision;allorsonoftefieldstmaybenied in with pn>repoga' nddefatul t parameters, hich the user has an option to cange.fi necessary SWith reference to Fgure 913. if 'pump 33 does not comain enough anSalne for the patient insion, computer 17 wil present a waning, via a screen 901. which includes an option for the user to direct the lin p via a subsequent screen 902, Once pump 33 has been filled, computer 17 presents an indication to the user, via a screen 903. According to some embodiments, if the user does not re-fi 10 pump 33, yet attempts to proceed with an infusion,system 10 will preclude the infusion and present another screen, that conmmuni cates to the user that no infusion is possible, if the pump is not refilled, and asking the user to refill the pump, as in screen 901 LWh~en pump 33 containS a sufficient volume ot eluant tor the patient infusion, computer 17 presents a screen 975, which is shown in Figure 9C, and allows the user 15 to enter a connand for system 10 to start the patient infusion. During the infuson, computer 17 prtwides the user with an indication that the infusion is in process and with a option or the user to abort the infusion, via a screen 976. As previously described, the system rnay provide an indication that an elution is in progress, for exam ple, light projetor 100 (Figure iC may pro a flashing light signal during that 20 portion of' the elation process when eluate is diverted from generator 21 through waste line 305w and into wase bottle 23, and then a steady light signal during that portion of the elution process when activity detector 25 has detected that a prescribed dose rate threshold is reached for example, . mCi/sec, and the ehuite is being diverted from generator 2, throunh the new patient line for infsion into the patiem, Another type 25 of light signal, for exaple the more rapidly flashing l previously d may be projiectedf when a peak bolus of radioactivty is detected i th eiuate. At the completion of the infusion, a screen 977 is displayed by computer 17 to inftmn the user of the completion of the infusion and a ine sincethe completion. Conpue aso displays a summary ofthe infusionper screen 97$ 30 With further reference to Figure 90, screen 976 shows an exemparyactivty proiue activityt mCisec on rais versustimesee, on xaxis 1 for the infusionijected dose (dgnated between thet vertical esy IThose kidle in th a il t the ofh profile depends upon the infusion flow rate WVO 200)9f52321 PcTru2sn9M7{}3 for a given vosune of the dose, which flow rate as controlled, for example, byvthse speedough the patient line and o Strontiam-82 remaining in the generator, In the absence of flow rate control, activity profiles may change over the life of the generator. Euthermore, the peak bolus of 5, injected doses from a relatively new generator, may exceed a saturation level of the imaging equipment, i.e. PET scanner. According to some preferred methods ofuhe present invention, in order to maintain reliatively consistent, and desirabie/etThctive, activity profiles for patient injections, over the life of the generator, the operating speed of pump 33 may be varied (both over the course 10 of a single injection and from injection to injection), according to feedback tro activity detector 25, Such a method may be implemented via incorporation oh another quaht controetin which p amp 33 is operated to driveflow through the eneraror at a constant ratei order to collect, indto computer, a p!uranly of anvity measurement from activity detector 25 he plurhality measurements comprise a characteristics or 15 baseine activity pmfilefronwich the computr may calc ate an appropriate flowrate orohie to control a speed of pup 3 iordero acieve the desirable/effective acti vity proflie i general at the start of generator ltewhen Strontimn42 is pientifit he pumnp is controled to drive infusion flow atelativel lower rates, andthen, toward the end ofgcerator life when much of he Strontium 20 82 has beers depted, the pmup is controled toarive snraion flowe ely buger rates, Aswas described aboveri conantion with QigreD, if a desired nfusioninjection owrate is relaively high that is, high enough t o 'reatetoo nuch back pressure infow through e m gerator nv-passbie 33 nmy be employed by adjusting divergence valve 35BG to divert a fow chMnh therethrougn 25 a sufficient volume has been punmped trough generator at a wrfowrate. According to this method, once adose of dhate, fm generator 2 has owed into patient Iine 5mdivergence valve 35130isset to divert he fowofelndant through by pass ine 303,and then pump speed is increased to pinmp eirnt at a higher flow rate t order to push th~e dose out from patient line 305pfor injection at the higher flow ote. 30 Consistency of activity p rolIes among indeed doses cart greatlyfaciiitate the use of PET scamnirrg for the qpuamtinceations of flow. for example in coronary perfesion studies, Aiernative.nfusion circuit conbfgurationgeeagcodn oatmtv methods, t achieve consistency Of acftypie anag idet&teoss as we! as a W0 2009/1523 s San 200 morenitom level ofradianhtyv across each indiduad dose, willbe described below, in non junction with Pigres 12A& Priter 7 (Figure 1B) may be activated to print out ahrco oft infi~on summary, on which the patient identification number and pertinent infusion 5 andsystm paamtr"'sare also printed, for reference. A~hermatively, or in addition, accordng to some embodiments, the summary may be downloaded onto a computer readable storage device to be electronical ly transferred to one or more remore computers and/or the summary may be atomatically transferred to the one or mre remote computers, ia wnrdess comuncation or a cable connecton, for example, 10 over arn tranet netwok and/or the internet in order o protect private patient intformationuthe files may be encrypted for transmission over he internmt theone o more remote computers may be included, for example, n a hospitalntformation systen, and/or a bi-giytn, and/or i a agedicaI inagingytn nfsn parametersfomrexamplecorresponding to the activity profile may also be collected 1$and eeedrasneaily transferred for analyst m conjunetion with captured images. for examapiei order to quantfy coronary flow, ia a softvnrn package that is loaded into a systemtaat includes the PET scanner. Wih reference back to Figur 9A the user may sev"t an iterm95 from main menu 40.in order have systend10 perform data operations such as, archivig a data 20 baes patient infusion ntormation and qualiy control test resutsirnginmittingt patient intusion summary records to US813 as storage devi ces.and various tpes of data filterigfo example acor ding to date ranges and/or oat lent identification 25 collected by computer over the course of' system operationand which defines system operation, may be transmitted to a ocal or remote computerized inventory system and/or to computers of technical support personuci, mamntenance'/sel ct riders and/orauppliers of infusion cireult elements/orn ponets, thereby fateiitatna more efficient ystem operation and maintenance. 30 Turning now to Fgure 10, an item 981 tbr cornputridaditated purging of the tubing lines of systemn 10 is shown included in main menu 470. When a user sel ets item981. computer 17 guide the user to selet either an ai purge or a saine purge, 'Ihe direcetm provided by computr17isnot explicitly laid therein. b a saline W 02O9/i52323 PC/UIS2009/103O1 purgi. as procedures toa salute purging shoud beeadily apparent to those silled la the art, wih reference to thdeschematiceX nfusion crc3it 300 shown in Figure ID DA s line urge of ircuit 300 is desired to assure that athe air is removedfromn cii 300 when a new generator and/or a new complete oer partialtubing set is installed. An 5. air purge ofote uig He .e iircui 300rmay bepertormed afer \emoving eervotr i$~y~pssioggenratr 2. y connecting tubing ine 304 to tubinI in 3.05. and coupling ie 305p in a vialfor exampeais directed bythe computer ;nterfae in screens 93 anid 94 shown in Fignre 10. The air purge is desirablser blowing out the tubing lines thereby &Aemoving allremaining ehuant and Ahuate prior to 0 installng a new generator and/or prior to transporting system 10 fronmane she toe another. If generator 21 is not deplted and will be used in system 10at the new site, t is important to by-pass the generator prior to purging the tuheg Hines of ircuit 300 mdM compromise cot the finetion and the aseptic nturett oftgenerat2 1 According to preferred embodiments once the user has fobiow-- the instrucdosns presented in screens 983 and 984and selects to start the an-~i*erg eapvia screen. 985computer 1 7 directs the controller system 0to c a t ry out a c-onmplete airpnurge, in which pump 3 and divergence ves 35$Oand5W a re automaually controlled. The automatedar purge preferabtunciudes tiefolio win 20 steps, wich may be best understood ith rference totubing crcuit 300 in Figure ED: pumlping anrmining vlme of etant left inpump 33, hrough lnies 302, 34, 05 and 305w.towastebotte 23; refilling punp 33 with air nd-pnmping the through lines 302, 04,30 5 and 305w, into waste bottle 23 (lines 304 and 305 have been previous y connected directly to one another, in order to by-pass generator 21;if 2$ generator 1 s depleted and will be replaced with a new generator, pumping air tharough generator 21 may he acceptable);refilling pump 33 withr and then pumping portiona naidaaNies2 504,05 and 305p~ into the via 1 , andtse a remnainig portion ot the anyr through lines 302. 304303 and 35-. nto the via With refere-nelo Figure 1 D and the previous description of diveroence valves 35BC. 30 35W!> it should be understood how divergence valves 35B0. 35WP are auzonaticailly controled Io carry ou-t de above steps. The purge operations which arefacilitated by seleting item 981tfrom tman menau 470. znay also be accessed via the selection or an item 991tfor generator setup.

W) 2P09/152323 PC T/P2S 9/ 7V3 Ween he usr sect sitem991 computer 17 may preen an opnton to guidance in removing an oK depleted, generator and a set offing tines priorto instaingthe 'W gencrtertor an opten to just be guided inte insta- nation of ew ger7r Accordlin g to some emnbodiments, computer 1 is pre-programmed to calculate an 5 amont ofacdtivicftin adepicted enerator, for example by tracking actiwoi a-eate oer a life orthe nerator. At an end of the lfe of the generator computer 17 maygfnTher comine thi tnM tatUIonalong w oi odh ertn generato infornaion, into a report that may accompary a declmtaionf dangerous goods for shipping e depleted generor outfor disposal or-some-basesbackdo the 10 raufautuurertbr investigation. An exmpe of such areportis shown in Pinrei According toethose emibodimuents of system 10 h'include an encoded information readeconarputermay confirm that the new genertris proper bypocessing information that is read fhorn 'an encoded label/ag attached thereto. Fiunres 2A3 are schematics of alternate h sionccuits 100 tk 008 that may be employed by system 10 in plae of cii 300 (Figuro D according to someadditiona embhdimens ofhe present invention Circits I0A. I00B are config-redto alow foratnative methods of operation, to that plevi o y deseuibed or circuit00 when a relatily evenor unifomleve of activity ovenach injected dose, alongwith the retively consistent level of activity from injection mnection is 20 desiredir example. in order to faciitate a qu'ntmicaton f coronary ary b1000 noivra NE scanning. Figure 12C is a seinaiclustrating actvirotles , 1200B for two need doses, wherein profile 1200B has a more unilonmlevelo actiiy than profi 1200A.: proti 1.200B ma be civdvath prto f circus 1300A.1300 as described bew. 5 Similarto circui300FigureD) dashedines arc shownin each ofFigures 1 A13to indicate a general boundary of a building assemiblyfor portions or each circuit 137% N 00B, The shielding assemblyI for each of circuits iO0A, 130013nay be very si'igt inr most respects, to shieAng assembly 200; whichis described above for system 0 ad the elements of each okmurcuits I 00A. 008B may be arrned 30 wih rcpecti s therrespective shielding and wittesapect to shelli13ootsystem 0 in a sinul ar manner to that described above for cireut 300. circuit 300. eluamt reservoir 15 pump 33, radioisotope generator 21 through which the WO 20u9/152323 PT/US20 9/t4'7031 n, ftered ehiant is 1nm edi create the rdioactive elnateactivlts'detector 25. ad waste bottle 23. Figure 1 2A further ibln'ats two Fliers 3and ty p rcur inisa"e'sinct un circu1300A ~ct MirJi3VA hktherinedes bypass tubing lie 03,hich is ionated downstreat oi cvergence valve 35B30 like i crcit $ 300. and wich accommodates the prev iously de scrbed eluant/saline flush. However ci in contrast to circuit 300. circuit I 00A further includes aee'proportiona ave 1335 integrated into by-ass/thsh lne 03 so that chircut I 00A may be operated, or exaratue. - orv~ > in on -t agmlaccordtng to pre-nrogrammed parameters o ptri cnmto with feedbackkof information Ibm activity detector 25, foraecntrolledhby-passof 10 generator 2! in order to ixelnani with equate and, hereby.achieveda htieiv uniform level of aivyveeahptentinjection, for example, according to posfile 1 0013o eFiguren I20It should henoted that, ii addition to the controlled inxng, a flow rate or each ;niecrioni may be varied, if necessary inorderto matain a onssten actt evl circuit 300, ehuantresevu ofj pen 33 r~aiisto~ Yne nernor 2i, aenld e ter gQ and waste botte 23. as well as the tw~oflters 37 and two pressure transducers 1334 as ir circuit I 300K, in contrast to circuts 300r andI30A circuit 130$ ibriher scnec an eluate reservoir 1350, which is hown located downstream ot generator 2*kn btwee:nr first and second segmients 305AX 300B ofehe ninate' tingne It V1,iiC smyhit to should be noted that arunmp is omnhned with reservoirn1350 for exagesik o syrige ounm 33 a stt when a divergenicevalve 15510 is set t allow fluid commnictio bewee reervir 350 and tubing line secgnent 305A, the associated' rump may be operated to draw tn a vohume of eluate. nd, then, when diwergnce 25 valve 133510 is set t allow fluid communication between reservoir 1350 and tubing line segment 305B, te pamnp may be operated to pushthe volume of chuate out through tuing line segmet 30B (or a patient injection, wen divergence viuve 35WP s set to direct fow into patient line 30 5p. With referee back o Figures 3A-f& siewall 205ofsW iit assembly 200 may be enlarged to either enclose clnate 30 reservoir 150. For example, nother shieded well, to house the eluate reservor.n may extend alongside well 55, ii which activity detector 25 s described as being mount Furthemtore, idewall 205 may incude another valve actator r:'mptace fbr 04 dIergence valve 13510. SOiila to reptacle 253, shown in Flire3A for divergence valve 3P. olcon of discrete volmes of eme. in a reservoir 350, may hel to achieveaon uniform activity level over each COn example like that of a profile 200B in rig to preferred methods feedback an activity detectorn 25 be t used to conro! the pump associted with reservoir 150 in order o vary inecdon flow rate and. thereby, maintain a relativeN consista t vit lee across mutie injections, ndh neessary.tovay eetion flovrten over S anindivuA injection to maintain the uniform activity level Feedback Non the pressure transducer1334 tht is downstream om detector 25 1and/or from a flow peter not show of CIcuit 10013 may also be used t controtheXarying ofin o flow rate. Wit further reference to Ficures 12A1B it should be noted that alenatve circuits may he conagured to emplammatonothe mtos descrbed for circuits 1300A and 1300B. Furthmore some infusion circuits of the present invention may employ nutipie generators 21. as mentioned abovem e omiunction with Fire 2A. t help matainthe relatively unifOm levelof activity over each inection 20 and the relatinly consistent levelof activity from inecdon to injecdenn in the fberoing detailed description the invenion s been described ith reference to specificembodints owveer it na be appreciated that various modhnications and charges can be made without depardtilg kromt the scope Of he 5 inventIon as set forth rathe appendedclaims in the claims which follow and in the preceding description of the inemon except where the coext requires otherwise due to express lmguage or necessary implication, the word "comprise" or variations such as "comprises" or "comprisirg" is 30 used in an inclusive sense, ie. to specify the presence of the stated features hut not to preclutde the presene or additioincof further features in various enmbodimnents of the t is ja be understood that, if any prior an p Iublctio is refrre to herein such reference does not constitute an admission that the publcon fms a part of the como general knowledge in the art, in Australia or any other country.

Claims (54)

1. A mobile radioisotope generator system comprising: a movable platform carrying an infusion tubing circuit, an activity detector, a dose 5 calibrator, a computer, and a shielding assembly containing a strontium/rubidium radioisotope generator configured to generate a radioactive eluate via elution of an eluant, the infusion tubing circuit including a tubing line connected between the strontium/rubidium radioisotope generator and the dose calibrator and configured to supply a portion of radioactive eluate to the dose calibrator, 10 the activity detector being positioned downstream of the strontium/rubidium radioisotope generator and configured to measure an activity of the radioactive eluate flowing through the infusion tubing circuit, and the computer being electronically coupled to the dose calibrator and configured to execute automated quality control testing using the dose calibrator. 15

2. The system of claim 1, wherein the automated quality control testing comprises breakthrough testing, and the computer is further configured to prevent a patient infusion procedure if a breakthrough test result exceeds an allowable limit. 20

3. The system of claim 2, wherein the allowable limit includes a ratio of an activity of strontium-82 divided by an activity of rubidium-82 and a ratio of an activity of strontium 85 divided by an activity of rubidium-82 each being less than 0.02 microcurie / millicurie.

4. The system of claim 1, wherein the computer is configured to collect and store 25 quality control test parameters and results.

5. The system of claim 1, wherein the computer is configured to automatically transfer quality control test information to one or more remote computers. 30

6. The system of claim 1, wherein the movable platform further carries a waste reservoir and the infusion tubing circuit further includes a waste tubing line and a divergence valve, the waste tubing line 6202596_1 (GHMatters) P85620.AU.1 JMEAD 36 being configured to provide fluid communication between the strontium/rubidium radioisotope generator and the waste reservoir via the divergence valve, and the computer is configured to receive activity measurements from the activity detector, control the divergence valve to direct eluate to the waste reservoir until the 5 activity detector measures a threshold amount of radioactivity in the eluate, and, upon receiving an indication from the activity detector that the eluate has the threshold amount of radioactivity, control the divergence valve to direct eluate to the dose calibrator.

7. The system of claim 6, wherein 10 the movable platform further carries a pump electronically coupled to the computer and connected to a supply of eluant, the computer is configured to control the pump to supply the eluant to the strontium/rubidium radioisotope generator and generate the portion of radioactive eluate, and 15 the computer is configured to execute the automated quality control testing by controlling the pump, the divergence valve, the dose calibrator, and the activity detector.

8. The system of claim 1, wherein the movable platform further carries a printer configured to provide a printout of quality control test information. 20

9. The system of claim 1, wherein the dose calibrator is at least one of integrated into the shielding assembly or contained within a well of the shielding assembly.

10. The system of claim 1, wherein the computer is configured to execute automated 25 quality control testing by at least receiving activity data from the dose calibrator and calculating at least one of breakthrough test results and calibration coefficient results.

11. The system of claim 1, wherein the computer is configured to execute automated quality control testing by at least receiving a first activity measurement from the dose 30 calibrator at a first time, receiving a second activity measurement from the dose calibrator at a second time later than the first time, and calculating breakthrough test results using the first activity measurement and the second activity measurement. 6202596_1 (GHMatters) P85620.AU.1 JMEAD 37

12. The system of claim 1, where the computer is configured to execute automated quality control testing by receiving activity data from the dose calibrator and calculating a ratio of an activity of strontium-82 divided by an activity of rubidium-82 and a ratio of an 5 activity of strontium-85 divided by the activity of rubidium-82.

13. The system of claim 1, wherein the movable platform further carries a touch screen display and the computer is further configured to indicate via the display if results of the quality control testing are within allowable limits. 10

14. The system of claim 1, wherein the dose calibrator comprises a removable sample collection reservoir configured to receive the portion of eluate.

15. The system of claim 1, wherein the computer is electronically coupled to the dose 15 calibrator via one of a wired or wireless connection.

16. The system of claim 1, wherein the movable platform rests on wheels configured to roll and swivel. 20

17. The system of claim 1, further comprising an eluant reservoir containing saline as the eluant, the eluant reservoir being connected to the movable platform and positioned outside of the shielding assembly.

18. The system of claim 17, further comprising an encoded information reader 25 configured to read encoded information from at least one of the eluant reservoir, the infusion tubing circuit, and the strontium/rubidium radioisotope generator, and wherein the computer is further configured to receive information read from a label attached to the at least one of the eluant reservoir, the infusion tubing circuit, and the strontium/rubidium radioisotope generator. 30 6202596_1 (GHMatters) P85620.AU.1 JMEAD 38

19. The system of claim 1, further comprising a pressure sensor in communication with the computer and configured to measure pressure of the eluate within the infusion tubing circuit. 5

20. The system of claim 1, wherein the computer is configured to connect to a removable computer readable storage device and transfer quality control information to the removable computer readable storage device.

21. A mobile radioisotope generator system comprising: 10 a shielding assembly configured to contain a strontium/rubidium radioisotope generator that generates radioactive eluate via elution of an eluant and an infusion tubing circuit comprising an eluate tubing line configured to convey eluate from the strontium/rubidium radioisotope generator; means for measuring an activity of the eluate flowing through the eluate tubing 15 line; means for receiving eluate from the eluate tubing line and calculating breakthrough activity within the eluate; and means for receiving activity data from the means for measuring the activity of the eluate and also receiving breakthrough activity data from the means for receiving eluate 20 and calculating breakthrough activity and controlling the mobile radioisotope generator system based on the received activity data and breakthrough activity data.

22. The system of claim 21, wherein the means for receiving activity data, receiving breakthrough activity data, and controlling the mobile radioisotope generator system is 25 configured to prevent a patient infusion procedure if breakthrough activity data exceeds an allowable limit.

23. The system of claim 21, wherein the means for receiving activity data, receiving breakthrough activity data, and controlling the mobile radioisotope generator system is 30 configured to electronically transfer quality control test information and infusion information to one or more remote computers. 6202596_1 (GHMatters) P85620.AU.1 JMEAD 39

24. The system of claim 21, wherein the shielding assembly is configured to further contain a waste reservoir and the infusion tubing circuit further includes a waste tubing line and a divergence valve, the waste tubing line being configured to provide fluid communication between the 5 strontium/rubidium radioisotope generator and the waste reservoir via the divergence valve, and the means for receiving activity data, receiving breakthrough activity data, and controlling the mobile radioisotope generator system is configured to control the divergence valve to direct eluate to the waste reservoir until the activity data indicates a 10 threshold amount of radioactivity in the eluate, and, upon receiving an indication that the eluate has the threshold amount of radioactivity, control the divergence valve to direct eluate to the means for receiving eluate from the eluate tubing line and calculating breakthrough activity within the eluate. 15

25. A method comprising: delivering eluant to a strontium/rubidium radioisotope generator carried by a movable cart and thereby generating radioactive eluate via elution; measuring, with an activity detector carried by the movable cart, an activity of the eluate within a tubing line of an infusing tubing circuit; 20 delivering a portion of eluate via the tubing line to a dose calibrator carried by the movable cart, and performing quality control testing on the eluate delivered to the dose calibrator.

26. The method of claim 25, wherein performing quality control testing on the eluate 25 comprises conducting breakthrough testing, and further comprising preventing, via a computer carried by the movable cart, a patient injection procedure if a breakthrough test result exceeds an allowable limit.

27. The method of claim 25, further comprising storing, on a computer carried by the 30 movable cart, quality control testing information. 6202596_1 (GHMatters) P85620.AU.1 JMEAD 40

28. The method of claim 27, further comprising transmitting, via the computer carried by the movable cart, quality control information to one or more remote computers.

29. The method of claim 27, further comprising transferring, via the computer carried 5 by the movable cart, quality control information to a removable computer readable storage device.

30. The method of claim 25, wherein delivering the portion of eluate via the tubing line to the dose calibrator comprises delivering the portion of eluate to a removable sample 10 collection reservoir.

31. A system comprising: a shielding assembly configured to contain a radioisotope generator that generates radioactive eluate via elution; 15 a computer carried by the shielding assembly, wherein the computer is configured to receive a user input and, responsive to receiving the user input, control the radioisotope generator to generate a sample of eluate via elution during breakthrough testing; and a dose calibrator electronically coupled to the computer and configured to measure an activity of the sample of eluate generated during breakthrough testing, 20 wherein the computer carried by the shielding assembly is configured to receive the activity data from the dose calibrator and calculate breakthrough test results.

32. The system of claim 31, wherein the radioisotope generator comprises a strontium rubidium generator configured to generate rubidium-82 by decay of strontium-82. 25

33. The system of claim 31, wherein the computer is configured to calculate the breakthrough test results by at least calculating a ratio of an activity of strontium-82 divided by an activity of rubidium-82 and a ratio of an activity of strontium-85 divided by the activity of rubidium-82. 30

34. The system of claim 33, wherein the computer is further configured to indicate if the breakthrough test results are within allowable limits. 6202596_1 (GHMatters) P85620.AU.1 JMEAD 41

35. The system of claim 34, wherein the allowable limits include the ratio of the activity of strontium-82 divided by the activity of rubidium-82 and the ratio of the activity of strontium-85 divided by the activity of rubidium-82 each being less than 0.02 5 microcurie / millicurie.

36. The system of claim 31, wherein the computer is further configured to prevent a patient infusion procedure if a breakthrough test result exceeds an allowable limit. 10

37. The system of claim 31, further comprising an activity detector.

38. The system of claim 37, wherein the computer is configured to divert eluate generated via elution to a waste bottle until the activity detector detects a given level of activity. 15

39. The system of claim 38, wherein the given level of activity is approximately 1.0 millicurie per second.

40. The system of claim 31, further comprising a display configured to display the 20 breakthrough test results.

41. The system of claim 40, wherein the computer is configured to control the display to provide an indication of progress of the breakthrough testing. 25

42. The system of claim 31, further comprising a cabinet structure, wherein the shielding assembly is positioned inside the cabinet structure and the computer is carried by the cabinet structure.

43. The system of claim 31, wherein the dose calibrator is configured to physically 30 receive the sample of eluate generated during breakthrough testing.

44. A method comprising: 6202596_1 (GHMatters) P85620.AU.1 JMEAD 42 generating, with a radioisotope generator contained within a shielding assembly, a radioactive eluate via elution of an eluant; measuring, with a dose calibrator electronically coupled to a computer carried by the shielding assembly, an activity of the radioactive eluate; and 5 determining, with the computer, an activity of rubidium-82 within the radioactive eluate.

45. The method of claim 44, further comprising determining, with the computer, an activity of strontium-82 and an activity of strontium-85 in the radioactive eluate. 10

46. The method of claim 45, further comprising determining, with the computer, a ratio of the activity of strontium-82 divided by the activity of rubidium-82 and a ratio of the activity of strontium-85 divided by the activity of rubidium-82. 15

47. The method of claim 46, further comprising determining, with the computer, if the ratio of activity of strontium-82 divided by the activity of rubidium-82 and the ratio of the activity of strontium-85 divided by the activity of rubidium-82 are within allowable limits.

48. The method of claim 47, wherein the allowable limits include the ratio of the 20 activity of strontium-82 divided by the activity of rubidium-82 and the ratio of the activity of strontium-85 divided by the activity of rubidium-82 each being less than 0.02 microcurie / millicurie.

49. The method of claim 44, further comprising displaying breakthrough test results 25 determined by the computer.

50. The method of claim 44, further comprising preventing, with the computer, a patient infusion procedure if a breakthrough test result exceeds an allowable limit. 30

51. The method of claim 44, further comprising measuring, with an activity detector electronically coupled to the computer, an activity of the radioactive eluate. 6202596_1 (GHMatters) P85620.AU.1 JMEAD 43

52. The method of claim 51, further comprising controlling, with the computer, a diverter valve to divert the radioactive eluate to a waste bottle until the activity detector detects a given level of activity. 5

53. The method of claim 52, wherein the given level of activity is approximately 1.0 millicurie per second.

54. The method of claim 44, wherein the shielding assembly is positioned inside a cabinet structure and the computer is carried by the cabinet structure. 10 6202596_1 (GHMatters) P85620.AU.1 JMEAD