AU2015200752B2 - 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

INWSION SYSTEMS INCLUDING COMPUTER-FACILITATED M AINTENANCE AN D/OR OPE RATION

RELA TB D A PPL ICATIONS priorityte#he following IKS, patent implications; U.T ptbeni. application serial No, 12/137,356. Hied iPpEl 1, 2C0B; 1j.<e patent application serial No. 12/137,363, filed June 11, 2008; l .S, patent application serial No, 12 '.3L36-L filed June 1. 2008. nod U.S. patent application serial Ho, 12/1117,377. filed June 11,2008.

Toe present application is a divisional application derived front parent: app'iue.mr n. .r ... NGP25“4 A' winch is howm rcorporstud »n its entirety by reference,

TECHNICAL FIELD

The present inventfon ;j^ai:ns^-^tet»s;tiia*ig«n^%a^i?ifuise radtopharmaeeuiknls. and, mote particiiiafijvto ^ theilinned maintenance and/Pti ppetatioh. BACKGROUND-

Hnctearmedicineempipyym^ diagnostic ..imaging. Positron emission tomography (PEI) is one type of diagnostic imaging, which ufiiicci doses of within ^radioitolofeig^^tofj that are itdcCted, or infused into a patient. The infused dose of radiophaiasdoeutleal is ahsoffeed fey cells of a: target organ, of the patient, and emits iadihiidh,: which ipdpected by a PET scanner, in order to generate an image of the organ. An example of a radioactive isotope, which may be used lor PET, ?» Rpfeidlnni-82 (produced b\ ov A. cay ot MrontKni>82L and an example of a radioisotope generator which yields a saline solution of Rubidium-82, via elution, is the CardioGen-82Φ available front Braeco Diagnostics Inc, (Princeton. NJ). A PET scanner in combination with Infused doses of radiopharmaceutical» may also be employed:#» quantify blood flow rate, for example, through the coronary arteries of a patient.

Set up, maintenance and operational procedures for infusion systems that both generate and inject doses of radiopharmaceuticals are relatively involved in order to assure the safety and efficacy of each injected dose for the patient. Efficiency in carrying out these procedures is highly desirable for technical personnel, who work with the systems on a routine basis and would like to avoid unnecessarily prolonged exposure to radioactive radiations. Thus there is a need for new system configurations that facilitate more efficient set up, maintenance and operation.

SUMMARY OF THE INVENTION

In accordance with a first aspect of the present invention, there is provided a mobile radioisotope generator system comprising: a movable platform carrying an infusion tubing circuit, an activity detector, a dose calibrator, a computer, and a shielding assembly containing a strontium/rubidium radioisotope generator configured to generate a radioactive eluate via elution of an eluent, 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, 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, wherein the computer is configured to determine an activity of strontium-82 and an activity of strontium-85 in the portion of radioactive eluate through automated quality control testing using the dose calibrator, the computer is configured to control the mobile radioisotope generator system to deliver a dose of radioactive eluate to a patient during a patient infusion procedure, and the computer is further configured to prevent the patient infusion procedure if a quality control test result exceeds an allowable limit.

In accordance with a second aspect of the present invention, there is provided a mobile radioisotope generator system comprising: a shielding assembly configured to contain a strontium/rubidium radioisotope generator that generates radioactive eluate via elution of an eluent 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 line; means for receiving eluate from the eluate tubing line and measuring breakthrough activity of the eluate; and means for receiving activity data from the means for measuring the activity of the eluate and controlling the mobile radioisotope generator system based on the received activity data to deliver a dose of eluate to a patient during a patient infusion procedure, wherein the means for receiving activity data and controlling the mobile radioisotope generator system is further configured to receive breakthrough activity data from the means for receiving eluate and measuring breakthrough activity, determine at least an activity of strontium-82 and an activity of strontium-85 in the eluate from the breakthrough activity data, and prevent the patient infusion procedure if the activity of strontinum-82 or the activity of strontium-85 exceeds an allowable limit.

In accordance with a third aspect of the present invention, there is provided a method comprising: delivering eluent 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; delivering a portion of eluate via the tubing line to a dose calibrator carried by the movable cart, performing quality control testing on the eluate delivered to the dose calibrator, quality control testing including determining an activity of strontium-82 and an activity of strontium-85 in the eluate, and preventing, via a computer carried by the movable cart, a patient injection procedure if a quality control test result exceeds an allowable limit.

In accordance with a fourth aspect of the present invention, there is provided a system comprising: a shielding assembly configured to contain a radioisotope generator that generates radioactive eluate via elution; 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, wherein the computer carried by the shielding assembly is configured to receive the activity data from the dose calibrator and calculate breakthrough test results, and the computer is further configured to prevent a patient infusion procedure if a breakthrough test result exceeds an allowable limit.

In accordance with a fifth aspect of the present invention, there is provided A method comprising: generating, with a radioisotope generator contained within a shielding assembly, a radioactive eluate via elution of an eluent; measuring, with a dose calibrator electronically coupled to a computer carried by the shielding assembly, an activity of the radioactive eluate; determining, with the computer, an activity of rubidium-82 within the radioactive eluate, and preventing, with the computer, a patient infusion procedure if a breakthrough test result exceeds an allowable limit.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings are illustrative of particular embodiments of the present invention and therefore do not limit the scope of the invention. The drawings are not to scale (unless so states) and are intended for use in conjunction with the explanations in the following details description. Embodiments of the present invention will hereinafter be described in conjunctions with the appended drawings, wherein like numerals denote like elements.

Figure 1A is a first perspective view of an infusion system, according to some embodiments of the present invention.

Figure IB is another perspective view of a portion of a cabinet structure of the system shown in Figure 1A, according to some embodiments.

Figure 1C is a second perspective view of the system shown in Figure 1A, according to some embodiments.

Figure ID is a schematic of an infusion circuit, according to some embodiments of the present invention.

Figure IE is a perspective view of exemplary sample vial shielding that may be employed in conjunction with the infusion system of Figure 1A.

Figure 2A is a perspective view of a shielding assembly for an infusion system, such as that shown in Figures 1A-C, according to some embodiments of the present invention.

Figure 2B is a perspective view of a framework of the system, according to some embodiments, with an enlarged detailed view of a component of the system, according to some embodiments.

Figure 3 A is another perspective view of the shielding assembly shown in Figure 2A.

Figure 3B is a perspective view of the infusion circuit, shown in Figure 1C, configured and routed, according to some embodiments.

Figure 3C is a perspective view of a disposable infusion circuit subassembly, according to some embodiments.

for the .subassembly show! in Figure 3C, according to somsiethfeoiiffieats.

Figure 4 is a mia menu screen shot from an interface of a computon wineh may be included in systems of the present invention, according to aomo emhodtments.

Figure 5 Λ is a schematic showing a for group of saecessivc screen shots it>tu me computer interface, according to sdMgtpibcxitmems.

Figure SB is a pair of screen shots from the computer interface, which provide Indications rela^ in a resoreoir of the system, according to some embod; stems.

Figure 5C is a schematic showing a seemid group of successive screen shots from the computer sutedace, according to some omfeodlmenfr.

Figure 6 is a sebemuhe showing a third group of successive scmspesbois :1¾¾ the cotup,her interface, according to some embodiments.

Figures 7 A-Care schematics .from the computer intetfaee, according to some embodiments.

Fignres SAcB «re schematics showing a frfrh group of suec^ive screen shots from the computer inieifaecgaecorSiug to some embodiments.

Figures 9A-C are schematics Showing a sixth jgpup frf successive screen shots from the comp user •'tefr.a, e, aceordingitosomee

Figure 10 \s a a hematic showing1 a seveath |rospof supecssivc:screen Shots ; from the compuie: unbrace, according ro:Sotne embodiments, " g,~ M w a», v «.emr arv rej» + inch η 5, r>e 'je*wr Vd bs he cos " ,~ meindsditn inibsiort system, according to some embodiments,

Fi|pres ii2A~B arc schematics of alternative mfa^dmgi«^i|s:iihhtipEii^-be ds|>Ipi^:by'smb^(i«sents of the present invention.

Figure ISC is a schematic iOusfraiing exemplary aedyI# profiles of ih|celed doses of a radiopharmaceutical,

DETA.1 LED DESCRIPTION ile::frt|loWib|:d:eta|led description:Is exemplary in nainfe and is not intended:tp limit the scope, applicability, or configuration of the inveutinuin any way. Ratlfru the following description provides practical illustrations jfcr implementing exemplary1 embodiments. Utilising the teaching provided birtpio, thosebkilfed in the art mil ro^ptlKeihid msnvofthe examples have suitable alternatives that can be utihzoa.

Figure 1A is; a first perspective view of ah:iniusiou#stem 10, accormnu to some embodiments of the present invention, wherein system 10 is shown supported by a eabmc vrne'ure wl \t n^iudcs a piattbrtn .113 (seen bcder in Figure 0B.J and a shell 13; shell 13 extends upward from a start 11, that sprrouuus platform i s J, to. surrounds an interior space in which a portion of infusion system 10 ;s contained seen in Figure 1C). Shell may be formed from paneisof irsjecnotn-rboided po;yufothsne

methods known to those skilled in the -art. Figure 1A illnshates thtt d&amp;blnet structure of system 10 including a grip or handle 14, which extends laterally; from sbeil 13, iupmxnmty fo m torpor surface 131 thereof, and a post 142, which ¢x^ds'^wa^.foβm^si¾f!3, and to which awork surface*; or tray ib and a computer 13 are. preferably, atta^l, -via.M

According to some embodiments, computer .17 is coupled to a eonimller of system 1¾ which is mounted within the interior space surroutided by shell: O; and, a tnonitor X /2 of eompnter !7 not only displays indications of system operation tor a user of system t% but also serves as a; device for user input Mowevety secordmg to alternate embodirnems, another type of user fppm device, known to those skilled in the art, may be employed by compute 17. Other types of user input deyieos may hv included, for example, a keyboard,: a series of control buttons or levers, a bar code reader par other reader of encoded infemabod), &amp; scanner, « computer readable medium containing pertinent data, etc. The ttser input device may be mourned on the cabinet structure of sysiem 10, as shown, Or may be tethered : user input device may be for MUmple, located id n separate control, room. According to sbrhe additional user input device, for example, in addition to a touch screen of computer ;12s rnay be tefoom from system 11) and used to start and stop fo&amp;sibns, as: well as to mmitm system operation both, during qua!;· v control infusions and during patient mraslons, Operation of system 10, which is ibciih&amp;tediy epfopter 17, will be deseribeihelpw, !p^

Figures 4-9C.

Figure 1A further tfh#|p# 122,upo an ted to atr underside of platform-113, to make system 10 mobile; handle 14 is shown located at an elevation suitable for a person to grasp in order to numeuver system 10, iron-oisc location snothfd upon pairs of wheels 121, 122, According to some prelmhed embodiments, one or both pairs of wheels 12 K 122, are casters, allowing for rotation in a hormoatal plane (swivel), in. order to provide additional flexibility for tmnstmeting system 10 in relatively tight spaces.

Figaro IB is &amp; perspective view of a portion of system 10, on a side 111 of the cabinet structure, which is in proximity to wheels 121. Figure IB illustrates a lever or pedal 123, which is located, for activation by a foot of the person, who grasps handle. 14 to maneuver system .10. In a neutral post don, pedal 125 allows wheels 121, 122 to rotate, and, if embodied as casters, to swivel freely. Pedal 125 may bo depressed to a tarsi position which, prevents a swiveling of wheels 122, according to those embodiments in which wheels 122 arc casters, and maybe further depressed to brake wheels 121, 122 from rolling and swiveling, upon reaching « desired location. According to some ernbodirooms, braking maybe designed to slow system 10, for example, when rolling down an incline, and. according ui ^rifuh^ermfebdi^Cat^;: system 10 mas include a motor to power movement thereof. iFigurc llB IgTiher aypar access:'|4bel,::|24 pf shell 1;|, tor okdmpfei providing access motrenii boarddbf thb afofofoentioned controller eontamed within the inteciii^ade^^^^.snwouaded by shell 13; an optional lock 184, to secure panel 174; a power jack 118, a for providing earned out by system 10p«8#of system q^hyiip«hot;^':ne^il%. In some embodiments. system 10 may further include a power stop by which auxiliary befppPettt may be powered, and one or more additional elecbical connectors, or ports (not stownbwfoch arc supported by platform. 113 and may be mtpgratbdproximity to jack ll8 orpbntbr Id?;<x>mmdnicata with, other devices used for nuclear imaging procedures.. for example, a Ρ1ΙΓΓ seannetvcaiitertt, and/or for coupling to an intranet network, and/of to the irprnet, ibb example., to lmfc-;^.::wilh:::80iwme programs for various types of data analysis, and/or to llpk tp compmem of cossulfing clMciapsiphysicpM; and/or to link Imp service providers and/or component suppliers data bases for enhanced nudntemsncc and in ventory rnanagernen f.

FlpirelA hirthcrillusttites upper surface 131 of shell 13 including several openings 133,. 135, 139 formed therein. Figure 1C is a partially exploded perspective view of system 10, wherein a rembvabie accesspanel 132 is shown as a comourad porticn. of upper Mrfoee: 131, which, when e’^ppsed, ^jl^mgiivvW aPk that c tarot; therewith, may he removed from another opening Wf formed in upper surfoce 131. Figure 1C also provides a better %dew of atiother panel 134 which may be lifted away from opening 139. According to the illustrated embodiment, openings lev and 13 7 provide n user of system 10 with independent access to separate:|fortionB: of infusion system '1% which dtp contained within shell 13, tor example, to set hi and mamtath spiern ID; and openings 133 and 135 provide passageways for tubing lines to |.w&amp;s thtougit sltell 13, Figure 1C iurther illustrates an optional switch 102. widen in case of&amp;n erhorgency, maybe activated to abort limctioa of system 10. With reference to Figures 1A end 1C, h may be appreciated mat ran. arrangement of features formed in upper surface 131 of shell 13, in conjunction with bin lb, tray 16 and computer 1¾ provide a relatively ergohoptie ind^rgatdzed Work area for technical pefoOMel who pperatersystemi 10,.

Turning now to Figure 313,: a sohdffiidip of an mfdsupn eippitidOD, which they ho-ihmrpdrgfod by system ID, is shown.: Figure ID III>nitrates circuit 300 generally divided into a first part lODAywhibh includes components and a second pari 300BS wMcfombldti^Cbmp^en^pss^mh^ within the interior space surrounded by shell 13. (Parts 300A and 3ΐίίΒ arc delineated by dotted lines in Figure ID, | Figure ID further illustrates second part 3t)0B of circuit 300 including a portion contained within j shfoidipi psemhly 200, which tsdesij^ dashed line. Some embodiments of sMelding assembiy 206 will be described in greater deteih ih cerfomeiioa with Figures 2A-B and 3A-B, below.

Aeeording to 300 includes: an eluant reservoir i5, lor example., a bag, boule or other container, containing .saline as the eluant, which is shown hanging from a post, or hanger 141 above upper surface 131 of Shall 13 in Figure 1A; a syringe pump 33, for pumping the eluant from reservoir 15, and a pi >mutv· yvringe 34 ιοι vfter device or sensor), for monitoring pumping pressure, a filter 37. which may also serve as a bubble trap, for the pumped cluunu a radioisotope generator 21. through which the filtered eluant is. pumped to creates pdfoncuve emote, for example an eluato carrying Rubidium-82 that is generated by foe-decay of Strontium-SO, via elution, within a column of generator 21; and art activity detector 2;\ for measuring the activity of the ciu&amp;tc discharged from generator 2?, in order to provide feedback for directing the flow of the eiuate, via a divergence valve 35WP, either to a waste bottle 23 or through a patient line 30Sp, tor example, to inject a dose of the radiopharmaceutical eiuate into a patient. Wife reference back to Figure 1 A, patient line 305p is she*·a extending out from Midi 13, through opening .135, to a distal end thereof, which, according to some embodiments, includes a filter. Patient line 3Con may be coupled to another tine that includes a patient injection needle toot .shown?. AhumariViVv. p-bent .me 305r may -x ooupVi to auC'dmr one tmv- 'ho with Much extenls from a source of another active substance, for example, a stress agent; the other line is coupled to the line thwuteliides the patient injection needle, in order to permit injection of the additional; active substance.

Figure ID Siu^tiSrsaiMuMttiBhii^lfee^Ob'Siiapi^ m reservoir 15 and to pump 33, and, with reference to Figures t&amp;*l| it may be appreciated thad opening 133 pmvides the passageway for tubing line 301 to enter the interior space surrounded by shell 13. According to some pmluttid embpiments, openmg Inoliuelddes a imnitmet-type saal that prevents leakage of eluant, which may spill from feservoir 15, into trie interior space through opening 133, while allowing a uper to aspsmble tpbisg line 301 through opening 133. Likewiseppaumg for patient line 305p, may include a gromrtietHtypeseal. Aemrdmgmisome mubodunenfs, shell 13 further supports holders to safely bold, fbr examplm duung; transport of system 1¾ porrions of tubing Hues for example, line 301 dhd/or line 3i)5p,

Figure ID further illustrates anothereluaut tubing-tine 302 coupled to pump 33 and 8divergence valve ;|5BG5 which may eitbef Simet pumped eluant through a tubing lino 304, to generator 31,or direct the pumped eluant through a by-pass tubing ime 303, directly to patient line 305p. Divergence valve 35BG, ax well as divergence valve35WIF, which dlmets oluam hom au dluate tubing Hoe 305 either to a waste ime 305:W or to patient line 305p, may each be.-automatically operated by a corresppudmg senmmptor {«ptsbOw»), coupled to the controller (not shown) of system 10. which controller receives feedback from activity detector 35. When system 10 is operating ibr uutomatic infusion, to deliver a dose of radiopharmaceutical to a patient tor example, Rubidium-S2 for diagnostic Imaging, divergence valve 35BC m irnhahy set io direct Guam to generator 21 and divergence valve 35WP is set. to direct eiuate from generator kuo waste bottle. 23, nntil activity detector 25 detects the desired activity of the eUidtfc* at which time the feedback front activity detector 2d causes the controller to direct the corresponding servo-rootor to re-set valve 35 WP for diverting the flow of eluaie info patient line 305p. According to some embodiments, once a prescribed volume of the eluaie has passed through patient line 305p, the controller directs the corresponding servomotor to re-set divergence val ve 3580 for diverting the flow of eluant through by-pass line 303 and into patient, line 305p in order to flush, or push any eluaie remaining in patient line 305ρ πύο the patient. According to some embodiments, the controller may also direct the corresponding servomotor to re-set divergence valve 35WP back toward waste bottle 23, prior to the flush through ivy-pas! line 303, in order to prevent back flow of eluapiythrough, hoc 305, toward, generator 21. According, to some preferred methods of Operation, m certain situations, which will, be described in greater detail below, eluant is pumped through by-pass hue 303 •Immediately folknving the. flow of the proscribed volume of cloatc into patleni line 305p, at a higher speed, in order to push the eluate in patientdike 305, thereby increasing a flow rate of the injection ofshiate our fkun patient line 305p and into patient. For example, once the pteseribed; volume of eluate has flowed into patient line 30Sp, and once divergence vaIvs,35B<34^'S^;id- by-pass line 303, the speed of pump 53 may be ud|usted to idereasc ihe flow rate of eluant to between approximately ?0ml.-'min and approximately lQ0mL;min. This method far more&amp;sing tie injeebon folh' rate, is desirable, if a relatively high flow rate is desired for patient ngeetioo and a ftow rate through generator 21 is lh«i.ted, ibr example, to below approximately (t’ypical flow rate may be approxintatoiy SOmLhnin), in Φί&amp;ίύc&amp;pesssive backpressure created by ihe column of generator 2] in upstream ..portions· of iubiug circuit 300, the excessive back pressure could damage filt^^Toro^emd^mpOdbilbwtbrough eluant tubing line 30¾ Although not sfewmiu Figarre 11¾ a number of sensors, for example, to measure pressure and/or flow velocity, maybe incorporated into circuit 500, according to some alternate embodiments, in. order to monitor for iluw unomaiies, ibre-xpnple, related to oceiuklons/plugs in circuit 300 and/or leaks, and/or to provide feedback for control of an aeuvns levri of infused doses or 'udiopharmaceutical. Suitable sensors for any of the above purposes are known to those skilled in the art. Example! oi flow: nistemtluist may he incorporated into ciroutt pOO, include the butova-Some# Model 205 TrsrisiSxfiBie -Ultrasonic Liquid Flow Meter that employs digital signal processing. (available from Sierra lastnimeip, fee.) and die biocat LA10-C differentia? pressure .flow meter. Oik? example ©fa pressure sensor feat may be employed to detect ihfesion circuit mdmions Is ike PRD / PretfeoroCfeelusion Defector (available f|bm ΙΝΊκΟΪΕΚα,' ©t'Edgcwood, NY. a Grove,III), which employs pulse-type ultrasound; this sensor detects subtle changes ir. positive sad negative air pressure and produces a corresponding passive resistive output signal, which may be routed to the system controller and/or computer 1 L On or more of this type ofsensor may be iacorporaied into infusion circuit 300 by simply Sfepg tlfe sfersor atmtad anyof the febfeg lines of Inffefen fefeuit 300; in fact, theiPRD / ftessure-Ocolnsfen Dcfeefenmay be a soiabfe alternative to pressure syringe 34 of fefeuit 300, Other types of pressure sensors, for example·, simtipr U> tho# known in tke art for blood pressure momtoring, may be employed in infMlon oIrcufeoOO.

System 10 may flutber ineitfee Sensors^todetect flufe levels in «heard reservorr 15 and waste bottle 23. Soure examples of suehfetts^^ the febremenhooed pulse-type ultrasound, are the Drip CMfepler Libnuf Level Sensor arid the CU'> Continuous Level Detector (both avaifeblsij§i^..lNT^®pis^^;: Jtemaitvely, for example, an HPQ-T pipe mounted, self^pi^Ji^lI^pid··*^^· (available ihoxn Yuma take Sensing Control, Ltd. k or an SlybSO Non-fevsstv©

Disposabi«'Reuse,bie Level Switch (available from Cosense, fee. ofBauppaugs, NY) ntsv be employed to detect the fluid levels. AUcrnately or in addition, system 10 can Include additional radiation and/or moisture detectlOnsonsors, widen can: defect leaks. Who reference to Figure ID. such sensors am preferably located hr proximity to linings 311.312, 313. 314 and 3.13 that join portions of circuit 300 to one another. Sofee examples of leak dfeefeionseasors inclndo, wkhotfeiim^ m the WQ-D leak dfeefeion sensor defector (all; available System 10 may ffether include additional sensors fe defect eofeatninants and/or air bubbles within the tnfeng hpfe of cimuu; examples of such sensors include the Point-air Detection (PAD) Sensor, that employs pulse-ty^fel##soupid::ior afe bnlbfe detection, and the Blood tfethponerit Defector to p#lto.C^Atcirytepd:;:ipid· detection of nrtwafeed elenfefes in the tubfeglfees: (both available Irbfe IN I ROTFk Ay j&amp;ocording ιο those embodiment t^Jnsdudc any of the above sensors, (he sensors We linked into the controller of system 10 and.· or compeer '17- either of winch may promfe a signal to a user of system 10» when a flow anomaly is delected. and/or information to die user, via monitor 172, concerning fluid levels, pressure and or flow through circuit 300. Computer 17 nuty be pc-prOgrammcd to display, for example,on thonitor 172, a graphic of infusion circuit 300 whefeim^cht^one. of th§: an anomaly has be^;^t^^.j|;Mghiight©d, and/of to proyide gnfdance, to the system user, tor cormehngdhe anomaly. It should be noted that the alternative infusion circuits illni^tedin iigures 12A--B, which will be described below, may also mCindc any or all of these types of sensors.

With further reference to Pigp® ID, it may be appreciated &amp;at shielding assembly 200 encloses those portioasof circuit 300 fs^m'-wh)oh':iPife>a»l(iye xadWo» mw emanate, with the exception of that portion of pattern line 3tBp, which must assembly;200 in order to .be:'pdf|iied'to'-Ote..patii^Lh:lbP injection, or in order to be coupled to shielded sample vials, as will be described below. Thus, technical ptuonnel, who opemfe system 10, ap protected from radiation by shielding assembly 200, except at those times when mtinbisloh lsMhn#P^ejbr when quality control testa requim eoHectiomofeto During infusions and quality control test sample collection, all teOhnical personnel: are typically in another room, or otherwise distanced from system 10, in: rmdarfo avoid, exposure to radiation during die infusion, and, according to some preferred embodiments of the present indention, system 10 includes at least hue OmaM for fnfbtmmgaeehm^ that an infusion is about

With mfeenoe badh tOfilgures 1A and 1C, system 10 is shown including a pifeje^ri^.mohieipi'Oo/po.st 142, According to tlm illustrated emboditueut, projector 100* projects a light signal upward, for maxis&amp;pra·Ytstbili%%h.en pump 33 is pumping eluant and elution is tukiog place within generator 21, or at all times when: pump 33 is pumping eluant. Accus'd mg to some embodiments, the light signafpashes on and off when the eluato is being diverted from generator 21 brio waste bottle 3¾ and the light signal shines steadily when the ciuate is bemg diverted;thmugh patient, line 3(>5p, or visa versa. According to other embodiments, a prefeetor 100 shines a isg>n having a first c<vw t>» mu.C-.re that eloate is being diverted to waste bottle 2i, ;and then shines a light having a sseonde different color, to indicate that eiuuts is being directed ίο patient Ime 305p tor infusion. Eight projector I£H> may Mthef pnjeeia Ptore r spidi y Hushing light, for example, for approximatcly five seconds, once a peak bol us of radioactivity is detected in the eluaie, to provide further iuioonatior, to teeliiieal personae!, Alternative means of;informing technical personnel that an infusion is taking place may also be iseorpor&amp;ted by system 10. for exatdpie, including audible alarms or other types of visible or readable signals that arc apparent at a distance from system, including tn the control room.

If shouff be noted that, according to alternate embodiments, an ‘on board5 dose eaKbrater for quality control tests, and circuit 3t>0 is expanded to include elements for an automated eolleciiorr of eluate samples for activity measurements, via the on board dose calibrator. According to a first set of these alternate en.boc,ocnts, a sample collection reservoir is integrated into circuit 300, downstream of divergence valve 35WP and in communication with tubing line 303P, in order to receive qualify control test samples of eiitate., via tubing line 395P, mi both the reservoir and the dose calibrator are located in a separate shielded: well. According to a second set of these sitem&amp;ieemhodimcmtA: Vfetsie bottle^23 is cohfvgnred to receive tie quality control test samples of elpidm via tnbmg ltne 3 03¾ and a dose edllbratords integrated into shielding assembly 200. Quality control procedures will bd desetibed in greater detail below, in. conjunction with Ficnrcsb-bB,

When maintenance of system 10 requires the emptying waste bottle 23, relatively easy access to waste bottle 23 is provided through opening .139 in top surface 131 of shell 13. It should be noted that technical personnel am preferably trained to empty waste bottle 23 at times when the elnate, conihismimm 23, has decayedisufbciently to ensure that the radioactivity dferedf has felled below a threshold to: be safe. Opening .li3^p#fe^iy1(E^dd:-dt ah ete<- atiod of between appfexiPrsiely 2 feet sttd appfeximniely 3 feeg lbr eyarnple* opening 139 tn^y be at ;m oleyaion of approximately 24 inches, with respect to a lower surface of platform 113, or at M elevaiion of approxitnately 32 inches, with respect to a ground surface upon which wheels 121,122 rest. According to the illustrated^eml^ImiHii bpeuing 139 is accessed by lifting panel .134; just within opening '139, a shielded lid or do; >r 223 (Figure 2A) may be lifted away from a emnpartnient of shielding assembly 200 that contains waste bottle 23 Whir further reference to F.g,uc It', h muy >c impreoama in# Opening 137 movides access to order portions of circuit 300 tor additional maintentfoce procedures, such as changing pdf generator 2 i and/or oilier components of circuit 3IHh as .wilt be d vSC|i|c| ::ti#osgi

Ifortfeose embodiment':* of system 30 in which automated quality control tests are performed and/or when system 10 is employed for relatively high volume .^ratsoa^i^aagemeat of w'a^:::a*0i«become burdensome, even though access to waste bottle 23 is greatly foeltitsfod, as described above, ;1%u% In <sa#r to facilitate waste management, some embo&amp;^sbs of system TO may employ a separation system to separate salts, including fodloaetive element s, from water, for ex ample, via evaporation or reverse osmosis, in an evaporation type system, the water component of the waste ls evaporated, wink in a reverse esnfoli type system the water is sep^edi e«ge confirmed to be tionmfoioaerive, via a rachairon detector, is piped to adrdin. According fo some other embodiments. circuit 300 maybe c<ni%«n^.:^i&amp;aitfew^^-::may iron* foo tubing lines thereof aodfor to perform die bypss flash thm was described above, preferably ate ihc radioactivity oft be waste drops below a critical threshold.

Figures 1A .ud 1C Anther Uiustmte a pair of relatwolv shallow external recesses 190, which are formed in upper surface 131 of shell 1¾ for^esamp^r tn order to catch any spills from infusion system; one offeeefop ΓΌ is shown loeafctt id proximity to post, or hunger 141, which holds reservoir 15, and in proximity"^ opening 133, through which tubing line 301 passes. Another recess 192 is shown formed in upper surface 131; a width and depth of recess 192 muy accommodate simage of recheic.d documeniatioa associated wire utfusion system 10, for example, a technical manual and or maintenance records, or pritUonts frem ptntter 1 IT flupne IS). With reference to Figure K\ upper surface 131 ofshell !;Shlt^©W0tfo:Mm: include additional recesses 101, which are each sired to hold a shielded test v-ai, which contains samples from infusion system 10, teexnntp^®’ for foSidohrongh testing and/or calibration, which will be described in greater detail, below. Ah exemplary te^: vial shieldis shown in Figure I E, The test vial shield of Figure l E is preferably formed from Tungsten rather than lead, for example, to reduce exposure to lead, for improved shielding, and to redueethe weight shield. Figure IE if!|islrbpa foefost vial shield including a handle to simplify muni putation thereof, but alternative configurations of test vial shields have no handle - for these a sUag,:©r strap, may be employed tor handling.

Addition! receptacles ISO are shown. for· nod in bin >3. on either 'due· of a handle 182, which &amp;ilit8tes rernov'dl oi'fe 18 away from shell 13. Technical personnel may,.thus;*·ecmvtmfontly transp#bln 18 to a storage ate» for a collection of supplies, for example, sharps, gloves, tubing lines, etc..., into one or momreceptacles ! SO thereof, and· or to a waste container where separate reoepfoeles 1 'tO of bin may be emptied of waste, such as packaging for the aforementioned supplies, for example, Ispositeddherein iuriug mfhsiim procedures. According to some embodiments, one or more additional receptacles are formed in one or more disposal containers^ for es&amp;ffi|ie, to contain sharps and/or radioactive waste (otherilum that contained in waste bottle 23), wiieh may be integrated into liddB;! or otherwise fitted into, or «bached to shell 13, separate from bio 18.

Figure 2A is a perspective view of shielding assembly 200, according to some 'φ^-pt^mt pventiou. With reference to Figures 1C and 2A, together,, it may be appreciated thalopen^ 131 of shell 13, provides access to a lid or door 221 of a sidewall |p ofshielding: assembly p0f v#icl: sldewail 201 encloses a compartment sized to ccm^fe':» ra4i0isli^l gm^tor of system 10, for example, generator 21. previously mdobneoib alternate embodiments, the compartment enclosed by slbewaM:2i>l is large enough to hold more than one generator, for example, to tSerease system:operatingefficiency for relatively high sfobahe ogbmtfofo fe some of these alternate embodirnenis, tubing hncs 304 and 305 ape each bmpehed for parallel flo#:'^u.^femtiinplc generators, :i:n: wh|ch:case diyCfgeheCrvaives foay be employed to aiforsate the flow ihroggh thc generators, one at a time. Isothers of these al ternate emfo>dimettia, the foulhpte geberafors arc eoojreetod in series between ttfoing line 304land tubing line 30$. In mat be included in circuit 300, dowdpaam of the getmmdorsandupsnoam of divergence valve 35 WP, in eonjhmctibn with a second pump, in some cases. Embodiment* including multiple generators and/or an duate reservoir and second; pump can |e emplo>'ed ro better manage an acm,t>x.«e fenrdo λ ,\focm mje not an esairp e, ,s ce- ;r so j K lev, r conjunction with Figures I2A-B.

According to the brnbodimeht d 137 and door 221 am located at a lower elevation, for example, with respect to platform 113, than «reopening 139 and lid 22 A which provide access to the comparimest being formed by « sidewall 203 of .shielding assembly 200 to contain waste bottle 23, as previously described. Whet) panel 132 is separated from shell 13, and door 221 opened, generator 21 maybe lifted oih from an opening 231 |Figm®iMywMeS: mates with door 221 of sidewall 201. 3 weight of generator 21, which includes its own shielding, may he between approximately 23 and approximately 25 pounds, thus, according to some preferred embodiments of the .present ins option, the elevation oi each ot openings ϋ ? and 231, with respecttorho lowermost portion of the cabinet smnctu· c. v cotwee i approximately 1 fbot an# approximately 2 &amp;dihtate -an ergonomic stdp.ee tor tedmicai pcmnnel feiift generator 21 out from the compartment.

According to an exemplary embodiment* "when shielding assembly 200 is coMnided. to the cabinet structure of Figure 1A, openings 13? and 231 are located at an elevation of apnToximatciv 12 inches, with respect to the lower siuhaee ot piationn t i a, or at an elevation of approximately 19 inches, with respect to the aground surface upon which wheels 12:1,2:22 rest. Figure 1C further illustrates access-panel 132 including a security feck 138, which Mates with a framework 19 of system 10, shown in Figure 2B, in order to limit access to generator 21,,

Figures 1C and 2Λ further illustrate a Mm § door (Figure 3A) of shielding assembly 200, which encloses sniotiar eornpanmetU lhal is accessible through opening 137 of shell 13, and which is Ideated aujacenrihe compartment enclosed by sidewall 201. Each oi doors 2..:1, ec5 are shown being .umHipH h·,.··« mma^nding hinge H, shown attached to sidewall^wOlfey illustrates each of lid 223 and dbors 221, 22g 227 toclm&amp;i a handle 232.212, 2$2 md 272, respeemeh. foi moving Ud 223 and doors 221, 223, 227, in order to provide; access to the eofresponding compartments, which can fee seen in Figures 3A-t3. Hgure uA furtner nlnsmate» optional thumb screws 290, one securing lid 223 to sidewaa abn and another sect;: mg door 221 to sidewall 201, or other mPims lor securing the doors, winch: arc know» m thoseskiildd;:in die art, may be incorporated. Each sidewall cOl. 203. 205 and me forrespondidg Hd/door 223, 221,225,227 thereof may be individually cast from .W« antimony lead, prWM:ό#ρτ known shielding materials, and then assembled together iKvotdun m methods known to those ^kdied m the am

According to the illustrated embodiment, doors 22i, 33b arc hmggd lo oped to an upward directioimpen^towaDand-C, and, wun reverence »aek to $ gone 1C, a tpvl|!d each of doors 221,225 in an o peered position, thereby, preventing d0^4l2,J2S:;i$m failing closed, which eouMpncffcmsh fisgers of technical personae! and/or tubing lines of circuit 300, when ia tie midst of® maiiucnarxe procedure. Figaro 2B is a perspective view of framework 19 of dtp cabinet structure of system If), according to some embodiments, to which latch component )91 is mounted; Figure 2B includes an enlarged detailed view of later;, component 191, according to some embodiments. Figure 2B illustrates latch component 191 including a first pin 193, corresponding to door 225, and a second pin 195, correspond^ 193, 195 includes a levetpnd 193¾ IfSfl,

respectively, and a holding end I93B, 195B, respectively. An edge of each door 221, 225, upon open tog of doors 221,225. may push past die holding end 195B, .I95B of the corresponding pin 195, 193. in a first direction, per arrow F, and then may rest against a respective side Si:-5 and S93 of each end IW8, 193B. until the correspondmg lever end 195 A, 193A is rotated in a countsr~eloch's ise direction, perarrow do, thereby moving the corresponding holding end 193B, 195B closing of doors 221,225. Doors 225 being held by 193 in ns open position may be Men. in Figure 3A,

With fonhWMefbnee to some preferred embodiments of the present inventlom an edie of door 235 oveiaap tloor 221 to prevent door 221 bom being opened;per atmw 1¾ ¾door 225 id:not opeoed, per amow β; and an edge of door 227 ovcd^pi#t:^g0#;:^r::225':'to prevent door 225 front being opened if door 22" is not opened, per arrow B; and an edge oi hd 223 os eriaps doo; 227 to prevent door 2P born being opened if lid 223 'finis, add cphtdinutg lenefstor 2i >s ostlv systematical!;, allowed through a sequential opomngm hd 2„3 and aoors 25/. '225, 22.1, since, when generator 21 Is replaced it is typically desirable to also replace those portions o* circuit 30Q which are shielded ivund hd 223 ana doors 22/, 2c5. 1'he routing of these portions of circuit 300 will lie described m conjunction with Figures 3A-C.

Figure 3A is another perspective view of shielding assembly 20%:aecomfug to some embodiments of dip present invention. In Figure 3A, lid 223 and doors 221,225, :aud 227 are opened to provide a view into openings 233.. 2?h ana 23.1 of sidewalls 203, 205 and 201, respectively, and into a passageway 207, which is formed in opposite the eompiar{^^|;#iiCp#^6M tysstebottle 23. 2M is ste^-ii'fK^^^^erikaUy along sidewai! 203 and having a grooved cswnsion 2l3:fqnued in a perimeter surface of opening 233. Ait optional retaining member 237, for example, formed Horn, an elongate atrip of resilient plastic having a generally e-shape cross-section, is shown being mo anted along a length of passageway 207 to hold lines 305w and 305p in place within passageway 207. Figure 3A further illusfrates·§ pair of passageways 251 b and. 251 g, which are formed as grooves in a portion of sidewall 205, and another pair of passageways 2 i 5i and 215o, which are formed as grooves in a portion of sidewall 201. A routing of portions of tubing circuit 300 ptgnre IDs through passageways 207, 251 b, 251c, 215i and 215o is shown in Figure 38.

Figure 3B Illustrates tubing line 304 being routed through passageways 251 g-and 2151, eiuate tubing line 305 being routed through passageway 2.15ο,. and both, waste im-, 305¾ .cv p Uscu I no 3C5T> br.ng u < . u .dong passrtgew -.y 2Cr A aste line 305w further ex-ends through grooved extension 213 to waste bdMie 23, usd patient !isrci3;0Sp Asrther estenda oupiyard from shielding assembly 200, for ejthraffo out through opening 13:5:¾ .upper surface 131 of shell 13 (Figure IA|. AccpMipf db the illustrated etsbudlsrenh; each passageway former! in shielding assembly 200, by-being accessible along a length thereof, can fact! riV < At \ v λο * nun* o" s corresponding tubing line therethrough, when foe corresponding Ud/door is open, and a depth of each passageway prevents pinching andfor ortishiugiofthoeortespondiag tdbii% line touted therethrough, when the comeifodndmg Ed/dhof is ctoseddowii focreevei With further reference to Figures 3A-B, it may be appreciated that foe compartment formed by sidewall 201 may have a shape matehmgan exterior eontour of generator 21, such that generator 21 is ‘keyed" to the compartment, for example, to prevent installation of an improper generator into system 10, and/or vo facilitate the proper orientation oi generator 21 within the compartment for the proper routing of tubing hues. Alternately, or in addition, according io alternate embodiments, if system 1 communication with computer 17, an unique. w€lii'^E..^nets:fof,:Tnay be provided, for example, in a bar code label or a radlofosquenpy Identiricatkm (EFID > tag Umt is attached fo each generator, so that the reader may transfer the information to eotspuer 17s;whe^:-^a^#fi$|nstdled* in order to cither enable system operation onto provide an indication to the user that an incorrect generator has beets installed. Of course a user of system 10 may,alternately, mamially emerm&amp;HToatmmthat is provideii;« | |eoemtoriabel # marking, into computer 1 ?, in order to either enable •systew'l^ # |ρ: receive'.:feedfe#k from -computer 1? that the incorrect g aeratorid installed.

Figure 5 A further illustrates sidewall 205 including a valve actuator receptacle 253, isvfo which divergence valve 35WP i.s mounted, to he controlled by one of the servomotors (not shown s of system 10, and an opening 325 for activity detector 25. Activity detector 25 is mounted its a shielded well 255 that extends dbwhhysrd from opening 325 (shown in Figure 3B), and, wish reference to Figure 5B, miring hue 305 passes over opening 325 so that detector 25 can dc'.o s ass aviririlv cl the eiuate, winch passes therethrough According to souse embodiments, the positioning, within the companment enclosed by sidewall 205, of the components o f the portion of infusion circuit 300 which are shown routed therein* ,is?l^l|tat^%:F«>vidi«g the compoaeats Counted in a frame 59 as a disposable ..subassembly' 390¾ illustrated by Figures 3C-D.

Figure 3C is a perspective vig-w· 3D iha perspecti ve vie w of frame 3 A According to Figure 3D,

Dame 3<:> is formed from mating-trays 39Λ, 39B, for oxampl^..fgtn^.'M5n|#; thermofbrmed plastic, which fit together to capture, therebetween, htid hold, i.n frxel relation to a perimeter edge of Dame eluant tubing line 504, by-pass tobthg;::teiMl,:F!«a^ tuhjasg. tia# 3¾ and patient line 305p. Figure 3C iliushates the:perimeter edge dhrided^into a &amp;st sirie 391, a v.'coeo swie 592, opposite first side 391, &amp; third -^ie:393f;!60^atng;::jNtw^:: first and second sides 59 L 392, and

Although Figure 3D shows toys 39A. 39B mdivrddsd!yfcimedi-:%rgtD«g;fo^&amp;^ according to alternate embodiments, mating trays of frame 39 may be pads Of a; continuous ahem of plastic folded over on itself.

According to the illustrated embodiment, an end 404A, of eluam line 304, and an end 403, of by-pass Hue 303 extend from third side 393 of frame 39 to cripple with divergence valve 35BG and an upstream section, of eluant tubing bne 302. Figure 3G further illustrates an opposite end 404.B of eluant line extending iron* first side 391 of y , i 59 «e <, a muly extending end 405 of eluate line 305, anil on#4Q6jokI 40? of fv-tiem Uric 305ρ and waste line .>05sv, respectively, extending frcro .second Side 3y3 of frame 39 Although ends she, 40? are shown extending upward iron: tray 3S% as fney would w-thin shielding assent W _00, η shou'e oe arsnrer < a , ri t e tuning lines of circuit 300 are preferably flexible and would drop down.-under their owf weight rather than extending upward, as shown, if not supported. Htdernug haokdp Figure 1D. in conjunction with Figure 5C„ it can be seen that fittings are provided tor coupling «subassembly 390 Into circuit 300: first titling 311 couples the section, of eluant line 302 to filter 37; second fitting 3.12 couples eluant line 304 to an inlet port or generator 21; third fitting 313, which may incorporate a cheek valve, couples eiuate line 305 to an outlet pod of generator 21; ffilnth Shihg 314 couples wa^te line 305w to waste bottle 23; and· fifth fitting 305p to an extension thereof, which extends vouMle shell 13 (designated by the dotted line). Each of One fitrings 311, 312,313,314, 315 may be of the Loer typCjinay be a ty*v vm »Kc fo. -xhunely high pressure application*, or maybe any other ssitafele type that Is known to those sallied indie art. •As previously mentioned, when generator 2.1 is replaced, it is typically desirable to also replace those portions of circuit 300 which are shielded behind hd 223 and doors .127f 22:5, and. In those instances wherein system 10 is moved to a new slthieaeh day, these portions may be replaced daily. Thus, according to the dlustrated embodiment, these portions are conveniently hold together by frame 39, as subassembly 390, in order to facilitate relatively .speedy removal and replacement, while assuring a proper assembly orientation, via registration with features formed, iu Mdvswu 295 -i :re -5 \h to ample ?e. λ,ι nor o' duel gone* w '> r '-WPwnh· valve actuator receptacle 253, registration of tubing line ends 403 ana 404A Mtn passageways 251b and 25 ig, respectively, registration of tubing line ends 41)4B and 405 with ....passageways 2151 and 2l5o, respectively, and registration o.i tubing hoe ends 406 ami 407 with passageway 207.

With further reference to Figure 3B, other portions of tubing crremi 300 are shown. Figure 3B uhisirstes eluant tubing line 301 extending ifooi reservoir 15, cut d, tn * .< h ' i r i u elW o^yuraepn tp 3 h wh\J w * o >,i. o an actuating platform 433. According to the illustrated embodiment, platform 4.33 is actuated by another servomotor fool shown.; of system 10. which is controlled by the controller and computer 17 of system 10, to c tusc a p n tgsr of pump 3¾ v nose, per·· arrow 1, ®o as to draw is eluant from reservoir 15, itough iubisg line 30!, and then to cause the phmger to move in the oppostte::^^&amp;>»::S®i:iSS te;jpmp fc4wi: 302, to either generator 21 or to by-pass Mbs 303, Although the illustrated embodiment includes syringe pump333o&amp;^':^t^l©:'pbm|^ known to those skilled •in the art, muyM substituted for pump 33, in order to draw eluant from .reservoir Id and te fmnp the entem throughout circuit 300, Although not shown, it should be appreciated that divergence valve 35BG is fitted into another valve actuating receptacle mounted within shell 13 andieoupled to yet another servomotor (not Shown) of system 10,

Fllpire 3iB further linsttates a filter holder 3! 7 that is mounted alongside an mtendr surface of shell 13 to hold filter 3? figure ID1 of tubing line 302, Filter holder 317, like frame 39 for subassembly 390, may be plastle sheet; holder 317 may have a clam-shell structure to enclose filter 3? tn an interior spues; yet allow fobiaglme 302, on either side of filter 37, to extend out from dm interior spade, In between opposing sides ofthe clam-shell structure. Holder 317 is shown including an appendage307 fc hahgfog holder 317 fiom a strsetum (not sh-'un) in,--tec sh::! 1?

Turning now' to operation ofsystem 10 willbbds8£fibe&amp; aceordmg: W some smbddimehts ofthe present invention:, A^prdVfi|^y-mih^dtt#».:iuidr'wilh raferettee back to Figure 1 A, computer 1? of system 10 includsi momfor 172, which, preferably, hot Only displays iudioations of system opet mion to inform a user <>fs>stem 10, but is also configured as a touch semen to· receive input from the user. It should be tmderstood that com peter 1:7 is coupled id the controller of system 10, which may be mounted within the interior spueeteurteunded by shell 13; Although Figure FA shows computer 17 mounted to 142 of sptem 10, for di rect hardwiring to the controller of system 10, according to some alternate embodiments, computer .17 is coupled to the controller'via a fietebie lead that allows computer 17 to be positioned somewhat remotely from those pMkrns of system 10, fiom which radioactive radiation may emanate; or, according to some other embodiments, 7% Mirelessly cspdpl^klbi#iample, via two-way iotemshryy.fodhe opntrdS^of ^afbmlQ, for even greater flexibility in positioning 10 may bo monitored and controlled remotely, away from radioactive radiation. teeming to some preferred embodiments, computer 1? h pre-programmed tbf guide lithe user, via monitor 1 '2, u cough procedures necessary to maintain system Iff: ttvpndorm quality control to operate system 10 Ibr patient mfessohsyuswei Mto interact with the user, vis the touch-scree® capability of monitor 172, according to preferred embodiments, in order to track volumes of eluinf andduaie contained within system. 10, to track a time from;eornpletion of each elution fi^ormed by system 10, to calculate one or more system pirameters lor the qr-aliry M&amp;irot tests, and to pcrfcn various data operations. Cioppufer !7 may also be pre* programmed to isletaefc with the controller of system if) in order to keep a running tally of countof ehaidns per unit time, for a given; generator employed by the system, and may further categorize each of the counted elutions, for example, as bemg generated either as a sample, lot quality control testing, or as a dose, for patient injection. The elation couut and categorization, along with roeasmemeuts ma.de on. each sample or dose, lor example, activity level, volume, flew rate, etc....., may he maintained iu a stored record on computer 171 All or a portion of this stored, infbtmairou ouftbe compiled in areppit, to he prtnted iocply., andfor ad be detnronkuUy transferred *o a reHtoidlbcaiionylbr to technical support personnel, suppliers, service providers, etc..., as previously described. Compote· 17 may furtber interact with the user andor a reader of encoded informative Ibr example,bar code reader or axadldirequency identUaeation {RFID) tag readm. to store and organize product inforntaiiodieoliected front a product iahets/iaip,thereby htcihtatlug inyeptpry cohtroh andfof eoa&amp;mmgihat the proper components, f or example, of the t#lug being used in the system. it should he tmdsmiood in nature endurepresented to provide an outline of some rpethods or the present invention in. which computer 17 procedures, without; limiting the scope of the invention to any pirtieniar computer interlace format Computer 17 may also include; s proitropammed user manual, which may be viewed ou monitor 172, either independent of system operation ox in conjunction with system operation, for e.vamplc. via pop up help screens. Although the Bngtish language m employed in the screen shots of Figures 4-9C, it should bo understood thuf, uceorosng foisotue embedments:, eop^utqplf is pre-pmgramiped to provide rntdipie languages.

Figure ·) is a screen shot of a main menu 4?Q, vvhieh is presented by computer i ? on. monitor i 72, according so some embodiments. Main menu -470 includes a listing of each computer-facilitated operation shat may be selected by the user, once the user has logged on. According to some multi-lingual embodiments, computer If presents a list of languages from which the user may select, prior to presenting main menu 470.

Figure a A is a schematic showmg a.,scries of screen shots which includes a log Is screen 570. According^fo sometouch-selects the data entry fields of screen 5?§ dr 571» M of any of the: other setcenB preseossd herein» below, a virtnal keyboard Is displayed for tonch~seie<t data entry isrto tbs setectei data entry field; aitorindely» computer 17 may be augmented with SSother type of device for of which include, ydf^ot ianitaidfo a peripheral keyboard device» a storage niedfom (i.e. disk) reader, a .scanner, a bar code reader (or other readerof encoded informat ion), a hand control (i.e. mouse, joy stick, etc...). ^rno.^^to^^scpecii· 570 may foriher jsdldde another data entry field in which the user is requiredto;enter a license ligy related fo the generator employed by system 10 in order to ICk the key may be time sensitive, related *o generator comrachtemts. Of course any number of log in ret|-uirc;ttj6e^Qi«;according be presented on nfoltiplbiseqdshttidiy appearingiSerecnb rafoer thaufon e singlbfog in screen.

Alter the user entersrihefappmpriat|;:m&amp;rrnarion into data entry fields of log in. screen 570, computer 17 presents a request for the user to confirm the volume of eluant that is within wservoir IS (e.g, saline in saline bug), via a screen 571, and then bring»· up main menu 470. if the user determines that the volume of eluant/saline is insufficient, the user selects a menu item 573, to replace the saline beg, if system 10 includes an encoded information reader, such as a bar code or BIFID tag reader, confirm mien that tire selected reservoir is proper, i)e.containstide proper saline solution, may be carried out by computer if, prior;fo cohnoming flierescrvon· into circuit 300» by processing information to the reservoir. i^^mariydi^::pr'-|7 addition, tubing line 301 of circuit 300 may be provided with a connector the rrvpcr type of reservoir 13, to 80¾¾¾^ embodiments, isystem 10 may:feriher isclii#:ii|:^|fiio1M^':i)r chargeldeiebmr, w'lueb: is located jusi lipyjlrsiffi of reservoir 15 and is linked to computer 77, so that an error messsp may be presented on monitor 172 stating that the wrong osmoiariiy or charge is deteetedin dte:Aanta!^Kbd::%::»isemir, indicting an Improper soMob, On e example of a charge detector ta by system dd is tie SciOo#^

Conductivity Sensor (available from SciLog* fee, of Middleton. Wf).

Qpce the reservoir/soline bag is successfeHy replaced» compmer 1? prompikfhe user to emer a quantity of .saline contained by the new saline bag, via a screen 574. Alternatety, if system 10 inefedes rho aforementioned reader, and the saline ban includes a tag by which volume information is provided, the reader may amomailealiy transfer the quantity information to computer 17, Thus, computer 1" uses either the. confirmed duanf/saline volume, via screen 571, or the hewly Mt^bdieitiaaiKs^litBe volume as a baseline from which to track depletion of reservoir volume, via aedvstions of pump 33, in the operation of system 10. With reference to Figure SIS, during the operation of system 10, whepeomputer l”? detects that the has been depleted to a !7 %ps ilte useri via a screen 5 7 7. if the userhas disregarded screen W7and·#ϋ^; saline bag, computer 17 detects when ,tibe:^he:"bag.:»s of the same to the uspf via a defeen 578. To replemsh the resemur/sahne bag, the user may either refill the reservoiribag orpepiace the empty reservonfhag with a mil mservolrfeag. According to some embodiments, system 10 automaiicdily pedludes any fhrfeer operation of the .system until the reservoir is replenished. Itshpld fee noted that, as previously mentioned, system 10 can include a fluid level senaottemtpled to fed: ehiant reservoir in order to detect when the level of saline drops below a certain level.

In addition to tracking the volume of eluant in reservoir 15, computer Π also tracks a volume of the etuate which is discharged from generator 21 into waste bottle 23, With reference to Figure 5C an item 583 is provided in main menu 470, to be 'selected by ho ^h? . the on * empire, v stebodeSi, w hi ' f e use* ό ν«ί uem 583, computer 17 presents a screen 584. by which the user may effectively eomtMnd computer 17 ίο set a waste bottle level indioator tp zero, once ihe user has emptied wastefefete 23, 'Typically, the user, when powering up system 10 for operation, each day, tyil;:#^ 23, or confirm that waste bottle 23 was emptied at :.1¾¾¾..* day, and utilize sereehf S4 to sot the waste bottle ted iaiteatof to zero, of waste bottle 23 via feooifetfeg of fee©pemtloo oF|^^ 33 arid divergence val ve 35WP, arid provide an. teteiiort be emptied, te example, vis presentation of .screen 5M, in order to wan» ihirasfer th%,unl^sr^ipiie4 the waste bottle will overflow. According to some embodiments, system 10 atnomurfiealiy |pi*$feides.mf '&amp;ft&amp;e®:#peraticaa of the system until the waste bottle is emptied. According· to: soins alem^yeiiemboditrtents, a fluid level sensor may be coupled to bottle».:fera®"«®e*ii6tied above to conjunction wife Figure ID, ·τ· oter tp automatically defect when waste bottle is Filled to a predetermined ted and to provide, via cotBpitet .1?» an indication to te nser feat waste bottle :23 needs fe be ^^feed:.®^oi^%til&amp;feati'cally preclude operation of spite ll0wtte^#e:Wi^5beitfe is emptied.

In addition to the above tefeteadee steps mlafedto #h^::dnd:d^fe^htfees: of system 10, fee user of system 10 will typically perform quality control tests each day. prior to any patient infestons, methods, prior to performing the quality control tests (outlined fe conjunction wife Figures 7-3.-0 and 8Λ-8), the user may select an item 67? tern maidtenn 470. m order to direct system 10 to wash the eoimnu of generator 21, During the generator column wa§|y winch is performed by pumping « predetermined volume of eiuatfefor example, approximately :;0 milliliters, through generator 21 and into waste bottle 2¾ computer 17 provides an indication, via a screen. 676» feat the wash is m progress.

Also, during the generator column wash, fee system may preside a signal to indicate that eluatc b being diverted u» waste bottle 23, for example, light projector 100 (Fiftire 1C1 may project a ilaahfeg lign· .signal, as previously described.

Figure 6 further Illustrates a screen 677, which is presented by computer 17 upon completion of the Column wash, and which provides aniudiefeionef a time lapse since the completion of fee wash, in terms of a tete coufedowu, until smfesequefe elution process may be effectively carried out. While screen 67? is displayed, system H) may be reipfeg, from reservoir 15, pump 33,which has a capacity of approximately 55 tnilliliiers, aeeordfeg to some embodiments. According to some preferred embodiments of feei present invention, computer i7 starts a timer once any elntiiM process is completed and informs the user of the time lapse, either in terms of the ime countdown {screen 677h or in terms of a time from completion of the elution, for example, m will he described in conjunction, with Figure IB. Recording to an exempiaj^smbodlmei^ whemmgenemiorSl&amp;fc that fields a saline soinifos of fobtdittm -83:, prodpeed by the decay of Sh oe dum-82, via the elution, a tlrire required between όνο effective elation processes is approximately 10 mi mites .

Once the appropriate amount of time has lapsed» after the elution process of gepemtor column wash, a first quality control test may he performed. With relenaice to Figure ?A, the-user may select, from. main, menu 470, an item 773A, which directs computer 17 to begin a .sequeTtee for We^duough testing. According to some embodiments, in conjunction with the seleetlea of item 773 A, the user attaches a needle to an end of patient line adSpand inserts &amp; needle into collection of an eluafe .sample i? presents a screen 774, which instructs the user to Insert the teat vial into a vial shield, which may 10.1 ofshell 13 (Figure 1C).

Figure 7A farther illustraies a subsequdnihepen^7?S,jhy which compute? 17 teeeives input. from die user, fi>f systeni 10 to start the breakthrough elution, followed by a screen '.»70, which provides both ssindicarion that the elution is in progress and art option tin' the user to abort die etsiion. Aspreviot-sly described, the system may provide a signal to indicate that elution Is in progress, tor example, tight projector 1W (S-,.^ v tv mas pm ,u . hush, L.nt ouiU dunce d - p «no > ofiK <n process when elupe is diverted from generate 21 through waSteHne |iSw and info a steady light signal during that portion of the eiuhod prpeess when the eluateds;divertedftem generator 21 thmu^ppient line 305p and mtoitbe test: vdul, .for example, once activity detector 2S detects a dose rate of approximately 1,0 mCi/sec in die eluate discharged from generator 21 Another type oflight signal, for example, the ruche rapidly flashing light, as previously described, may be projected iwhen ijpeak bolus of rsdioadtlvity is detected in the eluate.

Up<m completion of the elution ptripp tor breakthrough testing, computer 17 presents a screen 777, shown in Figure ?B, which, like screen 677, provides an indicAfi!pfe#C^S^e;v|^^sh^^©.oompletion of the elution, but now in terms of a time since completion, of the breakthrough elution process. When tltc user transfers ;.he via! containing the sample of duatc into a dose calibrator to measure' the activity of the sample, the user roa> make a note of the ome lapse indicated on screen 7~". With further reference to Figure 78, once the user has received the active}, measure from the dose calibrator, the user proceeds to a screen 7 which: includes data entry fields for the activity measure and the time between that at which the dose calibrator measured the acti vity of the sample and that at which the ehttion was completed. tire user may enter the data via the touch -screen interface of monitor 172, or via arty of the other aforementioned devices for user data entry. Aeebihixtg to some alternate etnbodhncnts, computer 17 may receive the data, electronicaly» ppm the drip: eahbmtor, either via wireless communication or a cable cohopdotl;

Aiier the: data is enteredby the user} computer 17 presents screen 779. from which the user moves bach to main menu 470 to perform a system calibration, for v\am?!c, as v. 11 K described in conjunction with Figures 8A~B, although the breakihrough testing is not completed. With reference back re Figure 7Λ, an stem 773B is shown, somewhat faded, in main 'Miaou 470; item 7738 may only be effectively selected following the completion of steps for item 773Λ, so as to perform a second s; age of breakthrough testing. In the second stage, the breakthrough of the sample ofehtats: collected: :¾ testing is measured, at a time: of apptoxtmately 60 xnimnes from rite completion of the elution that prodneedthe sample. With mferegceio'^tg^7^:.^^:-ibet«ser:h^7soiecied' Mem: 773B horn, main menu 470, in order to direct computer 17 to provide breakthrough test resiats, a screed 7|| is displayed, SdreeU 781 1?^ the user in semen 778, along with another pair of dapieeiry FcMb is instructed to enter tire breakthrough reading of the sample at 60 niiaptes and the back radiation reading, respective!}'. After the user enters this remaining mfornn-tiion, as described above, computer 57 may calculate and thou display, on a semen 782. the Peafobrough teal results, According to the illustrated. embodiment, computer 17 also displays on semen 782 prorprogrorumed allowable, limits for the verily that the breakthrough test results are in eotnphanoc with ieceptahle iimliS} before moving on to a patient iufitslon. According to some embridimeots, system 18 will not allow an infusion if the results eheeed the acceptable Knciv uni tnuy present a screen explaining that the results are outside the acceptable

Iteits; Si<? screen mayfurther direct the user to eomaetthe generator supplier, lor example, to order a replacmnsp generator.

With reference to Figure 8A, during the aforementioned 60 minute tiindperiOd, while waiting to complete the breakthrough testing, the user may perform calibration by selecting item it 73 from main menu 470. Upon selection. of item 873, computer 17 presents a .screen 874,. which instructs the user to insert a new test vial into an elution vial shield. In addition to placing the vial In the shield, the user, preferably, replaces patient line 305p with a new patient line, and then attaches a needle to the end of the new patient hne tor insertion into thehesf:#ai, ip order to collect an eluate sample therefrom. Affer performing these steps, the user may move to screen §75, wherein a plurality of data entry fields are presented; all or some of the fields maybe filled in with pre-programmed default parameters, which the user has an option, to change, if necessary Once the user confirms entry of desired parameters for the calibration, the user may cuter a command, via interaction with a subsequent screen 876, to start the calihralionmhttiop;;

With reicrencc to Figure SBglftey edppatp l^siarls tlre?e|ufid!t pfocessga screed Sfanforots the user that the ealifeafionselution Islte option to abort the elution. AsprcvPusiy m indication brat ebtion is in progress, fer-example,·light projector lQ0 (Figure 10} may project a Hashing light signal during that ppsiou of^thesolution ptme^ when biuata-Is ip^edilPtn generator 21 through waste line 30Sw and Into waste bottle 23, and then a steady light siptal during that portion of the elution process when activity delector 25 has detected that a prescribed dose rate threshold is reached, tor example, I. .0 :m€i/sec,;aud the eiuate is being diverted from generator 21, through tire ttiw patient line, and: into the test vial . Another typo of light signal, :|<>r i^s;bre:. flashiaglighi, as previously described. may he projected whenape&amp;k bolus of radtoaetivity is detected in the el uate. Upon completion of the elution process %r eaiibrmion, computer 17 presents a screen 878, which provides an indication of a time lapse since, the- completionof the elution, in terms of of the calibration elution process. When the user transfers the vial containing the sample of eiuate into the dose calibrator, to measure the acti vity of the sample, the user may make a note of the time lapse indicated Pi screen 878. With further reference to lugttrs 88, once the usephas received the activity theasttre from. the dose calibmtqr, the user proceeds u> a screen 879, which includes data entry tie ids tor the activity measure and the Otpe, with respect to the completion of elution, at which the Jose calibrator meusumdldhe activity of the sample. Once the dinars input by the user, as desenbed above, computer calculates a calibration coefficient., or ratio, and presents the ratio on a sereen S8Q. According to Figure IB, screen 8¾ further provides no indication of a desirnble range -for the calibrationttiio anti presanmiM option for the user to re|eei the calculatfsi ratios in which bas% tbs user may instruct computer 17 to recaicolate the ratio.

As previously mentioned, some alternate embodiments of the present invention in.ch.tde an on hoMd doM caiihmtor so that the entire sequence of sample collection aafealchiaBo.ao^tepSviwhich.i^.d^nbsd.^Ovei in conjunction tvith Figures 6-&amp;B, tor die quality control gpcedures, Pray be automated. preferably induces screen shots, similar' to Anne of those described above, which, provide a user of the system with inlorutatipu at various stages over the course ot the automated procedure and that provide the user #ith ppppriomties to modify, override and/or abort one or more steps in the procedure. Regardless of the embodiment (i.e. whether syaLain .10 employs an on board dose calibrator or not), computer 17 may further collect all quality couhrilltest parameters:and;t«sults info a stored record and/or; compile a report including altor isomc oftheps^^m.imid-Tesul^fbr local prim out aud/or electronic transfer to a remote local ion.

With retcrehee to Figure 9 A, upon completroh of the: Aiwe-deseribcd quality eontred tests, the user may select air item 97 i, from main menu 470, in order h> direct system .10 to begma procedure for the generation and automatic infusion of a rldioplmrmaqeutieal into a patient As prevfonsly described, system 10 infeses the patient with the radiopharrnaceuiical so that nuclear diaynoshhinmgmgcquipmcnt, tor images of an organ of the patient, which absorbs the mdibphnrmaceuticulevia^^detection of radibactive mdlation. therefrom. According to frigtire OA, upon selection of hsm::f7|#cm^ 17 presents a screen 972 which includes a data entry held for a pat Lent ideal iftcatiai number. This ideruincadon number that is entered by dm user Is retained by computer 17, in coh|unctiOn with the petti aetn system parameters associated with the pact’s infusion. Ah#tbq;uscr enters the pabetu identification number computer 17 directs, per a screen 973, the hser to attach a skw patient line and to purge the patient line of air. A subsequent screen 974 presented by computer 1? includes data entry iieid$ by which the user may establish parameters for the automatic infusion: all or some of the fields maVfee filled in with pre-prognunmed default parameters, winch the user has an option ίο change, if peeessar y

With reference to Figure 98, if pump 33 does not eootaln enough eluant'saline. for the patient infusion, computer n:Av^lp^eo^wumti^y^U':«,sem^;:90is'wM!^ includes an option for the user to direct the refilling of pump 33s via a subsequent screen 902, Once pump 33 has been filled, computer 17 presents an indication to flip user, vd» a screen 903. According to some embodiments, if the user does ηο|:ί®··δ|Ι pump 33, yet attempts to pfoceed with an infusion, system 10 will preclude the to the user that up Iniusiori is possible, if the pump is not refilled, and asking theuser to refill the pump, .as in screen 901 When pump 33 contains a sufficient volume of eluant for the padept infusion, computer 17 presents a screen-975,which is shown in Figdre9C, imd allows tbe user to: enter a10 to start the patient infusion. During the infusion, eom'pptur 17 f foyides: the user with an indication that the infusion is in process and with a option |pr the user to abort the Infusion, via a screen 976. As previously described, the system may provide an indication that an elution is in progress, for \Mtrpe , _ i "os uo 10U 'F'gu.c ’ C1 o< ·, ο-ορχ' i fias, u i * -mu uf portion of the elution process when eluaie is diverted from generator 21 through waste Hue 305w and into waste 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, tor example, 1.0 mO sec. and the el see 'S being Jivetoed from generator 21, through *he new patient line for infusion Into the patient. Another type of light signal, for example, the more rapidly flashing light, previously described, may be projected when a peak bolus of radioactivity is detected in the eluatc. At the completion of the infusion, a screen 977 is displayed by computer .1 ? to inform the user of the completion of the infusion and &amp; rime since five completion. Computer 17 also di splay cviastrmmary of the infusion, per screen 978. W'ith further reference to Figure 9€. screen 976 slmvs art exemplary aptigity profile (activity - m€I/sec, on y-axis, versus time -- see, on x-axis) for the iefasiorgripetoed dose (designated between the two vertical lines). Those skilled in the art will appreciate that the shape-of this profile depends upon the infusion fipw rittp, fora ^veav^liMieorthc dose. which flow rate {.\ eouts oiled, fur example, by the Spoilt flow through the pattern line, ani upon the «mount oi $tre#tum^,:^ipsdsm|| in the gettmtcKy ;fe the absence of flow rate control, activity profiles may change over hie life of the generator. Furthermore, the peak bolus of radioactivity, particularly lor injected doses from a relatively new generator., may exceed a saturation level of the imaging equipment, i.e, PUT scanner. According to some preferred methods of tire present invention, in order to maintain relatively consist cm. and desbabie/effeenve, activity profiles for patient injections, over the life of the generator, tire operating speed of pump 33 may be 'varied (both over the course of a single injection and iron? injection to injection), according to feedback morn activity detector 25. Such a method may he intpiernemed via incorporation of another quality control test in which pump 33 is operated ίο generaior at a constant rate, in order to collect. into computer, a pfoia^::of;ia^'Vi^: meaeemetrtk front activity detectot· 35; the plurality of measuTements ipppriSO a chamctedstlei dr basdioe activity profile from which the computer 17 may calculate an appropriate fow rate prof ic to eonsroi a-peed;#i|p^p-33f.m. order to achieve the desirable/eilective activity profile. in general, at the startsof pnet^or life, when Strotitium-82 is plentiful, the pump is couitoled to drivsinfosipn flow- at relatively lower rates, and, then, toward the end of generator life, when much of the Strontium--82 has been depleted, the pump is controlled to drive infusion flow ut relatively higher rates. As v as described above, in conjunction with Figure 1D. if a desired infusion, injection flow rate is relatively high, that is, high enough φ preate too much back pressure. via flow through the column of generator 21. by-pass lino 303 may be cmployed ihy adjusting divergence valve 35BG to divert a flow- of eluant therethrough vdiumeat a lower flow rate. Aceording to this method, cnee a doseiof eloaie, from generate* 3 \ , has flowed into pahentlihe 30ip, diverpnee valve 358G is set to divert the flow of eluant through bypass Mite 303, and then pump .^^;tsdn<ai^s^:-lhv]ph?np ehtanr at a higher flow ram in out from patient line 305p, for injection at the higher How rate.

Consistohby'df'dcdvit^'ptoflldli^^ag.'m^irt'ed doses ean greatly facilitate;the use of PET scanning for the qiunitihcation of flow, for example, in coronary perfusion shtdies, Altetpiiitto infusion circuit etmligurattoo-*, operable acvomny to ally; at' < methods, ttpipbtpvp-eqpgpfbley -of activity profiles among injected doses, a$ well as a more uniform level of jfdi|activify scon* c<uh trdmdua cfovs, w ^ X· dcvcnfvd' below, in coipmction with bigures 12A-C:

Printer 1X7 (Fibres! B) may be activated. to print oat a. hard copy of the mfe?oa«ma®ry, on which the patient identification number and pertinent infusion and system p^rsmciers mc ^ pmmd, for roforettec, Altemailvely, or Ipaddition, according to some embodtm^{ssAi^my»y may be dowfoadsd oido o eompaier readable storage device to be electronically transferred to one or more remote computers and/or the summary may be automatic-ally transfcnbitto the one or more remofe iootfotoni, via wireless communication or a cable cormectida, for example» over an intranet network and/or the internet. in order to protect pnyate p^Mt information,tteiles. may be encrypted for transmission over the internet. The one or more remote computers may be included, .forexan^fo^ln:a:lc«plfM::Mfomtation· ^temg»nd7or a-bi-^j^i^t^xanaforin a «iedkal imaging system, lufosion parameters, for example* corresponding to the activity profile, may also be boiltsited and ol^tibolcally transferred for analysis in conjunction with capmred images, for example, m brdbr^ coronary flow, via asofiwaro package that is loaded into a system that, includes the PET scanner. -§A the user may select an menu 470. in order have system 10 perform data operations, such as, archiving a data base of patient infusion information and quality control test resalts, transmitting p„ r , ro usar -'Cirm.ii) τ,ο.α- ο ί Mi ,n ό \ ot^ge dc' - i Vi-rano o -- o" data 'ihenng. for example, aecosding a date ranges and-br panent identification numbers. for example, to search fora particular set of data armor to compile a summary report of related sets of data. Additionally, certain information, which is collected by computer .17 over the course of system operation, and which defines system operation, may be transmitted to a local or remote computerised invemory system and/or to computers of technical support personnel, maintenance/service providers and/or suppliers of infusion circuit elements·· components, thereby facilitating more off,·, or a\ ,? opera* a\ n)i'> en„ ce.

Turning now to Figure .10. au item 98! for computer-facilitated purging of the tubing lines of system 10 is shown included in main menu 470. When a user selects item %i, computer 17 guides the user to select either ao air purge or a sauna purge. The direction provided by computer 17 is not explicitly laid out herein, for a saline iipuigl, -safiae purging should be read ,l> apruwm m those skrivd tr the art, with reference to the sebemltlc oftahtsion circuit 3(10 shown in Figure ID· A Mline purge of circuit 300 is desired to assure that all the air is removed imm citwud 300 when, a new generator aadfor anew complete or partial tubing set is installed. .An air purge of the tubing lines of circuit 300 may be performed alter removing reservoir 15, by-passing generator 21, by conneotin g tubing line 304 to tubing line 305, and coupling patient line 305p to a vial, for example, as is directed by the computer interface, hi screens 4S5 and 9b 1 shown in Figure 10, The air purge is desirable for blowing out the iuhiu|: lines, thereby removing all remaining eluant and eluate, prior to installing a new generator anchor prior to transporting system 10 from one site to andiier. If generator 21 is not depleted and will be used in system 10 at the new- site,it is important, to by-pass the generator prior to purging the tubing lines of circuit 300 with air, so that air is no- blown across the generator, since air through generator 21 tti»y ebmpsmmtse bolfefhe function and the asepifepthure of generator 21.

Aceordmg to preferred embodiments, the iustnietions pmsenteddnscreens for example. via screen 9¾ computer to carry out a complete air purge, in which pump 33 and aeiooinrically cppttplied. The automated steps, which may be best understood whth reShodee to tulihg circuit 300 in Figure 1Ϊ>: pumping any remaining volume 3-3> through lines 302, 304, 305 and 305 w, to waste bottle 23; refilling pump 33 with air and pumping the atr through lines 302, 304,305 and 505w, into waste bottle 23 (linhhldd and 305 have beep previous y connected directly to one another, in order to by-pass genemtdr 2ft .if generator 21 is depleted and will be replaced with a new geoerafor, pnmpiag dif throe git- generator 21 may be acceptable); refilling pump 33 wlih nlrandltfeen: pumping a portion of the air through lines 502, 304, 305 end 305p, into the vial and then a renmining portion of the air through boos 502, 30 h and -t'^p, run the \ \n. \V;*h reference lo Figure ID and the previous description of divergence valves 35BO, 35 WP, it should be understood how divergence val ves 35BG, 35WF are autoraadmily c^ntro’led to carry out the above steps.

The purge operations, which are mcilitutcd by selecting hem· 9FI from main niean dTO, may also be accessed via the selection of an item 991 iiu generator,setup,

When the user selects item 99 L comparer 17 may present an option for guidance in removing an old, depleted, generator andiih setdf hihing lih% prior to inhiilling the new generator, or an option to just be guided in the ixt|^ilati^::of gen'opte,

Jfoeortfegfo smneer^ is pre-prcigrarnmed to calculate an amount of activity left in a depleted pneraior, ibr exampte,;by irateing activity of -akiate over a life of the generator Mm end of the life of the generator, computer 17 may further compile this tnfenaiaon, along with other pertinent generator iniormaviott, into a report that may accompany a deplardtipi oFdahgerous goods for shipping the depleted generator out for disposal of : ¾ some eases, hadififo the maimihcturer tor investigation. An example of such a report is shown in Figure 11, Aeepndmgmfe 10 that include an encoded information reader, computer 17 may confirm that the new generate· is proper by proeessing information: that is mad from aUeueorted label/tag attached thereto.

Figures 12A-B are schematics of alternative infusion circuits 1300 A, 1300B fhatmtehe employed in place ^la^^IPKFigure ID), aceofoingto

Sdme addhiou#^Mthc pmsent iatenticfh. Circuits 1 '300A, 1 300B are configured to allow for alternative methodsofopemion, to that previously described for circuit 300, when areliiyely even, oruniform level of aofivlty over cate injected dose, along withthe relatively consistent level dErnfa/fy :&amp;em* desired, for example,· m ionfer to coronary artery blood flow via PET scanning, Figure 12C is a scheinaUe sllusuatmg activity protnes 1200A, .1200B tor two injected doses, wherein profile ΙΌ0Β has a more uniform level of activity than profile i 200A; profile 1200B may be achieved via tbs apetsfipn pf circuits 1300.A, 1300B as described below.

Similar to circuit 300 (Figure ID), dashed lined are shown in each of Figures 12A-B to indicate a general boundary of a shielding assembly for portions of each circuit Ι300Λ, 13008. The shielding assembly for each of circuits 1300A. 1300B maybe very similar, in most respects, to shielding assembly TOO, which is described above tesptern 10, and the elements of each of circuits I300A, 1300B maybe arranged wih; mspcct;fc fheir respect respect to shell 13 of system 10 m if similar manner to that described above for circuit 300.

Figure 12A illustrates circuit 1300A mcludfdg, like the previously described circuit 300, eluant reservoir 15, pump 33, radioisotope generator 21, through which the: filteredeluant is pumped t·..· c-eaic me tamour-ive c.u- e, detceto; 25. arid teastefeoiite 23. Figure .12A tWOter illustrates two filters 3? and two pressure transducers 1334 included in drefei130OA, Circuit 1300A flutter includes by-pass tubing line 103, which is located downstream of divergence, valve 35 EG. like in circuit 300, -and which accommodates the previously described eiuan|%aiiue flush. However, in contrast to circuit 300, cifetiit 1300A further includes a Hn^r/^portiona! vafve 1,3 35 integrated into fey~pais|0nsh lin e 303 so that circuit 1300A may be operttead, for example, according #:jpre^^^anmi©d p«ha|^rs of ctpputif 17, in eortentcliort with feedhack of infptostioo fiom activity detector 25, for a controlled by-pass of generator 21 in-order- to mix eluant with eluate and, thereby, achieve a relatively uniformleyef of aoivliy over patient injection, for example, according to profile 1200B of Figure ISC. It sh^iilbe tioted,t&amp;^i:m::.^^.#on'to ^{controlled, mixing,, a flow nate of each injection may fee varied, if necessary, in,ord^:lo-ri^.ntain a consisteM acti vity level.

Figure 12##d^t^:^<aiit:.'13008 Including, like the pfeviuusly circuit 300, eluant reservoir 15, pump 33, radioisotope gensgratet^l,. 25, and waste bottle 23, as well as the-.two filters 37 and twggteSSure transducers 1334, as-¾-circuit 1300A. In contrast to circuits 300 and : 300Λ, circuit 1300B further includes an. eluate reservoir 135i|l which is shown located downstream of generate? 21, in between first and second segments 305A, 305B of the cioatc tubing fine. It should be noted that a pump is combined with reservoir 1350. for example. similaf to'' syringe putftp 33. -mob. that, when a divergence valve 133510 is set to allow fluid-vomnumscat*on tew. cev wervotr 1350 and tubing .ine segr cut 305 3,. the assoetaw pump may be- operated fo draw In a volume of eluate, and, then, when d rvtePgeide valve 133510 Is set to allow '9uj##Bha^tcahonlN^w®^i reservoir 1350 and tubing hue :tegmeht:305B, the p^p--miy%p-op^tecl· to pash the volume of eluate out througfe tefing line segment 305B for a patient injeedoti, when divergence valve 35WP is set m direet^fipw'ihld; patient Κηο53Φ5ρ, ίο KguresBArfh sidewall 205 of shteldipg assembly 200 may feeienlatgedlte tettherieuclose eluare;: reservoir 1350. For example, another shielded well, teahouse the eiuate reservoir, only, extend alongside well 255 hi which activity detector 25 is deser.bed :et being mounted. Furthermore, sidewall 205 may include another valve actuator receptacle' lor divergence valve 133510, similar toyeeeptifole253, shown in .Figtu$13 A..for divergence sake 35WP.

Collection of discrete volumes of eluale, in a reservoir 135(), maylheip to achieve a more uniform activity kwel over each injection, for example, like that of a prnfoe 12(X)B in Figure 120. and, according to preferred methods, feedback from activity detecior 25 n|ay: be used to epniroi the pump associated with reservoir 1350, in order to vary injection flow rate and, thereby, maintain a relatively consistent actlv h> level across multiple injections, and, when necessary, to vary hqeeiiph flow rate ovir an mdividual Injeetion to inaihfoiu the uhifomi activity level. Feedback from the pressure transducer 133d, that is downstream from detector 25, and/or from a flew meter (not shown) of circui t 1300B may also he used to control the varying of injection flow rate, %?|lh further mferenee to Figures I2A-S, it should he noted that alternative eireni ts may1 be configured: fo employ a combination of foedaethois described for circuits leOOAand 1300B, Iforthetmore, some inft^icfi..blhjuits of the invention may employ multiple generators 21, as mentioned above, irreotpunefion with f igure 2A, to help maintain the relatively uniform level, of activity over each:iujehiOn and the relatively consistent level of activity front hqeciionfo injection;

Sldhs thefoigittton· has been described with reforgnee to spec I He embodiments, Ifowever, it may he appreciated that vdffous modiiicaiiohs and changes can he made without d«p^«g;foom.;Jhe..'aoope':iof&amp;: invention as set forth in the appended claims. the preceding description of foe invention., except, where the context requires otherwise due to express language or necessary· jtiplicatfon, the word -eompise" or variations such as ^comprises” or ^eomprisinj^ is used in an inclusive senseyt.c. to specify the presence of the stated features bntnofio preclude tile presence or addition of hiriher features in various embodiments of the invention. it is io be understood that., if any prior art publication is referred to herein, such reference does not oon.sim.nca» admission that the publication forms a part of the common general knowledge in the art. in Australia or any other country»

Claims (30)

1. THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

   1. A mobile radioisotope generator system comprising: a movable platform carrying an infusion tubing circuit, an activity detector, a dose calibrator, a computer, and a shielding assembly containing a strontium/rubidium radioisotope generator configured to generate a radioactive eluate via elution of an eluent, 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, 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, wherein the computer is configured to determine an activity of strontium-82 and an activity of strontium-85 in the portion of radioactive eluate through automated quality control testing using the dose calibrator, the computer is configured to control the mobile radioisotope generator system to deliver a dose of radioactive eluate to a patient during a patient infusion procedure, and the computer is further configured to prevent the patient infusion procedure if a quality control test result exceeds an allowable limit.
2. 2. The system of claim 1, wherein the allowable limit includes a ratio of the activity of strontium-82 divided by an activity of rubidium-82 and a ratio of the activity of strontium-85 divided by the activity of rubidium-82 each being less than 0.02 microcurie of strontium per millicurie of rubidium.
3. 3. The system of claim 1 or 2, 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 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 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.
4. 4. The system of claim 3, wherein the movable platform further carries a pump electronically coupled to the computer and connected to a supply of eluent, the computer is configured to control the pump to supply the eluent to the strontium/rubidium radioisotope generator and generate the portion of radioactive eluate, and 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.
5. 5. The system of claim 1 or 2, wherein the computer is configured to execute automated 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.
6. 6. The system of claim 1 or 2, wherein the computer is configured to execute automated quality control testing by at least receiving a first activity measurement from the dose 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.
7. 7. The system of claim 1 or 2, where the computer is configured to execute automated quality control testing by receiving activity data from the dose calibrator and calculating the ratio of an activity of strontium-82 divided by the activity of rubidium-82 and a ratio of an activity of strontium-85 divided by the activity of rubidium-82.
8. 8. The system of any one of claims 1 to 7, 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.
9. 9. A mobile radioisotope generator system comprising: a shielding assembly configured to contain a strontium/rubidium radioisotope generator that generates radioactive eluate via elution of an eluent 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 line; means for receiving eluate from the eluate tubing line and measuring breakthrough activity of the eluate; and means for receiving activity data from the means for measuring the activity of the eluate and controlling the mobile radioisotope generator system based on the received activity data to deliver a dose of eluate to a patient during a patient infusion procedure, wherein the means for receiving activity data and controlling the mobile radioisotope generator system is further configured to receive breakthrough activity data from the means for receiving eluate and measuring breakthrough activity, determine at least an activity of strontium-82 and an activity of strontium-85 in the eluate from the breakthrough activity data, and prevent the patient infusion procedure if the activity of strontinum-82 or the activity of strontium-85 exceeds an allowable limit.
10. 10. The system of claim 9, wherein the means for receiving activity data, receiving breakthrough activity data, and controlling the mobile radioisotope generator system is configured to electronically transfer quality control test information and infusion information to one or more remote computers.
11. 11. The system of claim 9 or 10, 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 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 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.
12. 12. A method comprising: delivering eluent 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; delivering a portion of eluate via the tubing line to a dose calibrator carried by the movable cart, performing quality control testing on the eluate delivered to the dose calibrator, quality control testing including determining an activity of strontium-82 and an activity of strontium-85 in the eluate, and preventing, via a computer carried by the movable cart, a patient injection procedure if a quality control test result exceeds an allowable limit.
13. 13. A system comprising: a shielding assembly configured to contain a radioisotope generator that generates radioactive eluate via elution; 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, wherein the computer carried by the shielding assembly is configured to receive the activity data from the dose calibrator and calculate breakthrough test results, and the computer is further configured to prevent a patient infusion procedure if a breakthrough test result exceeds an allowable limit.
14. 14. The system of claim 13, wherein the radioisotope generator comprises a strontium-rubidium generator configured to generate rubidium-82 by decay of strontium-82.
15. 15. The system of claim 13 or 14, 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.
16. 16. The system of any one of claims 13 to 15, wherein the computer is further configured to indicate if the breakthrough test results are within allowable limits.
17. 17. The system of claim 16, 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 microcurie / millicurie.
18. 18. The system of any one of claims 13 to 17, further comprising an activity detector arranged to measure an activity of the eluate.
19. 19. The system of any one of claims 13 to 18, 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.
20. 20. The system of claim 19, wherein the given level of activity is approximately 1.0 millicurie per second.
21. 21. The system of any one of claims 13 to 20, further comprising a display configured to display the breakthrough test results.
22. 22. The system of claim 21, wherein the computer is configured to control the display to provide an indication of progress of the breakthrough testing.
23. 23. The system of any one of claims 13 to 22, further comprising a cabinet structure, wherein the shielding assembly is positioned inside the cabinet structure and the computer is carried by the cabinet structure.
24. 24. The system of any one of claims 13 to 23, wherein the dose calibrator is configured to physically receive the sample of eluate generated during breakthrough testing.
25. 25. A method comprising: generating, with a radioisotope generator contained within a shielding assembly, a radioactive eluate via elution of an eluent; measuring, with a dose calibrator electronically coupled to a computer carried by the shielding assembly, an activity of the radioactive eluate; determining, with the computer, an activity of rubidium-82 within the radioactive eluate, and preventing, with the computer, a patient infusion procedure if a breakthrough test result exceeds an allowable limit.
26. 26. The method of claim 25, 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.
27. 27. The method of claim 26, 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.
28. 28. The method of claim 27, 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 microcurie / millicurie.
29. 29. The method of any one of claims 25 to 28, further comprising measuring an activity of the radioactive eluate with an activity detector and 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.
30. 30. The method of claim 29, wherein the given level of activity is approximately 1.0 millicurie per second.