AU2017235989A1 - 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 and/or 10 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 WO 2009/152323 PCT[US2909/047031 <c 00- - - - - - - - 0< (DI t

Description

INFUSION SYSTEMS INCLUDING COMPUTER-FACILITATED MAINTENANCE AN D/OR OPERATION

RELATED APPLICATIONS

The present application claims priority to the following U.S. patent applications: U.S. patent application serial No, 12/137,356. filed June ] L 2008; U.S. patent application serial No. 12/137.363, filed June ! 1,2008; U.S. patent application serial No. 12/137,364. filed June 11,2008; and. U.S. patent application serial No. 127137,377, Sled June 11. 2008.

The present application is a divisional application derived:fern parent application number 2009257432 which is herein incorporated m its entirety by reference.

TECHNICAL FIELD

The ptesem mventlon pertains to systems that generate mid infuse radiophannaeetnkals, and, mbre-partreularly,db:systerns iftc3Pdi0g;cOMputeN facilitated maintenance and/or operation.

BACKGROUND

Nuclear medicine employs radioactive material lor therapy and diagnostic imaging. Positron emission tomography (PET) is one type iAdiagnosticJmaging, which ail!fees doses of radiophMroaceotical, tor exablpie, generatedby; elution within a radioisotope generator, that are injected, or infused into a patient. The infused dose of radiopharmaceutical is absorbed by cells of a target organ, of the patient, and emits radiation., which is defected by &amp; PET scanner, in order to generate an image of the organ. An example of a radioactive isotope, which may be used lor PET', Is Rubidium-82 (produced by the decay of Stronti um-82); and an example of a radioisotope generator which yields a saline solution of Rubidium-82, via elution, is the CardioGen-82Φ available from Bracco Diagnostics Inc. (Princeton, NJ). A PET scanner in .combination with infused doses of radiopharmaceutical s may also be employed io: 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 radtopharniaceuticals 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 eonngunuions that facilitate more efficient set up, maintenance and operation.

SUMMARY OF .THE IN VENTION

In accordance with a first aspect of the present invention, there is provided a mobile radioisotope generator sy stem comprising: a movable platform carrying an .infusion tubing circuit, an activity detector, a dose calibrator, a computer, and a shielding assembly containing a strondum/rubidium radioisotope generator configured to generate a radioactive citrate-via elution of an eluant, the infusion tubing circuit including a tubing line connected between the strontium/rubidium radioisotope generator and the dose calibrator and configured to supply a portion of radioacti ve eluale to the dose calibrator. the activity detector being positioned downstream of the sttontium/rubldium radioisotope generator and configured to measure an activity of the radioactive eluale flowing through the infusion tubing circuit, and the computer being electronically coupled to the dose cal ibrator and configured to execute automated quality control testing using the dose calibrator.

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 duate via elution of an eluant, and an infusion tubing circuit comprising an eluale tubing line configured to convey eluate from the strontlnm/rubMium radioisotope generator; means for measuring an activ ity of the eiuate flowing through the eiuate tubing line; means for receiving el «ate from the eiuate tubing line and calculating breakthrough activity within the ei.uate; and means for receiving activity data from the means for measuring the activity of the eft.sate and also receiving breakthrough activity data from the means for receiving duals and calculating breakthrough activity and controlling the mobile radioisotope generator system based on the received activity data and breakthrough activity data, in accordance with a third aspect of the present invention, there is provi ded a method comprising: delivering eluant to a strontium/ruhidium radioisotope generator carried by a movable cart and thereby generating radioactive eluaie. via elution; measuring, with an activity detector carried by the movable cart, an activity of the eiuate wi thin a tubing line of an infusing tubing circuit; delivering a portion of eiuate via the tubing line to a dose calibrator carried by the movable can. and performing quality control testing on the eiuate delivered to the dose calibrator.

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 eiuate 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 eiuate via elution during breakthrough testing; and a dose cal ibrator electronically coupled to the computer and configured to measure an activity of the sample of eiuate 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.

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 etuaie via elution of an eluant; measuring, with a dose calibrator electronically coupled to a computer carried by the shielding assembly, an activity of the radioactive eluate; and determining, with the computer, an activity of ntbidium-82 within the rad ioact I ve el ante.

BRIEF DFCR IP'IION 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, fhe 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 l A 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 1 A, according to some embodiments.

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

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

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

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

Figure ;2B Is a perspective view of a Iramcwork of the system, according to some embodiments, with m enlarged detailed vie w of a component of the system , according to some ernbodimenis, figure 3A is another perspective view of the shielding assembly shown in Figure 2A,

Figure 3B Is a perspective view of the infusion circuit show m FigumilCy eouigured:: and routed, according to some embodiments.

Figure 3€ Is A perspective view of a disposable infusion circuit subassembly, according to some embodiments.

Figure. 3D us a (tame for the subassembly shown m Figure 3€, according to some embodiments.

Figure 4 is a main menu screen shot from an interface of a computer, winch may be included in systems of the present invention, according: to some embodiments.

Figure 5 A is a schematic showing a first group of successive screen shots torn tire computer interface, according to some embodiments.

Figure SB is a pair of screen shots horn the computer interface, which provide indications related to eluant volume levels in a reservoir of the system, according to some embodim eats.

Figure 5C is a schematic showing a second group of successive screen shots horn the computer interface, according to some embodiments.

Figure 6 is a schematic showing a third group of successive screen snots mom the computer interface, according to some embodiments.

Figures 7A-C are schematics showing a fourth group of successive screen shots .front the computer interface, according to some embodiments.

Figures 8A-B are schematics showing a fifth group of successive screen shots horn the composer interface, according to some embodiments.

Figures 9AC are schematics showing a sixth group of sdccesxfye semen .phots lonj the compuierlmerface, according to some emlxxmomnis.

Figure 10 is a schematic showing a'sevmt&amp;.poap-of^ceossiYStsoi^· shots: from the ©output er interface, according to: some embodiments.

Figure 11 is an exemplmy report which may be genimited by the: eo?ppmcr included in ittibsion systems, according to some embodiments.

Figures 12A-B are schematics of alternative infusion circuits that: may be employed by embodiments of the present invention.

Figure I2C is 8 schematic illustrating exemplary activity profiles of injected doses of a -radiopharmaceutical.

.DETA.I LED DESCRIPTION

The following detailed description Is exemplary in nature and is not intended to limit the scope, applicability, or cordlguration of the invention m any way. Rather, the following description-: provides practical Fdustmitons for implementing exemptary embodiments. Utilizing the teaching provided herein, those skilled in the an. will recognize that many of the examples have suitable alternatives that can be utilized.

Figure IA is a first perspective view of an infusion system .10, according to some, embodiments of the present invention» wherein system 10 is shown supported by a cabinet structure, which includes a platform 113 (seen better m figure χβ) and a shell 13; shell I 3 extends upward from a skirt 1:1. th at snrroun as p I at form. 113, to surrounds an interior spues in which a portion o1 infusion system !0 is contained (seen In Figure !€}. Shell may be formed from panels of Injectiort-ntoided polyurethane fitted together according to methods known to those skilled m the art;. Figure IA illustrates the cabinet structure of system 10 including a grip or handle Id. which extends laterally from shell 13, in proximity to an upper surface 131 thereof, and a post 142, wind; extends upward from shell 13, and to which a work surtaec, or tray 1 b amt a computer 1? are, preferably, attached, via an ergonomic, posiuonable mount According to some embodiments, computer 17 is coupled to a controller of system. 10, winch is mounted within tee interior space surrounded by shell 13; and, a monitor I /2 of computer 17 not only displays indications of system operation for a user of system !0t but also serves as a device for user input (e,g. touch screen input). However, according to alternate embodiments, another type of user input device, known to those sk illed in the art, may be employed by computer 17. Other types of user input devices may be included, for example, a keyboard, a series of control buttons or levers, a bar code reader (or other reader of encoded information), a scanner,. &amp; computer readable medium oontemiag perimewi data, etc* The user inputfatit&amp;wy be mounted on the cabinet structure'of system 10» as shown, Or may be tethered thereto;; abemarively toe user input device may be remote from system 19, for ex ample, located :m a separate control room. According to some additional embodiments, another user Input device, ibr example, in addition to a touch screen of computer 1 ?, may be remote from system 10 and used to start and stop Infusions, as well as to monitor system operation both -luring quality control infusions and during patient infusions. Operation of system 10, which is facilitated by computer 17, will be described below, in conjunction with Figures 4-913.

Figure !A further illustrates two pairs of wheels .12.1, .122, mouthed to an underside of platform 113, to make system; 10 mobile; handle 14 Is shown located a; ao elevation suitable for a person to grasp in order to maneuver system Kk from one location for another, upon pairs of wheels 121, 122, According to some preferred embodiments, one or both pairs of wheels 121, 122, are casters, allowing for rotation in a horizontal plane (swivel), in order to provide additional flexibility for maneuvering system 10 in relatively tight spaces.

Figure 1B is a perspective view of a portion of system 10, on a sid e 111 of the cabinet structure, 'which is in proximity to wheels 121, Figure IB illustrates a lever or pedal 12.5, which is located for activation by a foot of the person, who grasps handle 14 to maneuver system i 0. In a neutral position, pedal 125 allows wheels .121, Γ22 to rotate, and, if embodied as casters, to swivel freely. Pedal 125 may be depressed to a first position which prevents a swiveling of wheel s 122, according to those embodiMenfo in which wheels 122 are.casters, and may be further depressed to brake wheels 121, .122 from rolling and swiveling, upon reaching a desired location. According to some embodiments* braking may be designed to slow system 10, for example.; when rolling down an incline, and, according to yet further: embodiments,: system 10 may include a motor to power movement thereof.

Figure 1B further illustrates;, a rear access panel 174 of shell 13, for example, providing access to circuit boards of the aforementioned controller contained within the interior space that is stmouudsd by shell 1.3; an, optional lock 1B4, to secure panel 174 ; a power jack .118, for connecting system .10 to a power- source; and a printer 117 for providing documentation of each patient infusion carried out by sys tem 10, and of system quality control test results. In some embodiments, system 10 may further include &amp; power«trip by which additional efodhicai connectors, or ports (not shown), which are stipported by platform 113 and may be integrated, into shell 13, for example,:fo|>roxifoityfojs^ 1 IS or printer 117; these electncal comtecfors/ports allow system fO to ooramamcafo: with, other devices used for nuclear Imaging procedures, for example, a PEI scatmer/camem, and/or for coupling to an intranet network, and/or to the internet, tor example, to link up with software programs for various types of data analysis, and/or to link to computers of consulting cHmeians/physieians, and/or to link Into service providers-and/or component suppliers data bases for etfoaoced.m:aittientutce:and: inventory management.

Figure 1A further illustrates upper surface ! 3 i of shell 13 including several openings 133, 135,139 formed therein. Figure 1C is a partially exploded perspective view of system JO, wherein a removableaccess panel 132 is show® as a contoured portion. ofupper surface li!. which. when exposed, by lifting away a bin ib, that piates therewith, may be removed from another opening 13? formed in upper surface 131, Figure 1 € also provides a better view of another panel 134 which may be lifted away from opening 139. According to the illustrated embodiment, openings 139 and 137 provide a user of system 10 with independent access to separate portions of infusion system 10» which are contained within shell 13» for example, to set. up ana maintain system. 10; and openings 133 and 135 provide passageways for tubing lines to pass through shell 13, Figure 1C further illustrates an optional switch. 102, which in case of an emergency* may be activated to abort function of system 10. With reference to Figures 1A and 1C» It may be appreciated that an arrangement of features formed in upper surface 131 of shell 13, in conjunction with bin 18, tray 16 and computer 1?» provide a relatively ergonomic and organized work area for technical personnel who operate system 10 ,

Turning now to Figure ID, a schematic of an infusion circuit 300, which may be incorporated by system 10, is shown. Figure ID Illustrates circuit 300 generally dividedinto a first part:300A. which includes components mounted outside shell3 3,: hod a second pari 300B, which includes components mounted within foe interior space surrounded by shell 13. (Farts 300A and 300B are. delineated by:dotted lines!iteFIgure ID.) Figure ID further illustrate second part 3O0B of circuit 300 inefedkig aportion contained within a shielding assembly 200, which is designated: sohernsbcaMyas a dashed hue. -Somg' embodiment of shtelding assembiy OOO will be describee in greater detail, in conjunction with Figures 2.4-B and 3 A - B. below.

According to the illustrated embodiment, circuit 3.00 includes: an eluant reservoir IS, for example, a bag, bottle or other container, containing saline as foe eluant, which is shown hanging from a .post, or hanger 1.41 above upper sprtece lol Of shell 13 in Figure 1A; a syringe pump 33» for pumping the eluant fern reservoir 15» and a pressure syringe 34 (or other device or sensor), for monitoring pumping pressure: a filter 3?, which may also serve as. a bubble trap, for the pumped: eluant; a radioisotope generator 21, through which the filtered eluant Is pumped to create a radioactive eluate, for example an duals carrying Rubidium-82 that is generated by the decay of Strontium-82, via elution, within a column of generator 21; and an activity detector 25, for measuring the activity of the duals discharged from generator 21.» in order to provide feedback tor directing the flow of the eioate. vis a divergence valve 35WP, either to a waste bottle 23 or through, a patient line 305p, tor example, to i eject a dose of the radiopharmaceutical eluate into a patient. With reference back to Figure I A, patient line 305p is shown extending out from shell· 13. through opening 135, to a distal end thereof, which, according to some embodiments, includes &amp; filter. Patient line 305« may be coupled to another line that includes a patient, injection, needle (not shown). Alternatively, patient line 305p may be coupled to another ime ('nor shown), which extends from a source of another active substance, tor example, a stress agent; die other line is coupled to the line that includes the patient injection needle, in order to penult infection, of the addition al active substance.

Figure ID illustrates an eluant, tubing line 30! coupled to reservoir .15 and to pump 33, and, with reference to Figures 1A-8, it may be appreciated that opening 133 provides lire passageway for tubing line 301 to enter the interior space surrounded by shell 13. According to some preferred embodiments, opening 133 includes a grommet-typo seal thaiptevOTfe le^age of eluam, wlhsb may φΐΟ horn reservoir 15, into the interior space through opening 133, while allowing s userid assemble tubing line 301 through Opening 133. Likewise, opening 135, which provides;&amp; passageway for patient line 305p, may include a groatmet-type seal According to some embodiments, shell 13 further supports holders to safely hold, for example, during transput of system H), portions of tubing lines feat extend. Outwstd-feerefemhv &amp;*r example* hue 30.1 aud/pr lifte 3 OSp,

Figure ID further illustrates another eluant tubing line 302 coupled to pump 33 and a divergence valve 35BG, which may either direct pumped eluant through &amp; tubing line 304, to generator 21., or direct thepuinped eluant through a by-pass tubing Ime 303:, directly to patient line 3f)5p. Divergence- valve 35BG, as well as divergence valve 35 WF, which directs eluate from. an ciuate tubing line 305 either to a waste Hue 305w or to patient line 305p, may each be automatically operated by a corresponding servomotor (not shown}* coupled to the controller (not shown) of system 10, which controller receives feedback from activity detector 25. When system 10 is operating tor automatic infusion, to deliver a dose of radiopharmaceutical to a patien t tor example, Rubidmm-82 for diagnostic imaging, divergence valve 35 BO is initially set to direct eluant to generator 21 and divergence valve 35 WF is set to direct cluate front generator into waste bottle 23, until activity detector 25 detects the desired .activity of the citrate, at which time the feedback front activity detector 25 causes the controller to direct the eorrcspoading servo-motor to re-set .valve 3 5WF for diverting; foe flow of eldai¢:into patient line: 305p, According to some embodiment once a prescrfoed volume of the eluate has passed through patient line 305p, the:OOU'tmiier;dimdfo;lfee corresponding servomotor to re-set divergence valve 35BO for divefongihs: flow of eluautfofougb;by-pass line 303 and Into patient line. 305p:Id order to flash, or push any chia-e remaining in patient I me 305p into the patient. Accord mg to some embodiments, the controller may also direct the corresponding servomotor to to-sci dfoergeaes valve 35WP back toward rhe flush through by-pass hoe 305, in order to prevent back flow of ehuotmhrougb. tine 505. toward generator 21, According to some preferred methods of operation, in certain situations, which will: be described in greater detail below, eluant is pumped through by-pass line 505 immcdiatclv following tbs flow of the prescribed volume of eUnue into patient kne 30Sp, .at a higher speed, in order to push the du&amp;ie in. patient line 305, thereby increasing a flow rate of the injection of duate out from patient line 305p and into patient. For example, ©nee the pmscribed xobuneofdafoehas flowed too pniieMime 305p, and once divergence valve 35BG is set to divert flow thrmtih by-pass line 303, the speed of pump 33 may be adjusted to increase foe flow rate of eluant to between aggfoxteafoly and approximately: 1 (HhrJL'mkt. This method for increasing the injeeiion flow rate, is desirable, If a relatively high flow foie is desired for patienf itpeefkm and a flow rate through generator 2! is limited,; for example, to below sppfoxmisfoly 70mL/mto, maximum (typical flow rate may be sppfoxinmtoly 5®mUmhi%in order to avoid an excessive back pressure created by the ooiuirm of generator 21 in upstream portions of tubing circuit 300: the excessive back pressure could damage fitter 37 impede low

Although not shown in Figure ID, a number of sensors, for example, to measure pressure and/or flow velocity, maybe incorporated Into circuit 300, according tp some alfomato ctnbodiraents, in. order to monitor for tew anomalies, for example, related to occlusiorndplugs in circuit 300 and/or 3«aks,.aadtorfo|ptovife&amp;^ib^dk' for control of an activity level of infused doses of radiopharmaceutical Suitable sensors for any of the above purposes arc known to those skilled m the art. Examples of flow meters that may be incorporated into circuit 300, include the tonova-Sontofo Model 205 Transit-Time Ultrasonic liquid flow Meter that employs digital signal processing (available from Sierra Instruments, foe.) and the f local LA10-C differential pressure How meter. One example of a pressure sensor that may be employed, to detect infusion circuit occlusions is the PRO / Pressure-Occlusion Detector (availaoie itoui INTROTEKC- of Edgewooti, NY, a subsidiary of Magnetrol of .Downers Grove, Π,}, which employs pulse-type ultrasound; this sensor detects subtle changes in positive and negative air pressure and produces a corresponding passive resistive output signal, which may be routed to the system controller ami-or computer 1 ?. Cm or more of this tvpe of sensor maybe incorporated into infusion, circuit .ήΚ) by simply tiding tee sensor around any of the tubing fines of infusion circuit. 300; in feet, the FRO / Pressure-Occlusion Detector maybe a suitable alternative to pressure syringe 34 of circuit 300. Other types of pressure sensors, for example, similar to those known in the ait lor blood pressure· monitoring, may be employed in infusion circuit 300. 'System 10 may further include sensors to detect fluid levels in eluant reservoir 15 and waste bo;he 23. Some examples ofsuch sensors, which also employ die aforementioned pulse-type idtta^nnd, are:the Drip Chamber Liquid Level Sensor and the CU> / Continuous Level Detector (Noth available from INTROT.BK.&amp;); ahemativsly, tor example, an HPQ -T pipe mounted,:seti-contained:Ikpsin senior (hvaifahls fern Ysmatake Sensing Control, l td.), or an SL-L30 Non-l.uvass.ve Disposablo/Reusabie Level Switch (available from Cosense* Inc. of Hauppauge, NY) may be employed to detect the fluid levels. Alternately or in addition, system .10 can :include additiotud radiation andtor moisture detection sensors* which cast oetoci leaks. With reference to Figure ID, such soasotsiam preferably located in ptbkimifylo fittings 3 Π, 312,313, 314 and 315 that, join portions of circuit 300 to one another. Some examples of leak detection sensors include, without limitation, those m the HPQ-D teak detection sensor family, and the HPF-D040 fiberoptic leak detector (all available from Yamatake Sensing Control, Ltd.). System Ή) may further include additional sensors to detect, contaminants and/or air bubbles within the tubing lines of circuit; examples of such sensors include the Point.-air Detection (PAD) Sensor, that employs pulse-type ultrasound for air bubble detection, and the Blood Component Detector that employs optical sensing technology to perferm.Coionmetry-basedltsicl detection of unwanted elements in the tubing: lines (both· available: .from INTROTEKm

According to those embodiments that inclu de any of the above sensors, the sensors are linked into the controller of system 10 and/or computer 17, either of which may provide a signal to a user of system 10, when a flow anomaly is defected, and/or information to the user, via monitor 172, concerning fluid levels, pressure and/or flow through circuit 300. Computer 17 may be pre-programmed to display, for example, on monitor 172, a graphic of infusion circuit 300 wherein each zone of the Circuit, where an anomaly has been detected, is highlighted, and/or to preside guidance, to the system user, for correcting, the anomaly. It should be «ted that the alternative infusion d re tuts illustrated in Figures 12A-B, which tvi I i be described: below, may also iaclode any or all of these types of sensors.

With further reference to Figure ID, it may be appreciated that shielding assembly 200 encloses those portions of circuit 300 from, which radioactive radiation may emanate, with the exception of that portion of patient line 3 QS p, which must extend out from shielding assembly 200 in order to be coupled to the patient ibr injection, or in order to be coupled to shielded sample vials, as will be described below. Thus, technical personnel, who operate system 10, are protected from radiation by shielding assembly 200» except at those times when an infusion is. taking place, or when quality control tests require collection of eluate Into sample vials. Daring Musions and quality control test sample collection, all lebhoi©a! personnel am typieall y in another room, or otherwise dmianc e<l froth system. 1.0,-in order so a v did exposure to radiation during the infusion, and, according'to some preferred em bodiments of the present invention., system 10 includes at least one means for Informing technical personnel that m infusion is about to take place or is taking place. With reference back to Figures 1A and 1C, system 10 is shown including a light projector .100, mounted on post 142. Aceordipgt© the illustrated embodiment, projector 100, projects a light signal upward, for mimmum vdsibility, when pump 33 is pumping eluant and elution is taking place within generator 2.1, or at ail times when pump 33 is pumping eluant. According to some embodiments, the light signal flashes on arid off when the eluate is being diverted from generator 2! into waste bottle 23, and the light signal shines steadily when the eluate is feeing diverted through; patient line 3(>5p, or visa versa. According to other embodiments, a projector 100 shines &amp; light having a first color, to indicate that eluate is being diverted to waste bottle 23, and then shines a light having a second, different color, to indicate that einate is being directed to patient line 305p for infusion. Light projector 100 may farther project a more rapidly flashing light, for example, for approximately five seconds, once &amp; peak bolus of radioactivity is detected in the eluate, to provide further information to technical personnel. Alternative means of informing technical personnel that m infusion is taking place may also be incorporated by system 10. for example, including audible alarms or other types of visible or readable signals that, are apparent at a distance from system, including in the control room.

It. should be noted that* according to alternate embodiments, system 10 includes an dm board’ dose calibrator for quality control tests, aed emeu it 390 is expanded, to meliuie eleinenxs for an automated coileeiion^of eluate samples for activity measurements, via the on board dose calibrator. According ίο a first set of these alternate embodiments, a sample collection reservoir is integrated into circuit IKK}, downstream of divergence valve 35WP and in communication, with tubing line 305P, in order to receive quality control test samples of eluate, via tubing hue S05P, ano noth, the reservoir and the dose calibrator are located in a separate shielded well. According to a second set of these altenmieembodimeiits, waste bottle 23 is configured to receive the quality control test samples of eluate, via tubing line 305W, and a dose calibrator is integraMiinto shielding assembly 2QD. Quality controlproeedtpw will be desenbed in greater detail below, in conjunction with Figures 6-SB.

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' tfeaticdmicaipotshirnd are preferably trained to empty waste bottle 23 at times when the eluate, contained in waste bottle 23, has decayed, suffteienily to ensure that the radioactivity thereof has fallen : deiOW'U threshold to be safe. Opening 139 is preferably located al an elevation or between approximately 2 feet and approximately 3 feet; .for example, opening 139 may be at an elevation of approximately 24 inches, with respect to a lower surface or platlonn $13, or at an elevation of approximately 32 inches, with respect to a ground surface upon which wheels 121,122 rest. According to the 11 lustmed embodiment. Opening 139 is accessed by lifting panel 134; just within opening 139, a,shielded lid or door 223 (Figure 2A) may be lifted away from a compartment of shielding assembly 200 that contains waste bottle 23. With further reference to Figure 1C, it may be appreciated that opening 137 provides access to other .portions of circuit 300 for additional maintenance procedures, such as changing out generator 21 and/or other components of circuit 300, as will be described below.

For those embodiments of «system 10 In which automated quality control tests are nes formed and/or when system 10 is emplovcti for relauveh mgh vo'umr operation, management of waste may become burdensome, even though access to waste bottle 23 is greatly facilitated, as described above. Thus, in order to fac.ilii.ate waste management, some embodiments of system 10 may employ a separation system to separate salts, including radioactive elements, from water, for example, via evaporation or reverse osmosis. In an evaporation type system, the water component of the waste is evaporated, while in a reverse osmosis type system the water is separated from the salts, and, then, once confirmed to be non-radioaedve, via a radiation detector, is piped to a drain. According to some other embodiments; circuit 300 may be configured so that the waste may be used to purge air horn the tubing lines themofandfor to perform the bypass flush that was described the radioactivity of the waste drops below a critical threshold.

Figaros IA .and-ICforiber Iliustrate a pair of relatively shallow externa! fodess«$400t. which are formed &amp; upper smfaeo 131 of shell 13, for example, in order to catch any spills from infusion system; one of recesses 190 is shown located m proximity to post, or hanger 141, which holds reservoir 15, and in proximity to 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 may accommodate storage of technical dddhmenMiOd asiodidiedwitlrinfosioa system .10, for example, $ technical manual ppd/or maintenance records, drprinfotds Imm printer 112 (figure ; 8). With reference to Figure '1C, upper surface 131 of shell ! 3 is shown to also include additional recesses 101, which are each steed to hold a shielded test vrai, wfoieh contains samples from infusion system 10, for example, for breakthrough testing and/or calibration, which will be described in greater detail, below. An exemplary test vial shield is shown in Figure 1E. The test vial shield of Figure 1E is preferably formed from Tungsten rather than lead, for example, to reduce exposure to lead, for Improved shielding, and to reduce the weight of the shield. Figure IE Illustrates the test vial shield Including a handle to simplify manipubdfon thereof, but: alternative configurations of test vial shields have no handle —for these a sling, or strap, may be employed for handling.

Additional receptacles 180 are shown formed in bin 18, on either side of a handle 182, which facilitates removal of bin 18 away from shell 13. Technical personnel may, thus, conveniently transport bin 18 to a storage area for a collection ol supplies, for example, sharps, gloves, tubing lines, etc..., into one or more receptacles 180 thereof, and/or to a waste container where separate receptacles .180 of bin 18 may be emptied of waste, such as packaging for the aforementioned supplies, tor example, deposited therein during infusion procedures. According to some embodiments.. one or more additional receptacles are formed In one or more disposal containers, for example, to contain sharps and'or radioactive waste (other than that contained in waste bottle 23), which may be integrated into bin 18, or otherwise fitted into, or attached to shell 13, separate iron? bin 18.

Figure 2A is a perspective view' of shielding assembly 200, according to some embodiments of the present invention. With reference to Figures 1C and 2Ά, together, it may be appreciated that opening 137, in upper surface 131 of shell 13, provides access fo a id or door 221 of a sidewall 201 of shielding assembly 200, which ssdewail 201 encloses a compartment sized to contain a radioisotope generator of syster 10, for example, generator 21. previously introduced It should fee noted that, according to alternate embodiments, foe compastmeth enciosed.by sidewall 201 is large enough to hole! uKvre than one generator, for example, relatively high, volume operation.. In some of these ait^^eimhoditnen^fohihg;: im<5S 304 sud 305 are each branched for parallel flow through the muiriple generafom,: In wblch case divergence valves may be employed to alternate the flow throughthe generators, one at a time. In others of these alternate enfoodiments, the multiple generators are connected in series between tubing line:304 and tubing line 305. In .addition» a reservoir for accumulating eiuate may be Included in circuit 300, downstream of the generators and upstream of divergence valve 35 Wi\in conjunction with a second pump, in some cases. Embodiments including multiple generators and/or an. clusie reservoir and second pump can be employed to better panapfoh activity level of each dose, or patient injection, for example, as described below, p amjuaciien with Figures I2A-B.

According to the embodiment illustrated; in. Figure 2.A, opening 137 and coor 221 am located si a lower.elevation, for example, with respect to ntenonn 113, than arc opening 139 and lid 223, which provide access to the compartment being formed by a sidewall 203 of shielding assembly 200 to contain waste bottle 23, as previously described. When panel 132 is separated from shell 13, and door 221 opened, generator 21 maybe lifted out from an opening 231 (Figure 3 A) which mates with door 221 of sidewall 201. A weight of generator 21, which includes its own shielding, maybe between approximately 23 and approximately 25 pounds, thus, according to some preferred embodiments of the present invention, the elevation of each at openings 13/ and 231, with respect to the lowermost portion of the cabinet structure, is between approximately 1. foot and approximately 2 feet, in order to facilitate an ergonomic stance for technical personnel to lift generator 21 out from the compartment.

According to an exemplary embodiment, when shielding assembly 200 us contained is the cabinet structure of Figure 1A , openings 13? end 231 are located at an eievai'fo?' of approximately 12 inches, with respect to the lower surface of platform i 13, or at m elevation of approxim ately 19 inches, with respect to the ground surface upon which, wheels 121, 122 rest. Figure 1C further illustrates access panel 132 including a security lock 138, 'which mates with a framework 19 of system 10, shown in Figure ; 28, in order to limit access to, generator 21,

Figures 1C and 2A further illustrate a lid or a door β (Figure 3A) of shielding assembly 200, which encloses another compartment that is accessible through opening 13? of shell 13, and which is located adjacent the compartment enclosed by sidewall 20 i, Each of doors 221., 225 arc shown hemg attached by a eprresponding hinge- H, and another door 227 is shown attached to sidewall 203 by another hingeH, Figure 2A illosnmes each of lid 223 and doom 221, 225, 227 kelttdtng a handle 232,212, 252 :and:272,:respectively, isr moving:lid 223 and doors 22:1, 223,227, in order to provide: access lo the eoroesnonding compartments, which can be seen In Figures 3AA Figure.’2 A i&amp;rthor illudfraies optional thumb screws 290, one securing lid 223 to sidewall .203 and another securing door 221 to sidewall 201, or other means for securing the doors, which are known to those skilled in the art, may be incorporated. Each sidewall 201,203, 205 and the corresponding Hd/doof 223,22 L 225,227 thereof may be indi vidually cast from 3% antimony lead, or from other known shielding materials, and then assembled together according to methods known to those skilled in the art.

According to foe illustrated embodiment, doors 22 L 225 are hinged to open in an upward direction, per arrows D and C, and, with reference hack to Figure 1C, a latch component 191 is provided to hold each of doors 221,225 in an opened position, thereby, preventing doors 221, 225 from falling closed, which coaid pkch/cmsh fingers of technical personnel and/or tubing lines of circuit 300, when in the midst ot &amp; maintenance procedure. Figure: 28 is a perspective view of framework i 9 of the cabinet structure of system 10, according to some embodiments, to which latch component 191 is mounted; Figure 2B includes an enlarged detailed view of latest component 191, according to some embodiments. Figure 28 Illustrates latch component 191 mchtdmg a first pin 193, corresponding to door 225, and a second pin 195, corresponding to door 221; each pin 193,195 includes a lever end 193A, 1938, respecti vely, and a holding end .1938,1958, respectively. An edge of each door 221, 225, upon opening of doors 221, 225, may push past the holding end 1958, J93B of tire corresponding pin 195, 193, in a first direction, per arrow F, and then may rest against a respective side S95 and S93 ot each end 1958, 1918, until the corresponding lever end 195 A, 193A is rotated in a counter-clockwise direction, per arrow cc, thereby moving the ;corresponding holding end 193B, 1958 to make way for the closing of doors 2:21, 223. Doors 221,225.being held by latch 'component 191 m an open position may be seen in Figure 3 A.

With ferdrer reference to Figure 2Λ, according to some preferred embodiments of the present invention, an edge of door 225 overlaps door 221 to prevent door cad tom being opened, per anew D, i f door 2:2 3 is: not opened,: per grrow C\ ami, an edge:, of door 227 overlaps an edge of door 225 to prevent door 225 from being opened if dew 2:2? is not opened, per arrow By and ah: edge of hd 223 overlaps door .227 to prevent door 227 from being opened if lid 223 knot opened, per arrow A. Thus, aecessto the compartment enclosed by sidewall 20:1. arid eontammg generator &amp;i is only systematically allowed through a sequential opening of lid 223 and doors 227, 225, 221 * since, when generator 21 is replaced it is typically desirable to also replace those portions of circuit 300 which are shielded behind lid 223 and doors 227,225.

The routing of these portions of circuit 3Q0 will be described in conjunction wish Figures 3A-C.

Figure 3A is another perspective view ot rice dreg a&amp;-veo Pp 2D a „ordtru to some embodiments of the present invention. In Figure 3A, hu 223 and doors: 2cL 225, and 227 are opened to provide a view into openings 233,235 ana 231 o.v sidewalls 203, 205 and 201, respectively, and into a passageway 207, which is tormea In aklcwall 203, opposite the compartment, which contains waste bottle 23. Passagosvay 20? is shown extending vertically along -sidewall 203 and having a grooved extension 2.13 formed in a perimeter surface of opening 233. An optional retaining member 23?» for example, formed .from an elongate strip of resilient plastic having a .generally reshape eross-setehon, is shown being mounted along a length of passageway 207 to hold lines 305w and 305p in place within passageway 207. Figure 3A further illustrates a pair of passageways 251b and 25lgs which: are formed as grooves in a portion of sidewall 205. and another pair of passageways 215i and 2150, which arc .termed as grooves: in a portion: of sidewall 20 L A routing of portions oftubing circuit 300. (figure ID) through passageways 207, 25 lb, 251 eg 2 i Si and 21 So is shown m Figure 38.

Figure 3B illustrates tubing line 304 being routed through passageways 25 Ig and 2151, eluate tubing line 305 being routed through passageway 2.15o, and both, waste lino 305w and patient line 30Sp being routed along passageway 207. Waste line 305w further extends through grooved extension 2.13 to waste bottle 23, and patient line 305p Anther extends outward .from shielding assembly 200, for example, to extend outthrough opening 135¾ upper surface 131 of shell 73 (Figyre: fAy According to the illustrated embodiment, each passageway teopedin shielding assembly 200, by being accessible along a length thereof, can facilitate a relatively easy routing of the corresponding tubing line therethrough, whet? the corresponding ltd/door is open, and a depth of each passageway prevents pinching and/or crushing: of the corresponding tubing line-ro uteri therethrough, when the corresponding htedooc Is closed down thereover. With further reference to Figures 3 A-B, it may be appreciated drat the compartment formed, by sidewall 201 may have a shape matching an exterior contour of generator 21, such that, generator 21 is ; keyed! to the:compartment, ter example, to prevent install ation of an improper generator into system H>, and/or to facilitate the proper orientation of generator 21 within the compartment for the proper routing of tubing lines. Alternately, or in addition, according to alternate embodiments, if system 30 includes &amp; reader of encoded information in communication with computer 17, an unique identification and/or data associated with each .generator may be provided, ter example, in a bar code label or a radiolmmency: kientifreatlorrlEFiD'l itig that is attached to each generator, so that the reader may transfer the information to computer 17, when a generator 1$ installed, in order to either enable system, operation or to provide an indication to the user that an incorrect generator has been installed. Ot course a user of system 10 may, alternately, manually enter information, that is provided on a generator label or marking, into computer 17, in order to either enable system 10, or to .receive feedback from computer 17 that the incorrect generator is installed.

Figure 3A further illustrates sidewall 205 including a valve actuator receptacle 253, into which divergence valve 35WP is mounted, to be controlled by one of the servomotors (not shown) of system 10, and an opening 325 for activity detector 25. Activity detector 25 is mounted in a shielded well 255 that extends downward from opening 325 (shown in Figure 3 B), and, with reference, to Figure 3BS tubing line 305 passes over opening 325 so that detector 25 can detect an activity of the eluate, winch passes therethrough. According to some embodiments, the positioning, within the compartment enclosed by sidewall 205, of the components of the portion of mrusion circuit 300 which ^sliownrOu^dl.th^r^ is facilitated by providing the components mounted in a 1 lame 39 m a disposable subassembly 390, an embodimeM uf whioh is. illustrated by figures 3C-D.

Figure 3C is a perspective view of subassembly 390, and figure :3D is a perspective: vi ew of frame 3 9. According to the embodiment tllusmated by F tgure 3 % frame 39 is fanned from mating trays 39.A, 39B, for example, .formed from a thermbfonned plastic, which lit together to capture, therebetween, and hold, in nxed relation to a perimeter edge of frame 39, divergence valve 35 WF and portions of eluant tubing line 304, by-pass tubing line 303. eluate tubing line 305, waste line 305w aud patient line 305p. Figure 3C illustrates the perimeter edge divided .into &amp; ifrst side 391, a second side 392, opposite first side 391. adhihl first and second sides 391., 392, and a fourth side 394, opposite third side 393 Although Figure 3D shows frays 39A, 39B individually formed for iftiitg; fogethefr according to alternate embodiments, mating trays of frame 39 may be pans of a continuous sheet of plastic folded over on itself

According to the illustrated embodiment, an end 404A, of eluant line 304, and an end 403, of by-pass l ine 303 extend from third side 393 of frame 39 to couple with divergence valve 35BO and an upstream section of eluant tubing line 302. Figure 3€ further illustrates an opposite end 40413 of eluant line extending from first side 391 or frame 39, alongside a similarly extending end 405 of eluate line 305, and ends 406 and 407 of patient line 305p and waste Line 305%ν, respectively, extending from, second side 392 of frame 39. Although ends 406,40? are shown extending upward from tray 39a. as they would within shielding assembly 200, it should be appreciated, that the tubing lines of cireuit; 300 are preferably flexible and would drop down undertbeif own weight rather than extending upward, as shown.. If not supported. ;Referring back to Figure ID. in conjunction with Figure 3€, it can be seen that the aforementioned fittings are provided for coupling subassembly 390 into circuit 300; first fitting 311 couples the section of eluant line 302 to filter 37; second fitting 312 couples eluant line 304 to an inlet port of generator 21; third fitting 313, which may incorporate a check valve, couples ekmte line 305 to an outlet port of generator 21; fourth fitting 314 couples waste line 395w' to; waste; bottle 23·;· and fifth fitting 315 couples patient; line 305p to an extension thereof, which extends outside shell 1.3 (designated, by the dotted line). Each of the fittings 311* 312, 313, 314,315 may be of the Liter type, may be a type suitable for reldtiveiy high pressure applications, or may he: any other suitable

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 lid 223 and doors 22?, 225, and, in those instances wherein system 10 is moved to a new site each day, these portions may he replaced daily. Thus, according to the illustrated embodiment, these portions are conveniently held together by frame. 39, as subassembly 39Q, in order to: facilitate relatively speedy removal and replacement while assuring a proper assembly orientatloa, via, registration vvith:ifeaiMresiibrmed.:in: sidewall 205 (Figure 3A), for example: registration of divergence valve 35W:P with valve actuator receptacle 253.,: registration of tubing line ends 403 and 404A with: passageways 25 ib and 251 g, respectively, registration of tubing line ends 4048 and 405 with passageways 2151 and 2.5. So, respectively, and registration of tubing line ends 406 and 40? with passageway 207.

With further reference to Figure 3B, other portions of tubing circuit 300 are sho wn. Fi gure 3S illustrates clu&amp;rh: tubing line 301 extending item reservoir IS, outside of shell 13 (Figure 1 A), to syringe pump 33, which is mounted to an actuating platform 433. According to the illustrated embodiment, :piatfbrm.433 is aetpatediby •another.servomotor (.not shown) of system 10, which is eentmlled by the controller and computer 1? of system 10, to cause a plunger of pump 33 to move, per arrow !, so as to draw in eluant, from reservoir 15, through tubing line 301, and then to cause the plunger to move in the opposite direction so as to pump the eluanMhromfe tubing line 302, to cither generator 2 i or to by -pass line :303. A hhough fee illustrated embodiment includes «syringe pomp 33, other sultabk' pumps. know a to those vkfecd hi the art, may be substituted for pump 33, in order to draw eluant from reservoir 15 and to pump fee eluant throughout circuit 300, Although not shown, it should be appreciated that divergence valve 3SBG is fitted into another valve actuating receptacle mourned within shell 13 and coupled to yet another servomotor (not shown) of system It). figure 3B further illustrates a filter holder 317 that is mounted alongside an Ulterior surface of shell 13 to hold filter 37 (Figure ID) of tubing i.me 302. Filler holder 317, like frame 39 for subassembly 390, maybe formed from a thcrmo&amp;rmed plastic sheet; holder 317 may have a clam-shell structure to enclose filter 37 in an. interior space, yet allow tubing line 302, on either side of filter 37, to extend out from the interior space, In between opposing sides of the dam-shell structure. Holder 317 is shown including an appendage 307 ibr banging bolder 111::fiom.:a:;sfip<®3re;inot shown) inside shell 13.

Turuthg now to Figures 4-9€ details,soheefemg:oompufer~ihsilfefe|:operation of system 10 Will be described, according to ^me-efebckhmi»its.-ofitbe'^S«'eii1:: Invention* As previously mentioned, and wiiiyreterenee back to b tgure IA, computer 17 of system 10 includes monitor 172, which, preferably, not only displays indications of system operation to inform a user of system 10, but is also configured as a touch screen, to receive input fern the user, it should be understood that computer 1? is coupled to the controller of system 10, which may be mounted within the interior space.surrounded by shell 13. Although Figure IA shows computer demounted; ip post 142 of system I'D,· for direct hardwiring to the controller of system 10, secordlpg to some alternate embodiments, computer 1? is coupled to: the: controller via aileslbk lead that allows computer 17 to be positioned somewhat remotely from those portions of system ltd 1mm which radioactive radiation may emanate; or, according to some other embodiments, computer 17 is wirelessly coupled, for example, via two-way telemetry, to the controller of system 10, for even greater flexibility in positioning computer .17, so that the operation of system 10 maybe monitored and controlled remotely, away iMm radioactive radiation.

According to some preferred embodiments, computer 1? is pre-programmed to guide the user, via monitor .172, through procedures necessary to maintain system 10. to perform quality control tests on system K>, md to operate system 10 for patient infusions, as well as .to interact with the user, via the touch-semen capability of monitor 172, according to preferred embodiments, in order to track volumes of eluant and of «ate contained within system 10, to track a time from completion of each, elution performed by system 10, to calculate one or more system parameters lot the quality control tests, and to perform various data operations. Computer 17 may also he preprogrammed to internet with the controller of system 10 in order to keep a running tally or count of elutions per unit time, for a given generator employed by the system, md. may further categorize each of the counted elutions, for example, as being generated either as a sample, for quality control testing, or as a dose, for patient injection. The elation count and categorization, along with measurements made. on. each sample or dose, lor example, activity level, volume, How rate, etc. ,,, may he maintained iu a stored record on.;computer; 17 Al1 or a portion of this stored information can be compiled in a report, to be printed locally, and/or to be ckettonicully irsnxforred to e remote location, for example,:via-an jnmbet';cobbeciioh to technical support personnel, suppliers, service providers, etc..., as previously described. Computer 17 may further interact with the user and/or a reader of encoded information, for example, a bar code reader or a radiofrequency Identification (ROD) tag reader, to stone and organize prodnet mforntatioa collected from a product; lahels/tags, thereby facilitating Inyepfory conferoh and/or exm&amp;ming that the proper components, for ex ample, of the tubing ciremt, ahd/of accessories, author solutions ore being used m the system. it should be understood that screen shots shewn in Figures 4-9(/ are exemplary in nature and are presented to provide an outline of some methods of the present invention in which computer .17 facilitates the aforementioned procedures., without limiting the scope of the invention to any particular computer interface formal. Computer 17 may also Include a pre-programmed user manual, which may be viewed on monitor 1.72, either independent of system operation or m conjunction vwth system operation, for example, via pop-up help screens. Although the frn.gti.sh language is employed in the screen shots of Figures 4-9C, it. should iN understood that, according to some embodiments, computer 1" is pre-programmed to provide guidance in xmut-plc languages.

Figure 4 is a screen shot of a main menu 470., which is presented by computer I ? on monitor 172, according to some embodiments. Mam menu 4 70 includes a iSdsgobeaeh <®mp#er~&amp;diitat^ may be;selected by the user, once the user has logged on. According to some multilingual cmbodiments, eotopnter 17 presents a list of languages from which the user may select, prior topresenfeg-maut menu 470.

Figure 5A is a schematic showing a scries of screen shots which includes a log in screen 570. According to some embodiments, when the user touch-sciecis the data catty Odds of screen 570 or 571, or of any of the other, serseas presented herein, below, a virtual keyboard is displayed for touch-select data entry into the selected data entry' held; alternately, computer 17 may be augmented with, another type of device for user data entry, examples of which include, without limitation, a peripheral keyboard device, a storage medium (ft. disk) reader, a scanner, a bar code reader (or other reader of encoded «hand control (he, mouse, joy sriefe, etc- ,,φ

Although not shown, according to some embodiments, screen. 5 70 may forlher include another data entry' field in which the user is required to enter a license key related to the generator employed by system 10 in order to enable operation of system 10; the key may be time sensitive, related to generator cmrriaeh terms. Of course any number of ton in requirements may be employed, according to %^0tiS'<^bodtat^ts.,''aad;Stt8y |>e presented on multiple seqncntiaily appearing screens rather than on a single log. tn screen.

Alter the user enters the appippri ate infomiarion into data entry fields of log in screen 570, computer 17 presents a request fbr the user to eonHmrriie volume of daanithat is within reservoir 15 {e,g. saJmeiB saline bag), via a screen 571, and thee brings up main menu 470. If the user determines that the volume of eluaai/satmo is insufficient, the user selects a menu item 573, to replace the saline bag. If system 10 includes an encoded infbmnnion reader, such:as a bar code or RFID tag reader, confirmation that the selected reservoir is proper, i.e. coatains the proper saline solution, may be carried out by computer 17, prior to connecting the reservoir into circuit 300, by processing information read from a label-lag attached to tbs reservoir. Alternatively, or in addition, tubing line 301 of circuit 300 may be. provided with a connector which only mates who the proper type of reservoir 15. According to some embodiments, system 10 uta\ fin ther mchuL -in osmolarm. or charge 'iouv'cr, which is located j usf dnvmstreani of reservoir 15 and is linked to cotuputcr ; 7,: so -hat: an error message may be presented on monitor !72 stating that the wrong osmoiamy or charge h detected in the eluant supplied by reservoir, indicating m improper solution. One example of a charge detector that may be employed by system 10 is the SeiCon™ Conductivity Sensor (available from SciLog, Inc. of Middleton, WI).

Once the reservoir/saliae bag is successfully replaced, computer 11 prompts the user to enter a quantity of saline contained by the new saline bag, via a screen 5 74. Alternately, if system 10 includes the aforementioned reader, and the saline hag includes a tag by which volume information is provided, the reader may automatically transfer the quantity information to computer 17, Thus, computer 17 uses either the confirmed eluant/sahne volume, via screen 57.1, or the newly entered eluant/saline volume as a baseline from which id tfacfc depletion of reservoir volume, via activations of pump 33, in the operation of system 10. With reference to Figure 5S, during the operation of system 10, when computer 17 detects that the eluant mservoir/saline. bag has been, depleted toa predetermined vvdtrme^threshold, eomputsr 17 Warns the user, via a screen 577. If the user has disregarded screen 51Ί and continues to deplete the saline bag, computer 17 detects when the saline bag is empty and provides indication of the same to the user, via a screen 578. To replenish the resetvoir. sablne bag, the user may either refill the reservoir/bag or replace the empty mservoir/bag with. &amp; full t©§etvoir/bag; According to some emlxxirments, system 10 automatically precludes any: further operation of the system until the reservoir is replenished. It should be noted that, as previously mentioned, system 10 can include a fluid level sensor coupled to the eluant reservoir is order to detect when the le vel of saline drops below a certain level. la addition to tracking the volume of eluant, in reservoir 3 5, computer 17 also tracks a volume of the eluate 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 the user when the user empties waste bottle 23., When the user selects item; 583, computer 17 presents a semen 584, by which, the user may effecti vely command computer 17 to set a waste bottle level indicator to zero, once the user has emptied waste bottle 23. Typically, the user, when powering up system 10 for operation, each day, will either empty waste bottle 23, or confirm that waste bottle 23 was emptied at the end of operation, the previous day, arid utilize screen 584 to set the waste bottle level indicator to zero. Thus, computer 17, can track the tilling of waste bottle 23 via monitor?»*; of the operation of purop 33 and divergence valve 35 W'P, and provide an indication to the user when waste bottle 23 needs to be emptied, for example, via presentation of screen 584, in order to warn the user that, unless emptied, the waste horde will overflow, According to some embodiments, system 10 amomatieally precludes any further operation of the system until the waste bottle is emptied. According to some alternative embodiments, a fluid level sensor, may be coupled to waste bottle, for example, as mentioned above hi conjunction with Figure 1 D> in order to automatically detect when waste bottle is filled to a predetermined level and to provide, vis computer .17, an indication to the user that waste bottle 23 needs to be emptied and/or to automatically preclude operation of system 10 until the waste bottle is emptied, hi addition to the above maintenance steps related to eluant and: elaate Volumes of system 10, the user of system 10 will typically perform quality control tests each day, prior to any patient missions. With reference to Figure 6, according to preferred methods, prior to performing the quality control tests (outlined in conjunction with Figures 7A-C and SA-B), the user may select an item 675 from main menu 470, in order to direct system 10 to wash the column of generator 21. During the generator column wash, which is performed by pumping a predetermined volume of eluant, for example, approximately 50 milliliters, through generator 21 and Ihtotwaste bottle 23, computer 17 provides an indication, via a screen 676, that the w ash is In progress.

Also, during the generator column wash,, the system may preside a signal to indicate that eiuate it being diverted to waste bottle 23, for example, 1C) may: grrifect a. Sashing light signal, as previously described.

Figure 6 further illustrates a screen 677, which is presamed by computer 17 upon completion of the column wash, and which, provides an indication of a time lapse since the completion of the wash, in terms of a tune countdown:, until a subsequen t elution process may be effectively carried out. While screen 677 is displayed, system 10 may he refilling, from reservoir 15, pump 33, which has a capacity of approximately 55 milliliters, according to some embodiments. According to some preferred embodiments of the present invention, computer 17 starts a timer once any elution process is completed and informs the user of foe rime lapse, either in terms of the time countdown (screen 677), or m terms of a time from completion of the elation, for example, .as will be described in conjunction with Figure 7B. According to an exemplary embodiment, wherein generator 21 is the CardfoGen*82# that yields a saline solution of'Rubidium-82, produced by foe decay of Stroniium-82, -via the elution, a time required between two effective elution processes is approximately 10 minutes.

Once the appropriate amount of time has lapsed, after the elation process of generator column wash, a first quality control test may be performed. With reference to Figure 7A. the user may select, from main menu 470, as· item 773A, which directs computer 17 to begits a sequence for break through testing. According so some embodiments, in conjunction with the selection of item 773 A, the user attaches a needle to an end of patient, line oOSp and inserts the needle into to a test vial, for the collection of ao ekaue sample therefrom. and, according to Figure 7 A, computer 17 presents a screen 714:, which instruct.·, the user to insert the test vCal Into a vial silieid, which may beheld in recess tOi of shell 15 f Figure 1C).

Figure 7A fialher Olustrafos a subsequeuUscreen 775, fey which cdptppfor 17 receives Input, fem the user, fiir system 10 to shat the fereaktlamigfe elution, foilowed by a screen 5¾ which provides both m indication tfest the diuflon Isfit progress And an option for the user to abort the elution. As previously deaefibeA. thehystsm may provide a signal to indicate that elution is in progress* lor example, light: projector 100 (Figure 1C) may project a Hashing light signal during that portion of the el ution process when efoate is diverted fro® generator 21 through waste line 30Sw and into waste bottle 23, and then a steady light signal during that: portion of the el ution process when the eioate is diverted from generator 21 through patient line 305p and into the test vial, for example, once activity detector 25 detects a dose rate of approximately 1.0 mCi/se.e in the cleats discharged from generator 21, Another type of light signal, for example, the more rapidly flashing light, as previously described, may be projected when a peak bo ats of radioactivity is detected ® the duals.

Upon completion of the elution process for breakthrough testing, computer 17 presents a screen 777, shown in Figure ?B, which, like screen 677, provides an indication of a time lapse since the completion of the elution, but now in terms of a time since completion of the breakthrough elution process. When the user transfers the vial containing the sample of eluaie into a dose calibrator, to measure the activity of the sample, the user may make a note of the time lapse indicated on-screen ???. With further reference to Figure 7B, once the user has received the activity measure Γτότ.τ: fee dose calibrator, the user pmeeeds m a screen 77$, wh-ch includes daU; entry ficids tor the activity measure and the time between that at which fee dose calibrator measured the activity of the sample and that at which the elution was completed The user may enter the data, via the touch -screen interlace of monitor 172., or via an v Of the other aforementioned devices for user data entry. According to some alternate embodiments, computer 17 may receive the data, electronically, from fee dose calibrator, either via wireless communication or a cable connection.

After the data is entered by the user, computer 17 presents screen 779, from which the user moves back to main menu 470 to perform a system calibration, for example, as will be described in conjunction with Figures 8A~B, although the breakthrough testing is not completed. With reference back to Figure 7A, an item 773B is shown, somewhat faded, in main menu 470;Item 773B may only be effectively selected following the. completion of steps for hem 773Λ, so as to perform a-sec<mdi8^gO'ofbt«a.kfbi0tigh testing. In the second stage, the breakthrough of fee sample of duate collected in the test via! for the breakthrough testing is measured, Aha: time of approximatcly 60 minutes: from the completion oi'the elution that produced the sample. With reference to Figure 7C, ..after tenser selected Mem. 773B from, main menu 470, in order to difeet computer 17 to provide breakthrough test fesidts,: e screen 781 is displayed. Screen 781 includes,for inference,. fee values: previously entered by the user in screen 778, along with another pair of data entry fields into which the user is instructed to enter the breakthrough reading of the sample at 60 minutes and the background radiation reading, respectively. After the user enters this remaining Information, its described above, computer .17 may calculate and then display, on a screen 782, the breakthrough test results. According to the illustrated embodiment computer 17 also displays on screen 782 pre-programmed allow able limits for the result a so that the user may verify- that the breakthrough test: results are in pmupHaoee with acceptable limits, before moving on to &amp; patient irriMon. According toaoms embodiments, system 10 will not allow an Infusion if the results exceed, the: acceptable limits. ami may present a screen explaining that the msults are outside themfeepfeble limits; the screen may forthsr direct the usoi to courtm the generator supphe·, for: example, to order a replacement generator.

With reference to Figure $A, during the aforementioned 60 minute time period, while waiting to complete the breakthrough testing, the- user may perform calibration by selecting item 873 from main menu 470. Upon selection of item $73. computer '1.7 presents &amp; screen 874. which instructs the user to insert a new lest via! into an elution via! shield In addition to placing the vial in ihc shield., the user, preferably, replaces patient, line 305p with a sew patient line, and then attaches a needle to the end of the new patient line for insertion into the test vial, in. order to collect an sluate sample therefrom. After per fesmiag these steps, the user may move to scree®:875v wherein; a plurality of data entry fields are presented; all or some of the fields may be 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 enter a command, via interaction with a subsequent screen 876, to start the caiihmfioa: elution.

With reference to Figure EE, after computer 17 starts the elation process, a screen 87 informs the: user that the calibration elution is in progress and provides an option to abort the elation. As previonsiy :deseftbed, die system may provide an indication that elution is inprogress, for example. light projector 100: (Figure I Cl may flashing ligfet. signal during that portion of the daiiot; process wherr eiuate its diverted from generator 21 through waste line 30Sw and Into waste bottle 23, and then a steady light signal during that portion of the elution process whan aedvity detector 2.5 has detected that a prescribed dose rate threshold is reached, for example, 1 0 mCl/sec, andthe elnate is. being diverted from generator 2:.l,: through the' oewF«hent line, and into the test vial. Another type of fight signal, for example, the more rapidly flashing light, as previously described, may he projected wheu a peak bolus of radioactivity Is. detected in the eluate. Upon completion of the elution process for calibration, computer .17 presents a screen 878, which pro vides an indication of &amp; time lapse since the completion o f the elution, in terms of a time since completion of the calibration elution process. When the user transfers the vial confoinmgftfo sample of citrate into the dose calibrator, to measure tire activity of the sample, the user may make a note of the time lapse indicated on screen 878. With further reference to Figure SB, once the user has received the activity measure from, the dose calibrator, the user proceeds to a screen 879, which includes data entry fields tor the activity treasure and the time, with, respect to the completion of elution, at which the dose calibrator measured: the activity of the sample. Once the data is mput by the user, as described: above, computer calculates a calibration coefficient, or ratio. and presents the ratio on a screen 880. According to Figure 8.8, screen 880 further provides an indication of a desirable range for the calibration ratio and presents an. option for the user to reject the calculated ratio, in which case, the user may instruct computer I ? to recalculate the ratio.

As previously mentioned, same alternate embodiments of the-present invjmtkte include an on board dose calibrator so that:the entire sequence of sample collection and calculation steps, which are described above, in conjunction with Figures 6~8B, for the quality control procedures, may be automated. This automated alternative preferably includes screen shots, similar to some of those described above, which provide a user of the system with information at various stages over the course of the automated procedure and that provide the user with opportunities to modify, overrule and/or: abort one orrnore steps in the procedure. Reprdtess of dm (fc. whether system 10 employs an on board dose calibrator or not), computer 17 may 'bather collect ail quality control test parameters and results into a stored record and/or compile a report iucl udlng all or some of the parameters: and results for: local print put ami/or clsotrome transfer to a remote location.

With, reference to Figure 9 A, upon completion of the ahovC'-descrfoed quality control tests, the user may select an item 971, from, main menu 470.. hi order to direct system Ml to begin &amp; procedure for the generation and automatic: mfusion. of a radtoplMrnmceutical into a patient. As previously described, system 10 infuses the patient with the radtopharmaceniical so that nuclear diagnostic imaging equipotent, for example, a PET scanner, can create images of an organ of the patient, which absorbs the radiopharmaceutical, via detection of radioactive radiation therefrom. According to. Figure 9A, upon selection of item 971, computer .17 presents a screen 972 which indudes a data entry field for a patient identification number. This id&amp;ofiEeatiou number that is entered by tee user is retained by computer 17,in conjunction with the pertinent system parameters associated with the patient's infusion. After the user enters the patient identification number, computer 17 directs, per a screen 973, the user to attach a new patient line and to purge the patient line of air. A subsequent screen 974 presented by compute): 1? Includes data entry fields by which the user may: establish parameters fee the automatic inftision;; all or some of tbs Helds :oiay be filled m with pre^ogmtsnwd default parameters, W: hi ch the user has ao option to change. If Mcessaryr

With reference to Figure .9B, if pump 33 does not contain enough chmm .vd-uv: tor the patient infusion, computer 17 will present a.warning, via a screen 90 L which includes an option for the user to direct the refilling of pump 33, via a. subsequent screen 902. Once pump 33 has been filled, computer 17 presents an indication to the user, vis a screen 903, According to some embodiments, if the user does not re-fill pump 33, yet attempts:to psoceed with an inihsion5:system 10 will preclude the infusion and present another screen, tfiatcsmmanleates io the user that ao infitsiop Is possible» if the pump is not refilled, and asking the user to refill the pump, as in screen 901. When pump 33 contains a sufficient volume of eluant for the patient infusion, computer 17 presents a screen 975, which is shown in Figure 9C, and allows tire user to enter a command for syst em 10 to start the patient infusionDaring the In fission, computer 1,7 provides the user with so. indication that the infusion is in process and with a option for the user to aborithe nrfosion, via a screen: 97h. As previously described, the system may provide an.in^<^jd0a'd3i^;.^.bipiidnisiniprn^essi» for example, fight projector 100 (Figure 1C) may project a flashing light signal doting that portion of the elution process when.eiuate is diverted fiom generator 2 I through waste line 30Sw and into waste bottle 23, and then a steady light sigusldurmg that portion of the elution process when activity detector 25 has detected: lit at a; prescribed dose rate: threshold is reached, ibr example, 1.0 mCi/see. and the elnate is being diverted fiorn generator 21, through the 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 eluate. At the completion of the infusion, a screen 977 is di splayed by computer .17 to inform the user of the completion of the infusion and a time since the completion. Computer 1? also displays a summary of the infusion, per screen 978·

With, further reference to Figure 9€, screen 976 shows as exemplars activity profile (activity - mCi/sec, ony-axis, vcmus iime "- see, os x-uxisf for the infasion/injected dose (designated between the two vertical lines). Those skilled in the art will appreciate that the shape of this profile depends upon'the infusion flow rate, for a given volume of the dose, which How rate is controlled, lor example, by the speed at which, pump 33 drives flow through the patient line, and upon the amount of Stromia.tn.~82 remaining in the generator, in the absence of flow rate control, activity profiles may change over the life of the generator. Furthermore, the peak bolus of radioactivity, particularly for injected doses from a relatively new generator, may exceed a saturation level of the imaging equipment ie. PET scanner. According to some preferred methods of the present invention, in order to maintain relatively consistent, and deslrabie/effsctive, activity profiles for patient injections, over the life of the generator, fee operating speed of pump 33 may be -varied (both over the course of a single injection and from injection to injection), according to feedback from activity detector 25. Such a method may be implemented via incorporation of another qualify control test in which pump 33 is operated to drive flow through the generator at a constant rate, in order to collect, into computer, a plurality of activity measurements from activity detector 25; she plurality of measurements comprise a charaeteristle, or baseline activity prof is from which the computer 17 may calculate an appropriate fow rate profile to control a speed of ριπχφ 33. :¾ order to achieve the profile, In geneml, at the start of gen erator life, ^when Sfcroo.tiunr-82 is plentiful, the pump is comrolled to drive Infusion flow at relatively tower rates, smd, then, toward the end of generator lifer vvhen miseh of fee Siromium-82 has been depleted, the prop is controlled to drive infos ion flow at relatively higher ratesi As was described above, in coni unction with Figure 1D, If a desired: infitsion/hfieetion flow rate is relatively high, that is, high enough to create too much 'back pressure, via flow tkoagh the column of generator 21. by-pass line 303 .may he employed by adjnstiag divergence valve 35BG to divert aflow of efoMf ihfeeitiroiigh after a sullcieni volume has been pumped through generator at a lower How rate. According to this method, once a dose of eluate. from generator 21, hayfiowedipto patient line 30Sp, divergence valve. 35BG is set to divert the flow of eluant through b>v pass line 303, and then pump speed is Increased: to ptimp eluant at a higher flow rate lit order to .push the dose out from patient line 305p, for Injection at the:higher flow rate.

Consistency of activity-profiles- among. injected doses can--greatly::faefiitate the use of PET scanning for the quantification of flow, for example, in coronary perfusion studies. Alternative Infusion circuit configurations, operable according to alternative methods, to achieve consistency of activity profiles among injected doses, as well, as a mote uniform level of radioactivity across each individual dose, will be described below, in conjunction, with Figures 12A-C.

Printer 117 (Figure IB) may be activated to print out a hard copy of the infusion summary, on which the patient identification number and pertinent infusion and system parameters are also printed, for reference. Alternatively, or in addition, according to some embodiments, tire summary may be downloaded onto a computer readable storage device to fee electronically transferred to one or more remote computers and/or die summary may be automatically transferred to the one or more remote computers, feu wireless communications amfole:e^ far example, over an intranet network and/or foe internet. In:order to protect private patient information, foe files may he encrypted for transmission, over the internet The one or more remote computers may be included, tor example, in a hospital information system, and/or a billing system, and/or in a medical imaging system, infusion parameters, for example, corresponding tothe activity pmfile, may also be collected arid electronically transferred for analysis in conjunction with captured images, for example, k order to quantify coronary flow, via a software package that k loaded into a system that includes the PET scanner.

With «defence back fo Figure 9 A the user may select an item 993, from .main menu 470, in order have system .10 perform data operations, such as, archiving a data base of patient infusion information and quality control test, results, transmitting patient inhision summary records: to USB mass storage devices, and various types of data filtering, for example, according to numbers, lor example, to search for &amp; pariicol&amp;r set of onta and or to compil e a summary report of related sets of data. Addttionhiy, certain information, which is collected by computer 1 ? over the course of system operation, and which defines system operation, may be transmitted to a local or remote computerized, inventory system and/or to computers of technical support personnel, mamtenance/serekm providers and/or suppliers of infusion circxik eleraetrisfoomponenis, thereby facilitating, more eMcieni system operation and maintenance.

Turning now to Figure 10, an item 98 .1 for computer-foeuitaied purging of the tubing lines of system 10 is shown included in main menu 470. When s user selects item 981, computer 17 guides the user to select ei them an air purge ox a saline purge. The direction provided by computer 17 is not. explicitly laid out herein, for a saline purge, as procedures for saline purging should be readily apparent to those skilled in the art, with reference to the schematic of infusion circuit 300 shown, in Figure ID. A saline purge of circuit 300 is desired to assure that all the air is removed from circuit 300 when a new generator and/or a new complete or partial tubing set is installed. Ac sir purge of the t ubing lines of circuit 300 may fee performed after removing reservoir 15, by- passing generator 21, fey connecting tubing line 304 to tubing line 305, and coupling p&amp;iienr line 305p to a vial, for example, as is directed by the computer interface, in screens 983 and 984 shown in Figure 10- The air purge is desirable for blowing out the tubing lines, thereby removing ail remaining eluant and ehntie, prior to installing a new generator and/or prior to transporting system 10 from one site to another. If generator 21 is not depleted and will be used in system 10 at the new si te, it is important, to by-pass the generator prior to purging the tubing lines of circuit 300 with air, so that air is not blown across the generator, since air through generator 21 may compromise both the function and the aseptic nature of generator 21.

According to preferred embodiment once· the user has followed the iostmedons presented: in screens 983 and 984 and selects to start the air purge, for example, via screen 985, computer 17 directs the controller of system 10 to carry outM complete air purge, in which pump 33 and divergence: valves 358G and 35WP are autooiatically controlled. The automated'· air purge pteibrably includes 1 the foil bwing steps, which may be best understood with reference to tubing circuit 300 m Figure I D: p tunping any remaining volume of eluant left in pump 33, through lines 302, 304, 305 and 305w> to waste bottle 23; refilling pump 33 with air and pumping the am through Imps 302, 304,305 and 30Sw, into waste bottle 23 (lines 304 and 305 have been •previously connected directly to one another, m order to by-pass generator .21; If generator 21 Is depleted and: will be replaced with a new gesemtor, pump mg air through generator 21 may fee acceptable); refilling:pump 33 with air and then pumping a portion of the air through lines 302, 304,305 and 305p, into the vial, and then, a remaining portion of the air through lines 302,304,303 and 305p, into the vial. With reference to Figure 10 and the previous description of divergence:'valves; 351¾ 35WP, it should be understood how divergence valves 35SG, 35WP are automatically controlled to carry out the above steps.

The purge operations, which are gmilitated,by selecting item 981.from mam menu 470, may also be accessed via the selection of an item , 991 for generator setup.

When the user selects item 991, computer 17 may present an option, for guidance in removing an old, depleted, generator and a set of tubing lines, prior to installing the new -generator, or an option to just be guided in the msi&amp;Ilatuui of the new generator AeeotfMti§|ocomputer 17 is pre-programmed to calculate an amount or activity Soft In a depleted generator, for example, by tracking activity of eluate over a Is a; of the generator. At mend of the life of the generator, computer 17 may further compile this mlomiafcon, along w ife other pertinent generator infomn acton, into &amp;report that may accompany a declaration of dangerous goods for; shipping the depletedgenerator out for disposal or, in some leases, back to the uumufoeturer tor hwesipiofe An example of such a report is shown in Figure 11, According to those embodiments of system TO that include an encoded information reader, computer 17 may confirm that the new generator is proper by- processing kuormation that is read from an encoded labd/tag attached thereto.

Figures 12A-.8 are schematics of alternative infusion circuits 1.300A, 1300B •hat may be employed by system 10, in place of circuit 300 (Figure 1D), according to some additional embodiments of the present invention. Circuits I300A, 1300B are configured to allow for alternative methods of operation, to that previously described for circuit 300, when a relatively even, or uniform level of activity over each injected dose, alon g with the relatively consistent level of activity irom injection to injection is desired, for example, in order to facilitate a quantification of coronary artery blood flow via PBTscMmng< Figure 120 is &amp; schematic illushnting aetivity profiles dfifiOA, 1200B fbt two injected doses, wherein profile 1200B has a more uniform level of activity: than profile i;2f|0A; profile 120013 may be achieved, via the operation of circuits 1300A, 13008· ss described below,

Simi!ar to dreuif 300 (Figure ID), dashed tines are shown: 1« each of Figures 12A~B to indicate a general boundary' of a shielding' assembly for portions of each circuit 1300A, 13008. The shielding assembly for each, of circuits 1300A, 1300B maybe very situ ilar, in most respeets, to shielding; assembly1200* which is described above; for system. 10, and fee. elements of each of circuits 1300A, 130GB may fee arranged; with, respect to their rcsptwtive shielding and wife respect to shell 13 of system 1-0 in a; •Similar manner to that described above for circuit 300.

Figure 12A illustrates circuit 1300A including, like the previously described circuit 300, eluant reservoir 15, pump 33, radioisotope generator 21, through which the filtered ennrnt is pumped to create the radioactive eluate, activity defector 25. arid waste bottle 23. Figure 12A further illustrates two filters 3? and two pressure transducers 1334 included in circuit 1300A, Circuit 1300Λ further includes by-pass tubing line 303, which is located downstream of divergence valve 35 BG, like in circuit 300, and which aceora-nodate* the previous!? described eluanbsaline flush, However, in contrast to circuit 300, circuit 1300A further includes a hneanproporiionai valve 1335 integrated into by-pass/flush line 303 so that circuit. 1300a may he operated, for example, according to pre-programmed parameters of computer 17, in conjunction with feedback of information, from activity detector 25, for a controlled hy-pas$ of generator 21 in order to mix eluant wife eluate and, thereby, achieve a relatively uniform level of activity over each patient, injection, for example, according to profile 1200B of Figure !2C. it should be noted feat, in addition to the controlled mixing, a flow rate of each injection may be varied, if necessary, m order to maintain a consistent activity level. figure 12B illustrates circuit ! 3008 Including, like the previously described circuit 300, eluant reservoir 15, pump 33, radioisotepe generator 21, activity detector 25, and waste bottle 23, «.well as feetwo ftltersGdandtwo pressuretransditeet? 1334, as in circuit 1390A. In contrast to circuits 300 and 1300A, circuit 13098 lumber includes an eluate reservoir 1350, which is shown located downstream of generator 21, in between first and second segments 305A, 305B of fee eluate tubing line. It. should be noted that a pump is combined, wife reservoir 1350, for. example* similar to syringe pump 3¾ such that, when a divergence valve 133510 is set to allow fluid communication between. reservoir 1350 and tubing line segment 305A, the associated pump mm he operated to draw in a vol ume of eluate, and, then, when di vergence valve 133510 is set to allot? fluid communication between reservoir J35fi and tubing line segment 305B. the pump may be operated to push the volume of eluate out through tubing line segment 305B for a patient Injection, when divergence valve 3SWP is set to direct flow into patient line 305f Wife reference buck to Figures 3Λ-Β, sidewall 205 of shielding assembly 200 may fee enlarged to iinther enclose eluate reservoir 1350, For example, another shielded well, to house the eluate reservoir* may extend alongside well 255, in which activity detector 25 is described as being: mounted. Furthermore, sidewall 205 may include another valve actuator receptacle for divergence valve 133510, similar to receptacle 253, shown In Figure 3Aibr divergence valve 35WP.

Collection of discrete volumes of elnate, in a reservoir 1350, may help to achieve a more uniform activity level over each injection, for example, like that of a profile |200B in Figure !2€, and, according to preferred methods, feedback from activity detector 25 may be used to control the pump associated with reservoir 1350, in order to vary injection How rate and, thereby, maintain a relatively consistent activity level across multiple injections» and, when necessary., to vary injection ilow rate over an individual injection to maintain the uniform activity level. Feedback from the pressure transducer 1334, that is downstream from detector 25, and/or from a flow meter (not shown) of circuit I300B may also he used to control the varying of injection flow rate.

With further reference to Figures Γ2Α-Β. it should be noted felt alternative circuits may: be eonfi gored to employ a combination· o f the methods described for circuits 1300A and 130OB, Pinthermore, some infusion circuits of the present invention, may employ multiple generators 2.1 f m mentioned above, ibreonjupefiop· with. Figure 2A, ίο help maintain the relatively uniform level, of activity over each: injection, and the relatively consistent level of activity from injection to In j ection ;

In the foregoing detailed description, the inyeMlonbasbcen deseribed ^ith reference to specific embodiments. However, it may be appreciated that various modifications and changes can be made without depart ing from the scope of the invention as set forth in the appended claims, bribe claims which, follow and in the preceding description of the inveniiom except where the context requires otherwise due to express language or accessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, i.e. to specify the presence of the Stated features but not. to preclude the presence or sddMoo; of further featuresM Invent ion.

It. Is to be understood that, if any prior art publication is referred to herein, such reference does not constitute an admission that the publication forms'a part of the common general knowledge in the art, in Australia or any: other country.

Claims (90)

1. THE ΓΤ ATMS DEFINING THE INVENTION ARE AS FOLLOWS:

   1. An infusion system on-board a cart comprising: a cabinet structure that comprises: a platform, an exterior shell that extends upwardly above the platform and has a front side; a rear side; two sidewalls connecting the front side to the rear side; and a top surface; wherein the platform and the exterior shell collectively define an interior space of the cabinet structure and wherein the interior space of the cabinet structure is configured to receive a strontium-rubidium radioisotope generator having an inlet tubing port configured to receive saline and an outlet tubing port configured to discharge a rubidium radioactive eluate, an opening through the exterior shell configured to provide access to the strontium-rubidium radioisotope generator within the interior space of the cabinet structure, and an opening through the top surface of the exterior shell configured to provide access for inserting a waste bottle into or removing the waste bottle from the interior space of the cabinet structure; a computer with a touch screen display configured to receive an input from a user for controlling operation of the infusion system, wherein the touch screen display is mounted on a vertical post having a top end extending above the cabinet structure; a first shielding compartment in the interior space of the cabinet structure having a first opening facing vertically upwardly through which the strontium-rubidium radioisotope generator can be inserted into and removed from the first shielding compartment; a first door accessible via the opening through the exterior shell, the first door being configured to provide access to the first shielding compartment and to close over the first opening; a second shielding compartment having a second opening facing vertically upwardly through which the waste bottle can be inserted into and removed from the second shielding compartment; a second door accessible via the opening through the top surface of the exterior shell, the second door being configured to provide access to the second shielding compartment and to close over the second opening; wherein the first opening is located at a lower elevation than the second opening; a radioactivity detector positioned to measure radioactivity of the rubidium radioactive eluate flowing through an eluate tubing line in fluid communication with the outlet tubing port of the strontium-rubidium radioisotope generator; a shielded well on-board the cart configured to receive an eluate reservoir, wherein the eluate reservoir is configured to receive a test sample; and wherein the computer of the infusion system is configured to: provide a stop button on the touch screen display to abort a function of the infusion system in response to a user input activating the stop button, pump saline from a saline reservoir positioned outside of the interior space of the cabinet structure into the strontium-rubidium radioisotope generator through the inlet tubing port of the strontium-rubidium radioisotope generator thereby generating the rubidium radioactive eluate that is discharged through the outlet tubing port, fill the eluate reservoir in the shielded well on-board the cart with the test sample of the rubidium radioactive eluate, determine a strontium breakthrough test result on the test sample filled into the eluate reservoir in the shielded well on-board the cart while the eluate reservoir remains in the shielded well on-board the cart, and not allow a patient infusion if the strontium breakthrough test result is greater than or equal to an allowed limit.
2. 2. The infusion system of claim 1, further comprising: the strontium-rubidium radioisotope generator in the first shielding compartment in the interior space of the cabinet structure, and the eluate reservoir located in the shielded well on-board the cart and in fluid communication with the eluate tubing line.
3. 3. The infusion system of claim 1, wherein the first shielding compartment comprises two tubing passageways formed in a perimeter surface of the first opening, and each of the two tubing passageways has a depth configured to prevent pinching or crushing of a corresponding tubing line routed therethrough when the first door is closed thereover.
4. 4. The infusion system of claim 1, wherein the opening through the exterior shell configured to provide access to the strontium-rubidium radioisotope generator within the interior space of the cabinet structure is through the front side of the exterior shell.
5. 5. The infusion system of claim 1, further comprising: a handle configured for the user to grasp in order to move the infusion system, and four wheels mounted to an underside of the platform of the cabinet structure.
6. 6. The infusion system of claim 1, wherein access to an operation of the computer is regulated through a user login credential.
7. 7. The infusion system of claim 1, wherein the infusion system is configured to determine the strontium breakthrough test result on the test sample at least once a day.
8. 8. The infusion system of claim 1, wherein the function of the infusion system aborted in response to the user input activating the stop button is a patient infusion procedure.
9. 9. The infusion system of claim 1, further comprising a waste tubing line and a valve, wherein the waste tubing line is in fluid communication with the eluate tubing line and the waste bottle, and the valve is configured to control fluid flow between the eluate tubing line and the waste bottle via the waste tubing line.
10. 10. The infusion system of claim 1, further comprising a hanger configured to hold the saline reservoir at an elevation above the top surface of the exterior shell.
11. 11. The infusion system of claim 1, wherein the cabinet structure has a lowermost portion and the platform has a lower surface, the first opening is at a first elevation, the second opening is at a second elevation, the first elevation is between approximately 1 foot and approximately 2 feet, with respect to the lowermost portion of the cabinet structure, and the second elevation is between approximately 2 feet and approximately 3 feet, with respect to the lower surface of the platform.
12. 12. The infusion system of claim 2, wherein the cabinet structure has a lowermost portion and the platform has a lower surface, the first opening is at a first elevation, the second opening is at a second elevation, the first elevation is between approximately 1 foot and approximately 2 feet, with respect to the lowermost portion of the cabinet structure, and the second elevation is between approximately 2 feet and approximately 3 feet, with respect to the lower surface of the platform.
13. 13. The infusion system of claim 1, further comprising a dose calibrator in the shielded well on-board the cart and in communication with the computer to determine the strontium breakthrough test result.
14. 14. The infusion system of claim 1, wherein the computer of the infusion system is further configured to track a volume of the saline remaining in the saline reservoir and to alert the user via the touch screen display when the volume of the saline remaining in the saline reservoir is below a predetermined volume threshold.
15. 15. The infusion system of claim 1, wherein the strontium breakthrough test result is for at least one of strontium-82 and strontium-85.
16. 16. The infusion system of claim 1, wherein the computer of the infusion system is further configured to track a volume of the rubidium radioactive eluate discharged from the strontium-rubidium radioisotope generator to the waste bottle and to control the touch screen display to display a user screen guiding the user to empty the waste bottle.
17. 17. The infusion system of claim 1, wherein the first door is mounted via a hinge and configured to open in an upward direction.
18. 18. The infusion system of claim 1, further comprising: a USB port to transfer data and a power inlet port for connecting the infusion system to a power source, and a printer configured to print a document concerning a patient infusion or a quality control test result generated by the infusion system.
19. 19. The infusion system of claim 1, further comprising a light projector mounted on the top end of the vertical post extending above the cabinet structure, wherein the light projector is configured to: project a first light signal to indicate that an elution is taking place, and project a second light signal to indicate that a peak bolus of radioactivity is detected.
20. 20. The infusion system of claim 1, wherein the exterior shell further includes a saline tubing opening configured for a saline tubing line to pass from the saline reservoir outside of the exterior shell to the interior space of the cabinet structure.
21. 21. The infusion system of claim 1, wherein the computer of the infusion system is further configured to pump saline through the strontium-rubidium radioisotope generator at a rate less than approximately 70 ml/min.
22. 22. The infusion system of claim 1, further comprising an electrical connector port accessible through an electrical connector port opening on the exterior shell and configured to place the infusion system in communication with at least one of an intranet network, an internet network, and a device used for a nuclear imaging procedure.
23. 23. The infusion system of claim 1, further comprising: a front cover that is movable relative to the exterior shell to close the opening through the exterior shell configured to provide access to the strontium-rubidium radioisotope generator, and a top cover that is movable relative to the exterior shell to close the opening through the top surface of the exterior shell.
24. 24. The infusion system of claim 1, further comprising: a hanger configured to hold the saline reservoir at an elevation above the top surface of the exterior shell, a handle configured for the user to grasp in order to move the infusion system, four wheels mounted to an underside of the platform, a power inlet port for connecting the infusion system to a power source, and a printer configured to print a document concerning a patient infusion or a quality control test result generated by the infusion system; wherein: the first shielding compartment comprises two tubing passageways formed in a perimeter surface of the first opening, each of the two tubing passageways has a depth configured to prevent pinching or crushing of a corresponding tubing line routed therethrough when the first door is closed thereover, the first door is mounted via a hinge, access to an operation of the computer is regulated through a user login credential, the strontium breakthrough test result is for at least one of strontium-82 and strontium-85, and the exterior shell further includes a saline tubing opening configured for a saline tubing line to pass from the saline reservoir outside of the exterior shell to the interior space of the cabinet structure; and wherein the computer of the infusion system is further configured to: determine the strontium breakthrough test result on the test sample at least once a day, pump saline through the strontium-rubidium radioisotope generator at a rate less than approximately 70 ml/min, track a volume of the rubidium radioactive eluate discharged from the strontium-rubidium radioisotope generator to the waste bottle and to control the touch screen display to display a user screen guiding the user to empty the waste bottle, and track a volume of the saline remaining in the saline reservoir and to alert the user via the touch screen display when the volume of the saline remaining in the saline reservoir is below a predetermined volume threshold.
25. 25. The infusion system of claim 24, wherein the infusion system further comprises: the strontium-rubidium radioisotope generator with the inlet tubing port configured to receive saline and the outlet tubing port configured to discharge the rubidium radioactive eluate; a light projector mounted on the top end of the vertical post extending above the cabinet structure, wherein the light projector is configured to: project a first light signal to indicate that an elution is taking place, and project a second light signal to indicate that a peak bolus of radioactivity is detected; the eluate reservoir located inside the shielded well on-board the cart and in fluid communication with the eluate tubing line; a waste tubing line in fluid communication with the eluate tubing line and the waste bottle; a valve configured to control fluid flow between the eluate tubing line and the waste bottle via the waste tubing line; and a pedal configured to brake at least one of the four wheels when the pedal is depressed.
26. 26. The infusion system of claim 25, wherein the cabinet structure has a lowermost portion and the platform has a lower surface, the first opening is at a first elevation, the second opening is at a second elevation, the first elevation is between approximately 1 foot and approximately 2 feet, with respect to the lowermost portion of the cabinet structure, and the second elevation is between approximately 2 feet and approximately 3 feet, with respect to the lower surface of the platform.
27. 27. The infusion system of claim 24, further comprising a dose calibrator located in the shielded well on-board the cart and in communication with the computer, wherein the dose calibrator is configured to determine the strontium breakthrough test result; and wherein the opening through the exterior shell configured to provide access to the strontium-rubidium radioisotope generator within the interior space of the cabinet structure is through the front side of the exterior shell.
28. 28. The infusion system of claim 27, further comprising: the strontium-rubidium radioisotope generator with the inlet tubing port configured to receive saline and the outlet tubing port configured to discharge the rubidium radioactive eluate, the eluate reservoir located inside the shielded well on-board the cart and in fluid communication with the eluate tubing line, a waste tubing line in fluid communication with the eluate tubing line and the waste bottle, and a valve configured to control fluid flow between the eluate tubing line and the waste bottle via the waste tubing line.
29. 29. The infusion system of claim 28, wherein the computer of the infusion system is configured to: measure an activity of the test sample filled into the eluate reservoir in the shielded well on-board the cart while the eluate reservoir remains in the shielded well on-board the cart, wherein the activity is measured with the dose calibrator in the shielded well on-board the cart, and calibrate the infusion system based on the activity measured by the dose calibrator.
30. 30. The infusion system of claim 29, wherein the cabinet structure has a lowermost portion and the platform has a lower surface, the first opening is at a first elevation, the second opening is at a second elevation, the first elevation is between approximately 1 foot and approximately 2 feet, with respect to the lowermost portion of the cabinet structure, and the second elevation is between approximately 2 feet and approximately 3 feet, with respect to the lower surface of the platform.
31. 31. A method of using an infusion system on-board a cart to deliver a rubidium radioactive eluate comprising: installing a saline reservoir on the infusion system, wherein the infusion system comprises a platform and an exterior shell extending upwardly above the platform, and wherein the platform and the exterior shell collectively define an interior space of a cabinet structure; placing the saline reservoir in fluid communication through a saline tubing line with an inlet tubing port of a strontium-rubidium radioisotope generator located in a first shielding compartment in the interior space of the cabinet structure, wherein the strontium-rubidium radioisotope generator further comprises an outlet tubing port configured to discharge the rubidium radioactive eluate, and wherein the first shielding compartment has a first opening facing vertically upwardly; inserting a waste bottle into a second shielding compartment on-board the cart, wherein the second shielding compartment on-board the cart has a second opening facing vertically upwardly and being at a higher elevation than the first opening; placing the waste bottle in fluid communication with the outlet tubing port of the strontium-rubidium radioisotope generator through an eluate tubing line, wherein a computer on-board the cart is configured to control the fluid communication between the waste bottle and the outlet tubing port, and wherein the computer has a touch screen display mounted on a vertical post with a top end extending above the cabinet structure; inserting an eluate reservoir in a shielded well on-board the cart; placing the eluate reservoir in fluid communication with the eluate tubing line, wherein the computer is further configured to control the fluid communication between the eluate reservoir and the eluate tubing line; pumping a sample of the rubidium radioactive eluate into the eluate reservoir in the shielded well on-board the cart; measuring a radioactivity of the sample of the rubidium radioactive eluate flowing through the eluate tubing line with a radioactivity detector on-board the cart while the sample of the rubidium radioactive eluate is flowing through the eluate tubing line; measuring a calibration radioactivity of the sample pumped into the eluate reservoir in the shielded well on-board the cart while the eluate reservoir remains in the shielded well onboard the cart; comparing the radioactivity of the sample of the rubidium radioactive eluate flowing through the eluate tubing line measured by the radioactivity detector on-board the cart while the sample of the rubidium radioactive eluate is flowing through the eluate tubing line with the calibration radioactivity of the sample pumped into the eluate reservoir in the shielded well onboard the cart; and determining a strontium breakthrough test result on the sample pumped into the eluate reservoir in the shielded well on-board the cart while the eluate reservoir remains in the shielded well on-board the cart, wherein the computer of the infusion system is further configured to not allow a patient infusion if the strontium breakthrough test result is greater than or equal to an allowed limit.
32. 32. The method of claim 31, further comprising: placing the eluate tubing line in fluid communication with a patient, wherein the computer is further configured to control the fluid communication between the eluate tubing line and the patient; pumping a dose of the rubidium radioactive eluate to the patient; and flushing the rubidium radioactive eluate remaining in at least a portion of the eluate tubing line into the patient by pumping saline from the saline reservoir to the eluate tubing line through a by-pass line that by-passes the strontium-rubidium radioisotope generator, wherein the computer is further configured to control fluid communication via the by-pass line.
33. 33. The method of claim 31, wherein the computer of the infusion system is further configured to present on the touch screen display the strontium breakthrough test result.
34. 34. The method of claim 31, wherein the cabinet structure has a lowermost portion and the platform has a lower surface, the first opening is at a first elevation, the second opening is at a second elevation, the first elevation is between approximately 1 foot and approximately 2 feet, with respect to the lowermost portion of the cabinet structure, and the second elevation is between approximately 2 feet and approximately 3 feet, with respect to the lower surface of the platform.
35. 35. The method of claim 31, wherein the saline tubing line and the eluate tubing line are routed through two tubing passageways formed in a perimeter surface of the first opening, wherein each of the two tubing passageways has a depth configured to prevent pinching or crushing of a corresponding tubing line routed therethrough when a first door is closed over the first opening.
36. 36. The method of claim 31, wherein the infusion system further comprises a dose calibrator in the shielded well on-board the cart, wherein the dose calibrator is in communication with the computer to determine the strontium breakthrough test result.
37. 37. The method of claim 31, wherein the computer of the infusion system is further configured to: track a volume of saline remaining in the saline reservoir, and provide an alert via the touch screen display when the volume of saline remaining in the saline reservoir is below a predetermined volume threshold.
38. 38. The method of claim 31, wherein the computer of the infusion system is further configured to: track a volume of the rubidium radioactive eluate discharged from the strontium-rubidium radioisotope generator to the waste bottle, and present on the touch screen display a screen reminding a user to empty the waste bottle.
39. 39. The method of claim 32, further comprising: logging into the computer by entering a user login credential on the touch screen display, transferring a patient infusion record via a USB port, and printing a document concerning the patient infusion or a quality control test result via a printer.
40. 40. The method of claim 31, wherein the computer of the infusion system is further configured to: project a first light signal from a light projector mounted on the top end of the vertical post extending above the cabinet structure to indicate that an elution is taking place, and project a second light signal from the light projector to indicate that a peak bolus of radioactivity is detected.
41. 41. The method of claim 31, wherein the computer of the infusion system is further configured to pump saline through the strontium-rubidium radioisotope generator at a rate less than approximately 70 ml/min.
42. 42. The method of claim 31, further comprising: initiating a generator column wash through the touch screen display, wherein a predetermined amount of saline is pumped through the strontium-rubidium radioisotope generator and directed to the waste bottle during the generator column wash.
43. 43. The method of claim 32, further comprising: initiating a purging process through the touch screen display to purge a patient tubing line of air, wherein the patient tubing line is in fluid communication with the eluate tubing line.
44. 44. The method of claim 31, wherein the computer of the infusion system is further configured to track time passed from completion of pumping the sample of the rubidium radioactive eluate into the eluate reservoir to determining the strontium breakthrough test result.
45. 45. The method of claim 31, further comprising: entering a patient ID on the touch screen display, entering a patient dose on the touch screen display, and entering a flow rate on the touch screen display.
46. 46. The method of claim 32, wherein the computer of the infusion system is further configured to present on the touch screen display a screen reminding a user to insert the eluate reservoir in the shielded well on-board the cart.
47. 47. The method of claim 32, wherein the computer of the infusion system is further configured to present on the touch screen display a screen for starting the patient infusion by touching a button on the touch screen display.
48. 48. The method of claim 32, wherein the computer of the infusion system is further configured to present on the touch screen display a screen indicating that the patient infusion is in process, wherein the screen indicating that the patient infusion is in process displays a stop button to abort the patient infusion.
49. 49. The method of claim 31, wherein the saline reservoir is located outside of the interior space of the cabinet structure.
50. 50. The method of claim 31, wherein the infusion system further comprises: a handle configured for a user to grasp in order to move the infusion system, and four wheels mounted to an underside of the platform of the cabinet structure.
51. 51. The method of claim 32, wherein the computer of the infusion system is further configured to: present on the touch screen display a screen for starting the patient infusion by touching a button on the touch screen display; present on the touch screen display a screen reminding a user to insert the eluate reservoir in the shielded well on-board the cart; present on the touch screen display a screen indicating that the patient infusion is in process, wherein the screen indicating that the patient infusion is in process displays a stop button to abort the patient infusion; and present on the touch screen display the strontium breakthrough test result.
52. 52. The method of claim 51, further comprising: logging into the computer by entering a user login credential on the touch screen display, entering a patient ID on the touch screen display, entering a patient dose on the touch screen display, and entering a flow rate on the touch screen display.
53. 53. The method of claim 52, wherein the computer of the infusion system is further configured to: track a volume of saline remaining in the saline reservoir, provide an alert via the touch screen display when the volume of saline remaining in the saline reservoir is below a predetermined volume threshold, and present on the touch screen display a screen reminding the user to empty the waste bottle.
54. 54. The method of claim 53, further comprising: initiating a generator column wash through the touch screen display, wherein a predetermined amount of saline is pumped through the strontium-rubidium radioisotope generator and directed to the waste bottle during the generator column wash, and initiating a purging process through the touch screen display to purge a patient tubing line of air, wherein the patient tubing line is in fluid communication with the eluate tubing line.
55. 55. The method of claim 54, wherein the saline tubing line and the eluate tubing line are routed through two tubing passageways formed in a perimeter surface of the first opening, wherein each of the two tubing passageways has a depth configured to prevent pinching or crushing of a corresponding tubing line routed therethrough when a first door is closed over the first opening.
56. 56. The method of claim 55, wherein the infusion system further comprises: a handle configured for the user to grasp in order to move the infusion system, and four wheels mounted to an underside of the platform of the cabinet structure.
57. 57. The method of claim 56, wherein the computer of the infusion system is further configured to: project a first light signal from a light projector mounted on the top end of the vertical post extending above the cabinet structure to indicate that an elution is taking place, and project a second light signal from the light projector to indicate that a peak bolus of radioactivity is detected.
58. 58. The method of claim 57, wherein the cabinet structure has a lowermost portion and the platform has a lower surface, the first opening is at a first elevation, the second opening is at a second elevation, the first elevation is between approximately 1 foot and approximately 2 feet, with respect to the lowermost portion of the cabinet structure, and the second elevation is between approximately 2 feet and approximately 3 feet, with respect to the lower surface of the platform.
59. 59. The method of claim 56, wherein the infusion system further comprises a dose calibrator in the shielded well on-board the cart and in communication with the computer to determine the strontium breakthrough test result.
60. 60. The method of claim 59, wherein the cabinet structure has a lowermost portion and the platform has a lower surface, the first opening is at a first elevation, the second opening is at a second elevation, the first elevation is between approximately 1 foot and approximately 2 feet, with respect to the lowermost portion of the cabinet structure, and the second elevation is between approximately 2 feet and approximately 3 feet, with respect to the lower surface of the platform.
61. 61. A method of building an infusion system to deliver a rubidium radioactive eluate comprising: installing a first shielding compartment, a second shielding compartment, and a shielded well on a platform of a cart, wherein: the first shielding compartment has a first opening facing vertically upwardly, the first opening is configured for a strontium-rubidium radioisotope generator to be inserted into and removed from the first shielding compartment, the second shielding compartment has a second opening facing vertically upwardly, the second opening is configured for a waste bottle to be inserted into and removed from the second shielding compartment, the first opening is located at a lower elevation than the second opening, and the shielded well is configured to receive an eluate reservoir that is configured to receive a sample of the rubidium radioactive eluate; configuring a computer with a touch screen display for the infusion system to: fill the eluate reservoir in the shielded well on-board the cart with the sample of the rubidium radioactive eluate by pumping saline from a saline reservoir into the strontium-rubidium radioisotope generator via a saline tubing line thereby generating the rubidium radioactive eluate that is discharged through an eluate tubing line, determine a strontium breakthrough test result on the sample of the rubidium radioactive eluate filled into the eluate reservoir in the shielded well on-board the cart while the eluate reservoir remains in the shielded well on-board the cart, and not allow a patient infusion if the strontium breakthrough test result is greater than or equal to an allowed limit.
62. 62. The method of claim 61, further comprising configuring the computer to: measure a radioactivity of the sample of the rubidium radioactive eluate while the sample is flowing through the eluate tubing line to the eluate reservoir; measure a calibration radioactivity of the sample while the sample remains in the eluate reservoir in the shielded well on-board the cart; and compare the radioactivity of the sample measured while flowing through the eluate tubing line with the calibration radioactivity of the sample measured in the eluate reservoir in the shielded well on-board the cart.
63. 63. The method of claim 61, further comprising configuring the computer to: control a fluid communication between the strontium-rubidium radioisotope generator and the saline reservoir, control a fluid communication between the eluate tubing line and the eluate reservoir, control a fluid communication between the eluate tubing line and the waste bottle, place the eluate tubing line in fluid communication with a patient, pump a dose of the rubidium radioactive eluate to the patient; and flush the rubidium radioactive eluate remaining in at least a portion of the eluate tubing line into the patient by pumping saline from the saline reservoir to the eluate tubing line through a by-pass line that by-passes the strontium-rubidium radioisotope generator.
64. 64. The method of claim 61, further comprising installing an exterior shell extending upwardly above the platform, wherein: the exterior shell comprises a front side; a rear side; two sidewalls; and a top surface, the platform and the exterior shell collectively define an interior space of a cabinet structure, the cabinet structure has a lowermost portion and the platform has a lower surface, the first opening is at a first elevation, the second opening is at a second elevation, the first elevation is between approximately 1 foot and approximately 2 feet, with respect to the lowermost portion of the cabinet structure, and the second elevation is between approximately 2 feet and approximately 3 feet, with respect to the lower surface of the platform.
65. 65. The method of claim 61, wherein the infusion system is configured for the saline tubing line and the eluate tubing line to be routed through two tubing passageways formed in a perimeter surface of the first opening, wherein each of the two tubing passageways has a depth configured to prevent pinching or crushing of a corresponding tubing line routed therethrough when a first door is closed over the first opening.
66. 66. The method of claim 62, further comprising installing a dose calibrator in the shielded well on-board the cart, wherein the dose calibrator is in communication with the computer to measure the strontium breakthrough test result and the calibration radioactivity of the sample pumped into the eluate reservoir.
67. 67. The method of claim 61, further comprising configuring the computer to: track a volume of saline remaining in the saline reservoir, and provide an alert via the touch screen display when the volume of saline remaining in the saline reservoir is below a predetermined volume threshold.
68. 68. The method of claim 61, further comprising configuring the computer to: track a volume of the rubidium radioactive eluate discharged from the strontium-rubidium radioisotope generator to the waste bottle, and present on the touch screen display a screen reminding a user to empty the waste bottle.
69. 69. The method of claim 62, further comprising configuring the computer to allow a user to: log into the computer by entering a user login credential on the touch screen display, transfer a patient infusion record via a USB port, and print a document concerning the patient infusion or a quality control test result via a printer.
70. 70. The method of claim 64, further comprising installing a light projector on a top end of a vertical post extending above the cabinet structure to: project a first light signal from the light projector to indicate that an elution is taking place, and project a second light signal from the light projector to indicate that a peak bolus of radioactivity is detected.
71. 71. The method of claim 61, wherein the infusion system is configured to pump saline through the strontium-rubidium radioisotope generator at a rate less than approximately 70 ml/min.
72. 72. The method of claim 61, further comprising configuring the computer to allow a user to: initiate a generator column wash through the touch screen display, wherein a predetermined amount of saline is pumped through the strontium-rubidium radioisotope generator and directed to the waste bottle during the generator column wash.
73. 73. The method of claim 62, further comprising configuring the computer to allow a user to: initiate a purging process through the touch screen display to purge a patient tubing line of air, wherein the patient tubing line is in fluid communication with the eluate tubing line.
74. 74. The method of claim 61, further comprising configuring the computer to track time passed from completion of pumping the sample of the rubidium radioactive eluate into the eluate reservoir to measuring the strontium breakthrough test result.
75. 75. The method of claim 61, further comprising configuring the computer to allow a user to: enter a patient ID on the touch screen display, enter a patient dose on the touch screen display, and enter a flow rate on the touch screen display.
76. 76. The method of claim 62, further comprising configuring the computer to present on the touch screen display a screen reminding a user to insert the eluate reservoir in the shielded well on-board the cart.
77. 77. The method of claim 62, further comprising configuring the computer to present on the touch screen display a screen for starting the patient infusion by touching a button on the touch screen display.
78. 78. The method of claim 62, further comprising configuring the computer to present on the touch screen display a screen indicating that the patient infusion is in process, wherein the screen indicating that the patient infusion is in process displays a stop button to abort the patient infusion.
79. 79. The method of claim 64, wherein the saline reservoir is located outside of the interior space of the cabinet structure.
80. 80. The method of claim 64, wherein the infusion system further comprises: a handle configured for a user to grasp in order to move the infusion system, and four wheels mounted to an underside of the platform of the cabinet structure.
81. 81. The method of claim 62, further comprising configuring the computer to: present on the touch screen display a screen for starting the patient infusion by touching a button on the touch screen display; present on the touch screen display a screen reminding a user to insert the eluate reservoir in the shielded well on-board the cart; present on the touch screen display a screen indicating that the patient infusion is in process, wherein the screen indicating that the patient infusion is in process displays a stop button to abort the patient infusion; and present on the touch screen display the strontium breakthrough test result.
82. 82. The method of claim 81, further comprising configuring the computer to allow the user to: log into the computer by entering a user login credential on the touch screen display, enter a patient ID on the touch screen display, enter a patient dose on the touch screen display, and enter a flow rate on the touch screen display.
83. 83. The method of claim 82, further comprising configuring the computer to: track time passed from completion of pumping the sample of the rubidium radioactive eluate into the eluate reservoir to measuring the strontium breakthrough test result, track a volume of saline remaining in the saline reservoir, provide an alert via the touch screen display when the volume of saline remaining in the saline reservoir is below a predetermined volume threshold, track a volume of the rubidium radioactive eluate discharged from the strontium-rubidium radioisotope generator to the waste bottle, and present on the touch screen display a screen reminding the user to empty the waste bottle.
84. 84. The method of claim 83, further comprising configuring the computer to allow the user to: initiate a generator column wash through the touch screen display, wherein a predetermined amount of saline is pumped through the strontium-rubidium radioisotope generator and directed to the waste bottle during the generator column wash, and initiate a purging process through the touch screen display to purge a patient tubing line of air, wherein the patient tubing line is in fluid communication with the eluate tubing line.
85. 85. The method of claim 84, wherein the infusion system is configured for the saline tubing line and the eluate tubing line to be routed through two tubing passageways formed in a perimeter surface of the first opening, wherein each of the two tubing passageways has a depth configured to prevent pinching or crushing of a corresponding tubing line routed therethrough when a first door is closed over the first opening.
86. 86. The method of claim 85, wherein the infusion system further comprises: an exterior shell extending upwardly above the platform, wherein the platform and the exterior shell collectively define an interior space of a cabinet structure, a handle configured for the user to grasp in order to move the infusion system, and four wheels mounted to an underside of the platform of the cabinet structure.
87. 87. The method of claim 86, further comprising configuring the computer to: project a first light signal from a light projector mounted on a top end of a vertical post extending above the cabinet structure to indicate that an elution is taking place, and project a second light signal from the light projector to indicate that a peak bolus of radioactivity is detected.
88. 88. The method of claim 87, wherein the cabinet structure has a lowermost portion and the platform has a lower surface, the first opening is at a first elevation, the second opening is at a second elevation, the first elevation is between approximately 1 foot and approximately 2 feet, with respect to the lowermost portion of the cabinet structure, and the second elevation is between approximately 2 feet and approximately 3 feet, with respect to the lower surface of the platform.
89. 89. The method of claim 86, wherein the infusion system further comprises a dose calibrator in the shielded well on-board the cart and wherein the dose calibrator is in communication with the computer to measure the strontium breakthrough test result.
90. 90. The method of claim 89, wherein the cabinet structure has a lowermost portion and the platform has a lower surface, the first opening is at a first elevation, the second opening is at a second elevation, the first elevation is between approximately 1 foot and approximately 2 feet, with respect to the lowermost portion of the cabinet structure, and the second elevation is between approximately 2 feet and approximately 3 feet, with respect to the lower surface of the platform.