tffD
`
`Main Menu
`
`&15
`
`,.,1-1
`
`l
`
`Generator Column Wash
`
`Generator column ,vash is complete.
`
`Time until next elution!
`
`9 Min 50 Sec
`
`Generator Column Wash
`
`Gen«.atorcolurnn wash in progress.
`
`•
`
`I
`
`FIGURE 6
`
`1702 of 1754
`
`

`

`'f-:fO
`
`Main Menu
`
`&npty\'41stit 91:»ttl,t
`
`[ ~1'411i)rCdllm \\\uh
`.
`-
`p
`9-kil\rough~
`
`l>4:tt Ope!'alioin
`
`Log.w.,t
`
`:::,13B
`
`~?5
`
`Breakthrough Test
`Press start button to begin breakthrough tQst
`
`'i:/4
`
`Breakthrough Test
`
`fnsertMWqc\iialinto~tution \lfal sb'-\iki
`PrQss 110ttto co~.
`
`I
`
`7-;t~
`
`Breakthrough Test
`Breakthrough E-1ution in progress.
`
`-
`
`-
`
`FIGURE 7A
`
`1703 of 1754
`
`

`

`Breakthrough Test
`~akthrough elution compl'1te.
`Enw rf>.t2 roding fr<im dOSQ calibrator
`
`mCI
`
`Tfme c·
`
`Enter time sinc-e end of elution
`
`'"'~--']
`
`I
`
`Breakthrough Test
`
`Br#3akthrough elution complete.
`
`TimQfrom end of elution:
`
`8 Min 50 Sec
`
`-
`
`91-9
`
`Breakthrough Test
`
`Breakthrough elution compl'1te,
`Pf'Qss dona to mtUrn·to main menu.
`
`• • •
`
`FIGURE 78
`
`1704 of 1754
`
`

`

`'9f>!
`
`Breakthrough Test
`Breakthrough elution tompkrt~.
`mCI 54.5 Tfme 2 Mn30 w:
`Enter breakthrough ieading at 60 min
`
`Enter bac:lqJrouoo radiation reading
`
`Time 5
`
`• • •
`
`UC(
`
`Breakthrough Test
`Breakthrough test compkrte.
`~tS!
`Sr-82/Rb-82 = 0.0005 uCi / mCi
`Sr-85/Rb~82 = 0.11 uCi / mCi
`
`Results should not ex:ceed :ailowable limits:
`Sr-s21m:.s2 < 0.02 ua I mCi
`Sr-ss/Rb-ai < 0,2 ua I ma
`
`•
`
`FIGURE 7C
`
`1705 of 1754
`
`

`

`e1t/
`
`Infusion System Calibration
`
`Insert MW q<: vial into ~ution vial sheid.
`Pl'Qss nQXt to continua .
`
`I
`
`g-:;-b
`
`Infusion System Calibration
`Prffl start button to l»;.tln calibration.
`
`Main Menu
`
`limptyW.m9onle
`
`013
`
`sJS
`
`Infusion System Calibration
`
`~OmCi
`fsoml
`f so mt/min (DEFAULT)
`
`j
`
`P.ltient Oose
`
`Patient Volume
`
`FlowRate
`DoseRata
`1hmshofd
`Elution \iolu!Tl(!f
`
`•
`
`•
`
`FIGURE SA
`
`1706 of 1754
`
`

`

`to-:fr
`
`B,¥-8
`
`Infusion System Calibration
`
`..... -.. \ I
`t
`
`J
`if
`
`,~
`
`\
`
`--~~t~--~--"'
`Otl:nm_,11,._.,,
`
`.f#'~"~.._.«;H~~., -~-4-\'1~·'<'~0 ...... t<
`
`-
`
`Infusion System Calibration
`
`Calibratkln elution complet~.
`
`TIO'IQfrom end of elution:
`
`8 Min 50 Sec
`
`I
`
`BB(J
`
`Infusion System Calibration
`C~ibratioo elutkln com~
`Entw tb-62 telding from dose calibr.ator
`
`ma(
`
`Ent«tiffiQ slna'! end of elution
`
`Time
`
`I
`
`•
`
`Infusion System Calibration
`
`Calibratkln artion comp!~.
`Result:
`calibration Ratio = 0.96
`tewgenfflt« callbmk!nsho~ b!wtthln0.95 ti:, u,s
`Dallycallbmk!nshookl beWlthlnO.tto L 1
`
`FIGURE 88
`
`1707 of 1754
`
`

`

`•
`
`992-
`
`Automatic Infusion
`
`Enterpati~t id .
`Press nextto continue.
`
`I
`
`91-1
`
`Automatic Infusion
`
`•
`
`P<'itiient Dost
`
`P<'itientVolu~
`
`Row Rate
`DoseRate
`Threshold
`Elution Volume
`
`FIGURE 9A
`
`tj?-3
`
`Automatic Infusion
`Attach Hew P.tient UM
`
`1708 of 1754
`
`

`

`
`“Bulweyy
`
`
`
`
`
`
`uoIsnjuySnewony
`
`
`
`wepadeaedaodenw
`
`t
`
`ANEpeMesdeIng
`“teeBRINHA
`th ;11
`·- .
`penedundype
`~ i
`C I»
`E ll I
`~ ,1 '
`
`
`
`1709 of 1754
`
`~
`
`~
`
` iil
`
`.
`--
`'2
`
`,;I: . . .
`
`Vl
`Q.
`
`E ::,
`
`Q.
`<U
`~
`
`g6agnosis
`
`-LL
`
`1709 of 1754
`
`
`
`
`

`

`Automatic Infusion
`
`Patient id: d430b
`
`====~-"-~•~M-,-,.__,_""'""'
`
`__ , --·
`
`Automatic Infusion
`
`Infusion complete,
`
`i11T11i? from end of infusion:
`
`8 Min 50 Sec
`
`•
`
`•
`
`FIGURE 9C
`
`l·., '"""\·t
`
`\
`
`i
`f
`
`-··-
`
`Automatic Infusion
`,'' :
`
`t:r.,"'•*"""
`··~»;;c~:;,~,lHo,o.«»1'~*•""-"""
`
`. . . . . ..,..._, _ _ lb;
`
`I
`
`C/ 1-!
`
`Automatic Infusion
`
`Infusion Summ.uy.
`
`Patient Dose
`P-itkmtV•fu~
`Butlon V•tu~
`
`52 mCi
`14ml
`28 ml
`
`Press done to ~um to the main menu.
`
`1710 of 1754
`
`

`

`1/10
`
`qs3
`
`t/B I
`qq/
`
`•
`
`Purge With Air
`
`Remove saline bag.
`Attach elution test vial to patient line.
`
`q15~
`
`Purge With Air
`
`Wamlng: You must bypass the generator
`if you intend to continue using it.
`
`•
`
`I
`
`Purge With Air
`
`FIGURE 10
`
`1711 of 1754
`
`

`

`SHIELDING ASSEMBLIES FOR INFUSION SYSTEMS
`
`UTILITY PATENT APPLICATION
`Practitioner Docket No. 56782.1.5
`
`RELATED APPLICATIONS
`
`[01] The present application is related to the following commonly assigned utility
`
`patent applications, all of which are filed concurrently herewith and all of which
`
`are hereby incorporated by reference in their entireties: Practitioner Docket No.
`
`56782.1.6, entitled: INFUSION SYSTEM CONFIGURATIONS; Practitioner
`
`Docket No. 56782.1.7, entitled: INFUSION SYSTEMS INCLUDING
`
`COMPUTER-FACILITATED MAINTENANCE AND/OR OPERATION; and
`
`Practitioner Docket No. 56782.1.8, entitled: CABINET STRUCTURES
`
`SUPPORTING INFUSION SYSTEMS.
`
`TECHNICAL FIELD
`
`[02] The present invention pertains to systems that generate and infuse
`
`radiopharmaceuticals, and, more particularly, to shielding assemblies thereof.
`
`BACKGROUND
`[03] Nuclear medicine employs radioactive material for therapy and diagnostic
`
`imaging. Positron emission tomography (PET) is one type of diagnostic imaging,
`
`which utilizes doses of radiopharmaceutical, for example, generated by 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 detected by a PET scanner, in order to
`
`generate an image of the organ. An example of a radioactive isotope, which may
`
`be used for PET, is Rubidium-82 (produced by the decay of Strontium-82); and
`
`an example of a radioisotope generator, which yields a saline solution of
`
`Rubidium-82, via elution, is the CardioGen-82® available from Bracco
`Diagnostics Inc. (Princeton, NJ).
`
`[04] Whether the half-life of a particular radioactive isotope, employed by a
`
`radiopharmaceutical, is relatively short or long, a patient undergoing a nuclear
`
`imaging procedure is not typically exposed to a significant amount of radiation.
`
`1
`
`1712 of 1754
`
`

`

`UTILITY PATENT APPLICATION
`Practitioner Docket No. 56782.1.5
`
`However those personnel, whose job it is to set up and maintain
`
`radiopharmaceutical infusion systems, and to administer doses therefrom, are
`
`subject to more frequent exposures to radiation. Therefore, shielding
`
`assemblies, which provide a radiation barrier to protect these personnel from
`
`excessive exposure to radiation sources, are an important component of
`
`radiopharmaceutical generators and infusion systems. These shielding
`
`assemblies are typically formed with lead sidewalls, the bulk and weight of which
`
`can pose difficulties for the personnel who regularly set up, maintain and use the
`
`systems. Thus, there is a need for improved shielding assemblies employed by
`
`systems that generate and infuse radiopharmaceuticals.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[05] The following drawings are illustrative of particular embodiments of the present
`
`invention and therefore do not limit the scope of the invention. The drawings are
`
`not to scale (unless so stated) and are intended for use in conjunction with the
`
`explanations in the following detailed description. Embodiments of the present
`
`invention will hereinafter be described in conjunction with the appended
`
`drawings, wherein like numerals denote like elements.
`
`[06] Figure 1A is a first perspective view of an infusion system, according to some
`
`embodiments of the present invention.
`
`[07] Figure 1 B is another perspective view of a portion of a cabinet structure of the
`
`system shown in Figure 1A, according to some embodiments.
`
`[08] Figure 1C is a second perspective view of the system shown in Figure 1A,
`
`according to some embodiments.
`
`[09] Figure 1 D is a schematic of an infusion circuit, according to some embodiments
`
`of the present invention.
`
`[1 O] Figure 2A is a perspective view of a shielding assembly for an infusion system,
`
`such as that shown in Figures 1A-C, according to some embodiments of the
`
`present invention.
`
`2
`
`1713 of 1754
`
`

`

`UTILITY PATENT APPLICATION
`Practitioner Docket No. 56782.1.5
`
`[11] Figure 2B is a perspective view of a framework of the system, according to some
`
`embodiments, with an enlarged detailed view of a component of the system,
`
`according to some embodiments.
`
`[12] Figure 3A is another perspective view of the shielding assembly shown in Figure
`
`2A.
`
`[13] Figure 3B is a perspective view of the infusion circuit, shown in Figure 1 C,
`
`configured and routed, according to some embodiments.
`
`[14] Figure 3C is a perspective view of a disposable infusion circuit subassembly,
`
`according to some embodiments.
`
`[15] Figure 3D is a frame for the subassembly shown in Figure 3C, according to some
`
`embodiments.
`
`[16] Figure 4 is a main menu screen shot from an interface of a computer, which may
`
`be included in systems of the present invention, according to some
`
`embodiments.
`
`[17] Figure 5A is a schematic showing a first group of successive screen shots from
`
`the computer interface, according to some embodiments.
`
`[18] Figure 5B is a pair of screen shots from the computer interface, which provide
`
`indications related to eluant volume levels in a reservoir of the system, according
`
`to some embodiments.
`
`[19] Figure 5C is a schematic showing a second group of successive screen shots
`
`from the computer interface, according to some embodiments.
`
`[20] Figure 6 is a schematic showing a third group of successive screen shots from
`
`the computer interface, according to some embodiments.
`
`[21] Figures 7A-C are schematics showing a fourth group of successive screen shots
`
`from the computer interface, according to some embodiments.
`
`[22] Figures 8A-B are schematics showing a fifth group of successive screen shots
`
`from the computer interface, according to some embodiments.
`
`[23] Figures 9A-C are schematics showing a sixth group of successive screen shots
`
`from the computer interface, according to some embodiments.
`
`[24] Figure 10 is a schematic showing a seventh group of successive screen shots
`
`from the computer interface, according to some embodiments.
`
`3
`
`1714 of 1754
`
`

`

`UTILITY PATENT APPLICATION
`Practitioner Docket No. 56782.1.5
`
`DETAILED DESCRIPTION
`
`[25] The following detailed description is exemplary in nature and is not intended to
`
`limit the scope, applicability, or configuration of the invention in any way. Rather,
`
`the following description provides practical illustrations for implementing
`
`exemplary embodiments. Utilizing the teaching provided herein, those skilled in
`
`the art will recognize that many of the examples have suitable alternatives that
`
`can be utilized.
`
`[26] Figure 1A 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 in Figure 2B) and
`
`a shell 13; shell 13 extends upward from a skirt 11, that surrounds platform 113,
`
`to surrounds an interior space in which a portion of infusion system 10 is
`
`contained (-seen in Figure 1 C). Shell may be formed from panels of injection(cid:173)
`
`molded polyurethane fitted together according to methods known to those skilled
`
`in the art. Figure 1A illustrates the cabinet structure of system 10 including a grip
`
`or handle 14, which extends laterally from shell 13, in proximity to an upper
`
`surface 131 thereof, and a post 142, which extends upward from shell 13, and to
`
`which a work surface, or tray 16 and a computer 17 are, preferably, attached, via
`
`an ergonomic, positionable mount. According to some embodiments, computer
`
`17 is coupled to a controller of system 10, which is mounted within the interior
`
`space surrounded by shell 13, and a monitor 172 of computer 17 not only
`
`displays indications of system operation for a user of system 10, but also serves
`
`as a device for user input (e.g. touch screen input). However, according to
`
`alternate embodiments, another type of user input device, known to those skilled
`
`in the art, may be employed by computer 17. Other types of user input devices
`
`may included, for example, a keyboard, a series of control buttons or levers, a
`
`barcode reader (or other reader of encoded information), a scanner, a computer
`
`readable medium containing pertinent data, etc. The user input device may be
`
`mounted on the cabinet structure of system 10, as shown, or may be tethered
`
`thereto; alternatively the user input device may be remote from system 10, for
`
`example, located in a separate control room. According to some additional
`
`4
`
`1715 of 1754
`
`

`

`UTILITY PATENT APPLICATION
`Practitioner Docket No. 56782.1.5
`
`embodiments, another user input device, for example, in addition to a touch
`
`screen of computer 17, may be remote from system 10 and used to start and
`
`stop infusions. Operation of system 10, which is facilitated by computer 17, will
`
`be described below, in conjunction with Figures 4-9C.
`
`[27] Figure 1A further illustrates two pairs of wheels 121, 122, mounted to an
`
`underside of platform 113, to make system 10 mobile; handle 14 is shown
`
`located at an elevation suitable for a person to grasp in order to maneuver
`
`system 10, from one location 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.
`
`[28] Figure 1 B is a perspective view of a portion of system 10, on a side 111 of the
`
`cabinet structure, which is in proximity to wheels 121. Figure 1 B illustrates a
`
`lever or pedal 125, which is located for activation by a foot of the person, who
`
`grasps handle 14 to maneuver system 10. In a neutral position, pedal 125 allows
`
`wheels 121, 122 to rotate, and, if embodied as casters, to swivel freely. Pedal
`
`125 may be depressed to a first position which prevents a swiveling of wheels
`
`122, according to those embodiments 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. Figure 1 B further illustrates a rear access panel
`
`17 4, for example, providing access to circuit boards of the aforementioned
`
`controller contained within the interior space surrounded shell 13, an optional
`
`lock 184, to secure panel 17 4, 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 system 10, and of system quality control test results. In
`
`some embodiments, system 10 may further include one or more additional
`
`connectors, or ports (not shown), which allow system 10 to be coupled to, for
`
`communication with, other devices used for nuclear imaging procedures.
`
`[29] Figure 1A further illustrates upper surface 131 of shell 13 including several
`
`openings 133, 135, 139 formed therein. Figure 1 C is a partially exploded
`
`perspective view of system 10, wherein a removable access panel 132 is shown
`
`5
`
`1716 of 1754
`
`

`

`UTILITY PATENT APPLICATION
`Practitioner Docket No. 56782.1.5
`
`as a contoured portion of upper surface 131, which, when exposed, by lifting
`
`away a bin 18, that mates therewith, may be removed from another opening 137
`
`formed in upper surface 131. Figure 1 C 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 and maintain system 1 O; 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 1 A and 1 C, 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 17, provide a relatively ergonomic and organized work area for
`
`technical personnel who operate system 10.
`
`[30] Turning now to Figure 1 D, a schematic of an infusion circuit 300, which may be
`
`incorporated by system 10, is shown. Figure 1 D illustrates circuit 300 generally
`
`divided into a first part 300A, which includes components mounted outside shell
`
`13, and a second part 300B, which includes components mounted within the
`
`interior space surrounded by shell 13. (Parts 300A and 300B are delineated by
`
`dotted lines in Figure 1 D.) Figure 1 D further illustrates second part 300B of
`
`circuit 300 including a portion contained within a shielding assembly 200, which
`
`is designated schematically as a dashed line. Some embodiments of shielding
`
`assembly 200 will be described in greater detail, in conjunction with Figures 2A-B
`
`and 3A-B, below.
`
`[31] According to the illustrated embodiment, circuit 300 includes an eluant reservoir
`
`15, for example, a bag, bottle or other container, containing saline as the eluant,
`
`which is shown hanging from a post, or hanger 141 above upper surface 131 of
`
`shell 13 in Figure 1A; a syringe pump 33, for pumping the eluant from reservoir
`
`15, and a pressure syringe 34, for monitoring pumping pressure; a filter 37, 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
`
`6
`
`1717 of 1754
`
`

`

`UTILITY PATENT APPLICATION
`Practitioner Docket No. 56782.1.5
`
`example an eluate 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 eluate discharged from generator
`
`21, in order to provide feedback for directing the flow of the eluate, via a
`
`divergence valve 35WP, either to a waste bottle 23 or through a patient line
`
`305p, for example, to inject a dose of the radiopharmaceutical eluate into a
`
`patient. With reference back to Figure 1A, patient line 305p is shown extending
`
`out from shell 13, through opening 135, to a distal end thereof, which, according
`
`to some embodiments, includes a filter. Patient line 305p may be coupled to
`
`another line that includes a patient injection needle (not shown). Alternatively,
`
`patient line 305p may be coupled to another line (not shown), which extends
`
`from a source of another active substance, for example, a stress agent; the other
`
`line is coupled to the line that includes the patient injection needle, in order to
`
`permit injection of the additional active substance. Figure 1 D illustrates an eluant
`
`tubing line 301 coupled to reservoir 15 and to pump 33, and, with reference to
`
`Figures 1 A-B, it may be appreciated that opening 133 provides the passageway
`
`for tubing line 301 to enter the interior space surrounded by shell 13. According
`
`to some preferred embodiments, opening 133 includes a grommet-type seal that
`
`prevents leakage of eluant, which may spill from reservoir 15, into the interior
`
`space through opening 133, while allowing a user to assemble tubing line 301
`
`through opening 133. Likewise opening 135, which provides a passageway for
`
`patient line 305p, may include a grommet-type seal.
`
`[32] Figure 1 D further illustrates another eluant tubing line 302 coupled to pump 33
`
`and a divergence valve 35BG, which may either direct pumped eluant through a
`
`tubing line 304, to generator 21, or direct the pumped eluant through a by-pass
`
`tubing line 303, directly to patient line 305p. Divergence valve 35BG, as well as
`
`divergence valve 35WP, which directs eluate from an eluate tubing line 305
`
`either to a waste line 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 for automatic infusion, to deliver a
`
`7
`
`1718 of 1754
`
`

`

`UTILITY PATENT APPLICATION
`Practitioner Docket No. 56782.1.5
`
`dose of radiopharmaceutical to a patient, for example, Rubidium-82 for
`
`diagnostic imaging, divergence valve 35BG is initially set to direct eluant to
`
`generator 21 and divergence valve 35WP is set to direct eluate from generator
`
`into waste bottle 23, until activity detector 25 detects the desired activity of the
`
`eluate, at which time the feedback from activity detector 25 causes the controller
`
`to direct the corresponding servo-motor to re-set valve 35WP for diverting the
`
`flow of eluate into patient line 305p. According to some embodiments, once a
`
`prescribed volume of the eluate has passed through patient line 305p, the
`
`controller directs the corresponding servomotor to re-set divergence valve 35BG
`
`for diverting the flow of eluant through by-pass line 303 and into patient line 305p
`
`in order to flush, or push any eluate remaining in patient line 305p into the
`
`patient. According to some embodiments, the controller may also direct the
`
`corresponding servomotor to re-set divergence valve 35WP back toward waste
`
`bottle 23, prior to the flush through by-pass line 303, in order to prevent back flow
`
`of eluant, through line 305, toward generator 21.
`
`[33] With further reference to Figure 1 D, 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 305p,
`
`which must extend out from shielding assembly 200 in order to be coupled to the
`
`patient for 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. During infusions and quality control test sample
`
`collection, all technical personnel are typically in another room, or otherwise
`
`distanced from system 10, in order to avoid exposure to radiation during the
`
`infusion, and, according to some preferred embodiments of the present invention,
`
`system 10 includes at least one means for informing technical personnel that an
`
`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. According to the illustrated embodiment, projector 100, projects a light
`
`8
`
`1719 of 1754
`
`

`

`UTILITY PATENT APPLICATION
`Practitioner Docket No. 56782.1.5
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`signal upward, for maximum visibility, when pump 33 is pumping eluant and
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`elution is taking place within generator 21, or at all times when pump 33 is
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`pumping eluant. According to some embodiments, the light signal flashes on and
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`off when the eluate is being diverted from generator 21 into waste bottle 23, and
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`the light signal shines steadily when the eluate is being diverted through patient
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`line 305p, or visa versa. According to other embodiments, a projector 100 shines
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`a light having a first color, to indicate that eluate is being diverted to waste bottle
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`23, and then shines a light having a second, different color, to indicate that eluate
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`is being directed to patient line 305p for infusion. Light projector 100 may further
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`project a more rapidly flashing light, for example, for approximately five seconds,
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`once a peak bolus of radioactivity is detected in the eluate, to provide further
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`information to technical personnel. Alternative means of informing technical
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`personnel that an infusion is taking place may also be incorporated by system
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`10, for example, including audible alarms or other types of visible or readable
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`signals that are apparent at a distance from system, including in the control
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`room.
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`[34] When maintenance of system 10 requires the emptying waste bottle 23, relatively
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`easy access to waste bottle 23 is provided through opening 139 in top surface
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`131 of shell 13. It should be noted that technical personnel are preferably trained
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`to empty waste bottle 23 at times when the eluate, contained in waste bottle 23,
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`has decayed sufficiently to ensure that the radioactivity thereof has fallen below a
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`threshold to be safe. Opening 139 is preferably located at an elevation of
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`between approximately 2 feet and approximately 3 feet; for example, opening
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`139 may be at an elevation of approximately 24 inches, with respect to a lower
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`surface of platform 113, or at an elevation of approximately 32 inches, with
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`respect to a ground surface upon which wheels 121, 122 rest. According to the
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`illustrated embodiment, opening 139 is accessed by lifting panel 134; just within
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`opening 139, a shielded lid or door 223 (Figure 2A) may be lifted away from a
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`compartment of shielding assembly 200 that contains waste bottle 23. With
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`further reference to Figure 1 C, it may be appreciated that opening 137 provides
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`access to other portions of circuit 300 for additional maintenance procedures,
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`UTILITY PATENT APPLICATION
`Practitioner Docket No. 56782.1.5
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`such as changing out generator 21 and/or other components of circuit 300, as
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`will be described below.
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`[35] Figures 1A and 1C further illustrate a pair of relatively shallow external recesses
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`190, which are formed in upper surface 131 of shell 13, for example, in order to
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`catch any spills from infusion system; one of recesses 190 is shown located in
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`proximity to post, or hanger 141, which holds reservoir 15, and in proximity to
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`opening 133, through which tubing line 301 passes. Another recess 192 is
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`shown formed in upper surface 131; a width and depth of recess 192 may
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`accommodate storage of technical documentation associated with infusion
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`system 10, for example, a technical manual and/or maintenance records, or
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`printouts from printer 117 (Figure 1 B). With reference to Figure 1 C, upper
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`surface 131 of shell 13 is shown to also include additional recesses 101, which
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`are each sized to hold a shielded test vial, which contains samples from infusion
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`system 10, for example, for breakthrough testing and/or calibration, which will be
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`described in greater detail, below. Additional receptacles 180 are shown formed
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`in bin 18, on either side of a handle 182, which facilitates removal of bin 18 away
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`from shell 13. Technical personnel may, thus, conveniently transport bin 18 to a
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`storage area for a collection of supplies, for example, sharps, gloves, tubing
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`lines, etc ... , into one or more receptacles 180 thereof, and/or to a waste
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`container where separate receptacles 180 of bin 18 may be emptied of waste,
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`such as packaging for the aforementioned supplies, for example, deposited
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`therein during infusion procedures.
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`[36] Figure 2A is a perspective view of shielding assembly 200, according to some
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`embodiments of the present invention. With reference to Figures 1 C and 2A,
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`together, it may be appreciated that opening 137, in upper surface 131 of shell
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`13, provides access to a lid or door 221 of a sidewall 201 of shielding assembly
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`200, which sidewall 201 encloses a compartment sized to contain a radioisotope
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`generator of system 10, for example, generator 21, previously introduced.
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`According to the illustrated embodiment, opening 137 and door 221 are located
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`at a lower elevation, for example, with respect to platform 113, than are opening
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`139 and lid 223, which provide access to the compartment being formed by a
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`10
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`UTILITY PATENT APPLICATION
`Practitioner Docket No. 56782.1.5
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`sidewall 203 of shielding assembly 200 to contain waste bottle 23, as previously
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`described. When panel 132 is separated from shell 13, and door 221 opened,
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`generator 21 may be lifted out from an opening 231 (Figure 3A) which mates with
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`door 221 of sidewall 201. A weight of generator 21, which includes its own
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`shielding, may be between approximately 23 and approximately 25 pounds, thus,
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`according to some preferred embodiments of the present invention, the elevation
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`of each of openings 137 and 231, with respect to the lowermost portion of the
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`cabinet structure, is between approximately 1 foot and approximately 2 feet, in
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`order to facilitate an ergonomic stance for technical personnel to lift generator 21
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`out from the compartment. According to an exemplary embodiment, when
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`shielding assembly 200 is contained in the cabinet structure of Figure 1A,
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`openings 137 and 231 are located at an elevation of approximately 12 inches,
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`with respect to the lower surface of platform 113, or at an elevation of
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`approximately 19 inches, with respect to the ground surface upon which wheels
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`121, 122 rest. Figure 1 C further illustrates access panel 132 including a security
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`lock 138, which mates with a framework 19 of system 10, shown in Figure 2B, in
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`order to limit access to generator 21.
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`[37] Figures 1 C and 2A further illustrate a lid or a door 225 of another sidewall 205
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`(Figure 3A) of shielding assembly 200, which encloses another compartment that
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`is accessible through opening 137 of shell 13, and which is located adjacent the
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`compartment enclosed by sidewall 201. Each of doors 221, 225 are shown
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`being attached by a corresponding hinge H, and another door 227 is shown
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`attached to sidewall 203 by another hinge H. Figure 2A illustrates each of lid 223
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`and doors 221, 225, 227 including a handle 232,212, 252 and 272, respectively,
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`for moving lid 223 and doors 221, 225, 227, in order to provide access to the
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`corresponding compartments, which can be seen in Figures 3A-B. Figure 2A
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`further illustrates optional thumb screws 290, one securing lid 223 to sidewall 203
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`and another securing door 221 to sidewall 201, or other means for securing the
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`doors, which are known to those skilled in the art, may be incorporated. Each
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`sidewall 201, 203, 205 and the corresponding lid/door 223, 221, 225, 227 thereof
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`may be individually cast from 3% antimony lead, or from other known shielding
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`UTILITY PATENT APPLICATION
`Practitioner Docket No. 56782.1.5
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`materials, and then assembled together according to methods known to those
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`skilled in the art.
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`[38] According to the illustrated embodiment, doors 221, 225 are hinged to open in an
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`upward direction, per arrows D and C, and, with reference back to Figure 1 C, a
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`latch component 191 is provided to hold each of doors 221, 225 in an opened
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`position, thereby, preventing doors 221, 225 from falling closed, which could
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`pinch/crush fingers of technical personnel and/or tubing lines of circuit 300, when
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`in the midst of a maintenance procedure. Figure 2B is a perspective view of
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`framework 19 of the cabinet structure of system 10, according to some
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`embodiments, to which latch component 191 is mounted; Figure 2B includes an
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`enlarged detailed view of latch component 191, according to some embodiments.
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`Figure 2B illustrates latch component 191 including a first pin 193, corresponding
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`to door 225, and a second pin 195, corresponding to door 221; each pin 193, 195
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`includes a lever end 193A, 193B, respectively, and a holding end 193B, 195B,
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`respectively. An edge of each door 221, 225, upon opening of doors 221, 225,
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`may push past the holding end 195B, 193B of the corresponding pin 195, 193, in
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`a first direction, per arrow F, and then may rest against a respective side S95
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`and S93 of each end 195B, 193B, until the corresponding lever end 195A, 193A
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`is rotated in a counter-clockwise direction, per arrow cc, thereby moving the
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`corresponding holding end 193B, 195B to make way for the closing of doors 221,
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`225. Doors 221, 225 being held by latch component 191 in an open position may
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`be seen in Figure 3A.
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`[39] With further reference to Figure 2A, according to some preferred embodiments of
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`the present invention, an edge of door 225 overlaps door 221 to prevent door
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`221 from being opened, per arrow D, if door 225 is not opened, per arrow C; and
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`an edge of door 227 overlaps an edge of door 225 to prevent door 225 from
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`being opened if door 227 is not opened, per arrow B; and an edge of lid 223
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`overlaps door 227 to prevent door 227 from being opened if lid 223 is not
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`opened, per arrow A. Thus, access to the compartment enclosed by sidewall
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`201 and containing generator 21 is only systematically allowed through a
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`sequential opening of lid 223 and doors 227, 225, 221, since, when generator 21
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`1723 of 1754
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`UTILITY PATENT APPLICATION
`Practitioner Docket No. 56782.1.5
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`is replaced it is typic