Utility Patent Application
`Practitioner Docket No. 56782.1.8
`
`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
`
`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.
`
`[34] 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
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`Utility Patent Application
`Practitioner Docket No. 56782.1.8
`
`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
`
`signal upward, for maximum visibility, when pump 33 is pumping eluant and
`
`elution is taking place within generator 21, or at all times when pump 33 is
`
`pumping eluant. According to some embodiments, the light signal flashes on and
`
`off when the eluate is being diverted from generator 21 into waste bottle 23, and
`
`the light signal shines steadily when the eluate is being diverted through patient
`
`line 305p, or visa versa. According to other embodiments, a projector 100 shines
`
`a 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 eluate
`
`is being directed to patient line 305p for infusion. Light projector 100 may further
`
`project a more rapidly flashing light, for example, for approximately five seconds,
`
`once a peak bolus of radioactivity is detected in the eluate, to provide further
`
`information to technical personnel. Alternative means of informing technical
`
`personnel that an 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.
`
`[35] When maintenance of system 10 requires the emptying waste bottle 23, relatively
`
`easy access to waste bottle 23 is provided through opening 139 in top surface
`
`131 of shell 13. It should be noted that technical personnel are preferably trained
`
`to empty waste bottle 23 at times when the eluate, contained in waste bottle 23,
`
`has decayed sufficiently to ensure that the radioactivity thereof has fallen below a
`
`threshold to be safe. Opening 139 is preferably located at an elevation of
`
`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 of platform 113, or at an elevation of approximately 32 inches, with
`
`respect to a ground surface upon which wheels 121, 122 rest. According to the
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`Utility Patent Application
`Practitioner Docket No. 56782.1.8
`
`illustrated 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 1 C, 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.
`
`[36] Figures 1A and 1 C further illustrate a pair of relatively shallow external recesses
`
`190, which are formed in upper surface 131 of shell 13, for example, in order to
`
`catch any spills from infusion system; one of recesses 190 is shown located in
`
`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 documentation associated with infusion
`
`system 10, for example, a technical manual and/or maintenance records, or
`
`printouts from printer 117 (Figure 1 B). With reference to Figure 1 C, upper
`
`surface 131 of shell 13 is shown to also include additional recesses 101, which
`
`are each sized to hold a shielded test vial, which contains samples from infusion
`
`system 10, for example, for breakthrough testing and/or calibration, which will be
`
`described in greater detail, below. 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 of 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, for example, deposited
`
`therein during infusion procedures.
`
`[37] Figure 2A is a perspective view of shielding assembly 200, according to some
`embodiments of the present invention. With reference to Figures 1 C and 2A,
`
`together, it may be appreciated that opening 137, in upper surface 131 of shell
`
`13, provides access to a lid or door 221 of a sidewall 201 of shielding assembly
`
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`Utility Patent Application
`Practitioner Docket No. 56782.1.8
`
`200, which sidewall 201 encloses a compartment sized to contain a radioisotope
`
`generator of system 10, for example, generator 21, previously introduced.
`
`According to the illustrated embodiment, opening 137 and door 221 are located
`
`at a lower elevation, for example, with respect to platform 113, than are 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 may be lifted out from an opening 231 (Figure 3A) which mates with
`
`door 221 of sidewall 201. A weight of generator 21, which includes its own
`
`shielding, may be between approximately 23 and approximately 25 pounds, thus,
`
`according to some preferred embodiments of the present invention, the elevation
`
`of each of openings 137 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 is contained in the cabinet structure of Figure 1 A ,
`
`openings 137 and 231 are located at an elevation of approximately 12 inches,
`
`with respect to the lower surface of platform 113, or at an elevation of
`
`approximately 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 2B, in
`
`order to limit access to generator 21.
`
`[38] Figures 1 C and 2A further illustrate a lid or a door 225 of another sidewall 205
`
`(Figure 3A) of shielding assembly 200, which encloses another compartment that
`
`is accessible through opening 137 of shell 13, and which is located adjacent the
`
`compartment enclosed by sidewall 201. Each of doors 221, 225 are shown
`
`being attached by a corresponding hinge H, and another door 227 is shown
`
`attached to sidewall 203 by another hinge H. Figure 2A illustrates each of lid 223
`
`and doors 221, 225, 227 including a handle 232, 212, 252 and 272, respectively,
`
`for moving lid 223 and doors 221, 225, 227, in order to provide access to the
`
`corresponding compartments, which can be seen in Figures 3A-B. Figure 2A
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`Utility Patent Application
`Practitioner Docket No. 56782.1.8
`
`further illustrates 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 lid/door 223, 221, 225, 227 thereof
`
`may be individually 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.
`
`[39] According to the illustrated embodiment, doors 221, 225 are hinged to open in an
`
`upward direction, per arrows D and C, and, with reference back to Figure 1 C, 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 could
`
`pinch/crush fingers of technical personnel and/or tubing lines of circuit 300, when
`
`in the midst of a maintenance procedure. Figure 28 is a perspective view of
`
`framework 19 of the cabinet structure of system 10, according to some
`
`embodiments, to which latch component 191 is mounted; Figure 28 includes an
`
`enlarged detailed view of latch component 191, according to some embodiments.
`
`Figure 28 illustrates latch component 191 including 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, respectively, 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, 1938 of the corresponding pin 195, 193, in
`
`a first direction, per arrow F, and then may rest against a respective side S95
`
`and S93 of each end 1958, 1938, until the corresponding lever end 195A, 193A
`
`is rotated in a counter-clockwise direction, per arrow cc, thereby moving the
`
`corresponding holding end 1938, 1958 to make way for the closing of doors 221,
`
`225. Doors 221, 225 being held by latch component 191 in an open position may
`
`be seen in Figure 3A.
`
`[40] With further reference to Figure 2A, according to some preferred embodiments of
`
`the present invention, an edge of door 225 overlaps door 221 to prevent door
`
`221 from being opened, per arrow D, if door 225 is not opened, per arrow C; and
`
`an edge of door 227 overlaps an edge of door 225 to prevent door 225 from
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`Utility Patent Application
`Practitioner Docket No. 56782.1.8
`
`being opened if door 227 is not opened, per arrow B; and an edge of lid 223
`
`overlaps door 227 to prevent door 227 from being opened if lid 223 is not
`
`opened, per arrow A. Thus, access to the compartment enclosed by sidewall
`
`201 and containing generator 21 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 300 will be described in conjunction with Figures 3A-C.
`
`[41] Figure 3A is another perspective view of shielding assembly 200, according to
`
`some embodiments of the present invention. In Figure 3A, lid 223 and doors
`
`221, 225, and 227 are opened to provide a view into openings 233, 235 and 231
`
`of sidewalls 203, 205 and 201, respectively, and into a passageway 207, which is
`
`formed in sidewall 203, opposite the compartment, which contains waste bottle
`
`23. Passageway 207 is shown extending vertically along sidewall 203 and
`
`having a grooved extension 213 formed in a perimeter surface of opening 233.
`
`An optional retaining member 237, for example, formed from an elongate strip of
`
`resilient plastic having a generally c-shape cross-section, 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 251 b
`
`and 251 g, which are formed as grooves in a portion of sidewall 205, and another
`
`pair of passageways 215i and 2150, which are formed as grooves in a portion of
`
`sidewall 201. A routing of portions of tubing circuit 300 (Figure 1 D) through
`
`passageways 207, 251b, 251c, 215i and 2150 is shown in Figure 3B.
`
`[42] Figure 3B illustrates tubing line 304 being routed through passageways 251 g and
`
`215i, eluate tubing line 305 being routed through passageway 2150, and both
`
`waste line 305w and patient line 305p being routed along passageway 207.
`
`Waste line 305w further extends through grooved extension 213 to waste bottle
`
`23, and patient line 305p further extends outward from shielding assembly 200,
`
`for example, to extend out through opening 135 in upper surface 131 of shell 13
`
`(Figure 1 A). According to the illustrated embodiment, each passageway formed
`
`in shielding assembly 200, by being accessible along a length thereof, can
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`

`Utility Patent Application
`Practitioner Docket No. 56782.1.8
`
`facilitate a relatively easy routing of the corresponding tubing line therethrough,
`
`when the corresponding lid/door is open, and a depth of each passageway
`
`prevents pinching and/or crushing of the corresponding tubing line routed
`
`therethrough, when the corresponding lid/door is closed down thereover.
`
`[43] 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 3B), and, with reference to Figure
`
`3B, tubing line 305 passes over opening 325 so that detector 25 can detect an
`
`activity of the eluate, which passes therethrough. According to some
`
`embodiments, the positioning, within the compartment enclosed by sidewall 205,
`
`of the components of the portion of infusion circuit 300 which are shown routed
`
`therein, is facilitated by providing the components mounted in a frame 39 as a
`
`disposable subassembly 390, an embodiment of which is illustrated by Figures
`
`3C-D.
`
`[44] Figure 3C is a perspective view of subassembly 390, and Figure 30 is a
`
`perspective view of frame 39. According to the embodiment illustrated by Figure
`
`30, frame 39 is formed from mating trays 39A, 39B, for example, formed from a
`
`thermoformed plastic, which fit together to capture, therebetween, and hold, in
`
`fixed relation to a perimeter edge of frame 39, divergence valve 35WP and
`
`portions of eluant tubing line 304, by-pass tubing line 303, eluate tubing line 305,
`
`waste line 305w and patient line 305p. Figure 3C illustrates the perimeter edge
`
`divided into a first side 391, a second side 392, opposite first side 391, a third
`
`side 393, extending between first and second sides 391, 392, and a fourth side
`
`394, opposite third side 393. Although Figure 30 shows trays 39A, 39B
`
`individually formed for fitting together, according to alternate embodiments,
`
`mating trays of frame 39 may be parts of a continuous sheet of plastic folded
`
`over on itself.
`
`[45] According to the illustrated embodiment, an end 404A, of eluant line 304, and an
`
`end 403, of by-pass line 303 extend from third side 393 of frame 39 to couple
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`Utility Patent Application
`Practitioner Docket No. 56782.1.8
`
`with divergence valve 358G and an upstream section of eluant tubing line 302.
`
`Figure 3C further illustrates an opposite end 4048 of eluant line extending from
`
`first side 391 of frame 39, alongside a similarly extending end 405 of eluate line
`
`305, and ends 406 and 407 of patient line 305p and waste line 305w,
`
`respectively, extending from second side 392 of frame 39. Although ends 406,
`
`407 are shown extending upward from tray 39a, as they would within shielding
`
`assembly 200, it should be appreciated that the tubing lines of circuit 300 are
`
`preferably flexible and would drop down under their own weight rather than
`
`extending upward, as shown, if not supported. Referring back to Figure 1 D, in
`
`conjunction with Figure 3C, it can be seen that fittings are provided for coupling
`
`subassembly 390 into circuit 300: a first fitting 311 couples the section of eluant
`
`line 302 to filter 37; a second fitting 312 couples eluant line 304 to an inlet port of
`
`generator 21; a third fitting 313, which may incorporate a check valve, couples
`
`eluate line 305 to an outlet port of generator 21; a fourth fitting 314 couples waste
`
`line 305w to waste bottle 23; and a fifth fitting 315 couples patient line 305p to
`
`an extension thereof, which extends outside shell 13 (designated by the dotted
`
`line). Each of the fittings 311, 312, 313, 314, 315 may be of the Luer type, or any
`
`other suitable type that is known to those skilled in the art.
`
`[46] As previously mentioned, 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, and, in those instances wherein system 10 is moved to a
`
`new site each day, these portions may be replaced daily. Thus, according to the
`
`illustrated embodiment, these portions are conveniently held together by frame
`
`39, as subassembly 390, in order to facilitate relatively speedy removal and
`
`replacement, while assuring a proper assembly orientation, via registration with
`
`features formed in sidewall 205 (Figure 3A), for example: registration of
`
`divergence valve 35WP with valve actuator receptacle 253, registration of tubing
`
`line ends 403 and 404A with passageways 251 b and 251 g, respectively,
`
`registration of tubing line ends 4048 and 405 with passageways 215i and 2150,
`
`respectively, and registration of tubing line ends 406 and 407 with passageway
`
`207.
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`Utility Patent Application
`Practitioner Docket No. 56782.1.8
`
`[47] With further reference to Figure 3B, other portions of tubing circuit 300 are
`
`shown. Figure 3B illustrates eluant tubing line 301 extending from reservoir 15,
`
`outside of shell 13 (Figure 1A), to syringe pump 33, which is mounted to an
`
`actuating platform 433. According to the illustrated embodiment, platform 433 is
`
`actuated by another servomotor (not shown) of system 10, which is controlled by
`
`the controller and computer 17 of system 10, to cause a plunger of pump 33 to
`
`move, per arrow I, 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 eluant, through tubing line 302, to either generator 21 or to by-pass line
`
`303. Although the illustrated embodiment includes syringe pump 33, other
`
`suitable pumps, known to those skilled in the art, may be substituted for pump
`
`33, in order to draw eluant from reservoir 15 and to pump the eluant throughout
`
`circuit 300. Although not shown, it should be appreciated that divergence valve
`
`35BG is fitted into another valve actuating receptacle mounted within shell 13
`
`and coupled to yet another servomotor (not shown) of system 10.
`
`[48] Figure 3B further illustrates a filter holder 317 that is mounted alongside an
`
`interior surface of shell 13 to hold filter 37 (Figure 1 D) of tubing line 302. Filter
`
`holder 317, like frame 39 for subassembly 390, may be formed from a
`
`thermoformed 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
`
`clam-shell structure. Holder 317 is shown including an appendage 307 for
`
`hanging holder 317 from a structure (not shown) inside shell 13.
`
`[49] Turning now to Figures 4-9C details concerning computer-facilitated operation of
`
`system 10 will be described, according to some embodiments of the present
`
`invention. As previously mentioned, and with reference back to Figure 1A,
`
`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 from the user. It should be
`
`understood that computer 17 is coupled to the controller of system 10, which may
`
`be mounted within the interior space surrounded by shell 13. Although Figure 1A
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`Utility Patent Application
`Practitioner Docket No. 56782.1.8
`
`shows computer 17 mounted to post 142 of system 10, for direct hardwiring to
`
`the controller of system 10, according to some alternate embodiments, computer
`
`17 is coupled to the controller via a flexible lead that allows computer 17 to be
`
`positioned somewhat remotely from those portions of system 10, from 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
`
`away from radioactive radiation.
`
`[50] According to some preferred embodiments, computer 17 is pre-programmed to
`
`guide the user, via monitor 172, through procedures necessary to maintain
`
`system 10, to perform quality control tests on system 10, and to operate system
`
`10 for patient infusions, as well as to interact with the user, via the touch-screen
`
`capability of monitor 172, according to preferred embodiments, in order to track
`
`volumes of eluant and eluate contained within system 10, to track a time from
`
`completion of each elution performed by system 10, to calculate one or more
`
`system parameters for the quality control tests, and to perform various data
`
`operations. It should be understood that screen shots shown in Figures 4-9C 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 format.
`
`[51] Figure 4 is a screen shot of a main menu 470, which is presented by computer
`
`17 on monitor 172, according to some embodiments. Main menu 470 includes a
`
`listing of each computer-facilitated operation that may be selected by the user,
`
`once the user has logged on.
`
`[52] Figure 5A is a schematic showing a series of screen shots which includes a log
`
`in screen 570. After the user enters the appropriate information into data entry
`
`fields of log in screen 570, computer 17 presents a request for the user to
`
`confirm the volume of eluant that is within reservoir 15 (e.g. saline in saline bag),
`
`via a screen 571, and then brings up main menu 470. According to some
`
`embodiments, when the user touch-selects the data entry fields of screen 570 or
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`Utility Patent Application
`Practitioner Docket No. 56782.1.8
`
`571, or of any of the other screens presented herein, below, a virtual keyboard is
`
`displayed for touch-select data entry into the selected data entry field; 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 (i.e. disk) reader, a scanner, a barcode reader (or other reader
`
`of encoded information), a hand control (i.e. mouse, joy stick, etc ... ).
`
`[53]
`
`If the user determines that the volume of eluant/saline is insufficient, the user
`
`selects a menu item 573, to replace the saline bag, which leads computer 17 to
`
`prompt the user to enter a quantity of saline contained by the new saline bag, via
`
`a screen 574. Thus, computer 17 uses either the confirmed eluant/saline
`
`volume, via screen 571, or the newly entered eluant/saline volume, via screen
`
`574, as a baseline from which to track depletion of reservoir volume, via
`
`activations of pump 33, in the operation of system 10. With reference to Figure
`
`58, during the operation of system 10, when computer 17 detects that the eluant
`
`reservoir/saline bag has been depleted to a predetermined volume threshold,
`
`computer 17 warns the user, via a screen 577. If the user has disregarded
`
`screen 577 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 reservoir/saline bag, the user may either refill the
`
`reservoir/bag or replace the empty reservoir/bag with a full reservoir/bag.
`
`According to some embodiments, system 10 automatically precludes any further
`
`operation of the system until the reservoir is replenished.
`
`[54]
`
`In addition to tracking the volume of eluant in reservoir 15, 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 screen 584, by which the user
`
`may effectively 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
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`Utility Patent Application
`Practitioner Docket No. 56782.1.8
`
`day, and utilize screen 584 to set the waste bottle level indicator to zero. Thus,
`
`computer 17, can track the filling of waste bottle 23 via monitoring of the
`
`operation of pump 33 and divergence valve 35WP, and provide an indication to
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`the user when waste bottle 23 needs to be emptied, for example, via
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`presentation of screen 584, in order to warn the user that, unless emptied, the
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`waste bottle will overflow. According to some embodiments, system 10
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`automatically precludes any further operation of the system until the waste bottle
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`is emptied.
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`[55]
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`In addition to the above maintenance steps related to eluant and eluate volumes
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`of system 10, the user of system 10 will typically perform quality control tests
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`each day, prior to any patient infusions. With reference to Figure 6, according to
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`preferred methods, prior to performing the quality control tests (outlined in
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`conjunction with Figures 7A-C and 8A-B), the user may select an item 675 from
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`main menu 470, in order to direct system 10 to wash the column of generator 21.
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`During the generator column wash, which is performed by pumping a
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`predetermined volume of eluant, for example, approximately 50 milliliters,
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`through generator 21 and into waste bottle 23, computer 17 provides an
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`indication, via a screen 676, that the wash is in progress. Also, during the
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`generator column wash, the system may provide a signal to indicate that eluate it
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`being diverted to waste bottle 23, for example, light projector 100 (Figure 1 C)
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`may project a flashing light signal, as previously described.
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`[56] Figure 6 further illustrates a screen 677, which is presented by computer 17 upon
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`completion of the column wash, and which provides an indication of a time lapse
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`since the completion of the wash, in terms of a time countdown, until a
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`subsequent elution process may be effectively carried out. While screen 677 is
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`displayed, system 10 may be refilling, from reservoir 15, pump 33, which has a
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`capacity of approximately 55 milliliters, according to some embodiments.
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`According to some preferred embodiments of the present invention, computer 17
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`starts a timer once any elution process is completed and informs the user of the
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`time lapse, either in terms of the time countdown (screen 677), or in terms of a
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`time from completion of the elution, for example, as will be described in
`
`19
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`2723 of 2987
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`

`

`Utility Patent Application
`Practitioner Docket No. 56782.1.8
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`conjunction with Figure 78. According to an exemplary embodiment, wherein
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`generator 21 is the CardioGen-82® that yields a saline solution of Rubidium-82,
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`produced by the decay of Strontium-82, via the elution, a time required between
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`two effective elution processes is approximately 10 minutes.
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`[57] Once the appropriate amount of time has lapsed, after the elution process of
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`generator column wash, a first quality control test may be performed. With
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`reference to Figure 7 A, the user may select, from main menu 4 70, an item 773A,
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`which directs computer 17 to begin a sequence for breakthrough testing. In
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`conjunction with the selection of item 773A, the user attaches a needle to an end
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`of patient line 305p and inserts the needle into to a test vial, for the collection of
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`an eluate sample therefrom, and, according to Figure 7A, computer 17 presents
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`a screen 774, which instructs the user to insert the test vial into a vial shield,
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`which may be held in recess 101 of shell 13 (Figure 1 C).
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`[58] Figure 7A further illustrates a subsequent screen 775, by which computer 17
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`receives input, from the user, for system 10 to start the breakthrough elution,
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`followed by a screen 776, which provides both an indication that the elution is in
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`progress and an option for the user to abort the elution. As previously described,
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`the system may provide a signal to indicate that elution is in progress, for
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`example, light projector 100 (Figure 1 C) may project a flashing light signal during
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`that portion of the elution process when eluate is diverted from generator 21
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`through waste line 305w and into waste bottle 23, and then a steady light signal
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`during that portion of the elution process when the eluate is diverted from
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`generator 21 through patient line 305p and into the test vial, for example, once
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`activity detector 25 detects a dose rate of approximately 1.0 mCi/sec in the
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`eluate discharged from generator 21. Another type of light signal, for example,
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`the more rapidly flashing light, as previously described, may be projected when a
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`peak bolus of radioactivity is detected in the eluate.
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`[59] Upon completion of the elution process for breakthrough testing, computer 17
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`presents a screen 777, shown in Figure 78, which, like screen 677, provides an
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`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
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`20
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`2724 of 2987
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`

`Utility