U.S. patent application number 14/066343 was filed with the patent office on 2014-03-27 for infusion system with radioisotope detector.
This patent application is currently assigned to Bracco Diagnostics Inc.. The applicant listed for this patent is Bracco Diagnostics Inc.. Invention is credited to Ernest Balestracci, Jacob S. Childs, Daniel V. Clements, Daniel Darst, Eric J. Krause, Vishal N. Lokhande, Peter B. Madson, Charles R. Quirico.
Application Number | 20140084187 14/066343 |
Document ID | / |
Family ID | 41431916 |
Filed Date | 2014-03-27 |
United States Patent
Application |
20140084187 |
Kind Code |
A1 |
Quirico; Charles R. ; et
al. |
March 27, 2014 |
INFUSION SYSTEM WITH RADIOISOTOPE DETECTOR
Abstract
A shielding assembly for an infusion system includes a plurality
of compartments and a door for each compartment, and provides a
radioactive radiation barrier for the compartments. One of the
compartments contains a radioisotope generator of the infusion
system and another of the compartments may contain a waste bottle
of the infusion system. An opening into each of the generator and
waste bottle compartments may be oriented upward, and the opening
into the latter may be at a higher elevation than the opening into
the former, for example, to facilitate independent removal and
replacement of each. A door of at least one of the compartments,
other than the generator compartment, when closed, may prevent the
door of the generator compartment from being opened. A cabinet
structure for the infusion system may enclose the shielding
assembly and secure the generator.
Inventors: |
Quirico; Charles R.; (Cary,
NC) ; Balestracci; Ernest; (Iselin, NJ) ;
Darst; Daniel; (Zimmerman, MN) ; Krause; Eric J.;
(Big Lake, MN) ; Lokhande; Vishal N.; (Mountain
View, CA) ; Childs; Jacob S.; (Minneapolis, MN)
; Madson; Peter B.; (Shanghai, CN) ; Clements;
Daniel V.; (St. Joseph, MI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Bracco Diagnostics Inc. |
Monroe Township |
NJ |
US |
|
|
Assignee: |
Bracco Diagnostics Inc.
Monroe Township
NJ
|
Family ID: |
41431916 |
Appl. No.: |
14/066343 |
Filed: |
October 29, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13588341 |
Aug 17, 2012 |
|
|
|
14066343 |
|
|
|
|
12137356 |
Jun 11, 2008 |
8317674 |
|
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13588341 |
|
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Current U.S.
Class: |
250/506.1 |
Current CPC
Class: |
A61M 5/1407 20130101;
Y10T 29/49826 20150115; A61M 5/007 20130101; A61M 5/14 20130101;
A61M 2209/08 20130101; G21F 3/00 20130101; G01T 1/02 20130101; A61M
5/1785 20130101 |
Class at
Publication: |
250/506.1 |
International
Class: |
G21F 3/00 20060101
G21F003/00; G01T 1/02 20060101 G01T001/02; A61M 5/14 20060101
A61M005/14 |
Claims
1. (canceled)
2. A system comprising: a shielding assembly configured to contain
a radioisotope generator that generates radioactive eluate via
elution; a computer carried by the shielding assembly, wherein the
computer is configured to receive a user input and, responsive to
receiving the user input, control the radioisotope generator to
generate a sample of eluate via elution during breakthrough
testing; and a dose calibrator electronically coupled to the
computer and configured to measure an activity of the sample of
eluate generated during breakthrough testing, wherein the computer
carried by the shielding assembly is configured to receive the
activity data from the dose calibrator and calculate breakthrough
test results.
3. The system of claim 2, wherein the radioisotope generator
comprises a strontium-rubidium generator configured to generate
rubidium-82 by decay of strontium-82.
4. The system of claim 2, wherein the computer is configured to
calculate the breakthrough test results by at least calculating a
ratio of an activity of strontium-82 divided by an activity
rubidium-82 and a ratio of an activity of strontium-85 divided by
the activity of rubidium-82.
5. The system of claim 4, wherein the computer is further
configured to indicate if the breakthrough test results are within
allowable limits.
6. The system of claim 5, wherein the allowable limits include the
ratio of the activity of strontium-82 divided by the activity
rubidium-82 and the ratio of the activity of strontium-85 divided
by the activity of rubidium-82 each being less than 0.02
microcurie/millicurie.
7. The system of claim 2, wherein the computer is further
configured to prevent a patient infusion procedure if a
breakthrough test result exceeds an allowable limit.
8. The system of claim 2, further comprising an activity
detector.
9. The system of claim 8, wherein the computer is configured to
divert eluate generated via elution to a waste bottle until the
activity detector detects a given level of activity.
10. The system of claim 9, wherein the given level of activity is
approximately 1.0 millicurie per second.
11. The system of claim 2, further comprising a display configured
to display the breakthrough test results.
12. The system of claim 11, wherein the computer is configured to
control the display to provide an indication of progress of the
breakthrough testing.
13. The system of claim 2, further comprising a cabinet structure,
wherein the shielding assembly is positioned inside the cabinet
structure and the computer is carried by the cabinet structure.
14. The system of claim 2, wherein the dose calibrator is
configured to physically receive the sample of eluate generated
during breakthrough testing.
15. A method comprising: generating, with a radioisotope generator
contained within a shielding assembly, a radioactive eluate via
elution of an eluant; measuring, with a dose calibrator
electronically coupled to a computer carried by the shielding
assembly, an activity of the radioactive eluate; and determining,
with the computer, an activity of rubidium-82 within the
radioactive eluate.
16. The method of claim 15, further comprising determining, with
the computer, an activity of strontium-82 and an activity of
strontium-85 in the radioactive eluate.
17. The method of claim 16, further comprising determining, with
the computer, a ratio of the activity of strontium-82 divided by
the activity rubidium-82 and a ratio of the activity of
strontium-85 divided by the activity of rubidium-82.
18. The method of claim 17, further comprising determining, with
the computer, if the ratio of activity of strontium-82 divided by
the activity rubidium-82 and the ratio of the activity of
strontium-85 divided by the activity of rubidium-82 are within
allowable limits.
19. The method of claim 18, wherein the allowable limits include
the ratio of the activity of strontium-82 divided by the activity
rubidium-82 and the ratio of the activity of strontium-85 divided
by the activity of rubidium-82 each being less than 0.02
microcurie/millicurie.
20. The method of claim 15, further comprising displaying
breakthrough test results determined by the computer.
21. The method of claim 15, further comprising preventing, with the
computer, a patient infusion procedure if a breakthrough test
result exceeds an allowable limit.
22. The method of claim 15, further comprising measuring, with an
activity detector electronically coupled to the computer, an
activity of the radioactive eluate.
23. The method of claim 22, further comprising controlling, with
the computer, a diverter valve to divert the radioactive eluate to
a waste bottle until the activity detector detects a given level of
activity.
24. The method of claim 23, wherein the given level of activity is
approximately 1.0 millicurie per second.
25. The method of claim 15, wherein the shielding assembly is
positioned inside a cabinet structure and the computer is carried
by the cabinet structure.
Description
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/588,341, filed Aug. 17, 2012, which is a
continuation of U.S. patent application Ser. No. 12/137,356, filed
Jun. 11, 2008, and now issued as U.S. Pat. No. 8,317,674. The
entire contents of these applications are incorporated herein by
reference.
RELATED APPLICATIONS
[0002] The present application may be found related to the
following utility patent and patent applications, all of which are
hereby incorporated by reference in their entireties: U.S. Pat. No.
7,862,534, issued Jan. 4, 2011, and entitled: INFUSION SYSTEM
CONFIGURATIONS; U.S. patent application Ser. No. 12/137,364, filed
Jun. 11, 2008, now published as US 2009/0312630 and entitled:
INFUSION SYSTEMS INCLUDING COMPUTER-FACILITATED MAINTENANCE AND/OR
OPERATION AND METHODS OF USE; and U.S. patent application Ser. No.
12/137,377, filed Jun. 11, 2008, now published as US 2009/0309465
and entitled: CABINET STRUCTURE CONFIGURATIONS FOR INFUSION
SYSTEMS.
TECHNICAL FIELD
[0003] The present invention pertains to systems that generate and
infuse radiopharmaceuticals, and, more particularly, to shielding
assemblies thereof.
BACKGROUND
[0004] 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.RTM. available
from Bracco Diagnostics Inc. (Princeton, N.J.).
[0005] 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. 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
[0006] 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.
[0007] FIG. 1A is a first perspective view of an infusion system,
according to some embodiments of the present invention.
[0008] FIG. 1B is another perspective view of a portion of a
cabinet structure of the system shown in FIG. 1A, according to some
embodiments.
[0009] FIG. 1C is a second perspective view of the system shown in
FIG. 1A, according to some embodiments.
[0010] FIG. 1D is a schematic of an infusion circuit, according to
some embodiments of the present invention.
[0011] FIG. 2A is a perspective view of a shielding assembly for an
infusion system, such as that shown in FIGS. 1A-C, according to
some embodiments of the present invention.
[0012] FIG. 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.
[0013] FIG. 3A is another perspective view of the shielding
assembly shown in FIG. 2A.
[0014] FIG. 3B is a perspective view of the infusion circuit, shown
in FIG. 1C, configured and routed, according to some
embodiments.
[0015] FIG. 3C is a perspective view of a disposable infusion
circuit subassembly, according to some embodiments.
[0016] FIG. 3D is a frame for the subassembly shown in FIG. 3C,
according to some embodiments.
[0017] FIG. 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.
[0018] FIG. 5A is a schematic showing a first group of successive
screen shots from the computer interface, according to some
embodiments.
[0019] FIG. 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.
[0020] FIG. 5C is a schematic showing a second group of successive
screen shots from the computer interface, according to some
embodiments.
[0021] FIG. 6 is a schematic showing a third group of successive
screen shots from the computer interface, according to some
embodiments.
[0022] FIGS. 7A-C are schematics showing a fourth group of
successive screen shots from the computer interface, according to
some embodiments.
[0023] FIGS. 8A-B are schematics showing a fifth group of
successive screen shots from the computer interface, according to
some embodiments.
[0024] FIGS. 9A-C are schematics showing a sixth group of
successive screen shots from the computer interface, according to
some embodiments.
[0025] FIG. 10 is a schematic showing a seventh group of successive
screen shots from the computer interface, according to some
embodiments.
DETAILED DESCRIPTION
[0026] 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.
[0027] FIG. 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 FIG. 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 FIG. 1C). Shell may be formed from
panels of injection-molded polyurethane fitted together according
to methods known to those skilled in the art. FIG. 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 be
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
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 FIGS. 4-9C.
[0028] FIG. 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.
[0029] FIG. 1B 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. FIG. 1B 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. FIG. 1B further illustrates a rear access panel
174, 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 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 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.
[0030] FIG. 1A further illustrates upper surface 131 of shell 13
including several openings 133, 135, 139 formed therein. FIG. 1C is
a partially exploded perspective view of system 10, wherein a
removable access panel 132 is shown 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. FIG. 1C 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 10; and openings 133 and 135 provide
passageways for tubing lines to pass through shell 13. FIG. 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 FIGS. 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 17, provide a
relatively ergonomic and organized work area for technical
personnel who operate system 10.
[0031] Turning now to FIG. 1D, a schematic of an infusion circuit
300, which may be incorporated by system 10, is shown. FIG. 1D
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 FIG. 1D.) FIG. 1D 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 FIGS. 2A-B and
3A-B, below.
[0032] 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 FIG. 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
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 FIG. 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. FIG. 1D illustrates an eluant tubing line 301
coupled to reservoir 15 and to pump 33, and, with reference to
FIGS. 1A-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.
[0033] FIG. 1D 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 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.
[0034] With further reference to FIG. 1D, 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 FIGS. 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 vice 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.
[0035] 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 illustrated embodiment, opening 139 is
accessed by lifting panel 134; just within opening 139, a shielded
lid or door 223 (FIG. 2A) may be lifted away from a compartment of
shielding assembly 200 that contains waste bottle 23. With further
reference to FIG. 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.
[0036] FIGS. 1A and 1C 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 (FIG.
1B). With reference to FIG. 1C, 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.
[0037] FIG. 2A is a perspective view of shielding assembly 200,
according to some embodiments of the present invention. With
reference to FIGS. 1C 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 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 (FIG.
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 FIG. 1A,
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. FIG. 1C further
illustrates access panel 132 including a security lock 138, which
mates with a framework 19 of system 10, shown in FIG. 2B, in order
to limit access to generator 21.
[0038] FIGS. 1C and 2A further illustrate a lid or a door 225 of
another sidewall 205 (FIG. 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. FIG. 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 FIGS. 3A-B. FIG. 2A 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.
[0039] 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 FIG. 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 could
pinch/crush fingers of technical personnel and/or tubing lines of
circuit 300, when in the midst of a maintenance procedure. FIG. 2B
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; FIG. 2B includes an enlarged detailed view of latch
component 191, according to some embodiments. FIG. 2B 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, 193B, respectively, and a
holding end 193B, 195B, respectively. An edge of each door 221,
225, upon opening of doors 221, 225, may push past the holding end
195B, 193B 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 195B, 193B, until the corresponding lever end 195A,
193A is rotated in a counter-clockwise direction, per arrow cc,
thereby moving the corresponding holding end 193B, 195B 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 FIG. 3A.
[0040] With further reference to FIG. 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 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 FIGS. 3A-C.
[0041] FIG. 3A is another perspective view of shielding assembly
200, according to some embodiments of the present invention. In
FIG. 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. FIG. 3A further illustrates a pair of passageways
251b and 251g, which are formed as grooves in a portion of sidewall
205, and another pair of passageways 215i and 215o, which are
formed as grooves in a portion of sidewall 201. A routing of
portions of tubing circuit 300 (FIG. 1D) through passageways 207,
251b, 251c, 215i and 215o is shown in FIG. 3B.
[0042] FIG. 3B illustrates tubing line 304 being routed through
passageways 251g and 215i, eluate tubing line 305 being routed
through passageway 215o, 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 (FIG. 1A). According to the illustrated
embodiment, each passageway formed in shielding assembly 200, by
being accessible along a length thereof, can 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.
[0043] FIG. 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 FIG. 3B), and, with reference to FIG.
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 FIGS. 3C-D.
[0044] FIG. 3C is a perspective view of subassembly 390, and FIG.
3D is a perspective view of frame 39. According to the embodiment
illustrated by FIG. 3D, 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. FIG. 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 FIG. 3D 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.
[0045] 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 with divergence valve 35BG and
an upstream section of eluant tubing line 302. FIG. 3C further
illustrates an opposite end 404B 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
FIG. 1D, in conjunction with FIG. 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.
[0046] 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 (FIG. 3A), for example: registration of divergence
valve 35WP with valve actuator receptacle 253, registration of
tubing line ends 403 and 404A with passageways 251b and 251g,
respectively, registration of tubing line ends 404B and 405 with
passageways 215i and 215o, respectively, and registration of tubing
line ends 406 and 407 with passageway 207.
[0047] With further reference to FIG. 3B, other portions of tubing
circuit 300 are shown. FIG. 3B illustrates eluant tubing line 301
extending from reservoir 15, outside of shell 13 (FIG. 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.
[0048] FIG. 3B further illustrates a filter holder 317 that is
mounted alongside an interior surface of shell 13 to hold filter 37
(FIG. 1D) 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.
[0049] Turning now to FIGS. 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 FIG. 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 FIG. 1A 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.
[0050] 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
FIGS. 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.
[0051] FIG. 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.
[0052] FIG. 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 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. .
. . ).
[0053] 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 FIG. 5B, 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.
[0054] 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 FIG. 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 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 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 bottle will overflow. According to some embodiments, system
10 automatically precludes any further operation of the system
until the waste bottle is emptied.
[0055] In addition to the above maintenance steps related to eluant
and eluate volumes of system 10, the user of system 10 will
typically perform quality control tests each day, prior to any
patient infusions. With reference to FIG. 6, according to preferred
methods, prior to performing the quality control tests (outlined in
conjunction with FIGS. 7A-C and 8A-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 into waste
bottle 23, computer 17 provides an indication, via a screen 676,
that the wash is in progress. Also, during the generator column
wash, the system may provide a signal to indicate that eluate it
being diverted to waste bottle 23, for example, light projector 100
(FIG. 1C) may project a flashing light signal, as previously
described.
[0056] FIG. 6 further illustrates a screen 677, which is presented
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 time countdown, until a subsequent elution
process may be effectively carried out. While screen 677 is
displayed, system 10 may be 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 the time lapse, either
in terms of the time countdown (screen 677), or in terms of a time
from completion of the elution, for example, as will be described
in conjunction with FIG. 7B. According to an exemplary embodiment,
wherein generator 21 is the CardioGen-82.RTM. that yields a saline
solution of Rubidium-82, produced by the decay of Strontium-82, via
the elution, a time required between two effective elution
processes is approximately 10 minutes.
[0057] Once the appropriate amount of time has lapsed, after the
elution process of generator column wash, a first quality control
test may be performed. With reference to FIG. 7A, the user may
select, from main menu 470, an item 773A, which directs computer 17
to begin a sequence for breakthrough testing. In conjunction with
the selection of item 773A, the user attaches a needle to an end of
patient line 305p and inserts the needle into to a test vial, for
the collection of an eluate sample therefrom, and, according to
FIG. 7A, computer 17 presents a screen 774, which instructs the
user to insert the test vial into a vial shield, which may be held
in recess 101 of shell 13 (FIG. 1C).
[0058] FIG. 7A further illustrates a subsequent screen 775, by
which computer 17 receives input, from the user, for system 10 to
start the breakthrough elution, followed by a screen 776, which
provides both an indication that the elution is in progress and an
option for the user to abort the elution. As previously described,
the system may provide a signal to indicate that elution is in
progress, for example, light projector 100 (FIG. 1C) may project a
flashing light signal during that portion of the elution process
when eluate is diverted from generator 21 through waste line 305w
and into waste bottle 23, and then a steady light signal during
that portion of the elution process when the eluate 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/sec in the eluate 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 bolus of radioactivity is detected in the eluate.
[0059] Upon completion of the elution process for breakthrough
testing, computer 17 presents a screen 777, shown in FIG. 7B,
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 eluate into a dose
calibrator, to measure the activity of the sample, the user may
make a note of the time lapse indicated on screen 777. With further
reference to FIG. 7B, once the user has received the activity
measure from the dose calibrator, the user proceeds to a screen
778, which includes data entry fields for the activity measure and
the time between that at which the 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 interface of
monitor 172, or via any of the other aforementioned devices for
user data entry. According to some alternate embodiments, computer
17 may receive the data, electronically, from the dose calibrator,
either via wireless communication or a cable connection.
[0060] 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 FIGS. 8A-B, although the breakthrough testing is
not completed. With reference back to FIG. 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 item
773A, so as to perform a second stage of breakthrough testing. In
the second stage, the breakthrough of the sample of eluate
collected in the test vial for the breakthrough testing is
measured, at a time of approximately 60 minutes from the completion
of the elution that produced the sample. With reference to FIG. 7C,
after the user has selected item 773B from main menu 470, in order
to direct computer 17 to provide breakthrough test results, a
screen 781 is displayed. Screen 781 includes, for reference, the
values 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, as 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 allowable limits for the
results, so that the user may verify that the breakthrough test
results are in compliance with acceptable limits, before moving on
to a patient infusion. According to some embodiments, system 10
will not allow an infusion if the results exceed the acceptable
limits, and may present a screen explaining that the results are
outside the acceptable limits; the screen may further direct the
user to contact the generator supplier, for example, to order a
replacement generator.
[0061] With reference to FIG. 8A, 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 873, computer 17
presents a screen 874, which instructs the user to insert a new
test vial into an elution vial shield. In addition to placing the
vial in the shield, the user, preferably, replaces patient line
305p with a new patient line, and then attaches a needle to the end
of the new patient line for insertion into the test vial, in order
to collect an eluate sample therefrom. After performing these
steps, the user may move to screen 875, 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
calibration elution.
[0062] With reference to FIG. 8B, after computer 17 starts the
elution process, a screen 87 informs the user that the calibration
elution is in progress and provides an option to abort the elution.
As previously described, the system may provide an indication that
elution is in progress, for example, light projector 100 (FIG. 1C)
may project a flashing light signal during that portion of the
elution process when eluate is diverted from generator 21 through
waste line 305w and into waste bottle 23, and then a steady light
signal during that portion of the elution process when activity
detector 25 has detected that a prescribed dose rate threshold is
reached, for example, 1.0 mCi/sec, and the eluate is being diverted
from generator 21, through the new patient line, and into the test
vial. Another type of light signal, for example, the more rapidly
flashing light, as previously described, may be projected when 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 provides an indication of a time lapse
since the completion of the elution, in terms of a time since
completion of the calibration elution process. When the user
transfers the vial containing the sample of eluate into the dose
calibrator, to measure the activity of the sample, the user may
make a note of the time lapse indicated on screen 878. With further
reference to FIG. 8B, once the user has received the activity
measure from the dose calibrator, the user proceeds to a screen
879, which includes data entry fields for the activity measure 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 input by the user, as described above, computer calculates a
calibration coefficient, or ratio, and presents the ratio on a
screen 880. According to FIG. 8B, 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 17 to recalculate the
ratio.
[0063] With reference to FIG. 9A, upon completion of the
above-described quality control tests, the user may select an item
971, from main menu 470, in order to direct system 10 to begin a
procedure for the generation and automatic infusion of a
radiopharmaceutical into a patient. As previously described, system
10 infuses the patient with the radiopharmaceutical so that nuclear
diagnostic imaging equipment, 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 FIG. 9A, upon selection of item 971,
computer 17 presents a screen 972 which includes a data entry field
for a patient identification number. This identification number
that is entered by the 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 computer 17 includes data
entry fields by which the user may establish parameters for the
automatic infusion; 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.
[0064] With reference to FIG. 9B, if pump 33 does not contain
enough eluant/saline for the patient infusion, computer 17 will
present a warning, via a screen 901, 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, via a screen 903. According to some
embodiments, if the user does not re-fill pump 33, yet attempts to
proceed with an infusion, system 10 will preclude the infusion and
present another screen, that communicates to the user that no
infusion is possible, if the pump is not refilled, and asking the
user to refill the pump, as in screen 901. When pump 33 contains a
sufficient volume of eluant for the patient infusion, computer 17
presents a screen 975, which is shown in FIG. 9C, and allows the
user to enter a command for system 10 to start the patient
infusion. During the infusion, computer 17 provides the user with
an indication that the infusion is in process and with an option
for the user to abort the infusion, via a screen 976. As previously
described, the system may provide an indication that an elution is
in progress, for example, light projector 100 (FIG. 1C) may project
a flashing light signal during that portion of the elution process
when eluate is diverted from generator 21 through waste line 305w
and into waste bottle 23, and then a steady light signal during
that portion of the elution process when activity detector 25 has
detected that a prescribed dose rate threshold is reached, for
example, 1.0 mCi/sec, and the eluate is being diverted from
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 displayed by computer
17 to inform the user of the completion of the infusion and a time
since the completion. Computer 17 also displays a summary of the
infusion, per screen 978.
[0065] Printer 117 (FIG. 1B) may be activated to print out a hard
copy of the infusion summary, on which the patient identification
number and pertinent system parameters are also printed, for
reference. Alternatively, or in addition, according to some
embodiments, the summary of the infusion, which includes the
patient identification number and pertinent system parameters, may
be downloaded onto a computer readable storage device to be
transferred to one or more remote computers and/or automatically
transferred thereto, via wireless communication or a cable
connection. The one or more remote computers may be included, for
example, in a hospital information system, and/or an inventory
system, and/or a billing system, and/or in a medical imaging
system. With reference back to FIG. 9A the user may select an item
995, 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
infusion summary records to USB mass storage devices, and various
types of data filtering, for example, according to date ranges
and/or patient identification numbers, for example, to search for a
particular set of data and/or to compile a summary report of
related sets of data.
[0066] Turning now to FIG. 10, an item 981 for computer-facilitated
purging of the tubing lines of system 10 is shown included in main
menu 470. When a user selects item 981, computer 17 guides the user
to select either an air purge or 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 FIG. 1D. 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. An air purge of the tubing lines
of circuit 300 may be performed after removing reservoir 15,
by-passing generator 21, by connecting tubing line 304 to tubing
line 305, and coupling patient line 305p to a vial, for example, as
is directed by the computer interface, in screens 983 and 984 shown
in FIG. 10. The air purge is desirable for blowing out the tubing
lines, thereby removing all remaining eluant and eluate, 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 site, 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.
[0067] According to preferred embodiments, once the user has
followed the instructions 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 out a
complete air purge, in which pump 33 and divergence valves 35BG and
35WP are automatically controlled. The automated air purge
preferably includes the following steps, which may be best
understood with reference to tubing circuit 300 in FIG. 1D: pumping
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 air through lines 302, 304, 305 and 305w, into
waste bottle 23 (lines 304 and 305 have been previously connected
directly to one another, in order to by-pass generator 21; if
generator 21 is depleted and will be replaced with a new generator,
pumping air through generator 21 may be 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 FIG. 1D and the previous description of
divergence valves 35BG, 35WP, it should be understood how
divergence valves 35BG, 35WP are automatically controlled to carry
out the above steps.
[0068] The purge operations, which are facilitated by selecting
item 981 from main 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
installation of the new generator.
[0069] In the foregoing detailed description, the invention has
been described with reference to specific embodiments. However, it
may be appreciated that various modifications and changes can be
made without departing from the scope of the invention as set forth
in the appended claims.
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