Note: Descriptions are shown in the official language in which they were submitted.
RADIOISOTOPE ELUTION SYSTEM
[0001] The present application claims priority from U.S. Patent Application
Serial No, 13/353,888
filed January 19, 2012.
BACKGROUND
[0002] The present disclosure relates generally to a radioisotope elution
system and tools for use
therewith.
[0003] Nuclear medicine uses radioactive material for diagnostic and
therapeutic purposes by
injecting a patient with a dose of the radioactive material, which
concentrates in certain organs or biological
regions of the patient. Radioactive materials typically used for nuclear
medicine include Technetium-99m,
Indium-111, and Thallium-201 among others. Some chemical forms of radioactive
materials naturally
concentrate in a particular tissue, for example, radioiodine (1-131)
concentrates in the thyroid. Radioactive
materials are often combined with a tagging or organ-seeking agent, which
targets the radioactive material for
the desired organ or biologic region of the patient. These radioactive
materials alone or in combination with a
tagging agent are typically referred to as radiopharmaceuticals in the field
of nuclear medicine. At relatively
low doses of radiation from a radiopharmaceutical, a radiation imaging system
(e.g., a gamma camera) may
be utilized to provide an image of the organ or biological region in which the
radiopharmaceutical localizes.
Irregularities in the image are often indicative of a pathology, such as
cancer. Higher doses of a
radiopharmaceutical may be used to deliver a therapeutic dose of radiation
directly to the pathologic tissue,
such as cancer cells.
[0004] A variety of systems are used to generate, enclose, transport,
dispense, and administer
radiopharmaceuticals. One such system includes a radiopharmaceutical
generator, including an elution
column, and an input connector (e.g., an input needle) and an output connector
(e.g., an output needle) in
fluid communication with the elution column. Typically, a radiopharmacist or
technician fluidly connects an
eluant vial (e.g., a vial containing saline) to the input connector and
fluidly connects an empty elution vial (e.g.,
a vial having at least a partial internal vacuum) to the output connector. The
vacuum in the empty elution vial
draws the eluant (e.g., saline) from the eluant vial through the elution
column, and into the elution vial. The
saline elutes radioisotopes as its flows through the elution column so that
radioisotope-containing saline fills
the elution vial. The elution vial is typically housed in its own radiation
shielding container, sometimes referred
to as pharmacy shield or an elution shield.
[0005] This Background section is intended to introduce the reader to various
aspects of art that
may be related to various aspects of the present disclosure, which are
described and/or claimed below. This
discussion is believed to be helpful in providing the reader with background
information to facilitate a better
understanding of the various aspects of the present disclosure. Accordingly,
it should be understood that
these statements are to be read in this light, and not as admissions of prior
art.
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BRIEF SUMMARY
[0006] In one aspect, an elution tool for a radiopharmaceutical elution system
includes an elution tool
body having a top, an opposing bottom, and an opening in the top. The tool has
a vial chamber that extends from
the opening in the top toward the bottom and that is sized and shaped for
receiving an elution vial through the
opening in the top. An access opening extends through the bottom to the vial
chamber and is aligned with a
septum of the elution vial when the elution vial is received in the vial
chamber. An elution tool lid is secured to the
elution tool body by a hinged connection adjacent the top of the elution tool
body. The elution tool lid is rotatable at
the hinged connection and movable relative to the elution tool body between an
occluded position, in which the
elution tool lid occludes the opening in the top of the elution tool body, and
an exposed position, in which the
elution tool lid does not occlude the opening in the top of the elution tool
body to allow the elution vial to be
inserted into and removed from the vial chamber. The tool body and the lid
include at least one of depleted
uranium, tungsten, tungsten impregnated plastic, and lead. The tool also
includes a latching mechanism for
selectively and releasably locking the lid in the occluded position.
[00071 In another aspect, an elution tool includes an elution tool body
configured to be held in one hand
of a user. A dispensing cap is removably securable to the bottom of the
elution tool body. The dispensing cap
includes a dispensing cap body having a dispensing access opening that is
aligned with the access opening of the
elution tool body when the dispensing cap is secured to the elution tool body.
A dispensing lid is rotatably secured
to the dispensing cap body for selectively occluding and exposing the
dispensing access opening.
[0008] Various refinements exist of the features noted in relation to the
above-mentioned aspects of the
present disclosure. Further features may be incorporated in the above-
mentioned aspects of the present
disclosure as well. These refinements and additional features may exist
individually or in any combination. For
instance, various features discussed below in relation to any of the
illustrated embodiments of the present
disclosure may be incorporated into any of the above-described aspects of the
present disclosure, alone or in any
combination.
BRIEF DESCRIPTION OF THE FIGURES
[0009] FIGS. 1A and 1B are perspectives of one embodiment of a radioisotope
elution system.
[0010] FIG. 2 is a top plan view of the radioisotope elution system of FIG. 1.
[0011] FIG. 3 is a cross section of the radioisotope elution system of Fla 1
taken along line 3-3 in
FIG. 2.
[0012] FIG. 4 is an exploded view of the radioisotope elution system of FIG.1
,
[0013] FIG. 5 is an enlarged perspective of a radioisotope generator of the
radioisotope elution system
of FIG. I.
[0014] FIG. 6 is an enlarged perspective of an auxiliary shield assembly lid
of the radioisotope elution
system of FIG. 1.
[0015] FIG. 71s a front elevation of the auxiliary shield assembly lid of FIG.
6.
2
[0016] FIG. 8 is a top plan of the auxiliary shield assembly lid of FIG. 6.
[0017] FIG. 9 is a bottom plan of the auxiliary shield assembly lid of FIG. 6.
[0018] FIG. 10 is a cross section of the auxiliary shield assembly lid of FIG.
6 taken through line 10-
in FIG. 8.
[0019] FIG. ills a cross section of the auxiliary shield assembly lid of FIG.
6 taken through line 11-
11 in FIG. 8.
[0020] FIG. 12 is a perspective of the radioisotope generator in a non-use
configuration including a
cap cover.
[0021] FIG. 13 is similar to FIG. 12, but with the cap cover removed from the
cap of the radioisotope
generator.
[0022] FIG. 14 is a perspective of the elution column assembly removed
from a housing of the
radioisotope generator.
[0023] FIG. 15 is similar to FIG. 14, but with a column shield of the elution
column assembly removed
therefrom.
[0024] FIG. 16 is similar to FIG. 15, but with a conduit shield of the elution
column assembly removed
therefrom.
[0025] FIG. 17 is similar to FIG. 16, but with a U-shaped support of
the elution column assembly
removed therefrom.
[0026] FIG. 18 is a partial perspective of the elution system, including an
eluant shield and a sterile
vial holder on the lid of the auxiliary shield.
[0027] FIG. 19 is similar to FIG. 18, but with the eluant shield removed
therefrom.
[0028] FIG. 20 is an enlarged top perspective of the eluant shield.
[0029] FIG. 21 is an enlarged bottom perspective of the eluant shield.
[0030] FIG. 22 is an exploded perspective of a second embodiment of an elution
tool, including a
dispensing cap removed from a body of the elution tool.
[0031] FIG. 23 is similar to FIG. 22, but with a storage cap removed from the
body of the elution tool.
[0032] FIG. 24 is a perspective of the second embodiment of the elution tool
including the dispensing
cap, with a lid of the elution tool in an open position.
[0033] FIG. 25 is a perspective of the second embodiment of the elution tool
including the dispensing
cap, with the lid of the elution tool in a closed, unlocked position.
[0034] FIG. 26 is a top plan of the second embodiment of the elution tool
including the dispensing
cap, with the lid of the elution tool in a closed, unlocked position.
[0035] FIG. 27 is a perspective of the second embodiment of the elution tool
including the dispensing
cap, with the lid of the elution tool in a closed, locked position.
[0036] FIG. 28 is a top plan of the second embodiment of the elution tool
including the dispensing
cap, with the lid of the elution tool in a closed, locked position.
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[0037] FIG. 29 is a bottom perspective of the second embodiment of the elution
tool including the
dispensing cap, with a dispensing lid of the dispensing cap in a closed
position.
[0038] FIG. 30 is a bottom plan of the second embodiment of the elution tool
including the dispensing
cap, with a dispensing lid of the dispensing cap in a closed position.
[0039] FIG. 31 is a bottom perspective of the second embodiment of the elution
tool including the
dispensing cap, with a dispensing lid of the dispensing cap in an open
position.
[0040] FIG. 32 is a bottom plan of the second embodiment of the elution tool
including the dispensing
cap, with a dispensing lid of the dispensing cap in an open position.
[00411 FIG. 33 is a sectional view of the elution tool taken through the line
33-33 in FIG, 28.
[0042] FIG. 34 is a perspective of the sterile vial holder in FIG. 18.
[0043] FIG. 35 is an exploded perspective of the sterile vial holder.
[0044] FIG. 36 is a sectional view of the exploded sterile vial holder.
[0045] FIG. 37 is a top plan of a body of the sterile vial holder.
[0046] FIG. 38 is a perspective of a re-covering tool.
[0047] FIG. 39 is a sectional view of the re-covering tool.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0048] Referring to FIGS. 1A-4, one embodiment of a radioisotope elution
system 10 includes a
radioisotope generator 12 (FIGS. 3 and 4), which is removably receivable in an
auxiliary shield assembly 14. As
explained in more detail below, an elution tool 16, which houses an elution
vial 17 (broadly, a container), and an
eluant vial 18 (broadly, a container) are fluidly connectable to the
radioisotope generator 12. Herein, 'fluidly
connectable" refers to the ability of first component and a second component
to be connected (either directly or
indirectly) or interface in a manner such that fluid (e.g., eluate, eluant)
may flow therebetween in a substantially
confined flow path. The auxiliary shield assembly 14 includes a radiation
shielding body 20 that defines a cavity 22
in which the generator 12 is removably receivable, and a radiation shielding
lid 24 that may be positioned on the
body 20 toward a top thereof to substantially enclose the cavity 22 defined in
the body 20. In general, the radiation
shielding lid 24 facilitates proper alignment of the eluant vial 18 with the
radioisotope generator 12 when fluidly
connecting the eluant vial with the radioisotope generator. Additional
disclosure of the radiation shielding lid 24 is
set forth in detail below.
[0049] The elution tool 16 illustrated in FIGS. 1-11 may be of any appropriate
configuration (e.g., size,
shape, design), as is known to one having ordinary skill in the art, and may
include one or more suitable radiation
shielding materials, such as depleted uranium, tungsten, tungsten impregnated
plastic, or lead. A second
embodiment of the elution tool is illustrated in FIGS. 22-33 and described in
detail below. The illustrated elution
vial 17 is a generally cylindrical container, made from glass or other
material (e.g., plasfic), which includes a
septum 17a secured to a top portion thereof by a metal ring or cap 17b, as is
generally known in the art. The
elution vial 17 may be a different type of container suitably connectable to a
radioisotope generator end/or may
have a shape other than generally cylindrical. In one embodiment, the interior
of the elution vial 17 is at least
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partially evacuated such that the elufion vial has a reduced internal pressure
(i.e., at least a partial vacuum). The
eluant vial 18, like the elution vial 17, may be a generally cylindrical
container, which includes a septum (not
shown) secured to a top portion thereof by a metal ring or cap (not shown), as
is generally known in the art. The
eluant vial 18 may be a different type of container suitably connectable to a
radioisotope generator and/or may
have a shape other than generally cylindrical. The eluant vial 18 is filled
with an eluant fluid, such as saline. In
one embodiment, the volume of eluant fluid is less than the volume of the
elution vial 17. In another embodiment,
the interior volume of eluant vial 18 is less than the interior volume of the
elution vial 17, For example, the eluant
vial 18 may have an internal volume of about 26 milliliters, and the interior
volume of the elution vial 17 may be
about 36 milliliters. The elution vial 17 and/or the eluant vial 18 may be of
other configurations without departing
from the scope of the present disclosure.
[0050] Referring to FIGS. 3-5, the radioisotope generator 12 includes: a
housing 26; an elution column
assembly 28 (FIG. 3) disposed within the housing; and input and output
connectors 30, 32, respectively, in fluid
communication with the elution column assembly 28; and a hood or cap 38
secured to the housing. The generator
housing 26 is generally cylindrical and defines an axially extending cavity in
which the elution column assembly 28
is received. The housing cap 38 may be snap-fit on the housing 26, or secured
thereto in any other appropriate
manner. The housing cap 38 has a recessed portion 40 extending downward from
an upper surface of the cap.
The cap 38 also has a generally U-shaped channel 42 extending downward from
the upper surface and through a
sidewall of the cap to the recessed portion 40. As explained in more detail
below, the recessed portion 40 and the
channel 42 together constitute an alignment structure, more specifically
female alignment structure, for facilitating
proper alignment of the radiation shielding lid 24 on the generator 12. The
generator housing 26 and cap 38 may
be formed from plastic (such as by molding) or from other suitable, preferably
lightweight, material. Moreover, the
generator housing 26 itself may be free from lead, tungsten, tungsten
impregnated plastic, depleted uranium, or
other radiation shielding material, such that the housing provides little or
only nominal radiation shielding.
[0051] The generator 12 includes a generator handle 44 pivotally secured to
the cap 38. The handle 44
is pivotable between a stored position, in which the handle lies in a plane
substantially transverse to the axis Al of
the housing 26 (FIG. 3) and below the upper surface of the cap 38, and a
carrying position, in which the handle lies
in a plane substantially parallel to the axis of the housing and above the
upper surface of the cap. The generator
handle 44 allows a radiopharmacist or technician to lift the generator 12 for
placement of the generator in the
auxiliary shield assembly 14 and removal of the generator from the auxiliary
shield assembly. The generator
handle 44 may be formed from plastic or any other appropriate material and may
be pivotally connected to the
generator housing 26 by pivot connectors 46 (FIG. 5) or in any other
appropriate manner of connection.
[0052] Referring to FIG. 3, the input and output connectors 30, 32 extend
upward from the elution
column assembly 28 and through respective input opening 50 and output opening
52 in a bottom surface 53 of the
recessed portion 40 of the generator cap 38 such that respective terminal ends
or tips 30a, 32a of the input and
output connectors are disposed within the recessed portion. In the illustrated
embodiment, the input and output
connectors 30, 32 respectively include input and output needles or needles 30,
32 for piercing respective septums
17a of the elution vial 17 and the eluant vial 18, although it is contemplated
that the connectors may be of other
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configurations/types. In addition to the input and output connectors 30, 32, a
venting needle 54, in fluid
communication with atmosphere, extends through the bottom surface 53 of the
recessed portion 40 of the cap 38.
The venting needle 54 is adjacent to the input connector 30 and extends
through the same input opening 50 in the
generator cap 38. In the illustrated embodiment, the venting needle 54
includes a needle having a terminal end or
tip Ma disposed within the recessed portion 40 of the generator cap 38. The
venting needle 54 pierces the
septum 17a of the eluant vial 18, like the input needle 30, to vent the eluant
vial 18 to atmosphere.
[0053] As shown in FIGS. 12-13, in a non-use configuration of the generator -
such as during shipping -
the generator 12 may include needle covers 55a, 55b and a cap cover 56. In the
illustrated embodiment, the
needle covers include an input/venting needle cover 55a removably secured
directly to the input needle 30 and the
venting needle 54, and an output needle cover 55b removably secured directly
to the output needle 32. The
needle covers 55a, 55b protect the respective needles 30, 32, 54 and inhibit
contaminants from entering the
elution column assembly 28 via the needles. The illustrated needle covers 55a,
55b are solid, non-hollow, one-
piece members made of a suitable material (e.g., silicone) that is pierceable
by the needles 30, 32, 54, Before
operating the elution system 10, a technician can remove the needle covers
66a, 55b using forceps or another
suitable instrument. It is understood that the elution system 10 may not
include the needles covers 55a, 55b, or
the needle covers may be of other configurations without departing from the
scope of the present invention,
[0054] Referring still to FIGS. 12-13, the cap cover 56 is removably
insertable in the recessed portion
40 of the generator cap 38 to cover and protect the input, output, and venting
needles 30, 32, 54, respectively.
The cap cover 56 has a top surface 56a that is disposed over and covers the
needles 30, 32, 54 when the cap
cover is secured to the generator 12, and a sidewall 56b depending downward
from the top surface that frictionally
engages the sidewall of the recessed portion 40 such that the cap cover is
removably retained in the recessed
portion by friction-fit connection. The cap cover 56 has two finger recesses
67 in the top surface 56a thereof, and
a thumb recess 58 in the top surface and the sidewall 56b thereof. A
technician can grip and remove the cap
cover 56 using a single hand by inserting one or more of his/her fingers into
each of the finger recesses 57 and
inserting his/her thumb into the thumb recess 58, and then lifting the cap
cover upward and out of the recessed
portion 40. It is understood that a cap cover have other configurations and/or
can be removably secured to the
generator 12 in other ways without departing from the scope of the present
invention. It is also understood that the
elution system 10 may not include a cap cover without departing from the scope
of the present invention.
[0055] Referring to FIGS. 14-17, one embodiment of the elution column assembly
28 is shown in detail.
As shown in FIGS. 16 and 17, an input conduit 59 extends from the input
connector 30 and into a top 60a of an
elution column 60 to fluidly connect the input connector to the elution
column. An output conduit 61 extends from a
bottom 60b of the elution column 60 to the output connector 32 to fluidly
connect the elution column to the output
connector. The input and output conduits 59, 61, respectively, can be made
from suitable material, such as
Inconel 625. The elution column 60 may include a source of radioactive
material therein (e.g., molybdenum-99,
adsorbed to the surfaces of beads of alumina or a resin exchange column). In
the illustrated embodiment, a filter
62 (e.g., a conventional 0.2 micron filter) is fluidly connected to, and
inline with, the output conduit 61. A fillport
needle 63 is fluidly connected to conduit 64, which is in turn fluidly
connected to the elution column 60 for loading
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the product Ripon needle is typically only accessed during loading and not
accessed by the technician). A cover
63a, similar to the needle covers 55a, 55b described above, is removably
attached to the needle 63. A venting
conduit 65 (FIG. 17) fluidly connects the venting needle 54 with the
atmosphere. The venting conduit 65 has a
terminal end on which an air filter 66 is secured.
[0056] As shown in FIGS. 14-16, a generally rigid U-shaped support 67, which
may be formed from
plastic or other suitable, generally rigid material, provides structural
support to the input and output needles 30, 32,
the venting needle 54, and the fillport needle 63, and portions of the
respective conduits 59, 61, 64, 65. As shown
in FIGS. 14 and 15, the elution column assembly 28 also includes a conduit
shield 68 and a column shield 69. The
conduit shield 68 covers the respective conduits 59, 61, 64, 65, or portions
thereof, from adjacent the input, output,
and venting needles, 30, 32, 54, respectively, to adjacent the top 60a of the
elution column 60b. The conduit
shield 68 also covers the fillport needle 63 and the output filter 62. The
conduit shield 68 defines internal passages
for receiving and covering the respective components, while leaving the input,
output, and venting needles 30, 32,
54 and the air filter 66 exposed. The conduit shield 68 may be a two-piece
construction and may include (e.g., be
made from or have in their construct) lead, tungsten, tungsten impregnated
plastic, depleted uranium and/or
another suitable radiation shielding material. Referring to FIGS. 14 AND 16,
the column shield 69 defines a
chamber (not shown) for receiving the elution column 60 and a lower portion 71
of the conduit shield 68 therein.
The column shield 64 may be a one-piece construction and may include (e.g., be
made from or have in their
construct) lead, tungsten, tungsten impregnated plastic, depleted uranium
and/or another suitable radiation
shielding material.
[00571 Referring back to FIG. 1, the illustrated auxiliary shield assembly
body 20 includes a top ring 72,
a base 73, and a plurality of step-shaped or generally tiered, modular rings
74, which are disposed one over the
other between the base 73 and the top dng 72. Substantially all or part of the
illustrated auxiliary shield assembly
body 20 may be made of one or more suitable radiation shielding materials,
such as depleted uranium, tungsten,
tungsten impregnated plastic, or lead. The modular aspect of the rings 74 may
tend to enhance adjustment of the
height of the auxiliary shield assembly body 20, and the step-shaped
configuration may tend to contain some
radiation that might otherwise escape through a linear interface between the
modular rings. It is understood that
the auxiliary shield assembly body 20 may be of other configurations. In one
embodiment (FIG. 1B), an auxiliary
shield cover 75 is receivable over the body 20. The cover 75 has a smooth
exterior surface for ease of cleaning
and to protect the outer surface of the body 20. The cover 75 may be formed
from plastic (e.g., high-impact
polypropylene) or other material.
[00581 Referring now to FIGS. 6-11, the radiation shielding lid 24 includes: a
generally cylindrical lid
body 76 having upper and lower surfaces, 77, 78, respectively; an elution tool
opening 79; and an eluant vial
opening 80. In one example (of which an exemplary method of making is
explained in more detail below), the lid
body 76 includes a radiation shielding core 124 that is overnnoldecl with a
plastic material 126, 128. As an
example, the radiation shielding core 124 may include depleted uranium,
tungsten, tungsten impregnated plastic,
or lead. The upper and lower surfaces 77, 78, respectively, are generally
planar, although the surfaces may be
other than generally planar,
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[00591 A male alignment structure, generally indicated at 81, is provided on
the lower surface 78 of the
lid body 76 to facilitate proper alignment of the lid 24 on the generator 12.
More specifically, the male alignment
structure 81 has a shape generally corresponding with the combined shape of
the recessed portion 40 and the
channel 42 of the generator 12 (together, these recessed portion 40 and the
channel 42 constitute a female
alignment structure) so that the male alignment structure mates with the
generator in order to align the elution tool
opening 79 with the output needle 32 and the eluant vial opening 80 with the
input needle 30 and the venting
needle 54. As such, it may be said that the lid 24 is keyed with the generator
12 (e.g., the cap 38 thereof) such
that proper positioning of the lid 24 atop the generator 12 results in
alignment of the respective openings 79, 80
with the corresponding needles 32, 30. The structure 81 enables only one
position of the lid 24 relative to the
generator 12. The illustrated male alignment structure 81 includes a wall 81a
projecting outward from the bottom
surface 78 and surrounding the elution tad opening 79 and the eluant vial
opening 80. A plurality (e.g., a pair) of
handles 82 on the upper surface 77 of the lid body 76 allows the
radiopharmacist or technician to properly place
the lid 24 on the generator 12 and remove the lid from the generator.
[0060] The elution tool opening 79 extends through the lid body 76 from the
upper surface 77 through
the lower surface 78 thereof. The elution tool opening 79 is sized and shaped
for removably receiving the elution
tool 16 therein. For example, in the illustrated embodiment, the elution tool
opening 79 has a generally circular
circumference that is substantially uniform along its axis. In one embodiment,
the elution tool opening 79 has a
diameter slightly larger than an outer diameter of the elution tool 16 such
that the opening effectively aligns the
septum (not shown) of the elution vial 17 (FIG. 4) with the output needle 32
as the elution tool is inserted into the
opening. For example, the elution tool opening 79 may have a diameter that is
from about 0.25 mm (0.01 in) to
about 1.0 mm (0.04 in) larger than the outer diameter of the elution tool 16,
In one embodiment, the elution tool
opening 79 may have a diameter from about 46 mm (1.8 in) to about 48 mm (1.9
in), although it may alternatively
have a diameter falling outside this range. Other shapes and sizes of the
elution tool opening 79 may be
appropriate; however, it tends to be preferred that the shape and size of the
elution tool opening 79 be at least
generally complimentary to the shape and size of the elution tool 16 being
used with the radiation shielding lid 24
to reduce the likelihood of misalignment between the elution vial 17 and the
output needle 32.
[00611 As shown in FIGS. 9 and 10, the eluant vial opening 80 is spaced apart
and separate from the
elution tool opening 79, and is sized and shaped for removably receiving an
eluant vial 18 (FIG. 2), such as a vial
containing saline or other eluants. In the illustrated embodiment (FIG. 10),
the eluant vial opening 80 has a lower
end 86 at the lower surface 78 of the lid body 76 and an upper end 88
intermediate the upper and lower surfaces
77, 78, respectively. In one example, the eluant vial opening 80 may have a
diameter from about 34.0 mm (1.34
in) to about 34,5 mm (1.36 in), although it may alternatively have a diameter
falling outside this range. As with the
elution tool opening 79, other shapes and sizes of the eluant vial opening 80
may be appropriate; however, it tends
to be preferred that the shape and size of the eluant vial opening 80 be at
least generally complimentary to the
shape and size of the eluant vial 18 being used with the radiation shielding
lid 24 to reduce the likelihood of
misalignment between the eluant vial 18 and the input needle 30 and venting
needle 54.
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[0062] Referring to FIGS. 2, 6, 8, and 11, the illustrated lid 24 has two
finger recesses 90 formed in the
upper surface 77 of the lid body 76, which are diametrically opposite one
another with respect to the eluant vial
opening 80. The finger recesses 90 are defined by respective recessed surfaces
extending downward from the
upper surface 77 of the lid body 76 to the eluant vial opening 80, and are
sized and shaped to allow at least distal
portions of two fingers of a radiopharmacist or other appropriate technician
to enter the finger recesses. Recessed
surfaces defining illustrated finger recesses 90 are curved and generally in
the shape of a half-bowl such that the
recessed surfaces lead the radlopharmacist's or technician's fingers toward
the eluant vial opening 80. It is
understood that in other embodiments the lid 24 may have a single finger
recess, such as a finger recess that
completely or partially surrounds the eluant vial opening 80, or more than two
finger recesses. Referring to FIG. 8,
each illustrated finger recess 90 has an upper edge 92 adjacent the upper
surface 77 of the lid body 76 and a
lower edge 93 that is coextensive with a portion of the upper end 88 of the
eluant vial opening 80.
[0063] Referring to Fig. 11, the lid 24 of the auxiliary shield assembly 14
includes first and second
alignment wings 100, each designated generally at reference numeral 100,
extending upward from adjacent the
upper end 88 of the eluant vial opening 80 within the finger recesses 90. Each
of the first and second wings 100
has opposite sides 104, atop portion 106, and an inner surface 108 extending
partially around a circumference of
the upper end 88 of the eluant vial opening 80. In the illustrated embodiment,
the top portion 106 of each of the
wings 100 is disposed above the upper surface 77 of the lid body 76 (as seen
best in FIGS. 7 and 10), and the
inner surface 108 of each of the wings 100 is generally arcuate, although it
is understood that the wings 100 may
be of other shapes and relative dimensions. Together, the inner surfaces 108
of the wings 100 and the eluant vial
opening 80 define a vial passageway 107 extending from the top portions 106 of
the wings 100 through the lower
surface 78 of the lid body 76.
[0064] The wings 100 preferably enable alignment of the eluant vial septum
with the input needle 30
and venting needle 54 as the eluant vial 18 is inserted into the vial
passageway 107. As such, the wings 100
preferably make it is less likely that the input needle 30 or venting needle
54 will contact the metal ring or other
hard part of the vial and damage the needle. In one example, the inner surface
108 of each wing 100 may extend
at least 45 degrees and less than 180 degrees around the circumference of the
upper end 88 of the eluant vial
opening 80. In other examples, the inner surface 108 of each wing 100 may
extend at least 60 degrees, or at least
90 degrees, and less than 180 degrees around the circumference of the upper
end 88 of the eluant vial opening
80, Other configurations of the wings 100 do not depart from the scope of the
present disclosure.
[0065] To facilitate gripping of the eluant vial 18 during at least one of
insertion of the vial into the vial
passageway 107 and removal of the vial from the vial passageway, the
respective adjacent sides 104 of the first
and second wings 100 are spaced apart from one another about the eluant vial
opening 80 to define gaps or first
and second finger channels, each indicated at 112 (FIGS. 6 and '10), leading
from the finger recesses 90 to the vial
passageway. In the illustrated embodiment, the finger channels 112 are
diametrically aligned, relative to the vial
opening 80, with the finger recesses 90, and the respective sides 104 of the
wings 100 extend into the associated
finger recesses 90. Each of the first and second finger channels 112 are sized
and shaped to allow at least the
distal portion of one of the two fingers to enter the corresponding finger
channel from the associated finger recess
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90. For example, a minimum width of each of the finger channels 112 (i.e., the
distance between the respective
adjacent sides 104 of the first and second wings 100) may measure from about
19 mm (0.75 in) to about 21 mm
(0.83 in), and more specifically, from about 19.0 mm (0.748 in) to about 19.6
mm (0.776 in), although the minimum
width of each finger channel may fall outside this range. Thus, the finger
channels 112 allow the radiopharmacist
or technician to grip the eluant vial 18, such as by using his/her thumb and
forefinger, during at least one of
insertion of the vial in the vial passageway 107 and removal of the vial from
the vial passageway.
[0066] In the illustrated embodiment (FIGS. 8, 10, and 11), a diameter of a
portion of the vial
passageway 107 defined by the inner surfaces 108 of the wings 100 tapers from
the top portions 106 of the wings
toward the eluant vial opening 80. Tapering the inner surfaces 108 of the
wings 100 facilitates molding of the
wings when overmolding the lid 24 in one example, as described below. Although
this diameter of the vial
passageway 107, as defined by the inner surfaces 108, tapers along the length
of the passageway, a plurality of
alignment ribs 114 are provided on the inner surfaces to define an effective
inner diameter of the vial passageway
that is substantially uniform along the length of the passageway. The ribs 114
are spaced apart from one another
between the sides 104 of the wings and extend longitudinally along the
respective wings 100. The wings 100
project inwardly, generally toward a centerline of the passageway 107, such
that each rib 114 has a terminal,
guiding surface 115 (FIG. 11) generally facing the centerline of the
passageway. Each guiding surface 115 is
uniformly spaced from the centerline of the vial passageway 107 along its
length. In other words, the guiding
surface 115 of each rib 114 does not taper or flare with respect to the axis
of the vial passageway 107. Through
this configuration, the guiding surfaces 115 effectively align the elution
vial 18 with the input needle 30 and venting
needle 54 even though the inner surfaces 108 of the wings 100 are tapered. The
ribs 114 have depths projecting
into the vial passageway 107 relative to the respective inner surfaces 108,
Because the diameter of the vial
passageway 107 defined by the inner surfaces 108 of the wings 100 tapers, yet
the guiding surfaces 115 do not
taper or flare relative to the centerline of the vial passageway, the depths
of the ribs relative to the respective inner
surfaces 108 taper toward the eluant vial opening 80. The wings 100 may not
include the ribs 114 without
departing from the scope of the present disclosure.
[0067] As illustrated in FIG. 3, a bottom 116 of the eluant vial 18 lies
slightly below or at the top portions
106 of the wings 100 when the eluant vial is received in the vial passageway
107 and fluidly connected to the input
needle 30. Notches 118 in the top portions 106 of the wings 100 allow the
radiopharmacist or technician to view
the eluant vial 18 in the passageway without having to position his/her head
above the upper surface 77 of the lid
24.
[0068] In one example, the auxiliary shield lid 24 may be formed by a two-step
overmolding process. In
such a process, a radiation shielding core 124 (FIG. 10) - which may include a
suitable radiation shielding material
such as depleted uranium, tungsten, tungsten impregnated plastic, or lead ¨ is
provided. The core 124 may be
generally disk-shaped, having first and second openings, which will form the
elution tool and eluant vial openings,
79, 80, respectively, and recesses, which will form the finger recesses 90. A
first molded part is molded with a first
thermoplastic material 126 to form the bottom surface 78, the male alignment
structure 81, and the sidewall of the
body 76, and at least lower portions of the elution tool opening 79 and the
eluant vial opening 80. Next, the core
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124 is placed into the first molded part. Finally, this assembly is overmolded
with a second thermoplastic material
128 to form the top surface 77, the handles 82, the finger recesses 90, the
wings 100, and an upper portion of at
least the elution tool opening 79. The first and second thermoplastic
materials 126, 128, respectively, may include
polypropylene and polycarbonate, or other material, and the first and second
thermoplastic materials may be of the
same material. Other methods of making the auxiliary shield lid 24 may be
used.
[0069] Referring to FIGS. 18-21, an eluant shield 136 of the elution system 10
is positionable over the
eluant vial 18 when the vial is received in the eluant vial opening 80 in the
lid 24 and fluidly connected to the
generator 12 to inhibit exposure of the radiopharmacist or technician to
radiation when the eluant is fluidly
connected to the generator (e.g., during and after an elution process). The
eluant shield 136 has a top 138, an
opposing bottom 140, and a cavity 142 extending from the bottom toward the
top. A pair of shielding wings 144 at
the bottom 140 of the eluant shield 136 partially surround the cavity 142. The
shielding wings 144 are sized and
shaped to fit snugly within the finger recesses 90 in the lid 24 so that the
top portions 106 of the alignment wings
100 are received in the cavity 142 of the eluant shield 136 and the shielding
wings 144 oppose the sides 104 of the
alignment wings and the finger channels or gaps 112 between the sides of the
alignment wings. As such,
substantially an entirety of the eluant vial 18 is surrounded by radiation
shielding material of either the lid 24 or the
eluant shield 136. More specifically, when the eluant shield 136 is positioned
on the lid 24, substantially the
entirety of the eluant vial 18 is surrounded by a suitable radiation shielding
material, such as depleted uranium,
tungsten, tungsten impregnated plastic, or lead.
[0070] In one example, the eluant shield 136 may be formed by a two-step
overmolding process. In
such a process, a radiation shielding core 124, which may include a suitable
radiation shielding material such as
depleted uranium, tungsten, tungsten impregnated plastic, or lead ¨ is
provided. The core is substantially the
same shape as the eluant shield in finished form, including a pair of
shielding wings and a cavity. A first molded
part is molded with a first thermoplastic material to form the top 138. Next,
the core is placed into the first molded
part. Finally, this assembly is overmolded with a second thermoplastic
material to form the bottom 140, the
shielding wings 144, and the cavity 142. The first and second thermoplastic
materials, respectively, may include
polypropylene and polycarbonate, or other material, and the first and second
thermoplastic materials may be of the
same material. Other methods of making the eluant shield 136 may be used,
[0071] Referring to FIGS, 22-33, a second embodiment of an elution tool 150 is
generally indicated at
reference numeral 150. This elution tool 150 includes a body, generally
indicated at 162, having a top 154, and
opposing bottom 156; and a lid, generally indicated at 158, hingedly secured
to the top of the elution tool body. As
explained in more detail below, a dispensing cap 160 (FIG, 22) is removably
securabte to the bottom 156 of the
elution tool body 152 for configuring the elution tool in a dispensing tool
configuration, and a storage cap 162 (FIG.
23) is removably securable to the bottom of the elution tool body for
configuring the elution tool into a storage tool
configuration. In generally, the dispensing cap 160 and the storage cap 162
are interchangeably securable to the
elution tool body 152. In the illustrated embodiment, neither the dispensing
cap 160 nor the storage cap 162 are
secured to the elution tool body 152 when then elution tool 150 is inserted in
the auxiliary shield and the elution vial
17 in the elution tool is fluidly connected to the generator 12.
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[0072] The elution tool body 152 is sized and shaped to be slide* receivable
in the elution tool
opening 79 in the auxiliary shield lid 24. The body 152 has an upper
longitudinal portion 163 having first outer
diameter that defines an annular stop surface 164 to inhibit the top 154 of
the body from entering the elution tool
opening 79 in the auxiliary shield lid 24. A lower longitudinal portion 168 of
the body 152, having a second outer
diameter that is less than the first outer diameter, is receivable in the
dispensing and shielding caps 160, 162,
respectively, as explained in more detail below, An intermediate longitudinal
portion 168 of the body 162, having
an outer diameter that is less than the first outer diameter and greater than
the second outer diameter 0D2, is
sized and shaped to be slidably receivable in the elution tool opening 79. The
elution tool body 152 may include
(e.g., be made from or have in their construct) lead, tungsten, tungsten
impregnated plastic, depleted uranium
and/or another suitable radiation shielding material.
[0073] The elution tool body 152 is configured to receive the elution vial 17
therein, In particular, the
elution tool body 152 has a vial chamber 170 (Fig. 33) defined therein
extending from an opening 172 in the top
154 of the elution tool body to an opposing access opening 174 in the bottom
thereof. The top opening 172 is
sized and shaped to allow the elution vial 17 to be inserted into and removed
from the vial chamber 170, and the
vial chamber has a size and shape generally corresponding to the size and
shape of the elution vial such that the
elution vial fits generally snugly within the chamber. The bottom 156 of the
elution tool body 152 defines an
annular internal surface 178 surrounding the access opening 174. When the
elution vial 17 is received in the vial
chamber 170, the metal ring 17b of the vial contacts the internal surface 176
so that the septum 17a is aligned with
the access opening 174. Accordingly, when the elution tool 150 is inserted
into the elution tool opening 79 in the
lid 24, the output needle 32 enters the access opening 174 and pierces the
septum 17a.
[0074] The elution tool lid 158 is hingedly secured to the elution tool body
152 and configurable
between an open or exposed position (FIG, 24), in which the top opening 172 is
exposed and the elution vial 17
can be inserted into and removed from the vial chamber 170, and a closed or
occluded position (FIGS. 25-28), in
which the top opening is occluded and the elution vial is retained in the vial
chamber. The elution tool lid 158
includes a generally planar or disk-shaped lid body 178 that is receivable in
a lid recess 180 defined in the top 154
of the elution tool body 152 when the lid is in the closed position. The lid
body 178 has a lower face 178a that
seats on an inner annular flange or lid seat 182 of the lid recess 180, and an
upper face 178b that is substantially
coplanar with the top 154 of the elution tool body 152 when the lid 158 is in
a closed position. The upper face
178b of the lid body 178 has a plurality of gripping slots 179 formed therein
to provide a gripping region for the
radiopharrnacist or technician when opening and closing the lid, as explained
in more detail below. For reasons
which are apparent from the below description, the elution tool lid 158 has a
generally circular periphery, and the
lid recess 180 and the lid seat 182 have generally oblong peripheries.
Moreover, the elution tool lid 158 is sized
and shaped to allow for movement of the lid along the major axis of the lid
recess 180 when the lid is seated on the
lid seat 182. The elution tool lid body 178, may include (e.g., be made from
or have in their construct) lead,
tungsten, tungsten impregnated plastic, depleted uranium andlor another
suitable radiation shielding material.
[0075] Referring to FIGS, 22-28, the illustrated elution tool 150 includes a
hinged lid connection,
generally indicated 186, and a latching mechanism, generally indicated at 188,
for releasable locking the lid 158 in
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the closed position. The hinged lid connection 186 includes a hinge connector
190 extending radially or laterally
outward from the periphery of the lid body 178, and a hinge pin 192, adjacent
the periphery of the top 154 of the
elution tool body 152, to which the hinge connector is coupled. The hinge
connector 190 defines a slot 194 in
which the hinge pin 192 is received to allow both rotation of the hinge
connector (and the lid 158) about the hinge
pin, and limited transverse, linear movement of the hinge connector (and the
lid) relative to the hinge pin. The
latching mechanism 188 includes a latching member 194 extending radially or
laterally outward from the periphery
of the lid body 178, generally diametrically opposite the hinge connector 190.
The latching member 194 includes a
tongue 196 that is slidably receivable in a latching groove 198 adjacent the
periphery of the top 154 of the elution
tool body 152. A detent 200 (e.g., a bail detent) on the elution tool body 152
extends into the latching groove 198
and releasably engages the latching member 194 (e.g., an underside of the
latching member) as the tongue 196 is
slid into the latching groove to inhibit the latching member from
inadvertently withdrawing (e.g., sliding back out)
from the latching groove.
[0076] To lock the lid 158 in the closed position (FIGS. 27 and 28), the
radiopharmacist or technician
can rotate the lid about the hinge pin 192 to the closed position such that
the lid body 178 is seated on the lid seat
182 of the elution tool body 152. Once seated, the slot 194 in the hinge
connector 190 allows the radiopharmacist
or technician to move the lid 158 linearly toward the latching groove 198,
whereby the tongue 196 can be slid into
the latching groove 198. For example, while holding the elution tool 150 using
one hand, the radiopharmacist or
technician may contact the upper face 178b of the lid body 178 (more
specifically, the region defined by the
gripping slots 179) with his/her thumb to rotate the lid 158 to its closed
position and then linearly slide the lid
toward the latching groove 198. As the latching member 194 slides over the
ball detent 200, the ball detent
deflects and pushes against the latching member. Once the tongue 196 is
received in the latching groove 198, the
lid 158 is releasably locked in the closed position. The lid 158 may be
unlocked (FIGS. 25 and 26) by the
radiopharmacist or technician using his/her thumb to slide the lid away from
the latching groove 198, against the
pushing force of the ball detent, so that the tongue 196 is withdrawn from the
latching groove 198. Once unlocked,
the lid 158 can be rotated to the open position. It is understood that the lid
158 may be releasably lockable in the
closed position in other ways, and other ways of retaining the elution vial 17
in the elution tool 150 do not depart
from the scope of the present disclosure.
[0077] As disclosed above, dispensing cap 160 is removably securable to the
lower longitudinal portion
168 of the elution tool body 152, such as shown in FIG. 22, to configure the
elution tool in the dispensing
configuration. In the dispensing configuration, the elution tool 150 can be
used as a dispensing tool, whereby the
radiopharmacist or technician can hold the elution tool and withdrawal a
quantity of radiopharmaceutical from the
elution vial 17 housed in the elution tool without removing the dispensing cap
160. The dispensing cap 160
includes a body 204 (e.g., a generally cylindrical body) having a top 206 and
a bottom 208. The dispensing cap
body 204 defines a socket 210 extending from the top 206 toward the bottom 208
thereof that is sized and shape
for receiving the lower longitudinal portion 166 of the elution tool body 152.
The socket 210 has an open top end
to allow insertion of the lower longitudinal portion 166 of the elution tool
body 152 into the socket, and an access
opening 212 at the bottom 208 of the dispensing cap body 204 that is alignable
with the access opening 174 in the
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elution tool body 152 to provide access to the septum 17b of the elution vial
17 in the chamber 170 of the elution
tool body 152.
[0078] Referring to FIG. 22, the dispensing cap 160 includes a plurality of
magnetic couplers 214
attached to dispensing cap body 204 and surrounding the socket 210 for
releasably securing the dispensing cap to
the elution tool body 152 when the lower longitudinal portion 166 of the
elution tool body is received in the socket.
The magnetic couplers 214 are magnetically attracted to an annular coupler
surface 216 of the elution tool body
152 that is in opposing relationship with the magnetic couplers when the lower
longitudinal portion 166 of the
elution tool body is received in the socket 210 of the dispensing cap 160. In
another embodiment, the elution toot
body 152 may include magnetic couplers that are magnetically attracted to the
magnetic couplers (or some other
component or structure) of the dispensing cap body 204. The dispensing cap 160
also includes a locking pin 218
extending longitudinally outward from the top 206 of the dispensing cap body
204. The locking pin 218 is alignable
with and receivable in a locking cavity 220 in the annular coupler surface 216
of the elution tool body 162 to inhibit
the dispensing cap 160 from rotating about the elution tool body. In one
example of securing the dispensing cap
160 to the elution tool body 152, the radiopharmacist or technician may insert
the lower longitudinal portion 166 of
the elution tool body 152 into the socket 210 of the dispensing cap 160 and
then rotate the dispensing cap about
the elution tool body (or vice versa) until the locking pin 218 aligns with
and enters the locking cavity 220. The
dispensing cap 160 may be removably securable to the elution tool body 152 in
other ways.
[00791 The dispensing cap 160 includes a dispensing lid 222 pivotably secured
to the bottom 208 of the
dispensing cap body 204 by a pivot pin 223 (e.g., a pivot bolt) for
selectively opening and closing the access
opening 212 of the socket 210 and for providing suitable radiation shielding
when the elution vial 17 is received in
the elution tool 150. More specifically, the dispensing lid 222 is received in
a recess 224 formed in the bottom 208
of the dispensing cap body 204, and is pivotable about a pivot axis defined by
the pivot pin 223 that is generally
parallel to the longitudinal axis of the elution tool 150. The dispensing lid
222 is pivotable between a non-
dispensing position (FIGS. 29 and 30), in which the dispensing lid is aligned
with and opposing (i.e., covering) the
access opening 212 of the socket 210, and a dispensing position (FIGS. 30 and
31), in which the dispensing lid is
at least partially misaligned with the access opening (i.e., the access
opening is at least partially uncovered) to
allow access to the septum 17b of the elution vial 17. A detent 226 (e.g., a
ball detent) on the bottom 208 of the
dispensing cap body 204 releasable locks the dispensing lid 222 in the non-
dispensing position. Moreover, when
the dispensing lid 222 Is moved to the dispensing position, the detent 226 is
removably receivable in one of a
plurality of slots (e.g., three slots, not shown) formed on an underside of
the dispensing lid. Accordingly, the
dispensing lid 222 is releasably lockable in a selected one of a plurality of
dispensing positions, each providing a
different degree to which the lid is open.
100801 To position the dispensing lid 222 in the dispensing position and
provide access to the elution
vial 17 in the elution tool 150 when the dispensing cap 160 is secured to the
elution tool, a radiopharmacist or
technician can hold the elution tool in one hand and use his/her thumb to grip
the dispensing lid and swing (i.e.,
rotate) the dispensing lid about the pivot pin 223 and away from the access
opening 212 in the dispensing cap. As
the radiopharmacist or technician swings the dispensing lid 222 open, the
detent 226 resiliently deflects to allow
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the dispensing lid to slide over the detent. The radiopharmacist or technician
may continue to rotate the
dispensing lid 222 until the lid is at a selected dispensing position and the
detent 226 enters one of the slots (not
shown) on the underside of the lid. With the dispensing lid 222 in a selected
dispensing position, the
radiopharmaceutical in the elution vial 17 is accessible to the
radiopharmacist or technician, in that the
radiopharmacist or technician can insert a dispensing needle of a syringe (not
shown) through the access
openings 212, 174 in the respective dispensing cap 160 and the elution tool
body 150 and into the elution vial 17,
by piercing the septum 17b, to withdraw a desired quantity of
radiopharmaceutical from the elution vial. After
withdrawing the desired quantity of radiopharmaceutical, the radiopharmacist
or technician can position the
dispensing lid 222 in the non-dispensing position by rotating or swinging the
lid toward the access opening 212,
whereby the detent 226 deflects as the lid slides toward the access opening. A
wall 228 partially defining the
recess 224 in the dispensing cap 160 acts as a stop for inhibiting the lid
from sliding past the access opening 212
as the lid being closed,
[0081] The dispensing lid 222 may include (e.g., be made from or have in their
construct) lead,
tungsten, tungsten impregnated plastic, depleted uranium and/or another
suitable radiation shielding material. In
contrast, the dispensing cap body 204 may be formed from a suitable material,
such as aluminum, plastic or other
corrosion-resistant, lightweight material, or other material that has a
density less than the density of suitable
radiation shielding, such as that provided by lead, tungsten, tungsten
impregnated plastic, depleted uranium. The
dispensing cap body 204 does not need to provide suitable radiation shielding,
such as that provided by lead,
tungsten, tungsten impregnated plastic, depleted uranium and/or another
suitable radiation shielding material,
because such suitable radiation shielding is provided by the elution tool body
152. Accordingly, the dispensing cap
160 does not add a significant amount of weight to the elution tool 150 so
that the elution tool may be suitably used
as a dispensing tool for the radiopharmacist or technician.
[0082] Referring to FIG. 23, as disclosed above the storage cap 162 is
removably securable to the
elution tool body 152 to configure the elution tool in the storage
configuration. In the storage configuration, the
storage cap 162 must be removed from the elution tool body 152 in order for a
radiopharmacist or technician to
withdraw a quantity of radiopharmaceutical from the elution vial 17. The
storage cap 162 includes a storage cap
body 232 (e.g., a generally cylindrical body) having a top 234 and a bottom
236, and a radiation shield 238
secured to the bottom of the storage cap body. The storage cap body 232
defines a socket 240 extending from
the top 234 toward the bottom 236 of the storage cap body that is sized and
shape for receiving the lower
longitudinal portion 166 of the elution tool body 152. The socket 240 has an
open top end to allow insertion of the
lower longitudinal portion 166 of the elution tool body 152 into the socket.
The radiation shield 238 is secured to
the bottom 236 of the storage cap body 232 such that the shield is aligned and
in opposing relationship with the
access opening 174 in the elution tool body 152 when the storage cap 162 is
removably secured to the elution tool
150. In the illustrated embodiment, the radiation shield 238 is a press insert
into the storage cap body 232, The
radiation shield 238 may be secured to the storage cap body 232 in other ways
without departing from the scope of
the present disclosure.
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[0083] Referring to FIG. 23, the storage cap 162 is removably securable to the
elution tool body 152 in
substantially the same way as the dispensing cap 160, although the storage cap
can be removably securable in
other ways. More specifically, the storage cap 162 includes a plurality of
magnetic couplers 244 secured to the
storage cap body 232 and surrounding the socket 240. The magnetic couplers 244
are magnetically attracted to
the annular coupler surface 216 of the elution tool body 152. It is understood
that the elution tool body 152 may
include magnetic couplers secured thereto, that are magnetically attracted to
the magnetic couplers (or another
component or structure) of the storage cap body. The dispensing cap 160 may be
removably securable to the
elution tool body 152 in other ways without departing from the scope of the
present disclosure.
[0084] Referring to FIGS, 34-37, the radioisotope elution system 10 may also
include a sterile vial
holder, generally indicated at 250, for a vial 252 of sterile fluid (e.g.,
TechneStatTm) in which the output needle 32 is
stored when the elution system 10 is not in use. As explained in more detail
below, after the elution process, the
elution tool 150 may be withdrawn from the elution tool opening 79 in the
auxiliary shield lid 24, at which time the
sterile vial holder 250 can be inserted into the elution tool opening so that
the output needle 32 pierces a septum
252a of the sterile fluid vial. The sterile vial holder 250 includes a body,
generally indicated at 254, for holding the
sterile vial 252 therein, and a cap, generally indicated at 256, that is
removably securable to the body. The holder
body 254 has a generally cylindrical receptacle 258 having an open top 260, a
bottom 262, and a vial chamber 264
sized and shaped for receiving and retaining the sterile vial 252 therein. As
shown in FIG. 36, the bottom 262 of
the receptacle 258 defines an access opening 266 that is aligned with the
septum 252a of the sterile vial 252 when
the vial is received in the chamber 264 so that the output needle 32 pierces
the septum and enters the sterile vial
when the sterile vial holder 250 is inserted into the elution tool opening 79.
[0085] The holder body 254 includes a plurality of fins 268 (e.g., four fins)
projecting radially outward
from the receptacle 258 and spaced apart around the receptacle. The fins 268
define a diameter or cross-
sectional dimension of the receptacle 258 that is sized and shaped to fit
snugly within the elution tool opening 79
so that the access opening 266 (and the septum 252a) align with the output
needle 32 when the holder 250 is
inserted into the elution tool opening. The holder body 254 may be of other
configurations without departing from
the scope of the present disclosure.
[0086] The cap 256 of the sterile vial holder 250 is removably securable to
the body 254 by a twist-lock
mechanism, generally indicated at 270. The body 254 includes an annular female
twist-lock component 272 that
receives a male twist-lock component 274 projecting outward from a bottom
surface 276 of the cap 256. The
female twist-lock component 272 defines slots or grooves 278 that are spaced
apart around an interior surface 280
of the female twist-lock component to define gaps 281. The male twist-lock
component 274 includes a plurality of
tabs 282 that are receivable in the gaps 281 defined between the grooves 278
of the female twist-lock component,
and that enter the grooves 278 when the cap 256 is rotated about its
longitudinal axis relative to the holder body
254. When the tabs 282 are received in the grooves 278, the twist-lock
mechanism inhibits relative longitudinal
movement between the cap 256 and the holder body 254. In the illustrated
embodiment, the male twist-lock
component 274 also includes a longitudinal projection 284 that enters the vial
chamber 264 of the receptacle 258
and abuts the bottom of the sterile vial 252 to limit or restrict longitudinal
movement of the sterile vial in the
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chamber. It is understood that the cap 256 may be releasably securable to the
body 254 in other ways without
departing from the scope of the present disclosure.
[0087] The holder body 254 may be a one-piece component formed (e.g., molded)
from plastic or other
material that has a density less than the density of material that provides
suitable radiation shielding, such as that
provided by lead, tungsten, tungsten impregnated plastic, depleted uranium.
The cap 256, on the other hand, may
include suitable radiation shielding material such as depleted uranium,
tungsten, tungsten impregnated plastic, or
lead. In one example, the cap may be formed by a two-step overmolding process.
In such a process, a radiation
shielding core - which may include a suitable radiation shielding material
such as depleted uranium, tungsten,
tungsten impregnated plastic, or lead ¨ is provided. A first molded part is
molded with a first thermoplastic material
to form the top 260. Next, the core is placed into the first molded part.
Finally, this assembly is overmolded with a
second thermoplastic material to form the bottom 262, the male twist-lock
component 274, and the longitudinal
projection 284. The first and second thermoplastic materials, respectively,
may include polypropylene and
polycarbonate, or other material, and the first and second thermoplastic
materials may be of the same material.
Other methods of making the cap 256 may be used.
[0088] Referring to FIGS. 38 and 39, the elution system 10 may also include a
re-covering tool,
generally indicated at 290, for reapplying the input/venting needle cover 55a
and the output needle cover 55b on
the respective input and venting needles 30, 54 and the output needle 32. The
re-covering tool 290 has a first
longitudinal portion 292, defining an output needle cover cavity 294 for
snugly receiving the output needle cover
55b therein, and a second longitudinal portion 296, defining an input/venting
needle cover cavity 298 for snugly
receiving the input/venting needle cover 55a therein, The first longitudinal
portion 292 has a size and shape such
that it is snugly receivable in the elution tool opening 79 in the auxiliary
shield lid 24, and the second longitudinal
portion 296 has a size and shape such that it is snugly receivable in the
eluant vial opening 80 in the auxiliary
shield lid. The re-covering tool 290 may be formed from plastic, or other
suitable material, and may be molded as
a single, one-piece structure.
[0089] To reapply the covers 55a, 55b, the radiopharmacist or technician
inserts the covers into the
respective cavities 294, 298. The covers 55a, 55b are held in the respective
cavities 294, 298 by friction-fit
engagement between the walls of the cavities and the covers. The
radiopharmacist or technician can then insert
the second longitudinal portion 296 into the eluant vial opening 80, whereupon
the input and venting needles 30,
54 pierce the cover 55a. Upon withdrawing the second longitudinal portion 296
from the eluant vial opening 80,
the cover 55a remains secured to the input and venting needles 30, 54. The
radiopharmacist or technician can
then insert the first longitudinal portion 292 into the elution tool opening
79 to reapply the cover 55b in a similar
manner. It is understood that the covers 55a, 55b may be reapplied in any
order without departing from the scope
of the present disclosure.
[0090] In a method of using the radioisotope elution system 10, the
radiopharmacist or technician
manually inserts the radioisotope generator 12 into the cavity 22 of the
auxiliary shield body 20, the handle is
folded down, and the cap cover 56 is removed in the manner set forth above.
The auxiliary shield lid 24 is then
manually placed in the cavity, on top of the radioisotope generator 12. The
lid 24 may be rotated to thereby mate
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the male alignment structure 81 on the lid with the female alignment structure
(i.e., the recessed portion 40 and the
U-shaped channel 42) in the cap 38 of the generator 12. Upon mating, the
eluant vial opening 80 is disposed over
and generally vertically aligned with the input needle 30 and the venting
needle 54, and elution tool opening 79 is
disposed over and generally vertically aligned with the output needle 32.
Using forceps (or another tool), the
radiopharmacist or technician removes the two covers 55a and 56b. The eluant
vial 17 is manually inserted into
the passageway defined by the wings 100 and the eluant vial opening 80. The
passageway guides the eluant vial
17 in a substantially vertical direction, such that the longitudinal axis of
the eluant vial is generally aligned with the
axes of the input needle 30 and the venting needle 54. More specifically, the
passageway guides the eluant vial
17 such that the input needle 30 and the venting needle 54 pierce the septum
of the vial to fluidly connect the
interior of the eluant vial to the generator 12. The radiopharmacist or
technician can view the bottom 116 of the
eluant vial 18 through the notches 118 in the respective wings 100 when the
vial is received in the passageway
107 to confirm that the eluant vial 18 is fully inserted onto the generator
12. Accordingly, the radiopharmacist or
technician does not have to position his/her head directly above the lid 24 to
confirm that the needles 30, 54
actually pierced the &tient vial septum. To this effect, the radiopharmacist
or technician reduces any likelihood of
radiation exposure from the generator 12 when positioning his/her head over
the eluant vial opening 80. Once
confirmation is made that the vial is properly placed, the eluant shield 136
may be placed over the bottom of the
eluant vial in the manner set forth above.
(00911 In this method, the elution vial 17 is inserted into the elution tool
150 and the lid 158 is closed in
the manner set forth above. The elution tool, which does not have either the
dispensing cap 160 or the storage
cap 162 secured thereto, is manually inserted into the elution tool opening 79
such that the output needle 32
pierces the septum of the elution vial to fluidly connect the elution vial b
the generator 12. The vacuum (or
reduced pressure) in the elution vial 17 draws the saline from the vial 18
through the radioisotope column and into
the elution vial 17.
[0092] After the elution vial 17 is filled with the desired quantity of
radioisotope-containing saline, the
elution tool 160 can be manually removed from the lid 24, at which time the
dispensing cap 160 or the storage cap
162 can be secured to the elution tool body 152 in the manner set forth above.
With the dispensing cap 160
secured to the elution tool body 152, the radiopharmacist or technician can
withdraw desired quantities of the
radiopharmaceutical from the elution vial 17 in the manner set forth above.
(01:193] With the elution tool 150 removed from the lid 24, the sterile vial
holder 250 can be inserted into
the elution tool opening 79 so that the output needle 32 pierces the sterile
vial 252. The now empty eluant vial 18
may remain on the radioisotope generator 12 until a subsequent elution in
order to keep the needles 30, 54 sterile.
When it is time for a subsequent elution, the eluant vial 18 can be manually
removed from lid 24, such as by the
radiopharmacist or technician inserting his/her thumb and forefinger into the
respective finger recesses 90 and
then into the respective finger channels 112 to grip (or pinch) the eluant
vial. The radiopharmacist or technician
can then lift the eluant vial 18 upward off the needles 30 and 54 and out of
the lid 24.
(0094] When introducing elements of the present invention or the embodiment(s)
thereof, the articles
'a", "an", 'the" and "said" are intended to mean that there are one or more of
the elements. The terms
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'comprising', "including" and "having" are intended to be inclusive and mean
that there may be additional elements
other than the listed elements.
10095] As various changes Gould be made in the above apparatus and methods
without departing from
the scope of the disclosure, it is intended that all matter contained in the
above description and shown in the
accompanying figures shall be interpreted as illustrative and not in a
limiting sense.
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