Note: Descriptions are shown in the official language in which they were submitted.
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RADIATION SHIELDING LID FOR AN AUXILIARY SHIELD ASSEMBLY
OF A RADIOISOPTOPE ELUTION SYSTEM
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present disclosure relates generally to a radiation shielding lid
for an auxiliary
shield assembly of a radioisotope elution system.
[0002] 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.
[0003] 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 an elution tool or
an elution shield.
[0004] To reduce the amount of radiation exposure on the radiopharmacist or
technician,
the radiopharmaceutical generator is housed within a radiation shield
assembly, sometimes referred
to as an auxiliary shield, that includes a removable radiation shielding lid
to allow the generator to be
inserted into and removed from the shield assembly. The radiation shielding
lid is disposed over the
input connector and output connector of the generator, and includes an eluant
opening and an eluate
opening that are respectively aligned with the input connector and output
connector of the generator
and are sized and shaped for respectively receiving the eluant vial and the
elution tool so that the
respective vials can be fluidly connected to the input and output connectors.
Although this type of
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system generally tends to work well, one problem associated with this type of
system is that the input
connector and/or output connector of the generator - particularly where the
input and output
connectors are hollow needles ¨ may be bent, crushed, or broken due to
misalignment of the eluant
vial and/or the elution vial with the respective input and/or output
connectors when making the fluid
connection(s). As a result of the broken or deformed needles, the system
operates less effectively or
become completely useless. If the system contains radiopharmaceuticals, then
the damaged
connectors can result in monetary loss and/or delays with respect to nuclear
medicine procedures.
Another result of this misalignment problem can be that the input connector
and/or output connector
of the generator may undesirably puncture a retaining ring/collar of the
respective eluant vial and/or
elution vial causing damage to the vial(s).
[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.
BRIEF SUMMARY
[0006] One aspect of this disclosure relates to a radiation shielding lid for
a radiation
shielding container that includes a body having an upper surface and an
opposing lower surface. A
vial opening is defined in the body of the lid. This vial opening has a lower
end found at the lower
surface of the body and an upper end intermediate the upper and lower surfaces
of the body. A finger
recess is defined in the upper surface of the body and is sized and shaped to
allow at least a distal
portion of each of at least two digits (e.g., thumb/fingers of a technician)
to enter the finger recess.
This finger recess has an upper edge adjacent the upper surface of the body
and a lower edge
adjacent the upper end of the vial opening. First and second wings extend
upward from adjacent the
upper end of the vial opening. Each of these first and second wings has
opposite sides, a top portion,
and an inner surface extending partially around a circumference of the upper
end of the vial opening.
The inner surfaces of the first and second wings and the vial opening together
define a vial
passageway extending from the top portion of each of the first and second
wings through the lower
surface of the body. The vial passageway is sized and shaped for receiving a
vial therein.
Respective adjacent sides of the first and second wings are spaced apart from
one another around
the vial opening to partially define first and second finger channels leading
from the finger recess to
the vial passageway. Each of the first and second finger channels are sized
and shaped to allow at
least the distal portion of each of at least two digits to enter the
corresponding finger channel from the
finger recess. One benefit of this arrangement may be to facilitate gripping
of the vial during insertion
of the vial into the vial passageway and/or removal of the vial from the vial
passageway.
[0007] In some embodiments of the first aspect, the inner surface of each of
the first and
second wings extends at least 45 degrees and less than 180 degrees around the
circumference of the
upper end of the vial opening. The top portions of the first and second wings
may extend above the
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upper surface of the body. The inner surface of each of the first and second
wings may extend at
least 60 degrees around the circumference of the upper end of the vial
opening, or may extend at
least 90 degrees around the circumference of the upper end of the vial
opening. The inner surfaces
of the first and second wings may be diametrically opposed to one another with
respect the vial
opening.
[0008] In some embodiments of the first aspect, the sides of the respective
first and second
wings extend into the finger recess. The finger recess may include first and
second finger recesses,
and the first and second finger recesses may be diametrically opposed to one
another with respect to
the vial opening. The lower edge of the first finger recess may extend between
the corresponding
adjacent sides of the first and second wings to partially define the first
finger channel, and the lower
edge of the second finger recess may extend between the corresponding adjacent
sides of the first
and second wings to partially define the second finger channel. The top
portions of the first and
second wings may extend above the upper surface of the body, and at least one
of the first and
second wings may have a notch in the corresponding top portion.
[0009] In some embodiments of the first aspect, the upper end of the vial
opening may be
substantially circular, and the inner surfaces of the first and second wings
may be generally arcuate.
A portion of the vial passageway defined by the inner surfaces of the wings
may taper from the top
portions of the wings toward the vial opening. Each of the first and second
wings may include a
plurality of ribs on the inner surface of each wing projecting inward into the
vial passageway, and the
ribs on each wing may be spaced apart from one another between the opposite
sides of each wing.
The ribs may project generally toward a centerline of the passageway from the
inner surface of the
corresponding wing, such that each rib has a terminal, guiding surface
generally facing a centerline of
the vial passageway, and each guiding surface may be uniformly spaced from the
centerline of the
vial passageway along its length. The body may be substantially disk-shaped
and may be formed, at
least in part, from a radiation shielding material including at least one of
depleted uranium, tungsten,
tungsten impregnated plastic, or lead. An elution tool opening may be defined
in the body, and the
elution tool opening may be spaced apart and separate from the vial opening.
[0010] A second aspect of this disclosure also relates to a lid for a
radiation shielding
container that includes a body having upper and lower surfaces. In this second
aspect, a vial opening
in the body has a centerline extending through the upper and lower surfaces of
the body. The vial
opening is sized and shaped to accommodate insertion of a vial therein and
removal of the vial
therefrom. First and second alignment wings extend upward from the vial
opening. Each of these
first and second alignment wings has opposite sides, a top portion, and an
inner surface extending
partially around a circumference of the vial opening. In some embodiment, the
first and second
alignment wings may be said to enable or promote alignment of a longitudinal
axis of a vial with the
centerline of the vial opening as the vial is inserted into the vial opening.
Respective adjacent sides of
the first and second alignment wings partially define at least one finger
channel sized and shaped to
allow at least a distal portion of at least one finger (e.g., a finder of a
technician) to enter the finger
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channel. Such an arrangement may be found by users to facilitate insertion of
the vial into and/or
removal of the vial from the vial opening.
[0011] In some embodiments of the second aspect, the inner surface of each
alignment
wing extends at least 45 degrees and less than 180 degrees around the
circumference of the vial
opening, and the finger channel may include at least a first finger channel
and a second finger
channel. First and second finger recesses may be in the upper surface of the
body. Each of the first
and second finger recesses may have an upper edge adjacent the upper surface
of the body and a
lower edge leading to the vial opening. The first and second finger recesses
may be diametrically
opposed to one another with respect to the vial opening. An elution tool
opening defined in the body
may be spaced apart and separate from the vial opening.
[0012] Yet a thirri aspect of this disclosure also relates to a radiation
shielding lid that
includes a body having an upper surface and an opposing lower surface. In this
third aspect, the body of
the lid includes at least one appropriate radiation shielding material (e.g.,
a material capable of
shielding radiation emitted by medical radioisotopes (e.g., beta and/or gamma
radiation)). Examples
of such radiation shielding material include depleted uranium, tungsten,
tungsten impregnated plastic,
and lead. A first opening is defined in the body of the lid. This first
opening has a lower end at the
lower surface of the body and an upper end intermediate the upper and lower
surfaces of the body. A
second opening is also defined in the body of the lid. However, this second
opening has a lower end
at the lower surface of the body and an upper end at the upper surface of the
body. The second
opening is spaced apart and separate from the first opening. In addition, a
recess is defined in the
body of the lid. At least a portion of an upper end of this recess is located
at the upper surface of the
body, and at least a portion of a lower end of this recess is located at the
upper end of the first
opening. Further, first and second wings extend upward (e.g., away from the
lower surface of the
body) and only partially about a circumference of the upper end of the first
opening such that a first gap is
defined between the first wing and the second wing.
[0013] In some embodiments of the third aspect, the first and second wings
have top
portions extending above the upper surface of the body. A diameter of the
first opening may be less
than a diameter of the second opening. The first and second wings may be
diametrically opposed to
one another with respect the first opening. The finger recess may include
first and second recesses,
and the first and second recesses may be diametrically opposed to one another
with respect to the
vial opening. The gaps may be diametrically aligned with the first and second
recesses relative to the
first opening. At least one of the first and second wings may have a notch in
a top portion thereof.
[0014] Still a fourth aspect of this disclosure relates to a method of using a
radiation
shielding lid. In this method a first container having non-radioactive medical
fluid (e.g., saline) therein
is inserted into a first opening defined in and extending entirely through the
radiation shielding lid.
The insertion of the first container into the first opening includes the first
container being passed
between first and second opposing wings that extend away from a bottom of the
lid upward beyond a
top of the radiation shielding lid. A second container is inserted into a
second opening defined in and
extending entirely through the radiation shielding lid. This second opening is
separate and distinct
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from the first opening. A user (e.g., a technician) may contact the first
container (e.g., a substantially
cylindrical side wall thereof, as opposed to the top or bottom of the first
container) with first and
second digits while the first container is located in the first opening. More
particularly, while the first
container is in the first opening, the user may contact the first container
such that at least a portion of
his/her first digit is located in a first gap between the first and second
wings of the lid, and at least a
portion of his/her second digit is located in a second gap between the first
and second wings of the lid
that is separate and distinct from the first gap.
[0015] In some embodiments of the fourth aspect, the contacting may further
include the
first digit being located within a first recess defined in the lid, and the
second digit may be located
within a second recess defined in the lid. The first recess may be separate
and distinct from the
second recess. An interior of the second container may be at least partially
evacuated. The non-
radioactive medical fluid in the first container may include saline. The
method may further include
drawing the non-radioactive medical fluid from the first container, through
the radioisotope generator,
and into the second container after the inserting of the first container and
the inserting of the second
container. The non-radioactive medical fluid elutes a radioisotope as it flows
through the radioisotope
generator so that it includes the radioisotope prior to entering into the
second container. The inserting
of the second container may occur while the first container is in the first
opening.
[0016] 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
[0017] FIG. 1 is a perspective of one embodiment of a radioisotope elution
system.
[0018] FIG. 2 is a top plan view of the radioisotope elution system of FIG. 1.
[0019] FIG. 3 is a cross section of the radioisotope elution system of FIG. 1
taken along line
3-3 in FIG. 2.
[0020] FIG. 4 is an exploded view of the radioisotope elution system of FIG.
1.
[0021] FIG. 5 is an enlarged perspective of a radioisotope generator of the
radioisotope
elution system of FIG. 1.
[0022] FIG. 6 is an enlarged perspective of an auxiliary shield assembly lid
of the
radioisotope elution system of FIG. 1.
[0023] FIG. 7 is a front elevation of the auxiliary shield assembly lid of
FIG. 6.
[0024] FIG. 8 is a top plan of the auxiliary shield assembly lid of FIG. 6.
[0025] FIG. 9 is a bottom plan of the auxiliary shield assembly lid of FIG. 6.
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[0026] FIG. 10 is a cross section of the auxiliary shield assembly lid of FIG.
6 taken through
line 10-10 in FIG. 8.
[0027] FIG. 11 is a cross section of the auxiliary shield assembly lid of FIG.
6 taken through
line 11-11 in FIG. 8.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0028] Referring to FIGS. 1-4, 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 herein
below.
[0029] The illustrated elution tool 16 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. The illustrated elution vial 17 is a generally cylindrical
container, made from glass or
other material (e.g., plastic), 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 elution
vial 17 may be a
different type of container suitably connectable to a radioisotope generator
and/or may have a shape
other than generally cylindrical. In one embodiment, the interior of the
elution vial 17 is at least
partially evacuated such that the elution 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.
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[0030] 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.
[0031] 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.
[0032] Referring to FIG. 3, the input and output connectors 30, 32 extend
upward from the
elution column assembly 28 and through respective openings 50, 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 for piercing
respective septums of the elution vial 17 and the eluant vial 18, although it
is contemplated that the
connectors may be of other configurations/types. In addition to the input and
output connectors 30,
32, a venting connector 54, in fluid communication with atmosphere, extends
through the bottom
surface 53 of the recessed portion 40 of the cap 38. The venting connector 54
is adjacent to the input
connector 30 and extends through the same opening 50 in the generator cap 38.
In the illustrated
embodiment, the venting connector 54 includes a venting needle having a
terminal end or tip 54a
disposed within the recessed portion 40 of the generator cap 38. The venting
needle 54 pierces the
septum of the eluant vial 18, like the input needle 30, to vent the eluant
vial 18 to atmosphere.
[0033] Referring to FIG. 3, the elution column assembly 28 may be any
appropriate type of
elution column assembly known to those having ordinary skill in the art, such
as, the elution column
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assembly disclosed in US Patent No. 5,109,160 or the elution column assembly
found in the Ultra-
Technekow dry-top eluting (DTE) generator distributed by Mallinckrodt LLC. For
example, the
elution column assembly 28 may include a radioactive column (not shown)
including source of
radioactive material (e.g., molybdenum-99, adsorbed to the surfaces of beads
of alumina or a resin
exchange column), and input and output conduits (not shown) fluidly connecting
the input needle 30
to the column and the output needle 32 to the column. The elution column
assembly 28 may include
a column radiation shield (not shown) having a cavity in which the radioactive
column is received, and
a conduit radiation shield (not shown) surrounding the input and output
conduits. The respective
radiation shields 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.
[0034] Referring back to FIG. 1, the illustrated auxiliary shield assembly
body 20 includes a
top ring 56, a base 58, and a plurality of step-shaped or generally tiered,
modular rings 60, which are
disposed one over the other between the base 58 and the top ring 56.
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 60 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.
[0035] Referring now to FIGS. 6-11, the radiation shielding lid 24 includes: a
generally
cylindrical lid body 72 having upper and lower surfaces, 74, 76, respectively;
an elution tool opening
78; 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 72 includes a radiation
shielding core 124 that is
overmolded 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 74, 76, respectively, are generally planar, although the surfaces may
be other than generally
planar.
[0036] A male alignment structure, generally indicated at 81, is provided on
the lower
surface 76 of the lid body 72 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
78 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 78, 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 76 and surrounding the elution tool opening 78
and the eluant vial
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opening 80. A plurality (e.g., a pair) of handles 82 on the upper surface 74
of the lid body 72 allows
the radiopharmacist or technician to properly place the lid 24 on the
generator 12 and remove the lid
from the generator.
[0037] The elution tool opening 78 extends through the lid body 72 from the
upper surface
74 through the lower surface 76 thereof. The elution tool opening 78 is sized
and shaped for
removably receiving the elution tool 16 therein. For example, in the
illustrated embodiment, the
elution tool opening 78 has a generally circular circumference that is
substantially uniform along its
axis. In one embodiment, the elution tool opening 78 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 78 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 78 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 78 may be appropriate; however, it tends to be preferred
that the shape and size
of the elution tool opening 78 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.
[0038] As shown in FIGS. 9 and 10, the eluant vial opening 80 is spaced apart
and
separate from the elution tool opening 78, 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 76 of
the lid body 72 and an
upper end 88 intermediate the upper and lower surfaces 74, 76, 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 78, 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.
[0039] Referring to FIGS. 2, 6, 8, and 11, the illustrated lid 24 has two
finger recesses 90
formed in the upper surface 74 of the lid body 72, 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 74 of the lid body 72 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 radiopharmacist'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
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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 74 of the lid body 72 and a lower edge 93 that is coextensive
with a portion of the upper
end 88 of the eluant vial opening 80.
[0040] Referring to Fig. 11, the lid 24 of the auxiliary shield assembly 14
includes first and
second wings, 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, a top 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 74 of
the lid body 72 (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 76 of the lid body 72.
[0041] 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.
[0042] 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 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 (0.772 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
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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.
[0043] 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.
[0044] 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 74 of the lid 24.
[0045] 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, 78, 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 76, the male alignment structure 81, and the sidewall of
the body 72, and at least
lower portions of the elution tool opening 78 and the eluant vial opening 80.
Next, the core 124 is
placed into the first molded part. Finally, this assembly is overmolded with a
second thermoplastic
material 128 to form the top surface 74, the handles 82, the finger recesses
90, the wings 100, and an
upper portion of at least the elution tool opening 78. The first and second
thermoplastic materials
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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.
[0046] In an exemplary 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 auxiliary shield lid 24 is manually placed in
the cavity, on top of the
radioisotope generator 12. The lid 24 may be rotated to thereby mate 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 78 is disposed over and generally vertically aligned with the output
needle 32. 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. Accordingly, the wings 100 give the
radiopharmacist or technician
confidence that the input needle 30 and venting needle 54 will pierce the
septum, and therefore, the
radiopharmacist or technician does not have to position his/her head directly
above the lid 24 to
confirm that the needles will properly pierce the eluant 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.
[0047] The elution tool 16, which includes the elution vial 17 therein, is
manually inserted
into the elution tool opening 78 such that the output needle 32 pierces the
septum of the elution vial to
fluidly connect the elution vial to 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.
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 eluant vial septum. Once confirmation is made that the
vial is properly placed, an
eluant vial shield (not shown) may be placed over the bottom of the eluant
vial.
[0048] After the elution vial 17 is filled with the desired quantity of
radioisotope-containing
saline, the elution tool 16 can be manually removed from the lid 24. A vial
(not shown) containing a
sterile liquid may be placed on the output needle 32. The 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
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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 and out
of the lid 24.
[0049] 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 "comprising", "including" and "having" are intended to be
inclusive and mean
that there may be additional elements other than the listed elements.
[0050] As various changes could 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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