Note: Descriptions are shown in the official language in which they were submitted.
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BIO-HAZARDOUS MATERIAL TRANSPORTING PIG WITH
SAFETY CONTAINER CLOSURE REMOVER
FIELD OF THE INVENTION
[0001] This invention relates to radiopharmaceuticals. In particular this
invention
relates to a pig for storing and transporting bio-hazardous products and
substances.
BACKGROUND OF THE INVENTION
[00021 The transportation of bio-hazardous materials and substances, for
example
radioactive materials or biological substances such as pathogens, presents a
potentially
dangerous situation and must be subject to strict controls.
[00031 For example, radioactive pharmaceutical products, known as
"radiopharmaceuticals," are prepared for patient injection, ingestion or other
forms of
administration in specially equipped and controlled facilities.
Radiopharmaceuticals are
well known for use as markers in nuclear medicine diagnostic procedures, and
to treat
certain diseases.
[0004] Unless properly shielded, such products become a radiation hazard
for
individuals handling the product. The container in which the
radiopharmaceutical is
stored before use is typically made of plastic, for example polyethylene,
which has no
radioactivity-shielding properties. Therefore the storage, transportation and
administration of radiopharmaceuticals is carefully controlled by rules
designed to
regulate the handling of such materials in a manner that reduces the radiation
hazard.
[0005] For example, radioiodine pills or capsules are an ingestible
radiopharmaceutical
that can be used for treating certain pathologies, such as thyroid diseases,
or in
conjunction with a diagnostic procedure to diagnose certain types of
illnesses. Each
metered (for example assayed or calibrated) dose of the radiopharmaceutical
product, for
example in the case of a treatment for thyroid issues a radioiodine pill, is
placed by the
manufacturer into the plastic container to be shipped to a qualified facility
for
administration to a particular patient or patient category. This represents
the first
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opportunity for hazardous exposure to the radioactive contents, and
accordingly is
effected at the manufacturer in a shielded booth or other enclosure, or under
other
radioactivity-shielded conditions.
[0006] The container containing the radiopharmaceutical pill or capsule
must then be
shipped to the destination hospital or clinic for administration to the
patient. To effect this
safely, the pill container is dropped into a radioactivity-shielding container
commonly
known as a "pig" for interim storage and delivery to the destination.
[0007] A conventional pig comprises a two-part vessel which is either
formed from a
radioactivity-shielding material, for example lead or tungsten, or has an
exterior shell
encasing a radiopharmaceutical container compartment that is lined with a
radioactivity-
shielding material such as lead or tungsten. A non-limiting example is
described and
illustrated in US Patent No. 6,586,758 issued July 1, 2003 to Martin, which is
incorporated herein by reference in its entirety.
[0008] When the pig is assembled, the radiopharmaceutical container
compartment is
sealed in order to contain the radiation and thus minimize human exposure to
the
radioactive contents of the radiopharmaceutical compartment. The compartment
is sized
to accommodate the radiopharmaceutical product, in the ingestible radioiodine
example a
pill or dissolving capsule, however other types of radiopharmaceuticals (for
example
liquids) may be contained within a syringe, ampule (bottle or other glass
container) or the
like, in which case the radiopharmaceutical compartment would be dimensioned
accordingly.
[0009] Once the radiopharmaceutical container has been placed into the
radiopharmaceutical compartment and the pig assembled, the pig is ready to be
shipped
to the patient's location. Because this part of the delivery process occurs
entirely within
the confines of the manufacturing plant, which is specifically designed and
staffed so as
to meet all regulatory guidelines and procedures, there is less chance of
human exposure
to the radioactive radiopharmaceutical product up to the point that the pill,
capsule,
syringe or the like is sealed in the radiopharmaceutical container compartment
of the pig.
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[0010] At the destination staff trained in handling radioactive substances,
for example a
nuclear medicine technologist or technician, opens the pig and then removes
the closure
from the radiopharmaceutical container to vent the container bottle. This is
the second
opportunity for exposure to the radioactive contents of the
radiopharmaceutical container,
in the presence of hospital or clinic staff. The technologist must transfer
the radioiodine
(for example, 1311) to a Dose Calibrator to assay (measure) the activity of
the capsule,
which must be within 10% of prescribed activity. After recording the assay,
the
technologist must retrieve plastic container containing the capsule and return
the
radiopharmaceutical container to the pig's radiopharmaceutical container
compartment,
which is the third opportunity for exposure to radioactivity. The technologist
then applies
the lid to the pig for delivery to the patient.
[0011] The pig is opened in the patient's presence in order to gain access
to the
radiopharmaceutical container and remove the container closure for
administration of the
radiopharmaceutical product to the patient, providing a fourth opportunity for
exposure to
the radioactive contents of the radiopharmaceutical container. In this step
exposure of
radioactivity to the ambient environment is unavoidable in order to access the
radiopharmaceutical product for administration to the patient, so great care
must be taken
to handle the unshielded radiopharmaceutical product using proper safety
equipment and
procedures.
[0012] However, the venting and assaying steps of the transportation
process can
present an unnecessary risk of exposure to the technologist and other staff.
Although the
types of destination facilities to which these products are shipped are
equipped to
properly handle radiopharmaceutical products and the staff at such facilities
are well
trained in safety policies and procedures, this step in particular can
increase the risk of
human exposure to the radioactive contents of the radiopharmaceutical product.
[0013] There is accordingly a need for a device that reduces opportunities
for human
exposure to the contents of the container when the pig reaches a hospital or
clinic setting
and the product in the container is exposed to the ambient environment.
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BRIEF DESCRIPTION OF THE DRAWINGS
[0014] In drawings that illustrate an embodiment of the invention by way of
non-
limiting example only,
[0015] Figure 1 is a side elevation of a radiopharmaceutical pig containing
a
radiopharmaceutical container.
[0016] Figure 2 is a top plan view of the embodiment of Figure 1.
[0017] Figure 3 is a cross-sectional elevation of the embodiment of Figure
1 taken
along the line 3-3 in Figure 2.
[0018] Figure 4 is a cross-sectional elevation of the embodiment of Figure
1 taken
along the line 4-4 in Figure 2
[0019] Figure 5 is a perspective view of a closure for the
radiopharmaceutical
container.
[00201 Figure 6 is a perspective view of a closure remover component of the
pig.
[0021] Figure 7 is a perspective view of a cap for the radiopharmaceutical
container.
[0022] Figure 8 is a perspective view of a bottle for the container.
[00231 Figure 9 is a perspective view of the assembled pig.
DETAILED DESCRIPTION OF THE INVENTION
[0024] The invention relates to a pig 20 for transporting a container 10
containing a
bio-hazardous product. The radiopharmaceutical container 10 comprises a bottle
12 and a
closure 14 for sealing the bottle 12. The closure 14 is configured to co-act
with the pig
20, in particular the closure remover 34, to allow the closure 14 to be
removed from the
bottle 12 without opening the pig 20 and exposing the user to the radioactive
contents of
the product, as described in detail below.
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[00251 The invention will be described in the context of a
radiopharmaceutical product,
in particular a radioiodine pill 2, as a non-limiting example of a type of bio-
hazardous
product for which the pig 20 is a suitable protective device. However, the pig
20 may be
configured to be suitable for transporting virtually any type of
radiopharmaceutical
product, and is also suitable for transporting other bio-hazardous non-
radioactive
products or substances such as biological pathogens, for example. The
embodiments of
the invention described herein are for purposes of example only and the
invention is not
intended to be limited to the specific embodiments described.
[00261 The pig, in the embodiment illustrated a radiopharmaceutical pig 20,
comprises
a cylindrical base 22 and a complementary cylindrical cap 30 for attachment to
the base
20. The cap 30 has threading 30a about its internal rim that is complementary
to
threading 22a about the external rim of the base 22, so that the cap 30 can be
screwed to
the base 22 in a tightly-sealed fashion to avoid any substantial leakage of
radiation from
the pig 20. Alternatively the cap 30 may be formed with exterior threading
complementary to interior threading in the base 22 (not shown). Although
threading is a
particularly convenient method of attaching the cap 30 to the base 22, these
components
22, 30 may be attached together in any other suitable manner. Also, in the
embodiment
shown the base 22 and cap 30 have a cylindrical exterior, which simplifies the
provision
of a threaded connection, however any other convenient configuration may be
used with
a closure mechanism suitable for substantially preventing leakage of
radioactivity from
the pig 20.
[00271 The components of the radiopharmaceutical pig 20 shown may be formed
from
a radioactivity-shielding material such as lead or tungsten, or may be formed
from any
suitably strong metal or plastic. In the case of the radiopharmaceutical pig
20 shown the
portions surrounding the compartment 24 are lined with a suitably
radioactivity-resistant
liner formed from a material such as lead or tungsten. If the pig is used to
transport
toxins, biological pathogens or other non-radioactive products or substances,
the
compartment 24 may be hermetically sealed when the pig 20 is closed to prevent
exposure to the ambient environment.
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[00281 In the case of the radiopharmaceutical pig 20 shown, the assembled
cap 30 and
base 22 thus provide a radioactively-shielded compartment 24, for shielding
the
radioactive contents of the radiopharmaceutical container 10 contained when
sealed into
the radiopharmaceutical compartment 24. In the embodiment shown the
compartment 24
is defined by a cavity formed largely within the base 22 which is sized to
receive the
bottle 12 in a close fit, preferably a clearance fit but alternatively an
interference fit,
however the compartment 24 may be formed by defined by suitably sized and
aligned
adjoining cavities formed respectively in the base 22 and the cap 30.
[0029] The closure 14 comprises a projecting member 16 which comprises an
aperture
18, for reasons described below. The container 10 may be formed from any
suitable
material, for example polypropylene as is conventional or another suitable
plastic, and the
closure 14 is attached to the bottle 12 via a threaded connection so that
rotation of the
closure 14 relative to the bottle 12 in one direction seals the bottle 12 and
in the other
direction removes the closure 14. Other types of rotary connection between the
closure 14
and the bottle 12, for example a bayonet-type fitting, may also be possible.
[**the
threaded connection in Figs 3-4 is inconsistent with the views of the bottle
and
closure]
[00301 The cap 30 comprises a cap opening 32 disposed concentrically with
and in
communication with the radiopharmaceutical compartment 24. A closure remover
34 is
rotatably disposed within the cap opening 32. The closure remover 34 includes
a lower
recess 40 defined within the base wall 42, which is seated on top of a
circumferential
flange 12a extending about the rim of the bottle 12 and preferably also
overlaps the top
surface of the base 22 about the flange 12a. The base wall 42 comprises a
flange 42a
disposed within a groove 42b circumscribing the lower rim of the cap opening
32 in a
clearance fit, as best seen in Figure 7.
[00311 The closure remover recess 40 is also radioactively-shielded, being
either
formed from or lined with a radioactivity-shielding material. Thus, when the
closure
remover 34 is seated over the compartment 24 it closes the cap opening 32 in
order to
radioactively seal the radiopharmaceutical compartment 24. Also, when the cap
30 is
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removed from the base 22 it is possible to manipulate the sealed container 10
by handling
only the cap 30, thereby shielding the technologist's extremities from
radiation.
[0032] The closure remover 34, best seen in Figure 6, comprises an axial
passage 36
for receiving the projecting member 16 of the container closure 14 in
substantially
rotationally fixed relation. In the embodiment shown a collar 46 through which
the
closure remover 34 extends is rotationally fixed to a cover flange 48 which
rotates on top
of the cap 30, and rotationally fixed to the closure remover 34 by set screws
47, as best
seen in Figure 9. The collar 34 supports a pin 38 which retractably extends
transversely
into the closure remover 34 as far as axial passage 36, so that when fully
extended the tip
of the pin 38 projects into the projecting member's aperture 18. This, the pin
38 can be
extended to lodge the pin 34 in the projecting member aperture 18, as shown in
Figure 3,
and retracted to release the closure 14 from the closure remover 34.
Accordingly, when a
radiopharmaceutical container 10 is sealed within the radiopharmaceutical
compartment
24 of the pig 20, the pin 38 lodges into the aperture 18 of the projecting
member 16. The
pin 38 is preferably spring-biased to the extended position, and may have a
rounded tip as
shown so that when the cap 30 is placed over the base 22 and the projecting
member 18
of the closure 14 slides into the passage 36, the pin snaps into the aperture
18 without
manual assistance.
[00331 The flange 12a circumscribing the bottle 12 is provided with bosses
12b which
seat in complementary holes 12c formed in the base, as best seen in Figure 3,
to prevent
the bottle 12 from rotating within the compartment 24. It will be appreciated
that the
bottle 12 can be rotationally fixed relative to the compartment 24 in many
other ways.
[00341 In use, a radiopharmaceutical pill 2 is placed into the bottle 12
using
conventional techniques and equipment to avoid exposure to staff. To preserve
the
radiopharmaceutical pill 2, the bottle 12 optionally may be provided with fins
12d that
confine the pill 2 to an axially central portion of the container 10 and thus
reduce the
amount of pill surface touching the bottle 12, as shown in Figure 8, in order
to reduce
exothermic contact of the pill 2 with the wall of the bottle 12. The closure
14 may
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optionally be designed to accommodate a desiccant or other product-stability
material or
method (not shown) in order to control the humidity within the container 10.
[00351 The container 10 is then placed into the container compartment 24.
The closure
projecting member 16 is inserted into the passage 36 in the cap 30 until the
tip of the pin
38 locks into the aperture 18. The entry point for the projecting member 16
into the
passage 36 may be chamfered as at 36a for easier insertion. The closure 14 is
then
centred over the bottle 12 and the cap 30 is rotated in the closing direction
to seal the cap
30 to the base 22. The body 15 of the closure 14 rises toward the upper limit
of the recess
40 and the aperture 18 rises as the cap 30 is screwed to the base 22. This
seals the
container 10, and at the same time seals the container compartment 24 by
lodging the
base wall 42 of the closure remover 34 against the surface of the base 22
surrounding the
container compartment 24, confining radioactivity from the pill 2 within the
container
compartment 24.
[0036] The closure 14 is then engaged to the bottle 12 by rotating the
closure remover
34 in the sealing direction, threading the closure 14 to the bottle 12. In the
embodiment
illustrated a slot 50 through the flange 48 overlays an indicator 52, for
example a dot
printed or etched at the position on top of the cap 30 which indicates when
the closure 14
is fully sealed to the bottle 12.
[00371 The pig 20 can then be transported to the patient's facility for
administration of
the radiopharmaceutical pill 2.
[00381 When the pig 20 arrives at the destination, the pig is taken to a
room designed to
contain the radioactivity and protect staff, as is conventional. The closure
remover 34 is
rotated in the removal direction, which removes the closure 14 from the bottle
12. As the
closure remover 34 is rotated the closure 14 unscrews from the bottle 12,
while the lower
flange 42a of the closure remover 34 is vertically constrained by the groove
42b and thus
remains seated against the flange 12a of the bottle 12 and the surrounding top
surface of
the base 22. This causes the body 15 of the closure 14 to rise into the recess
40 in the
closure remover 34. The projecting member 16 and aperture 18 in turn rise
without
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dislodging the pin 38, since the vertical span of the aperture 18 is
sufficient to
accommodate the travel distance of the closure 14 (in relative terms the pin
38 moves
toward the other end of the aperture 18). When the cap 30 is released from the
base 22,
the tip of the pin 38 intruding into the aperture 18 suspends the closure 14
within the
closure remover 34, to vent the bottle 12 without requiring any direct human
contact with
the bottle 12 or closure 14.
1100391 The bottle 12 is vented for the required interval. The container 10
can then be
sealed and the cap 30 replaced in the manner described above, again without
personnel
handling the container 10 or removing the container 10 from the pig 20, and
delivered to
the patient for administration by a qualified professional. This significantly
reduces the
potential hazard of exposure to the radiopharmaceutical pill 2 in the
radioactivity venting
step.
[00401 Various embodiments of the present invention comprising been thus
described
in detail by way of example, it will be apparent to those skilled in the art
that variations
and modifications may be made without departing from the invention. The
radiopharmaceutical pig 20 described and illustrated is particularly suitable
for
transporting radioactive substances such as radiopharmaceuticals due to the
radioactivity-
shielding character of the container 24, but can be adapted to transport other
bio-
hazardous products and materials without the use of radioactivity shielding by
hermetically sealing the container 24. The invention includes all such
variations and
modifications as fall within the scope of the appended claims.
