Note: Descriptions are shown in the official language in which they were submitted.
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Title: Holder for radioactive substances.
The invention relates to a holder for radioactive
substances, especially for liquid radioactive
pharmaceuticals.
Radioactive substances, such as pharmaceuticals ale
presently packaged within a glass container, normally
referred to as vial, which is surrounded by a lead shielding.
An absorbent material is placed between the vial and the
shielding, after which the vial and shielding are positioned
within an air and fluid tight tin. Such package is a legal
and tested method for packaging radioactive liquids, normally
preventing leakage of said substance and increase of
radiation to the environment.
When this known package is handled inappropriately,
for example when it is dropped the glass vial can break,
which will result in contamination of the absorbent material
with the radioactive liquid. Consequently, the level of
radioactivity outside the package may then increase
significantly. Furthermore, such package is relatively
difficult to handle and costly, especially since a tin has to
be used for air and liquid tight sealing of said package.
It has been proposed to use a plastic inner container
in order to avoid breakage. However, a glass vial is
preferred since it has superior properties for contacting
different kinds of radioactive substances without the risk of
contamination to said substances and physical or chemical
reactions between said vial and said substances. Moreover,
glass vials are relatively easy to clean, for example by
sterilisation.
A main object of the present invention is to provide
for a holder for radioactive substances in which the
drawbacks of the known holders as discussed hereabove are
avoided, maintaining the advantages thereof. This main object
is reached according to the present invention by providing
for a holder having the features of claim 1.
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'In a holder according to the present invention the
first container is air sealed and liquid tight, which first
container contains the radioactive substance. Said first
container is then enclosed within an air and liquid tight
second container, which second container is essentially
unbreakable. The thus gas and liquid tight first and second ,
containers are enclosed within shielding means preventing
leakage of radiation to the environment.
When the first container, for example a glass vial,
is damaged, for example by inappropriate handling of tk~e
holder, the radioactive substance cannot reach the shielding
means since the substance will be contained within the
essentially unbreakable second container. Since this second
container is gas and liquid tight, said substance cannot
leave said second container. Thus the shielding means do not
necessarily have to be air and liquid tight, nor do these
shielding means have to be contained within a further air and
liquid tight containing means such as a tin known from the
prior art.
Since the first and second liquid and air tight
containers are provided within the shielding means, a holder
according to the present invention is very safe and easy to
use, relatively small with respect to the inner dimensions of
the first container and relatively economical in use.
Especially when the first container is made of glass and the
second container is made of a relatively clear plastic
material, the substance contained within the first container
can be visually checked from the outside of the second
container without the necessity of opening said second
container, whereas the advantages of glass are provided for.
In an advantageous embodiment a holder according to
the present invention is further characterized by the
features of claim 2.
By providing for a third container in which the first
and second container can be enclosed, said third container
providing for the shielding means, a holder according to the
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present~invention is even more practical in use. The first
and second container can be withdrawn from said third
container, for example for visual inspection of the substance
contained therein or for assessment of the radioactivity of
said substance. Thus the radioactivity can be measured
without the necessity of removal of the first container~from
the second container depending on the type of radiation. This
has the major advantage that even during handling of the
first and second containers without said shielding the danger
of leakage of the substance to the environment is ._
sufficiently prevented by said second container. Therefore,
all necessary inspections of the substance are possible
without the necessity of direct contact with the first
container or the substance.
In a first preferred embodiment a holder according to
the present invention is characterized by the features of
claim 4.
The combination of a glass first container, a plastic
second container and a metal third container provides for the
combination of a relatively inert vial in direct contact with
the contained substance, an easy to handle, essentially
unbreakable second container and a good shielding means.
Especially lead is advantageous for the shielding means.
Instead of use of a third container the second
container itself can be provided with or provide for the
shielding means. For example, the second container can be
provided with a layer of lead or similar shielding material
or, when the radiation is of an alpha- or beta-type, the
second container can be made of an appropriate plastic
material such as PVC, polycarbonate or the like plastic
material absorbing or reflecting alpha- or beta-type
radiation. However, a third container, essentially providing
for the shielding means is preferred since it is then
possible to measure the radiation of the substance through
said first and second containers.
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'In a further advantageous embodiment a holder
according to the present invention is characterized by-the
features of claim 5.
By providing for a septum in the first and second
container, which septa during use overlay each other at least
partly, a needle can be introduced into the first container,.
without the necessity of removal of said first container ~rom
said second container. Thus at least part of the substance
can then be removed from or a further substance can be
introduced into said first container directly, preventi-ng
contamination of and leakage from said first container to the
environment.
In a further elaboration of the present invention a
holder is further characterized by the features of claim 7.
By providing for a stop or the like in the shielding
means the first and second septa can be penetrated or
otherwise engaged after removal of said stop without the
necessity of complete removal of the shielding means. This
further reduces the risk of radiation to the environment,
which could be hazardous, for example to humans, animals,
plants or products:
In a second preferred embodiment a holder according
to the present invention is further characterized by the
features of claim 8.
Such holder has the advantage that, if necessary, the
lid of the second container can be removed or repositioned
without the necessity of removal of said first and second
containers from the third container and without the necessity
of manual engagement of said lid, said second container or
even the third container. This has the important advantage
that the risk of contamination of for example an operator is
even further reduced without impairment of the functionality
of the holder.
At least the first and second container are
preferably made of a material suitable for use in an
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autoclave or other sterilisation means. This provides for the
possibility of easy cleaning of said containers.
The invention further relates to a set or a holder
according to the present invention and an instrument for
engagement of said holder, characterized by the features of
t
claim 12. ~~
The present invention further relates to the use of a
holder or.a set according to the present invention,
characterized by the features of claim 13.
Measurement of the radiation of the substance through
the first and second container has the advantage that the
risk of contamination of the environment by the radioactive
substance is significantly reduced.
The present invention further relates to the use of a
holder or set, characterized by the features of claim 14.
The invention further relates to a method for
shielding a radioactive substance, characterized by the steps
according to claim 15.
Such method provides for the possibility of easy
handling of a radioactive substance without the risk of
contamination of the environment by said substance and
without the risk of an allowable increase of radiation to the
environment. Furthermore, this method provides for a holder
containing a radioactive substance which is easy to handle,
for example in storage, transport and treatment, suitable for
use with all kinds of radioactive substances, which is very
safe and economical. Moreover, such method and holder can be
easily used in normal, existing production environments,
hospitals and the like.
Further advantageous embodiments of a holder, use or
method according to the present invention are described in
the sub claims.
In order to further elucidate the present invention,
embodiments of a holder and method according to the present
invention are described hereafter, with reference to the
drawings. These show:
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'Fig. 1 partially in sectional view a first and second
container, in assembled position;
fig. 2 a second container in opened position in top
and side view;
fig. 3 a first and second container, in assembled
position, enclosed within a third container; ~~ .
fig. 4 partly in sectional side view part of an
assembly as shown in figures 1-3, together with an instrument
for opening, closing and manipulating the second container;
and
fig. 5A and 5B the assembly as shown in figure 4 in
sectional view along the line V-V, before and during
engagement of a second container.
fig. 6 a first and second container, in assembled
position enclosed within a third container in an alternative
embodiment;
fig. 7a-c a dispensing assembly according to the
present invention;
fig. 8a-b an alternative embodiment of an instrument
for opening, closing and manipulating the first and second
container;
fig. 9 an instrument according to fig. 8,
manipulating a second container; and
fig. 10 the instrument according to fig. 8,
manipulating the first container.
Figure 1 shows in side view a first container 1,
enclosed within a second container 2. The first container is
made of glass and is somewhat bottle or vial shaped, having a
lid 4 provided with a piercable first septum 6, shown in
dotted lines. The container or vial 1 is intended for
containing radio-active substances. The glass is inert to
such substances. The lid 4 closes the first container 1
liquid and air tight. The glass of the first container 1 is
preferably clear, such that a substance contained therein can
be visually inspected, although the glass may also be made
partly or completely opaque.
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-The second container 2 comprises a container body 8,
a second septum 10 and a second lid 12. As shown in figure 1
the second septum 10 can be clamped between the upper edge 14
of the container body 8 and the inner top surface 16 of the
second lid 12, in order to close said second container liquid
r
and air tight. An opening 18 is provided in said top surface.
16, such that the second septum 10 is engagable from the .
outside through said opening 18. The second lid 12 is
provided with inner thread 20, cooperating with outer thread
22 on the container body. The second lid 12 is provided-with
a circumferential wall 24 on top of the top surface of the
lid 12, in which wall notches 26 are provided for example two
positioned opposite each other, the use of which will be
explained later. The outer dimensions of the first container
1 are preferably such that it can fit snugly into the
container body 8, such that when the second container 2 is
closed the second septum 10 lies at a relatively short
distance from the top of the first lid 4 of the first
container 1. The second septum 10 thus lies at a short
distance from the first septum 6, such that a needle (not
shown) can pierce the first 6 and second septum 10 in order
to penetrate the first container 1 for introduction of fluid
into or withdrawal of liquid from said first container
without the risk of contamination. Once tightly closed, the
second container 2 encloses the first container 1 liquid and
air tight.
The second container is made of a plastic material,
preferably a clear plastic material, such that the first
container 1 and even the substance contained therein can be
visually inspected through said second container 2. The
plastic material used for the second container is for example
polycarbonate or a similar material which can for example be
sterilized in an autoclave at a temperature of for example
120°C. The second container 2 preferably has a relatively
thin wall, minimizing the risk of interference during
measurement of for example radio activity of a substance
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contained in the first container. Moreover, the overall size
of the second container can thus be minimized.
When the radioactive substance contained in the first
container radiates only alpha or beta type radiation, the
second container can be made of a non-scattering plastic
material absorbing or reflecting alpha or beta type ~~ .
radiation, such~as PVC, polycarbonate or the like, wherein
the second container itself provides for shielding means.
However, as shown in figures 3 and 4, preferably a third
container 30 is used, in which the first and second .-
containers 1, 2 can be enclosed. In the embodiment shown in
figure 3, the first and second containers 1, 2 are made
cylindrical, the first and second septum 6, 10 respectively
being clamped under the relevant lid 4, 12, such that the
first and second septum 6, 10 are piercable by the same
needle through opening 18. The third container 30 is made of
a shielding material, impenetrable by alfa, gamma or beta
type radiation. The third container is.preferably made of
lead or a different suitable shielding material, depending on
the type of radiation. The second container fits relatively
snugly into the third container, whereby the third container
is provided with a third lid 32, which can close the third
container. The third lid 32 is provided with a central
opening 34, closed by a lead stopper 36. When the stopper 36
25 has been removed the opening 18 and the underlying septa 6,
10 of a first and second container 1, 2 can be engaged, for
example by said needle, without the necessity of completely
removing the third lid 32. Thus the risk of leakage of
radiation to the environment is even further reduced. The
30 third lid 32 can be fixed onto the wall 38 of the third
container 30, for example by bayonet screw threader snap
fitted thereon.
A radioactive substance can be easily, economically
and savely shipped in a holder according to the present
invention, since leakage of said radioactive substance to the
environment is prevented effectively. Should the first
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container 1 break or otherwise leak, the radioactive
substance will be retained within the plastic second
container in a liquid and air tight manner. Thus, even if the
second container is removed from the shielding means, for
example said third container 30; the risk of contamination of
the environment is prevented.
Direct contact between the first and/or second
container 1, 2 and an operator or even close proximity
should, where possible, be prevented. To this end, an
instrument 40 has been provided for, as shown in figure 4.
This instrument 40 comprises a relatively long, cylindrical
handle 42, through which a central shaft 44 extends
coaxially. The shaft 44 is at one end provided with a grip
46, engaging the first end 48 of the handle 42, whereas the
shaft 44 is provided at the opposite side with a
substantially rectangular or oval spreading element 50,
securely connected to said shaft 44. The handle 42 is at the
second end provided with a slit 52, whereas the spreading
element 50 is positioned between the two parts 54 positioned
on either side of said slit 52. Both parts 54 are at their
free end provided, on the outside, with a stub 56, extending
approximately perpendicular to the longitudinal axis L of the
shaft 44. By rotation of the shaft 44 and thus the spreading
element 50 over an angle of approximately 90°, relative to
the handle 42 and by means of the grip 46, as shown in figure
5B, the halves 54 and thus the stubs 56 are forced outward.
The stubs 56 are positioned and dimensioned such that these
can be inserted into the notches 26 of the circumferential
wall 24 of the second lid 12, as shown in figure 5B. In this
position the instrument 40 securely engages the lid 12, such
that the second container 2 and the first container 1
contained therein can be manipulated by the instrument 40,
for example taken out of or positioned in the third container
30. Therefore, the first and second containers l, 2 can be
transferred from the third container 30 to for example a
radiation measuring unit or an infuser or the like, without
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an operator having to physically engage said containers.
Moreover, the lid 12 can be rotated by means of the
instrument 40, in order to unscrew the lid from the container
body 8 or to screw said lid 12 onto said container body 8,
for example when the vial 1 has to be positioned in or taken
out of the second container 2. To this end the second
container 2 is provided near the bottom thereof with a nuxiber
of outwardly protruding fins 58, whereas the third container
30 is provided with a preferably corresponding number of fins
60 in the wall 38, parallel to the longitudinal axis A.of
said third container. When the second container 2 is
positioned into the third container 30, the fins 38 slide in
between the fins 60. Thus, rotation of the second container 2.
relative to the third container 30 is prevented by
cooperating fins 58 and fins 60. Therefore, the container
body 8 will be retained by the third container 30 when the
instrument 40 is rotated around the longitudinal axis L
thereof, providing for the possibility of positioning or
removing of the lid 12. The instrument can be disengaged from
the second container 2 by rotation of the spreading element
50 back to the position as shown in figure 5A, whereby the
halves 54 are forced inward by their resilience, disengaging
the stubs 56 from the notches or openings 26.
Use of the instrument 40 has the advantage that
distance is provided between the person handling said
instrument 40 and the first 1 and/or second container 2 and
thus the source of radiation.
A holder according to the present invention can for
example be used as follows.
A radioactive substance, for example a medicine, is
positioned into the first container 1, which is then closed
by the first lid 4. Then the first container 1 is positioned
into the second container 2, which is then closed in a liquid
and air tight manner, using the second lid 12 and the second
septum 10. The lid 12 is screwed on using for example an
instrument 40 as shown in figure 4. Without disengaging said
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instrument 40 the second and first containers 2, 1 are lifted
and positioned inside the third container 30, providing-for
shielding means. The instrument 40 is then removed, after
which the lid 32 is positioned on the third container 30,
thus completely shielding the first and second container to
the environment. The holder is then ready for storage and
transportation in a safe and economical manner.
In a hospital or the like the first and second
container 1, 2 can be removed from the shielding means 30
after removal of the lid 32, using an instrument 40, far
example for measurement of the radiation of the substance
contained in the first container 1, without removal of the
first container from the second container 2. When only (part
of) the substance has to be withdrawn from the first
container 1 an appropriate needle can be inserted through the
first and second septum 6, 10, after removal of the stopper
36 from the opening 34 in the lid 32, leaving said lid 32 on
the third container 30. This has the advantage that the
radioactive substance can be withdrawn with minimal risk of
radiation to the environment.
Fig. 6 shows in cross section an assembly according
to the present invention, in an alternative embodiment,
comprising a first and second container 1, 2, enclosed within
a third container 130 comparable to a container 30 according
to fig. 3, having an outer wall 138 having a width which is
relatively small compared to the wall 38 of the embodiment
described before. The third container 130 is enclosed within
an outer container part 170, closely fitting and enclosing
the third container 130, which fourth, outer container 170 is
made of a shielding material, suitable for protection against
the radiation of the sample within the first container. The
outer container 170 is for example made of lead. A handle
172, pivotable around an axis 173 is attached to the third
container 130. Two stubs 174 are connected to the handle 172,
which stubs can engage in slots 175 in the wall of the fourth
container 170 and the lid 132 of the third container 138 when
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the handle is in a horizontal position, as shown in fig. 7B
(with respect to a dispensing device). In this positior~ the
third container 138 can not be moved relative to the fourth
container 170, due to the locking engagement of said stubs
174 and slots 175, which have a substantially elbow shape.
When the handle 172 is moved to the upward position, as shown
in fig. 6, the stubs 174 can be moved vertically out of the
slots 175, through their open to ends. Thus the third
container 138 can be lifted out of the fourth container by
means of the handle 172, and can be positioned in the means
as shown in fig. 7. Fig. 6 thus shows the assembly in a
transporting position, the environment being protected
against radiation in a suitable and safe manner. The outer
container 170 forms a storage and transporting means, the
handle 172 both locking and carrying means.
Before use the first 1, second 2 and third container
130 are taken ou.t of the outer container 170. To which end
the handle 172 is moved upward to an upright position. The
third container 130 can then be lifted out of the outer
container 170 and can be positioned in for example an
assembly 180 as shown in fig. 7, as discussed hereafter.
An assembly 180 according to fig. 7 comprises a foot
plate 181, two parallel arms 182 extending upwardly
therefrom. Between the free ends of the arms 182 a casing 183
is suspended on a pivot axis 184, said casing 183 being
comparable to the outer container 170 and made of similar
shielding material such as lead. As shown in fig. 7 a pin 185
extends through one of said arms 182 into a retaining hole
186, such that pivoting of said casing 183 around said axis
184 is prevented as long as said pin 185 is not retracted
from said hole 186. The third casing 130 containing the first
and second containers 1, 2, can be placed in the casing 183
in an upright position, the septa 6, 10 near said neck 188.
The handle 172 is then pivoted to a position as shown in fig.
7B, enclosing the third container 130 in said casing 183, the
casing 183 being provided with slots 175A comparable to the
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slots 1~5 in the fourth container 170, having the same
fonction. A needle 190 of the dispensing means 199 such as an
infusion system can then be introduced into the first
container through said septa 6, 10. The casing 183 with said
containers 1, 2, 130 will then be pivoted around said axis
t
184 after retraction of said pin 185, over an angle of 180°,.
after which said pin 185 is repositioned in a further
retaining hole 186a. In this position the,contents of the
first container 1 can be dispensed through said dispensing
means 191 under the influence of gravity, whereas the --
environment is shielded by at least the third container 130
and the casing 183.
A transporting and storage assembly according to fig.
6 and dispensing assembly 180 according to fig. 7 has the
advantage that the first, second and third containers can be
transported and stored in a safe and convenient manner,
whereas only the third container has to be handled when
transferring the first and second container into the
dispensing assembly 180 without the risk of contamination.
This is very convenient to the person transferring said
containers since this means a major reduction in weight and
dimension. The outer container 170 can stay in position, for
example in a transport box and can be re-used. Preferably,
the outer form and dimensions of the third container 130
match the inner dimension and form of the outer container 170
and/or the casing 183 in such a manner that only containers
of a certain type can be used therewith.
Fig. 8 shows an alternative embodiment of an
instrument 140 for handling first 1 and second containers 2.
This instrument 140 comprises a relatively long, cylindrical
handle 142 through which a central shaft 144 extends
coaxially. The shaft 144 is again at one end provided with a
grip 146 and at the other end with a locking element 150
extending perpendicular to the shaft 144, which locking
element 150 has a length approximately equal to the diameter
of the handle 142 (fig. 8a?. Two slits 152 are provided on
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opposite sides in the outer wall 145 of the handle 142, which
slits 152 are open to the lower end 143 of said handle-142.
Two cut-outs 151 are provided in the side edges of said slits
152, opposite each other, positioned such that when the
locking element 150 extends between said cut-outs the grip
146 abuts the upper end 147 of the handle 142. The locking .
element 150 has a diameter corresponding to the width of the
slits 152. The cut-outs 151 are for example semi circular
having a radius larger than the radius of the locking element
150. As can be understood from fig. 8a, when the grip 1.46
abuts said upper end 147, the part 154 of the handle 142
extending on opposite sides of the slits 152 can be moved
toward each other, the cut-outs 151 enclosing the locking
element 150. Near the lower end 143, stubs 156 are positioned
on the outer side of the part 154, extending radially into
opposite directions. Therefore, when the parts 154 of the
handle 142 are moved towards each other as discussed here
above, said subs 156 are moved inward, that is to a position
closer to each other. In this position the instrument 140 can
be introduced into the circumferential wall 24 of the lid 12
of the second container 2, after which the parts 154 can be
released, such that the stubs 156 are forced into the notches
or openings 26 in said circumferential wall. The shaft 144
can then be pulled upward by the grip 146, such that the
locking element 150 is forced into the slits 152, preferably
in abutment with the side edges thereof. In this position, as
shown in fig. 9, the parts 154 are kept outward and retained
in this position by said locking element 150. In this
position the second container 2 can be manipulated with said
instrument 140 without the risk of disengagement of said
instrument 140 from said second container 2, at least from
the lid thereof. In this position the lid 12 can be screwed
on or from said second container, whereas said second
container can also be manipulated. It will be clear that the
instrument 140 can be released from the second container by
pushing the shaft 144 and locking element 150 down, back to
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the position as shown in fig. 8a, after which the parts 154
can be resiliently forced toward each other again in order to
retract the instrument 140 from said lid 12.
On the lower end 143 of the parts 154 a rim 157 is
provided, extending inward, which rim can be positioned under
the lid 4 of the first container 1. In this position the ~~ .
first container 1 can be easily manipulated by the instrument
140. Once. again, the length of the instrument 140 provides
for further protection of a person handling the first and
second containers. w
It will be clear to a person skilled in the art that
an instrument according to the present invention could be
designed in several equivalent manners. For example, the
length of the shaft 144 could be designed such that when the
grip 146 abuts the upper end 147, the locking element 150 is
positioned in the slits 152 below the cut-outs 151 and should
be retracted in order to enable movement of the parts 154
toward each other.
The present invention is not limited to the
embodiments shown and described with reference to the
drawings. Many variations are possible within the scope of
the present invention as defined in the claims.
For example the first container can be made of a
different material inert to radioactive substances and
sterilization equipment. Furthermore, the first, second and
third containers can have a different shape or configuration,
as long as the first container, closed air and liquid tight
can be enclosed within said second container in an air and
liquid tight manner, shielding means, preferably in the form
of a third container being provided for containing said first
and second containers. The shielding means can however also
be provided for by the second container or by at least one
appropriate layer on said second container. Before withdrawal
of the substance from the first container 1 said first
container 1 can be retracted from the second container 2,
such that for example the first lid 4 can be removed, if
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necessary or desired. However, in view of the risk of
contamination by radiation a method as described here before
is preferred. Furthermore, the instrument and the second lid
can be designed in a different manner for engagement of the
first with the latter. Moreover, other means can be provided
for prevention of rotation of the second container relative .
to the third container, for example by using second and tk~ird
containers having at least partly a non circular form. The
holder or at least the first and/or second can be sterilized
in an autoclave, the containers or at least the space between
the first and second container being filled with water or the
like. However, any appropriate means for cleaning the holder
can be used. Spreading and locking of the instrument can be
obtained in a different manner, for example by a conical
element moving in axial direction or similar constructions.
Absorption means can be provided for in the second container.
These and similar alternatives are considered to fall
within the scope of the present invention.
