Transport container for radioisotope elution system

Abstract

The invention relates to a transport container for a radioisotope elution system, said transport container comprising a hollow housing (20), which is disposed in a way to surround a radiation shield (2) that is made from radio-opaque material, especially from lead, and that encloses a radioactive isotope-carrying elution column (1); a seat (27), which is provided in an upper portion (22) of the housing (20) and which carries an elution slot (23) and a solution slot (25) that are adjacent to each other; a protective upper lid (10), which is arranged to cover the seat (27) in an entirely impermeable manner; and a base (30), which is mounted via a lower side (24) of the housing (20) and which has a cup-form bottom (36) where the radiation shield (2) is to fit.

Description

[0001] TRANSPORT CONTAINER FOR RADIOISOTOPE ELUTION SYSTEM

[0002] TECHNICAL FIELD

[0003] The present invention relates to a transport container used as a secondary package in the radioisotope elution system.

[0004] STATE OF THE ART

[0005] The radioactive elution system enables the radioactive substances and the radiopharmaceuticals to be eluted, stored, and transported in a safe manner. During the process of elution, the radioactive substances are extracted with a solvent via an adsorbent, and thus, a particular radioactive isotope is obtained. These isotopes are generally used in the practices of medical diagnosis and treatment. An outer container, which constitutes a secondary package of the elution system, is designed specially to enable the radioactive substance to be eluted in an effective and safe manner.

[0006] A variety of systems are available to prepare, preserve, transport, dispense, and use the radiopharmaceuticals. A radiopharmaceutical generator, which comprises an elution column, and an input connector (e.g., an injector needle) and an output connector (e.g., an output needle) in fluid communication with this column, may be mentioned as an example of these systems. In a standard procedure, a technician transfers a vial with eluent capacity (e.g., a vial containing saline) to the input connector, while adding an empty elution vial with partial vacuum to the output connector. The vacuum in the empty elution vial enables the eluent (e.g., saline) to pass through the elution column and fill into the elution vial. The saline, while flowing through the column, elutes the radioisotopes and is filled into the elution vial as radioisotope-enriched saline. The elution vial is usually preserved in a special radiation shielding box; these boxes are sometimes referred to as pharmacy shield or elution shield.

[0007] The patent document no. WO2013169314 discloses an elution tool for a radiopharmaceutical elution system. There is provided an elution tool. The tool has a vial chamber sized and shaped for receiving an elution vial. An access opening is aligned with a septum of the elution vial when the elution vial is received in the vial chamber. The elution tool lid is secured to the elution tool body by a hinged connection. There is a generator handle rotatably secured to the lid. The handle is rotatable between a storage position, at which said handle is located below the upper surface of the lid on a plane substantially perpendicular to the axis of the housing, and a transport position, at which said handle is located above the upper surface of the lid on a plane substantially parallel to the axis of the housing. The generator handle allows a technician to lift the generator in order to position said generator into an auxiliary shield apparatus and remove said generator from the auxiliary shield apparatus. The generator handle may be manufactured from plastic or another suitable material and may be rotatably connected to the generator housing via rotary connections or other suitable types of connection.

[0008] OBJECT OF THE INVENTION

[0009] An object of the invention is to provide an easily dismountable base for the transport apparatus of a radioisotope elution system.

[0010] In order to achieve said object, the invention provides a transport container for a radioisotope elution system, said transport container comprising a hollow housing, which is disposed in a way to surround a radiation shield that is made from radio-opaque material, especially from lead, and that encloses a radioactive isotope-carrying elution column; a seat, which is provided in an upper portion of the housing and which carries an elution slot and a solution slot that are adjacent to each other; a protective upper lid, which is arranged to cover the seat in an entirely impermeable manner; and a base, which is mounted via a lower side of the housing and which has a cup-form bottom where the radiation shield is to fit. The transport container comprises a snap-fit apparatus, which is arranged between the lower side of the housing and the base in a way to provide the locking in a locking mode upon said lower side of the housing and said base being arranged in an engaged state via their opening portions that correspond to one another. The base in the lower part of the container supports the radiation shield, which is manufactured from lead or a similar radio-opaque material, and the radioisotope vial, which is inside the radiation shield. First the radiation shield is positioned in a filled state on the base, and then, the cylindrical housing is fitted over the radiation shield and is mounted via its lower side to the base by way of snap-fit. In this way, when the base is being carried for example by way of pulling via the handle on the protective upper lid, the materials with radioactive load transfer the weight to the housing via the snap-fit system, and the weight is then transferred from there to the protective upper lid and the handle. When the elution process is completed and the container in the state of a waste is delivered to the refill plant, the snap-fit system is opened to pull up the housing from the protective upper lid, and the radiation shield may be accessed easily. In a preferred embodiment of the invention, the snap-fit apparatus comprises a holder extension and a corresponding fixing tab, which is coupled by flexing in a way to fit in the opening of the holder extension that is near the bottom, said holder extension and said fixing tab being provided in an opposite manner in the corresponding opening portions of the lower side of the housing and the base. In this way, upon the housing being positioned on the base via a downward movement, the mounting in the form of snap-fit will be provided between the fixing tab and the holder extension, and when the radiation shield is positioned on the base, the housing will be simply fitted over the same, thereby forming a package surrounding the base and the radiation shield.

[0011] Preferably, the fixing tab is in the form of an extension of the lower side of the housing itself and the corresponding holder extension is in the form of an extension of the base itself. In this way, the snap-fit components are also formed automatically when the housing and the base are being formed via a simple operation of plastic injection.

[0012] Preferably, the base comprises a seat-form recess, which is provided in a way to face the bottom of said base and in which the fixing tab, extending through the same to the bottom, fits. The recess prevents the fixing tab that fits in said recess from moving away from the holder extension in cases of any interaction, such as an impact, involving the container, and thus prevents the snap-fit apparatus from opening.

[0013] Preferably, the recess extends axially upwards in a stepped section that rises through angular radial expansion from the peripheral edge of the bottom in the base. In this case, the recess moves the fixing tab away from the bottom by way of lifting up the same and prevents the tab from being pushed in case the container fits on a floor.

[0014] Preferably, the transport container comprises multiple recesses, which are provided in a radially spaced apart manner on the base and each of which is engaged by the corresponding fixing tab. In this case, both the amount of load that is to be borne is increased and the remaining fixing tabs are enabled to safely bear the load in case any of the tabs breaks or opens.

[0015] Preferably, in the locking mode, the outer wall of the extended body of the fixing tab abuts the inner wall of the holder extension in a way to entirely support the same. In this way, the tab is prevented from being dislocated due to the vibration. Preferably, the bottom of the base is positioned, via the free end of its peripheral edge, in a sealing manner in way to apply pressure on the inner wall of the lower side of the housing. In this way, the sealing and the safety are ensured. Moreover, the structural strength is increased and the ability to absorb the vibrations is also improved as a result of the outer peripheral edges of the base abutting the inner wall of the housing.

[0016] A preferred embodiment of the invention comprises a key member with a crown form, which comprises multiple pusher extensions each fitting in a corresponding recess in way to push the fixing tab radially inwards when seated on the base in an unlocking mode. In this way, the detachment of the housing from the base may be performed only by the authorized technical team having the key.

[0017] Preferably, the pusher extension comprises a wedge-like sectional form with radially inward inclination, which is arranged in a way to abut and engage the holder extension via the front face thereof when the base is seated. When the container returns to the production following the performance of the radioisotope elution, it is possible for the housing to unfasten, by its own weight, the snap-fit system, upon said housing being simply fitted on the key member.

[0018] BRIEF DESCRIPTION OF THE FIGURES

[0019] Figure 1 is a perspective assembly view of a representative embodiment of a three-piece container for the radioisotope elution system according to the invention, comprising a base, a housing, and a protective upper lid for the same.

[0020] Figure 2 is a perspective view of the container shown in Figure 1 where the protective upper lid and a handle for the same are shown in a zoomed-in state.

[0021] Figure 3 is a perspective view of the protective upper lid of the housing in the disassembled state.

[0022] Figure 4 is a perspective view of the upper portion of the housing in a state without lid and suitable for elution, along with the slots thereof on a seat.

[0023] Figure 5 is a cross-sectional view of the protective upper lid in a state mounted and locked to the housing. Figure 6 is a cross-sectional view of the embodiment shown in Figure 5, in the unlocked state.

[0024] Figure 7 is a perspective view of the base, which is locked to the lower portion of the housing, along with a key member.

[0025] Figure 8 is a view of the base locked to the housing in a state carrying thereon a radiation shield that surrounds an elution column.

[0026] DETAILED DESCRIPTION OF THE INVENTION

[0027] In this detailed description, the structure according to the invention and the preferred embodiments of the same will be described only for the purpose of enabling a better understanding of the subject matter, in a way not leading to any limiting effect.

[0028] Figure 1 presents a perspective view of a container manufactured from plastic material, which is prepared to transport a radioisotope in an elution system. The container has a cylindrical form and comprises, in the respective order from the bottom to the top, a base (30); a housing (20), which fits in a bottom recess (32) of the base (30) and is locked via a lower side (24) thereof to the base (30) in an upright manner; and a protective upper lid (10), which fits in an upper portion (22) of the housing (20) and is locked to the housing (20) in a manner releasable with the help of a pushbutton (52).

[0029] The protective upper lid (10) has a cup-like form. A top portion (12), with an inverted cup structure and a flat ceiling, of the protective upper lid (10) fits peripherally in an upper portion (22) of the housing (20) via a skirt portion (1 1 ), which is a cylindrical extension arranged with a diameter equal to the outer diameter of the housing (20). A handle (40) has a bridge member (41 ) with a U-like form, the sides of which are arranged angularly outwards, and it is fixed to the skirt portion (1 1 ) via the opposite free connection ends (48) by extending in a way to pass through the center of the top portion (12). The bridge member (41 ) comprises a straight upper extension (42), arranged parallel to and distanced from the ceiling of the top portion (12), and a first side extension (44) and an opposite second side extension (46) with mirror symmetry with said first side extension (44), which extend from the opposite ends of said straight upper extension (42). The first and second side extensions (44, 46) bend inwards from their lower ends to thus form an elbow and the elbow provides the connection end (48) and joins the skirt portion (11 ) along its width. The handle (40) and the protective upper lid (10) are manufactured together as a monolithic structure, by means of plastic injection. The handle (40) is manufactured with a D-like sectional form wherein it has a short depth at the first and second side extensions (44, 46) and a long depth at the upper extension (42). The angle of the first and second side extensions (44, 46) with the upper extension (42) is 120 degrees. The elbow portion also joins the skirt portion (1 1 ) as a result of the connection end (48) making an angle of 120 degrees in the opposite direction with the corresponding first and second side extensions (44, 46). In this way, the handle (40) forms on the protective upper lid (10) a monolithic structure, which has a hollow central portion and which follows a diamond-like line so that the short side will be the upper extension (42) and the long side will be the skirt portion

[0030] (11 ).

[0031] As shown in Figure 2, two opposite pushbuttons extend outward and perpendicular to the extension axis of the bridge member (41 ) on the peripheral edge of the cup-form top portion

[0032] (12) that faces radially outwards. For this purpose, a cup-form cut is formed and the respective pushbutton (52) is positioned in the top portion (12). The cut structure is arranged in a way to penetrate the ceiling of the top portion (12). Thus, the pushbutton (52) is accessible from the top along the entire length. The pushbutton (52) has a rectangular form and is positioned in the top portion (12) in such a way that its short side extends to the ceiling and its long side extends to the peripheral edge of the cup form.

[0033] Figures 3 and 4 show the upper portion (22) of the housing (20), where the protective upper lid (10) is removed to mount a radioisotope elution system to the container. For this operation, the protective upper lid (10) is pulled and removed from the upper portion (22) of the housing (20) by pushing the pushbutton (52). In order to achieve the pulling action, the technician is required to mutually push the pushbutton (52) while at the same time gripping the handle (40) via the upper extension (42) and pulling the same in the direction of separation. The cylindrical seat (27) located on the upper portion (22) of the housing (20) fits into the skirt portion (11 ). The upper surface of the seat (27) is planar and a cylindrical elution slot (23) and a solution slot (25), which is distanced from the elution slot (23) and is provided with a narrow diameter, extend inwards. The vacuum vial and the saline vial (not shown) of an elution system are fitted respectively into the elution slot (23) and the solution slot (25) and the transfer of the fluid into the housing (20) is enabled by means of the needles shown at the bottom. The elution system is a system known in the art and an elution system of the mentioned type is disclosed in the description of the document no. WO2013169314 incorporated herein by reference.

[0034] The opposite inward upper recesses (21 ) are formed at each of the sections of the seat (27) corresponding to the pushbutton (52) on the protective upper lid (10). The upper recess (21 ) has a triangle-like form that narrows down radially inwards and a lock tab (26) is present at the inner corner of the same.

[0035] Figure 5 shows the lid lock (50) in detail, by taking a cross-section of the protective upper lid

[0036] (10) and the upper portion (22) of the housing (20) in a direction perpendicular to the extension axis of the handle (40). The planar ceiling of the top portion (12) of the protective upper lid (10) extends inwards from the section where the pushbutton (52) fits, thereby forming a support pin (122). The support pin (122) extends radially outwards and a compression spring (54) is mounted between said support pin (122) and a corresponding pusher pin (53) behind the pushbutton (52). The two opposite pushbuttons (52) of the lid lock (50) have equivalent geometrical forms and both have the structure of a plastic trigger. In the section where the trigger portion extends radially outwards, a trigger seat (16) is formed in the top portion (12). The trigger portion of the pushbutton (52) extends radially outwards from the trigger seat (16). A lever portion (55) is disposed at the lower end of the trigger portion of the pushbutton (52). The lever portion (55) is formed below the top portion (12) by being bent towards a corresponding abutment surface of a central hub (14) that extends partially to the skirt portion

[0037] (11 ). A channel is formed inside the skirt portion (1 1 ) and a latch (56) in the form of a flat arm extends to the channel in the continuation of the lever portion (55) of the lid lock (50). The free end of the latch (56) bends radially inwards in an angled manner to thereby form a hook (58). Upon the compression spring (54) pushing the pushbutton (52) outwards, the latch (56), by using the support of the lever portion (55), pushes the hook (58) to the lock tab (26) and the hook (58) engages the lock tab (26) in a way to switch into a locking mode. In this way, the lid lock (50) inside the channel blocks the respective movement due to the engagement, when it is attempted to pull up the protective upper lid (10) via the handle (40). In the locking mode, the skirt portion (11 ) fits on the upper side of the upper portion (22) in a sealing manner. A gasket form, which extends, in a way to provide the sealing, radially inwards from the inner wall of the skirt portion (11 ) to a cylindrical hub (14) mounted in a coaxial manner inside the protective upper lid (10), fits in the radial outer portion of an inner lid (17) with a cup form. The inner lid (17) fits via its inner side on the outer side of the seat (27) in the upper portion of the lock tab (26). Moreover, an inner gasket (28) is provided, which peripherally fits in a corresponding inner cavity of the hub (14) along the peripheral edge of a raised portion of the seat (27) that carries the elution slot (23) and the solution slot (25). In order to enable the hub (14) to fit in the top portion (12), a cylindrical upper wall (19) engages, in the manner of a close- fit, the inner wall of the inner extension where the support pin (122) is also disposed.

[0038] Figure 6 provides the cross-sectional view of Figure 5 in the unlocked state. Here, the pushbuttons (52) are, via two opposite trigger portions, pushed radially inwards with respect to the protective upper lid (10). During the pushing action, the pushbutton (52), via the pusher pin (53) behind it, compresses the compression spring (54) in a way that a force is applied on the support pin (122). As the trigger portion advances radially inwards, the lever portion (55) abuts the corresponding abutment portion (18) on the outer wall of the hub (14) and enables the hook (58) at the end of the latch (56) to move radially outwards. In this case, the locking is terminated upon the hook (58) being separated from the corresponding lock tab (26). When the protective upper lid (10) is pulled up while the application of the compressive force continues, the skirt portion (11 ) separates from the upper portion (22) where it fits and the lid becomes entirely detached from the housing (20).

[0039] Figure 7 provides a perspective view of the lower portion of the housing (20). A flexible fixing tab (29), which enables the snap-fit, is located on the circular lower side (24) of the hollow cylindrical lower portion of the housing (20). The base (30) is in the form of a cup with opening facing upwards. The outer diameter of the upper opening portion of the base (30) and the outer diameter of the housing (20) are arranged to be the same. Thus, the housing (20) with tubular form may be fitted on the base (30) by way of being pushed down. Meanwhile, the flexible fixing tab (29) is enabled to engage a bottom recess (32), which is located in the angular transition area provided at the corner between the bottom and the lateral wall in the peripheral lower side of the base (30). The fixing tab (29) extends downwards in an inverted manner and catches on the upper side of the bottom recess (32). As a result, an annular key member (60), via the pusher extensions (62) thereon corresponding to each of the recesses, fully fits in the bottom recess (32) and thus, by pushing the fixing tab (29) radially inwards, enables the housing (20) to be detached from the base (30) when desired. The snap-fit connection is shown in more detail in Figure 8 illustrating the lower portion of the container via a cross-section. The lead radiation shield (2) is fitted on the circular bottom (36) of the base (30). In order to ensure that the radiation shield (2) is not dislodged, a mounting surface with coaxial steps engaging each other from the narrow towards the wide is disposed on the bottom (36) and on the bottom of the radiation shield (2). At the center of the radiation shield (2), an elution column (1 ) containing the radioisotope is fitted by means of a slot-like structure in a way constituting a shape connection. The peripheral edge of the bottom (36) of the base (30) is bent inwards and the transverse tabs are formed at the free end thereof. In this way, the peripheral edge of the bottom (36) enters the housing (20) from the lower side (24) thereof via the inner radial portion. Meanwhile, the flexible tab engages the holder extension (34) on the bottom recess (32) in a way to contact the same via its inner wall and thus fits in the opening of the holder extension (34) by way of snap-fit. As a result, the base (30) is mounted on the lower side (24) of the housing (20). The pusher extensions (62) on the crown portion (61 ) of the key member (60) have a wedgelike sectional form and their inclinations have a direction opposite to the tab end of the fixing tab (29) and have the same or a smaller angle. In this way, each of the pusher extensions (62) fits on the inclined head portion of the corresponding fixing tab (29) and pushes the same radially inwards. The push force originates from the weight of the housing (20) itself. When the base (30) fits on the key member (60), the weight load on the base (30) causes the fixing tab (29) to flex radially inwards due to its angle. When the fixing tab (29) has sufficiently flexed inwards, it becomes released from the front face of the holder extension (34) and enables the detachment of the base (30) and the housing (20) by disrupting the snap-fit connection between the base (30) and the housing (20).

[0040] REFERENCE NUMERALS

[0041] 1 Elution column 30 Base

[0042] 2 Radiation shield 32 Bottom recess

[0043] 10 Protective upper lid 34 Holder extension

[0044] 11 Skirt portion 36 Bottom

[0045] 12 Top portion 40 Handle

[0046] 122 Support pin 41 Bridge member

[0047] 13 Slot 42 Upper extension

[0048] 14 Hub 44 First side extension

[0049] 15 Outer gasket 46 Second side extension

[0050] 16 Trigger seat 48 Connection end

[0051] 17 Inner lid 50 Lid lock

[0052] 18 Abutment portion 52 Pushbutton

[0053] 19 Upper wall 53 Pusher pin

[0054] 20 Housing 54 Compression spring

[0055] 21 Upper recess 55 Lever portion

[0056] 22 Upper portion 56 Latch

[0057] 23 Elution slot 58 Hook

[0058] 24 Lower side 60 Key member

[0059] 25 Solution slot 61 Crown portion

[0060] 26 Lock tab 62 Pusher extension

[0061] 27 Seat

[0062] 28 Inner gasket

[0063] 29 Fixing tab

Claims

CLAIMS1. A transport container for a radioisotope elution system, said transport container comprising a hollow housing (20), which is disposed in a way to surround a radiation shield (2) that is made from radio-opaque material, especially from lead, and that encloses a radioactive isotope-carrying elution column (1 ); a seat (27), which is provided in an upper portion (22) of the housing (20) and which carries an elution slot (23) and a solution slot (25) that are adjacent to each other; a protective upper lid (10), which is arranged to cover the seat (27) in an entirely impermeable manner; and a base (30), which is mounted via a lower side (24) of the housing (20) and which has a cupform bottom (36) where the radiation shield (2) is to fit, characterized in that the transport container comprises a snap-fit apparatus, which is arranged between the lower side (24) of the housing (20) and the base (30) in a way to provide the locking in a locking mode upon said lower side (24) of the housing (20) and said base (30) being arranged in an engaged state via their opening portions that correspond to one another.

2. A transport container according to Claim 1 characterized in that the snap-fit apparatus comprises a holder extension (34) and a corresponding fixing tab (29), which is coupled by flexing in a way to fit in the opening of the holder extension (34) that is near the bottom (36), said holder extension (34) and said fixing tab (29) being provided in an opposite manner in the corresponding opening portions of the lower side (24) of the housing (20) and the base (30).

3. A transport container according to Claim 2 characterized in that the fixing tab (29) is in the form of an extension of the lower side (24) itself and the corresponding holder extension (34) is in the form of an extension of the base (30) itself.

4. A transport container according to Claim 3 characterized in that the base (30) comprises a seat-form bottom recess (32), which is provided in away to face the bottom (36) of said base (30) and in which the fixing tab (29), extending through the same to the bottom (36), fits.

5. A transport container according to Claim 4 characterized in that the bottom recess (32) extends axially upwards in a stepped section that rises through angular radial expansion from the peripheral edge of the bottom (36) in the base (30).

6. A transport container according to Claims 4-5 characterized in that the transport container comprises multiple bottom recesses (32), which are provided in a radiallyspaced apart manner on the base (30) and each of which is engaged by the corresponding fixing tab (29).

7. A transport container according to Claims 4-6 characterized in that in the locking mode, the outer wall of the extended body of the fixing tab (29) abuts the inner wall of the holder extension (34) in a way to entirely support the same.

8. A transport container according to any one of the preceding claims characterized in that the bottom (36) of the base (30) is positioned, via the free end of its peripheral edge, in a sealing manner in way to apply pressure on the inner wall of the lower side (24) of the housing (20).

9. A transport container according to Claims 6-8 characterized in that the transport container comprises a key member (60) with a crown portion (61 ), which comprises multiple pusher extensions (62) each fitting in a corresponding bottom recess (32) in way to push the fixing tab (29) radially inwards when seated on the base (30) in an unlocking mode.

10. A transport container according to Claim 9 characterized in that the pusher extension (62) comprises a wedge-like sectional form with radially inward inclination, which is arranged in a way to abut and engage the holder extension (34) via the front face thereof when the base (30) is seated.

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