Modular container for transporting radiopharmaceuticals or thermolabile drugs

Abstract

A modular container (1) for carrying at least one article (34) including a radiopharmaceutical, comprising two container bodies (2) which can be coupled together and a rigid casing (3) formed by two covers (4) connected to each other by means of two connector elements (5) to hold the two container bodies (2) coupled together. Each container body (2) has a base portion (6), which has an inner face (7) that can be coupled to the inner face (7) of the other container body (2) and a respective inner compartment (36) accessible from the first inner face (7) and suitable to be arranged upside down on the inner compartment (36) of the other container body (2) to close the box (35) between the two inner compartments (36) when the two first inner faces (7) are coupled together. The box (35) consists of two half-boxes (37; 52), each of which has at least one closed cavity for containing a eutectic solution and at least one cup seat (38; 53) for the article (34). The half-boxes (37; 52) can be positioned on top of each other so that the cup seat (38; 53) of one half-box (37; 52) is arranged upside down on the cup seat (38; 53) of the other half-box (37; 52) to close the article (34) between the two cup seats (38; 53).

Description

[0001] "MODULAR CONTAINER FOR TRANSPORTING RADIOPHARMACEUTICALS OR

[0002] THERMOLABILE DRUGS"

[0003] Cross-Reference To Related Applications

[0004] This patent application claims priority from Italian patent application no . 102024000008134 filed on April 11 , 2024 , the entire disclosure of which is incorporated herein by reference .

[0005] Technical field

[0006] The present invention relates to a modular container for transporting radiopharmaceuticals or thermolabile drugs .

[0007] In particular, the present invention finds advantageous , but not exclusive, application in the distribution to so-called radiopharmacies of radiopharmaceuticals contained in hermetic and shielded vials , to which the following description will make explicit reference without thereby losing generality .

[0008] Background

[0009] To date , most radioisotope-containing radiopharmaceuticals are normally distributed to so-called radiopharmacies in liquid form inside hermetic vials which in turn are enclosed inside shielded containers , for example made of lead, to contain the radiation emitted by the radiopharmaceuticals .

[0010] The shielded container must be capable of being safely transported by land and air and must therefore comply with stringent requirements set by the IAEA ( International Atomic Energy Agency) . In particular, IAEA Document No SSR- 6 (Rev . l ) identi fies the type of containment package to be used for the transport of radiopharmaceuticals as TYPE-A PACKAGE . This type of package must be substantially simple and inexpensive , and at the same time have high mechanical strength .

[0011] TYPE-A PACKAGE transport containers are normally prepared by hand by an operator, who inserts the shielded radiopharmaceutical containers one by one into the shielded container and then closes the shielded container . The manual preparation of well-known TYPE-A PACKAGE transport containers is too laborious and exposes the operator to radiation for a signi ficant amount of time .

[0012] Summary

[0013] The obj ect of the present invention is to provide a transport container for one or more shielded radiopharmaceutical containers , which is free from the drawbacks described above and at the same time easy and inexpensive to manufacture .

[0014] A modular container in accordance with the present invention for carrying at least one article comprising a radiopharmaceutical or thermolabile drug is provided as defined in the appended claims .

[0015] The claims describe preferred embodiments of the present invention to be considered as an integral part of the present speci fication .

[0016] Brief Description of the Drawings

[0017] For a better understanding of the present invention, a preferred embodiment thereof will now be described, purely by way of a non- limiting example and with reference to the accompanying drawings , wherein :

[0018] - Figure 1 is an exploded view of the modular container of the present invention;

[0019] - Figures 2 to 6 show, according to as many axonometric views , preparation steps for the modular container in Figure 1 ;

[0020] - Figure 7 is an exploded view of some parts of a first further embodiment of the modular container in Figure 1 ;

[0021] - Figure 8 shows a preparation step for a part o f the modular container in Figure 7 ; and

[0022] Figure 9 shows some parts of a second further embodiment of the modular container in Figure 1 .

[0023] Description of embodiments

[0024] In figure 1 , the number 1 indicates , as a whole , the modular container of the invention for containing at least one article (not shown) comprising a radiopharmaceutical , for example a shielded container enclosing a vial in turn containing a radiopharmaceutical . The modular container 1 comprises two container bodies 2 that can be coupled together to contain the article , and a removable rigid casing 3 formed by two rigid covers 4 connected to each other by means of two connector elements 5 to hold the two container bodies 2 coupled together .

[0025] Each container body 2 comprises a respective base portion 6 , which has an inner face 7 that can be coupled to the inner face 7 of the other container body 2 according to a movement parallel to an axis 2a perpendicular to the face 7 to achieve the coupling between the two container bodies 2 , a bottom outer face 8 parallel to the inner face 7 , two other lateral outer faces 9 and 10 parallel to each other and orthogonal to the inner face 7 and comprises at least one cup seat 11 accessible from the inner face 7 , i . e . , having a mouth opening onto the inner face 7 and suitable to be arranged upside down, coaxially, on the cup seat 11 of the other container body 2 to close the article between the two cup seats 11 when the two inner faces 7 are coupled together .

[0026] Preferably, the cup seat 11 is cylindrical in shape . In particular, the axis of the cup seat 11 is parallel to the axis 2a . In the example shown, the base portion 6 comprises four cup seats 11 arranged with respective axes parallel to each other and in two rows so that each cup seat 11 of one container body 2 is suitable to be arranged upside down on another cup seat 11 of the other container body 2 . Advantageously, each cup seat 11 is provided with a respective inner j acket 12 , only one of which is shown in Figure 1 for simplicity, made of shielding material , for example lead, to shield the radiation from the radiopharmaceutical contained in the article placed in the respective cup seat 11 .

[0027] Furthermore , each container body 2 comprises a wall 13 , which proj ects from the base portion 6 and has a second inner face 14 which is flat and transverse , and in particular perpendicular, to the inner face 7 , and the respective base portion 6 comprises a third inner face 15 , which is flat and parallel to the inner face 14 to abut against the inner face 14 of the other container body 2 when the inner faces 7 of the two container bodies 2 are coupled together .

[0028] The wall 13 proj ects from one side of the base portion 6 so that the wall 13 and the base portion 6 define a single exposed outer face 16 of the container body 2 transverse , and in particular orthogonal , to the bottom outer face 8 and therefore parallel to the axis 2a .

[0029] Essentially, the two container bodies 2 have respective L-shapes complementary to each other so that they can be coupled together . Advantageously, the two container bodies 2 are identical , thus reducing production costs , so that either one of the two is turned upside down on the other at hal f a round angle to close one or more articles between a pair of cup seats 11 or between respective pairs of cup seats 11 , respectively .

[0030] Advantageously, each base portion 6 comprises a protrusion 17 , which protrudes from the inner face 7 and extends along the inner face 7 in a C-shape , and a groove

[0031] 18 , which is formed along the inner face 7 and has a shape complementary to the protrusion 17 to couple with the protrusion 17 of the other base portion 6 when the two inner faces 7 are coupled together . In particular, the protrusion 17 defines a semi-perimeter around the mouths of the cup seats 11 , and the groove 18 defines the remaining semiperimeter around the mouths of the cup seats 11 . In this way, an internal volume can be sealed more carefully between the two container bodies 2 coupled together, containing the articles accommodated in the respective pairs of cup seats 11 .

[0032] Advantageously, each container body 2 is made in one piece . In particular, each container body 2 is made of heatinsulating material , for example high-density polystyrene .

[0033] Each cover 4 comprises a first portion 19 , which is suitable to be placed on the bottom outer face 8 of a container body 2 , and a second portion 20 , which is orthogonal to the first portion 19 and is suitable to be placed on the same lateral outer face 9 , 10 of both container bodies 2 .

[0034] Each connector element 5 comprises a pin 21 and a lever 22 integral with the pin 21 . Each cover 4 comprises at least one first annular element 23 at an edge of the first portion

[0035] 19 , and at least one second annular element 24 at an edge of the second portion 20 . The annular element 23 of one cover 4 and the annular element 24 of the other cover 4 are designed to be arranged coaxially with each other so that they can be engaged simultaneously by one of the two pins 21 in order to achieve a respective connection between the two covers 4 . Each lever 22 allows the respective pin 21 to be removed in order to disconnect the covers 4 and remove the rigid casing 3 .

[0036] According to the particular embodiment shown in Figure 1 , each cover 4 comprises a plural ity of annular elements 23 arranged in a comb shape , and a plurality of annular elements 24 arranged in a comb shape and suitable to be arranged alternately and coaxially with the annular elements 23 .

[0037] The connection defined by each pin 21 which engages the annular elements 23 of one cover 4 and the annular elements 24 of the other cover 4 forms a latch closure . For this purpose , the second portion 20 of each cover 4 comprises an eyelet 25 and each lever 22 has a bi furcated end 26 that can be locked at the eyelet 25 by means of a padlock (not shown) .

[0038] Essentially, the two covers 4 have respective L-shapes that are closed around four sides of the assembly formed by the two container bodies 2 coupled together to hold the two container bodies 2 together in the direction of the axis 2a . Advantageously, the two covers 4 are identical , thus reducing production costs .

[0039] Advantageously, each cover 4 comprises at least two retaining elements 27 and 28 , which protrude from two respective opposite side edges 19a and 19b of the first portion 19 . The exposed outer face 16 has two end portions 29 and 30 parallel to the bottom outer face 8 . The retaining element 27 is designed to embrace an end portion 29 , 30 of the exposed outer face 16 of a container body 2 , and the retaining element 28 is designed to embrace the other end portion 30 , 29 of the exposed outer face 16 of the other container body 2 to hold the two container bodies 2 together in a direction orthogonal to the axis 2a and to the outer faces 16 .

[0040] According to the particular embodiment shown in the figures , each cover 4 comprises two retaining elements 27 on one side edge and two other retaining elements 28 on the opposite side edge .

[0041] Advantageously, the first portion 19 of each cover 4 comprises two coupling elements 31 to facilitate stable stacking of several modular containers 1 at the first portions 19 of the covers 4 . Each coupling element 31 comprises a protrusion 32 and a groove 33 of a shape complementary to the protrusion 32 so that an upward- facing protrusion 32 of a first modular container 1 mates with the downward- facing groove 33 of another modular container 1 stacked on top of the first .

[0042] Advantageously, each cover 4 is made in one piece , e . g . , of printed material . In particular , each cover 4 is made of plastic material .

[0043] Figure 2 shows the modular container 1 with a first container body 2 laid on a first cover 4 , and the rigid casing 3 open, and in particular with the second cover 4 connected to the first cover 4 via a single connector element 5 (not visible in Figure 2 ) and rotated around the pin 21 of said connector element 5 , and four articles 34 arranged in the four cup seats 11 of the container body 2 . In particular, each article 34 is a shielded container containing a vial (not visible ) with a radiopharmaceutical . Figure 3 shows the modular container 1 shown in Figure

[0044] 2 with the addition of the second container body 2 upside down on top of the first container body 2 and ready for coupling with the first container body 2 .

[0045] Figure 4 shows the modular container with the two container bodies 2 coupled to each other and the rigid casing

[0046] 3 still open .

[0047] Figure 5 shows the modular container 1 with the rigid casing 3 closed, resulting from the rotation of the second cover 4 around the pin 21 of a connector element 5 , and the pin 21 of the other connector element 5 ready to engage the respective annular elements 23 and 24 arranged coaxially with each other and with the annular elements 23 alternating with the annular elements 24 . Therefore , the connection defined by each pin 21 engaging the annular elements 23 of one cover 4 and the annular elements 24 of the other cover

[0048] 4 also creates a hinge allowing the rigid casing 3 to be opened and closed in order to insert and remove the articles 34 .

[0049] Figure 6 shows the modular container 1 with the rigid casing 3 closed, with both the connector elements 5 having their respective pins 21 in the engaged position and their respective levers 22 locked in their eyelets 25 . The pins 21 are not visible because they are completely hidden inside the respective annular elements 23 and 24 .

[0050] Of course , to extract the articles 34 from the modular container 1 , it i s suf ficient to reverse the steps shown in Figures 2 through 6 .

[0051] The two exposed outer faces 16 remain visible even when the rigid casing 3 is closed . Therefore , labels (not shown) can be attached to the exposed outer faces 16 , which provide information about the contents , sender, and recipient of the modular container 1 .

[0052] According to a further embodiment of the present invention shown in Figure 7 , in which the corresponding elements are indicated with the same numbers as in Figure 1 and in which the rigid casing 3 has been removed for ease of illustration, the modular container 1 comprises a thermostabili zing box 35 to contain at least one article 34 , and each container body 2 comprises , instead of the four cup seats 11 , an inner compartment 36 , which is accessible from the inner face 7 , i . e . , it has a mouth opening onto the inner face 7 , and is suitable to be arranged upside down on the inner compartment 36 of the other container body 2 to close the box 35 between the two inner compartments 36 when the two inner faces 7 are coupled together .

[0053] The box 35 compri ses two box portions , and in particular two hal f-boxes 37 , each of which comprises at least one cup seat 38 for a respective article 34 . The inner compartment 36 of each container body 2 accommodates a respective hal fbox 37 .

[0054] The two hal f-boxes 37 are suitable to arrange themselves on top of each other to define the box 35 , in particular so that the cup seat 38 of one hal f-box 37 is arranged upside down on a corresponding cup seat 38 of the other hal f-box 37 to close the article 34 between the two cup seats 38 . In the example shown in Figure 7 , the cup seats 38 are four for four articles 34 .

[0055] Each hal f-box 37 comprises at least one closed cavity for containing a thermostabili zing fluid, and in particular a liquid eutectic solution .

[0056] In greater detai l , each hal f-box 37 comprises a first body 39 and a second body 40 superimposable on the first body 39 . The first body 39 has at least one cup recess 41 , and the second body has at least one through opening 42 suitable to align with the cup recess 41 of the first body

[0057] 39 to define a respective cup seat 38 when the second body

[0058] 40 is superimposed on the first body 39 . In particular, the cup recess 41 and the through opening 42 have , transversely to the axis 2a, the same circular cross-section .

[0059] Each of the two bodies 39 and 40 comprises a respective closed cavity to contain the thermostabili zing fluid . In particular, the two bodies 39 and 40 are completely hollow and filled with the thermostabili zing fluid . Each body 39 , 40 comprises a respective filling noz zle 43 , 44 for the insertion of the thermostabili zing fluid . In the case where the thermostabili zing fluid is a liquid eutectic solution, then the two bodies 39 and 40 are actually two eutectic bodies .

[0060] Each hal f-box 37 is provided with a plurality of C- shaped clips 47 to assemble the two bodies 39 and 40 , i . e . , to retain the body 40 superimposed on the body 39 . The body 39 has a respective plurality of s ide shoulders 45 , and the body 40 has a plurality of side shoulders 46 opposite the side shoulders 45 when the body 39 is superimposed on the body 40 . Each clip 47 is designed to grip a side shoulder 45 and a corresponding side shoulder 46 . Figure 8 shows the two hal f-boxes 37 assembled by the clips 47 , and the articles 34 inserted in the seats 38 of the hal f-box 37 shown below .

[0061] In place of the protrusion 17 and the groove 18 in Figure 1 , the base portion 6 of each container body 2 of the embodiment in Figure 7 comprises at least one protrusion 48 , which protrudes from the inner face 7 , and at least one groove 49 , which is formed along the inner face 7 and has an overall arrangement and shape complementary to the protrusion 48 to couple with the protrusion 48 of the other base portion 6 when the two inner faces 7 are coupled together . In particular, the base portion 6 comprises two protrusions 48 located on the sides of the inner compartment 36 and two grooves 49 located on the sides of the inner compartment 36 . Each groove 49 is aligned with the protrusion 48 which is located along the same side of the inner compartment 36 .

[0062] Again with reference to Figure 7 , each seat 38 is advantageously provided with a respective inner j acket 12 .

[0063] Advantageously, the bottom outer face 8 of the base portion 6 of at least one of the two container bodies 2 has a recess 50 containing a geo-localizing device 51 . In the example in Figure 7 , there is a recess 50 on each of the two bottom outer faces 8 for modularity reasons , hence with the possibility of inserting the geo-locali zing device 51 into either of the two recesses 50 .

[0064] According to a further embodiment of the present invention shown in Figure 9 , the box 35 comprises two hal fboxes 52 which di f fer from those in Figures 7 and 8 substantially in that each of them is a single body, i . e . , it is not defined by two superimposable bodies . Each hal fbox 52 comprises at least one cup seat 53 , and in particular four cup seats 53 , for at least one respective article 34 . Each hal f-box 52 comprises a respective closed cavity to contain the thermostabili zing fluid, and in particular is completely hollow and filled with the thermostabili zing fluid . Although the invention described above makes particular reference to a very precise embodiment , it is not to be construed as limited to this embodiment, since all the variations, modifications or simplifications covered by the attached claims fall within its scope, such as for example: the modular container 1 is used to hold articles comprising thermolabile drugs; and the inner jackets 12 are made of other materials, such as aluminium, stainless steel or plexiglass, depending on the type of article to be transported .

[0065] The main advantage of the modular container 1 described above is that it is very quick to prepare, both when it is closed and when it is opened, and therefore this reduces the exposure time of the operator to radiation. In addition, it is very robust, due to the rigid casing 3, and protective for the contents, due to the coupling of two container bodies 2 made of lightweight and heat-insulating material, such as high-density polystyrene.

[0066] The embodiments in Figures 7 to 9 have a further double advantage guaranteed by the thermostabilizing box 35: the articles 34 are more thermally insulated and the modular container 1 is more robust, in the sense that, for example, in the event of a strong impact caused by a fall from a height of up to 9 metres the box 35 is able to hold the articles 34 together, and therefore, the container bodies 2 also deform less. It is recalled, in fact, that the articles 34 are relatively heavy and therefore produce high inertia during a fall.

[0067] The modular container 1 is cost-effective to manufacture, as it essentially consists of only three different pieces, namely the container body 2, the cover 4, and the connector element 5, and for each different piece, two copies. For this reason, the container of the invention is defined as modular. The embodiments 7 to 9, in balance with the advantages described above, have the cost of having only one additional different piece, namely the half-box 52, or only two additional different pieces, namely the bodies 39 and 40 to form the half-box 37.

[0068] Lastly, the modular container 1 can be reused many times .

Claims

C L A I M S1. A modular container to carry at least one article(34) comprising a radiopharmaceutical or thermolabile drug, the modular container (1) comprising a thermostabilizing box(35) to contain the article (34) , two container bodies (2) that can be coupled with each other to contain the box (35) , and a rigid casing (3) formed by two covers (4) connected to each other by means of two connector elements (5) to hold the two container bodies (2) coupled together; each container body (2) comprising a respective base portion (6) , which comprises a first inner face (7) that can be coupled with the first inner face (7) of the other container body (2) to realize the coupling between the two container bodies (2) , and a respective inner compartment (36) accessible from the first inner face (7) and suitable to be arranged upside down on the inner compartment (36) of the other container body (2) to close the box (35) between the two inner compartments(36) when the two first inner faces (7) are coupled together; the box (35) comprising two box portions (37; 52) , each comprising at least one closed cavity to contain a thermostabilizing fluid and at least one cup seat (38; 53) for the article (34) ; the box portions (37; 52) being suitable to arrange themselves on top of each other so that the cup seat (38; 53) of one box portion (37; 52) is arranged upside down on the cup seat (38; 53) of the other box portion (37; 52) to close the article (34) between the two cup seats (38; 53) .

2. The modular container according to claim 1, wherein the two box portions are two half-boxes (37; 52) .

3. The modular container according to claim 1 or 2, wherein the inner compartment (36) of each container body(2) is suitable to accommodate one respective portion of the two box portions (37; 52) .

4. The modular container according to any one of claims 1 to 3, wherein each box portion (37; 52) comprises a first body (39) and a second body (40) superimposable on the first body (39) , the first body (39) having at least one cup recess (41) and the second body (40) having at least one through opening (42) suitable to align with said cup recess (41) to define said cup seat (38) when the second body (40) is superimposed on the first body (39) .

5. The modular container according to claim 4, wherein said at least one closed cavity comprises at least a first closed cavity defined in the first body (39) and a second closed cavity defined in the second body (40) .

6. The modular container according to claim 4 or 5, and comprising a plurality of clips for each box portion (37; 52) for retaining the second body (40) superimposed on the first body (39) .

7. The modular container according to any one of claims 1 to 6, wherein said thermostabilizing fluid comprises a eutectic solution.

8. The modular container according to any one of claims 1 to 7, wherein the base portion (6) of at least one of the two container bodies (2) comprises a bottom outer face (8) , which is parallel to the first inner face (7) and has a recess (50) containing a geo-localizing device (51) .

9. The modular container according to any one of claims 1 to 8, wherein the base portion (6) comprises a bottom outer face (8) parallel to the first inner face (7) and two lateral outer faces (9, 10) parallel to each other and orthogonal to the first inner face (7) , and each cover (4) comprises afirst portion (19) , which is suitable to be placed on the bottom outer face (8) of a container body (2) , and a second portion (20) , which is orthogonal to the first portion (19) and is suitable to be placed on the same lateral outer face (9, 10) of both container bodies (2) .

10. The modular container according to claim 9, wherein each container body (2) comprises a wall (13) , which projects from the base portion (6) and has a second inner face (14) which is flat and transverse to the first inner face (7) , and the respective base portion (6) comprises a third inner face (15) , which is parallel to the second inner face (14) to abut against the second inner face (14) of the other container body (2) when the first inner faces (7) of the two container bodies (2) are coupled together.

11. The modular container according to claim 10, wherein each container body (2) comprises an exposed outer face (16) which is transverse to the bottom outer face (8) and extends along the base portion (6) and the wall (13) , and each cover (4) comprises at least one first retaining element (27) and a second retaining element (28) , which protrude from two respective opposite side edges (19a, 19b) of the first portion (19) and are designed to embrace a first end portion (29, 30) of the exposed outer face (16) of one container body (2) and, respectively, a second end portion (30, 29) of the exposed outer face (16) of the other container body (2) .

12. The modular container according to any one of claims 1 to 11, wherein each base portion (6) comprises at least one protrusion (48) , which protrudes from the first inner face (7) , and at least one groove (49) , which is formed along the first inner face (7) and has a shape complementary to the protrusion (17) to couple with the protrusion (17) ofthe other base portion (6) when the two first inner faces (7) are coupled together.

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