Shielded device for transport and administration of liquid radiopharmaceuticals

Abstract

Shielded device for the transport and administration of liquid radiopharmaceuticals, comprising a container (1) with a seat (2) to accommodate a main shield (3) configured to accommodate a cartridge (4) of the type provided with a body (10) for the containment of a quantity of radiopharmaceutical and its escape from an opening (12) by the action of a sliding piston (15), this main shield (3) being provided with a first open end (7) to allow the connection of the opening (12) to a line (6) for the infusion of the radiopharmaceutical coming out of the cartridge (4) and a second open end (8) to allow the connection of the piston (15) of the cartridge (4) with a pusher (5), including a first movable shielding wall (13) arranged at said first open end (7) of the main shield (3) and configured to be able to pass between a complete closed position (P1) in which access to the opening (7) is impeded, and at least one position (P2) of opening and access allowed at the end (7) of the shield (3), in which said container (1) is composed of at least a first and a second section (9, 10) movable to each other and connected to the movable wall (13) to make it pass reversibly between said closed position (P1) and said at least one position (P2) to allow the cartridge (4) to be connected to the line (6).

Description

[0001] SHIELDED DEVICE FOR TRANSPORT AND ADMINISTRATION OF LIQUID RADIOPHARMACEUTICALS

[0002] ******

[0003] Technical field of the invention

[0004] The invention concerns a shielding device designed to safely manage the transport and administration of radiopharmaceuticals.

[0005] Background art

[0006] At present, there are several known shielding systems that involve the transport of a syringe that is first filled, placed in a shielded transport container, transported to the place of administration and then made accessible for administration to the customer.

[0007] In general, systems of known type have the disadvantage of not adequately protecting the operator and the patient from possible contamination, in all phases of radiopharmaceutical dose management, i.e. from filling to personalized administration.

[0008] From W002083210A1 a method for preparing, packaging and handling an individual dose of a radiopharmaceutical compound is known, involving the filling of a cartridge equipped with a piston and its insertion into a shielding device comprising an internal shielding part for the operator and an external shielding part for transport to the place of administration, in which the protective cover of the container is removed and a plunger is applied to the cartridge piston. The cartridge and the inner protective part are then removed from the outer part and the cartridge is connected to the injection media.

[0009] However, these well-known systems have some drawbacks, in particular in relation to the handling and management of the shielded syringe, which is complex and unsafe due to the rod that comes out of the syringe and because it is still required to open both ends of the shielded container to connect the pusher and the infusion line.

[0010] Aim of the invention

[0011] A first purpose of the invention is to propose a dose management solution from transport to infusion that is simple and safe for the operator and the patient.

[0012] A further purpose is to allow the administration of a personalized controlled dose.

[0013] Summary of the invention

[0014] These and other technical purposes and advantages have been achieved, according to the invention, with a shielded device for the transport and administration of liquid radiopharmaceuticals according to at least one of the attached claims.

[0015] A first advantage obtained according to the invention consists essentially in the fact that the device of the invention makes it possible to manage, from a disposable cartridge, both the transport and the infusion of radiopharmaceuticals, in particular radiopharmaceuticals used in Theragnostics, minimizing any exposure of the operator and avoiding any type of contamination.

[0016] A second advantage is that the device can be equipped with an adjustable plunger and customized labels that allow the operator to manage the administered dose even without having visual feedback of the administration.

[0017] An additional advantage is that the device is a compact and easily usable solution for both dose transport and infusion.

[0018] A further advantage is that the device prevents dripping of radiopharmaceuticals and allows safe waste management.

[0019] List of drawings

[0020] These and other advantages will be better understood by a skilled person from the description below and from the attached drawings, given as a non-limiting example, in which: fig.1 shows an exploded view of the shielded device of the invention; fig.2 shows a partial exploded view of the device in Fig.1 , in combination with two possible types of radiopharmaceutical cartridges; fig.3a-3e show successive operating configurations of the device; fig.4 shows an elevation view of the device; fig.5 shows a plan view of the device of fig.4; fig.6 shows a second elevation view of the device, in a different operating configuration than fig.4; fig.7 shows a three-quarter view of the device; fig.s 8a-8c show respectively a three-quarter partial exploded view of a device according to the invention in a complete closed and shielded operating position, a partial exploded view in longitudinal section and a section view C-C of fig.8b; fig.9 shows a three-quarter view of the device in a partial shielding operating position with cartridge accessible to the infusion line; fig.s 9a-9c show respectively a view from below, a longitudinal section view and a C-C section view of fig.9b with infusion adapter extracted; fig.s 9a'-9c' show respectively a view from above, a longitudinal section view and a c-c section view of fig.9b with infusion adapter inserted; fig.10 shows a three-quarter view of the device in an operating position of partial shielding and device ready for the infusion phase; fig.s 10a-10d, show respectively: a view from below, a view in partial longitudinal section, a view in section c-c and a view in section d-d of the device of flG.10b in a phase of preparation of the infusion with the pusher blocked; fig.s 10a'-10d', show respectively: a view from below, a view in partial longitudinal section, a view in section C-C and a view in section D-D of the device of fig.10b' in the initial infusion phase with pusher free to slide; fig.s 10a”-10d" show respectively: a view from below, a view in partial longitudinal section, a view in section C-C and a view in section D-D of the device of fig.10b" in the final infusion phase with pusher at the end of the stroke; fig.11 shows a three-quarter view of the device in an operating position at the end of use with the exploded view of the cartridge at the end of use; fig.s 11 a-11 d, show respectively: a view from below, a view in partial longitudinal section, a view in section C-C of the device of Fig.11 b in the final phase of complete opening of the shield for the extraction of the cartridge; fig.s 12a, 12b show respectively the device being infused with two different and controlled quantities of radiopharmaceutical; fig.13 shows an adapter according to the invention for connecting the device to an infusion line.

[0021] Detailed Description

[0022] With reference to the attached drawings, a preferred form of realization of a shielded device for the transport and administration of radiopharmaceuticals according to the invention is given as an example of embodiment.

[0023] With reference to fig.1-3, in the preferred form of realization illustrated, the device includes a cylindrical container 1 equipped with a seat 2 inside which it is possible to insert a main shield 3 formed by a hollow cylinder in shielding material of a size suitable for housing a cartridge 4 for the containment of a radiopharmaceutical liquid and locked in position inside seat 2 by a flange 44 fixed to container 1 by means of fixing means for example a bayonet joint 45.

[0024] In particular cartridge 4, visible in section in figure 6a, is of the type equipped with a body 40 intended to receive a quantity of radiopharmaceutical during the filling phase, which at one end has a nozzle 12 for the leakage of the liquid contained, which is obtained by sliding of a sliding piston 15 along the body 40. Figure 2 illustrates two possible types of commercial cartridges 4 or 4' that can be used with the device, i.e. a cartridge 4 in which nozzle 12 is closed by a cap 41 carrying a perforable septum 42 and a cartridge 4' in which nozzle 12 is closed by a luer lock closure 43.

[0025] The main shield 3 is open both at the lower end 7 corresponding in use to the position of the nozzle 12, to allow the connection of the cartridge 4, 4' to a radiopharmaceutical infusion line 6, and at the upper end 8 corresponding to the position of the piston 15 when the cartridge is completely filled, to allow the connection of the piston 15 with a pusher 5 which, by pressing on the piston, induces the leakage of the radiopharmaceutical from the nozzle 12 towards the infusion line 6.

[0026] In the example illustrated, the device is described in combination with a manual pusher, but it is intended that alternatively it can be interfaced with a dedicated injection pump.

[0027] Preferably, the pusher 5 includes two shafts or pushrods 67 designed to press on the piston 15 of the cartridge 4 and a pair of guide arms 24 sliding in contact with the body 1 during infusion stroke of the pusher.

[0028] According to the invention, at the lower open end 7 of the main shield 3, once assembled in body 1 , a shielding movable wall 13 is provided which is configured to pass between a closure position in which it guarantees the shielding of the end 7, and an opening position in which the nozzle 12 is accessible for connection to the infusion line and the cartridge 4 is therefore not completely shielded.

[0029] In the illustrated and described example, the passage between the two positions of the shielding wall 13 is obtained by maneuvering two sections 9, 10 of container 1 that are mutually movable by rotation and interacting with the wall 13 to make the wall 13 pass reversibly between the closure position P1 and the opening position P2, schematized respectively in fig.8a and 9a.

[0030] In the example described, the device can be operated manually, but the device can be integrated with automatic infusion systems.

[0031] The mechanism for transforming the reciprocal movement of sections 9, 10 constituting container 1 into an opening movement of the shielded wall 13 may be of different types. In the example better illustrated in fig.6a and 8a, the kinematic transformation takes place thanks to the conformation of the wall 13 composed of radial sectors 16, 16' integral in rotation with the first section 9 and constrained by means of sliding pins 17, 17' to the respective cam profiles 18, 18' integral in rotation with the second section 10, in such a way that by reciprocally rotating the two sections 9, 10, the pins 17 , 17', in their different operating positions are dragged by the profile 18, 18' and moved radially by closing or opening, partially or completely, the central part of the shielded wall 13 which corresponds to the cartridge, making the cartridge accessible for connection to line 6 (fig.8c) or removable from shield 3 (fig.8d) once emptied and at the end of use.

[0032] With further reference to figure 1 , the device also includes a second mobile shield wall 14 arranged at the upper open end 8 of shield 3 and configured to be able to switch between a position of blocked access to the pusher 5 and a position of allowed access to the pusher 5.

[0033] In the example described, the upper mobile part is formed by a block 14 in shielding material crossed by slots 46 of shape and size corresponding to a pair of pushrods 67 of the pusher 5 and is contained within a third upper section 11 of container 1 which can be manoeuvred with respect to the first central section 9 to reversibly pass block 14 between the blocked access position and the allowed access position of the pushrods 67 of the pusher 5 to the piston 15 of the cartridge.

[0034] In more detail, as illustrated by fig.6a, the upper section 11 is formed by a cylindrical wall 48 that can be superimposed on shield 3 and protruding axially in order to accommodate a shielded disc 49 equipped with through slots 47 aligned with slots 46 of block 14 when the latter is in the permitted access position and it is superimposable on shield 3 with the interposition of a sealing ring 55 that prevents any accidental leakage of liquid.

[0035] Advantageously, the slots 46 / 47 being configured in this way allow the pusher 5 to be used avoiding contact with the inner walls of the syringe during and after administration and the consequent radioactive contamination.

[0036] As it can be better seen in fig.6a, the cylindrical wall 48, the shielded disc 49 and the block 14 are held in position by an upper flange 50 constrained to section 11 by means, for example, of a reversible bayonet joint 51 , in such a way that the disc 49 is stopped in rotation with respect to the flange 50, while the block 14 can rotate being dragged by the pushrods 67 inside a seat 56 of the flange 50.

[0037] Figures 3a-3e illustrate the relative positions that the lower section 10 can assume with respect to the central section 9 during the use of the device, recognizable by corresponding graphic references to the sliding limit of the two sections.

[0038] In particular:

[0039] - fig.3a shows the position P1 of complete closure of the lower shielding part, with access prevented to the cartridge with the safety cover 58 inserted to protect access to the cartridge;

[0040] - fig.3b shows the position P1 of fig.3a, after the removal of the safety cover 58;

[0041] - fig.3c shows the position P2 of partial opening obtained by rotating the lower section 10 to cause a sliding of sectors 16 sufficient to give access to the opening 12 of cartridge 4 by means of an infusion line, for example a needle inserted in the cartridge;

[0042] - fig.3d shows the safety position P3 obtained by rotating the lower section 10 until the sectors 16 radially retract into the needle lock position; - fig.3e shows the position P4 of complete opening of sectors 16 and 16' for cartridge extraction.

[0043] In more detail, with reference to figures 8-11 , the different positions that can be assumed by sections 9, 10 during use are illustrated, which section, s being rotating each other, activate and deactivate the operating functions of the device.

[0044] Fig.s 8a-8c show the closed configuration of full shielding, in which the cartridge 4, previously filled with radioactive liquid, is completely enclosed by the main shield 3 and the shielding walls of the lower and upper ends 13, 14 (which will be better described later) so that the drug can be transported safely from the point of filling to the point of infusion and administration.

[0045] In particular, the movable wall 13 has all sectors 16, 16' converging with pins 17, 17' at the point of maximum radial convergence of paths 18, 18' (fig.8c), sections 9, 10 are in the reciprocal closing position, with needle 31 of the adapter and pushrods 67 of pusher 5 which cannot access respectively piston 15 and opening 12 of cartridge 4, also due to the presence of lower and upper safety caps 60, 61 , preferably identical to each other which, when inserted in their respective seats, guarantee both liquid tightness and complete shielding. This is because plugs 60, 61 have mounting pins 70, 71 that can only be inserted into the respective housings 72, 73 when the device is completely closed and shielded both at the bottom and at the top.

[0046] This is because the 2 caps, identical to each other, have four plugs that are inserted into appropriate seats only if the shields are in the closed position both above and below.

[0047] Fig.s 9-9c' show the device in the configuration of access allowed to cartridge 4 for the insertion of needle 31 (fig.9a'-c'), obtained by removing caps 60, 61 and rotating the lower section with respect to the central section 9 (position P2) in order to retract sectors 16 of wall 13 (fig.9a, a'), with pins 17 engaged at the furthest point from the center of paths 18 (fig.9c, b'), while the access of the pusher 5 to the piston 15 of the cartridge remains impeded with the slots 46 of block 14 staggered with respect to the slots 47 of the shielded disc 49.

[0048] Fig.10 shows the device in the configuration of access allowed to cartridge 4 for the insertion of needle 31 and of safe locking of needle 31 , obtained by further rotating the lower section 10 with respect to the central section 9 (position P3) in order to advance sectors 16 of wall 13 (fig.10a, a', a"), with the pins 17 engaged at a point of intermediate distance from the center of the paths 18.

[0049] Fig.s 10b-d show a configuration with impeded access of pusher 5 to piston 15, with slots 46 of block 14 offset with respect to slots 47 of shielded disc 49 (fig.10d), while in fig.s 10d'-d" it is shown the alignment of slots 46, 47 obtained by rotating pusher 5 and then block 14 with respect to shielded disc 49 to allow pusher 5 to perform its stroke thus causing sliding of piston 15 into the cartridge 4 to the end position shown in fig.10b" in which the radiopharmaceutical has been expelled from cartridge 4, in this case through adapter 30 connected to the infusion line.

[0050] Fig.11 shows the device in the final configuration, in which the pusher 5 has been removed, the upper safety cap 61 has been reapplied and the lower section 10 has been rotated again in position P4 with respect to the central section 9 in order both to move back sectors 16, 16' of block 14 and completely free the lower opening 7 of shield 3, from which the cartridge 4 can be removed without the need to remove the adapter 30 which can remain with the needle 31 safely inserted into the cartridge.

[0051] It should be noted that at the top, the upper section 11 is always represented in the closed condition with the reference arrow in a position corresponding to the closed padlock symbol on the outer surface of the central section, and that at the end of use, to reinsert the upper cap 61 , the upper section with the arrow must be positioned in correspondence with the open padlock symbol and rotated.

[0052] Fig.s 12a, 12b illustrate a device in which on the external surface of body 1 there is an area 25 for the application of graduated indications 29 associated with the position assumed by the pusher during the infusion phase and with the corresponding infused dose of radiopharmaceutical, and possibly of a QR code associated with the use of the device and / or the patient receiving the infusion. Advantageously, the position of the pusher is indicated by the position of the lower end of the pusher rods 24 positioned at areas 25 and of the graduated indications 29, so as to indicate the different stroke performed by the pusher and to allow the healthcare professional to perform a partial dose injection.

[0053] The QR code, printed on the label, will allow communication with an automatic injector system, defining the customized volume to be dispensed. The plunger inlet has been designed to limit operator exposure.

[0054] Figure 13 shows an adapter that is particularly advantageous for connection to an infusion line 6 when cartridge 4 has a perforate septum 43 closing nozzle 12.

[0055] The adapter 30 is in fact equipped with a needle 31 with side holes 32 that prevent needle clogging due to the perforation of the septum 35 and with an anti-slip collar 33 that prevents the needle from detaching with the consequent leakage of radioactive liquid and exposure risks for operators and patients. In addition, the 30 adapter is equipped with a standard "luer-lock" type output that makes the device usable with most infusion systems. The present invention has been described according to preferred forms of implementation, but equivalent variants can be conceived without leaving the scope of protection granted.

Claims

CLAIMS1. Shielded device for the transport and administration of liquid radiopharmaceuticals, comprising a container (1 ) provided with a seat (2) to house a main shielding (3) configured to house in turn a cartridge (4) of the type provided with a body (10) for containing a quantity of radiopharmaceuticals and releasing this quantity of radiopharmaceuticals from an opening (12) by the action of a sliding piston (15), said main shielding (3) being provided with a first open end (7) to allow the connection of the opening (12) to an infusion line (6) of the radiopharmaceuticals exiting the cartridge (4) and a second open end (8) to allow the connection of the piston (15) of the cartridge (4) with a pusher (5), characterized in that the device comprises a first movable shielding wall (13) disposed at said first open end (7) of the main shielding (3) and configured to be able to pass between a completely closed position (P1 ) in which access to the opening (7) is prevented, and at least one position (P2) of opening in which access to the end (7) of the shielding (3) is enabled, wherein said container (1) is composed of at least a first and a second section (9, 10) mutually movable and connected to the movable wall (13) to make it pass reversibly between said closing position (P1 ) and said at least one opening position (P2) to allow the cartridge (4) to be connected to the line (6).

2. Device according to Claim 1 , wherein said first and second sections (9, 10) are manoeuvrable to make said first movable shielded wall (13) pass from said line connection position (P2) to a blocking position (P3) of the connected line, in order to allow the safe infusion of the radiopharmaceuticals.

3. Device according to any of the preceding claims wherein said first and second sections (9, 10) are manoeuvrable to make said first movable shielded wall (13) pass into a fully open position (P4) for the extraction of the empty cartridge (4) from the shielding (3).

4. Device according to any of the preceding claims, wherein said first movable shielding wall (13) is formed by a plurality of sectors (16, 16’) constrained by sliding pins (17, 17’) to one or more cam profiles (18, 18’) with variable radial distance from a convergence centre, in response to the reciprocal position of the first and second sections.

5. Device according to any of the preceding claims, comprising a second movable shielded wall (14) arranged at said second open end (8) of the shielding (3) and configured to be able to pass between a position in which access of the pusher (5) to the second opening (8) is blocked and a position in which the pusher (5) is allowed access to the piston (15) of the cartridge (4).

6. Device according to any of the preceding claims, wherein said second movable shielding wall (14) comprises a block (14) made of shielding material crossed by at least one slot (46) for the passage of the pusher (5) in a rotatably movable manner with respect to a shielding disc (49) provided in turn with at least one slot (47) so that said slots of the block (14) and said slots of the disc (49) are aligned only at the position in which the pusher (5) is allowed access to the piston (15) of the cartridge (4).

7. Device according to any of the preceding claims, comprising removable safety caps (60, 61 ) to close access to said first and second ends of the shielding.

8. Device according to any of the preceding claims, wherein said pusher (5) comprises at least one push rod (67) passing through said slots of the block (14) and of the disc (49) and intended to press on the piston (15) of the cartridge.

9. Device according to any of the preceding claims, wherein said pusher (5) comprises a pair of arms (24) which can slide on demand during the infusion stroke of the pusher in order to indicate the amount of infused liquid.

10. Device according to Claim 9 wherein on the external surface of the body(1 ) an area (25) is provided for the application of graduated indications (29) associated with the position assumed by the arms (24) of the pusher (5).

11. Assembly for the transport and administration of liquid radiopharmaceuticals, comprising a device according to any of the preceding claims, and at least one adapter (30) for connecting the device to an infusion line (6) provided with a needle (31 ) with side holes (32) and anti-slip collar (33) insertable in a pierceable septum (35) of the cartridge (4) and a luer lock for connection to the infusion line (6).

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