Radioisotope elution system with modular units

Abstract

The present invention relates to a radioisotope elution apparatus comprising a fluid transport line (30) in which a solution delivered from a solution vessel (60) by a pump (40) is transported. The apparatus comprises multiple units (A-D) including an elution column (20) having an inlet (22) and an outlet (24). The inlet is connected to a feed line (32) of the fluid transport line (30) to receive the solution, and the outlet is connected to a collection line (38) to transport the solution and the radioisotope. The multiple units are connected in series or in parallel such that the fluid transport line (30) and the corresponding inlet and outlet (22, 24) can be separated.

Description

Technical Field

[0001] The present invention relates to a radioisotope elution system commonly used in nuclear medicine practice, wherein a generator having a particular chromatographic column structure is dissolved by an elution fluid through an elution system including a radioisotope generator. Background Technology

[0002] Radioactive elution systems enable the safe elution, storage, and transport of radioactive materials and radiopharmaceuticals. During elution, radioactive materials are extracted with a solvent via an adsorbent, thus yielding specific radioactive isotopes. These isotopes are commonly used in medical diagnostic and therapeutic practices. An external container, constituting a secondary package for the elution system, is specifically designed to enable the efficient and safe elution of radioactive materials.

[0003] Various systems can be used for the preparation, preservation, transport, distribution, and use of radiopharmaceuticals. One such system is a radioisotope generator (1), such as... Figure 1 The elution column, including an input connector (e.g., an injection needle) and an output connector (e.g., an output needle) in fluid communication with the elution column, can be mentioned as examples of these systems. In standard procedure, a technician transfers a vial with eluent capacity (e.g., a vial containing saline) to the input connector while simultaneously adding an empty elution vial with a partial vacuum to the output connector. The vacuum in the empty elution vial allows the eluent (e.g., saline) to pass through the elution column and fill the elution vial. The saline elutes the radioactive isotope as it flows through the column and fills the elution vial as a radioactive isotope-rich saline solution. The elution vials are typically stored in dedicated radiation-shielded cases; these cases are sometimes referred to as pharmacy shielding or elution shielding.

[0004] Patent document WO2013169314 discloses an elution tool for a radiopharmaceutical elution system. The tool has a vial chamber sized and shaped to receive an elution vial. When the vial is received in the vial chamber, the access opening aligns with the septum of the vial. The elution tool cap is hinged to the elution tool body. Summary of the Invention

[0005] The purpose of this invention is to provide a modular supply system that can be integrated with a radioactive isotope elution system according to usage requirements.

[0006] To achieve the aforementioned objective, the present invention relates to a radioisotope elution apparatus comprising a fluid transport line in which a pressurized solution is delivered from a solution vessel. The elution apparatus includes multiple units, each comprising an elution column having an inlet and an outlet. The inlet is connected to a feed line of the fluid transport line for solution input, and the outlet is connected to a collection line for delivery of the solution and the radioisotope. The multiple units are connected in series or parallel, allowing the fluid transport line and the corresponding inlet and outlet to be separated. In this manner, a modular radioisotope generator structure is obtained, and the continuity of the elution process is possible even if a unit with reduced efficiency is removed from its location. Due to the modular structure, the generator's operating time is increased, and simultaneously, hospital inventory management is facilitated. Even in the event of a failure, units can be easily bypassed, thus enabling continuous operation of mission-critical generator systems.

[0007] A preferred embodiment of the invention includes a flow control valve connected to a controller for signal transmission and adapted to the column inlet on the feed line to regulate the flow rate of the solution. The flow control valve allows the operator to adjust the flow rate of the solution in a desired manner. For example, when column inefficiency is detected, the flow can be simply cut off by reducing the flow rate setting, bypassing the corresponding unit.

[0008] A preferred embodiment of the invention includes a buffer reservoir connected on one side to the feed line to accumulate the solution and on the other side to transfer the solution to the inlet of a flow control valve. By preventing irregularities in the flow, the buffer enables the formation of a laminar solution flow into the column.

[0009] A preferred embodiment of the invention includes a check valve that connects the column outlet to the collection line to prevent the return of solutions containing radioactive isotopes to the column. The check valve ensures that the fluid transfer line proceeds in a single direction from the column inlet to the column outlet. In this way, in the event of any pump failure, it is not necessary to completely shut down the system. Furthermore, in the event that unit shutdown is required, the collection line prevents fluid from leaking out of the system when the column is removed from its location.

[0010] A preferred embodiment of the invention includes a radioactive isotope material that is accessed in a manner that provides fluid communication between the inlet and outlet of the column. The material is removed from the column after extraction for a radioactive isotope generator within the column.

[0011] In a preferred embodiment of the invention, the inlet and outlet of each of these units are independently connected in parallel to the feed line and collection line, respectively, in a manner that provides fluid communication. This parallel connection allows the generator to operate using the other active units even if one of these units is deactivated for any reason. In this way, continuous operation of the system is guaranteed, even if any module of the generator performing a critical task in a hospital fails or becomes less efficient. In an alternative embodiment, the columns can also be connected in series by filling columns with low activity.

[0012] A preferred embodiment of the invention includes a non-transparent shield, a column assembled inside the non-transparent shield, and the non-transparent shield includes a solution tank and an elution tank, which provide fluid transfer to an inlet and an outlet, respectively, in a manner interconnected with a fluid transport line. The unit structure operates by directly connecting the column or shield to the fluid transport system and disconnecting it from the fluid transport system.

[0013] In a preferred embodiment of the invention, the shielding element is made of tungsten. Because the structure formed by tungsten is more compact than that formed by similar shielding elements, it is possible to construct a modular and lightweight generator device in which adjacent units are combined. In another embodiment, the shielding element may be made of lead.

[0014] A preferred embodiment of the invention includes a housing in which the units are arranged adjacently in a basket-like portion, and the housing carries fluid delivery lines. The housing allows the generator structure to form a synthesizer in which the units are combined together through connection to the fluid lines. Due to this structure, the units can be easily stored and, for example, transferred within a hospital as a single, integrated component.

[0015] A preferred embodiment of the invention includes slots arranged in an orderly manner within the basket-like portion, with corresponding units fitting removably into each of these slots. These slots allow the installed units to remain stationary in their position.

[0016] A preferred embodiment of the invention includes a pump connected via an outlet to a feed line and via an inlet to a solution vessel, and the pump is arranged to deliver the solution to the feed line by pressurizing the solution. The pump is preferably a peristaltic pump, by which precise extraction can be performed.

[0017] To achieve the stated objective, the present invention includes the following process steps: connecting units in series or in parallel in a manner that provides fluid communication; feeding a solution obtained from a solution vessel into a fluid transport line via a pump; transporting the solution fed from the fluid transport line into a column via the column inlet to achieve elution; and introducing pressurized elution fluid from the column outlet into a collection line.

[0018] A preferred embodiment includes the following process steps: the controller closes the control valve connected to the unit selected for removal, and removes the selected unit from the fluid transfer line. Attached Figure Description

[0019] Figure 1 This is a perspective view of a representative embodiment of a radioisotope generator according to the prior art.

[0020] Figure 2 This is a rear perspective view of a representative embodiment of the radioisotope elution apparatus according to the present invention.

[0021] Figure 3 This is an operation flowchart of the radioisotope elution apparatus according to the present invention. Detailed Implementation

[0022] In this specific description, the structure of the invention and its preferred embodiments are described only for the purpose of better understanding the subject matter, without any limiting effect.

[0023] Figure 2A perspective view of an elution system with a modular structure according to the invention is provided. Here, a basket-shaped part (12) is formed in a stepped manner in the rear of a housing (10) having an outer shell structure. Cylindrical tanks (14) are opened in an orderly and equidistant manner on the flat upper wall of the basket-shaped part (12). Corresponding units (A, B, C, D) are arranged vertically in each tank (14), and their vertical movement is restricted by the bottom of a shield (50). The shield (50) is made of tungsten and houses a column (20) having a chromatographic structure. A radioactive isotope, such as Ga68, is present inside the column (20) as the elution material. A feed line (32) in the form of a tubular tube partially forms a fluid transport line (30) inside the housing (10), which is connected via its free end to a corresponding solution tank (52) on the shield (50) in a manner that provides fluid communication. On the other hand, a tubular collection line (38) forms the opposite portion of the fluid transfer line (30), which is connected via its free end to a corresponding elution tank (54) on the shield (50) in a manner that provides fluid communication. An HCl solution supplied from the feed line (32) through the inlet (22) of the column (20) and via the solution tank (52) permeates the eluent material inside the column (20), and is transferred to the collection line (38) via the outlet (24) of the column and via the elution tank (54). The extracted product is then transported from the collection line (38) to a reactor vessel (not shown).

[0024] Figure 3 Provided Figure 2A representative flow chart of the elution system is shown. Here, a peristaltic pump (40) is connected via a pipe to the inlet of the feed line (32) through its outlet, and via its inlet to the outlet of the solution vessel (60) containing the HCl solution. In this way, the peristaltic pump (40) draws the solution from the solution vessel (60) under vacuum and delivers the solution to the feed line (32) under pressure. A corresponding buffer reservoir (33) for each unit (AD) is connected to the feed line (32) in parallel. The volume of each buffer reservoir (33) is selected to be 4 ml. A flow control valve (34) is positioned at the outlet of the buffer reservoir (33). The flow control valve (34) is connected to a controller (31) adapted on the housing (10) by transmitting an electrical signal, and the flow rate of the valve is controlled by the controller. In this manner, the amount of solution to be supplied from the buffer reservoir (33) connected to the feed line (32) to the inlet (22) of the column (20) can be regulated via the flow control valve (34), and it is even possible to completely stop the feed solution to the inlet (22). The column (20) has a chromatographic structure widely used in radioisotope generators and is covered by a tungsten shield (50). Fluid containing the eluent material carried by the solution is supplied from the outlet (24) at the lower part of the elongated cylindrical body (26) of the column (20) through the check valve (35) and introduced into the collection line (38). The connection of each unit (AD) to the fluid transfer line (30) is as described above, and each unit includes a column (20) comprising a body (26) having an inlet (22) and an outlet (24) fluidly connected to the shield (50), and a radioisotope is carried for use in the column. The solution tank (52) and elution tank (54) of the shield (50) are connected to the corresponding inlet (22) and outlet (24) of the column (20) via intermediate pipes, respectively. Therefore, the solution tank (52) and elution tank (54) are connected to the fluid transfer line (30) via a flow control valve (34) and a check valve (35), respectively, to form a closed flow loop. A controller (31) is connected to a sensor (not shown) to control the operating pressure and status of the pump (40), the operating flow rate and status of the flow control valve (34), and the status of the check valve (35). In this case, the controller can detect a decrease in efficiency, for example, in any of the units (AD), and accordingly warn the operator. Based on this, if it is necessary to immediately bypass the unit (AD) in the closed loop, the controller closes the corresponding flow control valve (34), and thus allows the unit (AD) to be removed from the system. The check valve (35) prevents the solution containing the elution material from flowing back into the unit (AD), thereby ensuring the safety of the system.In this way, by using quick-connect components, for example, the unit (AD) can be removed from its tank (14) in the housing (10) by simply removing the connection of the corresponding feed line (32) and collection line (38) of the solution tank (52) and elution tank (54) on the shield (50).

[0025] Figure Labels 1. Radioactive isotope generator 10. Shell 12 basket-shaped pieces 14 slots 20 bars 22 Entrances 24 Exports 26 main body 30 Fluid transmission lines 31 Controller 32 Feed line 33 Buffer Storage 34 Flow control valve 35 Check valve 38 Collection pipeline 40 pumps 50 shielding components 52 Solution tank 54 Washing and Extraction Tank 60 Solution containers AD Unit

Claims

1. A radioisotope elution apparatus, the radioisotope elution apparatus comprising a fluid transport line (30) in which a pressurized solution is transported from a solution vessel (60), characterized in that, The radioisotope elution apparatus includes multiple units (ADs), each unit including an elution column (20) having an inlet (22) and an outlet (24). The inlet is connected to the feed line (32) of the fluid transport line (30) to input the solution, and the outlet is connected to a collection line (38) to transport the solution and the radioisotope. The multiple units are connected in series or in parallel so that the fluid transport line (30) and the corresponding inlet and outlet (22, 24) can be separated.

2. The radioactive isotope elution apparatus according to claim 1, characterized in that, The radioisotope elution apparatus includes a flow control valve (34) connected to a controller (31) for signal transmission and adapted to the inlet (22) of the column (20) via its own inlet on the feed line (32) to regulate the flow rate of the solution.

3. The radioactive isotope elution apparatus according to claim 2, characterized in that, The radioisotope elution apparatus includes a buffer reservoir (33) which is connected to the feed line (32) on one hand to accumulate the solution and on the other hand to transfer the solution to the inlet of the flow control valve (34).

4. The radioactive isotope elution apparatus according to any one of the preceding claims, characterized in that, The radioisotope elution apparatus includes a check valve (35) that connects the outlet (24) of the column (20) to the collection line (38) to prevent the radioisotope-containing solution from returning to the column (20).

5. The radioisotope elution apparatus according to any one of the preceding claims, characterized in that, The radioisotope elution apparatus includes a radioisotope material that is touched in a manner that provides fluid communication between the inlet (22) and the outlet (24) of the column (20).

6. The radioisotope elution apparatus according to any one of the preceding claims, characterized in that, The inlet (22) and outlet (24) of each unit in the unit (AD) are independently connected in parallel to the feed line (32) and the collection line (38) respectively in a manner that provides fluid communication.

7. The radioisotope elution apparatus according to any one of the preceding claims, characterized in that, The radioisotope elution apparatus includes a non-transmissive shield (50), the column (20) is assembled inside the non-transmissive shield, and the non-transmissive shield includes a solution tank (52) and an elution tank (54), the solution tank and the elution tank respectively providing fluid transfer to the inlet (22) and the outlet (24) in a manner interconnected with the fluid transfer line (30).

8. The radioactive isotope elution apparatus according to claim 7, characterized in that, The shielding element (50) is made of tungsten.

9. The radioactive isotope elution apparatus according to any one of the preceding claims, characterized in that, The radioisotope elution apparatus includes a housing (10) in which the units (AD) are arranged adjacent to each other in a basket-shaped portion (12), and the housing carries the fluid transport line (30).

10. The radioactive isotope elution apparatus according to claim 9, characterized in that, The radioisotope elution apparatus includes tanks (14) arranged in an orderly manner in the basket-like (12) portion, and corresponding units (ADs) fitting in each of the tanks in a removable manner.

11. The radioisotope elution apparatus according to any one of the preceding claims, characterized in that, The radioisotope elution apparatus includes a pump (40) connected via an outlet to the feed line (32) and via an inlet to the solution vessel (60), and the pump is arranged to deliver the solution to the feed line (32) by pressurizing the solution.

12. A elution method for a radioactive isotope elution apparatus according to any one of the preceding claims, characterized in that, The method includes the following process steps: connecting the units (AD) in series or in parallel in a manner that provides fluid communication; feeding a pressurized solution obtained from a solution vessel (60) into a fluid transfer line (30); conveying the solution fed from the fluid transfer line (30) to the column (20) via the inlet (22) of the column (20) for elution; and introducing pressurized elution fluid at the outlet (24) of the column (20) into a collection line (38).

13. The elution method according to claim 12, characterized in that, The method includes the following process steps: the controller (31) closes the flow control valve (34) connected to the selected unit (AD) to be removed, and removes the selected unit (AD) from the fluid transfer line (30).

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