Radioisotope elution system having modular cells

Abstract

The invention relates to a radioisotope elution apparatus, which comprises a fluid transmission line (30) where a solution delivered from a solution vessel (60) by means of a pump (40) is conveyed. The apparatus comprises multiple cells (A-D), which comprise an elution column (20) with an inlet (22) connected to a feeding line (32) of the fluid transmission line (30) in a way to enable the input of the solution and an outlet (24) connected to a collection line (38) in a way to convey the solution and the radioactive isotope and which are connected in series or parallel in a way that the fluid transmission line (30) and the corresponding inlet and outlet (22, 24) may be separated.

Description

[0001] DESCRIPTION

[0002] RADIOISOTOPE ELUTION SYSTEM HAVING MODULAR CELLS

[0003] TECHNICAL FIELD

[0004] The present invention relates to a radioisotope elution system generally used in the practices of nuclear medicine, wherein a generator particularly with the structure of a chromatographic column is dissolved with an elution fluid by means of an elution system comprising a radioisotope generator.

[0005] STATE OF THE ART

[0006] 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.

[0007] A variety of systems are available to prepare, preserve, transport, dispense, and use the radiopharmaceuticals. A radioisotope generator (1 ), which is shown in Figure 1 and 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.

[0008] 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.

[0009] OBJECT OF THE INVENTION

[0010] An object of the invention is to provide a modular supply system in accordance with the need of use along with a radioisotope elution system.

[0011] In order to achieve said object, the invention relates to a radioisotope elution apparatus, which comprises a fluid transmission line where a pressurized solution is conveyed from a solution vessel. The elution apparatus comprises multiple cells, which comprise an elution column with an inlet connected to a feeding line of the fluid transmission line in a way to enable the input of the solution and an outlet connected to a collection line in a way to convey the solution and the radioactive isotope and which are connected in series or parallel in a way that the fluid transmission line and the corresponding inlet and outlet may be separated. In this way, a modular radioisotope generator structure is obtained and the continuity of the elution process becomes possible even in case a cell with decreased efficiency is removed from its location. Owing to a modular structure, the operation time of the generator is increased and at the same time, the stock management of the hospitals is facilitated. Even in the case of a malfunction, it is possible to easily bypass a cell and thus enable the continuous operation of the generator system with a critical mission.

[0012] A preferred embodiment of the invention comprises a flow controlled valve, which is connected with a controller in a way to enable the signal transmission and is adapted to the column inlet on the feeding line in a way to allow the flow rate adjustment of the solution. By means of the flow controlled valve, the flow rate of the solution may be adjusted by the operator in the manner desired. For example, when inefficiency is detected in the column, the flow may be shut down simply by reducing the flow rate setting and it becomes possible to bypass the respective cell.

[0013] A preferred embodiment of the invention comprises a buffer reservoir, which on the one hand is connected to the feeding line in a way to accumulate the solution and which on the other hand transfers the solution to the inlet of the flow controlled valve. The buffer, by preventing the irregularities in the flow, enables the development of a laminar solution flow into the column. A preferred embodiment of the invention comprises a check valve, which connects the column outlet with the collection line in such a way that the return of the radioactive isotope-containing solution to the column is prevented. The check valve ensures that the fluid transmission line advances in a single direction from the column inlet to the column outlet. In this way, there is no need to entirely deactivate the system in case of any pump malfunction. Moreover, in cases where it is necessary to deactivate a cell, the collection line is prevented from leaking out a fluid from the system when the column is removed from its location.

[0014] A preferred embodiment of the invention comprises the radioisotope material accessed in a way to provide the fluid communication between the inlet and outlet of the column. This material is taken out of the column upon the radioisotope generator being extracted in the column.

[0015] In a preferred embodiment of the invention, the inlet and the outlet of each of the cells are, independently of one another, connected in parallel respectively to the feeding line and the collection line in a way to provide the fluid communication. The parallel connection allows the generator to perform its operation with the other active cells, in case one of the cells is deactivated for any reason. In this manner, the way for the continuous operation of the system is cleared even in case any module of the generator performing critical mission in the hospitals becomes damaged or has decreased efficiency. In an alternative embodiment, it is also possible to connect the columns in series by charging the same with low activity.

[0016] A preferred embodiment of the invention comprises a radio-opaque shield, inside which the column fits and which includes a solution slot and an elution slot providing the fluid transfer respectively to the inlet and the outlet in the manner of an interconnection to the fluid transmission line. The cell structure operates by way of the column or the shield directly being connected to and disconnected from the fluid transmission system.

[0017] In a preferred embodiment of the invention, the shield is manufactured from tungsten. Since tungsten forms a structure that is more compact than those formed by the similar shields, it allows the building of a modular and light-weight generator apparatus where adjacent cells are combined. In an alternative embodiment, the shield may be manufactured from lead.

[0018] A preferred embodiment of the invention comprises a housing, in which the cells are adjacently disposed in a basket portion and which carries thereon the fluid transmission line. The housing allows the generator structure, where the cells are combined through connection with the fluid line, to form a kind of a synthesis machine. Owing to this structure, the cells may be easily stored and may, for instance, be transferred as a one-piece component within a hospital.

[0019] A preferred embodiment of the invention comprises the slots, which are arranged in an ordered manner in the basket portion and in each of which the respective cell fits in a removable manner. The slots enable the mounted cells to remain stationary at their location.

[0020] A preferred embodiment of the invention comprises a pump, which is coupled via an outlet to the feeding line and via an inlet to the solution vessel and which is arranged to convey the solution to the feeding line by pressurizing the same. The pump is preferably a peristaltic pump, by means of which a precise extraction may be performed.

[0021] In order to achieve said object, the invention comprises the process steps of connecting the cells in series or parallel in a way to provide the fluid communication; feeding the solution obtained from the solution vessel to the fluid transmission line via the pump; conveying the solution fed from the fluid transmission line to the column via an inlet thereof to enable the elution; and introducing the pressurized elution fluid at the column outlet to the collection line.

[0022] A preferred embodiment comprises the process steps of a controller closing a control valve connected to a cell that is selected to be removed and the selected cell being removed from the fluid transmission line.

[0023] BRIEF DESCRIPTION OF THE FIGURES

[0024] Figure 1 is a perspective view of a representative embodiment of a radioisotope generator according to the state of the art.

[0025] Figure 2 is a rear perspective view of a representative embodiment of a radioisotope elution apparatus according to the invention.

[0026] Figure 3 is an operation flowchart of the radioisotope elution apparatus according to the invention. 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 2 provides a perspective view of an elution system with modular structure according to the invention. Here, a basket (12) portion is formed in a stepped manner in the rear part of a housing (10) with the structure of a case. The cylindrical slots (14) are opened in an ordered and equidistant manner on the planar upper wall on the basket (12). A respective cell (A, B, C, D) is seated in each slot (14) in a perpendicular manner and with movement limited in the vertical direction from the bottom of a shield (50). The shield (50) is manufactured from tungsten and it houses a column (20) with chromatographic structure. A radioisotope, e.g., Ga68, is present as the elution material inside the column (20). A feeding line (32) with a tubular form, which partially forms a fluid transmission line (30) inside the housing (10), is coupled via a free end thereof to a respective solution slot (52) on the shield (50) in a way providing the fluid communication. On the other hand, a collection line (38) with a tubular form, which forms the opposite part of the fluid transmission line (30), is coupled via a free end thereof to a respective elution slot (54) on the shield (50) in a way providing the fluid communication. HCI solution, which is supplied from the feeding line (32) to the column (20) via the inlet (22) thereof and via the solution slot (52), penetrates the elution material inside the column (20) and transfers the same to the collection line (38) via the outlet (24) thereof and via the elution slot (54). The extracted product is conveyed from the collection line (38) to a reactor vessel (not shown).

[0029] Figure 3 provides a representative flowchart of the elution system shown in Figure 2. Here, a peristaltic pump (40) is, by means of pipes, connected via an outlet thereof to the inlet of the feeding line (32) and via an inlet thereof to the outlet of the solution vessel (60) containing the HCI solution. In this way, the peristaltic pump (40) draws the solution from the solution vessel (60) by means of vacuum and delivers the same in a pressurized state to the feeding line (32). A respective buffer reservoir (33) for each cell (A-D) is connected to the feeding line (32) by the parallel connection. The volume of each buffer reservoir (33) is selected as 4 ml. A flow controlled valve (34) is positioned at the outlet of the buffer reservoir (33). The flow controlled valve (34) is connected, in a way to transmit the electric signals, with a controller (31 ), which is adapted on the housing (10), and the flow rate of said valve is controlled by said controller. In this way, it is possible, via the flow controlled valve (34), to adjust the quantity of the solution to be supplied to the inlet (22) of the column (20) from the buffer reservoir (33) connected with the feeding line (32) and to even entirely stop the feeding of the solution to the inlet (22). The column (20) has a chromatographic structure widely used in the radioisotope generators and is covered by the tungsten shield (50). The fluid, which is supplied from the outlet (24) in the lower part of the elongated cylindrical body (26) of the column (20) and which includes the elution material carried by the solution, passes through a check valve (35) and is introduced to the collection line (38). The connection of each cell (A-D) with the fluid transmission line (30) is as described above and each cell comprises a column (20), which includes a body (26) having an inlet and outlet (22, 24) connected in fluid communication with a shield (50) and for which the radioisotope is carried. The solution slot (52) and elution slot (54) of the shield (50) are respectively connected via intermediate pipe connections to the corresponding inlet and outlet (22, 24) of the column (20). As a result, the solution slot (52) and elution slot (52) are incorporated, via the connections of the flow controlled valve (34) and the check valve (35) respectively, in the fluid transmission line (30) in a way to form a closed flow circuit. The controller (31 ) is coupled with the sensors (not shown) in a way to control the operating pressure and the status of the pump (40), the operating flow rate and the status of the flow controlled valves (34), and the status of the check valve (35). In this case, when, for example, a drop occurs in the efficiency of any one of the cells (A-D), the controller may detect this condition and accordingly warn the operator. Based on this, in the cases where it is necessary to immediately bypass the cell (A-D) in the closed circuit, the controller closes the respective flow controlled valve (34) and thus enables the cell (A-D) to be taken out of the system. The check valve (35) prevents the movement of the solution containing the elution material back into the cell (A-D) and thereby ensures the safety of the system. In this way, by the use of the quick coupling members, for instance, it is possible to remove the cell (A-D) from its slot (14) in the housing (10) by simply removing the respective feeding line (32) and collection line (38) connections of the solution slot (52) and the elution slot (54) on the shield (50).

[0030] REFERENCE NUMERALS

[0031] 1 Radioisotope generator 33 Buffer reservoir

[0032] 10 Housing 34 Flow controlled valve

[0033] 12 Basket 35 Check valve

[0034] 14 Slot 38 Collection line

[0035] 20 Column 40 Pump

[0036] 22 Inlet 50 Shield Outlet 52 Solution slot Body 54 Elution slot Fluid transmission line 60 Solution vessel Controller A-D Cell Feeding line

Claims

CLAIMS1 . A radioisotope elution apparatus, which comprises a fluid transmission line (30) where a pressurized solution is conveyed from a solution vessel (60), characterized in that the radioisotope elution apparatus comprises multiple cells (A-D), which comprise an elution column (20) with an inlet (22) connected to a feeding line (32) of the fluid transmission line (30) in a way to enable the input of the solution and an outlet (24) connected to a collection line (38) in a way to convey the solution and the radioactive isotope and which are connected in series or parallel in a way that the fluid transmission line (30) and the corresponding inlet and outlet (22, 24) may be separated.

2. A radioisotope elution apparatus according to Claim 1 characterized in that the radioisotope elution apparatus comprises a flow controlled valve (34), which is connected with a controller (31 ) in a way to enable the signal transmission and is adapted with its own inlet to the inlet (22) of the column (20) on the feeding line (32) in a way to allow the flow rate adjustment of the solution.

3. A radioisotope elution apparatus according to Claim 2 characterized in that the radioisotope elution apparatus comprises a buffer reservoir (33), which on the one hand is connected to the feeding line (32) in a way to accumulate the solution and which on the other hand transfers the solution to the inlet of the flow controlled valve (34).

4. A radioisotope elution apparatus according to any one of the preceding claims characterized in that the radioisotope elution apparatus comprises a check valve (35), which connects the outlet (24) of the column (20) with the collection line (38) in such a way that the return of the radioactive isotope-containing solution to the column (20) is prevented.

5. A radioisotope elution apparatus according to any one of the preceding claims characterized in that the radioisotope elution apparatus comprises the radioisotope material accessed in a way to provide the fluid communication between the inlet and outlet (22, 24) of the column (20).

6. A radioisotope elution apparatus according to any one of the preceding claims characterized in that the inlet (22) and the outlet (24) of each of the cells (A-D) are, independently of one another, connected in parallel respectively to the feeding line (32) and the collection line (38) in a way to provide the fluid communication.

7. A radioisotope elution apparatus according to any one of the preceding claims characterized in that the radioisotope elution apparatus comprises a radio-opaqueshield (50), inside which the column (20) fits and which includes a solution slot (52) and an elution slot (54) providing the fluid transfer respectively to the inlet and the outlet (22, 24) in the manner of an interconnection to the fluid transmission line (30).

8. A radioisotope elution apparatus according to Claim 7 characterized in that the shield (50) is manufactured from tungsten.

9. A radioisotope elution apparatus according to any one of the preceding claims characterized in that the radioisotope elution apparatus comprises a housing (10), in which the cells (A-D) are adjacently disposed in a basket (12) portion and which carries thereon the fluid transmission line (30).

10. A radioisotope elution apparatus according to Claim 9 characterized in that the radioisotope elution apparatus comprises the slots (14), which are arranged in an ordered manner in the basket (12) portion and in each of which the respective cell (A- D) fits in a removable manner.1 1 . A radioisotope elution apparatus according to any one of the preceding claims characterized in that the radioisotope elution apparatus comprises a pump (40), which is coupled via an outlet to the feeding line (32) and via an inlet to the solution vessel (60) and which is arranged to convey the solution to the feeding line (32) by pressurizing the same.

12. An elution method for a radioisotope elution apparatus according to any one of the preceding claims characterized in that the method comprises the process steps of connecting the cells (A-D) in series or parallel in a way to provide the fluid communication; feeding the pressurized solution obtained from the solution vessel (60) to the fluid transmission line (30); conveying the solution fed from the fluid transmission line (30) to the column (20) via an inlet (22) thereof to enable the elution; and introducing the pressurized elution fluid at the outlet (24) of the column (20) to the collection line (38).

13. An elution method according to Claim 12 characterized in that the method comprises the process steps of a controller (31 ) closing a flow controlled valve (34) connected to a cell (A-D) that is selected to be removed and the selected cell (A-D) being removed from the fluid transmission line (30).

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