JP2009165597A - Ri compound synthesizing apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an RI compound synthesizing apparatus that shortens the transfer time of an RI compound from the reactor vessel to the storage container. <P>SOLUTION: An FDG (fluorodeoxyglucose) synthesizing vessel 1 that obtains<SP>18</SP>F-FDG through synthesizing reaction in a reactor vessel 7 is provided with a vial 13 that stores<SP>18</SP>F-FDG before its divided injection, a transfer tube 15 for the airtight connection of the reactor vessel 7 with the vial 13, a pressure transportation means 25 to pressure transport<SP>18</SP>F-FDG from the reactor vessel 7 to the vial 13, and a pressure reduction means 37 to reduce the pressure of the vial 13 by sucking its gases through a suction tube 29 connected with the vial 13. Because pressure within the vial 13 is reduced by the pressure reduction means 37 in this FDG synthesizing apparatus 1, the pressure transportation efficiency of<SP>18</SP>F-FDG by the pressure transportation means 25 can improve and the transfer time for<SP>18</SP>F-FDG in a certain amount to be transferred from the reactor vessel 7 to the vial 13 can be shortened, as compared with the case when the vial 13 is released to open air and its interior is kept at an atmospheric pressure level. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to an RI compound synthesizing apparatus that obtains a radiochemical isotope labeled compound from a radioisotope.

For example, a radiopharmaceutical isotope-labeled compound (RI compound) used for PET (positron tomography examination) or the like is synthesized by an RI compound synthesizer. Patent Document 1 discloses a device that synthesizes and administers a radiopharmaceutical (RI compound) labeled with a radionuclide (a radioisotope). This device includes a drug synthesis unit (reactor) for synthesizing RI compounds and a drug administration unit (dispensing device), and the drug synthesis unit is connected to a vial (storage container) of the drug administration unit with a tube. ing. The RI compound synthesized in the drug synthesis unit is transferred to the vial through the tube. The RI compound in the vial is dispensed in a necessary amount at the drug administration part, and diluted with physiological saline or the like and administered to the patient.
JP 2005-230366 A

  Since the RI compound decays with time, it is desirable to shorten the time taken from synthesis of the RI compound to dispensing as much as possible in order to improve the quality of the RI compound. However, the RI compound is a very special drug that emits radiation, and a hot cell or the like that shields radiation may be required, and layout restrictions such as where to place the reactor and the storage container are large. Therefore, it is difficult to reduce the distance from the reactor to the storage container, and it has been difficult to shorten the time required for transfer from the reactor to the storage container.

  An object of the present invention is to solve the above problems, and an object of the present invention is to provide an RI compound synthesizer capable of shortening the transfer time of the RI compound from the reactor to the storage container.

  The present invention relates to an RI compound synthesizer for introducing a radiochemical isotope into a reactor to obtain a radiochemical isotope labeled compound, a storage container for storing the radiochemical isotope labeled compound before dispensing, a reactor and a storage A transfer pipe for airtightly connecting the container, a pumping means for pumping the radiochemical isotope-labeled compound from the reactor to the storage container via the transfer pipe, a suction pipe connected to the storage container, and a suction pipe And depressurizing means for sucking and depressurizing the gas in the storage container.

  According to the RI compound synthesizing apparatus according to the present invention, since the inside of the storage container is decompressed by the decompression means, the radiochemical liquid isotope labeled compound by the pumping means is compared with the case where the inside of the storage container is opened to the atmosphere and maintained at atmospheric pressure The pumping efficiency is improved, and the time for transferring a predetermined amount of the radiochemical isotope-labeled compound from the reactor to the storage container is shortened. Furthermore, as the transfer time is shortened, the amount of radioactivity decay associated with the transfer is reduced, and the radiochemical liquid isotope labeled compound stored in the storage container can be substantially increased. Furthermore, in addition to the pumping by the pumping means, the inside of the storage container is decompressed to improve the transfer efficiency, so the variation in the transfer time due to the length of the transfer pipe is reduced, and the optimal according to the layout while shortening the transfer time It becomes easy to select a transfer pipe having a length.

  Furthermore, it is preferable to further comprise control means for controlling the pressure feeding by the pressure feeding means and the pressure reducing by the pressure reducing means, and the control means preferably starts the pressure feeding by the pressure feeding means after starting the pressure reducing by the pressure reducing means. Since the inside of the storage container is depressurized before the start of pumping, the pumping can be started smoothly.In particular, since the inside of the storage container has been previously depressurized, the gas in the storage container flows back into the reactor, There is no risk of inconvenience.

  Furthermore, the tube diameter of the suction tube is preferably larger than the tube diameter of the transfer tube. The smaller the diameter of the transfer pipe, the smaller the amount of radiochemical isotope-labeled compound remaining in the transfer pipe. However, the smaller the diameter of the transfer pipe, the longer the transfer time. In the above configuration, by making the pipe diameter of the suction pipe larger than the pipe diameter of the transfer pipe, the inside of the storage container can be decompressed in a short time compared to the case where both pipe diameters are the same. improves. As a result, it is possible to effectively reduce the amount of radiochemical isotope-labeled compound remaining in the transfer pipe without causing a delay in transfer time.

  ADVANTAGE OF THE INVENTION According to this invention, the transfer time of the radioactive chemical liquid isotope labeled compound from a reactor to a storage container can be shortened.

  Hereinafter, preferred embodiments of an RI compound synthesis device according to the present invention will be described with reference to the drawings. FIG. 1 is a cross-sectional view showing an outline of a hot cell in which an FDG synthesizer according to an embodiment of the present invention is housed, and FIG. 2 is a cross-sectional view of a vial. In the description of the drawings, the same or corresponding elements are denoted by the same reference numerals, and redundant description is omitted.

As shown in FIG. 1, the FDG synthesizer (RI compound synthesizer) 1 is also a radiopharmaceutical isotope-labeled compound (also referred to as “radiopharmaceutical agent” or “RI compound”) used in, for example, a PET examination in a hospital or the like. ¹⁸ F-FDG (fluorodeoxyglucose) as a synthetic reaction. The FDG synthesizer 1 is accommodated in the hot cell 3 together with the dispensing device 2. The hot cell 3 has an appropriate thickness capable of shielding radiation using a radiation shielding material such as lead, iron, tungsten, and aluminum. In the dispensing device 2, ¹⁸ F-FDG synthesized by the FDG synthesizer 1 is dispensed by the action of a syringe, and is diluted with physiological saline or the like and then administered to a patient.

The FDG synthesizer 1 includes an apparatus main body 5. The apparatus body 5 includes a main tube 9 for introducing ¹⁸ F ⁻ as a radioisotope (RI) into the reactor 7, a reagent tube 11 for introducing various inorganic and organic reagents into the reactor 7, and a reaction. It is comprised by various components, such as a heater which should be arrange | positioned around the container 7. Furthermore, the FDG synthesizer 1 collects ¹⁸ F-FDG synthesized in the reactor 7 for dispensing by the dispensing device 2 and temporarily stores the vial (storage container) 13, the reactor 7, A transfer tube (transfer tube) 15 that hermetically connects the vial 13 is provided.

  The hot cell 3 is formed with an upper chamber 3a and a lower chamber 3b arranged in the vertical direction, and the upper chamber 3a and the lower chamber 3b are provided with doors that can be opened and closed independently. In the upper chamber 3a, the apparatus main body 5 of the FDG synthesis apparatus 1 is disposed. In the lower chamber 3b, a main space R1 and a sub space R2 defined by an inner wall 3d made of lead or the like are formed. A dispensing device 2 is disposed in the main space R1, and a vial is placed in the sub space R2. 13 is arranged. The vial 13 is placed on a load cell 17 installed for weight measurement, and a radiation sensor 19 is disposed around the vial 13.

  The reactor 7 of the apparatus main body 5 is kept airtight and is connected to a gas cylinder 21 arranged outside the hot cell 3 via a gas supply line 23. The gas cylinder 21 stores an inert gas such as Ar gas or He gas. The inside of the gas cylinder 21 is pressurized, and the inert gas is maintained at a predetermined positive pressure. The gas supply line 23 is provided with a normally closed two-way solenoid valve 24. When the two-way solenoid valve 24 is opened and the gas supply line 23 communicates, the inert gas in the gas cylinder 21 is introduced into the reactor 7 through the gas supply line 23. The gas cylinder 21 and the gas supply line 23 constitute a pressure feeding means 25.

The tube diameter d1 (see FIG. 2) of the transfer tube 15 is about 1 mm, and the upstream end of the transfer tube 15 is connected to the reactor 7 in an airtight manner. A column 27 is attached to the transfer tube 15, and the column 27 is filled with an ion exchange resin for removing ¹⁸ F-FDG impurities. At the downstream end of the transfer tube 15, a filter 15a (see FIG. 2) and a transfer injection needle 15b are attached. The transfer injection needle 15 b is inserted into the rubber stopper 13 a of the vial 13.

The vial 13 is held airtight by a rubber stopper 13a. The transfer tube 15 is airtightly connected to the vial 13 through a transfer injection needle 15a inserted into the rubber stopper 13a. A dispensing injection needle 27 a attached to the upstream end of the dispensing tube 27 is inserted into the rubber stopper 13 a. The dispensing tube 27 is connected to a syringe (not shown) of the dispensing apparatus 2, and a fixed amount of ¹⁸ F-FDG is sucked out of the vial 13 by the action of the syringe.

  Further, a suction injection needle 29 a attached to the upstream end of the suction tube (suction tube) 29 is inserted into the rubber stopper 13 a. The tube diameter d2 (see FIG. 2B) of the suction tube 29 is larger than the tube diameter d1 of the transfer tube 15 (see FIG. 2C). The suction tube 29 is provided with a filter 29b alongside the suction needle 29a. On the downstream side of the suction tube 29, one branch line 29c opened to the atmosphere and the other branch line 29d airtightly connected to a waste liquid tank 31 installed outside the hot cell 3 are provided. A three-way solenoid valve 33 is attached to the suction tube 29, and one of the branch lines 29 c and 29 d communicates by switching the three-way solenoid valve 33. A suction pump 35 is connected to the waste liquid tank 31 for maintaining the inside of the waste liquid tank 31 at a predetermined negative pressure. The waste liquid tank 31 and the suction pump 35 constitute a decompression means 37.

Further, the FDG synthesis device 1 includes a control device (control means) 39 connected to the two-way solenoid valve 24 and the three-way solenoid valve 33 by wire or wirelessly. The control device 39 controls the opening and closing of the inert gas by controlling the opening and closing of the two-way solenoid valve 24, and controls the timing of starting and stopping the pumping of ¹⁸ F-FDG from the reactor 7 to the vial 13. Control. Further, the FDG synthesizer 1 controls the switching of the three-way electromagnetic valve 33 to control the timing of the decompression start and decompression stop in the vial 13. The control device 39 includes a CPU, a RAM, a ROM, an input device, an output device, a communication module, and the like. Each function of the control device 39 reads predetermined software on hardware such as a CPU and a RAM to operate a communication module, an input device and an output device under the control of the CPU, and This is realized by reading and writing.

Next, a method for transferring ¹⁸ F-FDG from the reactor 7 to the vial 13 will be described. When a predetermined amount of ¹⁸ F-FDG is generated by the synthesis reaction in the reactor 7, the control device 39 of the FDG synthesizer 1 first sets the three-way electromagnetic so that the vial 13 and the waste liquid tank 31 communicate with each other. The valve 33 is switched. Since the waste liquid tank 31 is adjusted to a negative pressure by the suction pump 35, the gas in the vial 13 is sucked toward the waste liquid tank 31 and the inside of the vial 13 is decompressed by switching the three-way electromagnetic valve 33.

Next, the control device 39 opens the two-way electromagnetic valve 24 and sends an inert gas into the reactor 7. When the inside of the reactor 7 is pressurized, ¹⁸ F-FDG in the reactor 7 is pushed out to pass through the transfer tube 15 and is pumped to the vial 13.

The control device 39 closes the two-way solenoid valve 24 when a predetermined amount, for example, ¹⁸ F-FDG of about ¹⁸ ml is accumulated in the vial 13. Further, the control device 39 switches the three-way electromagnetic valve 33 to release the inside of the vial 13 to the atmosphere. Thereafter, the dispensing device 2 is operated to dispense a fixed amount of ¹⁸ F-FDG from the vial 13.

In the FDG synthesizer 1, the inside of the vial 13 is decompressed by the decompression means 37, so that the ¹⁸ F-FDG pumping efficiency by the pumping means 25 is improved as compared with the case where the inside of the vial 13 is opened to the atmosphere and maintained at atmospheric pressure. The time for transferring a predetermined amount of ¹⁸ F-FDG from the reactor 7 to the vial 13 is shortened. Specifically, about ¹⁸ ml of ¹⁸ F-FDG in the open air condition requires about 5 minutes to pump from the reactor 7 to the vial 13, but if the pressure inside the vial 13 is reduced, the transfer time is reduced to about half. Is done.

Further, as the transfer time is shortened, the amount of attenuation of the radioactivity of ¹⁸ F-FDG accompanying the transfer is reduced, and ¹⁸ F-FDG stored in the vial 13 can be substantially increased. In particular, ¹⁸ F-FDG has a half-life of about 110 minutes, and even when the time is shortened from several seconds to several minutes, the effect is very large.

  Furthermore, in the FDG synthesizer 1, since the inside of the vial 13 is reduced in pressure in addition to the pressure feeding by the pressure feeding means 25 to improve the transfer efficiency, the variation in the transfer time due to the length of the transfer tube 15 is reduced and the transfer time is shortened. Thus, it becomes easy to select the transfer tube 15 having the optimum length along the layout of the reactor 7 and the vial 13.

Further, since the controller 39 of the FDG synthesizer 1 depressurizes the inside of the vial 13 before the start of ¹⁸ F-FDG pumping, the pumping can be started smoothly. Therefore, there is no possibility that the gas in the vial 13 flows back into the reactor 7 and causes inconvenience.

Moreover, the amount of ¹⁸ F-FDG remaining in the transfer tube 15 decreases as the tube diameter d1 of the transfer tube 15 decreases, but the transfer time is delayed as the tube diameter d1 of the transfer tube 15 decreases. However, in the FDG synthesizer 1 described above, since the tube diameter d2 of the suction tube 29 is larger than the tube diameter d1 of the transfer tube 15, the inside of the vial 13 can be made in a shorter time than when both the tube diameters d1 and d2 are the same. Therefore, the pumping efficiency by the pumping means 25 is improved. As a result, the amount of ¹⁸ F-FDG remaining in the transfer tube 15 can be effectively reduced without causing a delay in the transfer time.

(Second Embodiment)
Next, the FDG synthesis device 40 according to the second embodiment will be described with reference to FIG. Note that in the FDG synthesizer 40, the same structures and elements as those of the FDG synthesizer 1 according to the first embodiment are denoted by the same reference numerals and description thereof is omitted. Moreover, since the dispensing apparatus which dispenses ¹⁸ F-FDG synthesized by the FDG synthesis apparatus 40 is substantially the same as the dispensing apparatus 2 described in the first embodiment, the same reference numerals are given. Therefore, the description is omitted.

  The FDG synthesizer 40 according to this embodiment includes first to fourth synthesizer main bodies 41, 42, 43, 44. The plurality of synthesis apparatus main bodies 41 to 44 are accommodated in the first to fourth hot cells 47A, 47B, 47C, and 47D, respectively. In addition, the dispensing device 2 is disposed away from the synthesis device main bodies 41 to 44 due to the facility layout, and the first to fourth hot cells 47A, 47B, and 47C that accommodate the synthesis device main bodies 41 to 44 are disposed. , 47D is housed in a hot cell 49 different from the above.

  The plurality of synthesis apparatus main bodies 41 to 44 have reactors 51, 52, 53, and 54, respectively, and a gas supply line 55 is connected to each of the reactors 51, 52, 53, and 54. The gas supply line 55 includes first to fourth branch lines 55a, 55b, 55c, and 55d that branch to correspond to the plurality of reactors 51 to 54, and each of the branch lines 55a to 55d includes a first line. To fourth four-way solenoid valves 57, 58, 59, 60 are provided. The upstream end of the gas supply line 55 is connected to a gas cylinder 21 that stores an inert gas. The gas cylinder 21 is maintained at a predetermined positive pressure in a pressurized state. The gas cylinder 21 and the gas supply line 55 constitute a pressure feeding means 61.

  The vial 63 of the FDG synthesizer 40 is accommodated in the hot cell 49 on the dispensing device 2 side. The vial 63 is connected to the reactors 51 to 54 of the first to fourth synthesizer main bodies 41 to 44 via transfer tubes 65a, 65b, 65c, and 65d, respectively. Columns 27a, 27b, 27c, and 27d filled with ion exchange resins are attached to the transfer tubes 65a to 65d, respectively.

  Further, the suction tube 29 is connected to the vial 63 in an airtight manner, and the suction tube 29 branches into one line 29c opened to the atmosphere and the other line 29d connected to the waste liquid tank 31. . Further, the suction tube 29 is provided with a three-way electromagnetic valve 33, and one of the lines is brought into a communication state by switching the three-way electromagnetic valve 33. A suction pump 35 is connected to the waste liquid tank 31 for maintaining the inside of the waste liquid tank 31 at a predetermined negative pressure. The waste liquid tank 31 and the suction pump 35 constitute a decompression means 37.

The FDG synthesis device 40 includes a control device 66 connected to the three-way solenoid valve 33 and the plurality of two-way solenoid valves 57 to 60 in a wired or wireless manner. The controller 66 performs switching of the three-way solenoid valve 33 and opening / closing control of the plurality of two-way solenoid valves 57 to 60, control of timing of pressure reduction in the vial 63, and ¹⁸ F− from the reactors 51 to 54 to the vial 63. Controls the timing of FDG pumping.

In the FDG synthesizer 40, first, for example, the synthesis is performed in the reactor 51 of the first synthesizer body 41. When a predetermined amount of ¹⁸ F-FDG is generated in the reactor 51, the controller 66 switches the three-way electromagnetic valve 33 and starts the pressure reduction in the vial 63 by the pressure reducing means 37, and then the first two-way electromagnetic valve. 57 is opened, the inside of the vial 63 is pressurized with an inert gas, and ¹⁸ F-FDG is pumped out to the vial 63. When a predetermined amount of ¹⁸ F-FDG accumulates in the vial 63, the dispensing device 2 operates to start dispensing ¹⁸ F-FDG.

When ¹⁸ F-FDG in the vial 63 is exhausted, the vial 63 is washed and ¹⁸ F-FDG is performed in the reactor 52 of the second synthesizer main body 42. When a predetermined amount of ¹⁸ F-FDG is generated in the reactor 52, the controller 66 closes the first two-way solenoid valve 57, opens the second two-way solenoid valve 58, and inactivates the inside of the vial 63. Pressurize with gas to pump ¹⁸ F-FDG into the vial 63. When a predetermined amount of ¹⁸ F-FDG accumulates in the vial 63, the dispensing device 2 operates to start dispensing ¹⁸ F-FDG. Thus, when ¹⁸ F-FDG in the vial 63 is exhausted, the vial 63 is washed each time, and the synthesis is performed while sequentially switching the reactors 51 to 54 of the first to fourth synthesizer bodies 41 to 44. The ¹⁸ F-FDG produced in each of the reactors 51 to 54 is sequentially transferred to the vial 63.

  According to the FDG synthesizer 40 according to the present embodiment, the inside of the vial 63 is reduced in pressure in addition to the pressure feeding by the pressure feeding means 61 to improve the transfer efficiency. Variations in the transfer time due to the length of the tubes 65a to 65d are reduced, and it becomes easy to select the transfer tubes 65a to 65d having the optimum length along the facility layout while shortening the transfer time.

In the FDG synthesizer 40, one vial 63 and each of the plurality of reactors 51 to 54 are connected by a plurality of transfer tubes 65a to 65d. However, when synthesizing with ¹⁸ F-FDG, for example, the first reactor 51, only the transfer tube 65 a may be connected to the vial 63. Then, when the transfer and dispensing of ¹⁸ F-FDG synthesized in the first reactor 51 to the vial 63 are completed, the transfer tube 65b of the second reactor 52 and a new vial 63 are subsequently set, The ¹⁸ F-FDG synthesized in the second reactor 52 may be transferred and dispensed.

  As mentioned above, although this invention was concretely demonstrated based on the embodiment, this invention is not limited to the said embodiment.

In the above embodiment, the RI compound synthesizer is described by taking an FDG synthesizer that synthesizes ¹⁸ F-FDG as a radiochemical liquid isotope-labeled compound, but other radiochemical liquid isotope labeled compounds may be used.

In the first embodiment, the tube diameter d2 of the suction tube 29 is made larger than the tube diameter d1 of the transfer tube 15 in order to achieve both reduction of the remaining amount of ¹⁸ F-FDG in the transfer tube 15 and shortening of the transfer time. However, both pipe diameters may be the same, or the diameter of the suction tube 29 may be smaller than the diameter of the transfer tube 15.

  Further, in the above embodiment, the pressure feeding is started after the decompression in the vial 13 or the vial 63 is started. However, the decompression and the pressure feeding are started at the same time, or the decompression is started more than the start of the pressure feeding. Or later.

It is a sectional side view showing the outline of the hot cell to which the FDG synthesizer concerning a 1st embodiment of the present invention is attached. It is a figure which expands and shows a vial, (a) is sectional drawing of a vial, (b) is sectional drawing along the bb line of (a), (c) is cc of (a) It is sectional drawing along a line. It is a figure which shows the outline of the FDG synthesizer which concerns on 2nd Embodiment of this invention.

Explanation of symbols

  DESCRIPTION OF SYMBOLS 1,40 ... FDG synthesizer (RI compound synthesizer), 7, 51, 52, 53, 54 ... Reactor, 13, 63 ... Vial (storage container), 15, 65 ... Transfer tube (transfer tube), 25, 61: pressure feeding means, 29: suction tube (suction tube), 37: pressure reducing means, 39, 66 ... control device (control means), d1: diameter of transfer tube, d2: diameter of suction tube.

Claims (3)

In an RI compound synthesizer that obtains a radiochemical isotope-labeled compound by introducing a radiochemical isotope into the reactor,
A storage container for storing the radiochemical isotope-labeled compound before dispensing;
A transfer pipe for hermetically connecting the reactor and the storage container;
A pumping means for pumping the radiochemical isotope-labeled compound from the reactor to the storage container via the transfer pipe;
A suction tube connected to the storage container;
Decompression means for sucking and decompressing the gas in the storage container through the suction pipe;
An RI compound synthesizer characterized by comprising: A control means for controlling the pressure feeding by the pressure feeding means and the pressure reduction by the pressure reducing means;
2. The RI compound synthesizing apparatus according to claim 1, wherein the control means starts pressure feeding by the pressure feeding means after starting pressure reduction by the pressure reducing means.   The RI compound synthesizing apparatus according to claim 1 or 2, wherein a diameter of the suction pipe is larger than a diameter of the transfer pipe.

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