CN217450185U - Multifunctional full-automatic synthesis device for radiopharmaceuticals - Google Patents
Multifunctional full-automatic synthesis device for radiopharmaceuticals Download PDFInfo
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- CN217450185U CN217450185U CN202122862685.9U CN202122862685U CN217450185U CN 217450185 U CN217450185 U CN 217450185U CN 202122862685 U CN202122862685 U CN 202122862685U CN 217450185 U CN217450185 U CN 217450185U
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Abstract
The utility model provides a multifunctional full-automatic synthesis device for radiopharmaceuticals, which comprises a synthesis module, a control system module and external equipment; the control system module comprises a main control module, a synthesis control module and an upper computer communication module, wherein the synthesis control module and the upper computer communication module are connected with the main control module; the synthesis control module is also connected with the synthesis module; the upper computer communication module is also connected with external equipment; and a visual interface module is arranged in the external equipment. The utility model discloses a multi-functional full-automatic synthesizer can realize radiopharmaceutical's automatic synthesis to be equipped with visual interface module, operation step in can the accurate positioning synthesis process.
Description
Technical Field
The utility model relates to a nuclear medicine and molecular imaging technical field particularly, relate to a multi-functional full-automatic synthesizer of radiopharmaceutical.
Background
Nuclear medicine, as a discipline for studying the application of nuclide medicine, plays an important role in the early detection and early treatment of cancer. Positron Emission Tomography (PET) is widely used in nuclear medicine as an imaging modality that introduces radionuclides to a tumor site in a patient's body, and employs detectors and visualization tools to locate the tumor. In the selection of radiopharmaceuticals, the selection is currently made 68 Ga, the most commonly used isotope for PET imaging, is widely used in nuclear medicine, 177 lu has an obvious advantage in tumor treatment due to its excellent radiation physical properties, and is also used in clinical research.
For diagnostic nuclides at present 68 Ga and therapeutic nuclides 177 There are two ways of automated synthesis and manual synthesis for Lu-labelled radiopharmaceuticals. Because the medicine has the radioactivity, the manual operation synthesis is not beneficial to the radiation protection of workers, and the risk of human errors in the pharmaceutical process is increased. And the automatic synthesizer that has now on the market only possesses the synthesis of limited kind of medicine, and the synthetic step is loaded down with trivial details, still accompanies the unstable problem of medicine synthesis, and synthetic efficiency is not high, and bulky and lack visual interface, can't let the accurate positioning synthesis step of staff.
SUMMERY OF THE UTILITY MODEL
The utility model aims at providing a multi-functional full-automatic synthesizer of radiopharmaceutical to solve the technical problem that current radiopharmaceutical synthesis exists.
The utility model provides a multifunctional full-automatic synthesis device for radioactive drugs, which comprises a synthesis module, a control system module and external equipment; the control system module comprises a main control module, a synthesis control module and an upper computer communication module, wherein the synthesis control module and the upper computer communication module are connected with the main control module; the synthesis control module is also connected with the synthesis module; the upper computer communication module is also connected with external equipment; and a visual interface module is arranged in the external equipment.
Further, the synthesis module comprises a waste liquid bottle, a product bottle, a first sterile filter membrane, a second sterile filter membrane, an exhaust needle, a separation and purification column, a reaction tube, a heater, a nuclide generator, a one-way valve, generator leacheate, a first injection pump, a second injection pump, a third injection pump and an exhaust filter membrane;
the waste liquid bottle is connected with a No. 2 interface of the first injection pump; the product bottle is connected with a No. 1 interface of the first injection pump; placing the sterile filter membrane I and the exhaust needle on a product bottle; the lower end of the first injection pump is connected to a No. 6 interface of the second injection pump through a separation and purification column;
the No. 1 interface of the injection pump II is connected with normal saline, the No. 2 interface is connected with ethanol, the No. 3 interface is connected with a precursor, the No. 4 interface is connected with nuclide, and the No. 5 interface is connected with a first interface of the reaction tube;
the heater is arranged below the reaction tube, and a second interface of the reaction tube is connected with a second sterile filter membrane and a third interface of the reaction tube and is connected with a No. 1 interface of the injection pump III through a one-way valve, a nuclide generator and an exhaust filter membrane in sequence; the No. 2 interface of the injection pump III is connected with generator leacheate.
In some embodiments, the multifunctional fully-automatic radiopharmaceutical synthesis apparatus further comprises an injection pump control circuit board for connecting the synthesis module and the synthesis control module; the injection pump control circuit board comprises an injection pump control circuit board I, an injection pump control circuit board II and an injection pump control circuit board III;
the driving end of the injection pump I is connected with the synthesis control module through the injection pump control circuit board I;
the driving end of the injection pump II is connected with the injection pump control circuit board II through the injection pump control circuit board II to form a control module;
and the driving end of the injection pump III is connected with the injection pump control circuit board III through the injection pump control circuit board III to form a control module.
Further, the injection pump control circuit board I, the injection pump control circuit board II and the injection pump control circuit board III are respectively and correspondingly provided with a communication interface I, a communication interface II and a communication interface III with the synthesis control module; and the upper computer communication module is connected with external equipment through a communication interface IV.
In some embodiments, the external device is a computer or a tablet.
In some embodiments, the multi-functional fully automated radiopharmaceutical synthesis apparatus further comprises a power source; the power supply is connected with the control system module.
To sum up, owing to adopted above-mentioned technical scheme, the beneficial effects of the utility model are that:
1. the utility model discloses a multi-functional full-automatic synthesizer can realize radiopharmaceutical's automatic synthesis to be equipped with visual interface module, operation step in can the accurate positioning synthesis process.
2. The utility model discloses an automatic drip washing of nuclide generator that multi-functional full-automatic synthesizer can realize to be equipped with aseptic filter membrane and fully guarantee nuclide generator's safe in utilization.
3. The utility model discloses a multi-functional full-automatic synthesizer can be used for 68 Ga-FAPI、 68 Ga- PSMA-11、 68 Ga-DOTATATE and 177 the full-automatic synthesis of Lu-DOTATATE, and the synthesis of other prodrugs can be performed. Through verification, the utility model has the characteristics of accuracy and high efficiency in the process of synthesizing the radioactive drug, 68 the synthesis time of Ga-FAPI is 19 minutes, and the radiochemical purity is more than or equal to 99.5 percent; 68 the synthesis time of Ga-PSMA-11 is 11 minutes, and the radiochemical purity is more than or equal to 99.5 percent; 68 the synthesis time of Ga-DOTATATE is 16 minutes, and the radiochemical purity is more than or equal to 99.5 percent; 177 Lu-DOTATATE synthesis time: the radiochemical purity is more than or equal to 99.5 percent within 21 minutes.
Drawings
In order to more clearly illustrate the technical solution of the embodiments of the present invention, the drawings in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention, and therefore should not be considered as limiting the scope, and those skilled in the art can also obtain other related drawings based on the drawings without inventive efforts.
Fig. 1 is a structural diagram of the multi-functional fully automatic radiopharmaceutical synthesizer of the present invention.
Fig. 2 is a structural diagram of a synthesis module of the present invention.
Reference numerals:
100-a control system module, 101-a main control module, 102-a synthesis control module and 103-an upper computer communication module;
200-a synthesis module, 201-a waste liquid bottle, 202-a product bottle, 203-a sterile filter membrane I, 204-a sterile filter membrane II, 205-an exhaust needle, 206-a separation and purification column, 207-a reaction tube, 208-a heater, 209-a nuclide generator, 210-a one-way valve, 211-generator leacheate, 212-an injection pump I, 213-an injection pump II, 214-an injection pump III and 215-an exhaust filter membrane;
300-injection pump control circuit board, 301-injection pump control circuit board I, 302-injection pump control circuit board II and 303-injection pump control circuit board III;
401-communication interface one, 402-communication interface two, 403-communication interface three, 404-communication interface four;
500-an external device;
600-power supply.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention, as generally described and illustrated in the figures herein, may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the present invention, presented in the accompanying drawings, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative work belong to the protection scope of the present invention.
Examples
As shown in fig. 1, the present embodiment provides a multifunctional fully-automatic radiopharmaceutical synthesis apparatus, which includes a synthesis module 200, a control system module 100, and an external device 500; the control system module 100 comprises a main control module 101, and a synthesis control module 102 and an upper computer communication module 103 which are connected with the main control module 101; the synthesis control module 102 is further connected with a synthesis module 200; the upper computer communication module 103 is also connected with an external device 500; the external device 500 is provided with a visual interface module. Wherein:
the synthesis module 200 is used for synthesizing a radiopharmaceutical; as shown in fig. 2, the synthesis module 200 comprises a waste liquid bottle 201, a product bottle 202, a first sterile filter 203, a second sterile filter 204, a vent needle 205, a separation and purification column 206, a reaction tube 207, a heater 208, a nuclide generator 209, a one-way valve 210, a generator leacheate 211, a first syringe pump 212, a second syringe pump 213, a third syringe pump 214, and a vent filter 215;
the waste liquid bottle 201 is connected with a No. 2 interface of a first syringe pump 212; the product bottle 202 is connected with the No. 1 interface of the first injection pump 212; a first sterile filter membrane 203 and a vent needle 205 are placed on the product bottle 202; the lower end of the first injection pump 212 is connected to a No. 6 interface of a second injection pump 213 through a separation and purification column 206;
the No. 1 interface of the second injection pump 213 is connected with the physiological saline, the No. 2 interface is connected with (75%) ethanol, the No. 3 interface is connected with the precursor, the No. 4 interface is connected with the nuclide, and the No. 5 interface is connected with the first interface of the reaction tube 207;
the heater 208 is arranged below the reaction tube 207, and the second interface of the reaction tube 207 is connected with the sterile filter membrane II 204, and the third interface is connected with the No. 1 interface of the injection pump III 214 through the one-way valve 210, the nuclide generator 209, and the exhaust filter membrane 215 in sequence; interface 2 of syringe pump three 214 is connected to generator eluate 211.
Wherein, the waste liquid bottle 201, the product bottle 202, the first sterile filter membrane 203, the second sterile filter membrane 204, the exhaust needle 205, the separation and purification column 206, the reaction tube 207, the heater 208, the nuclide generator 209, the one-way valve 210, the exhaust filter membrane 215, the generator leacheate 211, the first syringe pump 212, the second syringe pump 213 and the third syringe pump 214 are communicated by adopting connecting pipelines. The waste liquid bottle 201 is used for containing waste reagents after synthesis is completed; the first sterile filter membrane 203 and the exhaust needle are connected with the product bottle 202 and are used for filtering tiny particles in air and controlling the air pressure inside and outside the bottle; the separation and purification column 206 is used for separating and purifying the synthetic radiopharmaceuticals; the reaction tube 207 performs a heating reaction of the drug; the nuclide generator 209, generator leacheate 211, and one-way valve 210 provide nuclide leacheate to the reaction tube 207, and syringe pump one 212, syringe pump two 213, and syringe pump three 214 are used to control and drive the flow of the various fluids in the lines throughout the radiopharmaceutical synthesis step.
The control system module 100 is used for controlling the first syringe pump 212, the second syringe pump 213 and the third syringe pump 214 in the synthesis module 200. The visual interface module in the external device 500 can display monitoring information during the radiopharmaceutical synthesis process and send a control signal to the near-field control system module 100, so as to realize remote monitoring and control. The main control module 101 is configured to receive and recognize the control signal, and send the control signal to the first syringe pump 212, the second syringe pump 213, and the third syringe pump 214 through the synthesis control module 102 to implement control. The external device 500 is typically a computer or a tablet computer.
In some embodiments, the multifunctional fully automated synthesis apparatus further comprises an injection pump control circuit board 300 for connecting the synthesis module 200 with the synthesis control module 102; the injection pump control circuit board 300 comprises a first injection pump control circuit board 301, a second injection pump control circuit board 302 and a third injection pump control circuit board 303;
the driving end of the injection pump I212 is connected with the synthesis control module 102 through the injection pump control circuit board I301;
the driving end of the second injection pump 213 is connected with the combined control module 102 through a second injection pump control circuit board 302;
the driving end of the injection pump III 214 is connected with the synthetic control module 102 through the injection pump control circuit board III 303.
Further, the first syringe pump control circuit board 301, the second syringe pump control circuit board 302, the third syringe pump control circuit board 303 and the synthesis control module 102 are respectively provided with a first communication interface 401(COM1), a second communication interface 402(COM2) and a third communication interface 403(COM3) correspondingly; the upper computer communication module 103 is connected with the external device 500 through a communication interface four 404(COM 4).
In addition, the multifunctional full-automatic synthesis device further comprises a power supply 600; the power supply 600 is connected to the control system module 100 to supply power to the multifunctional full-automatic synthesizer.
The working principle of adopting the multifunctional full-automatic synthesis device to synthesize the radioactive drugs marked by the diagnostic nuclide 68Ga and the therapeutic nuclide 177Lu is as follows:
(1) starting the multifunctional full-automatic synthesis device;
(2) a control signal is sent through a visual interface module in the external device 500 to control the initialization of the synthesis module 200;
(3) in the preparation stage, the connecting pipelines (mainly the connecting pipelines of the waste liquid bottle 201, the product bottle 202 and the syringe pump 212) after the last automatic synthesis are replaced manually, the separation and purification column 206 is replaced, and the sterile filter membrane one 203, the sterile filter membrane two 204, the exhaust needle 205, the product bottle 202 and the waste liquid bottle 201 are replaced;
(4) uniformly mixing the buffer solution and the precursor, and then connecting the mixture to a No. 3 interface of a second injection pump 213; respectively linking a No. 1 interface and a No. 2 interface of a second injection pump 213 from the physiological saline and 75% ethanol;
(5) in the step (4), the generator leacheate 211 is manually connected to the interface No. 2 of the third injection pump 214;
(6) waiting for the completion of the quick self-checking of the multifunctional full-automatic synthesis device;
(7) performing a self-cleaning step, controlling an injection pump II 213 to extract 1ml of 75% ethanol from the interface No. 2 through a visual interface module, and injecting the extracted 1ml of 75% ethanol into the reaction tube 207 through the interface No. 5;
(8) the second injection pump 213 is controlled by the visual interface module to pump back the reaction solution in the reaction tube 207, and then the reaction solution passes through the No. 6 interface, the separation and purification column 206 and the No. 2 interface of the first injection pump 212 to reach the waste solution bottle 201;
(9) controlling a second injection pump 213 to extract 5ml of physiological saline from the No. 1 interface through the visual interface module, and injecting the extracted 5ml of physiological saline into the reaction tube 207 through the No. 5 interface of the second injection pump 213;
(10) after the reaction tube 207 stays for 2 seconds, the second injection pump 213 is controlled to be pumped back through the visual interface module, and the waste liquid bottle 201 is reached through a No. 6 interface of the second injection pump 213 through the separation and purification column 206 and the first injection pump 212;
(11) preheating the reaction tube 207 to a desired temperature;
(12) in the processes of the steps (6) to (10), the whole operation pipeline is disinfected, and the separation and purification column 206 is activated at the same time;
(13) in the formal synthesis stage, the second injection pump 213 is controlled by the visual interface module to pump the precursor through the No. 3 interface of the second injection pump 213 and transfer the precursor to the reaction tube 207 through the No. 5 interface of the second injection pump 213;
(14) controlling a third injection pump 214 to extract generator leacheate 211 through a No. 2 interface of the third injection pump 214 through a visual interface module, and then obtaining nuclide leacheate through an exhaust filter membrane 215 and a nuclide generator 209 through a No. 1 interface of the third injection pump 214;
(15) the nuclide leacheate enters the reaction tube 207 through the one-way valve 210 and is uniformly mixed with the precursor in the reaction tube 207;
(16) after the reaction in the reaction tube 207 is finished, the heater 208 is turned off, the second injection pump 213 is controlled by the visual interface module to extract the physiological saline from the interface No. 1 of the second injection pump 213, and the extracted physiological saline is injected into the reaction tube 207 through the interface No. 5 so as to dilute the reaction liquid in the reaction tube 207, and then the reaction liquid is sucked out and transferred to the separation and purification column 206 through the interface No. 6 of the second injection pump 213, and finally transferred to the waste liquid bottle 201 through the interface No. 2 of the first injection pump 212;
(17) controlling a second injection pump 213 to suck the normal saline for multiple times through a visual interface module so as to respectively clear the reaction tube 207 and wash the separation and purification column 206;
(18) controlling an injection pump II 213 to absorb 75% ethanol through a No. 2 interface by using a visual interface module, absorbing a small amount of physiological saline through a No. 1 interface of the injection pump II 213, and leaching the medicine product adsorbed on the separation and purification position to a product bottle 202 through a No. 6 interface of the injection pump II 213 by using an injection pump I212 and a sterile filter membrane I203;
(19) finally, the line is flushed again with saline as per the preparation phase, transferring the product in its entirety into the product bottle 202, until the synthesis is complete.
(20) After the synthesis is finished, the product is manually collected to a transfer lead tank, transported to a designated place to finish a subsequent experiment, and the power supply 600 is turned off.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (5)
1. The multifunctional full-automatic synthesis device for the radiopharmaceuticals is characterized by comprising a synthesis module (200), a control system module (100) and an external device (500); the control system module (100) comprises a main control module (101), and a synthesis control module (102) and an upper computer communication module (103) which are connected with the main control module (101); the synthesis control module (102) is also connected with a synthesis module (200); the upper computer communication module (103) is also connected with an external device (500); a visual interface module is arranged in the external equipment (500);
the synthesis module (200) comprises a waste liquid bottle (201), a product bottle (202), a sterile filter membrane I (203), a sterile filter membrane II (204), an exhaust needle (205), a separation and purification column (206), a reaction tube (207), a heater (208), a nuclide generator (209), a one-way valve (210), generator leacheate (211), a syringe pump I (212), a syringe pump II (213), a syringe pump III (214) and an exhaust filter membrane (215);
the waste liquid bottle (201) is connected with a No. 2 interface of a first injection pump (212); the product bottle (202) is connected with a No. 1 interface of a first syringe pump (212); the sterile filter membrane I (203) and the exhaust needle (205) are placed on the product bottle (202); the lower end of the first syringe pump (212) is connected to a No. 6 interface of a second syringe pump (213) through a separation and purification column (206);
the No. 1 interface of the injection pump II (213) is connected with the physiological saline, the No. 2 interface is connected with the ethanol, the No. 3 interface is connected with the precursor, the No. 4 interface is connected with the nuclide, and the No. 5 interface is connected with the first interface of the reaction tube (207);
the heater (208) is arranged below the reaction tube (207), and the second interface of the reaction tube (207) is connected with the sterile filter membrane II (204) and the third interface are sequentially connected with the No. 1 interface of the injection pump III (214) through the one-way valve (210), the nuclide generator (209) and the exhaust filter membrane (215); the No. 2 port of the syringe pump III (214) is connected with generator leacheate (211).
2. The multi-functional fully automated radiopharmaceutical synthesis apparatus of claim 1, further comprising an injection pump control circuit board (300) for connecting the synthesis module (200) with the synthesis control module (102); the injection pump control circuit board (300) comprises a first injection pump control circuit board (301), a second injection pump control circuit board (302) and a third injection pump control circuit board (303);
the driving end of the injection pump I (212) is connected with the synthesis control module (102) through the injection pump control circuit board I (301);
the driving end of the injection pump II (213) is connected with the synthesis control module (102) through the injection pump control circuit board II (302);
the driving end of the injection pump III (214) is connected with the synthesis control module (102) through the injection pump control circuit board III (303).
3. The multifunctional full-automatic radiopharmaceutical synthesis apparatus of claim 2, wherein the syringe pump control circuit board one (301), the syringe pump control circuit board two (302), the syringe pump control circuit board three (303) and the synthesis control module (102) are respectively provided with a communication interface one (401), a communication interface two (402) and a communication interface three (403) in correspondence; and the upper computer communication module (103) is connected with an external device (500) through a communication interface IV (404).
4. The multifunctional fully automated radiopharmaceutical synthesis apparatus of claim 1, wherein the external device (500) is a computer or a tablet.
5. The multifunctional fully automated radiopharmaceutical synthesis apparatus of claim 1, further comprising a power source (600); the power supply (600) is connected with the control system module (100).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202122862685.9U CN217450185U (en) | 2021-11-22 | 2021-11-22 | Multifunctional full-automatic synthesis device for radiopharmaceuticals |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202122862685.9U CN217450185U (en) | 2021-11-22 | 2021-11-22 | Multifunctional full-automatic synthesis device for radiopharmaceuticals |
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| CN217450185U true CN217450185U (en) | 2022-09-20 |
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| CN202122862685.9U Active CN217450185U (en) | 2021-11-22 | 2021-11-22 | Multifunctional full-automatic synthesis device for radiopharmaceuticals |
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