Reaction device for radionuclide labeled microspheres

Abstract

The utility model provides a reaction device for radionuclide labeled microspheres. The reaction device comprises a control module, a reaction module and a transfer module, wherein the control module comprises a control module main body, a replaceable clamping plate, a peristaltic pump, a bubble sensor, a reagent bottle, an empty bottle and a pipeline, the reaction module comprises a stirrer, a reactor and an outer cylinder, and the transfer module comprises a lifter and a transfer device. The reaction device for the radionuclide labeled microspheres is controlled by an automatic program, the material quantity can be accurately calculated, and the accuracy of the production process is improved; the device does not need manual operation in the whole process, the whole experiment process is carried out in a closed environment, aerosol leakage is avoided, and the radiation risk of technicians is reduced.

Description

Technical Field

[0001] This utility model relates to the field of microsphere labeling technology, and in particular to a reaction device for radionuclide labeling microspheres. Background Technology

[0002] Microsphere radioembolization is an important cancer treatment method. Its principle involves injecting radiolabeled microspheres into the tumor, directly killing cancer cells while simultaneously creating an embolic effect, causing ischemia and necrosis of the cancer cells, achieving a result similar to surgical resection. This technology has been commercialized and is widely used in the treatment of certain cancers, such as... 90 SIR-Spheres® resin microspheres were approved by the FDA in 2002 for the treatment of colorectal cancer liver metastases and were approved for marketing in China in 2022. 90 TheraSphere® glass microspheres were approved by the FDA in 2005 as a Class III medical device for the treatment of liver tumors. 166 Ho polylactic acid microspheres (QuiremSpheres®) received EU quality control approval in 2015 for use in radioembolization therapy for unresectable liver cancer.

[0003] At present, the radionuclide labeling of microspheres, such as 188 Re、 90 Y、 166 Ho et al. primarily relied on manual methods, and have not yet developed a production module capable of automating microsphere labeling. However, manual labeling has limitations in terms of accuracy and safety during the process of radionuclide labeling of microspheres. Utility Model Content

[0004] To solve the above-mentioned technical problems, this utility model provides a reaction device for radionuclide-labeled microspheres.

[0005] To achieve the above objectives, the present invention provides the following technical solution:

[0006] A reaction apparatus for radionuclide-labeled microspheres, characterized in that it comprises a control module, a reaction module, and a transfer module; wherein the control module comprises a control module body, a replaceable card plate, a peristaltic pump, a bubble sensor, reagent bottles, empty bottles, and pipelines; the reaction module comprises a stirrer, a reactor, and an outer cylinder; and the transfer module comprises a lift and a transferor.

[0007] Specifically, the microspheres may be selected from resin microspheres.

[0008] Furthermore, the reactor includes a reaction cylinder and a filter membrane; the reaction cylinder is equipped with a detachable top cover and a bottom cover; the top cover has multiple pipe joints at its upper end, the bottom cover has pipe joints at its bottom, and a thickened platform is provided inside; the filter membrane is located on the thickened platform of the bottom cover.

[0009] Specifically, the top cover has three pipe joints: one is connected to the control module via a pipeline, another is equipped with a pipette, and the remaining one is connected to the atmosphere.

[0010] The pipe joint of the bottom cover is connected to the control module via a pipeline.

[0011] Specifically, the bottom cover has one or more pipe joints; preferably one.

[0012] Specifically, the inner walls of the top cover and bottom cover are fixed to the reaction cylinder by a threaded structure, and the filter membrane is screwed onto the thickened platform by the thread action between the lower end of the reaction cylinder and the bottom cover, thus fixing it inside the reaction cylinder; a rubber ring for sealing is also installed between the filter membrane and the thickened platform.

[0013] Furthermore, the stirrer comprises, from top to bottom, a rotating cylinder, a hollow rotating motor, and an annular fixing plate, the bottom of which is fixed to the base by multiple fixing seats; wherein, the hollow rotating motor and the rotating cylinder are both hollow cylindrical structures.

[0014] Specifically, two opposite-polarity magnets are symmetrically distributed on the outer wall of the rotating cylinder; both the rotating cylinder and the reaction cylinder are made of non-metallic, magnetically permeable materials; and the base is equipped with a knob for controlling the stirrer switch and rotation speed.

[0015] Furthermore, the upper surface of the outer cylinder is annularly sealed, and a support platform is installed at the opening. The support platform includes an upper support and a lower support. The upper support has a semi-circular structure, and its inner diameter matches the outer diameter of the reaction cylinder. The inner diameter of the lower support is slightly larger than the outer diameter of the bottom cover.

[0016] Furthermore, the bottom cover of the reaction cylinder is slightly lower than the distance between the upper and lower supports, so that the bottom cover of the reaction cylinder can pass through the upper and lower supports and sink into the outer cylinder. At this time, the top cover of the reaction cylinder is suspended on the upper support, and the bottom cover of the reaction cylinder is placed inside the rotating cylinder. During device operation, a magnetic stirrer is placed above the filter membrane inside the reaction cylinder for stirring.

[0017] Furthermore, the outer cylinder covers the rotating cylinder, the hollow rotating motor, and the annular fixing plate, and is fixed to the base at the bottom. A pipeline outlet is also opened on the side wall so that the pipeline connected to the pipe joint at the bottom of the reaction cylinder bottom cover can pass through and connect to the replaceable card plate of the control module.

[0018] Furthermore, the elevator includes a sensor, a slide rail, a slider, and a support rod; the upper end of the support rod is fixed to the pipette, and the lower end is fixed to the slider.

[0019] Furthermore, the transfer device includes a second slider, a second slide rail, a three-way valve, and a syringe. The head of the syringe is connected to one of the valve ports of the three-way valve, and the piston rod at the tail is fixed to the second slider by a bracket. The other two valve ports of the three-way valve are respectively connected to a pipette and a product bottle.

[0020] Specifically, the control module, elevator, and transfer device are all controlled by a PLC and driven by a motor.

[0021] Furthermore, the control module is also equipped with corresponding control valves on its pipeline to control the operating status of the fluid passage.

[0022] Specifically, the control module includes two bubble sensors for accurately measuring the amount of liquid flowing through them; bubble sensor 1 is installed on the main pipeline connecting the reagent bottle and the empty bottle in series, and bubble sensor 2 is installed on the pipeline connected to the bottom cap of the reaction tube.

[0023] The beneficial effects of this invention are as follows: 1. The reaction device for radionuclide-labeled microspheres of this invention is automatically controlled by a program, which can accurately calculate the amount of material and improve the accuracy of the production process; 2. The device does not require manual operation throughout the entire process, and the entire experimental process is carried out in a closed environment, which avoids aerosol leakage and reduces the radiation risk to technicians. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the structure of the device of this utility model;

[0025] Figure 2 This is a schematic diagram of the stirrer in the reaction module of this utility model;

[0026] Figure 3 This is a schematic diagram of the reactor structure in the reaction module of this utility model;

[0027] Figure 4 This is a schematic diagram of the elevator structure in the control module of this utility model;

[0028] Figure 5 This is a schematic diagram of the transferor in the control module of this utility model;

[0029] Figure 6 This is a schematic diagram of the control system terminal interface in an embodiment of the present utility model.

[0030] The attached figures are labeled as follows:

[0031] 11-Control module main body; 12-Replaceable card plate; 13-Peristaltic pump; 14-Bubble sensor; 21-Agitator; 211-Mounting slot; 212-Rotating cylinder; 213-Magnet; 214-Hollow rotary motor; 215-Annular fixing plate; 216-Fixing base; 217-Conduit seat; 218-Base; 22-Reactor; 221-Pipe joint; 222-Top cover; 223-Reaction cylinder; 224-Filter membrane; 225-Magnet; 226-Rubber ring; 227-Bottom cover; 228-Thickened platform; 23-Outer cylinder; 241-Upper support; 242-Lower support; 31-Elevator; 311-Sensor; 312-Slide rail one; 313-Slider one; 314-Support rod; 315-Mounting base; 316-Pipette; 32-Transfer device; 321-Slider two; 322-Slide rail two; 323-Three-way valve; 324-Instrument; 325-Support; R1~R4 Reagent bottles; R5~R7-Empty bottles; R8-Product bottles; V1~V9-Control valves. Detailed Implementation

[0032] The structural features of this utility model are further described below with reference to the accompanying drawings and embodiments, so that those skilled in the art can implement it based on the description. The preferred embodiments described below are only examples, and those skilled in the art can conceive of other obvious variations.

[0033] like Figures 1-5 As shown, a reaction device for radionuclide-labeled microspheres includes a control module, a reaction module, and a transfer module; wherein, the control module includes a control module body 11, a replaceable card plate 12, a peristaltic pump 13, a bubble sensor 14, reagent bottles, empty bottles, and pipelines; the reaction module includes a stirrer 21, a reactor 22, and an outer cylinder 23; and the transfer module includes a lift 31 and a transferor 32.

[0034] The reactor 22 includes a reaction cylinder 223 and a filter membrane 224; the reaction cylinder 223 is equipped with a detachable top cover 222 and a bottom cover 227; the top cover 222 has three pipe joints 221 at its upper end, the bottom cover 227 has one pipe joint 221 at its bottom, and a thickened platform 228 is provided inside; the filter membrane 224 is located on the thickened platform of the bottom cover 227, and a rubber ring 226 is installed between the filter membrane 224 and the thickened platform 228.

[0035] The stirrer 21 includes, from top to bottom, a rotating cylinder 212, a hollow rotating motor 214, and an annular fixing plate 215. The bottom of the annular fixing plate 215 is fixed to the base 218 by multiple fixing seats 216.

[0036] A support platform is installed at the opening of the outer cylinder 23. The support platform includes an upper support 241 and a lower support 242. The upper support 241 has a semi-circular structure. The top cover 222 of the reaction cylinder 223 is suspended on the upper support 241, and the bottom cover 227 of the reaction cylinder 223 is placed inside the rotating cylinder 212. The bottom of the outer cylinder 23 is fixed to the base 218, and a pipeline outlet is also opened on the side wall.

[0037] The elevator 31 includes a sensor 311, a slide rail 312, a slider 313, and a support rod 314; the upper end of the support rod 314 is fixed to the pipette 316, and the lower end is fixed to the slider 313.

[0038] The transfer device 32 includes a second slider 321, a second slide rail 322, a three-way valve 323, and a syringe 324. The head of the syringe 324 is connected to one of the valve ports of the three-way valve 323, and the piston rod at the tail is fixed to the second slider 321 by a bracket 325. The other two valve ports of the three-way valve 323 are connected to a pipette 316 and a product bottle R8, respectively.

[0039] The control module's pipeline is also equipped with corresponding control valves V1 to V9.

[0040] The following examples and... Figure 6 The automated labeling of radionuclides with microspheres is explained.

[0041] The specific working principle of this utility model is as follows:

[0042] The reaction device for radionuclide-labeled microspheres proposed in this invention is program-controlled. After the device is assembled, the corresponding program can be set according to the process requirements, and the labeling process can be automated by clicking "start run".

[0043] In actual use, all valves and pumps are initially closed. A certain amount of microspheres are added to the filter membrane 224 of reactor 22. The program is started, valves V1 and V7 are opened, and the reagent in R1 is drawn to the top of the filter membrane 224 inside reactor 22 by the peristaltic pump. When it flows through the bubble sensor 1, fluid metering begins. When the liquid flow rate reaches the program-set value, valve V1 is automatically closed, stopping the liquid addition. Reagents in R2 to R4 can be added to reactor 22 according to the amount or volume set according to the actual process requirements, and a marking operation is performed. (The solutions in R2 to R4 include radioactive nuclide solutions, reaction reagents, etc.)

[0044] During the labeling process, the stirrer needs to be turned on. The magnetic ball starts to rotate under the influence of the magnetic field, so that the reagent and microspheres can fully contact and react.

[0045] A filter membrane is installed at the bottom of reactor 22 for liquid filtration. When liquid needs to be extracted from reactor 22 during the reaction, all other valves are closed, and valves V5 and V8 are opened. Under the action of the peristaltic pump, the liquid in reactor 22 is drawn to the area below the filter membrane and flows into empty bottle R5 through the pipeline, while the microspheres remain inside the reactor. When the bubble sensor 2 detects that the liquid volume has reached the programmed value, it automatically closes valve V8 and stops the extraction.

[0046] When it is necessary to clean the residual liquid in the pipeline during the reaction, keep other valves closed and open any of valves V9 and V5~V6. Under the action of the peristaltic pump, the air in R7 will blow the residual liquid in the pipeline to the corresponding vial.

[0047] After the reaction is complete, the product is collected. At this point, the peristaltic pump and valve are shut off, and the elevator 31 is lowered to insert the pipette into the reaction solution and into contact with the surface of the filter membrane 224. The motor drives the support 325 to pull the syringe 324 upward, drawing the liquid from the reactor 22 into the syringe 324. The three-way valve 323 is switched, and the syringe 324 is pushed downward, pushing the liquid in the syringe 324 along the pipeline to the product bottle R8, completing the transfer of the marked product.

Claims

1. A reaction apparatus for radionuclide-labeled microspheres, characterized in that, It includes a control module, a reaction module, and a transfer module; wherein, the control module includes a control module body, a replaceable card plate, a peristaltic pump, a bubble sensor, reagent bottles, empty bottles, and pipelines; the reaction module includes a stirrer, a reactor, and an outer cylinder; and the transfer module includes a lift and a transferor.

2. The apparatus according to claim 1, characterized in that, The reactor includes a reaction cylinder and a filter membrane; the reaction cylinder is equipped with a detachable top cover and a bottom cover; the top cover has multiple pipe joints at its upper end, one of which is fitted with a pipette; the bottom cover has pipe joints at its bottom and a thickened platform inside; the filter membrane is located on the thickened platform of the bottom cover, and a rubber ring is installed between the filter membrane and the thickened platform; the stirrer includes, from top to bottom, a rotating cylinder, a hollow rotating motor, and an annular fixing plate, the bottom of which is fixed to a base by multiple fixing seats; both the hollow rotating motor and the rotating cylinder are hollow cylindrical structures.

3. The apparatus according to claim 2, characterized in that, The pipe joints of the top cover and the bottom cover are respectively connected to the control module via pipelines.

4. The apparatus according to claim 2, characterized in that, The upper surface of the outer cylinder is annularly sealed, and a support platform is installed at the opening. The support platform includes an upper support and a lower support. The upper support is a semi-circular structure, and its inner diameter matches the outer diameter of the reaction cylinder. The inner diameter of the lower support is slightly larger than the outer diameter of the bottom cover. The top cover of the reaction cylinder is suspended on the upper support, and the bottom cover of the reaction cylinder is placed inside the rotating cylinder.

5. The apparatus according to claim 4, characterized in that, The bottom cover of the reaction cylinder is slightly lower than the distance between the upper and lower supports.

6. The apparatus according to claim 4, characterized in that, The bottom of the outer cylinder is fixed to the base, and a pipeline outlet is provided on the side wall.

7. The apparatus according to claim 2, characterized in that, The elevator includes a sensor, a slide rail, a slider, and a support rod; the upper end of the support rod is fixed to the pipette, and the lower end is fixed to the slider.

8. The apparatus according to claim 2, characterized in that, The transfer device includes a second slider, a second slide rail, a three-way valve, and a syringe; the head of the syringe is connected to one of the valve ports of the three-way valve, and the piston rod at the tail is fixed to the second slider by a bracket; the other two valve ports of the three-way valve are respectively connected to the pipette and the product bottle.

9. The apparatus according to claim 1, characterized in that, The control module is also equipped with corresponding control valves on its pipeline.

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