A mobile radionuclide production device and method of use

Abstract

The application discloses a mobile radionuclide production device and a use method thereof, and belongs to the technical field of nuclear technology and nuclear medical technology.The device comprises a movable carrier, a radionuclide generation module, a shielding and protection module and an intelligent control module which are integrated on the movable carrier.The radionuclide generation module comprises at least one commercially available and regulatory approved radionuclide generator.The shielding and protection module is a fixed shielding structure arranged around the radionuclide generation module.The intelligent control module is electrically connected with the radionuclide generation module and is used for controlling the production process of the radionuclide.The mobile radionuclide production device and the use method thereof can realize on-site and rapid production of the radionuclide, and solve the problems of inflexibility of fixed facilities and large attenuation of long-distance transportation of short half-life radionuclides.

Description

Technical Field

[0001] This invention relates to the fields of nuclear technology and nuclear medicine, and in particular to a mobile radionuclide production device and its method of use. Background Technology

[0002] Medical radionuclides (such as) 212 Pb, 68 Ga、 90 Y、 99m Radionuclides such as tc are indispensable in nuclear medicine fields such as positron emission tomography (PET) imaging and targeted radiotherapy, serving as core materials for achieving accurate diagnosis and efficient treatment. Currently, the production of these medical radionuclides mainly relies on large-scale fixed facilities, including nuclear reactors. This traditional production model has many significant limitations and is difficult to adapt to the diversified needs of current nuclear medicine services.

[0003] First, existing fixed production facilities are bulky and complex in structure, resulting in long construction cycles, high initial investment and operation and maintenance costs, and are limited by site constraints, making them difficult to deploy flexibly. Second, most medical radionuclides have extremely short half-lives, and their activity decays severely during long-distance transportation, leading to a significant reduction in nuclide utilization and making it difficult to meet the immediate nuclide supply needs of hospitals in remote areas, primary healthcare institutions, or during public health emergencies. Third, the radiation shielding of fixed facilities is mostly made of heavy lead or concrete, whose weight and volume cannot meet the strict weight, volume, and power consumption limitations of mobile platforms, making it difficult to achieve mobile integration. Finally, the production process of fixed facilities is cumbersome, highly dependent on on-site operation by professional technicians, and has long deployment and start-up cycles with low response efficiency, further limiting the timeliness of nuclide supply.

[0004] Existing technologies do not fully consider the special operating conditions during mobile integration and fail to solve systemic challenges such as vibration protection on mobile carriers, compact radiation shielding, stable operation in mobile states, and rapid deployment. Therefore, they cannot be directly transferred to mobile platforms for on-site production of medical radionuclides. Thus, developing a radionuclide production device that integrates radiation protection, cooling purification, and intelligent control modules and can reliably operate on mobile carriers is of urgent practical significance and important application value for overcoming the limitations of traditional production models and improving the accessibility and emergency response capabilities of nuclear medicine services. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the prior art and provide a mobile radionuclide production device and its usage method to realize on-site and rapid production of radionuclides, and to solve the problems of inflexible fixed facilities and large attenuation of short half-life nuclides during long-distance transportation.

[0006] To achieve the above objectives, the present invention provides a mobile radionuclide production device, including a mobile carrier, and an integrated radionuclide generation module, a shielding and protection module, and an intelligent control module adapted to the mobile carrier and integrated on the mobile carrier. The nuclide generation module includes at least one commercially available and regulatory-approved radionuclide generator, wherein the radionuclide generator is a compact, molded product adapted for mobile scenarios. The shielding protection module is a fixed shielding structure set around the nuclide generation module, which takes into account both shielding efficiency and the carrying requirements of the mobile carrier. The intelligent control module is electrically connected to the nuclide generation module and is used for fully automated, unmanned operation control of the radionuclide production process, solving the technical problem that fixed nuclide production facilities rely on on-site operation by professional personnel.

[0007] Preferably, the movable carrier is a specially modified heavy vehicle. The interior of the heavy vehicle is reinforced with partitions for a driver monitoring area, a generator operation and shielding heat chamber area, and an equipment area. The structural strength of each partition is compatible with the radiation protection requirements.

[0008] Preferably, the chassis of the heavy vehicle adopts a reinforced beam and has a load-bearing capacity of 20 to 50 tons. The chassis is also equipped with a high-performance air suspension system and hydraulic leveling support legs. The air suspension system is used to offset the impact and vibration during transportation, and the hydraulic leveling support legs are used to realize the rapid deployment and fixation of the device on site.

[0009] Preferably, the nuclide generation module further includes a fully automated radiopharmaceutical synthesis module used in conjunction with the radionuclide generator. The fully automated radiopharmaceutical synthesis module and the radionuclide generator form an integrated production unit with linkage control, realizing continuous automated production of radionuclides from rinsing to synthesis and purification.

[0010] Preferably, the radionuclide generator is selected from one or more of the following: molybdenum-technetium generator, germanium-gallium generator, strontium-rubidium generator, thorium-lead generator, strontium-yttrium generator, tungsten-rhenium generator, and tin metastable indium generator. The radionuclide generator can be quickly replaced to adapt to the on-site production needs of different medical radionuclides, solving the technical problems of single type of nuclide production and slow response in fixed nuclide production facilities.

[0011] Preferably, the shielding protection module is a neutron and A composite shielding structure for radiation synergistic shielding is specifically a shielding heat chamber. The main shielding material is lead plate or lead-steel composite plate, and the matrix material is boron carbide filled with lithium hydride microspheres. The lithium hydride microspheres are arranged in a body-centered tetrahedral array. The composite shielding structure is integrated and reinforced with the chassis frame of the heavy vehicle, which reduces the overall weight of the shielding body while improving the adaptability of the shielding structure to the mobile carrier, thus overcoming the technical contradiction between the limited load-bearing capacity of the mobile platform and the strict requirements for radiation protection.

[0012] Preferably, the material ratio of the composite shielding structure, the arrangement parameters of the tetrahedral body-centered array of lithium hydride microspheres, and the thickness of each shielding layer are determined using the Monte Carlo particle transport algorithm to monitor neutrons, The design was obtained by simulating and calculating the transport, scattering, and absorption processes of X-rays in composite shielding materials and then optimizing the design. Specifically, the calculations are based on the Boltzmann particle transport equation, which is as follows: ; in, The direction of particle emission; The direction of particle incidence; For Hamiltonian operators; The particle position; The emission energy of the particle; The incident energy of the particle; This represents the total cross-section of the material. The material's scattering cross section; For the radiation source term of the nuclide generation module; The shielding effect is quantified by the dose equivalent rate calculation formula, which is as follows: ; in, The surface dose equivalent rate of the shielding body; The thickness of the shielding layer; The particle flux-dose conversion factor; The algorithm optimization goal is to achieve a dose equivalent rate of ≤2.5μSv / h at any point on the outer surface of the shielded hot chamber, and to make the overall weight of the composite shielding body suitable for the load-bearing requirements of a movable carrier of 20~50 tons. Compared with the shielding structure of traditional fixed nuclide facilities, the weight of the shielding body is reduced by more than 30% while achieving the same or even better shielding effect.

[0013] Preferably, it also includes an environmental control module and a power supply module electrically connected to the intelligent control module, wherein the environmental control module and the power supply module provide the device with the ability to operate independently without external power grid / site support; The environmental control module includes a dual-channel precision air conditioning system for temperature control and forced ventilation inside the shielded heat chamber. The temperature control accuracy of the dual-channel precision air conditioning system is ±0.5℃. The main cooling circuit is adapted to the equipment temperature control of the nuclide generation module, and the auxiliary cooling circuit is adapted to the environmental temperature control of the shielded heat chamber. The power supply module includes a vehicle-mounted diesel generator set with a rated power of 50~100KVA and an online uninterruptible power supply, which realizes continuous, stable and high-quality power supply throughout the entire process of the device.

[0014] Preferably, the intelligent control module further includes a safety monitoring unit that is linked with each functional module. The safety monitoring unit is used to monitor radiation dose rate, ambient temperature, access control status and vehicle attitude parameters in real time, and has data recording, audit tracking and safety interlock protection functions. When the detected parameters exceed the preset threshold, the safety monitoring unit triggers automatic shutdown protection to realize full-process safety monitoring of nuclide production in mobile scenarios.

[0015] The present invention also provides a method of using a mobile radionuclide production device, comprising the following steps: S1. Move the device to the user-designated site, and use hydraulic leveling support legs to complete the rapid deployment and horizontal fixation of the device, thus eliminating the dependence on fixed nuclide production sites; S2. Start the vehicle-mounted diesel generator set and online uninterruptible power supply of the device, turn on the dual-circuit precision air conditioning system, complete the system self-test of each functional module, and ensure that the parameters of the device's self-sustaining operation are normal. S3. The intelligent control module issues operation commands to control the designated radionuclide generator and its supporting fully automated radiopharmaceutical synthesis module to realize the fully automated production of radionuclide rinsing, synthesis and purification. S4. During and after the production process, the safety monitoring unit of the intelligent control module continuously monitors various safety parameters, and records and tracks the operation data and parameter data of the entire production process in real time until qualified medical radionuclide products are produced.

[0016] Therefore, the present invention employs the above-mentioned mobile radionuclide production device and method of use, and the technical effects are as follows: High mobility and rapid deployment capability: Through modular integrated design, the complete radionuclide production line is mounted on a mobile carrier, eliminating the dependence on fixed sites and enabling rapid response to the radionuclide needs of hospitals, disaster areas or remote areas, realizing the concept of "bringing the factory to the point of use".

[0017] Superior radiation safety performance: The composite shielding structure is composed of boron carbide and lithium hydride microspheres and optimized based on the Monte Carlo algorithm. While achieving high-efficiency shielding (external dose equivalent rate ≤10μSv / h), the weight of the shielding body is significantly reduced, overcoming the contradiction between the limited load-bearing capacity of mobile platforms and the strict requirements for radiation protection.

[0018] Production flexibility and efficiency: The combination of the nuclide generation module and the rapidly replaceable multi-specification target system supports... 212 Pb, 68 Ga、 90 Y、 99m The technology enables the production of various medical radionuclides, including Tc. Combined with a fully automated separation and purification process, it allows for rapid preparation of high-purity radionuclides from target activation and particle irradiation to finished products in mobile environments, achieving high production efficiency and high product purity (≥99.5%).

[0019] Intelligent, stable, safe, and reliable operation: The intelligent control module enables automated operation and closed-loop control of the entire device, featuring real-time fault diagnosis, threshold alarms, and automatic shutdown protection. The shock-absorbing system equipped on the mobile carrier ensures the mechanical stability of the equipment during transportation and operation.

[0020] The technical solution of the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the structural composition of an embodiment of a mobile radionuclide production device according to the present invention; Figure 2 This is a flowchart illustrating an embodiment of the method of using a mobile radionuclide production device according to the present invention. Detailed Implementation

[0022] The technical solution of the present invention will be further described below with reference to the accompanying drawings and embodiments.

[0023] Unless otherwise defined, the technical or scientific terms used in this invention shall have the ordinary meaning understood by one of ordinary skill in the art to which this invention pertains. The terms "comprising" or "including," as used in this invention, mean that the element or object preceding the word encompasses the elements or objects listed following the word and their equivalents, without excluding other elements or objects. The terms "connected" or "linked," etc., are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect.

[0024] Example 1 This embodiment provides a vehicle-mounted germanium-gallium generator production device based on a standard van modified from a conventional van, for the production of radionuclides.68 Ga production, such as Figure 1 As shown, the device is configured as follows: Mobile Carrier: A medium-sized van was selected, with the cargo box modified into a sealed cabin that meets radiation shielding requirements. The interior is divided into a front control area, a central equipment area, and a rear chemical treatment area, solid waste collection area, and power supply area. A high-performance air suspension system was added to the chassis.

[0025] Radionuclide generation module: The production of radionuclides is completed using mature equipment equipped with germanium-gallium generators.

[0026] Shielding module: Lead plates are used for radiation isolation in the van, with boron carbide matrix added to key areas. The interior is filled with 5mm diameter lithium hydride microspheres, and the filling structure was optimized using Monte Carlo simulation. Actual measurements show that the dose equivalent rate at any point on the outer surface of the shield is below 8.5 μSv / h during device operation.

[0027] Cooling circulation module: Cooling is achieved using the car's air conditioning system.

[0028] Separation and purification module: An integrated, automated chemical synthesis module is used. The product is eluted with potassium carbonate / acetonitrile solution, and then undergoes dehydration, nucleophilic fluorination, and other steps to finally obtain the corresponding ionic solution product.

[0029] The separation and purification module includes an adsorption unit, a dissolution unit, and a purification unit connected in sequence, which are used to rapidly and efficiently separate and purify radionuclides in the irradiated target material.

[0030] 1) The core structure of the adsorption unit includes the chromatographic column, heating mantle / temperature controller, inlet pipeline and multi-way valve, and waste liquid outlet, as detailed below: Chromatographic column: A slender cylindrical cavity (made of borosilicate glass or PEEK) filled with a specific adsorbent.

[0031] for 99m Tc: The adsorbent is usually aluminum oxide (Al2O3).

[0032] for 68 Ga: The adsorbent is usually germanium tin oxide (SnO2) or a specific resin.

[0033] Heating jacket / temperature controller: Wrapped around or placed outside the chromatographic column, used to heat the adsorption column and maintain it at a specific temperature (e.g., 40~80℃) to improve adsorption efficiency.

[0034] Inlet line and multi-way valve: Connects to the input line from the radionuclide generation module (such as generator eluent or target water), and pushes the feed solution to the chromatographic column through an inert gas (such as nitrogen or helium).

[0035] Waste liquid outlet: Connected to a waste liquid bottle for collecting unadsorbed impurity liquid.

[0036] 2) The core structure of the dissolution unit includes a dissolution agent storage bottle, a precision injection pump or metering valve, and a mixing / reaction circuit, as detailed below: Dissolving agent storage bottle: for storing small amounts of specific formulations of rinsing solution or dissolving solvent.

[0037] for 99m Tc (on an Al2O3 column): The dissolving agent is physiological saline (0.9% NaCl solution).

[0038] for 68 Ga (on a SnO2 column): The dissolving agent is a dilute hydrochloric acid solution (such as 0.05M HCl).

[0039] Precision injection pumps or metering valves: precisely control the volume and flow rate of the dissolving agent to ensure efficient and quantitative elution of adsorbed nuclides.

[0040] Mixing / Reaction Loop: A coiled pipe, sometimes with heating capabilities, that allows the dissolved nuclide to react with subsequently added ligands or precursors (e.g., 68 Ga ions bind to DOTA-TATE ligands (bifunctional peptide ligands).

[0041] 3) The core structure of the refining unit includes a solid-phase extraction column or filtration membrane, a sterile filter, a product bottle, and an online detector, as detailed below: Solid-phase extraction column or filtration membrane: A small secondary purification column or sterile filter used to remove solvents, excess reagents or tiny particulate impurities.

[0042] Sterile filters: Terminal sterile, pyrogen-free filters (typically with a pore size of 0.22 microns) are key components that ensure the final product is injectable.

[0043] Product vial: The final recipient of a radionuclide injection solution that has undergone all purification steps and meets pharmacopoeia standards (such as...). 99m Tc-sodium pertechnetate injection or 68 Sterile, vacuum-sealed vials of Ga-DOTATATE injection.

[0044] Online detectors: typically radioactivity meters or gamma detectors, installed in front of the product vials to measure and calibrate the total activity of the final product in real time.

[0045] Intelligent control module: Built on an industrial PLC and SCADA system, with an integrated touchscreen. It can monitor beam current (0-50 μA), target pressure, temperature at various points, radiation dose, and system vacuum level in real time. Multiple safety interlocks are set up to automatically stop the system immediately in case of dose exceeding limits or cooling failure.

[0046] This embodiment also provides a method for using a vehicle-mounted germanium-gallium generator production device based on a standard van modified from a truck. The operation process is as follows (e.g.) Figure 2 (as shown) S1. Move the device to the user-designated site and use hydraulic leveling support legs to complete the rapid deployment and horizontal fixation of the device, thus eliminating the dependence on fixed nuclide production sites. S2. Start the vehicle-mounted diesel generator set and online uninterruptible power supply of the device, turn on the dual-circuit precision air conditioning system, complete the system self-test of each functional module, and ensure that the parameters of the device's self-sustaining operation are normal; S3. The intelligent control module issues operation commands to control the designated radionuclide generator and its supporting fully automated radiopharmaceutical synthesis module, so as to realize the fully automated production of radionuclide rinsing, synthesis and purification. S4. During and after production, the safety monitoring unit of the intelligent control module continuously monitors various safety parameters. Simultaneously, it records and tracks operational and parameter data in real time throughout the entire production process, ensuring traceability until qualified medical radionuclides are produced. 68 Ga products.

[0047] This embodiment demonstrates that the device of the present invention can stably, safely, and efficiently produce radionuclides that meet medical requirements in a mobile environment, and has significant practical value.

[0048] Therefore, the present invention employs the above-mentioned mobile radionuclide production device and method, which can realize the on-site and rapid production of radionuclides, and solve the problems of inflexible fixed facilities and large attenuation of short half-life nuclides during long-distance transportation.

[0049] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit them. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the technical solutions of the present invention, and these modifications or equivalent substitutions cannot cause the modified technical solutions to deviate from the spirit and scope of the technical solutions of the present invention.

Claims

1. A mobile radionuclide production device, characterized in that: It includes a movable carrier, and a nuclide generation module, a shielding and protection module, and an intelligent control module integrated on the movable carrier; The nuclide generation module includes at least one commercially available and regulatory-approved radionuclide generator; The shielding protection module is a fixed shielding structure set around the nuclide generation module, which takes into account both shielding efficiency and the carrying requirements of the mobile carrier. The intelligent control module is electrically connected to the nuclide generation module and is used for fully automated, unmanned operation control of the radionuclide production process.

2. The mobile radionuclide production device according to claim 1, characterized in that: The mobile carrier is a heavy vehicle. The interior of the heavy vehicle is reinforced with partitions for driving monitoring, generator operation and shielding heat chamber, and equipment. The structural strength of each partition is adapted to the radiation protection requirements.

3. A mobile radionuclide production device according to claim 2, characterized in that: The chassis of the heavy vehicle adopts a reinforced beam, and the chassis is also equipped with an air suspension system and hydraulic leveling support legs. The air suspension system is used to offset the impact and vibration during transportation, and the hydraulic leveling support legs are used to enable the rapid deployment and fixation of the device on site.

4. A mobile radionuclide production device according to claim 3, characterized in that: The nuclide generation module also includes a fully automated radiopharmaceutical synthesis module used in conjunction with the radionuclide generator.

5. A mobile radionuclide production device according to claim 4, characterized in that: The radionuclide generator is selected from one or more of the following: molybdenum-technetium generator, germanium-gallium generator, strontium-rubidium generator, thorium-lead generator, strontium-yttrium generator, tungsten-rhenium generator, and tin-metastable indium generator.

6. A mobile radionuclide production device according to claim 5, characterized in that: The shielding protection module is a neutron and The composite shielding structure for radiation synergistic shielding is specifically a shielding heat chamber. The main shielding material is lead plate or lead-steel composite plate, and the matrix material is boron carbide filled with lithium hydride microspheres. The lithium hydride microspheres are arranged in a geometric pattern of a body-centered tetrahedral array. The composite shielding structure is integrated and reinforced with the chassis frame of the heavy vehicle.

7. A mobile radionuclide production device according to claim 6, characterized in that: The material ratios, tetrahedral body-centered array arrangement parameters of the lithium hydride microspheres, and the thickness dimensions of each shielding layer of the composite shielding structure are analyzed using the Monte Carlo particle transport algorithm to detect neutrons, The design was obtained by simulating and calculating the transport, scattering, and absorption processes of X-rays in composite shielding materials and then optimizing the design. Specifically, the shielding effect is quantified using the Boltzmann particle transport equation as the core calculation basis, and the dose equivalent rate calculation formula is as follows: ； in, The surface dose equivalent rate of the shielding body; The thickness of the shielding layer; For particle flux; For particle energy; The particle flux-dose conversion factor; The algorithm optimization goal is to achieve a dose equivalent rate of ≤2.5μSv / h at any point on the outer surface of the shielded heat chamber, and to ensure that the overall weight of the composite shield is compatible with the load-bearing requirements of a movable carrier of 20~50 tons.

8. A mobile radionuclide production device according to claim 7, characterized in that: It also includes an environmental control module and a power supply module electrically connected to the intelligent control module; the environmental control module includes a dual-path precision air conditioning system for temperature control and forced ventilation inside the shielded heat chamber; the power supply module includes an on-board diesel generator set and an online uninterruptible power supply.

9. A mobile radionuclide production device according to claim 8, characterized in that: The intelligent control module also includes a safety monitoring unit that is linked with each functional module. The safety monitoring unit is used to monitor radiation dose rate, ambient temperature, access control status and vehicle attitude parameters in real time.

10. A method of using a mobile radionuclide production device as described in any one of claims 1-9, characterized in that, Includes the following steps: S1. Move the device to the user-designated site and use the hydraulic leveling support legs to complete the rapid deployment and horizontal fixation of the device; S2. Start the vehicle-mounted diesel generator set and online uninterruptible power supply of the device, turn on the dual-circuit precision air conditioning system, complete the system self-test of each functional module, and ensure that the parameters of the device's self-sustaining operation are normal. S3. The intelligent control module issues operation commands to control the designated radionuclide generator and its supporting fully automated radiopharmaceutical synthesis module to realize the fully automated production of radionuclide rinsing, synthesis and purification. S4. During and after the production process, the safety monitoring unit of the intelligent control module continuously monitors various safety parameters, and records and tracks the operation data and parameter data of the entire production process in real time until qualified medical radionuclide products are produced.

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