Radiopharmaceutical dosage calculation method and device for analysis before imaging injection

Abstract

The invention relates to a radiopharmaceutical dosage calculation method and device for analysis before imaging injection. The calculation method comprises the following steps: acquiring the current radioactive activity of a medicine and the weight and height of a patient taking the medicine at present; generating a first standard curve based on the data in the data lookup table; generating a second standard curve based on a total activity dose formula; and putting the first standard curve and the second standard curve into the same coordinate system to form two standard curves which are enveloped to form a medication safety interval and are not completely overlapped, and determining the volume dose required by the currently injected and extracted medicine for the patient according to the standard curves. The calculation device can execute the calculation method, the accuracy of medicine dose calculation is improved, and the operation efficiency of the system and the user experience are remarkably improved. Through accurate activity measurement and accurate input of patient information, the system can quickly generate a personalized dosage scheme, errors caused by manual operation are reduced, and the use safety and effect are improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of radiopharmaceutical calculation, in particular to a method and device for calculating the dosage of radiopharmaceuticals for pre-imaging injection analysis. BACKGROUND

[0002] Radiopharmaceuticals are a class of drugs containing radioisotopes, widely used in medical diagnosis and treatment. The radioisotopes of radiopharmaceuticals will decay over time, and the activity will gradually decrease. The half-lives of different radioisotopes differ greatly. Therefore, the activity of radiopharmaceuticals changes at different rates over time, which poses different requirements for the use and management of the drugs.

[0003] CN116486991A discloses a method for controlling the activity of a radionuclide, mainly used in radiotherapy scenarios. The core of the method is to measure the actual activity of the radionuclide and compare it with the predetermined activity, combined with real-time monitoring of the patient's vital signs and nuclide distribution during the injection process, to dynamically adjust the injection speed and time. However, this method has the following significant technical limitations, which cannot meet the special needs of radiopharmaceutical dosage calculation in imaging diagnosis (such as PET-CT):

[0004] Firstly, the dosage calculation method of this prior art completely relies on the patient's basic physiological parameters such as weight, age, gender, and the matching results of historical treatment plans, without considering individualized parameters directly related to the metabolism and enrichment of radiopharmaceuticals (such as blood sugar level, insulin sensitivity index, liver enzyme activity, and kidney clearance rate). This single calculation method ignores the influence of individual differences on the drug metabolism rate and distribution characteristics, resulting in a lack of accuracy in the dosage calculation results, making it difficult to meet the dual constraints of dosage safety and imaging clarity in imaging scenarios.

[0005] Secondly, the dosage control process of this prior art relies on real-time monitoring during the injection process and the subjective experience adjustment of doctors, which is completely unfeasible in imaging scenarios. Imaging drugs (such as 18F-FDG) have a very short half-life (about 110 minutes), requiring a one-time accurate calculation of the dosage before injection, and the development must be completed immediately after injection, without tolerating dynamic adjustment during the injection process or additional dosage operations after injection. This prior art does not design a corresponding dosage calculation model for such time-sensitive needs, and its method will cause dosage error accumulation in imaging scenarios, leading to image quality degradation or excessive radiation risk.

[0006] Again, the prior art does not introduce a double-track mechanism combining data lookup table and numerical calculation, nor does it construct a medication safety interval formed by a standard curve envelope based on body surface area (BSA) and total activity dose (D). This lack of quantitative calibration and safety threshold constraint in dose calculation may cause the dose to deviate from the reasonable range due to individual differences or fluctuations in drug properties (such as activity decay rate) in the imaging scene, which cannot guarantee the imaging effect and patient safety.

[0007] Finally, the prior art does not disclose any technical features related to hardware composition and automated dose calculation, and its method highly depends on manual operation, which has problems such as large measurement error, complicated operation, and low efficiency, and is difficult to adapt to the demand for fast, efficient, and accurate access to radiopharmaceuticals in the imaging scene.

[0008] The above technical defects make the radionuclide activity control method of the prior art unable to be directly applied to the imaging diagnosis field, especially in the scene of PET-CT and other highly demanding scenarios in terms of dose accuracy and operation timeliness. SUMMARY

[0009] The present application discloses a method for calculating the amount of radiopharmaceuticals for imaging pre-injection analysis, which comprises the following steps:

[0010] Obtaining the current radioactivity of the drug in the storage bottle and the weight and height of the patient to be treated with the drug;

[0011] Generating a first standard curve based on the data in the built-in data lookup table corresponding to different types of radiopharmaceuticals summarized from experience;

[0012] Generating a second standard curve based on the total activity dose formula with the standard recommended dose for a specific drug type and diagnosis purpose as a coefficient;

[0013] Placing the first standard curve and the second standard curve in the same coordinate system to form two standard curves that do not completely overlap to form a safe interval for medication, and determining the required volume of the drug to be extracted for the current injection of the patient according to the standard curve, wherein the first standard curve and the second standard curve both take body surface area as the horizontal coordinate and total activity dose as the vertical coordinate.

[0014] The recommended dose or total activity dose is corrected according to the type of drug and the individualized condition of the patient, wherein the individualized condition is a physiological parameter related to the metabolism and enrichment of the patient to the radiopharmaceutical, including blood glucose level, insulin sensitivity index, liver enzyme activity, and / or renal clearance rate.

[0015] The dose calculation method for radiopharmaceuticals for pre-injection imaging analysis of the present application has significant innovation and unexpected beneficial technical effects compared to the prior art (such as CN116486991A). First, the present application designs a safety interval model of a double-standard curve envelope for the dual constraints of radiopharmaceutical dose in the imaging scene (such as PET-CT), i.e. the upper limit of radiation safety and the lower limit of imaging clarity. By combining the first standard curve generated from empirical data and the second standard curve based on the recommended dose formula, it ensures that the dose meets both radiation protection requirements (ALARA principle) and imaging quality needs (such as SUV value compliance). This safety interval model solves the dose deviation problem caused by relying solely on historical experience matching or single parameter calculation in CN116486991A, especially for imaging drugs (such as 18F-FDG) that must be accurately calculated once due to their short half-life (about 110 minutes), avoiding the technical defect of being unable to dynamically adjust the dose or supplementary injection after injection. Second, the present application introduces a patient individualization parameter correction mechanism, considering physiological parameters such as blood glucose level, insulin sensitivity index, liver enzyme activity, and kidney clearance rate, which are directly related to drug metabolism and enrichment, to dynamically adjust the recommended dose or total activity dose. For example, high blood sugar patients need to increase the dose to compensate for the competitive inhibition of drug uptake by glucose, while patients with renal dysfunction need to reduce the dose to avoid the increase in background noise caused by delayed drug clearance. This fine individualized adjustment cannot be achieved by the calculation method based solely on basic parameters such as weight and age in CN116486991A. In addition, the present application automatically calculates through software and hardware integration, combines the signal connection of the activity measurement unit and the analysis unit, and real-time corrects the dose loss caused by the adhesion of the syringe (the adhesion amount is predicted by image segmentation algorithm and neural network model), significantly reducing the manual operation error (the traditional method has a split error rate of >5%), and shortening the operation time from 2-3 minutes to seconds, greatly improving the efficiency and accuracy of drug dispensing. CN116486991A does not disclose any hardware composition and automation features, and its method of relying on manual experience to adjust the dose is completely impractical in the imaging scene. Through the synergistic effect of the double-curve safety interval and individualized parameter correction, the present application fills the technical gap in the field of imaging dose control. Finally, the present application uses a dual-track mechanism of data lookup table and numerical calculation to flexibly respond to the dose requirement differences of different drug types (such as 18F-FDG, 99mTc, etc.) and treatment purposes, while recording all calculation process data for subsequent optimization, providing a scientific basis for clinical decision-making. These innovations not only overcome the fundamental technical contradictions of CN116486991A in the imaging scene (such as dynamic adjustment being unfeasible, individualized parameters being missing, and manual errors being large), but also solve industry pain points (such as high repeat examination rate and insufficient radiation risk control), achieving a balance between dose accuracy, operation timeliness, and individualized adaptability, with significant clinical value and technical progressiveness.

[0016] The application also discloses a radioactive drug dose calculation device for imaging pre-injection analysis, which is used for determining the volume of a drug required for current injection extraction of a patient according to the radioactivity of the drug in a storage bottle and the related basic information of the patient. After receiving the current radioactivity and the weight and height of the patient, the calculation device generates a first standard curve based on searching data in a built-in data lookup table corresponding to different types of radioactive drugs according to the experience summary for different types of radioactive drugs, and generates a second standard curve based on a total activity dose formula with the standard recommended dose of a specific drug type and a diagnosis purpose as a coefficient, and the first standard curve and the second standard curve both take the body surface area as the abscissa and the total activity dose as the ordinate, so that the two standard curves form an incomplete overlap in the same coordinate system to form a safe interval for drug use.

[0017] The calculation device can correct the recommended dose or the total activity dose according to the drug type and in combination with the personalized conditions of the patient, wherein the personalized conditions are physiological parameters related to the metabolism and enrichment of the radioactive drug of the patient, including blood glucose level, insulin sensitivity index, liver enzyme activity and / or kidney clearance rate.

[0018] After receiving the current radioactivity of the drug in the storage bottle sent by the activity measurement unit and the related basic information of the patient sent by the input unit, the calculation device can determine the volume of the drug required for current injection extraction by searching the built-in data lookup table corresponding to different types of radioactive drugs according to the experience summary, and / or can determine the volume of the drug required for current injection extraction by numerical calculation according to the specific physiological parameters of the patient and the specific activity of the drug.

[0019] By combining the data lookup table and the numerical calculation, the application provides a flexible dose calculation method, which significantly improves the accuracy and personalization level of dose calculation. The data lookup table is based on rich clinical experience and data accumulation, which ensures the accuracy and reliability of dose calculation; the numerical calculation method can perform personalized dose calculation according to the specific physiological parameters of the patient and the characteristics of the drug, which improves the accuracy of the dose and the diagnosis / treatment effect. In addition, this flexible dose calculation method can also adapt to different types of radioactive drugs and different diagnosis / treatment needs, which improves the adaptability and expansibility of the system.

[0020] When the calculation device determines the volume of the drug required for current injection extraction by numerical calculation, the selected physiological parameters of the patient include the body surface area calculated based on the height and weight of the patient, and based on the obtained body surface area, the total activity dose that the patient should receive is calculated in combination with the recommended dose of the corresponding drug.

[0021] By calculating the body surface area of the patient and combining the recommended dose of the drug, the present application can provide a more personalized dose calculation method, significantly improving the accuracy of dose calculation and diagnosis / treatment effect. Body surface area is an important physiological parameter that can more accurately reflect the patient's metabolic demand and drug distribution characteristics, thereby improving the level of individualization of dose calculation. This dose calculation method based on body surface area not only helps to achieve a more scientific and individualized diagnosis / treatment plan, but also reduces the failure of diagnosis / treatment caused by inaccurate dose, improving the safety and effectiveness of use.

[0022] The computing device can receive the current radioactivity of the drug in the drug storage bottle through the activity measurement unit, and the activity measurement unit can be arranged with a corresponding detector at a special measurement site close to the corresponding drug storage bottle in the drug storage bottle storage area. The raw signal collected by the detector is sent to the processor of the activity measurement unit after conversion, so as to calculate the radioactivity of the drug through signal processing.

[0023] By arranging the detector at the special measurement site in the drug storage bottle storage area, the present application can significantly improve the accuracy and stability of activity measurement. This design not only reduces the interference and loss on the signal transmission path, but also ensures that each sample to be measured can be placed correctly in front of the detector, avoiding measurement errors caused by improper position. The design of the special measurement site can also realize multi-point synchronous measurement, further improving the consistency and reliability of the measurement results. In addition, this high-precision measurement method can also provide more reliable data support for subsequent dose calculation, which helps to realize more fine and individualized diagnosis / treatment plan, and improve the diagnosis / treatment effect and life quality of patients.

[0024] The processor of the activity measurement unit integrates the corrected signal using the gradient method to obtain the total energy or total count of the signal, and then calculates the radioactivity of the drug according to the integral result and physical parameters, wherein the physical parameters include detector efficiency and / or calibration factor.

[0025] By integrating the corrected signal using the gradient method and combining the detector efficiency and calibration factor, the present application can significantly improve the accuracy and stability of activity calculation. The gradient method can effectively eliminate noise and interference in the signal, improve the signal-to-noise ratio of the signal, and thus ensure the high precision of activity measurement. The introduction of detector efficiency and calibration factor further corrects the measurement result, eliminates systematic error, and ensures the reliability of activity calculation. This high-precision activity measurement method not only provides more reliable data support for dose calculation, but also helps to realize real-time monitoring and dynamic adjustment of drug activity, improving the intelligent level of the system.

[0026] The data processed by the processor of the activity measurement unit can be displayed to the user through a graphical interface, wherein the processor of the activity measurement unit can be communicatively connected with the medical terminal, so that the key parameters including the currently measured activity value, the reference value range can be displayed on the interface of the medical terminal, and the historical data query function is provided.

[0027] Through the communication connection between the graphical interface and the medical terminal, the application not only provides an intuitive data display function, but also realizes real-time sharing and remote management of data. The graphical interface enables medical personnel to intuitively view the current activity value and reference value range, and timely understand the activity state of the drug, thereby improving the convenience and accuracy of operation. At the same time, the historical data query function provides detailed medication records and historical data, which helps medical personnel to perform subsequent management and analysis, and optimizes the diagnosis / treatment scheme. In addition, the remote management function can also realize cross-regional data sharing and collaborative work, improve the utilization efficiency of medical resources, help to promote the construction of medical information, and improve the overall level of medical services.

[0028] The device can be communicatively connected with an input unit for acquiring relevant basic information of the current medication patient, to receive the weight and height of the current medication patient, wherein the input unit can be configured with a digital input device.

[0029] The input unit can verify the accuracy of the relevant basic information input through the input device by setting the numerical range of the corresponding parameters, so that the correct relevant basic information entered in the input unit can be transmitted to the computing device through a secure protocol.

[0030] By configuring a digital input device and setting the numerical range of the parameters, the application can significantly improve the accuracy and completeness of patient information entry. The digital input device provides a user-friendly operation interface, reduces the error of manual input, and ensures the accuracy and consistency of data. The parameter numerical range verification mechanism can automatically detect and correct input data errors, avoiding dose calculation errors caused by inaccurate data. In addition, the secure protocol transmission ensures the safety and integrity of data during transmission, preventing the risk of data tampering or leakage. This high-precision data entry and transmission mechanism not only improves the reliability and safety of the system, but also helps to realize standardized and standardized management of data, promotes the construction of medical information, and improves the overall level of medical services.

[0031] The computing device can be communicatively connected with a volume measurement unit for measuring the current residual volume of the drug in the drug storage bottle, wherein the volume measurement unit can be arranged with electrodes outside the corresponding drug storage bottle, so that the computing device can calculate the required drug volume of the patient based on the residual volume of the drug obtained by the volume measurement unit based on the capacitive volume measurement technology.

[0032] By arranging the (ring-shaped) electrodes outside the medicine storage bottle and using the capacitive volume measurement technology, the present application can achieve non-contact volume measurement, significantly improving the accuracy and stability of the measurement. The design of the ring-shaped electrode ensures uniform distribution of the measurement signal, avoiding measurement errors caused by improper positioning. This non-contact measurement method not only avoids contamination of the medicine and radiation exposure risk to the operator, but also enables multi-point synchronous measurement, further improving the consistency and reliability of the measurement results. In addition, this high-precision volume measurement method can provide more reliable data support for dose calculation, helping to achieve more precise and personalized diagnosis / treatment plans, and improving the diagnosis / treatment effect and quality of life of patients.

[0033] The computing device can be in communication connection with the timing unit, the timing unit can start timing when the computing device obtains the calculation result, and the timing unit can set different interval lengths for different types and states of medicines.

[0034] When the medicine taking operation is not completed within the set interval length, it is determined that the current medicine taking operation is invalid, and the timing unit sends an invalid signal to the computing device to make the computing device recalculate according to the current situation.

[0035] By monitoring the time interval of medicine taking in real time and setting different interval lengths, the present application can significantly improve the accuracy of medicine dosage and the diagnosis / treatment effect. Setting different interval lengths for different types and states of medicines can better adapt to the activity change characteristics of different medicines, improving the accuracy of the dose and the diagnosis / treatment effect. When the set interval length is exceeded, the system can timely issue an alarm and recalculate the dose, avoiding diagnosis / treatment failure caused by too low activity, improving the reliability and safety of the system. In addition, this real-time monitoring and dynamic adjustment mechanism can also realize whole-process tracking and management of the activity of the medicine, improving the intelligent level of the system, and helping to optimize the medical process and improve the overall level of medical services.

[0036] The timing unit can adjust the interval length of each medicine in real time based on parameters including the half-life of the medicine, the current activity value, and the maximum allowed activity loss, wherein the maximum allowed activity loss can be calculated by the computing device when calculating the volume of the medicine according to the preset maximum error value.

[0037] By adjusting the interval length of each drug in real time based on the half-life of the drug, the current activity value and the parameter of the maximum allowed activity loss, the present application can significantly improve the accuracy of drug dosage and the effect of diagnosis / treatment. The introduction of half-life and current activity value makes the setting of interval length more scientific and reasonable, and better adapts to the activity change characteristics of different drugs. The calculation method of the maximum allowed activity loss ensures the accuracy and reliability of the dosage calculation, and avoids the failure of diagnosis / treatment caused by too low activity. In addition, this dynamic adjustment timing mechanism can also realize real-time monitoring and dynamic adjustment of the activity of the drug, improving the intelligent level of the system.

[0038] In the field of nuclear medicine, traditional radiopharmaceutical dosage calculation often relies on manual operation, which is not only inefficient and prone to errors, but also lacks systematic data storage and subsequent analysis capabilities, making it difficult to meet the high standards of accuracy and safety required by modern medicine. However, the radiopharmaceutical dosage calculation device for pre-imaging injection analysis provided by the present application is connected in communication with the activity measurement unit and the input unit, forming a radiopharmaceutical dosage control system, realizing the full-process automatic management from drug activity measurement to patient information acquisition to dosage calculation. This system can not only accurately measure the current activity of the radiopharmaceutical in the storage bottle in real time, but also automatically calculate the personalized injection volume based on the patient's weight, height and other physiological parameters, ensuring the accuracy of each dose. At the same time, all data during the operation process are digitally recorded for future query and analysis, providing detailed historical medication records for medical staff, which helps to optimize treatment plans. This design not only improves the accuracy of drug dosage calculation, but also significantly improves the operation efficiency and user experience of the system. Through accurate activity measurement and accurate entry of patient information, the system can quickly generate personalized dosage plans, reducing human error, reducing repeated extraction, and reducing the time of medical staff frequently contacting radioactive drugs, improving the safety and effectiveness of diagnosis / treatment. In addition, the automatic management function of the system can also reduce the work burden of medical staff, improve the utilization efficiency of medical resources, help to optimize the medical process, and improve the overall level of medical services. BRIEF DESCRIPTION OF DRAWINGS

[0039] Figure 1 is a hardware connection diagram of a radiopharmaceutical dosage control system of a preferred embodiment provided by the present application;

[0040] Figure 2 is a data processing schematic diagram of the processor of the activity measurement unit of a preferred embodiment provided by the present application;

[0041] Figure 3 is a working schematic diagram of the calculation device of a preferred embodiment provided by the present application;

[0042] Figure 4 This is a schematic diagram of the standard curve and safety range of a preferred embodiment provided by the present invention;

[0043] Figure 5 This is a schematic diagram of the operation of a volume measuring unit according to a preferred embodiment of the present invention;

[0044] Figure 6 This is a schematic diagram of the operation of a timing unit according to a preferred embodiment of the present invention;

[0045] Figure 7 This is a flowchart of the calculation method according to a preferred embodiment of the present invention.

[0046] List of reference numerals

[0047] 100: Activity measurement unit; 110: Processor; 120: Detector; 200: Input unit; 210: Input device; 300: Computing device; 400: Medical terminal; 500: Drug storage bottle; 600: Volume measurement unit; 610: Electrode; 700: Timing unit. Detailed Implementation

[0048] The following is a detailed explanation with reference to the accompanying drawings.

[0049] Example 1

[0050] like Figure 1 As shown, this invention discloses a radiopharmaceutical dosage control system, comprising: an activity measurement unit 100 for measuring the current radioactivity of a drug in a storage bottle 500; an input unit 200 for acquiring relevant basic information of the current patient; and a calculation device 300 for determining the required volume of drug to be injected for the current patient based on the radioactivity of the drug in the storage bottle 500 and the relevant basic information of the current patient. Further, the calculation device 300 of this invention is particularly useful for analyzing radiopharmaceutical dosage before imaging injection. Preferably, the relevant basic information of the current patient may include the patient's weight and height. More preferably, the aforementioned relevant basic information may also include the patient's age. Preferably, the storage bottle 500 of this invention is typically a glass container and can be placed inside a lead can or lead box to effectively shield the radiation released by the radioactive material, reducing the impact on the surrounding environment and personnel. The storage bottle 500 may be, for example, a vial or ampoule.

[0051] Preferably, the activity measurement unit 100 relies on high-precision radiation detectors to complete the measurement of radioactivity. Depending on different application scenarios and technical requirements, the activity measurement unit 100 can select different types of detectors 120, such as scintillator detectors and semiconductor detectors. Preferably, the scintillator detector utilizes the characteristic of emitting fluorescence after absorbing rays by a specific material (such as NaI(Tl), which is an inorganic scintillator composed of sodium iodide crystal doped with thallium) to achieve activity measurement. When the gamma rays emitted by radioactive substances pass through the crystal, the crystal is excited to produce fluorescence, which is converted into an electrical signal by a photomultiplier tube and recorded after amplification. This method has high detection efficiency and good energy resolution, and is suitable for the measurement of various radionuclides. Preferably, the semiconductor detector, especially the high-purity germanium (HPGe) detector, is widely used for precise measurement due to its excellent energy resolution. The working principle of the HPGe detector is that under low-temperature conditions, when gamma rays enter the germanium crystal, electron-hole pairs are generated, and these carriers move under the action of an external electric field to form current pulses. After amplification and processing, the energy information of the rays can be obtained. Compared with the scintillator detector, the HPGe detector can more accurately distinguish rays of different energies, and is particularly suitable for precise measurement of low-activity samples.

[0052] Preferably, the electrical signals generated by the detector 120 can be converted into digital signals by an analog-to-digital converter (ADC), and then transmitted to the processor 110 of the activity measurement unit 100 through a standard interface (such as USB, Ethernet, or a dedicated data bus). Further, during this process, the stability and speed of signal transmission should be ensured to achieve real-time monitoring.

[0053] Preferably, the activity measurement unit 100 can also be equipped with a refrigeration device and a stable power supply to ensure that the detector 120 maintains optimal performance throughout the use cycle, especially for HPGe detectors that require a low-temperature environment to function properly.

[0054] Preferably, in order to obtain the most accurate measurement results, the detector 120 of the activity measurement unit 100 can be arranged at a special measurement site set in the storage area of the storage bottle 500, which is as close as possible to the corresponding storage bottle 500 to ensure that each sample to be measured can be correctly placed in front of the detector 120. Further, in order to protect the operating personnel from unnecessary radiation exposure, sufficient radiation shielding, such as lead plates or other heavy shielding materials, should be provided around the detector 120.

[0055] Preferably, the raw signal collected by the probe 120 is sent to the processor 110 of the activity measurement unit 100 after conversion, and signal processing is performed through the algorithm built-in the processor 110 of the activity measurement unit 100, including noise filtering, baseline correction and other steps, to calculate the radioactivity of the drug. The flow steps of data processing performed by the processor 110 of the activity measurement unit 100 can be as shown in Figure 2

[0056] Preferably, in the noise filtering step, the processor 110 of the activity measurement unit 100 can use a combination of low-pass filtering and median filtering to complementarily remove different types of noise and improve signal quality, wherein low-pass filtering can remove high-frequency noise such as electromagnetic interference, and in radioactivity detection, by setting the cutoff frequency to filter out signals higher than the frequency, electronic noise and environmental interference can be effectively removed; median filtering can remove spike noise such as transient interference caused by cosmic rays, and median filtering can effectively remove spike noise by smoothing the median value of signals within a certain window.

[0057] Preferably, in the baseline correction step, the processor 110 of the activity measurement unit 100 can correct baseline drift and baseline offset respectively, wherein baseline drift refers to slow changes in the signal baseline due to factors such as temperature changes and power fluctuations, and baseline offset refers to the overall upward or downward movement of the signal. Preferably, the processor 110 of the activity measurement unit 100 can use a polynomial fitting method to correct the baseline drift, because in radioactivity detection it can more flexibly adapt to changes in the baseline, especially in the case of complex baseline drift, wherein the polynomial fitting method uses a low-order polynomial (such as a first or second order polynomial) to fit the baseline, and then subtracts the fitted baseline from the original signal to obtain the corrected signal, thereby effectively removing the slow-changing baseline drift. Preferably, the processor 110 of the activity measurement unit 100 can use a reference signal correction method to correct the baseline drift, because in radioactivity detection it can provide higher accuracy, especially in the case of quantitative analysis, wherein the reference signal correction method uses a known reference signal for comparison to adjust the signal baseline to match the reference signal, to ensure high-precision measurement.

[0058] Preferably, in the step of calculating the radioactivity of the drug, the processor 110 of the activity measurement unit 100 can obtain the total energy or total count of the signal by integrating the corrected signal, wherein in radioactivity detection, the gradient method can be used for numerical integration because it is simple to calculate and can meet the accuracy requirements in most cases.

[0059] ​Preferably, the processor 110 of the activity measurement unit 100 can calculate the radioactivity of the drug according to the integral result and known physical parameters, and the calculation formula is as follows:

[0060]

[0061] wherein A is the radioactivity, in units of mCi; N is the number of counts detected in time t; ε is the detector efficiency; and t is the measurement time.

[0062] Preferably, the detector efficiency refers to the ratio of the number of rays that can be detected by the detector 120 to the number of rays actually emitted, which reflects the response capability of the detector 120 to rays of a specific energy and type, and can be determined by experimental calibration. Further, the processor 110 of the activity measurement unit 100 can also be provided with a calibration factor k for correcting the measurement result to compensate for possible systematic errors in the measurement process, which can be caused by factors such as the characteristics of the detector 120 itself, environmental conditions, and measurement methods. The calibration factor can also be determined by experimental calibration. Therefore, the calculation formula of the corrected radioactivity is as follows:

[0063]

[0064] wherein k is the calibration factor.

[0065] Preferably, the data processed by the processor 110 of the activity measurement unit 100 can be expressed in the internationally recognized unit of radioactivity (usually mCi) and displayed to the user through a graphical interface. Preferably, the processor 110 of the activity measurement unit 100 can be communicatively connected to the medical terminal 400, so that the interface of the medical terminal 400 can display key parameters such as the currently measured activity value, the reference value range, etc., and also provide a historical data query function to help the user understand the trend of the activity of the drug. Preferably, when the measurement result exceeds the preset safety range, the processor 110 of the activity measurement unit 100 can automatically trigger an alarm to remind the operator, wherein the alarm can be presented through vision (such as a red warning light), hearing (such as a beeping sound), or a combination of both, to ensure that attention can be quickly drawn even in a noisy environment. In addition, the alarm can also be reminded through the medical terminal 400.

[0066] Preferably, the activity measurement unit 100 can be communicatively connected to the computing device 300, so that the currently measured activity value of the activity measurement unit can be sent to the computing device 300, thereby facilitating the computing device 300 to calculate the amount of drug to be taken.

[0067] Preferably, in order to ensure the accuracy of the measurement, the activity measurement unit 100 can be calibrated regularly, and the calibration process and results can be recorded. In addition, a detailed maintenance plan can also be formulated, including cleaning, inspection and replacement of damaged parts, etc., to ensure the long-term stable operation of the equipment.

[0068] Preferably, in order to ensure the efficiency of the system and the accuracy of the data, the input unit 200 responsible for collecting and verifying the basic information and medical history of the patient can take into account user-friendliness, data verification and privacy protection in design. Preferably, the input unit 200 can be configured with a digital input device 210, which can be built-in in the medical care end 400, for example, the input device 210 can be a touch screen or a keyboard, etc. Preferably, when the input device 210 of the input unit 200 is a touch screen, the capacitive touch screen has better sensitivity and response speed, and is more suitable for use in medical environment. Preferably, when the input device 210 of the input unit 200 is a keyboard, it can be a standard QWERTY keyboard or a simplified keyboard specially designed for medical environment, to adapt to the case where there is a large amount of text information input.

[0069] Preferably, the patient data input through the input unit 200 can be stored in a structured manner to facilitate data exchange with the computing device 300. Preferably, the data storage format can include relational databases (such as MySQL, PostgreSQL) and NoSQL databases (such as MongoDB), wherein the relational database is suitable for structured data, supports complex queries and transaction processing; the NoSQL database is suitable for unstructured or semi-structured data, supports high concurrency access and distributed storage.

[0070] Preferably, the input unit 200 can verify the accuracy of the relevant basic information input through the input device 210, for example, the input data can be limited by setting a reasonable numerical range, so as to avoid the entry of incorrect data. Exemplarily, for age information, the input unit 200 can limit it to 0-130 years old; for weight, the input unit 200 can limit it to 0-500 kg; for height, the input unit 200 can limit it to 0-250 cm.

[0071] Preferably, the data transmission between the input unit 200 and the computing device 300 should use a safe and reliable protocol, such as HTTPS, TLS, etc., to ensure the security and integrity of the data during transmission. At the same time, the system needs to comply with relevant medical data protection laws and regulations to protect the safety of patients' personal information.

[0072] Preferably, the computing device 300 can be configured with a high-performance CPU to process data from the activity measurement unit 100 and the input unit 200 to determine the volume of the current injection of the drug for the patient by calculation. Preferably, a multi-core CPU can process multiple tasks in parallel to improve computing efficiency, and a high-frequency CPU can execute a single task faster to shorten the calculation time. Preferably, the computing device 300 can be provided with sufficient memory (e.g., at least 16 GB of RAM) to store and process a large amount of data, wherein a high-speed memory can improve data read / write speed and improve system performance. Preferably, the computing device 300 can be provided with a reliable storage device to save patient data and calculation results, wherein the storage device can have a large capacity (e.g., at least 500 GB) of storage space to accommodate a large number of data files and log records.

[0073] Preferably, the computing device 300 can be connected to the activity measurement unit 100 and the input unit 200 through wired and / or wireless communication, wherein the wired connection can include Ethernet connection suitable for long-distance transmission and USB connection suitable for short-distance transmission; the wireless connection can include Wi-Fi connection suitable for mobility scenarios and Bluetooth connection suitable for short-distance, low-power device communication. Preferably, data reception of the computing device 300 can be realized through standardized communication protocols (such as TCP / IP, HTTP) to ensure data integrity and security. Further, the computing device 300 can check the received data to ensure data accuracy and integrity, and the data after verification can be preprocessed through data cleaning, format conversion, and normalization to prepare for subsequent algorithm calculation, wherein data cleaning is used to remove invalid or erroneous data to ensure data quality; format conversion is used to convert data from different sources to a unified format for easy processing; normalization is used to scale data to the same range to improve the convergence speed and accuracy of the algorithm.

[0074] Preferably, as Figure 3As shown, the computing device 300 can be built-in with a data lookup table summarized from experience, and different types of radiopharmaceuticals can have corresponding data lookup tables. Exemplarily, the radiopharmaceuticals applicable to the radiopharmaceutical dosage control system of the present application can include but are not limited to 18F-FDG, TSPO, AV45, AV133, wherein the radioisotopes of the above four radiopharmaceuticals are all 18F, and the half-life thereof is about 110 minutes. Preferably, 18F-FDG is 2-[18F]fluoro-2-deoxy-D-glucose, which is the most commonly used positron emission tomography (PET) tracer, mainly used for the diagnosis of oncology, neurology and cardiology. It is taken up by cells and phosphorylated in cells by simulating the metabolic pathway of glucose, thereby showing the metabolic activity of cells in PET images. Studies have shown that fasting can significantly affect the metabolism and imaging contrast of 18F-FDG. During fasting, the metabolic substrate of the body shifts from glucose to free fatty acids, and this metabolic shift can be used to suppress the physiological uptake of myocardium, thereby improving the contrast of 18F-FDG in cardiology and cancer imaging. (Ahmadpour, S., Hosseinimehr, S., & Habibi, M. (2022). Various Aspects of Fasting on the Biodistribution of Radiopharmaceuticals. Current drug metabolism.) Preferably, TSPO is a [18F]TSPO ligand, which is used for PET imaging, mainly for the evaluation of brain inflammation and neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease. TSPO ligands can bind to translocator protein (TSPO) on mitochondria, thereby reflecting the degree of cell inflammation and damage. Research on TSPO radiopharmaceuticals mainly focuses on the optimization of pharmacokinetic parameters of other radiopharmaceuticals. Through a physiologically based pharmacokinetic (PBPK) model, the distribution and uptake of radiopharmaceuticals in the body can be simulated and predicted, thereby optimizing the treatment regimen.(Abdollahi, H., Fele-Paranj, A., Saboury, B., Uribe, C., & Rahmim, A. (2023). Radiobiological-guided radiopharmaceutical therapy: Radiopharmacokinetic parameter optimization using PBPK modeling. 2023 IEEE Nuclear Science Symposium, Medical Imaging Conference and International Symposium on Room-Temperature Semiconductor Detectors (NSS MIC RTSD), 1-1.) Preferably, AV45 is [18F] Florbetapir, a beta-amyloid (Aβ) tracer for PET imaging, mainly used for early diagnosis of Alzheimer's disease, which can specifically bind to Aβ plaques in the brain, showing the distribution of plaques in PET images. AV45 is mainly used for imaging studies of Alzheimer's disease. Similar radiopharmaceutical studies have shown that pharmacokinetic parameters such as binding rate, internalization rate, and serum protein binding rate have a significant impact on the biodistribution and effective dose of the drug. (Siebinga, H., De Wit-Van Der Veen, B., Stokkel, M., Huitema, A., & Hendrikx, J. (2022). Current use and future potential of (physiologically based) pharmacokinetic modelling of radiopharmaceuticals: a review. Theranostics, 12, 7804-7820.) Preferably, AV133 is [18F] Flutemetamol, AV133 is another beta-amyloid (Aβ) tracer for PET imaging, mainly used for the diagnosis of Alzheimer's disease, which can specifically bind to Aβ plaques in the brain, showing the distribution of plaques in PET images. The metabolism and enrichment of these four radiopharmaceuticals are significantly affected by patient physiological parameters: 18F-FDG: blood glucose (BG) and insulin sensitivity index (ISI) need to be corrected; TSPO ligands: liver enzyme activity (LEA) needs to be corrected; AV45 and AV133: kidney function (GFR) and blood glucose (BG) need to be corrected.(Abdollahi, H., Yousefirizi, F., Shiri, I., Brosch-Lenz, J., Mollaheydar, E., Fele-Paranj, A., Shi, K., Zaidi, H., Alberts, I., Soltani, M., Uribe, C., Saboury, B., & Rahmim, A. (2024). Theranostic digital twins: Concept, framework and roadmap towards personalized radiopharmaceutical therapies. Theranostics, 14, 3404-3422.).

[0075] Exemplarily, the following are partial data lookup tables for the four types of radiopharmaceuticals mentioned above.

[0076]

[0077]

[0078] Preferably, as shown in FIG. 3, the computing device 300 can calculate the dose of the radiopharmaceutical according to the patient-specific physiological parameters and the specific activity of the drug, wherein the patient-specific physiological parameters can be, for example, the body surface area BSA. Preferably, the body surface area can be calculated by the following formula: Figure 3

[0079] BSA = 0.007184 x H x W, 0.725 0.425

[0080] wherein BSA is the body surface area in square meters, H is the height in centimeters, and W is the weight in kilograms.

[0081] Preferably, after obtaining the body surface area, it can be used to calculate the dose of the radiopharmaceutical. Generally, the dose of the drug will give the required activity per unit of body surface area. Therefore, if the recommended dose of a drug is amCi / m2, then the total activity dose D that the patient should receive can be calculated by the total activity dose formula: 2

[0082] D = a x BSA.

[0083] Further, the recommended dose a of the drug can be determined by literature and guidelines recommendations, clinical trial data, and / or pharmacokinetic and pharmacodynamic models, etc., wherein different types of drugs can have corresponding recommended doses a.

[0084] ​​​​In nuclear medicine practice, the calculation of radiopharmaceutical dosage is a key step to ensure the effectiveness of diagnosis / treatment and patient safety. However, the current technology has obvious limitations in dealing with radiopharmaceuticals with different characteristics. On the one hand, due to the complexity of radiopharmaceuticals, including but not limited to their half-life, particle type (such as gamma rays, beta particles), chemical properties, and biodistribution characteristics, each drug has different requirements for dosage. On the other hand, the existing dosage calculation methods mostly fail to fully consider the diversity of these drug characteristics, resulting in recommended dosages that are often based on fixed patterns or empirical formulas, lacking targeted correction mechanisms. For example, when faced with radioisotopes with different half-lives, existing technology has difficulty adjusting in real time according to the activity of the drug over time; for example, for radiopharmaceuticals with strong affinity for specific tissues, the current approach does not provide sufficient flexibility to meet individualized diagnostic / treatment needs. In addition, traditional dosage calculation methods usually rely on manual input of parameters and offline processing, which not only increases the risk of human error, but also limits the effective use of historical data, making it impossible to support post-analysis and optimization.

[0085] Preferably, the computing device 300 of the present application can simultaneously use the above-mentioned data lookup table and numerical calculation method to accurately determine the total activity dose D that the patient should receive, wherein the computing device 300 can generate at least two standard curves through different data sources for different types of radiopharmaceuticals. Further, the computing device 300 can generate a first standard curve based on the data in the corresponding data lookup table, and can generate a second standard curve based on the total activity dose formula with the standard recommended dose for a specific drug type and diagnosis / treatment purpose as a coefficient, wherein the first standard curve and the second standard curve can both take body surface area BSA as the abscissa and total activity dose D as the ordinate, thereby forming two standard curves that do not completely overlap in the same coordinate system, and forming a safety interval through the envelope of the two standard curves.

[0086] Preferably, the precision of the total activity dose D that the patient should receive determined by simply using a data lookup table or numerical calculation is not high enough because the above-mentioned single method is more dependent on clinical experience data without being corrected based on the personalized situation of the patient, resulting in that the total activity dose actually received by the patient does not match the total activity dose that the patient needs to receive, which may cause poor imaging effect when performing PET-CT, as recorded in the following paper: Botkin C D, Osman M M. Prevalence, challenges, and solutions for (18) F-FDG PET studies of obese patients: a technologist's perspective. [J]. Journal of Nuclear Medicine Technology, 2007, 35(2): 80. However, if the obtained total activity dose D is simply corrected, it is difficult to determine whether the corrected value is reasonable. Therefore, the purpose of the safety interval provided by the present application is to correct the total activity dose D according to the type of drug and in combination with the personalized situation of the patient, especially by correcting the recommended dose a to achieve the correction of the calculation result of the total activity dose D, and then judging whether the corrected calculation result falls within the safety interval, wherein if the corrected calculation result falls within the safety interval, the corrected calculation result can be used as the dosage of the radiopharmaceutical; if the corrected calculation result does not fall within the safety interval, an alarm is issued, and the medical staff re-evaluates the patient carefully. Further, the computing device 300 can further set a neutral interval outside the safety interval between the two standard curves, which can exist as an additional safety margin to cope with potential uncertainties and changes, wherein the deviation amount of the neutral interval relative to the boundary value of the safety interval can be determined according to specific clinical experience and practice. Optionally, considering the safety and effectiveness of nuclear medicine, the deviation amount of the neutral interval relative to the boundary value of the safety interval can be set to ±5% to ±10%, wherein +5% to +10% is the deviation amount of the upper boundary value of the neutral interval relative to the upper boundary value of the safety interval, -5% to -10% is the deviation amount of the lower boundary value of the neutral interval relative to the lower boundary value of the safety interval, and the region between the upper boundary value and the lower boundary value of the neutral interval is the region of the neutral interval except the region of the safety interval. In the scenario where the diagnostic purpose is relatively easier, the combined interval of the neutral interval and the safety interval can be used as the basis for judging the corrected calculation result.

[0087] Preferably, the computing device 300 can correct the recommended dose a or directly correct the total activity dose D according to the drug type and in combination with patient individualization, wherein the patient individualization is a physiological parameter related to the drug type, which mainly considers one or more physiological parameters that have the most significant impact on the metabolism and enrichment of the corresponding type of radiopharmaceutical. Preferably, several physiological parameters that affect the metabolism and enrichment of a certain type of drug can be ranked in terms of impact degree to screen one or more physiological parameters with relatively higher impact degree to correct the recommended dose a or the total activity dose D using these physiological parameters.

[0088] Illustratively, the blood glucose level and insulin sensitivity index of the patient have a significant impact on the metabolism and enrichment of 18F-FDG (2-[18F]fluoro-2-deoxy-D-glucose); the liver enzyme activity of the patient has a significant impact on the metabolism and enrichment of TSPO (translocator protein); the kidney clearance and blood glucose of the patient have a significant impact on the metabolism and enrichment of AV45 ([18F] Florbetapir); the kidney clearance and blood glucose of the patient have a significant impact on the metabolism and enrichment of AV133 ([18F] Flutemetamol). Further, the physiological parameters related to the above four types of radiopharmaceuticals can include blood glucose level (BG), insulin sensitivity index (ISI), liver enzyme activity (LEA), glomerular filtration rate (GFR) to form blood glucose level correction coefficient (C BG ), insulin sensitivity index correction coefficient (C ISI ), liver enzyme activity correction coefficient (C LEA ), and glomerular filtration rate correction coefficient (C GFR ), respectively. Illustratively, the above four correction coefficients can be set as:

[0089]

[0090]

[0091] Therefore, for 18F-FDG (2-[18F]fluoro-2-deoxy-D-glucose), the total correction coefficient is: C 18F-FDG = C BG × C ISI ; for TSPO (translocator protein), the total correction coefficient is: C TSPO = C LEA ; for AV45 ([18F] Florbetapir), the total correction coefficient is: C AV45 = C BG × C GFR ; for AV133 ([18F] Flutemetamol), the total correction coefficient is: C AV133 = C BG×C GFR Based on this, the corrected total activity dose D can be obtained according to the drug type and the patient's individual circumstances.

[0092] like Figure 4 As shown, a first standard curve is generated based on data from the corresponding data lookup table in a coordinate system with body surface area (BSA) as the abscissa and total active dose (D) as the ordinate. A second standard curve is generated based on the total active dose formula, which uses a pre-defined standard recommended dose as a coefficient for a specific drug type and diagnostic purpose. A safety range is then formed by the envelope of the first and second standard curves. Finally, the total active dose (D) can be adjusted according to the drug type and the patient's individual circumstances to determine whether the adjusted D is above, within, or below the safety range. Furthermore, if the result indicates that the adjusted D is within the safety range, it means that the adjusted dose is within the recommended safety range, implying that the dose is considered compliant with standards and has a reasonable risk-benefit balance given the body surface area and patient characteristics. In other words, under normal circumstances, this dose is acceptable and can continue to be used. If the result of the judgment is that the corrected total activity dose D is above the safe range, it means that the corrected dose is higher than the recommended safe range, which may bring a higher risk of toxicity or adverse reactions, exceeding the diagnostic safety limit. A first alert needs to be issued to remind healthcare professionals to carefully consider whether the dose can be adjusted or other measures taken to reduce the potential risks, or to assess whether such a high dose is indeed necessary. If the result of the judgment is that the corrected total activity dose D is below the safe range, it means that the corrected dose is lower than the recommended safe range, which may lead to insufficient diagnostic effect because the dose may not be sufficient to achieve the required therapeutic effect. A second alert needs to be issued to remind healthcare professionals to assess whether the dose should be increased to ensure the effectiveness of the diagnosis while remaining within the safe limits. Furthermore, the total activity dose D corrected by the above method can be used for comparison with the safe range. Preferably, the above safe range can also be replaced by a combined range consisting of the neutral range and the safe range.

[0093] Preferably, such as Figure 5As shown, the radiopharmaceutical dosage control system of the present invention may further include a volume measurement unit 600 for measuring the current residual volume of the drug in the storage bottle 500. The volume measurement unit 600 may employ ultrasonic volume measurement technology, capacitive volume measurement technology, or optical volume measurement technology to measure the drug volume. Furthermore, considering that the top of the storage bottle 500 containing the radiopharmaceutical is equipped with a rubber stopper and aluminum foil, when using ultrasonic volume measurement technology and optical volume measurement technology, the sensor needs to be perpendicularly aligned with the liquid surface to emit ultrasonic waves or light, which is difficult to penetrate the rubber stopper and aluminum foil at the top of the storage bottle 500, affecting measurement accuracy. Therefore, the non-contact capacitive volume measurement technology can arrange the electrode 610 outside the storage bottle 500, determining the liquid volume by measuring the liquid's influence on the electric field. This method does not require the electrode 610 to directly contact the liquid, reducing the risk of liquid contamination and making it suitable for measuring sensitive liquids (such as radiopharmaceuticals). Further, as... Figure 5 As shown, the electrode 610 arranged outside the medicine storage bottle 500 can be a ring electrode so as to uniformly surround the bottle body.

[0094] Preferably, the calculation device 300 can calculate the current activity concentration of the drug in the drug storage bottle 500 based on the current activity and volume of the drug in the storage bottle 500, and the calculation formula is as follows:

[0095]

[0096] In the formula, C is the current activity concentration of the drug in the 500-liter storage bottle, A is the current activity of the drug in the 500-liter storage bottle, and V is the concentration of the drug. 残余 This refers to the residual volume of the medicine within the 500-liter storage bottle.

[0097] Furthermore, the calculation device 300 can calculate the required drug volume for the patient based on the total drug activity to be received and the current drug activity concentration in the storage bottle 500, using the following formula:

[0098]

[0099] In the formula, V 所需 D is the volume of drug required by the patient, C is the total drug activity that the patient should receive, and D is the current activity concentration of the drug within 500 of the storage bottle.

[0100] Preferably, the radiopharmaceutical dosage control system of the present invention may have a separate display unit near the storage area of ​​the drug storage bottle 500, and / or an integrated display unit on the medical care end 400, so as to display the calculation results to the medical staff through the display unit, thereby facilitating the medical staff to manually complete the drug dosage according to the calculated drug volume required by the patient.

[0101] Preferably, the radiopharmaceutical dosage control system of the present application can be further provided with a dispensing robot for automatically completing the drug dosage taking according to the control signal generated by the computing device 300, wherein the computing device 300 can generate the control signal for driving the dispensing robot according to the drug volume required by the patient in the calculation result. Preferably, the dispensing robot can include a stepper motor for precisely controlling the movement of the piston to achieve the extraction of the specified volume of drug. Preferably, the dispensing robot can include position sensors, pressure sensors and other acquisition elements for real-time monitoring of the position and pressure of the piston. Preferably, the dispensing robot can include a microcontroller in communication with the computing device 300 to control the stepper motor and sensors to execute the control logic according to the control signal.

[0102] Preferably, the medical staff can input and modify the prescription information through the operation interface of the medical terminal 400, and the patient can view his own examination information and drug dosage through the interface of the patient terminal. When the system is running, it should be able to notify the doctor and the patient of important updates or alarms related to the drug dosage in real time.

[0103] Preferably, as shown in Figure 6 The radiopharmaceutical dosage control system of the present application can be provided with a timing unit 700 for starting timing when the computing device 300 obtains the calculation result, wherein the timing unit 700 can set different interval lengths for different types and different states of drugs. When the drug dosage taking is not completed within the set interval length, it is determined that the drug dosage taking operation is invalid, and the timing unit 700 sends an invalid signal to the computing device 300, so that the computing device 300 re-calculates according to the current situation. Preferably, the timing unit 700 can adjust the interval length of each drug in real time based on the half-life of the drug, the current activity value, the maximum allowed activity loss and other parameters, wherein the maximum allowed activity loss can be calculated by the computing device 300 according to the preset maximum error value when calculating the drug volume.

[0104] The decay formula of the radiopharmaceutical is:

[0105] A(t) = Ae -λt ,

[0106] In the formula, A(t) is the activity of the drug at time t, A is the current activity of the drug, λ is the decay constant, t is the time, and e is the base of natural logarithm.

[0107] The relationship between the decay constant λ and the half-life T 1 / 2 is:

[0108]

[0109] Therefore, the timing unit 700 can set the interval length according to the following formula:

[0110]

[0111] wherein T 1 / 2 is the half-life of the drug, A is the current activity of the drug, A target is the deviation activity of the drug. Further, the deviation activity of the drug can be obtained by subtracting the preset maximum allowable activity loss from the current activity of the drug.

[0112] Exemplarily, if the maximum allowable activity loss is simply set as 0.03A, it can be calculated that, for a drug with a half-life of 110 minutes such as 18F-FDG, the taking operation needs to be completed within about 5 minutes after the calculation device 300 outputs the calculation result; and for a drug with a half-life of 68 minutes such as 68Ga, the taking operation needs to be completed within about 3 minutes after the calculation device 300 outputs the calculation result.

[0113] The radiopharmaceutical dosage control system provided with the timing unit 700 of the present application can be particularly suitable for drugs with a relatively short half-life, which require extremely high accuracy in dosage when used. Therefore, the timing unit 700 with a suitable interval length can be flexibly set according to the type and state of the drug to be taken, so as to ensure that the taking operation performed according to the calculation result output by the calculation device 300 can meet the accuracy requirement.

[0114] Preferably, the radiopharmaceutical dosage control system of the present application can be provided with a radioactive surface contamination measuring device for measuring the residual radioactivity on the table surface where the drug storage bottle 500 is located, so as to ensure the safety of the operating environment. Through real-time monitoring, radioactive contamination can be found and treated in time, so as to avoid environmental pollution and radiation hazards to the operator. Preferably, the radioactive surface contamination measuring device can use a Geiger-Müller (GM) counter or a semiconductor detector, wherein the GM counter is a gas discharge tube that causes the release and amplification of electrons when radioactive particles pass through the gas inside the tube, thereby generating an electrical signal, and the GM counter has high sensitivity to α and β particles; the semiconductor detector (such as a silicon PIN detector) measures the radioactivity level by detecting the electric charge generated by radioactive particles in the semiconductor material, and the semiconductor detector has higher energy resolution and sensitivity. Preferably, the radioactive surface contamination measuring device can be installed near the table surface where the drug storage bottle 500 is located, so as to ensure that the entire operating area is covered. Preferably, the data obtained by the radioactive surface contamination measuring device can be sent to the calculation device 300 for data processing, so as to determine the residual radioactivity on the table surface by the threshold set by the calculation device 300, and trigger an alarm when the radioactivity level exceeds the threshold.

[0115] Example 2

[0116] This embodiment is a further improvement of Example 1, and the repeated contents will not be described again.

[0117] As Figure 7 The present application also discloses a method for calculating the dosage of radiopharmaceuticals for imaging pre-injection analysis, comprising the following steps:

[0118] Obtaining the current radioactivity of the drug in the drug storage bottle 500 and the weight and height of the patient to be administered the drug;

[0119] Generating a first standard curve based on searching for data in a built-in data lookup table corresponding to different types of radiopharmaceuticals summarized empirically;

[0120] Generating a second standard curve based on the total activity dose formula with the standard recommended dose preset by the specific drug type and the purpose of diagnosis and treatment as a coefficient;

[0121] Put the first standard curve and the second standard curve into the same coordinate system to form two standard curves that do not completely overlap to form a safe interval for drug administration, and determine the volume of the drug required for the current injection extraction of the patient according to the standard curve, wherein the first standard curve and the second standard curve are both with body surface area as the horizontal coordinate and total activity dose as the vertical coordinate.

[0122] Unlike the prior art described in the background art, the present application introduces a double-track mechanism (combination of data lookup table and formula calculation) and constructs a safe interval, solving the problem of lack of quantitative calibration and safety threshold in the prior art, ensuring that the dose does not deviate from the reasonable range in the imaging scene, and avoiding the decline in image quality or radiation risk caused by the fluctuation of drug characteristics (such as activity decay).

[0123] Preferably, the recommended dose or total activity dose is corrected according to the type of drug and in combination with the individualized conditions of the patient, wherein the individualized conditions are physiological parameters related to the metabolism and enrichment of the patient to the radiopharmaceutical, including blood glucose level, insulin sensitivity index, liver enzyme activity and / or renal clearance. The technical improvement proposed by the present application directly addresses the defect of ignoring individualized metabolic parameters in the background art, by incorporating these parameters (such as blood glucose level, insulin sensitivity index), enhancing the accuracy of dose calculation, and meeting the dual constraints of dose safety and imaging clarity in the imaging scene.

[0124] Preferably, the first standard curve can be generated by searching for a built-in data lookup table (DLM), which is based on empirical summary and stores activity-body surface area mapping data corresponding to different types of radiopharmaceuticals (such as 18F-FDG, TSPO, AV45, AV133) for different purposes of diagnosis and treatment. By interpolating the data points through an interpolation algorithm (such as linear interpolation or spline interpolation), a curve (first standard curve) with body surface area as the horizontal coordinate and total activity dose as the vertical coordinate is generated.

[0125] Preferably, the first standard curve can be generated according to a standard recommended dose formula D = a x BSA preset according to specific drug types and diagnostic purposes, wherein a is a recommended dose coefficient corresponding to the drug type (such as a = 3.7 mCi / m for 18F-FDG). 2 ).

[0126] Preferably, the first standard curve and the second standard curve are superimposed in the same coordinate system to form two curves that do not completely overlap, and the envelope area thereof is defined as a safe interval. A neutral interval is further set, and the boundary values thereof are offset by ±5% to ±10% relative to the upper and lower boundaries of the safe interval, so as to provide an additional safety margin. This solves the problem of lack of safety threshold constraint in the background art, provides robustness guarantee for the imaging scene, and avoids dose error accumulation.

[0127] Preferably, the corresponding physiological parameter correction coefficient (such as the blood glucose correction coefficient C BG , the insulin sensitivity index correction coefficient C ISI for 18F-FDG; the glomerular filtration rate correction coefficient C GFR for AV45) is called according to the drug type, and is substituted into the corresponding correction formula. The corrected recommended dose coefficient is substituted into the dose calculation formula to calculate the corrected total activity dose.

[0128] Further, the safety check is realized by judging whether the corrected total activity dose falls within the safe interval or the neutral interval, wherein if the corrected total activity dose is within the safe interval, the next step is entered; if the corrected total activity dose exceeds the upper limit of the safe interval, a first alarm (such as a red warning light + a buzzer) is triggered to prompt that the dose needs to be reduced; and if the corrected total activity dose is lower than the lower limit of the safe interval, a second alarm is triggered to prompt that the dose needs to be increased. This safety check mechanism solves the defect of relying on dynamic adjustment during injection in the background art, realizes one-time accurate calculation, adapts to the timeliness requirement (such as 110 minutes for 18F-FDG) of imaging drugs with short half-life, and avoids post-injection supplement operation.

[0129] The computing device 300 of the present application can be used to execute the above-mentioned calculation method. Further, the computing device 300 can be interconnected with other functional units (such as the activity measurement unit 100, the input unit 200, the volume measurement unit 600, the timing unit 700, and / or the contamination detection unit) through wired or wireless communication protocols to form an integrated device system, so as to realize accurate calculation and safety control of the radiopharmaceutical dose. This solves the problem of relying on manual operation in the background art, improves efficiency and reduces errors through an automated system, and meets the demand for fast and accurate drug taking in the imaging scene.

[0130] Preferably, the activity measurement unit 100 can include a high-precision radiation detector group, the core component of which is a high-purity germanium (HPGe) detector or a NaI(Tl) scintillator detector, and the detector surface is covered with a lead shielding layer to reduce environmental radiation interference. The detector is maintained at a stable working temperature by a low-temperature cooling module (such as a Peltier cooler), and the light signal or charge signal generated by the radiation excitation is converted into an analog electrical signal by a photomultiplier tube (PMT) or a semiconductor charge amplifier. After the analog signal is quantized by an analog-to-digital converter (ADC), it is transmitted to the processor module through a USB 3.0 or Ethernet interface. The processor module has a joint algorithm of low-pass filter and median filter, which can reduce noise and eliminate baseline drift through polynomial fitting or reference signal correction method, and finally calculate the drug activity value based on the integral algorithm and the calibration factor (k).

[0131] Preferably, the input unit 200 can be designed in combination of a capacitive touch screen and a radiation-proof keyboard, the touch screen supports gesture operation and voice input, and the keyboard is optimized for medical scenarios and has a waterproof and stain-resistant coating. The input unit 200 has built-in data verification logic to dynamically check the numerical range of patient weight (0-500 kg), height (0-250 cm) and age (0-130 years), and transmit structured data to the computing device 300 through HTTPS / TLS protocol. The computing device 300 is composed of a multi-core high-performance CPU (main frequency ≥ 3.5 GHz) and at least 16 GB RAM, and the storage device is a solid state drive (SSD) with a capacity of ≥ 500 GB, which is used to store patient data, drug parameters and historical records. The computing device 300 has a built-in drug type identification module, which matches the corresponding data lookup table (DLM) through the preset drug half-life (such as 110 minutes of 18F-FDG) and the purpose of diagnosis and treatment (such as tumor diagnosis or evaluation of neurodegenerative diseases), and calculates the patient's BSA value based on the body surface area (BSA) formula.

[0132] Preferably, the volume measurement unit 600 uses a non-contact capacitive sensor array, and the electrodes 610 are arranged in a ring outside the drug storage bottle 500 to detect the residual volume by measuring the disturbance of the liquid to the electric field. After the sensor data is amplified by the signal conditioning circuit, the microcontroller calculates the volume value and inputs it into the computing device 300 together with the activity value of the activity measurement unit 100, which is used to calculate the current activity concentration and the required drug volume.

[0133] Preferably, the drug taking mechanical arm can be composed of a piston mechanism driven by a stepper motor, equipped with a position sensor and a pressure sensor to feedback the extraction state in real time, and the mechanical arm control signal is generated by the computing device 300 and transmitted through industrial Ethernet.

[0134] Preferably, the timing unit 700 can dynamically adjust the dispensing time limit based on the drug half-life formula, and then calculate the allowed dispensing interval time by presetting the maximum allowed activity loss (e.g. 3%) as follows:

[0135] The timing unit 700 is linked with the dispensing mechanical arm, and triggers an invalid signal and resets the calculation process when the time is up. This strengthens the design of time sensitivity for imaging scenarios, ensuring accurate one-time calculation and avoiding delays caused by dynamic adjustment in the background technology.

[0136] Preferably, the contamination detection unit integrates a Geiger-Muller counter (GM) and a semiconductor detector, which is installed around the tabletop of the drug storage bottle 500 to monitor the surface radioactive residue in real time, and triggers an alarm through threshold judgment.

[0137] In summary, the embodiment 2 of the present application effectively overcomes the limitations in the background technology by combining personalized parameter correction, hyperbolic safety interval mechanism and fully automated hardware system, providing an efficient, accurate and safe radioactive drug dose calculation scheme for imaging diagnosis (such as PET-CT).

[0138] Embodiment 3

[0139] This embodiment is a further improvement of embodiments 1 and 2, and the repeated contents will not be described again. This embodiment specifically relates to a computing device configured to perform the calculation method described in embodiment 2.

[0140] The computing device can include a multi-core central processing unit (main frequency ≥ 3.5 GHz), a field programmable gate array (FPGA) and an embedded digital signal processor (DSP). The multi-core processor can be used for parallel processing of dose calculation and interpolation operation, the FPGA can accelerate the activity decay model calculation, and the DSP can process sensor signal filtering and feature extraction.

[0141] The computing device can be equipped with a memory module with a capacity of ≥ 16 GB for caching patient data and intermediate calculation results, and a solid state disk with a capacity of ≥ 500 GB for storing data lookup tables (including activity-body surface area mapping data of 18F-FDG, TSPO and other drugs), standard recommended dose formula D = α × BSA, safety interval parameters, drug half-life values and physiological parameter correction coefficients C BG / C ISI / C GFR , etc.

[0142] The input interface module of the computing device receives the radioactivity value detected by the radioactivity measurement unit, the residual volume data collected by the volume measurement unit, and the patient's weight (0-150 kg), height (0-200 cm), age (0-100 years), and personalized metabolic parameters (blood sugar level, liver enzyme activity, etc.) transmitted by the input unit through USB 3.0 / ethernet protocol. All data transmission can be encrypted using HTTPS / TLS.

[0143] The dose calculation module of the computing device can generate a first standard curve through an interpolation algorithm, and a second standard curve based on D=α×BSA, and superimpose the two curves to form a safety interval and a neutral interval. The module calculates the corrected total activity dose by calling the physiological parameter correction coefficient, and judges whether the dose falls within the safety interval through the safety check unit. If it is within the interval, a confirmation signal is output to the dispensing mechanical arm. If it exceeds the upper limit, a red warning light and a buzzer are triggered. If it is below the lower limit, an incremental alarm is triggered.

[0144] The output control module of the computing device can send the extraction volume and pressure threshold instructions to the dispensing mechanical arm through industrial Ethernet, and can also synchronize the dose data to the hospital information system.

[0145] The communication module of the computing device is linked with the timing unit, and based on the half-life of the drug, the dispensing time is dynamically limited (allowing a maximum activity loss of 3%), and the process is automatically reset if the time is exceeded.

[0146] The computing device can be equipped with redundant power supply and electromagnetic shielding shell, and can also be equipped with temperature / humidity monitor to ensure stable operation. The hardware structure realizes integrated operation of dose calculation, safety check and system control, and meets the dual demands of precision and timeliness in imaging scenarios.

Claims

1. A method for calculating the dosage of radiopharmaceuticals for pre-injection analysis in imaging, characterized in that, It includes the following steps: Obtain the current radioactivity of the drug in the storage bottle (500) and the weight and height of the patient currently receiving the drug; The first standard curve is generated based on data from a built-in data lookup table of different types of radiopharmaceuticals, which is based on experience and summarized from the data. A second standard curve is generated based on a total activity dose formula that uses a pre-defined standard recommended dose as a coefficient for a specific drug type and treatment purpose. The first and second standard curves are placed in the same coordinate system to form two non-overlapping standard curves that form the safe range for drug administration. The volume of drug required for the current injection of the patient is determined based on the standard curves. Both the first and second standard curves use body surface area as the abscissa and total activity dose as the ordinate.

2. The calculation method according to claim 1, characterized in that, The recommended dose or total activity dose is adjusted based on the type of drug and in conjunction with the patient’s individual circumstances, which are physiological parameters related to the patient’s metabolism and accumulation of the radiopharmaceutical, including blood glucose levels, insulin sensitivity index, liver enzyme activity and / or renal clearance.

3. A device for calculating the dosage of radiopharmaceuticals for pre-injection imaging analysis, characterized in that, The computing device (300) is used to determine the required volume of drug to be injected for the current patient based on the radioactivity of the drug in the drug storage bottle (500) and the relevant basic information of the current patient. After receiving the current radioactivity and the weight and height of the patient currently receiving the medication, the computing device (300) generates a first standard curve based on data from a built-in data lookup table of different types of radiopharmaceuticals, and generates a second standard curve based on a total activity dose formula with a pre-set standard recommended dose as a coefficient for a specific drug type and treatment purpose. Both the first and second standard curves use body surface area as the abscissa and total activity dose as the ordinate, thus forming two non-overlapping standard curves in the same coordinate system, with the envelope forming the safe range for medication.

4. The computing device according to claim 3, characterized in that, The computing device (300) can adjust the recommended dose or total activity dose based on the drug type and in conjunction with the patient's individual circumstances, wherein the individual circumstances are physiological parameters related to the patient's metabolism and accumulation of the radiopharmaceutical, including blood glucose level, insulin sensitivity index, liver enzyme activity and / or renal clearance.

5. The computing device according to claim 3 or 4, characterized in that, After receiving the current radioactivity of the drug in the drug storage bottle (500) and the relevant basic information of the current patient, the computing device (300) can determine the volume of drug to be injected by searching a built-in data lookup table for different types of radiopharmaceuticals based on experience, and / or can determine the volume of drug to be injected by numerical calculation based on the patient's specific physiological parameters and the specific activity of the drug.

6. The computing device according to claims 3 to 5, characterized in that, When the computing device (300) determines the volume of drug to be injected by numerical calculation, the patient-specific physiological parameters it selects include the body surface area calculated based on the patient's height and weight, and the total activity dose that the patient should receive is calculated based on the obtained body surface area and the recommended dose of the corresponding drug.

7. The computing device according to any one of claims 3 to 6, characterized in that, The computing device (300) can receive the current radioactivity of the drug in the drug storage bottle (500) through the activity measurement unit (100). The activity measurement unit (100) deploys a corresponding detector (120) at a dedicated measurement point near the corresponding drug storage bottle (500) in the storage area of ​​the drug storage bottle (500). The original signal collected by the detector (120) is converted and sent to the processor (110) of the activity measurement unit (100) to calculate the radioactivity of the drug after signal processing.

8. The computing device according to any one of claims 3 to 7, characterized in that, The processor (110) of the activity measurement unit (100) integrates the calibrated signal using the gradient method to obtain the total energy or total count of the signal, and then calculates the radioactivity of the drug based on the integration result and physical parameters, wherein the physical parameters include detector efficiency and / or calibration factor.

9. The computing device according to any one of claims 3 to 8, characterized in that, The data processed by the processor (110) of the activity measurement unit (100) can be displayed to the user through a graphical interface. The processor (110) of the activity measurement unit (100) can communicate with the medical terminal (400) so that the interface of the medical terminal (400) can display key parameters including the currently measured activity value and the reference range, and provide a historical data query function.

10. The computing device according to any one of claims 3 to 9, characterized in that, The computing device (300) is communicatively connected to an input unit (200) for obtaining relevant basic information of the current patient receiving medication, so as to receive the weight and height of the current patient receiving medication, wherein the input unit (200) is configured with a digital input device (210).

11. The computing device according to any one of claims 3 to 10, characterized in that, The input unit (200) can verify the accuracy of the relevant basic information input by the input device (210) by setting the numerical range of the corresponding parameters, so that the correct relevant basic information entered in the input unit (200) can be transmitted to the computing device (300) through a secure protocol.

12. The computing device according to any one of claims 3 to 11, characterized in that, The computing device (300) is communicatively connected to a volume measuring unit (600) for measuring the current residual volume of the drug in the drug reservoir (500), wherein the volume measuring unit (600) is equipped with electrodes (610) on the outside of the corresponding drug reservoir (500), thereby enabling the computing device (300) to calculate the volume of drug required by the patient using the residual volume of the drug obtained by the volume measuring unit (600) based on capacitive volume measurement technology.

13. The computing device according to any one of claims 3 to 12, characterized in that, The computing device (300) can communicate with the timing unit (700), which can start timing when the computing device (300) obtains the calculation result. The timing unit (700) can set different interval durations for different types and states of drugs.

14. The computing device according to any one of claims 3 to 13, characterized in that, If the drug measurement is not completed within the set interval, the drug measurement operation is deemed invalid. The timing unit (700) sends an invalid signal to the computing device (300) so that the computing device (300) can recalculate based on the current situation.

15. The computing device according to any one of claims 3 to 14, characterized in that, The timing unit (700) can adjust the interval between each drug in real time based on parameters including the drug's half-life, current activity value, and maximum allowable activity loss. The maximum allowable activity loss can be calculated by the computing device (300) based on a preset maximum error value when calculating the drug volume.

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