A radiopharmaceutical injection device

Abstract

The application discloses a radioactive medicine injection device, which comprises an injection terminal, a mother liquor bottle, a weighing device, a saline container, a liquid path switching valve, a peristaltic pump, a measuring container, a first activity measuring instrument, a waste liquid bottle and a control unit. When the system is initialized, the measuring container is transferred into the mother liquor bottle, and the initial specific activity and the pump pipe coefficient are calculated. During injection, the control unit controls the liquid path switching valve and the peristaltic pump to execute one or more medicine liquid extraction, determines the target volume according to the target radioactivity value, the measured cumulative activity value and the current real-time specific activity, and updates the current real-time specific activity according to the current cumulative activity value and the extracted cumulative medicine liquid volume; when the final total activity meets the allowable error requirement, the medicine liquid is injected through the injection terminal, otherwise, the medicine liquid is discharged into the waste liquid bottle. According to the weight change of the mother liquor bottle and the activity change of the measuring container, an input liquid path causal signature group is formed to control subsequent extraction and injection.

Description

Technical Field

[0001] This invention belongs to the technical field of radiopharmaceutical injection equipment, and relates to a radiopharmaceutical injection device. Background Technology

[0002] The activity of medical radiopharmaceuticals decays over time. Existing injection devices typically calculate the volume of drug solution extracted based on the specific activity determined during the initialization phase. As injection time progresses and deviations arise between the actual and theoretical delivery volumes of the peristaltic pump, the initial specific activity becomes difficult to consistently reflect the actual drug solution state. Furthermore, deviations from previous extractions may be carried over to subsequent extraction processes, affecting the accuracy of the final drug solution activity.

[0003] To correct subsequent extraction volumes based on actual extraction results, the current cumulative activity value needs to accurately correspond to the cumulative volume of drug solution extracted. However, control commands from the fluid switching valve and peristaltic pump can only indicate predetermined actions and cannot directly prove that the drug solution or saline has been actually transferred along the predetermined fluid path. When there are abnormalities in pipeline connections, valve position mapping, or peristaltic pump operation direction, the correspondence between the current cumulative activity value and the cumulative volume of drug solution extracted may be unreliable, thus affecting the reliability of real-time specific activity updates, injection dosage control, and injection circuit operation. Summary of the Invention

[0004] To address the problems existing in the background art, the present invention proposes a radiopharmaceutical injection device.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: a radiopharmaceutical injection device, comprising: An injection terminal, used for injecting medication; Mother liquor bottles, mounted on the weighing device, are used to store the medicine solution; A measuring container, equipped with a first activity measuring instrument, is used to measure the radioactivity of the drug solution inside the measuring container; A saline container used to store physiological saline solution; A liquid circuit switching valve is connected to a measuring container via a measuring pipeline, to a saline container via a saline pipeline, to a mother liquor bottle via a drug extraction pipeline, and to an injection terminal via a target pipeline. A peristaltic pump is installed on the measuring pipeline; The control unit is electrically connected to the weighing device, the first activity measuring instrument, the liquid circuit switching valve, and the peristaltic pump. The control unit is used to control the transfer of the drug solution from the measuring container to the mother liquor bottle and calculate the initial specific activity and pump tube coefficient during system initialization; it is also used to draw the drug solution in the mother liquor bottle into the measuring container for activity measurement and judgment during injection, and control the drug solution to be directed to the injection terminal when the final total activity measured after the drug solution extraction meets the preset allowable error requirements.

[0006] Furthermore, a radiopharmaceutical injection device also includes a waste liquid bottle, which is connected to a liquid switching valve via a waste liquid pipeline; During injection, if the final total activity measured after the drug solution extraction meets the allowable error requirement, the liquid path switching valve is controlled to open the target pipeline for injection; otherwise, the liquid path switching valve is controlled to open the waste liquid pipeline to discharge the drug solution into the waste liquid bottle. The control unit is also used to control the liquid circuit switching valve and the peristaltic pump to perform one or more drug extractions. Each time the drug is extracted, the target volume is determined based on the target radioactivity value, the measured cumulative activity value and the current real-time specific activity. The corresponding drug is then extracted into the measuring container, the current cumulative activity value is measured, and the current real-time specific activity is updated in combination with the extracted cumulative drug volume until the preset extraction termination condition is met.

[0007] Furthermore, the control unit is also configured to perform input fluid path verification during system initialization and upon the first execution of the drug extraction, including: When the liquid medicine in the measuring container is drawn into the mother liquor bottle, an initialization recycling signature is formed based on the weight change of the mother liquor bottle obtained by the weighing device and the activity change of the measuring container obtained by the first activity measuring instrument. When physiological saline sequentially fills the saline tubing, the measuring tubing and the target tubing, a saline selection signature is formed based on the changes in the weight of the mother liquor bottle and the changes in the activity of the measuring container. When the medicine is first drawn from the mother liquor bottle to the measuring container, a first drawing signature is generated based on the weight change of the mother liquor bottle and the activity change of the measuring container. The initialization recovery signature, saline selection signature, and first extraction signature are combined according to the execution order of the corresponding liquid transfer action to form an input liquid path causal signature group. Based on the verification result of the input liquid path causal signature group, the system controls whether to allow the continued extraction of subsequent drug solutions or to perform error judgment and injection.

[0008] Furthermore, the control unit is configured to set action windows for the liquid transfer actions that form the initial recovery signature, the brine selection signature, and the first extraction signature, respectively; The system acquires the weight of the mother liquor bottle and the activity of the measuring container at the start of each action window and when the corresponding liquid transfer action stops and stabilizes sampling. It corrects the activity at the start of the action window and at the time of stable sampling to the same reference time. Based on whether the changes in weight and activity exceed the corresponding weight confirmation threshold and activity confirmation threshold, it determines whether there is an increase in weight, a decrease in weight, an increase in activity, a decrease in activity, or no new activity.

[0009] Furthermore, the control unit is configured to perform a liquid transfer action, in which the liquid in the measuring container is pumped into the mother liquor bottle by a peristaltic pump, as an initial recovery action; When the increase in weight of the mother liquor bottle corresponding to the initial recovery action exceeds the weight confirmation threshold, and the decrease in activity of the measuring container exceeds the activity confirmation threshold, the initial recovery signature is generated.

[0010] Furthermore, the control unit is configured to first control the liquid circuit switching valve and the peristaltic pump to transport physiological saline from the saline container to the measuring container via the saline pipeline and the measuring pipeline, then switch the liquid circuit switching valve and change the running direction of the peristaltic pump to discharge the physiological saline in the measuring container via the measuring pipeline and the target pipeline, and to use the above liquid transfer action as the saline selection action; When the weight loss of the mother liquor bottle corresponding to the saline selection action does not exceed the weight confirmation threshold, and the positive activity change of the measuring container does not exceed the activity confirmation threshold, the saline selection signature is formed. The decrease in the activity of the measuring container caused by the replacement of residual drug solution with physiological saline does not affect the formation of the saline selection signature.

[0011] Furthermore, the control unit is configured to determine a minimum verification volume based on conditions that enable the expected weight loss of the mother liquor bottle to exceed the weight confirmation threshold and the expected increase in activity of the measuring container to exceed the activity confirmation threshold. The target volume corresponding to the first drug extraction is configured to be no less than the minimum verification volume; When the weight loss of the mother liquor bottle corresponding to the first drug extraction exceeds the weight confirmation threshold, and the increase in activity of the measuring container exceeds the activity confirmation threshold, the first extraction signature is generated, and the drug transferred in the first extraction is retained in the measuring container as the drug to be injected in the current time.

[0012] Furthermore, the control unit is configured to: when the initialization recovery signature, saline selection signature, and first extraction signature are formed in their respective action windows, and are formed in the order of initialization recovery action, saline selection action, and first drug extraction, and no weight change or activity change that contradicts the corresponding liquid transfer action appears in each action window, the input liquid path causal signature group is determined to be verified, and the control unit is configured to continue subsequent drug extraction or perform error judgment and injection based on whether the current cumulative activity value meets the extraction termination condition; Otherwise, the input liquid path causal signature group verification is deemed to have failed, and subsequent drug extraction, error determination, and injection are stopped.

[0013] Furthermore, the control unit is configured such that, when the drug extraction line, saline line, target line, and measurement line are not replaced, and the valve position mapping of the liquid switching valve is not changed, the initial recovery signature and saline selection signature are formed once during the system initialization process, and the corresponding first extraction signature is re-formed during the first drug extraction process of each subsequent injection. If the initial extraction signature is not formed, stop the subsequent extraction of drug solution for the current injection, as well as error judgment and injection; After any of the pipelines is replaced or the valve position mapping of the fluid switching valve is changed, the input fluid path causal signature group is re-formed.

[0014] Furthermore, the control unit is configured to: when the input liquid path causal signature group verification fails, determine the liquid path abnormality type based on the unformed initialization recovery signature, saline selection signature, or first extraction signature, as well as the weight change of the mother liquor bottle and the activity change of the measuring container within the corresponding action window; control the liquid path switching valve to cut off the injection path from the measuring container to the injection terminal via the target pipeline; control the peristaltic pump to stop running; and stop the subsequent drug extraction, error judgment, and injection for the current injection.

[0015] Compared with the prior art, the present invention has the following beneficial effects: after each drug extraction, the current real-time specific activity is updated according to the measured current cumulative activity value and the cumulative drug volume extracted, so that the subsequent extraction volume can be corrected according to the actual extraction results, reducing the impact of radioactivity decay and pumping deviation on subsequent extraction calculations, reducing the transmission of previous extraction deviations to subsequent processes, and improving the accuracy of controlling the activity of the final drug to be injected.

[0016] Meanwhile, this invention forms an input liquid path causal signature group based on the changes in the weight of the mother liquor bottle and the changes in the activity of the measuring container to verify whether the liquid has completed the actual transfer along the predetermined liquid path; only after the verification is passed will extraction and injection continue, and if the verification fails, extraction will be stopped and the injection path will be cut off, thereby ensuring that the data on which the real-time specific activity update is based is reliable and improving the reliability of the injection liquid path operation. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 This is a flowchart of the system initialization process in this invention; Figure 3 This is a flowchart of the real-time calibration injection process using two drug extractions in this invention; Figure 4 This is a flowchart of one or more drug extractions and real-time specific activity updates in this invention; Figure 5 This is a flowchart of the verification process for the causal signature group of the input liquid path in this invention.

[0018] In the diagram: 1. Mother liquor bottle; 2. Weighing device; 3. Saline container; 4. Liquid circuit switching valve; 5. Peristaltic pump; 6. Measuring container; 7. First activity measuring instrument; 8. Waste liquid bottle; 9. Injection terminal; 10. Drug extraction pipeline; 11. Saline pipeline; 12. Waste liquid pipeline; 13. Target pipeline; 14. Measuring pipeline. Detailed Implementation

[0019] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0020] like Figures 1 to 5 As shown, this embodiment provides a radiopharmaceutical injection device, which is suitable for transferring the drug solution to be injected into the mother liquor bottle 1 through the measuring container 6, performing one or more drug solution extractions according to the target radioactivity value, measuring the current cumulative activity value during the drug solution extraction process, updating the current real-time specific activity in combination with the cumulative volume of extracted drug solution, and performing the final total activity measurement and error judgment after the extraction termination condition is met, and then injecting it into the patient through the injection terminal 9.

[0021] Figure 3 The diagram illustrates a real-time calibration injection procedure using two drug extractions, including determining the first target volume, first extraction and first activity value measurement, first specific activity determination, second target volume determination, second extraction, final total activity measurement, error assessment, and injection. The two drug extractions are a specific implementation of one or more drug extractions and do not constitute a limitation on the number of extractions. The device uses a weighing device 2 to obtain the weight of the mother liquor bottle 1, a first activity measuring instrument 7 to obtain the radioactivity in the measuring container 6, and controls the transfer of drug solution or saline between pipelines via a fluid switching valve 4 and a peristaltic pump 5.

[0022] like Figure 1 As shown, the radiopharmaceutical injection device includes a mother liquor bottle 1, a weighing device 2, a saline container 3, a liquid switching valve 4, a peristaltic pump 5, a measuring container 6, a first activity measuring instrument 7, a waste liquid bottle 8, an injection terminal 9, a drug extraction line 10, a saline line 11, a waste liquid line 12, a target line 13, a measuring line 14, and a control unit. The mother liquor bottle 1 is mounted on the weighing device 2, enabling the weighing device 2 to obtain the total weight of the mother liquor bottle 1 and the drug solution inside, and to determine the increase or decrease in weight of the mother liquor bottle 1 by the weight difference before and after the same liquid transfer action.

[0023] The measuring container 6 is placed within the detection range of the first activity measuring instrument 7, so that the first activity measuring instrument 7 can obtain the activity of the drug solution in the measuring container 6 and the activity change before and after the corresponding liquid transfer action.

[0024] Waste liquid line 12 connects to waste liquid bottle 8. Liquid line switching valve 4 is used to select the liquid line corresponding to mother liquid bottle 1, saline container 3, measuring container 6, waste liquid bottle 8, or injection terminal 9. Peristaltic pump 5 is used to drive the transfer of medication or saline solution in the selected liquid line. Injection terminal 9 is connected to liquid line switching valve 4 via target line 13. Injection terminal 9 can take different forms: in one application scenario, injection terminal 9 is an injection needle, the end of which is used to connect to the patient's intravenous access for direct injection of radioactive medication; in another application scenario, injection terminal 9 is a syringe used to receive radioactive medication output through target line 13, which is then injected into the patient by medical personnel using the syringe.

[0025] The control unit is electrically connected to the weighing device 2, the first activity measuring instrument 7, the liquid circuit switching valve 4, and the peristaltic pump 5. The control unit receives detection data from the weighing device 2 and the first activity measuring instrument 7, and controls the valve position switching of the liquid circuit switching valve 4 and the operation of the peristaltic pump 5 according to a preset program; the control unit can be a PLC controller or an embedded processor with data storage and processing capabilities. The control unit... Figure 1 It is not shown separately in the text.

[0026] In this embodiment, the tubing remains sealed at each stage: the drug solution enters the measuring container 6, flows from the measuring container 6 into the mother solution bottle 1, flows from the mother solution bottle 1 into the measuring container 6, and is injected into the patient from the measuring container 6 via the injection terminal 9. The drug extraction tubing 10 is filled with drug solution after system initialization, and the saline tubing 11, target tubing 13, and measuring tubing 14 are filled with physiological saline after system initialization, thus ensuring that subsequent injections are performed in a fully liquid state.

[0027] S1: System initialization.

[0028] Before system initialization, install the pipelines corresponding to the mother liquor bottle 1, saline container 3, measuring container 6, waste liquid bottle 8, and injection terminal 9, and confirm that the valve position mapping of the liquid path switching valve 4 is consistent with the actual connection relationship of the installed pipelines. Input the radionuclide half-life parameter corresponding to the drug solution, the activity reference time of the drug solution, and the parameters required for subsequent injection into the radiopharmaceutical injection device. The radionuclide half-life parameter is used to convert the activity at different collection times to the same reference time, and is used to calculate the real-time specific activity at the injection time from the initial specific activity.

[0029] First, all the drug solution to be injected is transferred into the measuring container 6. After the drug solution enters the measuring container 6, the flow of the drug solution is stopped and the first activity measuring instrument 7 completes stable sampling. The total activity of the drug solution is measured by the first activity measuring instrument 7. The total activity of the drug solution corresponds to a specific activity reference time.

[0030] When the activity values ​​of stable sampling are not obtained at the same time, each activity value is corrected to the activity reference time according to the nuclide half-life parameter before use.

[0031] Subsequently, a recovery path from the measuring container 6 to the mother liquor bottle 1 is established via the liquid switching valve 4, and the peristaltic pump 5 is controlled to pump all the liquid in the measuring container 6 into the mother liquor bottle 1, which is mounted on the weighing device 2. The weighing device 2 acquires the initial weight of the mother liquor bottle 1 before the liquid transfer begins and the stable weight of the mother liquor bottle 1 after the liquid transfer stops and stable sampling is completed. The difference between the two values ​​is used to determine the total weight of the liquid transferred into the mother liquor bottle 1. The weight of the mother liquor bottle 1 itself remains constant before and after the operation; therefore, the influence of the mother liquor bottle 1's own weight on the total weight of the liquid can be eliminated by the weight difference.

[0032] During the transfer of the liquid medicine in the measuring container 6 to the mother liquor bottle 1, the total number of operations of the peristaltic pump 5 from the start of the liquid transfer action to its stop is recorded. The total number of operations is a count result used by the control unit to represent the cumulative operation of the peristaltic pump 5, and a uniform counting method is used in the same system initialization.

[0033] In one embodiment, the total weight of the drug solution is converted into the total volume of the drug solution based on a pre-set density parameter of the drug solution to be injected; in another embodiment, the total weight of the drug solution is converted into the total volume of the drug solution based on a pre-established calibration relationship between the weight and volume of the drug solution to be injected. After obtaining the total volume of the drug solution, the initial specific activity at the activity reference time is obtained by dividing the total activity of the drug solution by the total activity of the drug solution.

[0034] Specific activity refers to the radioactivity per unit volume of drug solution, and its dimension can be expressed as activity units per volume unit.

[0035] Simultaneously, the pump tube coefficient of the peristaltic pump 5 is obtained by dividing the total volume of the liquid by the total number of operations of the peristaltic pump 5. The pump tube coefficient is used to characterize the correspondence between the number of operations of the peristaltic pump 5 and the liquid transfer volume under the current pipeline installation state; when the unit number of operations is used as the calibration unit, the pump tube coefficient represents the liquid transfer volume corresponding to each unit number of operations of the peristaltic pump 5, and the liquid transfer volume corresponding to a certain number of operation cycles is determined accordingly.

[0036] When subsequent extractions of the first target volume, the second target volume, or other target volumes from one or more extractions are required, the radiopharmaceutical injection device determines the number of operations of the peristaltic pump 5 based on the corresponding target volume and pump tube coefficient, and controls the peristaltic pump 5 to complete the corresponding liquid transfer action. If the total weight of the drug solution, the total activity of the drug solution, or the total number of operations does not generate valid data, or the total number of operations is zero, then valid initial specific activity and pump tube coefficient cannot be generated, the system initialization is determined to be incomplete, and subsequent real-time calibration injections are stopped.

[0037] The liquid transfer action from the measuring container 6 to the mother liquor bottle 1 also serves as the initialization recovery action.

[0038] At the start of the initial recovery process, the initial weight of mother liquor bottle 1 and the initial activity of measuring container 6 were recorded. After the peristaltic pump 5 stopped running and completed stable sampling, the stable weight of mother liquor bottle 1 and the stable activity of measuring container 6 were recorded. After correcting the initial and stable activities to the same reference time, the changes in the weight of mother liquor bottle 1 and the changes in the activity of measuring container 6 before and after the initial recovery were compared.

[0039] When the weight gain of mother liquor bottle 1 exceeds the weight confirmation threshold and the activity reduction of measuring container 6 exceeds the activity confirmation threshold, an initial recovery signature is generated.

[0040] The initialization recovery signature indicates that within the action window corresponding to the initialization recovery action, the radioactive drug solution in the measuring container 6 actually decreases, and the liquid in the mother liquor bottle 1 actually increases. The liquid transfer direction established by the liquid switching valve 4 and the peristaltic pump 5 is consistent with the expected recovery direction from the measuring container 6 to the mother liquor bottle 1.

[0041] After the medication is recovered, while the injection terminal 9 is not connected to the patient's intravenous access, the fluid switching valve 4 and the peristaltic pump 5 are controlled to deliver saline from the saline container 3 through the saline line 11 and the measuring line 14 to the measuring container 6. Then, the fluid switching valve 4 is switched and the running direction of the peristaltic pump 5 is changed to discharge the saline in the measuring container 6 through the measuring line 14 and the target line 13 from the initial discharge path corresponding to the injection terminal 9 until the saline line 11, the measuring line 14 and the target line 13 are filled with saline.

[0042] The filling volume of physiological saline can be determined based on the preset internal volumes of saline tubing 11, measuring tubing 14, measuring container 6, and target tubing 13, as well as the pump coefficient, ensuring that the actual delivery volume of the peristaltic pump 5 is not less than the amount of liquid required to complete the filling of the aforementioned tubing. The liquid discharged during initialization is received according to the original initialization procedure of the equipment and is not used as the medication injected into the patient via the injection terminal 9 in the current injection.

[0043] During the filling process of physiological saline, the drug solution is controlled to enter the drug extraction line 10 from the mother solution bottle 1. The number of peristaltic pump 5 operations required for filling is determined according to the preset internal volume of the drug extraction line 10 and the pump coefficient, so that the drug extraction line 10 is filled with drug solution. After the drug extraction line 10 is filled with drug solution, the extraction to the measuring container 6 is stopped. Therefore, before the formal injection begins, the drug extraction line 10 is filled with drug solution, and the measuring line 14, the target line 13, and the saline line 11 are filled with physiological saline.

[0044] Physiological saline is transported from saline container 3 to measurement container 6 via saline tubing 11 and measurement tubing 14. Then, the fluid switching valve 4 is switched and the running direction of the peristaltic pump 5 is changed. The physiological saline in measurement container 6 is transferred through measurement tubing 14 and target tubing 13, which is the saline selection action. At the start of the action window corresponding to the saline selection action and when the action stops and stable sampling is completed, the weight of mother liquor bottle 1 and the activity of measurement container 6 are obtained, and the activity before and after are corrected to the same reference time.

[0045] A saline selection signature is generated when the weight loss of mother liquor bottle 1 corresponding to the saline selection action does not exceed the weight confirmation threshold, and the positive activity change of measuring container 6 does not exceed the activity confirmation threshold. The fact that the weight loss of mother liquor bottle 1 does not exceed the weight confirmation threshold indicates that the saline selection action did not extract a verifiable amount of drug solution from mother liquor bottle 1; the fact that the positive activity change of measuring container 6 does not exceed the activity confirmation threshold indicates that the saline selection action did not introduce new radioactive drug solution into measuring container 6.

[0046] If the saline solution pushes the residual drug solution in the measuring container 6 or measuring tubing 14 out of the detection range of the first activity measuring instrument 7, causing a decrease in the activity of the measuring container 6, this decrease in activity is not a positive activity change and does not affect the formation of the saline selection signature.

[0047] The system initialization must be completed under the following conditions: total drug activity has been obtained; all drug solution has been transferred to mother liquor bottle 1; initial specific activity and pump tube coefficient have been established; measuring line 14, target line 13, and saline line 11 are filled with physiological saline; drug extraction line 10 is filled with drug solution; and initialization recovery signature and saline selection signature have been established. If any condition is not met, subsequent real-time calibration injection will not proceed.

[0048] In another embodiment for the first injection, after system initialization, the drug extraction tubing 10 is already filled with drug solution. When starting the first injection, the saline solution can be controlled to push the drug solution segment at the front end of the drug extraction tubing 10 along the measuring tubing 14 into the measuring container 6, and the drug solution segment is retained in the measuring container 6 as the initial drug solution for the first injection.

[0049] The first activity measuring instrument 7 measures the radioactivity of the initial drug solution to obtain the initial cumulative activity value of the first drug solution. When the first drug solution is subsequently extracted, the initial cumulative activity value is used as the measured cumulative activity value before the first supplementary extraction, and the target volume corresponding to the current extraction of the subsequent drug solution is calculated based on the target radioactivity value, the measured cumulative activity value, and the current real-time specific activity.

[0050] The first dose of drug solution includes an initial drug solution segment pushed to the measuring container 6 by the drug extraction tubing 10, and subsequent drug solutions extracted to the measuring container 6 one or more times. When input fluid path causal signature group verification needs to be performed, the initial cumulative activity value is lower than the normal extraction termination condition, and an initial extraction signature is formed during the first supplementary extraction of the first dose of drug solution; when the initial cumulative activity value has met the normal extraction termination condition, no further extraction of drug solution is required, and the final total activity measurement and error determination can be performed directly. This situation corresponds to an input fluid path verification implementation method that does not rely on the initial extraction signature.

[0051] S2: Real-time calibration injection.

[0052] During real-time calibration injection, when the drug solution is transferred from the mother solution bottle 1 to the injection terminal 9, or when the saline solution is transferred from the saline container 3 to the injection terminal 9, it first enters the measuring container 6 for transfer. Only after the drug solution has completed the radioactivity measurement by the first activity measuring instrument 7 in the measuring container 6 is it allowed to be injected into the patient through the target tubing 13 and the injection terminal 9.

[0053] The control fluid switching valve 4 and peristaltic pump 5 perform one or more drug extractions. Before each extraction, the target volume is calculated based on the target radioactivity value, the measured cumulative activity value, and the current real-time specific activity. After each extraction, the current cumulative activity value in the measuring container 6 is measured, and the current real-time specific activity is updated based on the current cumulative activity value and the cumulative extracted drug volume until the preset extraction termination condition is met.

[0054] When there is no initial drug solution for the current injection in the measuring container 6, the measured cumulative activity value before the first drug solution extraction is treated as zero. During the first drug solution injection, if the measuring container 6 retains the initial drug solution pushed in by the drug extraction tubing 10, the initial cumulative activity value measured by the first activity meter 7 is used as the measured cumulative activity value before the first supplementary extraction. After at least one subsequent drug solution extraction is completed, the measured cumulative activity value is the cumulative activity value measured by the first activity meter 7 for all the drugs injected in the current injection within the measuring container 6 after the previous drug solution extraction was completed.

[0055] The current cumulative activity value is the total activity of all extracted drug solutions in the current injection container 6 after the completion of this drug extraction, rather than just the activity increased by this drug extraction.

[0056] The current cumulative activity value is corrected to the unified reference time used for the current injection, and the current real-time specific activity is updated based on the current cumulative activity value and the cumulative volume of drug solution extracted. The cumulative volume of drug solution extracted includes the initial drug solution volume that has entered the measuring container 6 at the start of the current injection and the actual extraction volume of each subsequent drug solution extraction; if the initial drug solution volume does not exist, the initial drug solution volume is treated as zero. The initial drug solution volume is determined based on the preset internal volume of the corresponding tube segment of the drug extraction tubing 10 pushed into the measuring container 6, and the actual extraction volume of each drug solution extraction is determined based on the actual number of operations of the peristaltic pump 5 and the pump tube coefficient.

[0057] The extraction termination conditions include normal extraction termination conditions and abnormal extraction termination conditions. The normal extraction termination condition is when the current cumulative activity value reaches the stop interval set according to the target radioactivity value and allowable error requirements. The abnormal extraction termination conditions include when the current cumulative activity value exceeds the allowable upper limit, the updated current real-time specific activity cannot form a valid positive value, or the remaining target activity cannot form a valid target volume for this operation. When the normal extraction termination condition is met, the final total activity measurement is initiated; when the abnormal extraction termination condition is met, the drug extraction is stopped, and the process follows the path for not meeting the allowable error requirements.

[0058] In one specific embodiment employing two drug extractions, the real-time calibration injection includes the following steps S21 to S24.

[0059] In this two-stage drug extraction embodiment, before the first extraction, the measuring container 6 does not contain the initial drug solution for the current injection, and the measured cumulative activity value before the first extraction is zero. When the first dose of drug solution includes the initial drug solution segment pushed into the measuring container 6 by the drug extraction tubing 10, the aforementioned one or more drug extraction procedures are followed, and the calculation method of determining the first specific activity by dividing the first activity value by the actual extraction volume of the first drug solution is not directly adopted.

[0060] S21: Parameter acquisition and calculation.

[0061] When initiating a single injection, the target radioactivity value and injection time are entered. The target radioactivity value represents the radioactivity that the drug solution injected into the patient via injection terminal 9 should possess at the injection time. The target radioactivity value and the injection time together constitute the dosage requirement for this injection. The injection time can be the planned completion time of the drug solution injection or a pre-defined dosage reference time specified by the equipment. In the same injection, the target radioactivity value, the measured cumulative activity value, the current cumulative activity value, the first activity value, the second activity value, and the final total activity should be adjusted to the same injection time or the same unified reference time before comparison.

[0062] Before the first extraction, the real-time specific activity at the current injection moment is calculated based on the initial specific activity and radionuclide half-life parameters obtained during system initialization. After one extraction, the current real-time specific activity is updated based on the current cumulative activity value measured after this extraction and the cumulative volume of extracted drug solution; when calculating the target volume corresponding to the next extraction, the updated current real-time specific activity is used. If the radionuclide half-life parameter is missing, the injection moment is invalid, or the real-time specific activity cannot form a valid positive value, the injection is stopped.

[0063] S22: First sampling and measurement.

[0064] The volume of the first target is calculated based on the target radioactivity value, the preset first extraction ratio, and the real-time specific activity.

[0065] Specifically, the planned activity corresponding to the first extraction is first determined by multiplying the target radioactivity value by the first extraction ratio. Then, the planned activity is divided by the real-time specific activity to obtain the first target volume. The first extraction ratio is less than 1, so that the planned activity corresponding to the first target volume is lower than the target radioactivity value, thus reserving supplementary space for the second extraction and measurement.

[0066] The initial sampling ratio should not be arbitrarily reduced, but should simultaneously ensure that the first target volume is not less than the minimum validation volume. The minimum validation volume is determined based on two conditions: First, according to the conversion relationship between the total weight of the liquid medicine and the total volume of the liquid medicine, the expected weight reduction of the mother liquor bottle 1 corresponding to the minimum verification volume should exceed the weight confirmation threshold.

[0067] Secondly, based on the current real-time specific activity, the expected increase in activity in the measurement container 6 corresponding to the minimum validation volume should exceed the activity confirmation threshold. The minimum extraction volume that simultaneously satisfies both of the above conditions is taken as the minimum validation volume.

[0068] When configuring the first extraction ratio, first determine the total target volume corresponding to this injection based on the target radioactivity value and real-time specific activity. Then, select the first extraction ratio within a range less than 1, ensuring that the first target volume is not less than the minimum verification volume and is less than the total target volume. If the total target volume of this injection is insufficient to generate a two-way change exceeding the weight confirmation threshold and the activity confirmation threshold, the input liquid path verification requirements cannot be met by adjusting the first extraction ratio. The radiopharmaceutical injection device will not open the target pipeline 13 and will stop the automatic injection.

[0069] After the first target volume is determined, the target number of peristaltic pump 5 is determined based on the first target volume and the pump tube coefficient. The liquid circuit switching valve 4 first keeps the injection path from the measuring container 6 to the injection terminal 9 via the target pipeline 13 in a cut-off state, and then establishes the drug input path from the mother liquor bottle 1 to the measuring container 6 via the drug extraction pipeline 10 and the measuring pipeline 14.

[0070] Then, the peristaltic pump 5 is controlled to run in the direction of the liquid flowing from the mother liquor bottle 1 to the measuring container 6, so that the first target volume of liquid enters the measuring container 6.

[0071] In a liquid-filled pipeline, the first target volume of drug solution can form a drug solution segment located between columns of physiological saline. This segment is propelled by subsequent inflows of physiological saline along the drug extraction pipeline 10 and the measurement pipeline 14 into the measurement container 6. Once inside the measurement container 6, the drug solution segment can be contained within it together with the physiological saline used to propel it. A first activity meter 7 measures the radioactivity generated by the radioactive drug solution within the container. The coexistence of the drug solution and physiological saline within the measurement container 6 does not alter the measurement relationship of the first activity value.

[0072] The target volume for subsequent drug extraction can also be formed into a corresponding drug segment in the same manner as described above, and then propelled to the measuring container 6 by physiological saline.

[0073] The first liquid transfer action corresponding to the first extraction is also used to form the first extraction signature. At the start of this action, the initial weight of the mother liquor bottle 1 and the initial activity of the measuring container 6 are recorded; after the target number of cycles corresponding to the first target volume is reached, the peristaltic pump 5 is stopped and stable sampling is completed, obtaining the stable weight of the mother liquor bottle 1 and the stable activity of the measuring container 6.

[0074] After correcting the initial activity and stable activity to the same reference time, the weight loss of mother liquor bottle 1 and the increase in activity of measuring container 6 are determined.

[0075] When the weight loss of the corresponding mother liquor bottle 1 exceeds the weight confirmation threshold and the increase in activity in the measuring container 6 exceeds the activity confirmation threshold, an initial extraction signature is generated. The drug solution used to generate the initial extraction signature is retained in the measuring container 6 and entirely included in the first target volume. This portion of the drug solution is not returned to the mother liquor bottle 1, nor is it treated as separate verification waste. Thus, the initial extraction signature is generated using the drug solution required for the formal injection, without additional consumption of radiopharmaceuticals.

[0076] After the initial extraction signature is generated, the first activity measuring instrument 7 performs a stable sampling of the drug solution in the measuring container 6 to obtain the first activity value. When the first extraction is the first extraction of drug solution in the current injection, the first activity value is also used as the current cumulative activity value after the first extraction.

[0077] The first activity value includes the actual total activity of the drug solution to be injected in the measuring container 6 after the first target volume of the drug solution enters the measuring container 6, and is corrected to the unified reference time used for this injection according to the radionuclide half-life parameter.

[0078] The first specific activity is calculated based on the first activity value and the actual extraction volume of the first drug extraction. The actual extraction volume is determined based on the actual number of operations of the peristaltic pump 5 during the first drug extraction process and the pump tube coefficient. The first specific activity, as the current real-time specific activity updated after the first drug extraction is completed, is used to calculate the second target volume or the target volume corresponding to the current extraction for subsequent drug extractions.

[0079] The initialization recovery signature, brine selection signature, and first extraction signature are combined in the execution order of the corresponding liquid transfer actions to form the input liquid path causal signature group.

[0080] The three signatures correspond to the liquid transfer actions of the measuring container 6 recovering the drug solution from the mother liquor bottle 1, the physiological saline entering the measuring container 6 from the saline container 3, and the first target volume of drug solution entering the measuring container 6 from the mother liquor bottle 1. Each signature is formed by the weight change of the mother liquor bottle 1 and the activity change of the measuring container 6 within the same action window.

[0081] The action window begins when the fluid switching valve 4 and peristaltic pump 5 initiate the corresponding fluid transfer action and ends when the corresponding fluid transfer action stops and stable sampling is completed. The weight and activity at the beginning of the action window are used as the initial values, and the stable weight and stable activity at the end of the action window are used as the ending values.

[0082] Stable sampling refers to a state where, after the liquid transfer action stops, the data collected by the weighing device 2 and the first activity measuring instrument 7 no longer show the continuous unidirectional change caused by the continued liquid transfer, and the equipment reaches a stable state where it can compare the differences before and after the transfer. The action windows corresponding to different signatures are distinguished from each other, and data from other liquid transfer actions are not incorporated into the current action window.

[0083] Because radiopharmaceuticals undergo continuous natural decay within the action window, the original activity at different collection times cannot be directly subtracted.

[0084] For the same action window, any one of the following times is selected as the reference time: the start time of the action window, the stable sampling time, or the unified reference time for this injection. The initial activity and stable activity are then corrected to this reference time according to the radionuclide half-life parameter. The same reference time and the same radionuclide half-life parameter are used in each signature determination process, so that the activity change mainly reflects the change caused by the drug entering or leaving the measuring container 6.

[0085] The weight confirmation threshold is used to distinguish between weight changes caused by actual liquid transfer and those caused by the resolution capability of the weighing device 2, short-term fluctuations, and mechanical disturbances caused by the operation of the liquid switching valve 4 and the peristaltic pump 5. When determining the weight confirmation threshold, the weight change range of the mother liquor bottle 1 is collected under the conditions that the peristaltic pump 5 is stopped, the liquid switching valve 4 remains unchanged, and there is no liquid transfer within the mother liquor bottle 1. This is combined with weight fluctuations that may occur during normal operation of the liquid switching valve 4 and the peristaltic pump 5 but do not represent liquid migration, and a weight confirmation threshold higher than the aforementioned non-liquid migration fluctuations is set. Only when the increase or decrease in weight exceeds the weight confirmation threshold is it determined that a weight increase or decrease has occurred.

[0086] The activity confirmation threshold is used to distinguish between activity changes caused by actual radioactive liquid migration and activity fluctuations in the first activity measuring instrument 7 under conditions of no liquid transfer, as well as activity correction errors. To determine the activity confirmation threshold, activity sampling results are acquired under conditions where no new radioactive liquid enters or leaves the measuring container 6. The sampling results are corrected to the same reference time, the ranges of positive and negative activity changes under conditions of no liquid transfer are determined, and an activity confirmation threshold higher than this range is set. Only when a positive activity change, an increase in activity, or a decrease in activity exceeds the activity confirmation threshold is it determined that activity enhancement or deactivation has occurred.

[0087] No new activity means that, after correction for the radionuclide half-life parameter, the activity at the end of the action window does not show a positive change exceeding the activity confirmation threshold compared to the activity at the beginning of the action window. No new activity allows the activity of measuring container 6 to remain essentially unchanged, and also allows for a decrease in activity due to the replacement of residual drug solution with physiological saline.

[0088] The amount of activity reduction or increase required for initial signature recovery and initial signature extraction must exceed the activity confirmation threshold, respectively.

[0089] When the initialization recovery signature, saline selection signature, and first extraction signature are formed in their respective action windows, in the order of initialization recovery, saline prefilling, and first extraction, and no weight or activity change that contradicts the corresponding liquid transfer action appears in each action window, the input liquid path causal signature group is deemed to have passed verification.

[0090] Contradictory weight or activity changes include: no increase in weight of mother liquor bottle 1 or no decrease in activity of measuring container 6 during the initial recovery process; a decrease in weight of mother liquor bottle 1 exceeding the weight confirmation threshold or a positive activity change in measuring container 6 exceeding the activity confirmation threshold during the saline selection process; and no decrease in weight of mother liquor bottle 1 or increase in activity of measuring container 6 during the first extraction, or a change in the opposite direction to the expected one.

[0091] After the input fluid path causal signature group verification is passed, it is confirmed that the valve position mapping of the current drug extraction line 10, saline line 11, measurement line 14, fluid path switching valve 4 and the running direction of peristaltic pump 5 can jointly form an input fluid path consistent with the control requirements. Based on whether the current cumulative activity value meets the extraction termination condition, it controls the continuation of the second extraction or other subsequent drug extraction, or enters the error judgment and injection stage.

[0092] If the input fluid path causal signature group verification fails, stop the subsequent drug extraction, error judgment and injection of the current injection, and the target pipeline 13 will not be opened.

[0093] S23: Second sampling and measurement.

[0094] After the input liquid path causal signature group is verified, it is determined whether the first activity value meets the extraction termination condition.

[0095] When the first activity value meets the normal extraction termination condition, the second drug extraction will not be performed. The first activity value will be used as the final total activity in the current two extraction implementations, and the process will proceed to error judgment and injection.

[0096] When the first activity value meets the abnormal extraction termination condition, the subsequent extraction of the drug solution is stopped, the target pipeline 13 is not opened, and the path that does not meet the allowable error requirements is handled.

[0097] If the first activity value does not meet the normal or abnormal extraction termination conditions, the target radioactivity value and the first activity value are corrected to the same injection time or the same unified reference time, and the remaining target activity is determined based on the difference between the target radioactivity value and the first activity value; the second target volume is calculated based on the remaining target activity and the first specific activity. If an effective second target volume cannot be formed, the abnormal extraction termination conditions are applied.

[0098] When an effective second target volume can be formed, the target operating number of the peristaltic pump 5 is determined according to the second target volume and the pump tube coefficient. The liquid circuit switching valve 4 is controlled to establish the drug input path from the mother liquor bottle 1 through the drug extraction pipeline 10 and the measuring pipeline 14 to the measuring container 6. The peristaltic pump 5 is controlled to extract the drug solution of the second target volume into the measuring container 6, so that the drug solution of the first target volume and the drug solution of the second target volume together constitute the drug solution to be injected in the measuring container 6.

[0099] After the second extraction of the drug solution is completed, the peristaltic pump 5 is stopped, and the drug solution in the measuring container 6 and the first activity measuring instrument 7 are allowed to reach a stable sampling state. The cumulative total activity of all the drug solution to be injected in the measuring container 6 is measured by the first activity measuring instrument 7 to obtain the second activity value, and the second activity value is used as the final total activity in the current two extraction implementation.

[0100] S24: Error judgment and injection.

[0101] The allowable error requirement is set before the start of a single injection, corresponding to the target radioactivity value, to limit the acceptable deviation of the final total activity from the target radioactivity value.

[0102] The allowable error requirement can be represented by the allowable error range formed by the lower and upper limits of the target radioactivity value, or by the allowable activity difference between the target radioactivity value and the final total activity. Regardless of the representation method, the target radioactivity value and the final total activity being compared should be corrected to the same reference time and use the same activity unit.

[0103] When the final total activity meets the allowable error requirement, the drug solution is deemed to meet the target radioactivity value requirement.

[0104] The fluid switching valve 4 first disconnects the drug input path from the mother liquor bottle 1 to the measuring container 6, and establishes a saline input path from the saline container 3 through the saline pipeline 11 and the measuring pipeline 14 to the measuring container 6, controlling the peristaltic pump 5 to deliver physiological saline to the measuring container 6. Then, the fluid switching valve 4 is switched and the running direction of the peristaltic pump 5 is changed, establishing an injection path from the measuring container 6 through the measuring pipeline 14 and the target pipeline 13 to the injection terminal 9. This allows the physiological saline to propel the drug solution, whose activity has already been measured, into the measuring container 6 via the target pipeline 13 and the injection terminal 9 for injection into the patient. The physiological saline used to propel the drug solution first enters the measuring container 6, without forming an injection path that bypasses the measuring container 6.

[0105] The required volume of saline solution for injection is determined based on the internal volumes of the measuring container 6, measuring tubing 14, target tubing 13, and the corresponding fluid path of the injection terminal 9. This ensures that the medication in the measuring container 6 can be injected into the patient via the injection terminal 9, and that the target tubing 13 remains fully hydrated. The required saline solution volume is converted into the number of cycles of the peristaltic pump 5 using the pump tubing coefficient.

[0106] During injection, the first activity measuring instrument 7 continuously or intermittently acquires the residual activity within the measuring container 6 to confirm the extent to which the drug solution has been transferred from the measuring container 6 to the injection terminal 9. This residual activity is not used to recalculate the second target volume.

[0107] When the residual activity in the measuring container 6 exceeds the preset injection residue threshold, the saline input and injection output process is repeated: first, physiological saline is delivered from the saline container 3 to the measuring container 6; then, the fluid switching valve 4 is switched and the running direction of the peristaltic pump 5 is changed, causing the physiological saline to push the residual drug solution in the measuring container 6 and the corresponding injection fluid path through the target tubing 13 and the injection terminal 9 to be injected into the patient. The above process can be performed once or multiple times until the residual activity in the measuring container 6 is not higher than the injection residue threshold.

[0108] The injection residue threshold is determined based on the uninjected activity allowed by clinical quality control, the detection capability of the first activity measuring instrument 7, and the allowable residue in the measuring container 6 and the injection circuit.

[0109] When the final total activity does not meet the allowable error requirement, the fluid switching valve 4 does not establish an injection path from the measuring container 6 through the target pipeline 13 to the injection terminal 9. Instead, it establishes a discharge path from the measuring container 6 through the waste pipeline 12 to the waste bottle 8, controlling the peristaltic pump 5 to automatically discharge the medication in the measuring container 6 to the waste bottle 8. After the medication is discharged to the waste bottle 8, the injection ends, and the medication that does not meet the allowable error requirement is not injected into the patient through the injection terminal 9.

[0110] In a specific injection example, the target radioactivity value corresponding to the current injection is 10 mCi, the real-time specific activity before the first drug extraction is 20 mCi / ml, and the first extraction ratio is 1 / 2. Based on the target radioactivity value and the first extraction ratio, the planned activity corresponding to the first extraction is determined to be 5 mCi, and the first target volume is determined to be 0.25 ml based on the planned activity and the real-time specific activity.

[0111] After the control fluid switching valve 4 and peristaltic pump 5 draw 0.25 ml of drug solution into the measuring container 6, the first activity meter 7 measures the first activity value as 5.1 mCi. Based on the first activity value and the actual volume of the initial drug solution draw, the first specific activity is determined to be 20.4 mCi / ml.

[0112] The remaining target activity between the target radioactivity value and the first activity value is 4.9 mCi. Based on the remaining target activity and the first specific activity, the second target volume is determined to be approximately 0.24 ml. After the control fluid switching valve 4 and peristaltic pump 5 draw the second target volume of drug solution into the measuring container 6, the first activity measuring instrument 7 measures the final total activity of all drug solution in the measuring container 6, and compares the final total activity with the allowable error requirement corresponding to clinical quality control. When the final total activity meets the allowable error requirement, the drug solution is injected into the patient through the target tubing 13 and the injection terminal 9.

[0113] The above values ​​are only used to illustrate the two drug extractions and the real-time specific activity calibration process, and do not constitute a limitation on the target radioactivity value, the first extraction ratio, the drug volume, the real-time specific activity, or the number of drug extractions.

[0114] In embodiments not limited to two drug extractions, after each drug extraction, the first activity measuring instrument 7 measures all the drug extracted in the current injection in the measuring container 6 to obtain the current cumulative activity value.

[0115] The current cumulative activity value is corrected to the unified reference time used for the current injection, and the current real-time specific activity is updated based on the corrected current cumulative activity value and the cumulative drug volume extracted in the current injection. The cumulative drug volume is determined based on the actual number of operations of the peristaltic pump 5 and the pump tube coefficient in each drug extraction; the target volume for each injection can be used as a target value for controlling the operation of the peristaltic pump 5, but does not replace the cumulative drug volume determined based on the actual number of operations.

[0116] When the current cumulative activity value has not yet met the preset extraction termination condition, the remaining target activity is determined based on the target radioactivity value and the current cumulative activity value, and the target volume corresponding to the next drug extraction is calculated based on the remaining target activity and the updated current real-time specific activity.

[0117] Repeat the above process of drug extraction, current cumulative activity measurement, and current real-time specific activity update until the extraction termination condition is met. After the extraction termination condition is met, the final total activity is measured. If the final total activity meets the allowable error requirement, it is injected into the patient via injection terminal 9; otherwise, it is discharged into waste bottle 8.

[0118] The aforementioned steps S21 to S24 constitute a specific implementation method of two extractions in one or more drug extractions.

[0119] In a specific embodiment, anomaly control is implemented when the input fluid circuit verification fails.

[0120] When the input liquid path causal signature group verification fails, the liquid path anomaly type is determined based on the unformed initial recovery signature, saline selection signature or first extraction signature, as well as the weight change of mother liquor bottle 1 and the activity change of measuring container 6 in the corresponding action window.

[0121] Fluid circuit anomaly types are used to indicate the inconsistency between the actual fluid transfer result and the expected fluid transfer action, and do not require the identification of a single faulty component based on a single weight change and activity change.

[0122] During the initial recovery process, if the weight gain of mother liquor bottle 1 exceeds the weight confirmation threshold but the activity decrease in measuring container 6 does not exceed the activity confirmation threshold, it indicates that although mother liquor bottle 1 has gained weight, the increased liquid cannot be confirmed by the decrease in radioactive material in measuring container 6. If the activity decrease in measuring container 6 exceeds the activity confirmation threshold but the weight gain of mother liquor bottle 1 does not exceed the weight confirmation threshold, it indicates that the radioactive material may have left measuring container 6 but not entered mother liquor bottle 1. If neither weight nor activity changes exceed the corresponding confirmation threshold, it indicates that the corresponding liquid transfer path has not been actually established, the pipeline is blocked, or the peristaltic pump 5 has not achieved effective liquid transfer. In any of these cases, an initial recovery signature is not generated.

[0123] During the saline selection process, if the weight loss in mother liquor bottle 1 exceeds the weight confirmation threshold and the positive activity change in measuring container 6 exceeds the activity confirmation threshold, it indicates that the saline selection process actually causes the drug solution to enter the measuring container 6 from mother liquor bottle 1, and the valve position mapping or actual gate relationship of the liquid path switching valve 4 is inconsistent with the saline selection requirements. If the weight loss in mother liquor bottle 1 exceeds the weight confirmation threshold but no new activity is observed in measuring container 6, it indicates that the drug solution may have left mother liquor bottle 1 but did not enter measuring container 6. If no confirmable weight loss occurs in mother liquor bottle 1 but a new activity is observed in measuring container 6, it indicates that there is a source of radioactive drug solution in measuring container 6 or measuring pipeline 14 that does not correspond to the current saline selection process. In none of the above situations will a saline selection signature be generated.

[0124] In the action window corresponding to the first extraction, if the weight loss of mother liquor bottle 1 exceeds the weight confirmation threshold but the activity increase of measuring container 6 does not exceed the activity confirmation threshold, it indicates that the liquid may have left mother liquor bottle 1 but has not reached measuring container 6; if the activity increase of measuring container 6 exceeds the activity confirmation threshold but the weight loss of mother liquor bottle 1 does not exceed the weight confirmation threshold, it indicates that the new activity of measuring container 6 cannot be confirmed by the liquid output of the current mother liquor bottle 1; if mother liquor bottle 1 gains weight or measuring container 6 loses activity, the corresponding change is opposite to the weight loss and activity increase direction required for the first extraction; if there is no confirmed change in weight and activity, the corresponding liquid transfer path may not have been established or may have been blocked. In none of the above situations will a first extraction signature be generated.

[0125] If the input liquid path causal signature group verification fails, the control liquid path switching valve 4 cuts off the injection path from the measuring container 6 to the injection terminal 9 via the target pipeline 13, and controls the peristaltic pump 5 to stop running. At this time, the subsequent drug extraction, error judgment, and injection are stopped.

[0126] If there is already liquid medicine in the measuring container 6, it can be discharged to the waste liquid bottle 8 through the waste liquid pipeline 12 after confirming that the discharge path is safe, or it can be kept in the measuring container 6 and wait for manual processing; the target pipeline 13 should not be opened before the input liquid path status is re-verified.

[0127] After an input fluid path verification failure occurs, the installation status of the drug extraction line 10, saline line 11, measurement line 14, and target line 13 can be checked according to the type of fluid path anomaly. The valve position mapping of the fluid path switching valve 4 and the operating direction of the peristaltic pump 5 should also be checked. After reinstalling the lines, adjusting the valve position mapping, or adjusting the operating direction of the peristaltic pump 5, the system initialization should be re-executed, and the initialization recovery signature, saline selection signature, and first extraction signature should be regenerated.

[0128] In another specific embodiment, continuous injection is performed under the same piping conditions.

[0129] When the drug extraction line 10, saline line 11, target line 13 and measurement line 14 are not replaced, and the valve position mapping of the liquid switching valve 4 is not changed, the initialization recovery signature and saline selection signature can be generated once during the system initialization process and saved as the initialization verification result of the current pipeline installation status.

[0130] For each subsequent injection, the target radioactivity value and injection time are reacquired, and the target volume corresponding to each drug extraction is determined based on the target radioactivity value, the measured cumulative activity value and the current real-time specific activity. During the first drug extraction, the weight change of the mother liquor bottle 1 and the activity change of the measuring container 6 are reacquired.

[0131] Only when the weight loss of the mother liquor bottle 1 exceeds the weight confirmation threshold and the increase in activity of the measuring container 6 exceeds the activity confirmation threshold, can subsequent drug extractions or error judgments and injections be allowed to continue based on whether the current cumulative activity value meets the extraction termination conditions.

[0132] If the initial extraction signature is not generated for any subsequent dose, the extraction of subsequent drug solutions for that dose, as well as error assessment and injection, are stopped, and the injection path from the measuring container 6 to the injection terminal 9 via the target pipeline 13 is cut off. This process allows the radiopharmaceutical injection device to continuously verify the actual liquid transfer status from the mother liquor bottle 1 to the measuring container 6 during continuous use of the same pipeline.

[0133] If any of the drug extraction line 10, saline line 11, target line 13, or measurement line 14 is replaced, or if the valve position mapping of the liquid switching valve 4 is changed, the previously formed initialization recovery signature and saline selection signature will no longer be used as the verification basis for the current pipeline status.

[0134] At this point, the system initialization should be re-executed to regenerate the initialization recovery signature, brine selection signature, and current first extraction signature, and the input liquid path causal signature group should be re-verified.

[0135] In another specific embodiment, the parameters are determined and the equivalent implementation is described.

[0136] The weight confirmation threshold, activity confirmation threshold, minimum verification volume, initial sampling ratio, method for determining the actual sampling volume, sampling termination conditions, allowable error requirements, and waiting time required for stable sampling can all be configured according to the specific radiopharmaceutical injection device, including the weighing device 2, the first activity measuring instrument 7, the peristaltic pump 5, the internal volume of the tubing, and the nuclide to be injected. However, the aforementioned functional relationships should be maintained between the parameters. A sampling volume lower than the actual confirmable weight change of the weighing device 2 must not be used to form the initial sampling signature, nor should a sampling volume lower than the actual confirmable activity change of the first activity measuring instrument 7 be used to form the initial sampling signature.

[0137] The volume of a single extraction of radioactive drug solution can be in the sub-milliliter range. Within this volume range, a small amount of residual liquid in the pipeline, a single delivery deviation of the peristaltic pump 5, or a small amount of droplets may cause activity changes that can be detected by the first activity measuring instrument 7, and may affect whether the final total activity meets the allowable error requirements.

[0138] Therefore, this embodiment does not determine the drug injection result solely based on the current target volume or the theoretical number of peristaltic pump 5 operations. Instead, after each drug extraction is completed, the current cumulative activity value of the drug in the measuring container 6 is obtained through the first activity measuring instrument 7, and the current real-time specific activity is updated based on the actual measurement results to determine the current target volume corresponding to subsequent drug extractions.

[0139] The weight of mother liquor bottle 1 and the activity of measuring container 6 can be continuously acquired within the action window, or acquired separately at the start of the action window and during stable sampling.

[0140] When using continuous acquisition, the initial value at the start of the action window and the stable value after the action stops are determined from the continuous data. When using pre- and post-acquisition, the stable sampling results before the action starts and after the action stops are used as the initial and final values, respectively. Regardless of the method used, weight changes and activity changes that form the same signature should correspond to the same liquid transfer action.

[0141] Activity can be uniformly corrected to the start time of the action window, the stable sampling time of the action window, or the injection time. For initial recovery signatures, saline selection signatures, and first extraction signatures, the initial activity and stable activity within each signature must be corrected to the same reference time.

[0142] For comparisons of the target radioactivity value, the measured cumulative activity value, the current cumulative activity value, and the final total activity, each activity value should be corrected to the same injection time or the same unified reference time, and the same activity unit should be used. In the two-extraction implementation, the first activity value and the second activity value are used as the current cumulative activity value after the corresponding extraction is completed.

[0143] The initialization recovery signature and saline selection signature preferably reuse the drug recovery action and saline filling action that were originally required during system initialization; the first extraction signature preferably reuses the first drug extraction action in the current injection. Therefore, the input fluid path verification does not require the addition of a new mother liquor bottle 1, weighing device 2, saline container 3, fluid path switching valve 4, peristaltic pump 5, measuring container 6 or first activity measuring instrument 7, nor does it require the consumption of an additional radioactive drug solution specifically for verification.

[0144] It should be understood that the above embodiments have fully described each liquid transfer action, data acquisition timing, threshold determination method and anomaly handling method, but do not limit the present invention to the only software implementation form or the only control timing.

[0145] Without altering the following technical relationships, equivalent control can be implemented: when the drug solution and saline are transferred to the injection terminal 9, they are first transferred through the measuring container 6; the initialization recovery action in system initialization forms an initialization recovery signature; the saline selection action forms a saline selection signature; the first drug solution extraction forms a first extraction signature; the three signatures form an input fluid path causal signature group in the execution order; after each drug solution extraction, the current cumulative activity value is measured, and the current real-time specific activity is updated based on the current cumulative activity value and the cumulative drug solution volume extracted; after the input fluid path causal signature group is verified, the control continues to perform subsequent drug solution extraction or performs final total activity measurement, error judgment, and injection based on whether the current cumulative activity value meets the extraction termination condition; if the verification fails, the target pipeline 13 is cut off and the peristaltic pump 5 is stopped.

[0146] Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A radiopharmaceutical injection device, characterized in that, include: Injection terminal (9), used for injecting drugs; Mother liquor bottle (1) is set on weighing device (2) for storing medicine liquid; The measuring container (6) is equipped with a first activity measuring instrument (7) for measuring the radioactivity of the drug solution inside the measuring container (6); Saline container (3), used to store physiological saline; Liquid circuit switching valve (4) is connected to the measuring container (6) through the measuring pipeline (14), to the saline container (3) through the saline pipeline (11), to the mother liquor bottle (1) through the drug extraction pipeline (10), and to the injection terminal (9) through the target pipeline (13). A peristaltic pump (5) is installed on the measuring pipeline (14); The control unit is electrically connected to the weighing device (2), the first activity measuring instrument (7), the liquid circuit switching valve (4), and the peristaltic pump (5); The control unit is used to control the drug solution to be transferred from the measuring container (6) to the mother liquor bottle (1) and to calculate the initial specific activity and pump tube coefficient during system initialization; it is also used to draw the drug solution in the mother liquor bottle (1) into the measuring container (6) for activity measurement and judgment during injection, and to control the drug solution to be directed to the injection terminal (9) when the final total activity measured after the drug solution extraction meets the preset allowable error requirements.

2. The radiopharmaceutical injection device according to claim 1, characterized in that: It also includes a waste liquid bottle (8), which is connected to the liquid switching valve (4) through a waste liquid pipeline (12); During injection, if the final total activity measured after the drug solution extraction meets the allowable error requirement, the liquid circuit switching valve (4) is controlled to open the target pipeline (13) for injection; if it does not meet the requirement, the liquid circuit switching valve (4) is controlled to open the waste liquid pipeline (12) to discharge the drug solution into the waste liquid bottle (8). The control unit is also used to control the liquid circuit switching valve (4) and the peristaltic pump (5) to perform one or more drug extractions. Each time the drug is extracted, the target volume is determined according to the target radioactivity value, the measured cumulative activity value and the current real-time specific activity. The corresponding drug is then extracted into the measuring container (6), the current cumulative activity value is measured, and the current real-time specific activity is updated in combination with the extracted cumulative drug volume until the preset extraction termination condition is met.

3. The radiopharmaceutical injection device according to claim 2, characterized in that, The control unit is also configured to perform input fluid path verification during system initialization and upon the first execution of the drug extraction, including: When the liquid medicine in the measuring container (6) is drawn into the mother liquor bottle (1), an initialization recycling signature is formed based on the weight change of the mother liquor bottle (1) obtained by the weighing device (2) and the activity change of the measuring container (6) obtained by the first activity measuring instrument (7). When the saline solution is sequentially filled into the saline solution line (11), the measuring line (14) and the target line (13) by controlling the saline solution, a saline solution selection signature is formed based on the weight change of the mother liquor bottle (1) and the activity change of the measuring container (6); When the medicine is first drawn from the mother liquor bottle (1) to the measuring container (6), a first drawing signature is formed based on the weight change of the mother liquor bottle (1) and the activity change of the measuring container (6); The initialization recovery signature, saline selection signature, and first extraction signature are combined according to the execution order of the corresponding liquid transfer action to form an input liquid path causal signature group. Based on the verification result of the input liquid path causal signature group, the system controls whether to allow the continued extraction of subsequent drug solutions or to perform error judgment and injection.

4. A radiopharmaceutical injection device according to claim 3, characterized in that, The control unit is configured to set action windows for the liquid transfer actions that form the initial recovery signature, the brine selection signature, and the first extraction signature, respectively. The weight of the mother liquor bottle (1) and the activity of the measuring container (6) are obtained when each action window starts and when the corresponding liquid transfer action stops and stable sampling is completed. The activity at the start of the action window and at the stable sampling time is corrected to the same reference time. Based on whether the changes in weight and activity before and after exceed the corresponding weight confirmation threshold and activity confirmation threshold, the weight increase, weight decrease, activity increase, activity decrease or no new activity is determined.

5. A radiopharmaceutical injection device according to claim 4, characterized in that, The control unit is configured to perform a liquid transfer action, in which the liquid in the measuring container (6) is pumped into the mother liquor bottle (1) by the peristaltic pump (5), as an initial recovery action; When the weight gain of the mother liquor bottle (1) corresponding to the initial recycling action exceeds the weight confirmation threshold, and the activity reduction of the measuring container (6) exceeds the activity confirmation threshold, the initial recycling signature is formed.

6. A radiopharmaceutical injection device according to claim 4, characterized in that, The control unit is configured to first control the liquid circuit switching valve (4) and the peristaltic pump (5) to transport physiological saline from the saline container (3) through the saline pipeline (11) and the measuring pipeline (14) to the measuring container (6), then switch the liquid circuit switching valve (4) and change the running direction of the peristaltic pump (5) to discharge the physiological saline in the measuring container (6) through the measuring pipeline (14) and the target pipeline (13), and use the above liquid transfer action as the saline selection action; When the weight loss of the mother liquor bottle (1) corresponding to the saline selection action does not exceed the weight confirmation threshold, and the positive activity change of the measuring container (6) does not exceed the activity confirmation threshold, the saline selection signature is formed. The decrease in the activity of the measuring container (6) caused by the replacement of residual drug solution with physiological saline does not affect the formation of the saline selection signature.

7. A radiopharmaceutical injection device according to claim 4, characterized in that, The control unit is configured to determine a minimum verification volume based on conditions that enable the expected weight loss of the mother liquor bottle (1) to exceed the weight verification threshold and the expected increase in activity of the measuring container (6) to exceed the activity verification threshold. The target volume corresponding to the first drug extraction is configured to be no less than the minimum verification volume; When the weight loss of the mother liquor bottle (1) corresponding to the first drug extraction exceeds the weight confirmation threshold, and the increase in activity of the measuring container (6) exceeds the activity confirmation threshold, the first extraction signature is formed, and the drug transferred by the first drug extraction is retained in the measuring container (6) as the current drug to be injected.

8. A radiopharmaceutical injection device according to claim 4, characterized in that, The control unit is configured to: when the initialization recovery signature, saline selection signature, and first extraction signature are formed in their respective action windows, and are formed in the order of initialization recovery action, saline selection action, and first drug extraction, and no weight change or activity change that contradicts the corresponding liquid transfer action appears in each action window, the input liquid path causal signature group is determined to be verified as passed, and the control unit is configured to continue subsequent drug extraction or perform error judgment and injection based on whether the current cumulative activity value meets the extraction termination condition. Otherwise, the input liquid path causal signature group verification is deemed to have failed, and subsequent drug extraction, error determination, and injection are stopped.

9. A radiopharmaceutical injection device according to claim 8, characterized in that, The control unit is configured such that when the drug extraction line (10), saline line (11), target line (13) and measurement line (14) are not replaced and the valve position mapping of the liquid switching valve (4) is not changed, the initial recovery signature and saline selection signature are formed once during the system initialization process and the corresponding first extraction signature is re-formed during the first drug extraction process of each subsequent injection. If the initial extraction signature is not formed, stop the subsequent extraction of drug solution for the current injection, as well as error judgment and injection; After any of the pipelines is replaced or the valve position mapping of the liquid circuit switching valve (4) is changed, the input liquid circuit causal signature group is re-formed.

10. A radiopharmaceutical injection device according to claim 8, characterized in that, The control unit is configured to: when the input liquid path causal signature group verification fails, determine the liquid path abnormality type based on the unformed initial recovery signature, saline selection signature or first extraction signature, as well as the weight change of the mother liquor bottle (1) and the activity change of the measuring container (6) in the corresponding action window, control the liquid path switching valve (4) to cut off the injection path from the measuring container (6) to the injection terminal (9) through the target pipeline (13), control the peristaltic pump (5) to stop running, and stop the subsequent drug extraction and error judgment and injection of the current injection.

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