A seeding device and a check hot cell for radiopharmaceuticals
Patent Information
- Application Number
- CN202522064189.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-09-25
- Publication Date
- 2026-10-13
- Estimated Expiration
- 2035-09-25
AI Technical Summary
首先,传统的无菌检查隔离器需要操作人员通过手套手孔直接接触放射性药品,这使工作人员暴露于辐射环境中,即使在铅屏蔽的防护条件下,长时间累积的辐射剂量仍然存在健康风险;其次,手动操作过程中,需要开启西林瓶盖、抽取药液、注射到培养基等多个精细操作步骤,人工操作易导致接种量误差,影响检查结果的准确性;第三,操作人员长时间佩戴厚重的铅手套进行精细操作,容易出现疲劳和操作不稳定,增加了操作失误的风险
本实用新型主要提供了一种用于放射性药品的接种装置和检查热室,通过所述接种装置,实现了放射性药品无菌检查过程的高度自动化。该装置通过自动开盖模块、自动注射模块和剑式机械手的协同工作,使操作人员无需直接接触放射性药物样品即可完成药瓶开盖、样品抽取和培养瓶接种等全流程操作,显著降低了工作人员的辐射暴露风险,保障了操作安全性。
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Figure CN224849062U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of radiopharmaceutical detection technology, and in particular to an inoculation device and inspection hot chamber for radiopharmaceuticals. Background Technology
[0002] Aseptic testing of radiopharmaceuticals is a crucial aspect of quality control, typically performed using the direct inoculation method. This procedure involves drawing a specific amount of the radiopharmaceutical solution from a vial, inoculating it into a culture medium, and then observing for microbial growth. Because the samples are radioactive, traditional methods pose radiation safety risks, necessitating specialized shielding designs and procedures.
[0003] Currently, aseptic testing procedures for radiopharmaceuticals typically face the following technical challenges: First, traditional aseptic testing isolators require operators to directly contact radioactive drugs through the vents in their gloves, exposing them to radiation. Even with lead shielding, the cumulative radiation dose over a long period still poses a health risk. Second, manual operation involves multiple delicate steps, such as opening vials, drawing up the solution, and injecting it into the culture medium. Manual operation can easily lead to errors in inoculation dosage, affecting the accuracy of the test results. Third, operators wearing heavy lead gloves for extended periods while performing delicate operations are prone to fatigue and operational instability, increasing the risk of operational errors.
[0004] Therefore, when performing aseptic inspections on radiopharmaceuticals, how to minimize personnel radiation exposure while ensuring operational accuracy and the integrity of the aseptic environment, and how to reduce safety risks while improving operational efficiency, has become an urgent technical problem to be solved. Utility Model Content
[0005] This utility model discloses an inoculation device and an inspection hot chamber for radiopharmaceuticals, aiming to solve the technical problems existing in the prior art.
[0006] The present invention adopts the following technical solution: One embodiment of this utility model provides an inoculation device for radiopharmaceuticals, the inoculation device comprising: An automatic cap-opening module is used to open the caps of vials containing radioactive drugs. An automatic injection module is used to extract a predetermined amount of radioactive drug solution from a vial and inject it into a culture flask; Sword-shaped robotic arm used to grasp medicine bottles and move them to a different position.
[0007] As a preferred technical solution, the automatic cap opening module includes a translational cap opening mechanism and a chuck-type positioning mechanism. The chuck-type positioning mechanism is used to fix the bottle body of the medicine bottle, and the translational cap opening mechanism is used to translate and open the cap of the medicine bottle.
[0008] As a preferred technical solution, the chuck-type positioning mechanism includes radial clamping claws for synchronously clamping the bottle body of the medicine bottle; The translational opening mechanism includes a translational drive unit and a locking head. The translational drive unit is used to drive the locking head to translate, and the locking head can lock with the cap of the medicine bottle and drive it to separate from the bottle body.
[0009] As a preferred technical solution, the medicine bottle is configured with a first working position and a second working position, which are staggered in the vertical direction. The automatic cap opening module is located on one side of the first working position, and the medicine bottle is configured to be upright in the first working position; The automatic injection module is located directly below the second working position, and the medicine bottle is configured to be placed upside down in the second working position.
[0010] As a preferred technical solution, the sword-type robotic arm includes a gripping part and an operating part. The gripping part is located in a sterile inspection chamber and is used to grip and move the medicine bottle, and position it at least in a first working position and a second working position. The operating unit is located outside the sterile inspection room and is used to control the clamping, moving, and releasing actions of the clamping unit on the medicine bottle.
[0011] As a preferred technical solution, the automatic injection module includes an injection pump, a rotatable clamping arm, and an adjustable inoculation arm; The rotatable clamping arm is used to clamp the injection pump and rotate it at least 180°. An adjustable inoculation arm is located on one side of the injection pump and is staggered vertically with the rotatable clamping arm; the adjustable inoculation arm can move axially in the vertical direction to control the pump's extraction and injection actions.
[0012] As a preferred technical solution, the culture bottle is positioned directly below the second working position, and the rotatable clamping arm is positioned between the culture bottle and the second working position; When the rotatable clamping arm rotates the needle of the injection pump to a vertical position, the adjustable inoculation arm can clamp the piston of the injection pump and draw the liquid from the vial located in the second working position. When the rotatable clamping arm rotates the needle of the injection pump to a vertically downward position, the adjustable inoculation arm can clamp the piston of the injection pump and inject the drug solution into the culture flask.
[0013] As a preferred technical solution, a culture flask holder is also included for fixing the position of the culture flask; The culture flask holder is equipped with a contact sensor to determine whether the culture flask is placed in the correct position.
[0014] Another embodiment of this utility model provides a hot chamber for the examination of radiopharmaceuticals, including the inoculation device as described in any of the preceding embodiments.
[0015] As a preferred technical solution, the inspection hot chamber also includes a lead shielding module for radiation protection of the sterile inspection chamber.
[0016] As a preferred technical solution, the lead shielding module includes an inner transparent sealing door and an outer lead protective shielding door; The inner transparent sealing door is designed with an inflatable sealing structure to prevent the leakage of radioactive materials. The outer lead shielding door is used to prevent radiation leakage. The outer lead shielding door is interlocked with the radiation monitoring system in the inspection hot chamber and can only be opened when the internal radiation dose is within the safe limit.
[0017] One embodiment of the above-described utility model has the following advantages or beneficial effects: This invention primarily provides an inoculation device and inspection hot chamber for radiopharmaceuticals. The inoculation device achieves a high degree of automation in the aseptic inspection process of radiopharmaceuticals. Through the coordinated operation of an automatic capping module, an automatic injection module, and a sword-shaped robotic arm, the device allows operators to complete the entire process of vial opening, sample extraction, and culture flask inoculation without direct contact with the radiopharmaceutical sample, significantly reducing the radiation exposure risk for workers and ensuring operational safety.
[0018] The sterile inspection hot chamber of this invention also integrates a lead shielding module, forming a complete radiation protection and sterile environment assurance system through the structure of a double-layer shielding door. Attached Figure Description
[0019] To more clearly illustrate the technical solutions of the embodiments of this utility model, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of this utility model. The illustrative embodiments of this utility model and their descriptions explain this utility model and do not constitute an improper limitation of this utility model. In the accompanying drawings: Figure 1 This is a schematic diagram of the overall structure of the hot chamber system provided in a preferred embodiment of the present invention; Figure 2 This is a top view of the internal structure of the hot chamber system provided in a preferred embodiment of the present invention; Figure 3 This is a front view of the inoculation device provided in a preferred embodiment of the present invention; Figure 4This is a schematic diagram of the inoculation device provided in a preferred embodiment of the present invention; Figure 5 This is a schematic diagram of the opening mechanism provided in a preferred embodiment of the present invention.
[0020] Explanation of reference numerals in the attached figures: Aseptic inspection hot chamber 1, automatic cap opening module 11, translational cap opening mechanism 111, chuck positioning mechanism 112, automatic injection module 12, injection pump 121, rotatable clamping arm 122, adjustable inoculation arm 123, sword-type robotic arm 13, clamping part 131, operating part 132, culture bottle holder 14, culture bottle 141, vial 15, first working position 151, second working position 152, inner transparent sealing door 161, outer lead protective shielding door 162, aseptic transfer chamber 2, sliding tray 21. Detailed Implementation
[0021] To make the objectives, technical solutions, and advantages of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this utility model, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly stated otherwise.
[0022] In the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.
[0023] Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.
[0024] refer to Figures 1-4 To address the technical problems existing in the prior art, this invention provides an inoculation device for radiopharmaceuticals. Preferably, the inoculation device is configured in a sterile examination hot chamber 1. In some optional embodiments, a sterile transfer chamber 2 is also provided on one side of the sterile examination hot chamber 1, and the two are connected to form a hot chamber system. The sterile transfer chamber 2 can transfer radiopharmaceuticals into the sterile examination hot chamber 1 in a sterile environment through a sliding tray 21.
[0025] It should be noted that in this embodiment, components such as the aseptic transfer chamber 2 and the sliding tray 21 can be selected from existing structures in the prior art, and this embodiment does not limit their specific structures. Those skilled in the art can select suitable aseptic transfer chamber and sliding tray structures from the prior art and combine them with other components of this utility model according to actual application needs, as long as the function of transferring aseptic items can be achieved.
[0026] Specifically, the hot chamber described in this embodiment refers to a closed space structure specifically designed for handling radioactive materials. Its purpose is to ensure a sterile environment while effectively isolating radioactive rays through protective measures such as lead shielding to prevent operators from being harmed by radiation. It is also equipped with devices such as robotic arms inside to enable remote operation, thereby ensuring the safety and reliability of the radioactive material handling process.
[0027] Furthermore, in this embodiment, the aseptic inspection hot chamber 1 is the core working area of the entire hot chamber system. Its main function is to provide a working environment that meets the requirements of aseptic operation and effectively shields the radiation of radioactive materials, so that operators can safely complete the aseptic inspection of radiopharmaceuticals.
[0028] The radiopharmaceuticals mentioned in this embodiment refer to pharmaceutical preparations containing radionuclides, which are mainly used for medical diagnosis and treatment, such as positron emission tomography (PET) imaging agents and radiotherapy drugs. These drugs require sterility testing during production and quality control. However, due to their radioactive characteristics, traditional sterility testing methods pose a risk of radiation damage to operators. Therefore, specialized equipment and methods are needed to ensure the safety and reliability of the testing process.
[0029] refer to Figures 1-4 In a preferred embodiment, the sterile inspection hot chamber 1 is equipped with an inoculation device, which includes an automatic cap-opening module 11, an automatic injection module 12, and a sword-shaped robotic arm 13. This allows operators to complete the entire process of extracting a specified amount of drug solution from a sample vial and inoculating it into the culture medium without direct contact with the radiopharmaceutical. By setting up an inoculation device in the sterile inspection hot chamber 1, not only is the radiation dose received by operators significantly reduced, ensuring personnel safety, but the reliability and consistency of aseptic operation are also improved by reducing human intervention. This effectively solves the industry pain point of fully manual operation in the quality control of radiopharmaceuticals, providing a safer and more efficient technical means for the quality control of radiopharmaceuticals.
[0030] Preferably, the automatic cap opening module 11 is used to open the cap of the vial containing radioactive drugs; the automatic injection module 12 is used to extract a predetermined amount of radioactive drug solution from the vial and inject it into the culture bottle 141; and the sword-shaped manipulator 13 is used to grip the vial and move its position.
[0031] In a preferred embodiment, the vial in this example is used to store radiopharmaceuticals. The vial is preferably a vial 15. Specifically, a vial 15 is a sealed glass container specifically designed for the pharmaceutical field, primarily used to hold injectable medications to ensure the medication remains sterile during storage and transportation. Preferably, the vial 15 consists of two parts: a vial body and a cap. The vial body is made of transparent glass, cylindrical in shape, with a flat bottom for easy upright placement. The cap has a composite structure, including a rubber stopper and an aluminum-plastic cap. The rubber stopper seals the vial opening and provides the injection / puncture medium. The aluminum-plastic cap is an integrated plastic cap and aluminum sealing ring used to secure the rubber stopper to the vial opening.
[0032] In a preferred embodiment, such as Figure 4 , Figure 5 As shown, the automatic cap-opening module 11 includes a translational cap-opening mechanism 111 and a chuck-type positioning mechanism 112. The chuck-type positioning mechanism 112 includes radial clamping claws for simultaneously clamping and fixing the vial body 15. The translational cap-opening mechanism 111 includes a translational drive unit and a locking head. The translational drive unit drives the locking head to translate, and the locking head can engage with the cap of the vial 15 and separate it from the vial body. In this embodiment, the translational cap-opening mechanism 111 is specifically used to open the aluminum-plastic cap of the vial 15, thereby exposing the puncture-resistant rubber portion, rather than opening the rubber stopper as well. This is to allow the vial 15 to be inverted so that the automatic injection module 12 can extract the medication.
[0033] In a preferred embodiment, when the sword-type manipulator 13 places the vial 15 at the center of the chuck-type positioning mechanism 112, the radial clamping claws can retract towards the center to achieve a stable clamping of the vial 15, ensuring that the vial 15 remains stable in the vertical direction and will not shift or rotate during the opening process. Preferably, the inner surface of the radial clamping claws is designed with an arc-shaped groove that adapts to the outer diameter of the vial 15, increasing the contact area while reducing the local pressure on the vial body and preventing damage to the vial 15 during clamping.
[0034] In a preferred embodiment, the translation drive unit of the translation opening mechanism 111 adopts an electric push rod structure, which can provide a stable linear thrust to ensure that the translation movement of the locking head is precise and controllable; the locking head is designed to match the shape of the aluminum-plastic cap of the vial 15, and its inner edge has moderate elasticity. When the locking head contacts the aluminum-plastic cap, it can automatically adapt to the contour of the cap and form a firm lock.
[0035] Preferably, the sliding cap opening mechanism 111 enables the opening of the aluminum-plastic cap, primarily based on the special structural design of the vial 15 cap. The aluminum-plastic cap of the vial 15 is typically fixed to the bottle neck using a rolled edge method, rather than a threaded connection. In pharmaceutical industry standards, this type of cap is designed to be easy to tear or lift, allowing medical personnel to quickly expose the internal rubber stopper during use. The sliding cap opening mechanism 111 utilizes this characteristic, generating shearing force through relative motion to remove the aluminum-plastic cap.
[0036] Specifically, after the vial 15 is fixed by the chuck positioning mechanism 112, the translation drive unit first drives the engaging head to move towards the vial 15 until the engaging head fully contacts the aluminum-plastic cap and forms an engagement. Subsequently, the translation drive unit continues to drive the engaging head to translate horizontally. Since the vial body is fixed and cannot move, this translational force acts on the aluminum-plastic cap, causing it to separate from the vial body. At this point, under the action of horizontal shearing force, the aluminum-plastic cap can be smoothly removed without damaging the rubber stopper. The entire cap opening process is completed automatically without manual intervention, ensuring the aseptic nature of the operation and avoiding the risk of operators coming into contact with radioactive samples.
[0037] like Figure 3 In a preferred embodiment, the vial 15 is provided with a first working position 151 and a second working position 152, which are staggered in the vertical direction; the automatic capping module 11 is provided on one side of the first working position 151, and the vial 15 is configured to be upright in the first working position 151; the automatic injection module 12 is provided directly below the second working position 152, and the vial 15 is configured to be inverted in the second working position 152.
[0038] In a preferred embodiment, the second working position 152 is provided with a clamping arm, which may specifically adopt the same structure as the chuck-type positioning mechanism 112 of the first working position 151, so as to clamp and position the inverted vial 15.
[0039] Specifically, when the bottle is upright, the liquid naturally settles to the bottom. When the aluminum-plastic cap is removed, even if the rubber stopper is slightly loose, the liquid will not immediately flow out, thus avoiding environmental pollution and radiation risks to personnel caused by radioactive drug leakage.
[0040] Inverting vials 15 during drug extraction is done to improve efficiency and accuracy. Because radiopharmaceuticals are expensive, the sample volume submitted is usually small, typically only about 1 ml, while standard vials typically have a capacity of 10 ml. This means that when the vial is upright, the drug solution is only distributed in a small area at the bottom. If extraction is performed upright, the needle must penetrate deep into the bottom of the vial, easily introducing a large number of air bubbles, severely affecting the accuracy and integrity of the sample. When vials 15 are inverted, the drug solution flows naturally towards the mouth of the vial and accumulates inside the rubber stopper. This allows the needle to directly contact the drug solution after piercing the stopper, without needing to penetrate deep into the vial, greatly improving extraction accuracy and reducing air bubble contamination and residue. This inverted sampling method is similar to standard operating procedures in clinical medicine and better meets the professional requirements for precise sampling.
[0041] Furthermore, by staggering the two working positions, the structure of the inoculation device becomes more compact, while also facilitating the rapid movement and positioning of the vial 15 by the sword-type robotic arm 13 according to the operation sequence. After completing the capping operation, the sword-type robotic arm 13 only needs to perform simple rotation and displacement to move the vial 15 from the first working position 151 to the second working position 152, achieving seamless connection of the process and reducing intermediate steps and waiting time.
[0042] like Figure 2 Preferably, the sword-type robotic arm 13 includes a gripping part 131 and an operating part 132. The gripping part 131 is disposed within the sterile inspection hot chamber 1 and is used to grip and move the vial 15, positioning it at least in a first working position 151 and a second working position 152. The operating part 132 is disposed outside the sterile inspection hot chamber 1 and is used to control the gripping, moving, and releasing actions of the gripping part 131 on the vial 15. It should be noted that regarding... Figure 2 The multiple sword-shaped robotic arms 13 in the sterile inspection hot chamber 1 are actually schematic diagrams of the same sword-shaped robotic arm 13 in different moving positions.
[0043] Specifically, the sword-shaped manipulator 13 is a remote mechanical device specifically designed for manipulating items in confined environments. Its structure typically includes an external control lever, a sealing connector, an internal extension arm, and an end effector. The external control lever, serving as the operating part 132, is operated by an operator outside the sterile inspection chamber 1. The internal extension arm, serving as the gripping part 131, extends into the sterile inspection chamber 1, and its end is equipped with an actuator specifically designed for gripping vials 15. The sealing connector is located between the operating part 132 and the gripping part 131, passing through the wall of the sterile inspection chamber 1 to ensure isolation between the internal and external environments. The entire sword-shaped manipulator 13 allows the operator to control the movement of the internal gripping part 131 through precise hand movements, enabling precise gripping, rotation, and displacement of the vials 15.
[0044] It should be noted that this embodiment does not limit the specific structure of the sword-shaped manipulator 13. Those skilled in the art can select an appropriate sword-shaped manipulator 13 structure from the prior art and apply it to this invention according to actual needs. There are already many mature sword-shaped manipulator 13 products on the market that can meet the needs of handling radioactive materials. It is only necessary to make appropriate selections and adjustments according to the functional requirements of this embodiment.
[0045] It is worth noting that the portion of the sword-shaped robotic arm 13 that passes through the wall of the sterile inspection hot chamber 1 employs a combination structure of flexible sealing rings and bearings to ensure the sealing and integrity of the sterile environment. This also ensures that the negative pressure and sterile conditions within the sterile inspection hot chamber 1 are not disrupted during the robotic arm's movement in any direction. In this embodiment, the front of the sterile inspection hot chamber 1 is also provided with at least one observation window. This observation window is made of radiation-resistant lead glass, offering high transparency and excellent radiation shielding performance. This allows the operator to clearly observe the movement and position of the sword-shaped robotic arm 13, facilitating precise control of the robotic arm's direction of movement and operational actions, thereby improving operational accuracy and safety.
[0046] In a preferred embodiment, the automatic injection module 12 includes an injection pump 121, a rotatable clamping arm 122, and an adjustable inoculation arm 123; wherein, the rotatable clamping arm 122 is used to clamp the injection pump 121 and drive it to rotate at least 180°; the adjustable inoculation arm 123 is disposed on one side of the injection pump 121 and is staggered with the rotatable clamping arm 122 in the vertical direction; the adjustable inoculation arm 123 can move axially in the vertical direction to control the extraction and injection actions of the injection pump 121.
[0047] In a preferred embodiment, the culture flask 141 is positioned directly below the second working position 152, and the rotatable clamping arm 122 is positioned between the culture flask 141 and the second working position 152. When the rotatable clamping arm 122 rotates the needle of the injection pump 121 to a vertically upward position, the adjustable inoculation arm 123 can clamp the piston of the injection pump 121 and draw the drug solution from the vial 15 located in the second working position 152. When the rotatable clamping arm 122 rotates the needle of the injection pump 121 to a vertically downward position, the adjustable inoculation arm 123 can clamp the piston of the injection pump 121 and inject the drug solution into the culture flask 141.
[0048] Specifically, the syringe pump 121 includes three main parts: a needle, a barrel, and a piston. A rotatable clamping arm 122 is used to clamp the barrel of the syringe pump 121. Its rotation axis is parallel to the vertical direction and is driven by a stepper motor to ensure that the rotation angle is precisely controllable, enabling precise positioning of the syringe pump 121 needle from vertically upward to vertically downward.
[0049] Preferably, one side of the adjustable inoculation arm 123 is provided with a linear sliding structure, which can move precisely in the vertical direction driven by an electric push rod; its front end is provided with a groove specifically for clamping the piston of the injection pump 121, the shape of which matches the tail of the injection pump 121 piston to ensure a stable clamping. When the needle of the injection pump 121 is vertically upward, the adjustable inoculation arm 123 moves downward, driving the piston of the injection pump 121 to descend, realizing the extraction action; when the needle of the injection pump 121 is vertically downward, the adjustable inoculation arm 123 moves downward, pushing the piston to descend, completing the injection action.
[0050] The entire workflow of the automatic injection module 12 is as follows: First, the sword-type robotic arm 13 inverts the opened vial 15 and moves it to the second working position 152, where the clamping arm on the second working position 152 fixes the vial 15. Simultaneously, the rotatable clamping arm 122 rotates the needle of the injection pump 121 to a vertically upward position, aligning it with the rubber stopper of the vial 15. Then, the adjustable inoculation arm 123 first clamps the barrel of the injection pump 121 and moves it upward, allowing the needle to pierce the rubber stopper and enter the vial 15. Next, the adjustable inoculation arm 123 clamps the piston and moves it downward, pulling the piston to draw a predetermined amount of drug solution. After the drawing is completed, the rotatable clamping arm 122 descends and rotates 180°, making the needle point vertically downward, aligning it with the culture bottle 141 below. Finally, the adjustable inoculation arm 123 moves downward, pushing the piston to inject the drug solution into the culture bottle 141, completing the entire injection and inoculation process.
[0051] In a preferred embodiment, the sterile inspection hot chamber 1 is further provided with a culture bottle holder 14 for fixing the position of the culture bottle 141; the culture bottle holder 14 is provided with a contact sensor for determining whether the culture bottle 141 is placed in place.
[0052] Specifically, the culture flask holder 14 is positioned below the automatic injection module 12. Its structure is a circular groove adapted to the size of a standard culture flask 141. A pressure-sensitive contact sensor is built into the bottom of the holder. When the culture flask 141 is correctly positioned, the sensor transmits a signal change to the control system. The control system determines the strength and duration of this signal to accurately confirm whether the culture flask 141 is correctly and securely positioned. Subsequent injection operations are only initiated after the contact sensor confirms that the culture flask 141 is correctly positioned, preventing injection failure or drug leakage due to the culture flask 141 not being placed or being unstable.
[0053] It should be noted that this utility model embodiment mainly improves the structural design of the aseptic inspection hot chamber 1 and the mechanical layout of its components. The control system and related control methods and software algorithms all adopt existing technologies. This application does not make any innovative improvements at the software or control logic levels. Those skilled in the art can select appropriate control systems and software solutions to combine with the structural design of this utility model according to specific application requirements to achieve the expected functions. Specific implementation methods at the software level, such as signal processing, logic judgment, and motion control, are conventional technical means and are not within the scope of protection of this application.
[0054] In a preferred embodiment, the sterile inspection hot chamber 1 further includes a lead shielding module for radiation protection. Preferably, the lead shielding module includes an inner transparent sealing door 161 and an outer lead shielding door 162. The inner transparent sealing door 161 is configured as an air-filled sealing structure to prevent the leakage of radioactive materials; the outer lead shielding door 162 is used to prevent radiation leakage. The outer lead shielding door 162 is interlocked with the radiation monitoring system inside the sterile inspection hot chamber 1 and can only be opened when the internal radiation dose is within the safety limits.
[0055] Preferably, the inner transparent sealing door 161 is made of radiation-resistant acrylic material and has an inflatable sealing ring around its perimeter. When the door is closed, the sealing ring automatically inflates and expands, forming an airtight seal with the door frame to prevent the leakage of radioactive particles or gases. Compared to traditional mechanical compression seals, the inner transparent sealing door 161 has higher sealing reliability and lower sealing pressure requirements, reducing wear and tear on the door during opening and closing and extending its service life. Furthermore, the transparent design of the inner transparent sealing door 161 allows operators to observe the interior without opening the door, reducing unnecessary door opening operations.
[0056] Preferably, the outer lead protective shielding door 162 adopts a multi-layer composite structure, with the core being a high-purity lead plate. The thickness is optimized according to the radiation type and intensity of the radiopharmaceutical, and this embodiment does not impose specific limitations. The lead plate is covered with a stainless steel plate, which provides mechanical strength protection and prevents lead oxidation and shedding.
[0057] Preferably, the outer lead shielding door 162 is equipped with an electric switch mechanism that interlocks with the indoor radiation monitoring system. The door lock will only be released and the door can be opened when the monitoring system confirms that the indoor radiation dose is lower than a preset safety threshold.
[0058] In this embodiment, the specific implementation method of the radiation monitoring system, the interlocking judgment logic, and other control technologies all adopt existing mature technologies. This application does not make any innovative improvements to the working principle or control algorithm of the monitoring system. Those skilled in the art can select appropriate radiation monitoring equipment and interlocking control schemes to combine with the structural design of this utility model according to the actual application environment and safety requirements to achieve the expected safety protection function.
[0059] In summary, this utility model embodiment organically combines a sterile operating environment with radiation protection functions, and uses a mechanical structure to replace the traditional fully manual operation, which significantly reduces the radiation exposure risk of operators, while improving the reliability and consistency of sterile operation.
[0060] The embodiments of the present invention have been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of the present invention without departing from the spirit and scope of the claims, and all of these forms are within the protection scope of the present invention.
Claims
1. An inoculation device for radiopharmaceuticals, characterized in that, include: An automatic cap-opening module is used to open the caps of vials containing radioactive drugs. An automatic injection module is used to extract a predetermined amount of radioactive drug solution from the vial and inject it into a culture flask; A sword-shaped robotic arm is used to grip the medicine bottle and move its position.
2. The inoculation device for radiopharmaceuticals according to claim 1, characterized in that, The automatic cap opening module includes a translational cap opening mechanism and a chuck-type positioning mechanism. The chuck-type positioning mechanism is used to fix the bottle body of the medicine bottle, and the translational cap opening mechanism is used to translate and open the cap of the medicine bottle.
3. The inoculation device for radiopharmaceuticals according to claim 2, characterized in that, The chuck-type positioning mechanism includes radial clamping claws for simultaneously clamping the bottle body of the medicine bottle; The translational opening mechanism includes a translational drive unit and a locking head. The translational drive unit is used to drive the locking head to translate, and the locking head can lock with the cap of the medicine bottle and drive it to separate from the bottle body.
4. The inoculation device for radiopharmaceuticals according to claim 1, characterized in that, The medicine bottle is configured with a first working position and a second working position, which are staggered in the vertical direction. The automatic cap opening module is located on one side of the first working position, and the medicine bottle is configured to be upright in the first working position; The automatic injection module is located directly below the second working position, and the medicine bottle is positioned upside down in the second working position.
5. The inoculation device for radiopharmaceuticals according to claim 4, characterized in that, The sword-shaped robotic arm includes a gripping part and an operating part. The gripping part is used to grip and move the medicine bottle and position it at least in the first working position and the second working position. The operating unit is used to control the clamping, moving, and releasing actions of the clamping unit on the medicine bottle.
6. The inoculation device for radiopharmaceuticals according to claim 5, characterized in that, The automatic injection module includes an injection pump, a rotatable clamping arm, and an adjustable inoculation arm; The rotatable clamping arm is used to clamp the injection pump and drive it to rotate at least 180°. The adjustable inoculation arm is disposed on one side of the injection pump and is staggered with the rotatable clamping arm in the vertical direction; the adjustable inoculation arm can move axially in the vertical direction to control the pump's extraction and injection actions.
7. The inoculation device for radiopharmaceuticals according to claim 6, characterized in that, The culture flask is positioned directly below the second working position, and the rotatable clamping arm is positioned between the culture flask and the second working position. When the rotatable clamping arm rotates the needle of the injection pump to a vertically upward position, the adjustable inoculation arm can clamp the piston of the injection pump and draw the liquid medicine from the vial located in the second working position. When the rotatable clamping arm rotates the needle of the injection pump to a vertically downward position, the adjustable inoculation arm can clamp the piston of the injection pump and inject the drug solution into the culture flask.
8. The inoculation device for radiopharmaceuticals according to claim 1, characterized in that, It also includes a culture flask holder for fixing the position of the culture flask; The culture flask holder is equipped with a contact sensor to determine whether the culture flask is placed in the correct position.
9. A heated chamber for inspecting radiopharmaceuticals, characterized in that, Includes the inoculation device as described in any one of claims 1-8.
10. The inspection chamber for radiopharmaceuticals according to claim 9, characterized in that, It also includes a lead shielding module for radiation protection of the inspection hot chamber; the lead shielding module includes an inner transparent sealing door and an outer lead protective shielding door; The inner transparent sealing door is configured as an inflatable sealing structure to prevent the leakage of radioactive materials; The outer lead shielding door is used to prevent radiation leakage. The outer lead shielding door is interlocked with the radiation monitoring system in the inspection hot chamber and can only be opened when the internal radiation dose is within the safety limit.