Radiation shielding assembly, vial assembly system, assembly method

Abstract

The invention provides a radiation shielding assembly, a drug vial assembly system, a method of dispensing a drug vial assembly system, and a radiopharmaceutical infusion device. The radiation shielding assembly is used for shielding a medicine bottle assembly containing radiopharmaceuticals, and the medicine bottle assembly is provided with a puncture communication piece capable of transversely moving. The shielding body is provided with a top opening, a small bottle containing cavity and a combination port, and the medicine bottle assembly is contained in the containing cavity through the top opening. The containing cavity is provided with a circumferential matching wall, the distance between the matching wall and the vertical center line is gradually decreased from the starting end to the tail end, and a moving path is provided for assembly. The medicine bottle is guided to move along the wall, and the bottom puncture communicating piece is guided to transversely move inwards and is in butt joint with the combination port when reaching the assembly completion position. After assembly is completed, the puncture communicating piece is in butt joint with the combination port. According to the invention, only one needle puncturing the top of the medicine bottle is used as an inflow channel. Needle adjustment is not needed when medicine is nearly empty, operation is simplified, and the error rate is reduced.

Description

Technical Field

[0001] This disclosure relates to systems and methods for radiation embolization, and more specifically, to radiation shielding assemblies, vial assembly systems, methods for assembling vial assembly systems, and drug delivery devices. Background Technology

[0002] Radioembolization, also known as selective internal radiation therapy (SIRT), is used to treat primary or metastatic malignant liver tumors. In SIRT, radiolabeled microspheres are injected into the patient's hepatic artery. Due to increased angiogenesis in the liver tumor, the radiolabeled microspheres preferentially localize within the tumor. The radiolabeled microspheres decay and deliver radiation to surrounding tissues.

[0003] Existing microsphere infusion system reference Figure 1 Its main principle is to inject water into a conical-bottom bottle containing resin microspheres, and then use pressure to deliver the microspheres into the human body. Specifically, syringe SA contains water for injection, syringe SB contains contrast agent, and syringe SC is used to inject either water for injection or air into the conical-bottom bottle.

[0004] Manually operate the three-way valve VB on the infusion box to connect the LA and LB lines. Manually open the three-way valve VA and inject water for injection, contrast agent, and then water for injection sequentially through syringes SA and SB, respectively. The water for injection is to prevent the microspheres from mixing with the contrast agent. Manually operate the three-way valve VB on the infusion box to connect the LA and LC lines. Syringe SC, connected to the LD line, injects water for injection into the conical-bottom bottle V, which mixes the microspheres and then infuses them into the patient through the LC and LA lines.

[0005] When the microspheres in the conical-bottom bottle are nearly empty, air needs to be injected into the bottle using syringe SC to ensure all microspheres are infused into the patient. This typically involves first opening the infusion box cap, raising the needle connected to the LD tubing, and pushing the needle connected to the LC tubing down to the conical bottom area. Then, the LA and LC tubings are connected via the three-way valve VB on the infusion box, allowing air to be injected into syringe SC to infuse all the microspheres into the patient. This procedure is overly complicated and prone to errors. Summary of the Invention

[0006] To address the problems existing in the prior art, this disclosure provides a radiation shielding assembly, a vial assembly system, a method for assembling the vial assembly system, and a radiopharmaceutical delivery device.

[0007] In a first aspect, a radiation shielding assembly is provided for shielding a vial assembly containing a radiopharmaceutical, the vial assembly having a laterally movable puncture connector. The radiation shielding assembly includes a shielding body having a top opening, a vial receiving cavity, and a connection port. The radiation shielding assembly is configured to receive the vial assembly within the vial receiving cavity through the top opening, and the connection port is used to engage with the puncture connector. The vial receiving cavity is configured to include a circumferential mating wall having a starting end and a terminal end, the distance from the circumferential mating wall to the vertical centerline of the vial receiving cavity decreasing from the starting end to the terminal end. The circumferential mating wall provides a moving assembly path for the assembly of the radiation shielding assembly and the vial assembly, allowing the vial assembly to be moved to an assembled position via the circumferential mating wall; when the vial assembly is in the assembled position, the connection port engages with the puncture connector.

[0008] In some embodiments, the vial receiving cavity is configured to include a circumferential groove, the bottom of which provides a circumferentially mating wall, the distance from the circumferentially mating wall to the vertical centerline of the vial receiving cavity remaining constant and then gradually decreasing from the starting end to the ending end.

[0009] In some embodiments, the vial receiving cavity is configured to further include a longitudinal groove extending vertically along the inner wall of the vial receiving cavity, communicating with a circumferential groove, with the bottom end of the longitudinal groove adjacent to the starting end of the circumferential groove. The distance from the bottom of the longitudinal groove to the vertical centerline of the vial receiving cavity is equal to the distance from the starting end of the circumferential mating wall to the vertical centerline of the vial receiving cavity. The longitudinal groove and the circumferential mating wall provide a moving assembly path for the assembly of the radiation shielding assembly and the vial assembly, allowing the vial assembly to be moved to the assembled position via the longitudinal groove and the circumferential mating wall.

[0010] Specifically, the axis of the connecting port extends laterally, and a flexible seal is provided at the connecting port to seal it. When the vial assembly is in the assembled position, the puncture connector can extend through the flexible seal. Optionally, the flexible seal is a silicone component with a linear cut in the center.

[0011] Specifically, the mating port is configured as including an opening and a frustum-shaped cavity, the cavity being located outside and communicating with the opening. The cross-sectional area of ​​the inner end of the cavity of the mating port is larger than the cross-sectional area of ​​the outer end, and the flexible seal is configured as a frustum shape and adapted to be received within the cavity of the mating port. The opening is configured to be enclosed by a first opening and a second opening, both concentric semicircles, the diameter of the first opening being smaller than the diameter of the second opening, and the first opening being located at the end of the circumferential mating wall.

[0012] Specifically, the radiation shielding assembly also includes a top cover, which includes a rod extending along the height direction. The rod and the vial assembly are respectively provided with engagement features that engage with each other. One of the upper parts of the top cover and the shielding body is provided with a wedge-shaped protrusion, and the other is provided with a groove suitable for engaging the wedge-shaped protrusion. The wedge-shaped protrusion or groove on the top cover is located on the outer periphery of the rod. When the vial assembly is placed in the vial receiving cavity and the rod and the vial assembly are engaged through the engagement features, during the tightening of the top cover and the shielding body through the wedge-shaped protrusion and the groove, the circumferential mating wall abuts against the outside of the puncture connector.

[0013] Specifically, the shielding body also includes a pipe interface located at its bottom, which is connected to the connection port and extends to the outer periphery of the shielding body. A straight-through valve is provided on the portion of the pipe interface located on the outer periphery of the shielding body. When the vial assembly is in the fully assembled position relative to the radiation shielding assembly, the straight-through valve is in fluid communication with the radiopharmaceutical fluid in the vial assembly.

[0014] In a second aspect, a vial assembly system is provided, characterized in that it includes a vial assembly and the aforementioned radiation shielding assembly of the first aspect. The vial assembly further includes a vial and a sealing block selectively puncturable by a puncture connector. The vial includes a body and a top seal. The body has an upper opening, a drug-containing chamber, and a bottom channel. The top seal is configured to engage with the vial from the upper opening to provide a seal to the drug-containing chamber. The bottom channel extends from the lower part of the drug-containing chamber to the outside of the chamber and is in fluid communication with the chamber. The sealing block is fixedly disposed relative to the bottom channel. The puncture connector has a puncture end near the sealing block and a connecting end away from the sealing block. The puncture connector is laterally movably disposed at the bottom of the body. When the sealing block is not punctured, it provides a fluid blockage to the bottom channel. The vial assembly is configured to be moved to an assembled position via a circumferential mating wall. During the movement of the vial assembly to the assembled position, the circumferential mating wall abuts against the connecting end of the puncture connector, thereby moving the puncture end towards the sealing block. When the vial assembly is in the assembled position, the connecting end of the puncture connector aligns with the mating port, the sealing block is punctured by the puncture connector, and the puncture connector is in fluid communication with the bottom channel and the mating port.

[0015] Thirdly, a method for assembling the vial assembly system of the second aspect, comprising the steps of: moving the vial assembly downward from the top opening of the radiation shielding assembly to the bottom of the vial receiving cavity; rotating the vial so that the connecting end of the puncture connector moves from the starting end to the terminal end along the circumferential mating wall.

[0016] Fourthly, a radiopharmaceutical delivery device includes a vial assembly system as described in the second aspect, a delivery box, a first tube, a second tube, a third tube, a fourth tube, a three-way stopcock valve, and an operating lever. The delivery box has a cavity, within which the vial assembly system is installed, and the bottom of the drug-containing chamber is configured as a cone shape, wider at the top and narrower at the bottom. A first end of the first tube extends outside the delivery box, and a needle is connected to the second end of the first tube. The needle is configured to enter the vial from above the vial assembly system through the top opening of a radiation shielding assembly and the upper opening of the vial assembly. A first end of the second tube is fluidly connected to a puncture connector of the vial assembly system, and a second end of the second tube is fluidly connected to the three-way stopcock valve. A first end of the third tube is fluidly connected to the three-way stopcock valve, and a second end of the third tube extends outside the delivery box. A first end of the fourth tube extends outside the delivery box, and a second end of the fourth tube is fluidly connected to the three-way stopcock valve. The first end of the control lever extends outside the conveyor box, and the second end of the control lever is connected to a three-way stop valve. The first end of the control lever is configured to receive operator control to select the direction of the three-way stop valve, so that two of the second, third and fourth pipes are in fluid communication.

[0017] The features and advantages of this disclosure include:

[0018] This invention requires only a single needle inserted through the top of the vial to deliver the substance into the vial assembly. The bottom of the vial assembly features a laterally movable inward-moving puncture connector, and a radiation shielding component provides a circumferential mating wall. During assembly, the puncture connector, guided by the circumferential mating wall, moves laterally inward, connecting the drug-containing chamber of the vial assembly, the puncture connector, and the mating port of the radiation shielding component, forming an outflow channel for the vial assembly. Thus, when the microspheres in the vial are nearly empty, the step of adjusting the injection needle during infusion can be eliminated. It is even possible to directly inject air into the vial using a first syringe to deliver all the radioactive microspheres into the body. This simplifies the operation and reduces the error rate. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of this disclosure, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this disclosure. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This illustrates a prior art radiopharmaceutical delivery system;

[0021] Figure 2 Radioactive microsphere delivery systems of some embodiments of this disclosure are shown;

[0022] Figure 3AA perspective view of the vial assembly of some embodiments is shown;

[0023] Figure 3B It shows Figure 3A A cross-sectional view along the AA direction;

[0024] Figure 3C An exploded perspective view of the puncture needle and sleeve is shown, illustrating the connection between the puncture needle and the second stop, the sleeve and the first stop.

[0025] Figure 3D A three-dimensional connection diagram of the puncture needle tube and the sleeve is shown;

[0026] Figure 3E It shows Figure 3D A sectional view;

[0027] Figure 4A An exploded perspective view of a radiation shielding assembly in some embodiments is shown;

[0028] Figure 4B A longitudinal cross-sectional schematic diagram of a radiation shielding assembly according to some embodiments is shown;

[0029] Figure 4C It shows Figure 4B A schematic diagram of the radiation shielding assembly after the top cover has been removed;

[0030] Figure 4D A longitudinal three-dimensional sectional view of the radiation shielding body is shown;

[0031] Figure 4E A cross-sectional view of the radiation shielding body is shown, illustrating the change from the beginning to the end of the circumferential groove.

[0032] Figure 4F It shows Figure 4E The top view shows the change in distance between the circumferential groove and the vertical centerline to the vial-containing cavity from the beginning to the end of the circumferential groove.

[0033] Figure 5A A vial assembly system with several embodiments is shown, which is composed of vial assemblies and radiation shielding assemblies;

[0034] Figure 5B A portion of the vial assembly system is shown, demonstrating the connection between the limiting U-shaped groove on the top cover of the radiation shielding assembly and the limiting upright plate on the body of the vial assembly.

[0035] Figure 5C It shows along Figure 5A A partial sectional view along the BB direction;

[0036] Figure 5D It shows Figure 5C Enlarged view of point M in the middle;

[0037] Figures 6A to 6E A schematic diagram showing the positional relationship changes of components during the assembly process of the vial assembly and radiation shielding assembly in some embodiments is shown;

[0038] Figure 7A A three-dimensional schematic diagram of a radiopharmaceutical delivery device is shown for some embodiments;

[0039] Figure 7B A three-dimensional partial cross-sectional view of the internal arrangement of a radiopharmaceutical delivery device, illustrating some embodiments, is shown. Detailed Implementation

[0040] The technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this disclosure, and not all embodiments. Based on the embodiments of this disclosure, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this disclosure.

[0041] This disclosure relates to components, systems, and methods for delivering radioactive microspheres or other related elements. The system may include a drug delivery device for delivering microspheres to a patient via a conduit configuration, a vial assembly system, a radiation shielding assembly, a vial assembly, and a vial for containing the microspheres. Furthermore, this document discloses methods for safely and effectively assembling vial assemblies and radiation shielding assemblies, and for infusing drugs to a patient via components, parts, or devices in an operating system.

[0042] Radioactive microspheres can be made of ceramic or polymeric materials, such as glass microspheres, resin microspheres, etc. In some embodiments, the microspheres used are spherical in shape and have a diameter of about 5–100 μm (e.g., 20–80 μm, 30–50 μm, or about 35 μm). Typically, these microspheres can be delivered using a carrier fluid via an embolized microcatheter. The carrier fluid can be sterile water. Microspheres are denser than the carrier fluid, so when the carrier fluid is at rest, the microspheres tend to settle at the bottom of the container (vial) containing the carrier fluid and microspheres. Therefore, during infusion, the microspheres need to be dispersed or redispersed in the carrier fluid so that they can be delivered through the catheter.

[0043] Figure 2An embodiment of an infusion system 10 for delivering microspheres is shown. System 10 may include a first syringe 20, a second syringe 40, a vial 11, a three-way stopcock valve 60, and a lever 62. The first syringe 20 is connected to the vial 11 containing the microspheres via a first tubing 22, and the vial 11 is connected to the three-way stopcock valve 60 via a second tubing 24. The second syringe 40 is connected to the three-way stopcock valve 60 via a fourth tubing 42. The three-way stopcock valve 60 is connected to the patient via a third tubing 26 (a microcatheter line) and a microcatheter 80. The stopcock valve 60 is operated by the lever 62, allowing the third tubing 26 to selectively communicate with either the second tubing 24 or the fourth tubing 42.

[0044] A fluid connection is formed between the first syringe 20, the first tube 22, and the vial 11, which connects to the interior of the vial 11 via the top of the vial 11. A fluid connection is formed between the vial 11, the second tube 24, and the three-way stopcock valve 60, which connects to the interior of the vial 11 via the bottom of the vial 11.

[0045] The substances in the first syringe 20 and the second syringe 40 may be the same or different. The substance in the first syringe 20 may be the same or different at different times. The substance in the second syringe 40 may be the same or different at different times. In some cases, both the substances in the first syringe 20 and the second syringe 40 are sterile water. In some cases, the substance in the first syringe 20 is sterile water, and the substance in the second syringe 40 is a contrast agent. In some cases, the substance in the first syringe 20 is air. In some embodiments, the sterile water delivered to vial 11 can disperse the microspheres and deliver them to the patient through the second tube 24, the third tube 26, and the microcatheter 80.

[0046] In some embodiments, the vial 11 further includes a top seal 112. Optionally, the top seal 112 is a removable cap. Optionally, the top seal 112 is a diaphragm that can be punctured with a needle, for example, to insert microspheres into the vial by puncturing the diaphragm with a needle. Preferably, the top seal 112 is a rubber stopper, which is secured to the vial body 111 with an aluminum cap, preventing the rubber stopper from being removed from the vial body 111, and allowing microspheres to be inserted into the vial by puncturing the rubber stopper with a needle.

[0047] System 10 may include a housing 70, which may be used to hold some of the various components of system 10 therein and to provide shielding for the operator during use of system 10. Housing 70 may include transparent portions to allow observation of the components and may also include opaque portions for radiation protection of the operator. In some embodiments, housing 70 is made of a material including a radiation-opaque material, such as acrylic, wherein the thickness is sufficient to attenuate at least about 50% of radiation emitted from anywhere within the housing (such as vial 11) and from the first tube 22, second tube 24, third tube 26, and fourth tube 42. Other materials may also be coated on housing 70 or used in the construction of other containers within it. For example, housing 70 may contain a high-Z material such as lead. As another example, a shield may be added inside housing 70 to accommodate vial 11.

[0048] A portion of the first tube 22, a portion of the fourth tube 42, a portion of the third tube 26, the second tube 24, the vial 11, and the three-way stopcock valve 60 can be enclosed within the housing 70. One end of the lever 62 is connected to the three-way stopcock valve 60, the middle portion is supported and fixed by other components disposed inside the housing 70, and the other end extends to the outside of the housing 70. Optionally, the end of the lever 62 located outside the housing 70 is coupled to an operating knob 64, through which the operator controls the rotation of the lever 62.

[0049] During operation, the first syringe 20 and the second syringe 40 are used alternately to deliver the microspheres to the patient in multiple small equal portions within a predetermined time (e.g., 20 minutes). The operator can periodically check the position of the microcatheter 80 to ensure that it remains in the correct position during the delivery procedure and to confirm that blood is flowing forward without stagnation.

[0050] In some implementations, when the contents of vial 11 are plentiful, sterile water is used through the first syringe 20 and the first tube 22 to disperse the microspheres in vial 11 and discharge them through the second tube 24; when there are almost no microspheres in vial 11, air can be used through the first syringe 20 to expel the microspheres from vial 11 to empty the tubing.

[0051] In other embodiments, the entire process of transporting the microspheres in vial 11 is carried out by the first syringe 20 using air to enter vial 11 from the first tube 22, and the microspheres are discharged through the second tube 24 by the air.

[0052] It should be added that the fourth tube 42 can also be connected to two syringes via a second three-way valve, for example, see reference. Figure 1The arrangement of valve VA, syringe SA, and syringe SB is such that one syringe is used for infusing sterile water, and the other syringe is used for infusing contrast agent. Both syringes can be selectively connected to a three-way stopcock valve 60 via a second three-way valve.

[0053] refer to Figures 3A to 3E This disclosure provides one or more embodiments of a vial assembly 110. The vial assembly 110 includes a vial 11, a selectively puncturable sealing block 12, and a puncture connector 502. The vial 11 includes a body 111 and a top seal 112. The body 111 has an upper opening 113, a drug-containing chamber 114, and a bottom channel 115. The top seal 112 engages with the body 111 from the upper opening 113 and provides a seal to the drug-containing chamber 114. The bottom channel 115 originates at the bottom of the drug-containing chamber 114 and extends outward from the drug-containing chamber 114, and is in fluid communication with the drug-containing chamber 114. In some embodiments, the bottom 107 of the drug-containing chamber is configured as a cone (V-shape) that is wider at the top and narrower at the bottom to facilitate the discharge of the drug solution. Preferably, the upper side of the bottle body 111 is designed as a sloping shoulder that gradually widens from top to bottom, and two limiting plates 501 are symmetrically arranged on the sloping shoulder. When the medicine bottle assembly 110 is assembled with the radiation shielding assembly 130, the limiting plates 501 and the limiting U-shaped grooves 401 engage with each other to improve the assembly efficiency, as detailed below.

[0054] The sealing block 12 is fixedly disposed relative to the bottom channel 115. For example, the sealing block 12 may be fixedly connected to the end of the bottom channel 115, or to the actuation auxiliary cavity 14 (described in detail below) communicating with the bottom channel 115. The puncture connector 502 has an inner puncture end 117 and an outer connecting end 118. The puncture connector 502 is laterally movably disposed at the bottom of the bottle body 111, and the puncture connector 502 has a first position and a second position. The puncture of the sealing block 12 is achieved by the laterally inward movement of the puncture connector 502 (see reference). Figure 3B Triggered in the W direction (as shown); when the puncture connector 502 is in the first position, the sealing block 12 is not punctured, and the sealing block 12 provides fluid blockage to the bottom channel 115 (see reference). Figure 3B This then seals the drug receiving chamber 114 from below. When the puncture connector 502 is in the second position, the sealing block 12 is punctured by the puncture connector 502, and the puncture connector 502 is in fluid communication with the bottom channel 115 (see reference). Figure 5D ).

[0055] Further, in some embodiments, the bottom channel 115 may extend to the outside of the bottle body 111, and the piercing connector 502 may be laterally movably disposed on the outside of the bottle body 111. In other embodiments, the bottom channel 115 extends only within the bottom of the bottle body 111. Specifically, in some embodiments, the end of the bottom channel 115 is arranged longitudinally, for example, the bottom channel 115 extends entirely along the height direction, and the end of the bottom channel 115 has a hole near the side wall of the piercing connector 502, in which the sealing block 12 is disposed. In other embodiments, the end of the bottom channel 115 is arranged laterally, and the sealing block 12 is disposed near the port of the end of the bottom channel 115. The following description uses the example of the bottom channel 115 extending only within the bottom of the bottle body 111 and the end of the bottom channel 115 being arranged laterally.

[0056] refer to Figure 3B The bottle body 111 also has an actuation auxiliary cavity 14, which is located at the bottom of the vial 11. The sealing block 12 is fixedly located at the end of the bottom channel 115 or located in the actuation auxiliary cavity 14. The piercing connector 502 is laterally movable and passes through the actuation auxiliary cavity 14. When the piercing connector 502 is in the first position, the connecting end 118 of the piercing connector 502 extends to the outside of the actuation auxiliary cavity 14, which facilitates applying an inward thrust to the connecting end 118 to move the piercing connector 502 laterally inward. Preferably, the actuation auxiliary cavity 14 is configured to extend laterally, and the piercing connector 502, the end of the bottom channel 115, and the actuation auxiliary cavity 14 are arranged coaxially.

[0057] In some embodiments, the puncture connector 502 is configured as a puncture needle tube, which includes a lateral extension and a longitudinal extension. The inner puncture end 117 is located at the end of the lateral extension away from the longitudinal extension, and the outer connecting end 118 is located in the longitudinal extension. That is, the distance between the puncture end 117 and the connecting end 118 of the puncture needle tube remains constant. When the longitudinal extension of the puncture needle tube is subjected to a lateral inward thrust, the puncture needle tube moves laterally, causing the puncture end 117 to puncture the sealing block 12.

[0058] In other embodiments, the puncture connector 502 extends laterally, and the distance between the puncture end 117 and the connecting end 118 is variable. Specifically, the puncture connector 502 includes, in addition to the puncture needle 13, a sleeve 15 and an elastic member 18. (See reference...) Figure 3B and Figure 5DThe sleeve 15 is fitted onto the puncture needle 13, and the puncture needle 13 is in fluid communication with the sleeve 15. The puncture needle 13 can move relative to the sleeve 15 along the axial direction of the sleeve 15. The end of the sleeve 15 furthest from the puncture needle 13 is the connecting end 118 of the puncture connector 502, and the end of the puncture needle 13 furthest from the sleeve 15 is the puncture end 117 of the puncture connector 502. One end of the elastic element 18 is coupled to the puncture needle 13, and the other end of the elastic element 18 is coupled to the sleeve 15. The elastic element 18 tends to maintain a certain distance between the puncture end 117 and the connecting end 118 of the puncture connector 502. When the outer end of the sleeve 15 is subjected to a lateral inward thrust, at least part of the thrust can be transmitted to the puncture needle 13 through the elastic element 18, and the lateral movement of the puncture needle 13 causes the puncture end 117 to puncture the sealing block 12. In addition, when the puncture needle 13 punctures the sealing block 12, the elastic potential energy stored in the elastic element 18 can cause the sleeve 15 to move laterally outward so that the puncture end 117 and the connecting end 118 maintain a certain distance.

[0059] Optionally, the elastic element 118 is coupled to the puncture needle tube 13 in such a way that one end of the elastic element 118 is fixedly connected to the outer wall of the puncture needle tube 13, and the elastic element 118 is coupled to the sleeve 15 in such a way that the other end of the elastic element 118 is fixedly connected to the outer wall of the sleeve 15 or the inner end of the sleeve 15.

[0060] Preferably, the actuation auxiliary cavity 14 includes a wide portion and a narrow portion arranged laterally, with the wide portion connected to the bottom channel 115, i.e., the narrow portion is located on the outside, and the lateral outer contour dimension of the wide portion is larger than that of the narrow portion. The puncture needle 13, the sleeve 15, and the elastic element 18 are disposed within the wide portion of the actuation auxiliary cavity 14, and the outer end of the sleeve 15 can extend through the narrow portion to the outside of the bottle body 111. The narrow portion is configured to guide the lateral movement of the sleeve 15.

[0061] In some preferred embodiments, a first stop 16 is fixedly mounted on the sleeve 15, and a second stop 17 is fixedly mounted on the outer periphery of the puncture needle tube 13. An elastic element 18 is configured as a spring coil, which is sleeved on the puncture needle tube 13 and positioned between the first stop 16 and the second stop 17. Specifically, the first stop 16 may be fixed to the inner end of the sleeve 15 or to the outer periphery of the sleeve 15. The outer end of the spring coil is linked to the first stop 16, and the lateral inward movement of the first stop 16 causes the outer end of the spring coil to move laterally inward. The inner end of the spring coil abuts against the second stop 17, and when the outer end of the spring coil moves inward, the inner end of the spring coil generates an inward pushing force on the second stop 17. Preferably, see reference... Figure 3BThe sealing block 12 is fixedly disposed on the inner end of the actuation auxiliary cavity 14. The puncture connector 502 is arranged laterally on the side of the sealing block 12 opposite to the end of the bottom channel 115. The inner end of the puncture needle tube 13 is close to the sealing block 12. When the puncture connector 502 is in the first position, the first stop 16 abuts against the inner wall of the outer end of the wide portion of the actuation auxiliary cavity 14; when the puncture connector 502 is in the second position, the second stop 17 abuts against the sealing block 12.

[0062] More specifically, see Figure 3B The first stop 16 is initially positioned at the outer end of the wide portion of the actuation auxiliary cavity 14, and is fixed to the inner end of the sleeve 15, the outer end of which extends laterally beyond the actuation auxiliary cavity 14. The outer end of the puncture needle 13 passes through the first stop 16 and is inserted into the inner cavity of the sleeve 15 via the inner end. The outer end of the spring coil is linked to the first stop 16, and the lateral inward movement of the first stop 16 causes the outer end of the spring coil to move laterally inward. The inner end of the spring coil abuts against the second stop 17, and when the outer end of the spring coil moves inward, the inner end of the spring coil generates an inward pushing force on the second stop 17. Since the position of the second stop 17 relative to the puncture needle 13 is fixed, the inward pushing force on the second stop 17 is also the force that pushes the puncture needle 13 inward.

[0063] More specifically, the outer end of the sleeve 15 is implemented as an external force receiving end. When the outer end of the sleeve 15 receives a lateral inward external force, the sleeve 15 moves laterally inward. Since the position between the sleeve 15 and the first stop 16 is fixed, the lateral inward movement of the sleeve 15 drives the first stop 16 to move laterally inward. As described above, the lateral inward movement of the first stop 16 provides a lateral inward thrust to the puncture needle 13, or the puncture connector 502. Therefore, the puncture needle 13 will move laterally inward in the direction indicated by arrow W, thereby piercing the sealing block 12 and making the puncture needle 13, or the puncture connector 502, fluidly connected to the bottom channel 115.

[0064] In some embodiments, the sealing block 12 is made of rubber, thus creating frictional resistance during puncture. Preferably, the inner cavity 104 of the sleeve is provided with a blocking feature 101 for blocking the outer end of the puncture needle tube 13 (see reference). Figure 3E and Figure 5DThe sleeve 15 has a stepped abutment at its outer end, which abuts against the outer end of the puncture needle 13. When the outer end of the puncture needle 13 reaches the position of this abutment feature, the force on the sleeve 15 acts directly on the puncture needle 13. The sleeve 15 will push the puncture needle 13 inward together to overcome the friction of the sealing block 12, allowing the sealing block 12 to be completely punctured. In some embodiments, the abutment feature 101 is a variable diameter design feature, for example, referring to... Figure 3E The inner section of the sleeve's inner cavity 104 is designated as a large-diameter inner cavity, while the outer section is designated as a small-diameter inner cavity. The outer end of the puncture needle 13 can pass through the large-diameter inner cavity but cannot pass through the small-diameter inner cavity. It should be noted that the blocking feature 101 can be any other design feature that can block the non-puncture end 118 of the puncture needle, such as a protrusion formed inside the outer end of the sleeve, which can abut against the outer end of the puncture needle 13.

[0065] In some implementation schemes, refer to Figure 3B The actuation auxiliary cavity 14 is disposed inside the body 111 of the vial 11 and located below the drug receiving chamber 114, with the outer end of the sleeve 15 (outer end 118 of the puncture connector 502) extending to the outside of the body 111. Alternatively, while maintaining the basic premise that the actuation auxiliary cavity 14 is located below the drug receiving chamber 114, the actuation auxiliary cavity 14 may also be disposed outside the body 111 of the vial 11, with the outer end of the sleeve 15 (outer end 118 of the puncture connector 502) extending to the outside of the outer end 106 of the actuation auxiliary cavity.

[0066] refer to Figures 4A to 4F This disclosure also provides one or more embodiments of a radiation shielding assembly 130. The radiation shielding assembly 130 is used to shield a vial assembly 110 containing a radiopharmaceutical. The radiation shielding assembly 130 includes a shielding body 31 having a top opening 131, a vial receiving cavity 132, and a connection port 135. The radiation shielding assembly 130 can receive the vial assembly 110 within the vial receiving cavity 132 through the top opening 131, and the connection port 135 is used to engage a puncture connector 502 of the vial assembly 110.

[0067] In some embodiments, the radiation shielding assembly 130 further includes a top cover 139, which is sealed to the top opening 131 by a protrusion and a groove engaging. For example, one of the top cover 139 and the upper portion of the shielding body 31 has a wedge-shaped protrusion, and the other has a groove adapted to engage the wedge-shaped protrusion; the wedge-shaped protrusion or groove on the top cover is located on the outer periphery of the rod portion. Specifically, refer to... Figure 4AThe top cover 139 includes an upper cap and a lower stem. The stem has a circumferential protrusion 403 along its waist. In this example, two circumferential protrusions 403 are constructed and are circumferentially symmetrical. Specifically, the circumferential protrusions are constructed as wedge-shaped protrusions. A circumferentially extending groove 405 is provided at the top opening 131 of the vial receiving cavity 132. The bottom of the groove 405 is continuous in the circumferential direction, while the top of the groove 405 is discontinuous in the circumferential direction. A circumferential notch 404 is formed at the top of the groove 405 in the circumferential direction. The shape and size of the circumferential notch 404 are adapted to the circumferential protrusion 403. When the top cover 139 is engaged with the shielding body 31, the circumferential protrusion 403 aligns with the circumferential notch 404, causing the circumferential protrusion 403 to move downwards to a position abutting the bottom of the groove 405. Then, the top cover 139 is rotated to move the circumferential protrusion 403 to a position where the groove 405 is not aligned with the circumferential notch 404. The groove 405 provides a path for the top cover 139 to rotate and slide in the circumferential direction. The bottom and top of the groove 405 work together to restrict the longitudinal movement of the circumferential protrusion 403.

[0068] Preferably, the rod portion of the upper cover 139 and the bottle body 111 of the vial assembly 110 are respectively provided with mutually engaging engagement features. These mutually engaging engagement features enable the upper cover 139 and the vial assembly 110 to be combined together, facilitating the assembly of the radiation shielding assembly 130 and the vial assembly 110. When the vial assembly 110 is placed in the vial receiving cavity 132 and the rod portion of the upper cover 139 is engaged with the vial assembly 110 through the engagement features, during the tightening process of the upper cover 139 and the shielding body 31 through the wedge-shaped circumferential protrusion 403 and the sliding groove 405, the circumferential mating wall abuts against the outside of the puncture connector.

[0069] Specifically, please refer to Figure 4A The rod portion of the upper cover 139 can be hollow, with a downward-opening U-shaped groove 401 along its lower edge. In the example, two circumferentially symmetrical U-shaped grooves 401 are constructed. The groove spacing between the two sides of the U-shaped groove 401 is approximately equal to the thickness of the limiting plate 501, and the maximum longitudinal height of the limiting plate 501 is approximately equal to the depth of the U-shaped groove 401. (See also...) Figure 5B The limiting plate 501 can be engaged longitudinally with the limiting U-shaped groove 401. When the radiation shielding assembly 130 and the vial assembly 110 are assembled, the operator can quickly position the limiting U-shaped groove 401 to engage with the limiting plate 501 based on its visible position, thereby increasing the assembly speed between the upper cover 139 and the shielding body 31. Preferably, the engagement of the limiting U-shaped groove 401 and the limiting plate 501 will also facilitate the circumferential thrust provided by the circumferential sliding of the upper cover 139 in the slide groove 405 for the rotational assembly process of the vial assembly 110 in the vial receiving cavity 132.

[0070] The engagement features between the rod portion of the top cover 139 and the vial assembly 110 are not limited to the aforementioned specific fit of the U-shaped groove and the limiting plate. Those skilled in the art, understanding the connection principle of this invention, can make appropriate adjustments and modifications to obtain various different implementations. For example, the engagement features can be designed as mutually fitting arc-shaped protrusions and concave portions, or a combination capable of forming an undercut structure to enhance connection stability, or other mechanical connection methods such as beveled fits or mortise and tenon structures. These variations and alternatives based on the same concept all fall within the protection scope of this invention.

[0071] According to one or more embodiments provided in this disclosure, the vial receiving cavity 132 is configured to provide a circumferential mating wall having a starting end and a terminal end. The distance from the circumferential mating wall to the vertical centerline of the vial receiving cavity 132 decreases from the starting end to the terminal end. Specifically, the circumferential mating wall provides a moving assembly path for the assembly between the radiation shielding assembly 130 and the vial assembly 110, allowing the vial assembly 110 to be moved to an assembled position via the circumferential mating wall. A mating port 135 is located near the terminal end, and when the vial assembly 110 is in the assembled position, the mating port 135 engages with the puncture connector 502. When the vial assembly 110 and the radiation shielding assembly 130 are in the assembled position, the connecting end 118 of the puncture connector 502 extends outward through the mating port 135, the sealing block 12 is punctured by the puncture end 117 of the puncture connector 502, and the puncture connector 502 is in fluid communication with the bottom channel 115.

[0072] In an alternative embodiment, the vial receiving cavity 132 is configured to include a circumferentially extending flange disposed at the bottom of the vial receiving cavity 132 and providing a circumferentially mating wall. The circumferentially extending flange has a starting end and a terminal end, and the distance from the circumferentially mating wall to the vertical centerline of the vial receiving cavity 132 decreases from the starting end to the terminal end.

[0073] In the preferred embodiment, refer to Figures 4D to 4F The vial-receiving cavity 132 is configured to include a circumferential groove 134, the bottom of which provides a circumferentially mating wall 410. Different positions of the circumferentially mating wall 410 have different radial distances 402 from the vertical centerline of the vial-receiving cavity 132. Preferably, along the starting end 136 to the ending end 137, the distance from the circumferentially mating wall 410 to the vertical centerline of the vial-receiving cavity 132 remains constant initially and then gradually decreases (e.g., ...). Figure 4F Alternatively, the distance from the circumferential mating wall 410 to the vertical centerline of the vial receiving cavity 132 gradually decreases along the path from the starting end 136 to the ending end 137.

[0074] More preferably, the vial receiving cavity 132 is configured to further include a longitudinal groove 133, and the circumferential mating wall 410 provided by the longitudinal groove 133 and the circumferential groove 134 provides a moving assembly path for the assembly between the vial assembly 110 and the radiation shielding assembly 130, so that the vial assembly 110 can be moved to the assembly completed position through the circumferential mating wall 410 provided by the longitudinal groove 133 and the circumferential groove 134.

[0075] Specifically, the longitudinal groove 133 extends along the inner wall of the vial-receiving cavity 132 in the height direction. The longitudinal groove 133 communicates with the circumferential groove 134, and the bottom end of the longitudinal groove 133 is adjacent to the starting end 136 of the circumferential groove 134. The distance from the bottom of the longitudinal groove 133 to the vertical centerline of the vial-receiving cavity 132 is equal to the distance from the starting end 136 of the circumferential mating wall 410 to the vertical centerline of the vial-receiving cavity 132. The starting end 136 communicates with the bottom end of the longitudinal groove 133, and the terminal end 137 is close to the mating port 135. The distance from the terminal end 137 to the vertical centerline of the vial-receiving cavity 132 is less than the distance from the starting end 136 to the vertical centerline of the vial-receiving cavity 132.

[0076] Furthermore, please refer to the following: Figures 4B to 4F as well as Figure 5D The radiation shielding assembly 130 also includes a flexible seal 33, the central part of which may have a linear cut, such as a straight, cross, or fork-shaped cut. The flexible seal 33 is located at the mating port 135 and seals the mating port 135. An example flexible seal 33 is a silicone component, and the preferred linear cut is a straight cut. The straight cut not only guides and assists the connecting end 118 of the puncture connector 502 to pass smoothly through the silicone component, but also provides a good sealing effect. When the vial assembly 110 and the radiation shielding assembly 130 are in the assembled position, the connecting end 118 of the puncture connector 502 can extend through the flexible seal 33 (see reference). Figure 5D ).

[0077] Specifically, refer to Figures 4D to 4F as well as Figure 5DThe axis of the coupling port 135 extends laterally, and the coupling port 135 is configured to include an opening 406 and a frustum-shaped cavity 407, the cavity 407 being located outside and communicating with the opening 406. The cross-sectional area of ​​the inner end of the cavity 407 is larger than the cross-sectional area of ​​the outer end, and the flexible seal 33 is configured in a frustum shape and adapted to be received in the cavity 407 of the coupling port 135. The opening 406 is configured to be enclosed by a first opening 408 and a second opening 409, both concentric semicircles, the diameter of the first opening 408 being smaller than the diameter of the second opening 409, and the first opening 408 being located at the terminal end 137 of the circumferential mating wall 410. The diameter of the first opening 408 is smaller than the diameter of the second opening 409. This facilitates the smooth docking of the puncture connector 502 with the connecting port 135, and also prevents the puncture connector 502 from missing the first opening 408 if the vial assembly 110 moves too fast along the moving assembly path. When the puncture connector 502 moves into the second opening 409, the connecting end 118 can still abut against the silicone part (flexible seal 33). Because the silicone part has a slit, the connecting end 118 can further pass through the slit. In addition, the larger diameter of the second opening 409 facilitates the placement of the flexible seal 33 in the cavity 407.

[0078] Further, refer to Figure 4B and Figure 4C The radiation shielding assembly 130 also includes a conduit interface 122. The conduit interface 122 is located at the bottom of the shielding body 31, communicates with the connection port 135, and extends to the outer periphery of the shielding body 31. A straight-through valve 32 is provided on the portion of the conduit interface 122 located on the outer periphery of the shielding body 31. When the vial assembly 110 is in the assembled position relative to the radiation shielding assembly 130, the straight-through valve 32 is in fluid communication with the radiopharmaceutical in the vial assembly 110. During the assembly of the vial assembly 110 and the radiation shielding assembly 130, the straight-through valve 32 remains closed to prevent the outflow of the drug from the vial 11 containing radioactive microspheres. It should be noted that the conduit interface 122 shown in the attached drawings is a laterally arranged channel; such a radiation shielding assembly is suitable for accommodating a vial assembly 110 equipped with a puncture connector 502 having a straight outer portion. If the puncture connector 502 is configured to have a bent outer portion, those skilled in the art, based on their understanding of the fluid communication principle of the present invention, can appropriately adjust and modify the arrangement direction of the pipe interface 122 at the bottom of the shielding body 31 to meet the accommodating requirements of the corresponding vial assembly 110.

[0079] This disclosure also provides a vial assembly system 150, see reference. Figure 5A and Figure 5CThe vial assembly system 150 includes the aforementioned vial assembly 110 and radiation shielding assembly 130. Figure 5C and Figure 5D This shows the positional relationship between the vial assembly 110 and the radiation shielding assembly 130 when they are in their assembled position. (See also...) Figures 6A to 6E The following example illustrates the assembly method of the vial assembly 110 and the radiation shielding assembly 130, and the variations in their positional relationships, using a longitudinal groove 134 and a circumferential groove 135 providing a circumferential mating wall 410 to jointly provide a moving assembly path. Those skilled in the art, understanding the assembly principle of this invention, can make appropriate adjustments and modifications to obtain various different implementation methods. These modifications and alternatives based on the same concept all fall within the protection scope of this invention.

[0080] First, align the connecting end 118 of the puncture connector 502 extending from the bottle body 111 of the vial assembly 110 with the longitudinal groove 133 of the radiation shielding assembly 130, so that the connecting end 118 of the puncture connector 502 moves along the longitudinal groove 133 to the bottom end, reaching the starting end 136 of the circumferential mating wall 410 of the circumferential groove 134. Then, refer to... Figure 5B This allows the cap 139 and the vial 11 to engage, specifically by aligning and engaging the limiting U-shaped groove 401 with the limiting upright plate 501 of the vial 11. The vial 11 is rotated by sliding the cap 139 in the slide groove 405, causing the connecting end 118 of the piercing connector 502 to continue moving along the circumferential mating wall 410 provided by the circumferential groove 134 from the starting end 136 to the ending end 137, finally reaching the engagement port 135. Along the path to the ending end 137, the distance from the bottom of the circumferential groove 134 to the vertical centerline of the vial receiving cavity 132 decreases, thus the bottom of the circumferential groove 134 exerts an inward pressing force on the outer end 102 of the sleeve.

[0081] More specifically, during the aforementioned moving assembly process, the initial state of the piercing connector 502 is referenced. Figure 6A First, the sleeve 15 drives the first stop 16 to compress the spring coil, causing the puncture end of the puncture needle to gradually approach the sealing block 12, as... Figure 6B The distance between the circumferential joint wall 410 and the bottle body 111 decreases. When the puncture end of the puncture needle 13 enters the sealing block 12, although the distance between the circumferential joint wall 410 and the bottle body 111 is reduced compared to... Figure 6B The pressure is further reduced, but due to the presence of compressive force, it can only penetrate a portion of the sealing block 12; that is, it does not penetrate due to increased friction. Figure 6C Continue rotating the vial 11; the distance between the circumferential connecting wall 410 and the vial body 111 is compared to... Figure 6CAs the pressure decreases further, the first stop 16 continues to compress the spring coil, causing the stop feature 101 inside the sleeve to engage with the outer end of the puncture needle tube 13, as... Figure 6D As the vial 11 continues to rotate, the sleeve 15 will push the puncture needle 13 inward, causing the puncture tip to completely pass through the sealing block 12 and enter the bottom channel 115, where the second stop 17 abuts against the sealing block 12. At this point, the outer end of the sleeve reaches the engagement port 135 of the radiation shielding assembly 130. After the puncture connector 502 reaches the engagement port 135, the sleeve 15 loses its compressive force, the spring coil rebounds, and the outer end of the sleeve passes through the flexible seal 33 with a central slit, as shown. Figure 6E At this point, the vial assembly 110 is in the assembled position relative to the radiation shielding assembly 130, completing the fluid communication between the puncture connector 502 and the drug receiving chamber 114.

[0082] refer to Figure 7A and Figure 7B This disclosure also provides one or more embodiments of a radiopharmaceutical delivery device 100. The radiopharmaceutical delivery device 100 includes a delivery box 79 and a delivery kit, wherein the delivery kit includes the aforementioned vial assembly system 150, a first tube 22, a second tube 24, a third tube 26, a fourth tube 42, a three-way stopcock valve 60, and a control lever 62.

[0083] The delivery box 79 has a cavity suitable for housing the vial assembly system 150. The delivery box 79 can be a transparent box, such as transparent plastic or glass. The side wall of the delivery box 79 has a first hole 72, a second hole 74 and a third hole 76, the first hole 72 and the second hole 74 are both located on the first side wall 75, the third hole 76 is located on the second side wall 77, and the first side wall 75 and the second side wall 77 are opposite to each other.

[0084] The first end of the first tube 22 extends from the first hole 72 to the outside of the delivery box 79, and the second end of the first tube 22 is connected to the needle body 221. The needle body 221 is configured to enter the interior of the vial 11 from above the vial assembly system 150, through the top opening 131 of the radiation shielding assembly 130, and the upper bottle mouth 113 of the vial assembly 110. The first end of the second tube 24 is fluidly connected to the puncture needle tube 13 of the vial assembly system 150, preferably fluidly connected to the straight-through valve 32, and the second end of the second tube 24 is fluidly connected to the three-way stopcock valve 60. The first end of the third tube 26 is fluidly connected to the three-way stopcock valve 60, and the second end of the third tube 26 extends from the third hole 76 to the outside of the delivery box 79. The first end of the fourth tube 42 extends from the second hole 74 to the outside of the delivery box 79, and the second end of the fourth tube 42 is fluidly connected to the three-way stopcock valve 60.

[0085] The bottom of the cavity of the delivery box 79 is provided with a first mounting seat 71 for mounting the vial assembly system 150. The example first mounting seat 71 is a cylindrical recessed structure adapted to receive the bottom of the shielding body 31 of the radiation shielding assembly 130. A second mounting seat 73 is provided on the inner side of the second sidewall 77 of the delivery box 79 for mounting a three-way stopcock valve 60. The delivery box 79 also has a cover 78, which can be opened or closed relative to the delivery box 79 to facilitate the placement or installation of the delivery kit located within the box.

[0086] One end of the lever 62 is connected to the three-way stopcock valve 60, and the other end passes through the first sidewall 75. Preferably, the conveying device 100 also includes a control knob 64, which is located outside the first sidewall 75 and coupled to the end of the lever 62. The control knob 64 can be used to control the fluid connection switching of the three-way stopcock valve 60 by the lever 62. For example, in some cases, the switching selection is to fluidly connect the fourth pipe 42 and the third pipe 26; in other cases, the switching selection is to fluidly connect the second pipe 24 and the third pipe 26; and in still other cases, the switching selection is to fluidly connect the fourth pipe 42 and the second pipe 24.

[0087] Please refer to the above. Figure 2 , Figure 7A and Figure 7B When delivering microspheres, the radiopharmaceutical delivery device provided in this disclosure can be used according to the following steps.

[0088] (1) Dispense the required injection solution into vials 11.

[0089] (2) Fix the three-way plug valve 60 to the inner wall of the conveying box 79.

[0090] (3) Pass the first tube 22 corresponding to the first hole 72, the fourth tube 42 corresponding to the second hole 74, and the third tube 26 corresponding to the third hole 76 out from the inside of the conveying box 79.

[0091] (4) Connect the first tube 22 to the first syringe 20 containing sterile water, and connect the fourth tube 42 to the second syringe 40 containing sterile water. Fill all tubes with sterile water by injecting the first syringe 20 and the second syringe 40.

[0092] (5) The default connection of the three-way stopcock valve 60 is the third tube 26 and the fourth tube 42. To fill the second tube 24 with sterile water, the control knob 64 needs to be rotated to change the passage of the three-way stopcock valve 60, so that the second tube 24 is connected to the fourth tube 42. At this time, by pushing the second syringe 40, sterile water can flow into the second tube 24 through the three-way stopcock valve 60. Then, control the control knob 64 to rotate back to the initial position (the third tube 26 and the fourth tube 42 are connected).

[0093] (6) Insert the needle 221 connected to the first tube 22 into the small bottle 11 from above, reaching 5 mm below the liquid surface.

[0094] (7) Connect the end of the third tube 26 located outside the delivery box 79 to the patient's body. After successful connection, the control knob 64 can be turned to the "rinse / imaging" position. The fourth tube 42 and the third tube 26 are connected, and the contrast agent is injected through the second syringe 40 of the fourth tube 42.

[0095] (8) After the drug delivery device is fully assembled, close the lid 78 of the delivery box 79, turn the control knob 64 to the "treatment" position, connect the third tube 26 and the second tube 24, and inject sterile water into the vial from the first syringe 20 connected to the first tube 22.

[0096] (9) The operator delivers the medication slowly at a rate of approximately 5 ml per minute. To achieve a slow and controllable delivery rate, the operator can use the first syringe 20 to inject in pulsatile motions of 0.25 ml to 0.5 ml until all the sterile water in the first syringe 20 is used up.

[0097] (10) After all the sterile water in the first syringe 20 has been injected, there is drug residue in the vial 11. In order to reduce drug residue, without moving the needle body 221 connected to the first tube 22, the remaining drug in the vial 11 can be discharged by injecting air into the first tube 22 or by continuing to inject sterile water.

[0098] It should be noted that, according to the vial assembly, vial assembly system, or drug delivery device provided in this disclosure, the entire process of drug delivery can be carried out using air. That is, in the above steps (8) to (10), the first syringe 20 injects air into the vial 11 instead of sterile water, so that the drug flows out from the bottom of the vial and then further reaches the human body. When using air injection throughout the process, in the operation of the above step (6), the needle body 221 should be inserted 5 mm above the liquid surface.

[0099] The present invention has the following beneficial effects:

[0100] Only one puncture needle (needle body 221 in the example) is needed for use. When the microspheres in the vial are nearly empty, the step of adjusting the injection needle during infusion can be eliminated. It is even possible to directly inject air into the vial using the first syringe to deliver all the radioactive microspheres into the body. Therefore, the need for needle changes during surgery is eliminated, surgical time can be shortened, and the radiation risk to medical staff and patients can be reduced.

[0101] Because the fluid outlet channel of the vial assembly or vial assembly system is located at the bottom of the vial, the microspheres (which are heavier than water) will inevitably flow out of the vial with the water, regardless of whether air or sterile water is used to push the microspheres. Therefore, compared to methods that output the medication from the top of the vial, this invention eliminates the need to monitor microsphere residue inside the vial during infusion, and the delivery process does not require real-time monitoring. The shielding device can be made of lead material, which has a better shielding effect, thus increasing the shielding effectiveness. The areas through which the radionuclide passes (such as V-shaped vials, straight-through valves, etc.) are made of plastic or silicone rubber materials, isolating them from lead and preventing bremsstrahlung radiation.

[0102] The above descriptions are merely a few embodiments of this disclosure. Those skilled in the art can make various modifications or variations to the embodiments of this disclosure based on the content disclosed in the application documents without departing from the spirit and scope of this disclosure.

Claims

1. A radiation shielding assembly for shielding a vial assembly containing a radiopharmaceutical, the vial assembly being provided with a transversely movable piercing communication member, the radiation shielding assembly comprising: a shielding body having a top opening, a vial receiving cavity and a coupling port, the radiation shielding assembly being configured to receive the vial assembly in the vial receiving cavity through the top opening, the coupling port being configured to couple with the piercing communication member; the vial receiving cavity being configured to include a circumferential fitting wall having a starting end and a terminal end, the distance from the circumferential fitting wall to the vertical center line of the vial receiving cavity being decreasingly trended from the starting end to the terminal end; wherein the circumferential fitting wall provides a moving fitting path for the assembly between the radiation shielding assembly and the vial assembly, so that the vial assembly can be moved to a fitting completed position by the circumferential fitting wall; when the vial assembly is in the fitting completed position, the coupling port is coupled with the piercing communication member. the vial receiving cavity is configured to include a circumferential groove, the groove bottom of the circumferential groove provides the circumferential fitting wall, the distance from the circumferential fitting wall to the vertical center line of the vial receiving cavity remains constant and then gradually decreases along the starting end to the terminal end; the vial receiving cavity is further configured to include a longitudinal groove extending in the height direction along the inner wall of the vial receiving cavity, the longitudinal groove is communicated with the circumferential groove and the bottom end of the longitudinal groove is adjacent to the starting end of the circumferential groove; wherein the distance from the groove bottom of the longitudinal groove to the vertical center line of the vial receiving cavity is equal to the distance from the starting end of the circumferential fitting wall to the vertical center line of the vial receiving cavity; the longitudinal groove and the circumferential fitting wall provide a moving fitting path for the assembly between the radiation shielding assembly and the vial assembly, so that the vial assembly can be moved to a fitting completed position by the longitudinal groove and the circumferential fitting wall; the coupling port has an axis extending in the transverse direction, the coupling port is provided with a flexible sealing member for sealing the coupling port; wherein when the vial assembly is in the fitting completed position, the piercing communication member can extend through the flexible sealing member. the flexible sealing member is a silicone member, the middle part of the silicone member is provided with a linear cut; the coupling port is configured to include an opening and a circular truncated cone shaped cavity, the cavity is located outside the opening and communicated with the opening; the cross-sectional area of the inner side end of the cavity of the coupling port is greater than that of the outer side end, the flexible sealing member is configured to be circular truncated cone shaped and adapted to be received in the cavity of the coupling port; the opening is configured to be enclosed by a first opening and a second opening which are concentric semicircles, the diameter of the first opening is smaller than that of the second opening, the first opening is arranged at the terminal end of the circumferential fitting wall; the radiation shielding assembly further comprises a cover, the cover includes a rod portion extending in the height direction; the rod portion and the vial assembly are respectively provided with engagement features engaging with each other. ​ ​ ​ 2. The radiation shielding assembly of claim 1, wherein, ​ 3. The radiation shielding assembly of claim 2, wherein, ​ ​ 4. The radiation shielding assembly of claim 3, wherein, ​ ​ 5. The radiation shielding assembly of claim 4, wherein, ​ 6. The radiation shielding assembly of claim 5, wherein, ​ ​ ​ 7. The radiation shielding assembly of any one of claims 1 to 6, wherein, ​ ​ One of the upper cover and the upper portion of the shielding body is provided with a wedge-shaped protrusion, and the other is provided with a sliding groove adapted to engage the wedge-shaped protrusion, the wedge-shaped protrusion or the sliding groove provided on the upper cover is located at the outer periphery of the rod portion; When the vial assembly is placed in the vial accommodating cavity and the rod portion is engaged with the vial assembly through the engagement feature, in the process of screwing the upper cover and the shielding body through the wedge-shaped protrusion and the sliding groove, the circumferential fitting wall abuts to the outside of the puncture communication member.

8. The radiation shielding assembly of claim 7, wherein, The shielding body further comprises a pipeline interface provided at the bottom thereof, the pipeline interface being in communication with the combination port, the pipeline interface extending to the outer periphery of the shielding body, and a portion of the outer periphery of the shielding body being provided with a straight-through valve; when the vial assembly is in the assembly completion position relative to the radiation shielding assembly, the straight-through valve is in fluid communication with the radioactive drug in the vial assembly.

9. A vial assembly system characterized by, The system comprises a vial assembly and the radiation shielding assembly of any one of claims 1 to 8, the vial assembly further comprising a vial and a sealing block selectively punctured by the puncture communication member; The vial comprises a vial body and a vial top seal, the vial body being provided with an upper end opening, a drug accommodating cavity and a bottom passage, the vial top seal being configured to provide sealing of the drug accommodating cavity when the vial top seal is engaged with the vial from the upper end opening, the bottom passage extending from the lower portion of the drug accommodating cavity to the outside of the drug accommodating cavity, and the bottom passage being in fluid communication with the drug accommodating cavity; The sealing block is fixedly provided relative to the bottom passage, the puncture communication member has a puncture end close to the sealing block and an engaging end away from the sealing block, and the puncture communication member is transversely movably provided at the bottom of the vial body; when the sealing block is not punctured, the sealing block provides fluid blocking of the bottom passage; The vial assembly is configured to be moved to an assembly completion position through the circumferential fitting wall, in the process of moving the vial assembly to the assembly completion position, the circumferential fitting wall abuts to the engaging end of the puncture communication member so as to move the puncture end to the direction close to the sealing block; when the vial assembly is in the assembly completion position, the engaging end of the puncture communication member is in butt joint with the combination port, the sealing block is punctured by the puncture communication member, and the puncture communication member is in fluid communication with the bottom passage and the combination port.

10. A method of assembling the vial assembly system of claim 9, wherein, The system comprises the steps of: moving the vial assembly downward from the top opening of the radiation shielding assembly to the bottom of the vial accommodating cavity; rotating the vial so that the engaging end of the puncture communication member is moved from the starting end to the terminal end along the circumferential fitting wall.

11. A radiopharmaceutical delivery device, characterized by The system comprises: the vial assembly system, the delivery box, the first tube, the second tube, the third tube, the fourth tube, the three-way plug valve and the operating rod of claim 9; wherein, the delivery box has a cavity, the vial assembly system is installed in the cavity, and the bottom of the drug accommodating cavity is configured to be a taper that is large at the top and small at the bottom. a first end of the first tube extends out of the transport case, a second end of the first tube is connected to a needle configured to pass from above the radiation shielding assembly, through the top opening of the radiation shielding assembly, through the upper end vial port of the vial assembly, and into an interior of the vial; a first end of the second tube is fluidly connected to a piercing communication of the vial assembly system, a second end of the second tube is fluidly connected to the three-way stopcock valve; a first end of the third tube is fluidly connected to the three-way stopcock valve, a second end of the third tube extends out of the transport case; a first end of the fourth tube extends out of the transport case, a second end of the fourth tube is fluidly connected to the three-way stopcock valve; a first end of the lever extends out of the transport case, a second end of the lever is connected to the three-way stopcock valve, the first end of the lever is configured to receive operator control to select an orientation of the three-way stopcock valve to fluidly communicate two of the second, third, and fourth tubes.

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