JP2006212296A - Disposable saline water cartridge module for dispensing and injecting system for radiopharmaceutical - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a saline water cartridge which is easy to operate and is safe against nuclear radiation as well. <P>SOLUTION: The saline water cartridge comprises: a primary passage extending from a saline water reservoir to a radiopharmaceutical inlet port (71); and a secondary passage extending from the exit of the primary passage to a radiopharmaceutical outlet port (72) for a patient injection device to inject radiopharmaceuticals to a patient. A first check valve (75) is provided in the outlet of the primary passage to allow the radiopharmaceuticals injected from a radiopharmaceutical carrying syringe to flow to a radiopharmaceutical outlet port while preventing reverse flow. A second check valve (76) is arranged in the outlet of a saline water reservoir to allow saline water to be filled into the primary passage while preventing reverse flow. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates generally to a saline cartridge, but here relates to a saline cartridge for injection of a radiopharmaceutical.

  In recent years, positron tomography (PET) has been used for in vivo imaging and has been useful for early detection and treatment of cancer. A positron radionuclide for PET is created by a cyclotron, and other compounds are labeled to form compounds / molecules such as glucose, amino acids, and water, which are then injected into the human body. The positron is annihilated by electrons in the human body and emits gamma rays in the opposite direction, which is detected and imaged by PET.

  The PET device is very useful for medical diagnosis, but the positron radionuclide for PET emits strong radiation, so it should be handled, dispensed, transported, and injected with radiopharmaceuticals for PET without proper shielding. Serious disabilities may be caused to medical staff in charge. For example, in order to minimize the residual radioactivity of the syringe in which the radiopharmaceutical remains, the inside of the syringe body must be repeatedly washed with physiological saline, and the physiological saline must be injected into the patient's body. Such repeated operations result in excessive exposure of the PET operator's fingers and other parts of the body to the radiation of the radiopharmaceutical.

  Conventional measures for radiation shielding have focused on holding boxes and containers to prevent radiation leakage of received and stored radiopharmaceuticals. However, in the handling of radiopharmaceuticals, medical personnel such as engineers and nurses are still at risk of radiation damage during collection, transfer, dispensing, quality control, and radiopharmaceutical injection operations.

  There is a need for a saline cartridge for use in a system that is safe against nuclear radiation in the handling of radiopharmaceuticals, particularly systems that minimize the damage of nuclear radiation to medical personnel.

  Accordingly, the main object of the present invention is to provide a physiological saline cartridge used in a radiopharmaceutical dispensing and injection system for a radiopharmaceutical injection operation with minimal nuclear radiation damage.

  Another main object of the present invention is that the framework has an intermediate conduit connected to a radiopharmaceutical injection port, a radiopharmaceutical discharge port, and a physiological saline outlet. The radiopharmaceutical easily flows from the injection port to the discharge port in the cartridge. It is to provide a saline cartridge for a dispensing and infusion system of a radiopharmaceutical that merges with saline from a saline reservoir.

One main focus of the present invention is to provide a physiological saline cartridge for injecting radiopharmaceuticals, which can be discarded after injection to eliminate unexpected exposure and radiation contamination.
A further focus of the present invention is to provide a saline cartridge that is easy to operate and safe from nuclear radiation, thereby eliminating repeated washing of the radiopharmaceutical with saline and thereby reducing radiation damage. is there.

  In order to achieve the above object, a physiological saline cartridge for injecting a radiopharmaceutical is provided by the present invention, and its framework is a primary channel extending from a physiological saline reservoir to a radiopharmaceutical inlet, and an outlet of the primary channel. The device for injecting into the patient comprises a secondary channel extending to the radiopharmaceutical outlet for injecting the radiopharmaceutical into the patient. A first check valve is provided at the outlet of the primary flow path to allow the flow of the radiopharmaceutical injected from the syringe filled with the radiopharmaceutical to the discharge port and prevent the backflow. A second check valve is located at the outlet of the physiological saline storage tank and fills the primary flow path with physiological saline to prevent backflow.

  The physiological saline cartridge according to the present invention is effectively used in a radiopharmaceutical dispensing and infusion system, so that the operation of the radiopharmaceutical dispensing and infusion system becomes efficient and facilitates safe radiopharmaceutical injection. Furthermore, the saline cartridge according to the present invention facilitates the automation of radiopharmaceutical dispensing and infusion systems. The process of manually and repeatedly cleaning the syringe with the remaining radiopharmaceutical can be automated, thus promoting radiation safety.

Thus, according to the first aspect of the present invention, in order to achieve the above object, a physiological saline cartridge for injecting a radiopharmaceutical comprises the following: a predetermined amount of physiological saline is stored and physiological saline is stored. A frame having an internal space forming a water storage tank, the frame having a portion made of a material that can be penetrated by a needle, a drug injection port and a drug discharge port, and a needle of a syringe filled with a radiopharmaceutical pierced and inserted into the needle. The drug injection port penetrating the possible material part, the drug discharge port penetrating the needle stabable material part of the relay part of the patient injection mechanism, the saline storage tank outlet forming the primary and secondary flow paths inside the framework, The primary flow path is directly connected to the saline storage tank, and the physiological saline fills the primary flow path, and the radiopharmaceutical filled in the syringe can be injected into the primary flow path via the framework drug inlet, one The flow path has an opening to the secondary flow path that connects to the framework's drug outlet; it allows the saline to enter the primary flow path and mixes with the secondary when the radiopharmaceutical is injected into the primary flow path. First check valve in the primary flow path that flows into the flow path but prevents back flow of the mixture of saline and radiopharmaceutical; primary flow of physiological saline at the saline outlet of the saline storage tank A second check valve that allows entry into the tract and prevents reverse flow of saline; where the radiopharmaceutical filled in the syringe is injected into the primary flow path from the drug inlet of the framework and then the second check valve Therefore, the backflow to the physiological saline storage tank is prevented, and the medicine discharge port can be reached only through the first check valve.
The invention according to claim 2 is characterized in that the first check valve is open and the second check valve is closed when the syringe holding the radiopharmaceutical in the primary flow path of the cartridge injects the drug solution. It is comprised like the physiological saline cartridge of claim | item 1. According to a third aspect of the present invention, the first check valve is closed and the second check valve is opened when the physiological saline fills the primary flow path. Furthermore, the invention described in claim 4 has another opening for filling the physiological saline storage tank with a predetermined amount of physiological saline, and the opening is closed with a needle-piercing material part. As in the case of the physiological saline cartridge according to claim 1, the physiological saline cartridge according to claim 4, wherein the invention according to claim 5 is closed except that the air filter penetrates the material. Thus, in the invention according to claim 6, the physiological saline according to claim 4 is filled in the physiological saline storage tank before the predetermined amount of physiological saline is blocked by the needle-prickable material portion. Like the water cartridge, and the invention of claim 7 is preset The physiological saline cartridge according to claim 4, wherein the physiological saline is filled through the needle pierceable material portion in an additional manner after the saline reservoir is closed with the needle pierceable material portion. It is configured as follows.

  Since the present invention is configured as described above, the operation of dispensing and injecting the radiopharmaceutical is efficient, and the radiopharmaceutical can be safely injected. In addition, the dispensing and injection of the radiopharmaceutical can be easily automated. Furthermore, it can be automated instead of the manual operation of manually and repeatedly washing the syringe in which the radiopharmaceutical remains. Thereby, a radiation safety degree increases.

  FIG. 1 shows a radiopharmaceutical dispensing and infusion system (hereinafter abbreviated as “system”). The system is integrated into a radiation shielded sealed tub 1 and is shown with side walls, ceiling and floor (not numbered). An injection needle insertion hole 11 for inserting the relay portion 8 for injecting the liquid radiopharmaceutical into the patient is provided on the side wall of the sealed tank 1 where the radiation is shielded. There is a vial 2 in which a radiopharmaceutical containing liquid or liquid is stored inside a sealed tank 1 which is shielded from radiation.

  The system has a mechanical tong 12 and is supported or operated by an extension rod 13, protruding out of the radiation shielded sealed tank 1 and connected to a manual or other automatic drive mechanism (not shown in the figure) I do. The mechanical tong 12 grabs or releases the vial 2 and puts it in the vial container 21. Here, a drug tube 20 for supplying the radiopharmaceutical is detachably connected to the vial 2 and has a predetermined amount of radiopharmaceutical. Is supplied to vial 2. The supply of the radiopharmaceutical to the vial 2 is monitored by the radiopharmaceutical liquid level monitoring device 4 (CCD camera), and an image of the vial 2 is obtained from a viewing window (not shown) on the side wall of the vial container 21. The image is transferred and displayed on the monitor 41 or computer for visual monitoring or other operations. The liquid level of the medicine filled in the vial 2 is thus monitored precisely and / or visually. The tube 20 is removed when the vial 2 is filled with the radiopharmaceutical and reaches a preset liquid height.

  When the vial 2 is filled with the radiopharmaceutical, the amount of radioactivity is measured as shown in FIG. In this step, the vial 2 is transferred from the vial container 21 to the measurement container 24 by the mechanical tongs 12. The measuring container 24 has a T-shaped hook 241 and is gripped by the mechanical tongs 12. The measurement container 24 and the vial 2 contained in the measurement container 24 are inserted into the radioactivity measuring device 3 and the radioactivity of the liquid radiopharmaceutical filled in the vial 2 is measured. The measurement value from the radioactivity measuring instrument 3 is transferred to a computer and processed, but here it is not related to the present invention and will be explained heretofore.

  When the measurement of the radioactivity of the vial 2 is completed, the measurement container 24 and the vial 2 are returned to the original location of the measurement container 24 by using the mechanical tongue 12. The vial 2 is then removed from the measurement container 24 and transferred to the vial container 21.

  The system includes a disposable syringe supply module 5 in which a plurality of disposable syringes 51 are arranged in a row and a movable dispensing and injection mechanism 6, both of which are installed in a sealed tank 1 that is shielded from radiation. The movable dispensing and injecting mechanism 6 is located in the vicinity of the disposable syringe supply module 5 and the vial container 21, and accommodates a single disposable syringe 51 selected by the disposable syringe supply module 5. The movable dispensing and injecting mechanism 6 moves the selected disposable syringe 51 and draws the radiopharmaceutical stored in the vial 2 by the disposable syringe 51 close to the vial container 21 at the dispensing position. At the injection position, a disposable syringe 51 filled with a radiopharmaceutical injects the liquid radiopharmaceutical into the physiological saline cartridge 70 of the physiological saline cartridge module 7 and is installed in the sealed tank 1 where both are shielded against radiation.

  2 and 3, the disposable syringe 51 selected and filled with the radiopharmaceutical is moved to the injection position by the movable dispensing and injection mechanism 6, and the needle 512 of the disposable syringe 51 is moved to the physiological saline. Injection is performed through a drug injection port 71 made of rubber or a penetrable material in the cartridge 70 through which the needle 512 can penetrate. Before and after the syringe plunger 511 is pushed into the disposable syringe 51, respectively. Is shown.

  The movable dispensing and injection mechanism 6 includes a support base 61, a horizontal movement mechanism 62, a vertical movement mechanism 63, a grabbing and abandoning mechanism 64, and a syringe plunger drive mechanism 65. The horizontal movement mechanism 62 moves the support base 61 in the horizontal direction along at least one horizontal guide rail 621, and the vertical movement mechanism 63 moves the support base 61 in the vertical direction along at least one vertical guide rail 631. .

  The gripping and abandoning mechanism 64 includes a clip 641, an extension arm 642, and a gripping and abandoning controller 643 that controls the operation of gripping / discarding a single selected disposable syringe 51. When the grasping and abandoning controller 643 extends the extension arm 642, the clip 641 is opened to grasp one disposable syringe 51 of the syringe supply module 5.

  The syringe plunger drive mechanism 65 can be electrically or pneumatically driven, for example, a pneumatic cylinder, and is installed in correspondence with the position of the plunger 511 of the selected disposable syringe 51 that is held on the support base 61 and held by the clamp 641. Has been. One end of the plunger 511 is free to move and moves the plunger 511 in the opposite direction selected and pushes upward or pulls downward to inject / suction liquid into the saline cartridge 70. The syringe plunger drive mechanism 65 is attached with a pressure sensor 651 that detects the force applied to the plunger 511 of the disposable syringe 51, and ensures the safety of injection and suction of liquid entering and exiting the physiological saline cartridge 70.

  4 and 5 show the case where the needle 512 of the selected disposable syringe 51 is stuck in the physiological saline cartridge 70, and the case where the radiopharmaceutical filled in the syringe is injected into the physiological saline cartridge 70 and the physiological saline. The cases where the physiological saline of the cartridge 70 is sucked into the syringe for cleaning are shown. FIG. 6 is a perspective view of the physiological saline cartridge 70, and the physiological saline cartridge 70 forms a physiological saline storage tank 77 in which a certain amount of physiological saline is stored. The framework of the physiological saline cartridge 70 includes a pharmaceutical injection port 71, a chemical discharge port 72, an intermediate conduit 73, and a physiological saline outlet 74. The physiological saline outlet 74 is connected to the intermediate conduit 73 via the second check valve 76 at the outlet of the physiological saline storage tank 77. The physiological saline in the physiological saline storage tank 77 flows into the intermediate conduit 73 and impurities are stored in the physiological saline storage tank. To prevent entering 77.

  The intermediate conduit 73 extending from the saline reservoir outlet 74, which is the outlet of the physiological saline cartridge 70, is blocked by the rubber screen of the pharmaceutical inlet 71 or other penetrable material, and the chemical in the physiological saline cartridge 70. It functions as an inlet 71 and can be pierced with a needle 512 of a syringe. The branch path (no number) is formed between the outlet of the second check valve 76 formed by the intermediate conduit 73 and the medicine injection port 71, and the first check valve 75 blocks the outlet to the physiological saline cartridge 70 and discharges the medicine. 72 is a rubber screen or a penetrable material that serves as a medicine discharge port for the physiological saline cartridge 70. The first check valve 75 allows a mixed solution of physiological saline and the radiopharmaceutical injected from the disposable syringe 51 to the intermediate conduit 73 to flow from the intermediate conduit 73 to the branch passage, and the mixture from the branch passage to the intermediate conduit 73. Prevents backflow. Thus, the physiological saline in the physiological saline storage tank 77 passes from the physiological saline storage tank 77 via the second check valve 76, the intermediate conduit 73, the first check valve 75, and the medicine discharge port of the physiological saline cartridge 70 from the branch path. 72 is allowed to flow only as indicated by the arrows in FIGS.

  The physiological saline storage tank 77 of the physiological saline cartridge 70 forms an injection port (no number) closed by a needle stabable material portion 771. The physiological saline can be injected in advance from the injection port before the physiological saline storage tank 77 of the physiological saline cartridge 70 is blocked by the needle stabable material portion 771, and instead the filling port is blocked by the curtain 771. After that, the physiological saline can be filled in the physiological saline storage tank 77 by penetrating the needle pierceable material portion 771 with a syringe. The air filter 78 is inserted into the needle stabable material part 771 through the needle stabable material part 771 to guide the air to the physiological saline storage tank 77 and balance the air pressure when the physiological saline is drained from the physiological saline storage tank 77. The air filter 78 also serves to prevent impurities from entering the physiological saline storage tank 77 from the atmosphere.

  The relay unit 8 has a needle 83 and guides the liquid radiopharmaceutical to the relay unit 8 through the curtain of the drug discharge port 72 of the physiological saline cartridge 70. The tube 81 is connected to a needle 83 and connected to a needle 82 (see FIG. 1) pierced in a patient's body (not shown) via an injection needle insertion hole 11 provided in the tank 1. The three-way stopcock 811 is used manually, connected to the first part connected to the tube 81, the next part passes through the finishing filter 812, the needle 82, and the last part is filled with physiological saline 813. The role of the physiological saline injected by the physiological saline syringe 813 is to drive the air in the tube 81 before operating the three-way cock 811 before the needle 83 penetrates the medicine discharge port 72 of the physiological saline cartridge 70.

  The relay portion 8 has an outer tube 84 that covers the tube 81 and serves to support and align the needle 83 through the medicine discharge port 72. The outer tube 84 is formed with a flange stopper 841 on the outer periphery, and contacts the inner periphery of the injection needle insertion hole 11 in front of the physiological saline cartridge 70 to prevent the outer tube 84 from inadvertently dropping to the physiological saline cartridge 70 side. .

  In order to shield the injection needle insertion hole 11 with radiation, a lump 14 such as tungsten is inserted into the injection needle insertion hole 11. An opening (not numbered) with a diameter to better fit the mantle tube 84 is widened and has a conical and sloped inner surface.

  In operation, the support 61 holding the disposable syringe 51 selected by the movable dispensing and injection mechanism 6 is moved to the injection position along the horizontal guide rail 621 by the horizontal movement mechanism 62, and then the vertical movement mechanism 63 is moved. The support base 61 is moved upward along the vertical guide rail 631, and the needle 512 of the disposable syringe 51 passes through the drug injection port 71 of the physiological saline cartridge 70. Thereafter, the syringe plunger drive mechanism 65 injects the plunger 511 of the disposable syringe 51 into the radiopharmaceutical contained in the disposable syringe 51 via the drug inlet 71 of the intermediate conduit 73 of the physiological saline cartridge 70. At this time, as shown in FIG. 4, the second check valve 76 closes and prevents the radiopharmaceutical mixed in the intermediate conduit 73 with the saline flowing from the saline storage tank 77, while the first check valve 75 emits radiation. The medicine is opened to flow and flows through the branch path together with the physiological saline reservoir in the intermediate conduit 73, and then flows toward the radiopharmaceutical discharge port 72 through the relay portion 8 inserted into the drug discharge port 72.

  When the injection of the radiopharmaceutical from the disposable syringe 51 is completed, the plunger 511 is pulled down by the syringe plunger driving mechanism 65, and the physiological saline in a part of the intermediate conduit 73 is sucked into the disposable syringe 51 to inside the syringe. The remaining radiopharmaceutical is washed. In this situation shown in FIG. 5, the second reverse 76 opens to fill the intermediate conduit 73 with physiological saline, the first check valve 75 is closed, and the injection operation of the disposable syringe 51 previously causes a branch or relay unit 8. Inhibits radiopharmaceuticals. The physiological saline sucked into the syringe is injected into the intermediate conduit 73, and the branch path again causes the radiopharmaceutical remaining in the syringe to flow into the intermediate conduit 73. This washing step is repeated if necessary.

  While the embodiments of the present invention have been described above, it is apparent that various modifications and changes can be made without departing from the scope of the present invention as set forth in the claims.

1 is a perspective view of a radiopharmaceutical dispensing and infusion system, with a disposable saline cartridge manufactured according to the present invention. FIG. FIG. 2 is a perspective view of a radiopharmaceutical dispensing and infusion system, particularly showing the dispensing and infusion mechanism, wherein a single syringe containing a liquid radiopharmaceutical moves to the infusion position and disposes the liquid according to the present invention. The syringe plunger is infused into the saline cartridge and thus into the patient, and the syringe plunger is in an infused state. FIG. 3 is a perspective view similar to FIG. 2 but showing the syringe plunger being pulled down. FIG. 3 is a cross-sectional view of a syringe containing a liquid radiopharmaceutical penetrating a disposable physiological saline cartridge and a plunger being in an injecting state. FIG. 5 is a cross-sectional view similar to FIG. 4 but showing the plunger pulled down. 1 is a perspective view of a disposable physiological saline cartridge manufactured according to the present invention. FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Radiation-shielded sealed tank 11 Injection needle insertion hole 12 Mechanical tong 13 Extension rod 14 Tungsten lump 141 Tungsten surface 2 Drug vial 20 Drug tube 21 Drug vial 22 Drug liquid level monitoring hole 24 Measurement container 241 T-shaped rod 3 Radiation Capability measuring device 4 Drug level measuring device 41 Monitor 5 Syringe supply module 51 Disposable syringe 511 Syringe plunger 512 Needle 52 Syringe delivery mechanism 6 Movable dispensing and injection mechanism 61 Support base 62 Horizontal movement mechanism 621 Horizontal guide rail 63 Vertical Movement mechanism 631 Vertical guide rail 64 Grab and abandon mechanism 641 Clamp 642 Extension arm 643 Abandon controller 65 Syringe plunger drive mechanism 651 Pressure sensor 7 Saline cartridge module 70 Saline cartridge 71 Drug inlet 72 Drug outlet 73 Medium Conduit 74 Saline storage tank outlet 75 First check valve 76 Second check valve 77 Saline storage tank 771 Needle stabable material part 78 Air filter 8 Relay part 81 Tube 811 Three-way stopcock 812 Finish filter 813 Saline syringe 82 Patient Needle stabbed into needle 83 Needle 84 Mantle tube 841 Stopper

Claims (7)

A saline cartridge for radiopharmaceutical injection consists of:
A frame having an internal space for storing a predetermined amount of physiological saline and forming a physiological saline storage tank (77), the frame having a portion made of a material through which the needle can penetrate (71) And the medicine discharge port (72), the needle (512) of the syringe (51) filled with the radiopharmaceutical, the drug injection port (71) through which the needle pierceable material part of the injection port (71) penetrates, and the relay of the patient injection mechanism A medicine discharge port (72) penetrating the needle stabable material part of the part (8), a saline storage tank outlet (74) in which primary and secondary flow paths are formed inside the framework, and physiological saline in the primary flow path A radiopharmaceutical that is directly connected to the water storage tank (77) and that fills the primary flow path and is filled in the syringe (51) can be injected into the primary flow path via the framework drug inlet (71). The primary flow path is the framework drug delivery Having an opening to the secondary flow path leading to the outlet (72);
Primary that allows physiological saline to enter the primary flow path and mixes when the radiopharmaceutical is injected into the primary flow path and flows into the secondary flow path, but prevents backflow of the mixture of saline and radiopharmaceutical. A first check valve (75) in the flow path;
A second check valve (76) at the physiological saline outlet (74) of the physiological saline storage tank (77) that allows the physiological saline to flow into the primary flow path and prevents the physiological saline from flowing back;
Here, the radiopharmaceutical filled in the syringe (51) is injected into the primary flow path from the drug injection port (71) of the framework, and then flows back into the physiological saline storage tank (77) by the second check valve (76). Is blocked and can reach the medicine discharge port (72) only through the first check valve (75).   The first check valve (75) is open and the second check valve (76) is closed when the syringe (51) holding the radiopharmaceutical in the primary flow path of the cartridge injects the drug solution, Item 4. The physiological saline cartridge (70) according to item 1.   The saline cartridge (70) of claim 1, wherein the first check valve (75) is closed and the second check valve (76) is open when the saline fills the primary flow path.   The physiological saline according to claim 1, wherein the physiological saline storage tank (77) has another opening filled with a predetermined amount of physiological saline, and the opening is closed with a needle-piercable material part. Water cartridge (70).   The saline cartridge (70) of claim 4, wherein the material is blocked except for the air filter (78) passing therethrough.   The physiological saline cartridge (70) according to claim 4, wherein a predetermined amount of physiological saline is filled in the physiological saline storage tank (77) before being blocked by the needle-prickable material portion (771).   A predetermined amount of saline passes through the needle pierceable material portion (771) in an additional manner after the saline storage tank (77) is closed by the needle pierceable material portion (771). The saline cartridge (70) of claim 4, wherein the saline cartridge (70) is filled.

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