WO2001002048A1 - Radioactive material handling device - Google Patents

Radioactive material handling device Download PDF

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Publication number
WO2001002048A1
WO2001002048A1 PCT/JP2000/004369 JP0004369W WO0102048A1 WO 2001002048 A1 WO2001002048 A1 WO 2001002048A1 JP 0004369 W JP0004369 W JP 0004369W WO 0102048 A1 WO0102048 A1 WO 0102048A1
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WO
WIPO (PCT)
Prior art keywords
container
outer cylinder
hollow needle
stopper
substance
Prior art date
Application number
PCT/JP2000/004369
Other languages
French (fr)
Japanese (ja)
Inventor
Akiyo Shigematsu
Akiko Hatori
Original Assignee
Institute Of Whole Body Metabolism
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Institute Of Whole Body Metabolism filed Critical Institute Of Whole Body Metabolism
Publication of WO2001002048A1 publication Critical patent/WO2001002048A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents
    • GPHYSICS
    • G21NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21FPROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
    • G21F5/00Transportable or portable shielded containers
    • G21F5/015Transportable or portable shielded containers for storing radioactive sources, e.g. source carriers for irradiation units; Radioisotope containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/2013Piercing means having two piercing ends
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2051Connecting means having tap means, e.g. tap means activated by sliding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1007Arrangements or means for the introduction of sources into the body

Definitions

  • the present invention relates to a device for preparing a medical solution of a radioactive substance to be used for missile therapy for patients with metastatic malignant tumor immediately before medical treatment.
  • An object of the present invention is to provide a handling device that can be operated easily and reliably without any radiation leakage to the outside when handling dangerous substances including radioactive substances.
  • Another object of the present invention is to safely, easily and surely prepare a drug solution containing radiation used for missile therapy of a malignant tumor without substantially leaking the radiation to the outside. It is to provide a device for administration to a patient. Disclosure of the invention
  • the radioactive substance handling device of the present invention is configured such that an opening is sealed with an outer cylinder and a first stopper through which a hollow needle can easily penetrate, and the opening is downwardly slidable into the outer cylinder.
  • a first container inserted, a needle member provided with a hollow needle with both ends sharpened to move axially inside the outer cylinder, and an opening sealed with a second plug through which the hollow needle can easily penetrate upward.
  • the inside of the outer cylinder which is inserted into and fixed to the lower end of the outer cylinder, has a second container whose pressure is lower than that of the first container.
  • the first stopper penetrates the upper end of the hollow needle and the second stopper penetrates the lower end of the hollow needle, so that the inside of the first container and the second container communicate with each other, and the contents in the first container. Can be safely and reliably moved into the second container without substantial radiation leakage to the outside It is characterized by having been done.
  • substantially means that there is no problem in terms of leakage from the viewpoint of radiation handling standards.
  • the material of the first container and the second container must be impermeable to the contained fluid and must be chemically inert to the internal fluid. Both containers are preferably transparent or translucent.
  • the material of the outer cylinder is preferably transparent or translucent.
  • the fluid to be handled is a radioactive substance that emits a relatively high-energy solid ray
  • the fluid is a radioactive substance that emits gamma rays or X-rays
  • the first and second stoppers are made of a soft material that can be penetrated by a hollow needle, for example, natural or synthetic rubber. None of the stoppers shall be permeable to the contained fluid unless penetrated.
  • the needle member having the hollow needle penetrating through the columnar member be slidable in the axial direction of the outer cylinder along the inner surface of the outer cylinder.
  • the hollow needle can always move the outer cylinder.
  • the material of the hollow needle is preferably chemically inert to at least the passing fluid.
  • the substance handling apparatus of the present invention can be used for both liquid and gas, but is particularly suitable for handling liquid. Initially, the fluid containing radioactive material does not come into contact with the inside of the first container in which the fluid is stored, the inner surface of the hollow needle, and the second container in which the fluid is moved. No local contamination occurs. If radiation shielding material is used for the outer cylinder, radiation exposure of workers can be prevented. The downward movement of the first container may be performed directly by mechanical means, or may be performed indirectly from outside the outer cylinder.
  • a slidable magnetic member is inserted into the outer cylinder, a magnet movable along the outer cylinder is provided outside the outer cylinder, and the magnet is moved along the outer cylinder, so that the magnetic member becomes While pressing the first container and moving in the outer cylinder, before the upper end of the hollow needle penetrates the stopper of the first container so that the first container moves in the outer cylinder, the lower end of the hollow needle is
  • a restricting member for temporarily restricting the lower end of the hollow needle may be provided between the needle member and the second container so as not to penetrate the second stopper.
  • a member such as paper which can be broken if necessary, is inserted and fixed at a position where the lower end of the hollow needle in the outer cylinder is to be temporarily stopped. Further, the needle member may be stopped.
  • the outer cylinder is divided into a first container storage part and a second container storage part, and the upper part of the second container can be opened by rotating or moving the first container storage part or the second container storage part. can do.
  • the mutual movement or rotation of the divided outer cylinders can be performed by rotating or moving the second container housing by an electric mechanism or the like while fixing the first container housing or by fixing the second container housing to the second container housing.
  • One container storage section can be rotated or moved by an electric mechanism.
  • a hollow tube is inserted into the second container so as to reach near the inner bottom.
  • the inserted hollow tube plays a role of taking out the contents in the second container out of the container.
  • a hollow tube is connected to the end of the hollow tube, and the end of the tube is connected to a catheter.
  • a radiopharmaceutical solution is prepared.
  • the prepared drug solution is It is administered to the human body through a catheter via a hollow tube inserted in the second container.
  • a chemical supply pump and a filter are provided between the hollow tube and the catheter.
  • a column using an ion exchange resin and activated carbon as a filler and a Millipore filter are used.
  • yttrium 90 for example, in a chemical solution is used, simple yttrium and zirconium are removed with an ion exchange resin, unreacted protein antibodies are removed with activated carbon, and activated carbon and other fine particles are removed using a millipore filter. To remove.
  • FIG. 1 is a view showing an apparatus for handling radioactive substances and the like according to the present invention.
  • FIG. 2 shows a jig used for the apparatus shown in FIG.
  • FIG. 3 is a view showing another handling device for a radioactive substance or the like according to the present invention.
  • FIG. 4 is a view showing a state in which the first container storage section is rotationally moved to open the second container storage section.
  • FIG. 5 is a diagram showing a state in which the first container storage section and the second container storage section are mutually moved.
  • FIG. 6 is a diagram showing a state of an upper part of the second container storage part.
  • FIG. 7 is a diagram showing a state in which a drug solution is administered to a patient using the device of the present invention.
  • FIG. 1 shows an example of the apparatus of the present invention.
  • the main body of the device is the outer cylinder 1, the first container to be inserted upside down into the outer cylinder 1. It comprises a vessel 2, an isolation membrane 5a provided at an intermediate portion of the outer casing 1, a needle member 4 vertically penetrated by a hollow needle 3, and a second container 6 inserted into a lower end lb of the outer casing 1.
  • the first container 2 containing a liquid such as a radioactive substance is inserted into the outer cylinder 1 with the opening sealed with a rubber stopper 2a which can be easily penetrated by the hollow needle 3 facing downward, facing downward.
  • the first container 2 is placed at a position where the bottom 2b is located a little further behind the upper end la of the outer cylinder 1.
  • An iron core 7 is inserted between the bottom 2b of the first container 2 and the upper end la of the outer cylinder 1. Lead is enclosed as a weight inside the iron core 7.
  • the filter paper 11 is bonded to the opening at the upper end la of the outer cylinder 1, and the upper end of the iron core 7 is further bonded to the filter paper 11 (however, the iron core 7 is separated from the filter paper 11 later).
  • a permanent magnet 8 is provided near the upper end la of the outer cylinder 1 so that the magnetic pole sandwiches the outer cylinder 1, and is temporarily fixed at this position at first.
  • An electromagnet 9 and a braking member 10 that can be moved up and down as necessary are provided in an intermediate portion of the outer cylinder 1.
  • a pair of slits 5 are provided at opposing positions on the wall of the outer cylinder 1 at a position substantially lower than the distance from the electromagnet 9 to the length of the first container 2 plus the length of the hollow needle 3. .
  • an isolation membrane 5 a made of filter paper or the like having an appropriate thickness and easily penetrated by the hollow needle 3 is inserted from the outside of the outer cylinder 1.
  • a needle member 4 formed by vertically penetrating a hollow needle 3 having both sharpened ends so that the hollow needle 3 is parallel to the axial direction of the outer cylinder 1 in the outer cylinder 1 immediately above the separator 5a. It is placed upright.
  • the needle member 4 is movable in the axial direction of the outer cylinder 1 in an upright state, and initially, the lower end 3b of the needle is in contact with the separation membrane 5a and is stationary.
  • the stopper 6a of the second container 6 is inserted into the opening of the lower end lb of the outer cylinder 1, so that both are airtightly adhered.
  • a stopper 13 is provided inside the outer cylinder 1 so that the stopper 6a is located at a predetermined distance from the electromagnet 9 when the stopper 6a is inserted into the outer cylinder 1. You. This predetermined distance will be described later in the description of the operation.
  • the lower end lb of the outer cylinder 1 is also sealed with the filter paper 12 (indicated by the dotted line) to protect the inside of the cylinder, like the upper end la.
  • the second container 6 may be provided with a sleeve 14 to protect it during transportation, and when the second container 6 is inserted into the lower end lb of the outer cylinder 1, the upper part of the sleeve 14 also becomes Is inserted outside the lower end of the lb.
  • the bottom of the second container 6 is in close contact with the vibrating part of the shaker 15 that provides mechanical vibration.
  • the whole device is fixed by a support 16.
  • FIG. 3 shows another embodiment of the present invention.
  • the main body of the device is an outer cylinder 31 whose upper part is divided into a first container storage part 51 and a lower part is divided into a second container storage part 50, and the first part which is inverted and inserted into the first container storage part 51.
  • a hollow needle 33 is formed by a needle member 34 formed by vertically penetrating a columnar member.
  • the first container 32 containing the liquid of the radioactive substance is inverted and inserted into the first container storage part 51 with the opening sealed with a rubber stopper 32a that can be easily penetrated by a needle facing downward.
  • the first container 32 is initially placed at a position where the bottom 32b is slightly deeper than the upper end 3 la of the outer cylinder 31.
  • An iron core 37 is inserted between the bottom 32b of the first container 32 and the upper end 31a of the outer cylinder 31. Lead is enclosed as a weight inside the iron core 37.
  • a filter paper 41 is adhered to the opening of the upper end 31a of the outer cylinder 31, and an upper end of the iron core 37 is further adhered to the filter paper 41.
  • a permanent magnet 38 is provided so that the magnetic pole sandwiches the outer cylinder 31, and is initially temporarily fixed at this position.
  • An electromagnet 39 and a control that can be moved up and down as necessary A moving member 40 is provided.
  • an isolation membrane 35a such as filter paper that can be easily penetrated with a needle having an appropriate thickness is inserted.
  • a needle member 34 having a hollow needle 33 having both sharp ends penetrating the columnar member upward and downward is placed upright in the outer cylinder 31 immediately above the separator 35a.
  • the needle member 34 is movable in the axial direction of the outer cylinder 31 while being in an upright state. Initially, the lower end 33b of the hollow needle 33 is in contact with the separator 35a and is stationary.
  • the stopper 36a of the second container 36 is inserted into an opening of 3 lb at the lower end of the lower second container housing portion 50 of the outer cylinder 31, and both are airtightly adhered.
  • a stopper 43 is provided inside the outer cylinder 31 so that the stopper 36a is located at a predetermined distance from the electromagnet 39 when the stopper 36a is inserted into the second container storage part 50.
  • the lower end 31b of the second container storage section 50 is also sealed with a filter paper 42 (indicated by a dotted line) to protect the inside of the cylinder, similarly to the upper end 3la.
  • the second container 36 may be provided with a sleeve 44 for protecting it during transportation, and when the second container 36 is inserted into the lower end 31b of the second container storage 50, the sleeve 44 The upper part is also inserted outside the lower end 31b of the second container storage part 50.
  • the bottom of the second container 36 is in close contact with the vibrating part of the shaker 45 to provide mechanical stirring.
  • a stirrer such as a magnetic stirrer can be used instead of the shaker.
  • the whole device is fixed by a column 46.
  • This embodiment is different from the embodiment of FIG. 1 described above in that the outer cylinder 31 is basically divided into a first container storage 51 and a second container storage 50. Different. Other portions have a structure substantially similar to that of the embodiment of FIG. 1 described above. By dividing the outer cylinder 31 into two parts, the outer cylinder 31 is divided into a part in which the first container 32 is stored and a part in which the second container 36 is stored. The operation of administering the radiopharmaceutical liquid prepared in the second container 36 to the human body is significantly improved.
  • the first container storage section 51 is held on a support column 46 with a rotary support 49, and the second container storage section 50 is supported on a support column 48 with a support column 48.
  • the first container storage part 51 is rotated around the column 46 by the rotation support 49.
  • the first container storage 51 is rotated, for example, 90 degrees, the upper part of the second container 36 inserted in the second container storage 50 is opened.
  • the storage portion 51 of the first container is rotated around the column 46, but the second container storage portion 50 may be rotated. Further, either the first container storage section 51 or the second container storage section 50 may be moved right and left. It is only necessary that the upper part of the second container storage part is opened from the inside of the cylinder.
  • the first container storage section 51 and the second container storage section 50 can be connected by a hinge 66 so that they can rotate with each other. In this case, rotation is performed by one shaft (shaft) provided on hinge 66.
  • the yttrium 90 contained in the first container 32 is transferred via the hollow needle 33 into the second container 36, where it reacts with the monoclonal antibody.
  • the drug solution thus prepared in the second container 36 is administered to a human body.
  • a hollow tube 61 is inserted into the second container 36 to the bottom of the container 36.
  • the tube 62 is connected to the hollow tube 61.
  • the tube 62 is connected to a Helister pump 65 via a column 63 filled with ion exchange resin and activated carbon and a Millipore filter 64, and finally to a human body. Is administered. This situation is shown in FIG. [Operation (Part 1)]
  • the isolation membrane 5a is inserted into the slit 5 of the outer cylinder 1, and the needle member 4, the braking member 10, the first container 2, and the iron core 7 are inserted into the outer cylinder 1 in this order.
  • the needle member 4 descends and stops until the lower end 3b of the hollow needle 3 contacts the separator 5a.
  • the first container 2 moves in the outer cylinder 1 with the lower end in contact with the braking member 10 and the upper end (bottom 2b) in contact with the iron core 7, and the upper end of the iron core 7 Stops when it matches the upper end la of the outer cylinder 1.
  • the filter paper 11 is adhered to both of them, and the upper end la of the outer cylinder 1 is sealed.
  • the lower end lb of the outer cylinder 1 is also sealed with the filter paper 12.
  • the filter paper 12 sealing the lower end lb of the outer cylinder 1 is removed, and the upper part of the stopper 6 a of the second container 6 is inserted into the opening of the lower end lb to the stopper 13.
  • An electric current is passed through the electromagnet 9 to activate the electromagnet.
  • a jig 21 (FIG. 2) composed of a bar having a knob 22 and a collar 23, the filter paper 11 at the upper end la of the outer cylinder 1 is broken, and the iron core 7 is pushed down slightly.
  • the permanent magnet 8 is moved downward from the vicinity of the upper end la of the outer cylinder 1 along the outside of the outer cylinder 1, the iron core 7 in the outer cylinder 1 moves downward while pressing the first container 2.
  • the damping member 10 moves while being pushed by the lower end 2b, and does not hinder the movement of the first container 2.
  • the iron core 7 approaches the electromagnet 9, it is attracted to the electromagnet 9 and stops.
  • the lower end 3b of the hollow needle 3 penetrating the needle member 4 breaks through the separation membrane 5a, Further, the upper end 3a of the hollow needle 3 pierces and penetrates the rubber stopper 2a by piercing and penetrating the stopper 6a at the upper end of the second container 6.
  • the hollow needle 3 passes through the rubber 2a to the first container 2 containing the fluid and the stopper 6a to the second container 6 that is depressurized.
  • the fluid in the second container 6 is transferred by the pressure difference with the second container 6.
  • the position of the stopper 13 provided near the lower end lb of the outer cylinder 1 is such that when the iron core 7 is attracted to the electromagnet 9 and stops, the lower end 3b of the hollow needle 3 passes through the stopper 6a at the upper end of the second container 6. Position.
  • the fluid transferred to the second container 6 is stirred and homogenized by the vibration of the shaker 15.
  • the second container 6 that has received the fluid is detached from the stopper 6a and separated from the lower end lb of the outer cylinder 1.
  • the first container 32 enclosing yttrium chloride is inserted into the upper end of the radiation shielding outer cylinder 31 of the radiopharmaceutical handling device, and is fixed by the permanent magnet 38.
  • the outer cylinder 31 is composed of a triple pipe consisting of a vinyl chloride pipe (thickness 10 mm), a stainless steel pipe (thickness lmm), and a lead pipe (thickness 10 mm).
  • the radiation dose of yttrium 90 enclosed in the first container 32 was able to enter the worker at a remote distance of lm from the outer cylinder 31 and work for 7 hours and Z days was possible without any problem.
  • Second container 3 6 contains a monoclonal antibody protein activity against tumors of the blood system; equivalent to 10 to 20 mg. Due to its physicochemical properties, IDEC's Y2B8 or the like, in which thioprea is bound to the structural end of the CD20 mouse antibody and DTPA (diethylenetriaminepentaacetic acid) is further bound, is suitable as this antibody.
  • IDEC's Y2B8 or the like in which thioprea is bound to the structural end of the CD20 mouse antibody and DTPA (diethylenetriaminepentaacetic acid) is further bound, is suitable as this antibody.
  • DTPA diethylenetriaminepentaacetic acid
  • the radiation shielding outer cylinder 31 is divided into a first container storage part 51 and a second container storage part 50.
  • the upper part of the second container 36 is opened by the mutual rotation or movement of the first container storage part 51 and the second container storage part 50.
  • the first container storage unit 51 and the second container storage unit 50 are continuous.
  • An isolation membrane 35a synthetic fiber such as filter paper, millibore, etc.
  • the needle members of the hollow needles at both ends are placed near the center of the separator.
  • the upper and lower ends of the outer cylinder 3 are designed so as to maintain sterility by closely attaching a similar thin filter film.
  • the outer cylinder 31 is turned over and loaded and fixed in an outer box (an outer case of a violin). Then, the entire outer box is shipped to the place of use.
  • the leakage dose outside the box in this case was specified below 0.01 microsievert and was within the provisions for general type A transport.
  • Yttrium 90 anti-mouse CD20 antibody is considered appropriate for non-Hodgkin's disease patients who require cancer missile therapy.
  • 3 Radiation dose for internal treatment typically 0.4 mCi (l. 48 GBg ) / Kg body weight) is administered.
  • a set of instruments including a container loaded with therapeutic yttrium 90 is taken out of the outer box and fixed to the column 46. Work during this time The external exposure of workers by the industry is 0.05 microsievert Z. The time required for the work is less than 5 minutes. After the instrument is secured, the electrical connections required for remote operation are made (electrical connections are not shown).
  • An electric current is passed through the electromagnet 39 to activate the electromagnet.
  • the permanent magnet 38 is moved downward from the vicinity of the upper end 31a of the outer cylinder 31 along the outside of the outer cylinder 31, the iron core 37 in the outer cylinder 31 moves downward while pressing the first container 32.
  • the braking member 40 moves while being pushed by the lower end 32b.
  • the iron core 37 approaches the electromagnet 39, it is attracted to the electromagnetic stone 39 and stops.
  • the lower end 33b of the hollow needle 33 that has penetrated the needle member 34 breaks through the separator 35a, pierces the stopper 36a at the upper end of the second container 36, penetrates it, and at the same time, the upper end of the hollow needle 33 33a penetrates through rubber stopper 32a.
  • the hollow needle 33 passes through the rubber stopper 32a to the first container 32 filled with yttrium 90, and passes through the stopper 36a to the depressurized second container 36, respectively.
  • the yttrium chloride 90 initially in the first container 32 is transferred to the second container 36 by a pressure difference. After the yttrium chloride 90 alone has completely moved into the second container 36, the magnetic stirrer 45 is activated.
  • a yttrium 90 chemical is stirred together with a sleeve 44 filled with cooling water (the center of the bottom is shaped so that it can be in close contact with the bottom of the second container).
  • the chemical is initially suspended, but becomes transparent over time. After sufficient reaction (approximately 20-30 minutes), stop mixing.
  • the switch After the formation of the yttrium 90-Y2B8 chelate, the switch is energized to rotate the first container compartment 90 degrees. By this operation the second container 3 The upper part of 6 appears.
  • FIG. 6 shows a state where the upper part of the second container 36 is exposed.
  • the hollow needle 33b below the needle member penetrates a stopper 36a provided at the opening of the second container 36.
  • a radiological technician connects a hollow tube 61 to the tip of an extension tube 62 (tube) for injection filled with physiological saline through lead glass.
  • the hollow tube 61 is connected to yttrium 90-chelating antibody. It pierces the stopper of the second container 36 containing the product liquid and passes it to the bottom.
  • the radiation exposure to human hands during this time is less than 0.5 microsievert Z hours and the working time is less than 1 minute.
  • Injection tube 62 is passed through a column and a millibore filter to remove unreacted material, including zirconium 90, and is injected into the patient's brachial vein through a helicopter pump.
  • the internal packing material of the column is a cation adsorption resin maintained at pH 7.5 and activated carbon.
  • the radioactive substance brazing apparatus of the present invention contacts only the inside of each of the first containers 2 and 32, the hollow needles 3 and 33, and the second containers 6 and 36. It does not contaminate the outside of the container and the hollow needle for transfer.
  • the present invention is used for transferring a radioactive liquid or the like from a first container to a second container, and reacting a radioactive liquid or the like in the first container with another substance in the second container. It is also useful for the purpose. For example, it is also useful for mixing a solution containing a high concentration of a beta- or gamma-ray radioisotope with a highly radiation-sensitive protein reagent immediately before use for medical or other purposes.
  • the device of the present invention enables the preparation of a drug solution containing radiation, and is effectively applied for the purpose of reacting a radioactive liquid or the like in the first container with another substance in the second container. be able to. It is useful for research on the transfer, reaction, and preparation of radioactive materials, research and development of pharmaceuticals, and medical purposes.

Abstract

A radioactive material handling device capable of performing various kinds of handlings such as the movement of radioactive material from one container to the other container and the mixing, reaction, and control of the material by simple operations without allowing hazardous substances such as radioactive material to leak to the outside, comprising an outer tube, a first container having an opening closed by a first plug through which a needle can pass easily and be inserted slidably into the outer tube with the opening facing downward, a hollow needle capable of being moved in parallel with the axial direction of the outer tube and having sharpened both ends, and a second container having an opening closed by a second plug through which the hollow needle can pass easily, inserted fixedly into the lower end of the outer tube, and having an inside pressure reduced below that in the first container, wherein the first container is slid inside the outer tube to allow the upper end of the hollow needle to pass through the first plug and the lower end of the hollow needle to pass through the second plug so as to allow the first container to communicate with the second container in order to move the content in the first container to the second container without allowing it to leak to the outside.

Description

明 細 書 放射性物質の取扱装置 技術分野  Description Radioactive material handling equipment Technical field
一の容器内の物質を他の容器内に移動させ、 更に他の容器内に存 在させた他の物質と反応させるための装置、 更に詳しくは、放射線を外 部へ実質的に漏洩させることなく、放射性物質等を含む物質を移動させ. 反応させる装置に関する。特に、転移性悪性腫瘍患者に対するミサイル 療法に使用する放射性物質の薬液を医療直前に調製する装置に関す る。 背景技術  A device for moving a substance in one container into another container and reacting it with another substance present in another container, more specifically, substantially leaking radiation to the outside. And a device for transferring and reacting substances including radioactive substances. In particular, the present invention relates to a device for preparing a medical solution of a radioactive substance to be used for missile therapy for patients with metastatic malignant tumor immediately before medical treatment. Background art
放射性物質を含む危険な物質を取扱うに際し、放射線の外部への漏 洩なしに取扱う方法として、オークリッジ型フード等の中でマジックハンドを 用いる方法が従来から知られている。  As a method of handling dangerous substances including radioactive substances without leaking radiation to the outside, a method using a magic hand in an oak ridge type hood or the like has been conventionally known.
し力 し、かかる方法は、放射性同位元素等取极使用施設内に於ける オークリッジ又はカリホルユア型フード内での作業を要し、 医療現場での 取扱いには全く適していない。 通常、 医療従事者は、放射性医薬品に 限り取り扱うことが薬事法により認められている。特に、 医療従事者は毎 日多くの患者に接しているが、治療を目的としており、放射線取扱いの専 門家とは限らないのが現状である。 また、 治療現場に搬送された大線量 粒子線核種医薬品を、治療現場で開梱し、密封容器を取り出し、 開封 し、 治療器具に内容物を移動させて、患者体内に注入する一連の操作 は、特殊な放射線同位元素使用施設での作業とは全く異なる条件下で 行われる。このような状況を踏まえ、所謂放射線取扱施設とは全く異なる 作業条件下に曝される医療現場に於いて、放射線ひばくに対する安全 性を十分に配慮した取扱装置が求められている。 However, this method requires work in an Oak Ridge or Califorure-type hood in a facility that uses radioisotopes, etc., and is completely unsuitable for handling at medical sites. Normally, medical personnel are permitted by the Pharmaceutical Affairs Law to handle only radiopharmaceuticals. In particular, healthcare professionals are in contact with many patients every day, but they are intended for treatment and are not necessarily specialists in radiation handling. In addition, a series of operations for unpacking the large-dose nuclide radiopharmaceuticals transported to the treatment site at the treatment site, removing the sealed container, opening the package, moving the contents to a treatment instrument, and injecting it into the patient's body are as follows: Under completely different conditions than working in a special radioisotope facility Done. Under these circumstances, there is a need for a handling device that fully considers the safety against radiation exposure at medical sites exposed to completely different working conditions from so-called radiation handling facilities.
本発明の目的は、放射性物質を含む危険な物質を取扱うに際し、実 質的に放射線の外部への漏洩がなく、簡便かつ確実に操作できる取扱 装置を提供することにある。  SUMMARY OF THE INVENTION An object of the present invention is to provide a handling device that can be operated easily and reliably without any radiation leakage to the outside when handling dangerous substances including radioactive substances.
本発明の他の目的は、悪性腫瘍患者のミサイル療法に使用する放射 線を含む薬液を、 実質的にその放射線を外部に漏洩させることなく、安 全に、容易に、かつ確実に調製し、患者に投与するための装置を提供す ることにある。 発明の開示  Another object of the present invention is to safely, easily and surely prepare a drug solution containing radiation used for missile therapy of a malignant tumor without substantially leaking the radiation to the outside. It is to provide a device for administration to a patient. Disclosure of the invention
上記の目的を達成するため、 本発明の放射性物質取扱装置は、外 筒と、 中空針が容易に貫通できる第一の栓で開口が密栓され開口を下 向きにして外筒内に滑動可能に挿入された第一の容器と、外筒内側を 軸方向に移動できる両端が尖った中空針を備えた針部材と、 中空針が 容易に貫通できる第二の栓で密栓された開口部を上向きにして外筒の 下端に挿入されて固定される内部が第一の容器よりも減圧された第二の 容器とを有し、外筒内を第一の容器が下方に移動することにより、第一の 栓を中空針の上端が貫通するとともに、第二の栓を中空針の下端が貫 通して、第一の容器内と第二の容器内が連通し、第一の容器内の内容 物を第二の容器内に外部への実質的な放射線の漏洩なしに安全かつ 確実に移動させることができるように構成されたことを特徴とする。ここで、 実質的にというのは、放射線取扱いの基準から見て、漏洩が問題のない レベルであるという意味である。 第一の容器及び第二の容器の材質は、収容する流体を透過せず、 内 部の流体に対し化学的に不活性でなくてはならない。 いずれの容器も透 明または半透明であることが好ましい。 In order to achieve the above object, the radioactive substance handling device of the present invention is configured such that an opening is sealed with an outer cylinder and a first stopper through which a hollow needle can easily penetrate, and the opening is downwardly slidable into the outer cylinder. A first container inserted, a needle member provided with a hollow needle with both ends sharpened to move axially inside the outer cylinder, and an opening sealed with a second plug through which the hollow needle can easily penetrate upward. The inside of the outer cylinder, which is inserted into and fixed to the lower end of the outer cylinder, has a second container whose pressure is lower than that of the first container. The first stopper penetrates the upper end of the hollow needle and the second stopper penetrates the lower end of the hollow needle, so that the inside of the first container and the second container communicate with each other, and the contents in the first container. Can be safely and reliably moved into the second container without substantial radiation leakage to the outside It is characterized by having been done. Here, “substantially” means that there is no problem in terms of leakage from the viewpoint of radiation handling standards. The material of the first container and the second container must be impermeable to the contained fluid and must be chemically inert to the internal fluid. Both containers are preferably transparent or translucent.
外筒の材質は、透明または半透明であることが好ましレ、。取扱う流体が 比較的高エネルギーのべ一タ線を放射する放射性物質である場合には、 制動放射線の発生を防止するため、原子番号の比較的低い、例えば 1 0 以下の物質を用いることが好ましい。流体がガンマ線または X線を放射す る放射性物質である場合には、原子番号の比較的高い、例えば、 2 2以 上の物質を用いることが好ましい。  The material of the outer cylinder is preferably transparent or translucent. When the fluid to be handled is a radioactive substance that emits a relatively high-energy solid ray, it is preferable to use a substance with a relatively low atomic number, for example, 10 or less, to prevent the generation of bremsstrahlung. . When the fluid is a radioactive substance that emits gamma rays or X-rays, it is preferable to use a substance having a relatively high atomic number, for example, 22 or more.
第一の栓及び第二の栓は、 中空針により貫通できるような柔らかい材 料、例えば、天然又は合成ゴムで構成される。 いずれの栓も、貫通された 場合以外は収容する流体を透過してはならない。  The first and second stoppers are made of a soft material that can be penetrated by a hollow needle, for example, natural or synthetic rubber. None of the stoppers shall be permeable to the contained fluid unless penetrated.
外筒内を第一の容器が移動して、 中空針の上端が第一の容器の栓を 貫通するときに、 同時に中空針の下端が第二の容器の栓に貫通するた めには、 中空針が柱状部材を貫通して固定された針部材が外筒内面に 沿って外筒の軸方向に滑動できるようにしておくのが好ましい。このように 構成することにより、 中空針は常に外筒を移動することができる。 中空針 の材質は、少なくとも通過する流体に対して化学的に不活性であることが 好ましい。  In order for the lower end of the hollow needle to penetrate the stopper of the second container while the upper end of the hollow needle penetrates the stopper of the first container while the first container moves in the outer cylinder, It is preferable that the needle member having the hollow needle penetrating through the columnar member be slidable in the axial direction of the outer cylinder along the inner surface of the outer cylinder. With this configuration, the hollow needle can always move the outer cylinder. The material of the hollow needle is preferably chemically inert to at least the passing fluid.
本発明の物質取扱装置は、液体、気体、 いずれの場合にも使用でき るが、特に液体の取扱いに適する。 当初流体が収容される第一の容器 内、 中空針の内面、流体が移動される第二の容器内以外は、放射性物 質を含む流体が接触しないので、流体の移動に伴う放射線等による外 部汚染は生じない。外筒に放射線遮蔽材を用いれば、作業者の放射線 ひばくも防げる。 第一の容器の下方への移動は機械的手段によって直接行ってもよい が、外筒の外から間接的に行うこともできる。例えば、外筒内に滑動可能 な磁性部材を挿入し、外筒に沿つて移動可能な磁石を外筒の外側に設 け、この磁石を外筒に沿って移動させることにより、磁性部材が第一の容 器を押しながら外筒内を移動して、第一の容器が外筒内を移動するよう 第一の容器の栓を中空針の上端が貫通する前に、 中空針の下端が 第二の栓を貫通しないように、 中空針の下端を一時制止する制止部材を 針部材と第二の容器との間に設けてもよい。例えば、外筒内の中空針の 下端を一時制止したい位置に、必要に応じて破断できる紙等の部材を 挿入固定する。また、針部材を制止してもよい。 The substance handling apparatus of the present invention can be used for both liquid and gas, but is particularly suitable for handling liquid. Initially, the fluid containing radioactive material does not come into contact with the inside of the first container in which the fluid is stored, the inner surface of the hollow needle, and the second container in which the fluid is moved. No local contamination occurs. If radiation shielding material is used for the outer cylinder, radiation exposure of workers can be prevented. The downward movement of the first container may be performed directly by mechanical means, or may be performed indirectly from outside the outer cylinder. For example, a slidable magnetic member is inserted into the outer cylinder, a magnet movable along the outer cylinder is provided outside the outer cylinder, and the magnet is moved along the outer cylinder, so that the magnetic member becomes While pressing the first container and moving in the outer cylinder, before the upper end of the hollow needle penetrates the stopper of the first container so that the first container moves in the outer cylinder, the lower end of the hollow needle is A restricting member for temporarily restricting the lower end of the hollow needle may be provided between the needle member and the second container so as not to penetrate the second stopper. For example, a member such as paper, which can be broken if necessary, is inserted and fixed at a position where the lower end of the hollow needle in the outer cylinder is to be temporarily stopped. Further, the needle member may be stopped.
更に、 1本の外筒内に第一の容器と第二の容器とを収納すると第二の 容器の取扱いが困難になるので、外筒内の第二容器の取扱いを容易に するために、外筒を第一の容器収納部と第二の容器収納部とに分割し、 第一の容器収納部又は第二の容器収納部の回転又は移動により、 第 二の容器の上部を開放可能とすることができる。  Furthermore, if the first container and the second container are stored in one outer cylinder, it becomes difficult to handle the second container.To facilitate the handling of the second container in the outer cylinder, The outer cylinder is divided into a first container storage part and a second container storage part, and the upper part of the second container can be opened by rotating or moving the first container storage part or the second container storage part. can do.
分割した外筒の相互の移動又は回転は、第一の容器収納部を固定 し第二の容器収納部を電動機構等により回転又は移動すること、又は、 第二の容器収納部を固定し第一の容器収納部を電動機構により回転 又は移動することができる。  The mutual movement or rotation of the divided outer cylinders can be performed by rotating or moving the second container housing by an electric mechanism or the like while fixing the first container housing or by fixing the second container housing to the second container housing. One container storage section can be rotated or moved by an electric mechanism.
第二の容器には、その内底部近傍に達するように中空管を挿入する。 この挿入した中空管は、第二の容器内の内容物を容器の外に取り出す 役割を担う。 中空管の先には、 中空のチューブが接続され、チューブの先 端はカテーテルに接続される。  A hollow tube is inserted into the second container so as to reach near the inner bottom. The inserted hollow tube plays a role of taking out the contents in the second container out of the container. A hollow tube is connected to the end of the hollow tube, and the end of the tube is connected to a catheter.
第二の容器内で、放射性の薬液を調製する。 調製された薬液は、 第 二の容器に挿入された中空管を経て、カテーテルを通して人体に投与さ れる。 この際、 中空管とカテーテルとの間に薬液供給ポンプ及びフィルタ 一を設ける。 In a second container, a radiopharmaceutical solution is prepared. The prepared drug solution is It is administered to the human body through a catheter via a hollow tube inserted in the second container. At this time, a chemical supply pump and a filter are provided between the hollow tube and the catheter.
このフィルターには、イオン交換樹脂及び活性炭を充填剤とするカラム 及びミリポアフィルタ一を使用する。そして、薬液中の、例えばイットリウム 9 0を使用する場合には、イットリウム単体、 ジルコニウムをイオン交換樹脂 で除去し、活性炭で未反応の蛋白抗体を除去し、活性炭やその他微粒 子物をミリポアフィルタ一で除去する。 図面の簡単な説明  For this filter, a column using an ion exchange resin and activated carbon as a filler and a Millipore filter are used. When yttrium 90, for example, in a chemical solution is used, simple yttrium and zirconium are removed with an ion exchange resin, unreacted protein antibodies are removed with activated carbon, and activated carbon and other fine particles are removed using a millipore filter. To remove. BRIEF DESCRIPTION OF THE FIGURES
第 1図は、本発明による放射性物質等の取扱装置を示す図である。 第 2図は、第 1図で示す装置に使用する治具を示す。  FIG. 1 is a view showing an apparatus for handling radioactive substances and the like according to the present invention. FIG. 2 shows a jig used for the apparatus shown in FIG.
第 3図は、本発明による放射性物質等の他の取扱装置を示す図であ る。  FIG. 3 is a view showing another handling device for a radioactive substance or the like according to the present invention.
第 4図は、 第一の容器収納部を回転移動させ第二容器収納部が開 放された状態を示す図である。  FIG. 4 is a view showing a state in which the first container storage section is rotationally moved to open the second container storage section.
第 5図は第一の容器収納部と第二の容器収納部を相互に移動させる 状態を示す図である。  FIG. 5 is a diagram showing a state in which the first container storage section and the second container storage section are mutually moved.
第 6図は、第二の容器収納部の上部の状態を示す図である。  FIG. 6 is a diagram showing a state of an upper part of the second container storage part.
第 7図は、本発明の装置を使用して薬液を患者に投与する状態を示 す図である。 発明を実施するための最良の形態  FIG. 7 is a diagram showing a state in which a drug solution is administered to a patient using the device of the present invention. BEST MODE FOR CARRYING OUT THE INVENTION
以下に、 本発明の実施形態を説明する。 第 1図は本発明の装置の例 を示す。 装置の主体は、外筒 1、外筒 1に倒立して挿入される第一の容 器 2、外简 1の中間部に設けた隔離膜 5a、 中空針 3で上下方向に貫か れた針部材 4、 外筒 1の下端 lbに挿入される第二の容器 6で構成され る。 Hereinafter, embodiments of the present invention will be described. FIG. 1 shows an example of the apparatus of the present invention. The main body of the device is the outer cylinder 1, the first container to be inserted upside down into the outer cylinder 1. It comprises a vessel 2, an isolation membrane 5a provided at an intermediate portion of the outer casing 1, a needle member 4 vertically penetrated by a hollow needle 3, and a second container 6 inserted into a lower end lb of the outer casing 1.
放射性物質等の液体を収容した第一の容器 2は、 中空針 3で容易に 貫通できるゴム栓 2aで密栓された開口を下向きに、倒立して外筒 1に挿 入される。 第一の容器 2は、 当初、底 2bが外筒 1の上端 laより若千奥に 入った位置に置かれる。 第一の容器 2の底 2bと外筒 1の上端 laの間に、 鉄芯 7が挿入されている。 鉄芯 7の内部には、錘として鉛が封入されてい る。外筒 1の上端 laの開口部にはろ紙 11が接着され、ろ紙 11にはさらに 鉄芯 7の上端が接着されている(ただし、後に鉄芯 7はろ紙 11から離され る)。外筒 1の上端 la付近には、磁極が外筒 1をはさむように、永久磁石 8が設けられ、 当初はこの位置に一時的に固定されている。  The first container 2 containing a liquid such as a radioactive substance is inserted into the outer cylinder 1 with the opening sealed with a rubber stopper 2a which can be easily penetrated by the hollow needle 3 facing downward, facing downward. Initially, the first container 2 is placed at a position where the bottom 2b is located a little further behind the upper end la of the outer cylinder 1. An iron core 7 is inserted between the bottom 2b of the first container 2 and the upper end la of the outer cylinder 1. Lead is enclosed as a weight inside the iron core 7. The filter paper 11 is bonded to the opening at the upper end la of the outer cylinder 1, and the upper end of the iron core 7 is further bonded to the filter paper 11 (however, the iron core 7 is separated from the filter paper 11 later). A permanent magnet 8 is provided near the upper end la of the outer cylinder 1 so that the magnetic pole sandwiches the outer cylinder 1, and is temporarily fixed at this position at first.
外筒 1の中間部には、 電磁石 9と必要に応じ上下に移動可能な制動 部材 10が設けられている。 電磁石 9から第一の容器 2の長さに中空針 3 の長さを加えた距離にほぼ等しい距離だけ低い位置の外筒 1の壁の対向 する位置に、一対のスリット 5が設けられている。スリット 5には、 中空針 3で 容易に貫通できる適当な厚さのろ紙等からなる隔離膜 5aが外筒 1の外か ら揷入されている。 両端が尖った中空針 3を上下方向に貫通して形成さ れた針部材 4が、隔離膜 5aの直上の外筒 1内に、 中空針 3が外筒 1の軸 方向に平行になるように直立した状態で置かれている。この針部材 4は外 筒 1の軸方向に、直立状態のまま移動可能で、 当初は針の下端 3bが隔 離膜 5aに接して静止している。  An electromagnet 9 and a braking member 10 that can be moved up and down as necessary are provided in an intermediate portion of the outer cylinder 1. A pair of slits 5 are provided at opposing positions on the wall of the outer cylinder 1 at a position substantially lower than the distance from the electromagnet 9 to the length of the first container 2 plus the length of the hollow needle 3. . Into the slit 5, an isolation membrane 5 a made of filter paper or the like having an appropriate thickness and easily penetrated by the hollow needle 3 is inserted from the outside of the outer cylinder 1. A needle member 4 formed by vertically penetrating a hollow needle 3 having both sharpened ends so that the hollow needle 3 is parallel to the axial direction of the outer cylinder 1 in the outer cylinder 1 immediately above the separator 5a. It is placed upright. The needle member 4 is movable in the axial direction of the outer cylinder 1 in an upright state, and initially, the lower end 3b of the needle is in contact with the separation membrane 5a and is stationary.
外筒 1の下端 lbの開口部には、第二の容器 6の栓 6aが挿入され、 両 者は気密に密着される。栓 6aが外筒 1に挿入されたとき、電磁石 9から所 定の距離に位置するように、外筒 1の内側にストッパー 13が設けられてい る。この所定の距離については、後に操作の説明の項で述べる。外筒 1の 下端 lbも、栓 6aを挿入する前は上端 laと同様、筒内を保護するために ろ紙 12 (点線で示した)で密閉されている。 The stopper 6a of the second container 6 is inserted into the opening of the lower end lb of the outer cylinder 1, so that both are airtightly adhered. A stopper 13 is provided inside the outer cylinder 1 so that the stopper 6a is located at a predetermined distance from the electromagnet 9 when the stopper 6a is inserted into the outer cylinder 1. You. This predetermined distance will be described later in the description of the operation. Before inserting the plug 6a, the lower end lb of the outer cylinder 1 is also sealed with the filter paper 12 (indicated by the dotted line) to protect the inside of the cylinder, like the upper end la.
第二の容器 6には、輸送中にそれを保護するためのスリーブ 14を付設 してもよく、第二の容器 6を外筒 1の下端 lbに挿入すると、スリーブ 14の 上部も外筒 1の下端 lbの外側に挿入される。  The second container 6 may be provided with a sleeve 14 to protect it during transportation, and when the second container 6 is inserted into the lower end lb of the outer cylinder 1, the upper part of the sleeve 14 also becomes Is inserted outside the lower end of the lb.
第二の容器 6の底は、機械振動を与える震とう器 15の振動部分に密 着している。装置全体は支柱 16により固定されている。  The bottom of the second container 6 is in close contact with the vibrating part of the shaker 15 that provides mechanical vibration. The whole device is fixed by a support 16.
次に、本発明の他の実施形態を説明する。第 3図に本発明の実施形 態の他の例を示す。装置の主体は、その上部が第一の容器収納部 51、 下部が第二の容器収納部 50に二分割された外筒 31、倒立して第一の 容器収納部 51に挿入される第一の容器 32、 第二の容器収納部 50に 揷入された第二の容器 36、第一の容器収納部 51と第二の容器収納部 50との境目 35に挿入保持された隔離膜 35a及び中空針 33で柱状部材 を上下方向に貫かれて形成された針部材 34で構成される。  Next, another embodiment of the present invention will be described. FIG. 3 shows another embodiment of the present invention. The main body of the device is an outer cylinder 31 whose upper part is divided into a first container storage part 51 and a lower part is divided into a second container storage part 50, and the first part which is inverted and inserted into the first container storage part 51. Container 32, the second container 36 inserted into the second container storage unit 50, the separator 35a inserted and held at the boundary 35 between the first container storage unit 51 and the second container storage unit 50, and A hollow needle 33 is formed by a needle member 34 formed by vertically penetrating a columnar member.
放射性物質の液体を収容した第一の容器 32は、針で容易に貫通で きるゴム栓 32aで密栓された開口を下向きに、倒立して第一の容器収納 部 51に揷入される。 第一の容器 32は、 当初、底 32bが外筒 31の上端 3 laより若干奥に入った位置に置かれる。第一の容器 32の底 32bと外筒 3 1の上端 31aの間に、鉄芯 37が挿入されている。鉄芯 37の内部には、錘 として鉛が封入されている。外筒 31の上端 31aの開口部にはろ紙 41が 接着され、ろ紙 41にはさらに鉄芯 37の上端が接着されている。外筒 31の 上端 3 la付近には、磁極が外筒 31をはさむように、 永久磁石 38が設けら れ、 当初はこの位置に一時的に固定されている。  The first container 32 containing the liquid of the radioactive substance is inverted and inserted into the first container storage part 51 with the opening sealed with a rubber stopper 32a that can be easily penetrated by a needle facing downward. The first container 32 is initially placed at a position where the bottom 32b is slightly deeper than the upper end 3 la of the outer cylinder 31. An iron core 37 is inserted between the bottom 32b of the first container 32 and the upper end 31a of the outer cylinder 31. Lead is enclosed as a weight inside the iron core 37. A filter paper 41 is adhered to the opening of the upper end 31a of the outer cylinder 31, and an upper end of the iron core 37 is further adhered to the filter paper 41. Near the upper end 3 la of the outer cylinder 31, a permanent magnet 38 is provided so that the magnetic pole sandwiches the outer cylinder 31, and is initially temporarily fixed at this position.
外筒 31の中間部には、電磁石 39と必要に応じ上下に移動可能な制 動部材 40が設けられている。第一の容器収納部 51と第二の容器収納 部 50との境目 35には適当な厚さの針で容易に貫通できるろ紙等の隔離 膜 35aが挿入されている。 両端が尖った中空針 33が柱状部材を上下方 向に貫通した針部材 34が、 隔離膜 35aの直上の外筒 31内に直立した 状態で置かれている。この針部材 34は外筒 31の軸方向に、 直立状態の まま移動可能で、 当初は中空針 33の下端 33bが隔離膜 35aに接して静 止している。 An electromagnet 39 and a control that can be moved up and down as necessary A moving member 40 is provided. At a boundary 35 between the first container storage section 51 and the second container storage section 50, an isolation membrane 35a such as filter paper that can be easily penetrated with a needle having an appropriate thickness is inserted. A needle member 34 having a hollow needle 33 having both sharp ends penetrating the columnar member upward and downward is placed upright in the outer cylinder 31 immediately above the separator 35a. The needle member 34 is movable in the axial direction of the outer cylinder 31 while being in an upright state. Initially, the lower end 33b of the hollow needle 33 is in contact with the separator 35a and is stationary.
外筒 31の下部第二の容器収納部 50の下端 3 lbの開口部には、第二 の容器 36の栓 36aが挿入され、 両者は気密に密着される。 栓 36aが第 二の容器収納部 50に挿入されたとき、電磁石 39から所定の距離に位置 するように、外筒 31の内側にストッパー 43が設けられている。第二の容器 収納部 50の下端 31bも、栓 36aを挿入する前は上端 3 laと同様、筒内 を保護するためにろ紙 42 (点線で示した)で密閉されている。  The stopper 36a of the second container 36 is inserted into an opening of 3 lb at the lower end of the lower second container housing portion 50 of the outer cylinder 31, and both are airtightly adhered. A stopper 43 is provided inside the outer cylinder 31 so that the stopper 36a is located at a predetermined distance from the electromagnet 39 when the stopper 36a is inserted into the second container storage part 50. Before inserting the stopper 36a, the lower end 31b of the second container storage section 50 is also sealed with a filter paper 42 (indicated by a dotted line) to protect the inside of the cylinder, similarly to the upper end 3la.
第二の容器 36には、輸送中にそれを保護するためのスリーブ 44を付 設してもよく、 第二の容器 36を第二の容器収納部 50の下端 31bに挿入 すると、スリーブ 44の上部も第二容器収納部 50の下端 31bの外側に挿 入される。  The second container 36 may be provided with a sleeve 44 for protecting it during transportation, and when the second container 36 is inserted into the lower end 31b of the second container storage 50, the sleeve 44 The upper part is also inserted outside the lower end 31b of the second container storage part 50.
第二の容器 36の底は、機械的攪拌を与えるため震とう器 45の振動部 分に密着している。震とう器の代わりにマグネティック ·スターラー等の攪拌 機を使用することもできる。装置全体は支柱 46により固定されている。  The bottom of the second container 36 is in close contact with the vibrating part of the shaker 45 to provide mechanical stirring. A stirrer such as a magnetic stirrer can be used instead of the shaker. The whole device is fixed by a column 46.
本実施形態は、先に説明した第 1図の実施形態とは、 基本的には、外 筒 31が、第一の容器収納部 51と第二の容器収納部 50とに分割されて いる点で異なる。その他の部分は、概ね先に述べた図 1の実施形態と同 様な構造をとつている。外筒 31を 2分割することにより、第一の容器 32が 収納される部分と第二の容器 36が収納される部分とに分けられるので、 第二容器 36で調製された放射性薬液を人体に投与する際の操作が飛 躍的に向上する効果を奏する。 This embodiment is different from the embodiment of FIG. 1 described above in that the outer cylinder 31 is basically divided into a first container storage 51 and a second container storage 50. Different. Other portions have a structure substantially similar to that of the embodiment of FIG. 1 described above. By dividing the outer cylinder 31 into two parts, the outer cylinder 31 is divided into a part in which the first container 32 is stored and a part in which the second container 36 is stored. The operation of administering the radiopharmaceutical liquid prepared in the second container 36 to the human body is significantly improved.
第一の容器収納部 51は支柱 46に回転支持具 49で保持され、第二 の容器収納部 50は支持具 48で支柱 46に保持されている。 第一の容器 収納部 51は、回転支持具 49により支柱 46の回りを回転する。第一の容 器収納部 51を例えば 90度回転させると、第二の容器収納部 50に挿入 された第二の容器 36の上部が開放される。  The first container storage section 51 is held on a support column 46 with a rotary support 49, and the second container storage section 50 is supported on a support column 48 with a support column 48. The first container storage part 51 is rotated around the column 46 by the rotation support 49. When the first container storage 51 is rotated, for example, 90 degrees, the upper part of the second container 36 inserted in the second container storage 50 is opened.
上記の実施形態では、第一容器の収納部 51が支柱 46の回りに回転 させたが、第二の容器収納部 50を回転移動させてもよい。 また、 第一の 容器収納部 51又は第二の容器収納部 50のいずれかを左右に移動させ てもよい。第二の容器収納部上部が筒内から開放されればよいのである。 例えば、第 5図のように、第一の容器収納部 51と第二の容器収納部 50 とを蝶番 66で接続し、相互に回転できるようにすることもできる。この場合. 蝶番 66に設けた 1本のシャフト(軸棒)によって回転させるようになつてい る。  In the above embodiment, the storage portion 51 of the first container is rotated around the column 46, but the second container storage portion 50 may be rotated. Further, either the first container storage section 51 or the second container storage section 50 may be moved right and left. It is only necessary that the upper part of the second container storage part is opened from the inside of the cylinder. For example, as shown in FIG. 5, the first container storage section 51 and the second container storage section 50 can be connected by a hinge 66 so that they can rotate with each other. In this case, rotation is performed by one shaft (shaft) provided on hinge 66.
第一の容器 32内に入っているイットリウム 90は、 中空針 33を経由して 第二の容器 36内に移送され、 ここでモノクロナル抗体と反応させる。 この ようにして第二の容器 36で調製した薬液は、 人体に投与される。 この薬 液を人体に投与するために、 第二の容器 36に中空管 61が容器 36の底 まで挿入される。 中空管 61にチューブ 62が接続される。 第一の容器収納 部 51を回転移動させると、第二の容器 36の上部が筒 31から開放される ので、 中空管 61の挿入及び中空管 61とチューブ 62との接続が手際よく 簡単にかつ迅速に行うことができる。この状況を、第 4図に示した。  The yttrium 90 contained in the first container 32 is transferred via the hollow needle 33 into the second container 36, where it reacts with the monoclonal antibody. The drug solution thus prepared in the second container 36 is administered to a human body. In order to administer this drug solution to the human body, a hollow tube 61 is inserted into the second container 36 to the bottom of the container 36. The tube 62 is connected to the hollow tube 61. When the first container storage part 51 is rotated, the upper part of the second container 36 is opened from the cylinder 31, so that the insertion of the hollow tube 61 and the connection between the hollow tube 61 and the tube 62 are simple and easy. And quickly. This situation is shown in Figure 4.
チューブ 62はイオン交換樹脂及び活性炭を充填したカラム 63及びミリ ポアフィルター 64を経てへリスターポンプ 65に接続され、最終的には人体 に投与される。この状況を第 7図に示した。 [操作(その 1) ] The tube 62 is connected to a Helister pump 65 via a column 63 filled with ion exchange resin and activated carbon and a Millipore filter 64, and finally to a human body. Is administered. This situation is shown in FIG. [Operation (Part 1)]
外筒 1のスリット 5に隔離膜 5aを挿入し、外筒 1に針部材 4、制動部材 10、 第一の容器 2、鉄芯 7を順に揷入する。針部材 4は、 中空針 3の下 端 3bが隔離膜 5aに接するまで降下して静止する。 鉄芯 7を挿入すると第 一の容器 2は、下端が制動部材 10に接し、 上端(底 2b)に鉄芯 7が接し た状態で、外筒 1内を移動し、鉄芯 7の上端が外筒 1の上端 laに一致し た状態で停止する。この両者にろ紙 11を接着して、外筒 1の上端 laを封 じる。外筒 1の下端 lbも、ろ紙 12で密封する。  The isolation membrane 5a is inserted into the slit 5 of the outer cylinder 1, and the needle member 4, the braking member 10, the first container 2, and the iron core 7 are inserted into the outer cylinder 1 in this order. The needle member 4 descends and stops until the lower end 3b of the hollow needle 3 contacts the separator 5a. When the iron core 7 is inserted, the first container 2 moves in the outer cylinder 1 with the lower end in contact with the braking member 10 and the upper end (bottom 2b) in contact with the iron core 7, and the upper end of the iron core 7 Stops when it matches the upper end la of the outer cylinder 1. The filter paper 11 is adhered to both of them, and the upper end la of the outer cylinder 1 is sealed. The lower end lb of the outer cylinder 1 is also sealed with the filter paper 12.
この状態で、第一の容器 2内に多量の放射性物質が存在しても漏洩 のおそれなしに装置全体を輸送することができる。輸送の際には、もちろ ん、外筒 1の外側に放射線量に応じた遮蔽を施す。  In this state, even if a large amount of radioactive substance exists in the first container 2, the entire apparatus can be transported without fear of leakage. At the time of transportation, of course, shield the outside of the outer cylinder 1 according to the radiation dose.
第一の容器 2内の放射性物質を第二の容器 6内に移送するには、下 記の操作を行う。 まず、外筒 1の下端 lbを封じているろ紙 12を取り除き、 下端 lbの開口部に第二の容器 6の栓 6aの上部をストッパー 13の所まで 挿入する。  To transfer the radioactive substance in the first container 2 into the second container 6, the following operation is performed. First, the filter paper 12 sealing the lower end lb of the outer cylinder 1 is removed, and the upper part of the stopper 6 a of the second container 6 is inserted into the opening of the lower end lb to the stopper 13.
電磁石 9に電流を通じ、作動状態にする。つまみ部 22とつば 23を有す る棒から成る治具 21 (第 2図)を用いて、外筒 1の上端 laのろ紙 11を破り, 鉄芯 7を下方へすこし押し下げる。永久磁石 8を、外筒 1の上端 la付近 から外筒 1の外側に沿って下方へ移動させると、外筒 1内の鉄芯 7が第 一の容器 2を押しながら下方へ移動する。第一の容器 2の移動の際、制 動部材 10は下端 2bに押されながら移動し、第一の容器 2の移動を妨げ ない。 鉄芯 7は、 電磁石 9に接近すると電磁石 9に吸引されて停止する。 このとき、針部材 4を貫いた中空針 3の下端 3bは、隔離膜 5aを突き破り、 さらに第二の容器 6の上端の栓 6aに突き刺さって、これを貫通し、 同時に 中空針 3の上端 3aはゴム栓 2aに突き刺さり貫通する。 こうして、 中空針 3 はゴム拴 2aを貫通して流体が収容された第一の容器 2に、かつ、栓 6aを 貫通して減圧された第二の容器 6に、それぞれ通ずるので、 当初第一の 容器 2内にあった流体は第二の容器 6との圧力差により移送される。 An electric current is passed through the electromagnet 9 to activate the electromagnet. Using a jig 21 (FIG. 2) composed of a bar having a knob 22 and a collar 23, the filter paper 11 at the upper end la of the outer cylinder 1 is broken, and the iron core 7 is pushed down slightly. When the permanent magnet 8 is moved downward from the vicinity of the upper end la of the outer cylinder 1 along the outside of the outer cylinder 1, the iron core 7 in the outer cylinder 1 moves downward while pressing the first container 2. When the first container 2 moves, the damping member 10 moves while being pushed by the lower end 2b, and does not hinder the movement of the first container 2. When the iron core 7 approaches the electromagnet 9, it is attracted to the electromagnet 9 and stops. At this time, the lower end 3b of the hollow needle 3 penetrating the needle member 4 breaks through the separation membrane 5a, Further, the upper end 3a of the hollow needle 3 pierces and penetrates the rubber stopper 2a by piercing and penetrating the stopper 6a at the upper end of the second container 6. Thus, the hollow needle 3 passes through the rubber 2a to the first container 2 containing the fluid and the stopper 6a to the second container 6 that is depressurized. The fluid in the second container 6 is transferred by the pressure difference with the second container 6.
外筒 1の下端 lb近くに設けるストッパー 13の位置は、鉄芯 7が電磁石 9に吸引されて停止したとき、 中空針 3の下端 3bが第二の容器 6の上端 の栓 6 aを貫通するような位置とする。第二の容器 6に移送された流体は、 震とう器 15の振動により攪拌され、 均一化される。 流体を受け入れた第 二の容器 6は、栓 6aから外して、外筒 1の下端 lbから離す。  The position of the stopper 13 provided near the lower end lb of the outer cylinder 1 is such that when the iron core 7 is attracted to the electromagnet 9 and stops, the lower end 3b of the hollow needle 3 passes through the stopper 6a at the upper end of the second container 6. Position. The fluid transferred to the second container 6 is stirred and homogenized by the vibration of the shaker 15. The second container 6 that has received the fluid is detached from the stopper 6a and separated from the lower end lb of the outer cylinder 1.
[操作(その 2) ] [Operation (Part 2)]
無菌処理した無担体精製塩化イットリウム 90の 60mCi( 2. 22 X 10一3 GBg)にキレート化剤 EDTAの水溶液を加え、純水で希釈し塩化イツトリ ゥム 90の量を 20mCi(2. 22 X 10— 3GBg)とし第一の容器 32に封入した c この場合の pHは 2. 0であった。 An aqueous solution of chelating agent EDTA was added to 60mCi carrier-free purified yttrium chloride 90 was sterilized (2. 22 X 10 one 3 GBG), diluted with pure water the amount of chloride Itsutori © beam 90 20mCi (2. 22 X 10- 3 GBG) and then pH when the c this sealed the first container 32 2. was 0.
塩化イットリウムを封入した第一の容器 32は、放射性医薬品の取扱装 置の放射線遮蔽外筒 31内の上端に内填され、永久磁石 38で固定され る。外筒 31は、 内側から順に塩化ビニール(厚さ 10mm)管、 ステンレス 管(厚さ lmm)及び鉛管(厚さ 10mm)による三重管からなるものである。 この場合、第一の容器 32に封入されたイットリウム 90の放射線量は、外 筒 31から lmの遠隔距離での作業者立入りで、 7時間 Z日 の作業が支 障無く可能であった。  The first container 32 enclosing yttrium chloride is inserted into the upper end of the radiation shielding outer cylinder 31 of the radiopharmaceutical handling device, and is fixed by the permanent magnet 38. The outer cylinder 31 is composed of a triple pipe consisting of a vinyl chloride pipe (thickness 10 mm), a stainless steel pipe (thickness lmm), and a lead pipe (thickness 10 mm). In this case, the radiation dose of yttrium 90 enclosed in the first container 32 was able to enter the worker at a remote distance of lm from the outer cylinder 31 and work for 7 hours and Z days was possible without any problem.
次に、予め上記外筒 31の下部、 第二容器収納部 52に密封された第 二の容器 36が密封栓 36aを上方に向けて取り付けられた。 第二の容器 3 6内には血液系の腫瘍に対するモノクロナル抗体蛋白力; 10〜20mg相当 量が内填されている。この抗体としては、その物理化学的性質から、 CD2 0マウス抗体の構造末端にチォゥレアを結合させ、さらに DTP A (ダイェチ レントリアミンペンタァセティックァシド)が結合した IDEC社の Y2B8等が 適していた。 また、試 DTPAの lmgでこれに代替することも可能である。 D TPAは、反応物を pH4. 0〜7. 0付近に調整することにより、 単体のイット リウム 90イオンの容器壁への吸着を防止する。 Next, the second container 36 previously sealed in the lower part of the outer cylinder 31 and the second container storage part 52 was attached with the sealing stopper 36a facing upward. Second container 3 6 contains a monoclonal antibody protein activity against tumors of the blood system; equivalent to 10 to 20 mg. Due to its physicochemical properties, IDEC's Y2B8 or the like, in which thioprea is bound to the structural end of the CD20 mouse antibody and DTPA (diethylenetriaminepentaacetic acid) is further bound, is suitable as this antibody. Was. Alternatively, lmg of test DTPA can be used instead. DTPA prevents the adsorption of single yttrium 90 ions onto the vessel wall by adjusting the reaction to around pH 4.0-7.0.
放射線遮蔽用外筒 31は、第一容器収納部 51と第二の容器収納部 50とに分割されている。第一容器収納部 51と第二の容器収納部 50とは. 相互の回転又は移動により第二の容器 36の上部が開放される。 常時は. 第一の容器収納部 51と第二の容器収納部 50とは 1本に連なっている。 この両円筒の接続面に、隔離膜 35a (材質は濾紙様、ミリボアなどの合成 繊維)が設けられる。 この隔離膜の中央付近に両尖端の中空針の針部 材が置かれる。 また、外筒 3の上端ならびに下端も同様の薄いフィルタ一 膜を密着貼付することで無菌を保つように工夫されている。  The radiation shielding outer cylinder 31 is divided into a first container storage part 51 and a second container storage part 50. The upper part of the second container 36 is opened by the mutual rotation or movement of the first container storage part 51 and the second container storage part 50. Normally. The first container storage unit 51 and the second container storage unit 50 are continuous. An isolation membrane 35a (synthetic fiber such as filter paper, millibore, etc.) is provided on the connecting surface of the two cylinders. The needle members of the hollow needles at both ends are placed near the center of the separator. Also, the upper and lower ends of the outer cylinder 3 are designed so as to maintain sterility by closely attaching a similar thin filter film.
外筒 31は横倒しにされて、外装箱(バイオリンの外ケース状)に装填固 定される。そして、外装箱ごと、使用先に出荷される。この場合の箱外の 漏洩線量は、 0. 01マイクロシーベルト以下に規定され、一般 A型輸送の 規定内であった。  The outer cylinder 31 is turned over and loaded and fixed in an outer box (an outer case of a violin). Then, the entire outer box is shipped to the place of use. The leakage dose outside the box in this case was specified below 0.01 microsievert and was within the provisions for general type A transport.
イットリウム 90—抗マウス CD20抗体は、非ホジキンス病患者のうち癌ミ ザイル療法を必要とする患者に体重当たり適切と判断される ]3放射線の 体内治療用ひばく線量(通常 0. 4mCi(l. 48GBg)/Kg体重)が投与 される。  Yttrium 90—anti-mouse CD20 antibody is considered appropriate for non-Hodgkin's disease patients who require cancer missile therapy.] 3 Radiation dose for internal treatment (typically 0.4 mCi (l. 48 GBg ) / Kg body weight) is administered.
放射線治療室内で、外装箱から治療用イットリウム 90が装填された容 器を含む器具一式を取り出し、支柱 46にセット固定される。 この間の作 業による作業者の外部ひばくは 0. 05マイクロシーベルト Z時間で作業に 要する時間は 5分未満である。器具固定後、遠隔操作に必要な電気的 接続が行われる(電気的接続は図示していない)。 In the radiation therapy room, a set of instruments including a container loaded with therapeutic yttrium 90 is taken out of the outer box and fixed to the column 46. Work during this time The external exposure of workers by the industry is 0.05 microsievert Z. The time required for the work is less than 5 minutes. After the instrument is secured, the electrical connections required for remote operation are made (electrical connections are not shown).
イットリウム 90単体液は第一の容器 32から Y2B8— CD20モノクロナル 抗体を有する第二の容器 36への転送は、 自動的に行われる。  The transfer of yttrium 90 alone from the first container 32 to the second container 36 with the Y2B8-CD20 monoclonal antibody is automatic.
電磁石 39に電流を通じ、作動状態にする。鉄芯 37を下方へすこし押 し下げる。永久磁石 38を、外筒 31の上端 31a付近から外筒 31の外側に 沿って下方へ移動させると、外筒 31内の鉄芯 37が第一の容器 32を押し ながら下方へ移動する。 第一の容器 32の移動の際、制動部材 40は下 端 32bに押されながら移動する。鉄芯 37は、電磁石 39に接近すると電磁 石 39に吸引されて停止する。 このとき、針部材 34を貫いた中空針 33の 下端 33bは、隔離膜 35aを突き破り、 さらに第二の容器 36の上端の栓 3 6aに突き刺さって、これを貫通し、 同時に中空針 33の上端 33aはゴム栓 32aに突き刺さり貫通する。こうして、 中空針 33はゴム栓 32aを貫通してィ ットリウム 90が充填された第一の容器 32に、そして、栓 36aを貫通して減 圧された第二の容器 36に、それぞれ通ずるので、 当初第一の容器 32内 にあった塩化イットリウム 90は第二の容器 36に圧力差により移送される。 塩化イットリウム 90単体液が第二の容器 36内に完全に移動した後、 マグネティック.スターラー 45を作動させる。 第二の容器 36の外側は、冷 却水の満たされたスリーブ 44 (底部中央が第二の容器底部と密着できる 形状となっている)と共にイットリウム 90薬液が攪拌される。薬液は当初懸 濁状態であるが、時間の経過とともに透明になる。 十分反応を行った後 (約 20〜30分)混合を停止する。  An electric current is passed through the electromagnet 39 to activate the electromagnet. Push the iron core 37 down slightly. When the permanent magnet 38 is moved downward from the vicinity of the upper end 31a of the outer cylinder 31 along the outside of the outer cylinder 31, the iron core 37 in the outer cylinder 31 moves downward while pressing the first container 32. When the first container 32 moves, the braking member 40 moves while being pushed by the lower end 32b. When the iron core 37 approaches the electromagnet 39, it is attracted to the electromagnetic stone 39 and stops. At this time, the lower end 33b of the hollow needle 33 that has penetrated the needle member 34 breaks through the separator 35a, pierces the stopper 36a at the upper end of the second container 36, penetrates it, and at the same time, the upper end of the hollow needle 33 33a penetrates through rubber stopper 32a. Thus, the hollow needle 33 passes through the rubber stopper 32a to the first container 32 filled with yttrium 90, and passes through the stopper 36a to the depressurized second container 36, respectively. The yttrium chloride 90 initially in the first container 32 is transferred to the second container 36 by a pressure difference. After the yttrium chloride 90 alone has completely moved into the second container 36, the magnetic stirrer 45 is activated. On the outside of the second container 36, a yttrium 90 chemical is stirred together with a sleeve 44 filled with cooling water (the center of the bottom is shaped so that it can be in close contact with the bottom of the second container). The chemical is initially suspended, but becomes transparent over time. After sufficient reaction (approximately 20-30 minutes), stop mixing.
イットリウム 90— Y2B8のキレート物の生成後、 第一の容器収納部を 9 0度回転させるため、スィッチを通電する。 この操作によって第二の容器 3 6の上部が現れる。 After the formation of the yttrium 90-Y2B8 chelate, the switch is energized to rotate the first container compartment 90 degrees. By this operation the second container 3 The upper part of 6 appears.
第二の容器 36の上部が現れた状態を、第 6図に示した。 第二の容器 36の開口部に設けた栓 36aに、針部材の下の中空針 33bが貫通した状 態になっている。  FIG. 6 shows a state where the upper part of the second container 36 is exposed. The hollow needle 33b below the needle member penetrates a stopper 36a provided at the opening of the second container 36.
次に、放射線取扱臨床技師によって、鉛ガラス越しに、生理食塩水を 満たした注射用延長チューブ 62 (チューブ)の先端に中空管 61を接続し. 該中空管 61をイットリウム 90—キレート抗体生成液が入った第二の容器 36の栓に突き刺し底部まで通す。この間の人間の手に対する放射線ひ ばくは 0. 5マイクロシーベルト Z時間未満で、 作業時間は 1分未満であ る。  Next, a radiological technician connects a hollow tube 61 to the tip of an extension tube 62 (tube) for injection filled with physiological saline through lead glass. The hollow tube 61 is connected to yttrium 90-chelating antibody. It pierces the stopper of the second container 36 containing the product liquid and passes it to the bottom. The radiation exposure to human hands during this time is less than 0.5 microsievert Z hours and the working time is less than 1 minute.
注射用チューブ 62は、ジルコニウム 90を含む未反応物を除去するため カラムとミリボアフィルターを通り、ヘリスターポンプを通って患者の上腕部 静脈血管内に注入される。カラムの内部充填剤は、 pH7. 5に保持され たカチオン吸着樹脂と活性炭である。  Injection tube 62 is passed through a column and a millibore filter to remove unreacted material, including zirconium 90, and is injected into the patient's brachial vein through a helicopter pump. The internal packing material of the column is a cation adsorption resin maintained at pH 7.5 and activated carbon.
以上、本発明の放射性物質敢极装置によれば、放射性物質は、 第 一の容器 2、 32、 中空針 3、 33、第二の容器 6、 36のそれぞれ内側にの み接触するので、各容器及び移送のための中空針の外部を汚染すること がない。  As described above, according to the radioactive substance brazing apparatus of the present invention, the radioactive substance contacts only the inside of each of the first containers 2 and 32, the hollow needles 3 and 33, and the second containers 6 and 36. It does not contaminate the outside of the container and the hollow needle for transfer.
本発明の物質取扱装置による物質取扱いを無菌的に実施する場合 には、第一の容器 2、 32、 中空針 3、 33、第二の容器 6、 36のそれぞれ 内側だけでなく、第一の容器 2、 32のゴム栓 2a、 32a, 中空針 3、 33及び 第二の容器 6、 36の栓 6a、 36aの、各々の外面、針部材 4、 34、 隔離膜 5a、 35a、鉄芯 7、 37、制動き [5材 10、 40、ストッノ 一 13、 43、外筒 1、 31 の内面等を無菌処理し、無菌のろ紙 11、 41及び 12、 42で外筒 1、 31の 両端を使用直前まで密封しておくのがよい。 また、永久磁石 8、 38の代わりに電磁石を、又は電磁石 9、 3 9の代わり に永久磁石を用いてもよい。 When the substance handling by the substance handling apparatus of the present invention is performed aseptically, not only the inside of each of the first containers 2, 32, the hollow needles 3, 33, and the second containers 6, 36, but also the first container Rubber stoppers 2a, 32a, hollow needles 3, 33 of containers 2, 32 and stoppers 6a, 36a of second containers 6, 36, respective outer surfaces, needle members 4, 34, separators 5a, 35a, iron core 7 , 37, control movements (5 materials 10, 40, Stono 13 and 43, inner surfaces of outer tubes 1 and 31) are aseptically treated, and sterile filter papers 11, 41 and 12, 42 are used to assemble both ends of outer tubes 1 and 31. It is good to keep sealed until just before use. Further, an electromagnet may be used instead of the permanent magnets 8 and 38, or a permanent magnet may be used instead of the electromagnets 9 and 39.
本発明は、放射能を有する液体等を第一の容器から第二の容器へ移 送する用途、第一の容器中の放射能を有する液体等を第二の容器中で 他の物質と反応させる目的にも有用である。例えば、ベータ線又はガンマ 線放射性同位元素を高濃度で含む溶液を放射線感受性の強い蛋白 試薬と、医療等の目的で使用直前に混合する用途にも有用である。 産業上の利用可能性  The present invention is used for transferring a radioactive liquid or the like from a first container to a second container, and reacting a radioactive liquid or the like in the first container with another substance in the second container. It is also useful for the purpose. For example, it is also useful for mixing a solution containing a high concentration of a beta- or gamma-ray radioisotope with a highly radiation-sensitive protein reagent immediately before use for medical or other purposes. Industrial applicability
放射性物質を含む危険な物質を取り扱うに際し、放射線の外部への 実質的な漏洩なく容易で簡便な操作で、確実に取扱できることができる。 本発明の装置により、放射線を含む薬液の調製が可能で、第一の容器 中の放射能を有する液体等を第二の容器中で他の物質と反応させる目 的にも効果的に応用することができる。放射性物質の移動、反応、調製 等研究、医薬品の研究開発、医療目的に役立つものである。  When handling dangerous substances, including radioactive substances, it can be handled easily and easily with a simple operation without substantial leakage of radiation to the outside. The device of the present invention enables the preparation of a drug solution containing radiation, and is effectively applied for the purpose of reacting a radioactive liquid or the like in the first container with another substance in the second container. be able to. It is useful for research on the transfer, reaction, and preparation of radioactive materials, research and development of pharmaceuticals, and medical purposes.

Claims

請求の範囲 The scope of the claims
1 . 外筒と、 中空針が貫通できる第一の栓で密栓された開口部を下向 きにして外筒内に滑動可能に挿入された第一の容器と、外筒の軸方 向に平行に移動できる両端が尖った中空針と、 中空針が容易に貫通 できる第二の栓で密栓された外筒の下端に挿入されて固定される内部 が第一の容器よりも減圧された第二の容器とを備え、 1. The outer cylinder, the first container slidably inserted into the outer cylinder with the opening sealed with the first stopper through which the hollow needle can pass downward, and the axial direction of the outer cylinder. A hollow needle with both sharp points at both ends that can move in parallel, and a second needle whose inner part is inserted and fixed at the lower end of an outer cylinder sealed with a second stopper through which the hollow needle can be easily penetrated is lower than that of the first container. With a second container,
外筒内を第一の容器が下方に滑動することにより、第一の栓に中空 針の上端が貫通するとともに、第二の栓を中空針の下端が貫通して、 第一の容器と第二の容器が連通し、第一の容器内の内容物を第二の 容器内に外部への実質的な漏洩なしに移動させることができるように構 成されたことを特徴とする物質取扱装置。  When the first container slides downward in the outer cylinder, the upper end of the hollow needle penetrates the first stopper, and the lower end of the hollow needle penetrates the second stopper. A substance handling device, characterized in that the two containers communicate with each other and the contents in the first container can be moved into the second container without substantial leakage to the outside. .
2. 中空針が外筒内を滑動できる柱状部材を貫通して設けられている、 請求の範囲 1の物質取扱装置。 2. The substance handling device according to claim 1, wherein the hollow needle is provided through a columnar member that can slide in the outer cylinder.
3 . 外筒と、針が容易に貫通できる第一の栓で開口が密栓され、 開口 下向きにして外筒内に滑動可能に挿入される第一の容器と、 外筒の 軸方向に平行に移動できる、 両端が尖った中空針と、 中空針が容易 に貫通できる第二の栓で開口が密栓され、外筒の下端に挿入されて 固定される、 内部が第一の容器よりも減圧された第二の容器と外筒内 に滑動可能に挿入された磁性部材と、外筒の外に設けられ、 外筒に 沿って移動可能な磁石とから成り、 3. The outer cylinder and the first container, whose opening is sealed with a first stopper through which the needle can easily penetrate, and the first container which is slidably inserted into the outer cylinder with the opening facing downward, and parallel to the axial direction of the outer cylinder The opening is sealed with a hollow needle that can move, the both ends of which are sharp, and a second stopper through which the hollow needle can easily penetrate, and inserted and fixed to the lower end of the outer cylinder. A magnetic member slidably inserted into the second container and the outer cylinder, and a magnet provided outside the outer cylinder and movable along the outer cylinder,
磁石を外筒に沿って移動させることにより、磁性部材が外筒内を滑 動して、外筒内を第一の容器が移動し、第一の栓に中空針の上端が 貫通するとともに、第二の栓に中空針の下端が貫通して、第一の容器 と第二の容器が連通し、第一の容器の内容物を第二の容器に外部へ の漏洩なしに移動させることができるように構成されたことを特徴とする、 物質取扱装置。 By moving the magnet along the outer cylinder, the magnetic member slides in the outer cylinder, the first container moves in the outer cylinder, and the upper end of the hollow needle is inserted into the first stopper. At the same time, the lower end of the hollow needle penetrates through the second stopper so that the first container and the second container communicate with each other, and the contents of the first container are leaked to the second container without leaking to the outside. A substance handling device, characterized in that it can be moved.
4. 中空針が外筒内を滑動できる柱状部材を貫通して設けられている、 請求の範囲 3の物質取扱装置。 4. The substance handling apparatus according to claim 3, wherein the hollow needle is provided so as to penetrate a columnar member that can slide in the outer cylinder.
5. 外筒内を第一の容器が移動する前に中空針の下端が第二の栓に 到達しないように、 中空針の下端を制止する制止部材を具えた、請求 の範囲 1ないし請求の範囲 4のいずれかの物質取扱装置。 5. A stop member for stopping the lower end of the hollow needle so that the lower end of the hollow needle does not reach the second stopper before the first container moves in the outer cylinder. Any material handling equipment of scope 4.
6. 外筒が第一の容器収納部と第二の容器収納部とに分割され、第一 の容器収納部又は第二の容器収納部の回転又は移動により、 第二 の容器の上部を開放可能としたことを特徴とする請求の範囲 1ないし 請求の範囲 5のいずれかの物質取扱装置。 6. The outer cylinder is divided into the first container storage and the second container storage, and the upper part of the second container is opened by rotating or moving the first container storage or the second container storage. The substance handling apparatus according to any one of claims 1 to 5, wherein the substance handling apparatus is enabled.
7. 第一の容器収納部を固定し第二の容器収納部を電動機構等によ り回転又は移動すること、又は、第二の容器収納部を固定し第一の容 器収納部を電動機構等により回転又は移動することを特徴とする請求 の範囲 6の物質取扱装置。 7. The first container storage section is fixed and the second container storage section is rotated or moved by an electric mechanism, or the second container storage section is fixed and the first container storage section is electrically driven. The substance handling apparatus according to claim 6, wherein the substance handling apparatus is rotated or moved by a mechanism or the like.
8. 第二の容器の内底部に達するように中空針が挿入されたことを特徴 とする請求の範囲 6又は請求の範囲 7の物質取极装置。 8. The substance collection device according to claim 6 or 7, wherein the hollow needle is inserted so as to reach an inner bottom of the second container.
9 . 第二の容器に挿入された中空針に中空管を経てカテーテルに接続 するに際し、 中空管の途中に薬液供給ポンプ及びフィルターを設けた ことを特徴とする請求の範囲 6ないし請求の範囲 8のいずれかの物質 取扱装置。 9. A chemical solution supply pump and a filter are provided in the middle of the hollow tube when connecting the hollow needle inserted in the second container to the catheter via the hollow tube. Any material handling equipment in range 8.
1 0. フィルターが、イオン交換樹脂及び活性炭を充填剤とするカラム及び ミリポアフィルタ一から構成されることを特徴とする請求の範囲 9の物質 取扱装置。 10. The substance handling apparatus according to claim 9, wherein the filter comprises a column using an ion exchange resin and activated carbon as a filler and a millipore filter.
1 1 . 第一の容器及び/又は第二の容器の内容物が放射性物質である ことを特徴とする請求の範囲 1ないし請求の範囲 1 1のいずれかの物質 取扱装置。 11. The substance handling device according to any one of claims 1 to 11, wherein the content of the first container and / or the second container is a radioactive substance.
PCT/JP2000/004369 1999-07-06 2000-06-30 Radioactive material handling device WO2001002048A1 (en)

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EP1632268A1 (en) * 2004-09-03 2006-03-08 Mallinckrodt Inc. Container for radioactive material
WO2006135412A1 (en) * 2004-09-03 2006-12-21 Mallinckrodt Inc. Container for radioactive material
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