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WO2013108587A1 - Procédé de transfusion d'un fluide médical et dispositif de transfusion d'un fluide médical - Google Patents

Procédé de transfusion d'un fluide médical et dispositif de transfusion d'un fluide médical Download PDF

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Publication number
WO2013108587A1
WO2013108587A1 PCT/JP2013/000016 JP2013000016W WO2013108587A1 WO 2013108587 A1 WO2013108587 A1 WO 2013108587A1 JP 2013000016 W JP2013000016 W JP 2013000016W WO 2013108587 A1 WO2013108587 A1 WO 2013108587A1
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WO
WIPO (PCT)
Prior art keywords
syringe
container
drug solution
needle
plunger
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2013/000016
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English (en)
Japanese (ja)
Inventor
結輝 竹中
徹 中村
晃庸 奥田
剛史 東條
章博 太田
朗 ▲樋▼口
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Panasonic Corp
Original Assignee
Panasonic Corp
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 Panasonic Corp filed Critical Panasonic Corp
Priority to JP2013523402A priority Critical patent/JP5444509B2/ja
Publication of WO2013108587A1 publication Critical patent/WO2013108587A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/1782—Devices aiding filling of syringes in situ
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents

Definitions

  • the present invention relates to a drug solution transfer method and a drug solution transfer apparatus for transferring a drug solution such as an injection drug filled in a container between a container and a syringe in the field of medicine and the like.
  • a transfusion needle has been proposed in which a groove is provided in a part of the needle to eliminate the need for a pumping operation (see, for example, Patent Document 1).
  • the inside of the drug solution container can be made substantially equal to the atmospheric pressure by removing air from the groove.
  • FIG. 9 is a partial cross-sectional view of the transfusion needle 1 used in the conventional chemical liquid mixing apparatus.
  • FIG. 9 is a partial cross-sectional view of the transfer needle 1 as viewed from a plane perpendicular to the thickness direction of the rubber plug 8c when the conventional transfer needle 1 is pulled out of the rubber plug 8c.
  • the needle 2 and the needle base 3 are integrated.
  • the outer cylinder 4 is fitted to the outside of the needle 2 to form a groove 4 a between the needle 2 and the outer cylinder 4.
  • a filter 6 formed of a hydrophobic synthetic resin is attached.
  • Patent Document 2 after the clean air of an amount corresponding to the transfer amount is sucked into the syringe before the transfer of the drug solution, the suctioned clean air is injected into the drug solution container to Is disclosed to facilitate the transfer of the drug solution from inside the drug solution container into the syringe.
  • the present invention solves this problem, and provides a drug solution transfer method and a drug solution transfer apparatus capable of performing transfer of drug solution with high accuracy without occurrence of large variation in transfer amount of drug solution.
  • the purpose is to
  • a drug solution transfer method uses a syringe disposed below the vertical direction of a container having a drug solution inside, a gasket of a plunger of the syringe and the syringe
  • the needle of the syringe is punctured into the container in a state where there is an air reservoir with the inner wall surface of the container, and then the plunger is moved to transfer the drug solution from the container to the syringe through the needle
  • a drug solution transfer apparatus is disposed at a first holding portion for holding a container having a drug solution inside, and vertically below the container, A second holding unit for holding a syringe with a needle, a first moving unit for moving the first holding unit up and down in the vertical direction, and a plunger of the syringe held by the second holding unit in the vertical direction A second moving unit that moves up and down, and a control unit that controls the first moving unit and the second moving unit, the control unit is between the gasket of the plunger and the inner wall surface of the syringe.
  • each aspect of the present invention it is possible to provide a drug solution transfer method and a drug solution transfer apparatus capable of performing transfer of the drug solution with high accuracy without causing large variations in the transfer amount of the drug solution.
  • FIG. 1A is a schematic block diagram of a drug solution transfer apparatus according to a first embodiment of the present invention
  • FIG. 1B is a schematic block diagram of an example of a control unit or the like of the drug solution transfer apparatus according to the first embodiment of the present invention
  • FIG. 2 is a flowchart of the drug solution transfer method according to the first embodiment
  • FIG. 3A is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 3B is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 3A is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 3B is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 3C is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 3D is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 3E is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 3F is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 3G is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 3H is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 3I is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 3C is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 3D is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 3E is a partial cross-section
  • FIG. 3J is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 4 is a partial cross-sectional view of the drug solution transfusion apparatus according to the first embodiment
  • FIG. 5 is a side view showing the chemical liquid mixing apparatus according to the first embodiment
  • FIG. 6A is a partial cross-sectional view of a conventional drug solution transfer device
  • FIG. 6B is a partial cross-sectional view of a conventional drug solution transfer device
  • FIG. 6C is a partial cross-sectional view of a conventional drug solution transfer device
  • FIG. 7 is a cross-sectional view schematically showing the state in which air bubbles are generated inside the syringe in the conventional drug solution transfer apparatus
  • FIG. 8 is a partial cross-sectional view of the drug solution transfer needle of the drug solution transfer device according to the second embodiment of the present invention
  • FIG. 9 is a partial sectional view of a conventional transfusion needle
  • FIG. 10 is a partial cross-sectional view for explaining the problem in the conventional transfusion needle.
  • FIG. 10 is a partial cross-sectional view for explaining the problem of the conventional drug solution transfer needle.
  • the same components as those in FIG. 9 are denoted by the same reference numerals, and the description thereof is omitted.
  • the present invention solves the problems in this conventional transfusion needle by the embodiment described below.
  • FIG. 1A is a schematic configuration view of a part of a drug solution transfer apparatus 20 according to a first embodiment of the present invention.
  • FIG. 1B is a schematic block diagram of an example of a control unit or the like of the drug solution transfusion apparatus according to the first embodiment of the present invention.
  • FIG. 2 is a flowchart of a drug solution transfer method by the drug solution transfer apparatus according to the first embodiment of the present invention.
  • FIGS. 3A to 3J are diagrams for explaining the drug solution transfer method in the first embodiment, using side views of a part of the container and the syringe.
  • the drug solution transfer apparatus 20 includes a first holding unit 21, a second holding unit 22, a first moving unit 23, and a second moving unit 19. And a control unit 40.
  • the drug solution transfer apparatus 20 functions as an example of a drug solution mixing apparatus.
  • the liquid medicine mixing apparatus is an apparatus for injecting a liquid medicine transferred to a syringe 26 and injecting the liquid medicine transferred from the syringe 26 into an infusion vial or the like to mix the medicine.
  • the first holding unit 21 is an example of a container holding unit
  • the second holding unit 22 is an example of a syringe holding unit.
  • the first moving unit 23 is an example of a container moving unit that moves the container 24, and the second moving unit 19 is an example of a plunger moving unit that moves the plunger 26 b of the syringe 26.
  • the container 24 is an example of a drug solution container such as a vial or an infusion bag, for example.
  • the first holding unit 21 holds the container 24.
  • the second holding unit 22 is disposed vertically below the first holding unit 21 and holds the syringe 26 with the needle 25 attached thereto.
  • the first moving unit 23 is controlled by the control unit 40 and moves the first holding unit 21 vertically and vertically.
  • the second moving unit 19 is controlled by the control unit 40 to move the plunger 26 b of the syringe 26 in the vertical vertical direction.
  • a movable plate 19k for fixing the plunger 26b is movably attached to the syringe base 22a. Further, the second holding portion 22 and the second moving portion 19 of the plunger 26b are fixed to the syringe base 22a.
  • the control unit 40 controls various operations of the drug solution transfer apparatus 20.
  • the control unit 40 includes an arithmetic unit 40a, a storage unit 40b, and a determination unit 40c, and controls driving devices such as the motors 23a and 19m, the first moving unit 23, and the second moving unit 19, respectively.
  • the identification data of the container 24, the data of the empty amount for each container 24, the data of the position of the rubber plug 30, the data of the thickness of the rubber plug 30, and the sampling of the tip of the needle 25 Data on the position of the tip of the mouth 25a is stored in advance as a database. These data are stored for each rubber plug 30 or each needle 25 or each container 24.
  • the data of the emptying amount for each container 24 is the data of the lowering amount of the plunger 26b at the time of the emptying operation.
  • the camera 100 or the encoder 101 may be used to acquire necessary data and store the data in the storage unit 40 b without storing a part of the data in the storage unit 40 b in advance.
  • the storage unit 40b may be connected to a database storing a prescription or the like by communication or the like to acquire a predetermined amount of the drug solution recorded in the prescription of the database and store the predetermined amount in the storage unit 40b.
  • the operation unit 40a acquires necessary data from the storage unit 40b, and based on the position information of the rubber plug 30 of the container 24 and the position information of the tip of the liquid collection port 25a at the tip of the needle 25 and the position information of the plunger 26b. An arithmetic operation is performed in each step to be described later to obtain the relative position of the liquid collection port 25a with respect to the rubber plug 30, and also obtain the movement amounts of the container 24 and the plunger 26b.
  • the determination unit 40c confirms and determines the end (completion) of the operation in each step described later based on the calculation result in the calculation unit 40a, and outputs a drive stop signal to the drive device such as the motors 23a and 19m. Output
  • a vial or an infusion bag is used as the container 24 for example.
  • the container 24 has a drug solution stored in advance in its inside 24a.
  • a vial is used as an example of the container 24 as shown in FIG. 1A.
  • the vial which is an example of the container 24, is held by the first holding unit 21 in a state where the rubber plug 30 is disposed on the lower side in the vertical direction.
  • the state in which the rubber stopper 30 of the vial is disposed on the lower side in the vertical direction is the inverted state of the container 24 (vial).
  • a material of the rubber plug 30 butyl, chlorinated butyl, butadiene or isoprene is used.
  • the first holding unit 21 is fixed to the first moving unit 23.
  • the first moving unit 23 has a motor 23a whose rotation axis rotates forward and reverse, a ball screw shaft 23b rotated forward and reverse by the rotation of the rotation axis of the motor 23a, and a movable plate engaged with the ball screw shaft 23b. And 23c.
  • the movable plate 23 c is connected to the first holding unit 21 and vertically moves together with the first holding unit 21.
  • the motor 23a is driven and controlled by the control unit 40 to rotate the rotation shaft in the forward and reverse directions, and functions as an example of a first moving unit driving device.
  • a gasket 31 is fixed to the tip of the plunger 26b.
  • the drug solution transferred into the syringe 26 or the gas (for example, air) sucked into the syringe 26 contacts the gasket 31.
  • the gasket 31 is not referred to and is simply described as the plunger 26 b.
  • the surface of the gasket 31 is the upper end surface of the plunger 26b.
  • the drug solution transfer method of the first embodiment is a method for transferring a drug solution between the container 24 and the syringe 26 by controlling the drug solution transfer apparatus 20 including the above-described components.
  • the drug solution transfer method includes step S01, which is an example of a data acquisition step, step S02, which is an example of a blanking step, and step S03, which is an example of a needle insertion step.
  • step S04 which is an example of the first push and pull step
  • step S05 which is an example of the drug solution transfer step
  • step S06 which is an example of the negative pressure adjustment step
  • step S07 which is an example of the withdrawal step.
  • steps S01 to S03 are performed before the predetermined amount of the drug solution 27 is transferred (moved) from the inside 24a of the container 24 to the inside 26a of the syringe 26.
  • step S01 the control unit 40 performs various types of data on the position of the rubber plug 30 of the container 24, data on the thickness of the rubber plug 30, data on the position of the tip of the liquid collection port 25a at the tip of the needle 25, etc. Acquired from the sensor and storage unit 40b.
  • the various sensors are, for example, the camera 100 attached to the front or side of the syringe 26, the encoder 101 for measuring the movement amount of the first moving unit 23 of the first holding unit 21, or the second movement of the second holding unit 22.
  • the encoder 102 measures the amount of movement of the unit 19.
  • the encoders 101 and 102 are an example of a position sensor as a movement amount detection device.
  • Step S01 is, specifically, based on the information acquired by the camera 100 or the encoder 101 and the information stored in the storage unit 40b, the collection of the needle 25 with respect to the position and thickness of the rubber plug 30 of the container 24. The relative position of the mouth 25a is detected.
  • Step S02 is a step of emptying a predetermined amount of gas into the interior 26a of the syringe 26 before puncturing the needle 25 into the container 24.
  • the plunger 26 b of the syringe 26 is lowered by driving the motor 19 m of the second moving unit 19 in a state where the needle 25 is not inserted into the container 24.
  • this suction forms an air reservoir between the surface 31a (see FIG. 4) of the gasket 31 of the plunger 26b in the syringe 26 and the inner wall surface 26h (see FIG. 4) of the tip 26j of the syringe 26.
  • a constituent gas 28 is present.
  • Step S03 is a step of inserting the needle 25 into the container 24 by causing the needle 25 to puncture the rubber plug 30.
  • the container 24 is lowered by driving the motor 23a of the first moving unit 23, and the liquid collection port 25a of the needle 25 is inserted into the container 24. It is a step.
  • the container 24 is lowered to puncture the needle 25 of the syringe 26 into the rubber plug 30 of the container 24.
  • the syringe 26 is raised and the needle 25 is inserted into the rubber plug 30 of the container 24 Also good. That is, the container 24 and the needle 25 may be moved relative to each other to puncture the needle 25 in the rubber plug 30 of the container 24.
  • Step S04 is a step of transferring the drug solution 27 or the gas 28 between the container 24 and the syringe 26 by pushing and pulling the plunger 26b of the syringe 26.
  • the discharge of a predetermined amount of gas 28 from the syringe 26 to the container 24 or the suction of the chemical solution 27 from the container 24 to the syringe 26 is the same operation as in the prior art, and thus the detailed description is omitted.
  • the step of discharging the gas 28 of a predetermined amount or suctioning the chemical solution 27 is performed by driving the motor 19 m of the second moving unit 19 forward and reverse to move the plunger 26 b of the syringe 26 up and down.
  • step S04 the speed at which the plunger 26b is pulled is made lower than the speed at which the plunger 26b is pushed, thereby reducing the occurrence probability of air bubbles in the push and pull operation in step S04, and the accuracy of the transfusion operation. Can be raised.
  • the transfer speed is set to 1 m / s or less for the pulling speed of the plunger 26b (the suction speed for the drug solution) and 5 m / s or more for the pressing speed (the drug discharge speed) to the plunger 26b. I was able to improve the accuracy of the operation.
  • Step S05 is a step of transferring a predetermined amount of the drug solution 27 from the container 24 to the inside 26a of the syringe 26.
  • the step of transferring the chemical solution 27 of a predetermined amount is performed by driving the motor 19 m of the second moving unit 19 to lower the plunger 26 b of the syringe 26.
  • Step S06 is a step of adjusting the pressure of the gas 28 in the container 24 to a negative pressure by returning a part of the drug solution 27 in the syringe 26 to the container 24.
  • the motor 19 m of the second moving unit 19 is driven to raise the plunger 26 b of the syringe 26 to discharge a part of the drug solution 27 in the syringe 26 into the container 24. It does by doing.
  • Step S07 is a step of pulling out the needle 25 of the syringe 26 from the rubber plug 30 of the container 24.
  • the operation of pulling out the needle 25 is to move the needle 25 relatively in the direction away from the container 24 by raising the container 24 in the direction of the arrow 24 c by driving the motor 23 a of the first moving unit 23. To do.
  • the air (not shown) previously existing in the inside of the needle 25 is drawn to the inside 26 a of the syringe 26 so that the needle 25 can be operated. It is possible to treat the gas in the inside of the needle 25 and the evacuated gas as one mass of gas in the vicinity of the inside of the nozzle 26 and the mouth 26 x of the syringe 26.
  • the opening 26 x of the syringe 26 is in the vicinity of the tip 26 j of the syringe 26 and is a portion connecting the needle 25 and the inside 26 a of the syringe 26.
  • the gas in the needle 25 and the gas outside the syringe 26 are integrally suctioned by performing the empty pulling operation in step S02.
  • the possibility of irregular mixing of air and the drug solution 27 in the syringe 26 is reduced, and the generation of small air bubbles in the drug solution 27 transferred into the syringe 26 can be suppressed.
  • transfusion of the drug solution 27 becomes possible in a state where generation of small air bubbles is suppressed, the possibility of deterioration of transfusion accuracy due to air bubbles is reduced, and transfusion of the drug solution 27 with high accuracy becomes possible.
  • the transfer of the drug solution is described as an example, but it goes without saying that the mixing of the drug solution by the transfer of the drug solution is an example of the transfer of the drug solution.
  • the generation of air bubbles can be suppressed by performing the empty pulling in this manner. Specifically, the gas 28 and the drug solution 27 remaining inside the needle 25 are rapidly dropped in a narrow space surrounded by the inner wall surface 26 h of the syringe 26 and the gasket 31 of the plunger 26 by performing the emptying. It is possible to suppress the generation of air bubbles due to being mixed in the If generation of air bubbles can be suppressed in this manner, almost no air bubbles will be present inside the syringe 26, and transfusion of the drug solution 27 can be performed with high accuracy.
  • the variation in transfusion amount was 0.107 ml when the blanking process in step S02 in FIG. 2 was not performed, the blanking process in step S02 in FIG. 2 was performed
  • the variation of the transfusion amount in the case (in the case of the first embodiment) was 0.025 ml.
  • air bubbles that affect the accuracy of transfusion have a diameter of 50 ⁇ m or more and 3 mm or less, and in particular, air bubbles with a small diameter adhere to the wall surface of the syringe 26 and are difficult to peel off from the wall surface I know.
  • the first embodiment is considered to be particularly effective in suppressing the generation of air bubbles of this size.
  • the chemical solution transfer apparatus 20 in which the container 24 is disposed in the upper part in the vertical direction and the syringe 26 is disposed in the lower part along the axial center of the container 24 will be described as an example. .
  • the syringe 26 is held by the second holding portion 22 in a state where the needle tip of the needle 25 is directed substantially upward in the vertical direction.
  • the plunger 26 b of the syringe 26 is freely moved up and down by the second moving unit 19 along the direction (vertical direction) of the arrow 26 d.
  • the second moving unit 19 vertically moves together with the motor 19m whose rotation axis rotates forward and reverse, the ball screw shaft 19p rotated forward and reverse by the rotation of the rotation axis of the motor 19m, and the plunger 26b.
  • a movable plate 19k As an example, the second moving unit 19 vertically moves together with the motor 19m whose rotation axis rotates forward and reverse, the ball screw shaft 19p rotated forward and reverse by the rotation of the rotation axis of the motor 19m, and the plunger 26b. And a movable plate 19k.
  • the motor 19m functions as an example of a drive unit for the second moving unit, and is drive-controlled by the control unit
  • the movable plate 19k is coupled to the plunger 26b and engaged with the ball screw shaft 19p.
  • the plunger 26b moves up and down in the direction of the arrow 26d to transfer the chemical solution 27 or gas between the inside 26a of the syringe 26 and the inside of the container 24. It can be carried out.
  • the first holding unit 21 is disposed in the upper part in the vertical direction and the second holding unit 22 is disposed in the lower part in the vertical direction, when the container 24 is held in an inverted state, The drug solution 27 moves to a region adjacent to the rubber plug 30 in the container 24. Therefore, the drug solution 27 can be easily sucked from the needle 25 of the syringe 26.
  • the confirmation as to whether or not the needle 25 has been punctured by the rubber plug 30 and completely penetrated is specifically performed as follows.
  • the state in which the needle 25 completely penetrates the rubber plug 30 is the state in which the liquid collection port 25 a of the needle 25 is inserted into the container 24.
  • the calculation unit 40a calculates the relative position of the liquid collection port 25a before the movement with respect to the position of the container 24 and the position and thickness of the rubber plug 30,
  • the relative position of the liquid collection port 25a after movement with respect to the positions of the container 24 and the rubber plug 30 is calculated by calculating the amount of movement of the container 24 by the detection operation of the encoder 101 of the first moving unit 23.
  • the determination unit 40c of the control unit 40 determines whether the needle 25 completely penetrates the rubber plug 30 Confirm and judge.
  • the drive stop signal is output from the determination unit 40c to the motor 23a of the first moving unit 23 to drive the motor 23a.
  • the operation is stopped, and the liquid collection port 25 a at the tip of the needle 25 is held in the state of being inserted into the container 24.
  • the judgment unit 40c judges that the needle 25 does not completely penetrate the rubber plug 30, the motor 23a is kept driven until the needle 25 completely penetrates the rubber plug 30.
  • the position of the liquid surface of the chemical solution 27 in the syringe 26 is detected by the imaging operation of the camera 100, and the amount of movement of the encoder 102 is calculated.
  • the transfusion amount is calculated by calculating the increase or decrease of the amount of. For example, when the movement of the gas 28 in the syringe 26 into the container 24 is confirmed, a predetermined amount of gas (the gas 28 forming the air pool) based on the change in the position of the liquid surface of the drug solution 27 in the syringe 26
  • the determination unit 40c confirms and determines whether all the ink has been discharged into the container 24 or not.
  • the drive stop signal is output to the motor 19m of the second moving unit 19 to stop the drive of the motor 19m.
  • the motor 19m is kept driven until the plunger 26b is raised by the amount of movement.
  • FIGS. 3A to 3J are partial cross-sectional views of the drug solution transfer device 20 according to the first embodiment of the present invention, showing the positional relationship between the container 24 and the syringe 26.
  • FIGS. 3A to 3J and FIG. 4 in order to make it easy to understand the position of the needle 25 in the inside 24 a of the container 24, the amount of the drug solution 27, the position and size of the air bubbles, etc. , In a cross-sectional view.
  • FIG. 3A to 3J and FIG. 4 in order to make it easy to understand the position of the needle 25 in the inside 24 a of the container 24, the amount of the drug solution 27, the position and size of the air bubbles, etc.
  • FIG. 4 is a view for explaining a state in which the inner wall surface 26h at the tip of the syringe 26 does not get wet with the drug solution 27 at the time of transfer of the drug solution 27, and as a result, adhesion of air bubbles is prevented. Since the wetted surface is likely to adhere and be difficult to remove air bubbles, the first embodiment capable of transfusion of the drug solution without wetting the inner wall surface 26h of the syringe 26 can maintain high accuracy.
  • (A) of FIG. 4 shows the state immediately after the start of drug solution transfer operation (the state immediately before the state of FIG. 3D),
  • (b) of FIG. 4 shows the state of FIG. 3D,
  • FIG. 3E The state of FIG. 3E is shown,
  • (d) of FIG. 4 shows the state immediately before FIG. 3F, and (e) of FIG. 4 shows the state of FIG. 3F.
  • FIG. 3A shows an initial state, for example, immediately after taking out the syringe 26 from the sterilization pack of the syringe 26 before moving a predetermined amount of the drug solution 27 from the container 24 to the inside 26 a of the syringe 26.
  • the plunger 26 b is located near the tip 26 j of the syringe 26.
  • the inner wall surface 26h of the tip 26j of the syringe 26 and the gasket 31 at the tip of the plunger 26b are not in direct contact, but the gasket 31 of the inner wall surface 26h of the tip of the syringe 26 and the tip of the plunger 26b is The gap with is as small as possible.
  • the gas 28 in the syringe 26 is approximately zero on the scale of the syringe 26.
  • step S02 in FIG. 2 blanking is performed (see step S02 in FIG. 2).
  • air having a volume of 0.1 ml or more and less than 0.5 ml is evacuated.
  • air of 0.5 ml or more and less than 2.0 ml is evacuated.
  • the amount of emptying does not depend on the diameter and length of the needle 25.
  • the reason for setting the maximum amount of emptying is that if the amount of emptying is large, the generation of air bubbles can be suppressed, but transfer takes time and work efficiency is deteriorated.
  • the minimum amount of emptying is set because, if the amount of emptying is too small, the inner wall surface 26h of the tip 26j of the syringe 26 gets wet with the transferred chemical solution 27.
  • movement it is 5 mm or more.
  • the container 24 is moved down via the rubber plug 30 while keeping the evacuated gas in the interior 26a of the syringe 26 (ie, maintaining the gas 28 as an air reservoir in the syringe 26).
  • a state in which the needle 25 is punctured in the container 24 is shown (see step S03 in FIG. 2).
  • FIGS. 3D and 4B show a state where the liquid medicine 27 in the container 24 is sucked into the syringe 26 by pushing down the plunger 26b of the syringe 26 in the direction of the arrow 26e from the state of FIG. 3C. .
  • the gas 28 is preliminarily contained in the syringe 26 to form a lump of air pool. By doing so, the air (not shown) present inside the needle 25 is prevented from becoming a small air bubble.
  • FIGS. 3F to 3G and (d) to (e) in FIG. 28) are discharged into the container 24 as a mass of air 26y.
  • the operation shown in FIGS. 3D to 3G is step S04 shown in FIG.
  • step S05 After the gas 28 in the syringe 26 is pushed out into the container 24 as a mass of air 26y in step S04, as shown in FIG. 3H, the plunger 26b is pulled in the direction of the arrow 26e, It is moved into the syringe 26 (see step S05 in FIG. 2).
  • step S05 the volume of the gas 36 in the container 24 is increased by the volume of the drug solution 27 transferred (moved) into the syringe 26.
  • the pressure of the gas 36 in the container 24 with the increased volume is reduced from atmospheric pressure to negative pressure.
  • the pressure in the container 24 maintains a negative pressure to such an extent that the liquid medicine 27 does not leak from the tip of the needle 25 (hereinafter referred to as spill). I'm adjusting. Specifically, in the first embodiment, part of the drug solution 27 in the inside 26a of the syringe 26 is returned to the container 24 by raising the plunger 26b of the syringe 26 (see step S06 in FIG. 2). Thereby, the pressure of the gas 36 in the container 24 is adjusted to the optimal negative pressure.
  • the container 24 is relatively raised, and the needle 25 attached to the tip of the syringe 26 is pulled out of the rubber plug 30 of the container 24 (see step S07 in FIG. 2).
  • FIG. 5 is a side view which shows the chemical
  • the chemical solution mixing device 32 has a cylindrical third holding portion 33 in a chemical solution mixing area 32b surrounded by a cylindrical outer wall 32a.
  • the chemical solution mixing area 32b is an area for forming a working space for reliably preventing the leakage of the chemical solution 27 to the outside of the apparatus.
  • the cylindrical third holding portion 33 is configured by the second holding portion 22 and the first holding portion 21 which are divided in the vertical direction along the central axis 32 c.
  • the chemical liquid mixing apparatus 32 includes the first moving unit 23, the second moving unit 19, and the control unit 40 in addition to the third holding unit 33.
  • the control unit 40 controls the position of the combination of the syringe 26 and the container 24 (hereinafter referred to as the mixing set) around the axis of the cylindrical support 35 at a plurality of positions.
  • the plurality of positions include at least an installation position and a chemical solution transfer position.
  • the installation position is a position for installing the syringe 26 and the container 24 in the drug solution mixing device 32
  • the drug solution transfer position is a position for performing the drug solution transfer method of steps S01 to S07 described above. is there.
  • the second holding unit 22 and the first holding unit 21 are configured to include a plurality of holders 34a and 34b, respectively.
  • the second holding unit 22 and the first holding unit 21 are independently rotatable around the central axis 32c of the support unit 35 under the control of the control unit 40, and are relatively rotated.
  • the selected syringe 26 and the selected container 24 can be switched to be aligned in the vertical direction.
  • medical solution mixing apparatus 32 shown in FIG. 5 can hold
  • the syringe 26 may have different shapes, such as “volume 2.5 ml”, “volume 20 ml”, “volume 50 ml”, etc., depending on the type of the drug solution 27 to be aspirated.
  • a dedicated jig corresponding to the syringes 26 of a plurality of types of shapes is prepared, and the outer cylinder of the syringes 26 of a plurality of types of shapes can be securely fixed and held.
  • a dedicated jig corresponding to the plungers 26b having different shapes is prepared.
  • medical solution mixing apparatus 32 you may make it perform each step not only what implements a chemical
  • an empty pulling position for performing step S02, a needle insertion position for performing step S03, a primary push / pulling position for performing step S04, a drug solution transfer position for performing step S05, and step S06 The negative pressure adjustment position and the extraction position at which step S07 is performed may be performed at different positions.
  • the first moving unit 23 or the second moving unit 19 or the like is required at each position.
  • the present invention is not limited to this, and it goes without saying that two or three steps may be performed at one position.
  • the chemical solution mixing device 32 can efficiently and safely mix the chemical solution 27 even when mixing the plurality of types of chemical solution 27 using the plurality of types of containers 24 and the plurality of types of syringes 26.
  • FIGS. 6A to 8B are diagrams for explaining a conventional drug solution transfer method.
  • FIG. 7 is a view for explaining a state in which the inner wall surface 26h at the tip of the syringe 26 is partially wetted by the chemical solution 27, and air bubbles adhere to the wetted surface.
  • 7 (a) shows the state of FIG. 6A
  • FIG. 7 (b) shows the state of FIG. 6B
  • FIG. 7 (e) shows the state of FIG. 6C.
  • the conventional drug solution transfer method is performed using the syringe 26 and the container 24 of the drug solution transfer apparatus according to the first embodiment will be described.
  • step S02 in FIG. 2 the emptying (step S02 in FIG. 2) is not performed as in the first embodiment.
  • the needle 25 is inserted into the container 24 (step S03) as shown in FIG. 6B from the initial state shown in FIG. 6A without emptying (ie, without step S02), FIG. 6C and FIG.
  • the plunger 26b is pushed down in the direction of the arrow 26e to aspirate the drug solution 27 from the container 24 into the syringe 26 (step S04).
  • air bubbles 29 shown in FIG. 6C may be generated.
  • the first embodiment generation of small air bubbles (conventional small air bubbles 29) in the chemical solution 27 is suppressed, and variations in transfusion amount are reduced. Transfusion and mixing can be performed precisely.
  • the variation reduction of the transfusion amount in the case where the first embodiment is not applied, there is an error of 0.107 ml at 3 ⁇ in the case of applying the first embodiment in a syringe having a volume of 20 ml. Is an error of 0.025 ml at 3 ⁇ , and the variation can be reduced by 77%.
  • FIG. 8 is a cross-sectional view of a transfer needle 51 used in the drug solution transfer method according to the second embodiment of the present invention.
  • the drug solution transfer method of the second embodiment differs from the first embodiment in that a transfer needle 51 shown in FIG. 8 is used instead of the needle 25 of the first embodiment described above, and the other embodiment is the first embodiment. And the description of the same parts will be omitted.
  • the needle used in the second embodiment is a transfusion needle 51 including a cylindrical needle base 52, a first needle 53, and a second needle 54, as shown in FIG.
  • the needle base 52 is attached to the end of the syringe 26.
  • the first needle 53 has an air passage 55 inside.
  • the second needle 54 is longer than the first needle 53 and disposed parallel to the first needle 53.
  • the first needle 53 is provided with a first air vent 56 which is one end of the air passage 55 at the tip end side of the second needle 54 than the second air vent 57 which is the other end.
  • the second needle 54 connects one end of the liquid passage 58 to the inside of the needle base 52, and the other end is a liquid passage port 59 of the second needle 54.
  • the second needle 54 also has a tip 54 a having a liquid passage 59 and a base 54 b connected to the needle base 52.
  • the drug solution 27 is aspirated from the liquid passage port 59 of the second needle 54 and transferred to the inside 26 a of the syringe 26 through the inside of the second needle 54 and the needle base 52.
  • the chemical solution 27 inside the container 24 decreases and the volume of the gas 36 inside the container 24 increases
  • the pressure of the gas 36 inside the container 24 decreases and the pressure of the gas 36 becomes lower than atmospheric pressure.
  • the transfer needle 51 since the transfer needle 51 is used, when the pressure of the gas 36 is lower than the atmospheric pressure, the atmosphere outside the container 24 is the second vent 57 of the first needle 53.
  • the pressure difference between the inside 24a of the container 24 and the atmospheric pressure is reduced.
  • the drug solution transfer method according to the second embodiment uses this transfer needle 51, so a large force is not necessary between suction of the drug solution 27 and completion of suction of a predetermined amount, and the pumping operation is also performed. It is not necessary.
  • the empty pulling operation of step S02 of FIG. 2 is performed before transferring the drug solution 27 from the container 24 to the syringe 26.
  • the generation of the air bubbles 29 can be suppressed, and transfusion and mixing of the chemical solution can be performed accurately and efficiently.
  • the second embodiment regardless of the transfusion amount, it is possible to set the emptying amount at step S02 which is the emptying operation constant.
  • the second embodiment in the case of moving the chemical solution 27 using the pumping operation, it is necessary to change the emptying amount in step S02 according to the transfusion amount.
  • the second embodiment is the same as the second embodiment for a small amount of transfusion that does not require a pumping operation.
  • the small amount of transfusion referred to here means, for example, transfusion of 2 ml or less.
  • the case where the first holding unit 21 is moved by the first moving unit 23 has been described, but the second holding unit 22 is moved first while the first holding unit 21 is fixed. Even if it moves by the part 23, it can be set as the same movement relatively.
  • the drug solution transfer method and the drug solution transfer apparatus since the drug solution can be transferred with high accuracy, it is useful, for example, for drug solution transfer in a hospital or the like.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif ou un procédé de transfusion d'un fluide médical, comprenant : une première partie de retenue (21) qui retient un contenant (24) ; une seconde partie de retenue (22) qui retient une seringue (26) à laquelle une aiguille (25) est attachée ; une première partie de déplacement (23) qui déplace la première partie de retenue (21) de haut en bas dans la direction à l'aplomb ; et une partie de commande (40) qui commande la première partie de déplacement (23). Après l'évacuation de l'air externe et de l'air à l'intérieur de l'aiguille (25) en tant qu'espace d'air mort dans la seringue (26) par l'extraction d'un plongeur (26b) de la seringue (26) avant que l'aiguille (25) de la seringue (26) ne perce le contenant (24), la partie de commande (40) réalise un procédé de transfusion d'un fluide médical (27) du contenant de fluide médical (24) à la seringue (26) par l'intermédiaire de l'aiguille (25) par perforation du contenant (24) par l'aiguille (25) et déplacement du plongeur (26b).
PCT/JP2013/000016 2012-01-17 2013-01-08 Procédé de transfusion d'un fluide médical et dispositif de transfusion d'un fluide médical Ceased WO2013108587A1 (fr)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017035360A (ja) * 2015-08-11 2017-02-16 株式会社安川電機 薬液調製方法及び薬液調製システム
WO2019096904A1 (fr) * 2017-11-17 2019-05-23 Sanofi Système de mélange et/ou de reconstitution
WO2022162966A1 (fr) * 2021-01-27 2022-08-04 合同会社Teleimage Dispositif de remplissage d'injecteur
CN115362024A (zh) * 2020-04-02 2022-11-18 吉田工业株式会社 湿式微粒化装置及方法
JP2023052441A (ja) * 2015-11-25 2023-04-11 バイエル・ヘルスケア・エルエルシー シリンジ充填アダプタ

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Publication number Priority date Publication date Assignee Title
JP2010279409A (ja) * 2009-06-02 2010-12-16 Panasonic Corp 薬液吸入用複合針およびこれを用いた薬液容器並びに薬液吸入方法
WO2011010466A1 (fr) * 2009-07-23 2011-01-27 パナソニック株式会社 Dispositif d'entraînement de seringue et dispositif de distribution de médicament

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010279409A (ja) * 2009-06-02 2010-12-16 Panasonic Corp 薬液吸入用複合針およびこれを用いた薬液容器並びに薬液吸入方法
WO2011010466A1 (fr) * 2009-07-23 2011-01-27 パナソニック株式会社 Dispositif d'entraînement de seringue et dispositif de distribution de médicament

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017035360A (ja) * 2015-08-11 2017-02-16 株式会社安川電機 薬液調製方法及び薬液調製システム
JP2023052441A (ja) * 2015-11-25 2023-04-11 バイエル・ヘルスケア・エルエルシー シリンジ充填アダプタ
JP7448697B2 (ja) 2015-11-25 2024-03-12 バイエル・ヘルスケア・エルエルシー シリンジ充填アダプタ
WO2019096904A1 (fr) * 2017-11-17 2019-05-23 Sanofi Système de mélange et/ou de reconstitution
CN111356490A (zh) * 2017-11-17 2020-06-30 赛诺菲 混合和/或重配系统
JP2021503325A (ja) * 2017-11-17 2021-02-12 サノフイＳａｎｏｆｉ 混合および／または再構成システム
US11752263B2 (en) 2017-11-17 2023-09-12 Sanofi Mixing and/or reconstitution system
JP7346402B2 (ja) 2017-11-17 2023-09-19 サノフイ 混合および／または再構成システム
CN115362024A (zh) * 2020-04-02 2022-11-18 吉田工业株式会社 湿式微粒化装置及方法
WO2022162966A1 (fr) * 2021-01-27 2022-08-04 合同会社Teleimage Dispositif de remplissage d'injecteur

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