WO2014054279A1 - Syringe, drug solution injector, sealing member and method for producing sealing member - Google Patents

Syringe, drug solution injector, sealing member and method for producing sealing member Download PDF

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Publication number
WO2014054279A1
WO2014054279A1 PCT/JP2013/005857 JP2013005857W WO2014054279A1 WO 2014054279 A1 WO2014054279 A1 WO 2014054279A1 JP 2013005857 W JP2013005857 W JP 2013005857W WO 2014054279 A1 WO2014054279 A1 WO 2014054279A1
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WO
WIPO (PCT)
Prior art keywords
syringe
seal member
molecular weight
weight polyethylene
sealing member
Prior art date
Application number
PCT/JP2013/005857
Other languages
French (fr)
Japanese (ja)
Inventor
根本 茂
宗仁 栗本
Original Assignee
株式会社根本杏林堂
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 株式会社根本杏林堂 filed Critical 株式会社根本杏林堂
Publication of WO2014054279A1 publication Critical patent/WO2014054279A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513Piston constructions to improve sealing or sliding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14546Front-loading type injectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31515Connection of piston with piston rod
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/14Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
    • B29C45/14778Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles the article consisting of a material with particular properties, e.g. porous, brittle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0222Materials for reducing friction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2207/00Methods of manufacture, assembly or production
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/753Medical equipment; Accessories therefor
    • B29L2031/7544Injection needles, syringes

Definitions

  • the present invention relates to a syringe, particularly a syringe having an ultra high molecular weight polyethylene film bonded thereto, and a syringe for injecting a chemical solution, a seal member used for the syringe, and a method for manufacturing the seal member.
  • a medical instrument having a sliding member such as a gasket, the sliding member comprising a thermoplastic elastomer layer and a thermoplastic synthetic resin layer containing ultrahigh molecular weight polyethylene or the like coated on the outer surface side
  • a medical device that is configured and has a thermoplastic synthetic resin layer containing a lubricating component
  • a syringe as an example of the present invention includes a cylinder for filling a chemical solution, and a seal member that contacts an inner surface of the cylinder and is slidable in the cylinder.
  • a seal member that contacts an inner surface of the cylinder and is slidable in the cylinder.
  • a chemical injection device as another example of the present invention includes the syringe.
  • sealing member of the present invention is a sealing member used in a syringe for injecting a chemical solution
  • the sealing member includes a base and an ultrahigh molecular weight polyethylene film bonded onto the base.
  • the ultra high molecular weight polyethylene film has an ultra high molecular weight polyethylene layer and an adhesive film layer, and is bonded to the substrate via the adhesive film layer.
  • another example of the manufacturing method of the sealing member of the present invention is a manufacturing method of a sealing member used for a syringe for injecting a chemical solution, and the concave member to which the constituent material of the base member of the sealing member is supplied.
  • a first mold provided, and an outer peripheral runner groove having a shape surrounding the recess and a second mold provided with a runner for supplying the constituent material, and the outer peripheral runner groove
  • the base material is formed by supplying the constituent material to the concave portion via the substrate.
  • a syringe 1 for injecting a chemical liquid shown in FIG. 1 is provided at a cylinder 2 for filling the chemical liquid to be injected, a plunger 3 slidable in the cylinder 2, and a tip of the plunger 3. And a seal member 4 that is in contact with the inner surface of the cylinder 2 and is slidable in the cylinder 2.
  • the cylinder 2 has a hollow cylindrical portion, and a winged needle or the like is connected to the distal end portion 21 of the cylinder 2 via a tube (not shown). A slight gap is provided between the portion of the seal member 4 facing the top of the plunger 3 and the top of the plunger 3.
  • the plunger 3 when filling the chemical solution, the plunger 3 is pulled out toward the rear end portion 22 of the cylinder 2, and the cylinder 2 is filled with the chemical solution through a tube or the like.
  • the plunger 3 when injecting the drug solution, the plunger 3 is pushed toward the tip portion 21 of the cylinder 2 to inject the drug solution into the patient's body through a tube or the like.
  • the cylinder 2 and the plunger 3 can be formed from hard resin, soft resin, engineering plastic, glass, or the like.
  • the syringe 1 may be a prefilled syringe in which a chemical solution is filled in a cylinder in advance.
  • a prefilled syringe it is provided with a cylinder 2 filled with a chemical solution in advance, and a tip member 21 of the cylinder 2 is provided with a sealing member for sealing the cylinder 2 so that the chemical solution does not leak.
  • the filled chemical solution is accommodated and held in the cylinder 2 by the sealing member and the seal member 4.
  • a contrast agent, physiological saline, an anticancer agent, etc. are mentioned, for example.
  • Such a syringe 1 is used by being set in an injector which is an automatic injection device.
  • the injector controls the operation of the syringe holding unit to which the syringe 1 filled with the chemical solution is mounted, the plunger 3 of the syringe 1 toward the cylinder 2, the memory, the CPU, and the like. And a control circuit provided.
  • an injector is hold
  • FIG. 2 shows a schematic sectional view showing a central section of the gasket as the sealing member 4 and a schematic external view when viewed from the side.
  • a cross-sectional view is shown on the left side, and an external view is shown on the right side.
  • FIG. 3 shows a schematic front view and a schematic back view of the seal member 4.
  • the front means the surface when the seal member 4 shown in FIG. 2 is viewed from above
  • the back means the surface when the seal member 4 shown in FIG. 2 is viewed from below.
  • FIG. 3 a front view is shown on the upper side, and a back view is shown on the lower side.
  • the sealing member 4 includes a base body 40 and an ultrahigh molecular weight polyethylene film 6 bonded on the base body 40. Further, the seal member 4 has a height of, for example, 9 to 20 mm from the apex of the front end portion 43 to the rear end portion.
  • the ultrahigh molecular weight polyethylene film 6 has a thickness of 10 to 100 ⁇ m, for example.
  • the distal end portion 43 of the seal member 4 has a substantially conical shape and is a portion that comes into contact with the chemical solution filled in the cylinder 2.
  • annular protrusions 41 that are in contact with the inner surface of the cylinder 2 and an annular recess 45 provided between the annular protrusions 41 are formed on the side surface of the seal member 4.
  • the ultrahigh molecular weight polyethylene film 6 is adhered by an adhesive film layer 62 described later so as to be in close contact with the tip portion 43, the annular protrusion 41, and the annular recess 45 of the seal member 4.
  • a recess 46 into which the tip of the plunger 3 is inserted is formed inside the seal member 4.
  • An engagement groove 42 is formed in the recess 46, and the engagement groove 42 can be engaged with a protrusion formed at the tip of the plunger 3 by inserting the tip of the plunger 3.
  • a screw type mooring system in which a screw groove is provided so that the tip of the plunger 3 is formed in a male screw shape, and a screw groove is provided so that the inner surface of the concave portion 46 of the seal member 4 is formed in a female screw shape. You can also.
  • the seal member 4 has a substantially circular outer shape so as to contact the inner surface of the cylindrical portion of the cylinder 2.
  • An opening 47 that communicates with the recess 46 is formed on the rear end side of the seal member 4.
  • the tip of the plunger 3 is inserted into the recess 46 through the opening 47.
  • the substrate 40 can be formed from styrene elastomer, halogenated butyl rubber, styrene butadiene rubber, silicone rubber, or the like.
  • the ultra high molecular weight polyethylene film 6 has an ultra high molecular weight polyethylene layer 61 and an adhesive film layer 62.
  • the ultrahigh molecular weight polyethylene film 6 is bonded to the substrate 40 through the adhesive film layer 62.
  • the adhesive film layer 62 is made of a thermoplastic resin having a melting point lower than that of the ultrahigh molecular weight polyethylene layer 61.
  • the adhesive film layer 62 has a thickness of 10 to 100 ⁇ m, for example.
  • Examples of such adhesive film layer 62 include polyethylene film, polyvinyl alcohol film, ethylene-vinyl acetate copolymer film, ethylene-vinyl alcohol copolymer film, ethylene-methacrylic acid copolymer film, linear low density ( Rhodenity) polyethylene film and the like.
  • a linear low density polyethylene film or an ethylene-vinyl acetate copolymer film is excellent in adhesiveness. Therefore, the adhesive film layer 62 is preferably made of a linear low density polyethylene film or an ethylene-vinyl acetate copolymer film.
  • the adhesive film layer 62 is more preferably composed of a linear low density polyethylene film. Since no harmful additive is used in this linear low density polyethylene film, it is also suitable as a film used in the syringe 1 for injecting a chemical solution.
  • the film for the adhesive film layer 62 includes low density polyethylene, medium density polyethylene, ionomer, ethylene-acrylic acid ester copolymer, ethylene-methacrylic acid ester copolymer, ethylene-propylene copolymer, poly (ethylene butylene). ) Selected from a resin mixture comprising a polystyrene block copolymer and polypropylene, a hydrogenated styrene butadiene rubber and a resin mixture comprising polyethylene, a hydrogenated styrene butadiene rubber and a resin mixture comprising polypropylene, etc. It can be comprised from the resin made.
  • FIG. 5 shows a graph comparing the sliding resistance of the sealing member 4 with that of the comparative sealing member.
  • the vertical axis indicates the plunger pressing force (N), and the horizontal axis indicates the time (sec).
  • silicone oil is applied to the surface of the base made of silicone rubber. The comparison was performed by connecting a 21G winged needle to a 50 ml size syringe filled with water and pushing the plunger into the cylinder with the syringe fixed. The plunger was pushed horizontally with respect to the mounting surface of the syringe, and the plunger pushing force at the time of pushing was measured.
  • a push-pull gauge (tester) was used to measure the plunger pressing force, and the value at the time when the pressing force value did not change during pressing was measured.
  • the syringe which uses a polypropylene resin is used for the syringe.
  • the plunger pressing force of the seal member 4 according to the present embodiment has only a difference of about 20 N from the plunger pressing force of the seal member in the comparative example. It can be said that it has good sliding performance. That is, the same good sliding performance can be exhibited without using silicone oil.
  • this sealing member 4 it is possible to prevent the elution of silicone oil into the chemical solution and the peeling of the coating film.
  • good sliding performance can be exhibited, so that stable chemical injection can be performed.
  • medical solution can also be inject
  • FIG. 6 is a schematic cross-sectional view showing the molding die in a state before molding of the seal member 4, showing the lower die 8 (first die) on the lower side and the upper die 7 ( 2nd mold).
  • FIG. 7 is a schematic cross-sectional view showing a state before the constituent material of the base body 40 is injected in the molding process of the seal member 4.
  • FIG. 8 is a schematic cross section showing a state in which the constituent material of the base body 40 is injected in the molding process of the seal member 4.
  • FIG. 9 is a schematic cross-sectional view for explaining a trimming process for trimming the seal member 4 after the base body 40 is formed.
  • the lower mold 8 and the upper mold 7 are not shown for convenience of explanation.
  • the lower mold 8 includes a recess 81 into which the protruding portion 72 of the upper mold 7 is inserted during molding, and an air vent 85 as an air vent hole.
  • the recess 81 has an inner surface shape corresponding to the outer surface shape of the seal member 4, that is, an inner surface shape that substantially matches the outer surface shape of the seal member 4.
  • the protruding portion 72 is inserted into the recess 81 through the opening 82 of the recess 81.
  • the constituent material of the base body 40 of the seal member 4 is supplied to the recess 81.
  • the upper mold 7 or the lower mold 8 can be moved relative to the other in the vertical direction by a moving mechanism (not shown).
  • the upper mold 7 includes a runner 71 for supplying the constituent material of the base body 40.
  • die 7 is two, one or three or more runners may be sufficient.
  • the upper mold 7 is positioned between the protruding portion 72 having an outer surface shape corresponding to the inner surface shape of the concave portion 46 of the seal member 4, the runner 71 and the protruding portion 72, and the concave portion 81 of the lower mold 8.
  • the outer peripheral runner groove 73 having a shape surrounding the gate, the gate 74 that narrows the flow path of the constituent material of the base 40 when the mold is closed, and the air vent 75 as an air vent hole are provided.
  • the shape of the outer peripheral runner groove 73 can be selected from various shapes such as a circular shape, an elliptical shape, and a polygonal shape.
  • channel 73 of this embodiment has a shape surrounding the opening 82 of the recessed part 81 of the lower metal mold
  • FIG. Furthermore, in the case of this embodiment, the outer periphery runner groove 73 is larger than the outer shape of the seal member 4, and preferably has a circular shape. That is, the outer peripheral runner groove 73 is configured to be located slightly outside the opening 82. Therefore, as shown by the arrow A in FIG. 6, the outer peripheral runner groove 73 has a diameter (inner diameter) larger than the diameter of the opening 82. Thereby, the outer periphery runner groove
  • the width of the gate 74 substantially corresponds to the difference between the inner diameter of the outer peripheral runner groove 73 and the diameter of the opening 82.
  • the lower mold 8 provided with the concave portion 81 and the upper mold 7 provided with the outer peripheral runner groove 73 and the runner 71 are arranged to face each other.
  • the ultrahigh molecular weight polyethylene film 6 is placed on the lower mold 8 so that the adhesive film layer 62 faces the runner 71 side.
  • the protruding portion 72 of the upper mold 7 is brought into contact with the ultrahigh molecular weight polyethylene film 6, and the ultrahigh molecular weight polyethylene film 6 is pushed into the recess 81 of the lower mold 8.
  • the constituent material of the base body 40 is injected from the runner 71 of the upper mold 7.
  • the constituent material of the base body 40 is supplied to the recess 81 through the outer peripheral runner groove 73. Therefore, the constituent material of the base body 40 is guided to the outer peripheral runner groove 73 and flows into the recess 81 from the entire periphery of the protruding portion 72. That is, the constituent material of the base body 40 flows around the inner side of the outer peripheral runner groove 73 and flows into the recess 81.
  • the ultrahigh molecular weight polyethylene film 6 is pushed into the recess 81 from the entire periphery of the protruding portion 72 by the constituent material of the base body 40. Therefore, the ultrahigh molecular weight polyethylene film 6 can be accurately pushed into the recess 81 without performing pre-shaping with the upper mold 7. Thereby, the preliminary shaping process of the ultra high molecular weight polyethylene film 6 can be omitted. Then, after the molding of the seal member 4 is completed, trimming is performed at a position indicated by a dotted line in FIG. 9 to cut off an excess portion protruding from the main body of the seal member 4.
  • a concave portion is formed at a position corresponding to the gate 74 in the protruding portion, and a convex portion is formed at a position corresponding to the runner 71. Therefore, such a recessed part and a convex part are excised by trimming. Thus, the seal member 4 is manufactured. The trimming is performed at a position along the outer shape of the seal member 4.
  • the seal member 4 manufactured in this way is combined with the plunger 3 and the cylinder 2 manufactured separately. That is, the tip of the plunger 3 is inserted into the recess 46 of the seal member 4, and the protrusion formed at the tip of the plunger 3 is engaged with the engagement groove 42 in the recess 46. Then, the plunger 3 to which the seal member 4 is attached is inserted into the cylinder 2. In this way, the syringe 1 is manufactured. Furthermore, in the case of a prefilled syringe, the cylinder 2 is filled with a chemical solution, and a sealing member is attached to the tip portion 21 of the cylinder 2.
  • the gate mark is a protrusion or a recess formed in a portion of the base corresponding to the gate of the mold when the base of the seal member is formed.
  • the runner 171 and the gate 174 of the upper mold 170 for injecting the constituent material of the base 140 are located inside the tip portion of the base 140 of the seal member 104. It is arranged at the corresponding position. Therefore, a gate mark 172 is formed at a position corresponding to the runner 171 inside the tip portion of the base body 140.
  • a gate mark 173 is formed at a position corresponding to the runner 171 (a position corresponding to the air vent 175) outside the tip portion of the base 140.
  • the film 106 is easily peeled off from a portion between the gate mark 173 and the film 106 covering the base 140. Further, the gate mark 173 of the base 140 is also reflected on the outer side of the tip portion of the seal member 104. And since the front-end
  • the outer surface of the distal end portion of the seal member 4 manufactured by the manufacturing method according to the present embodiment is a smooth surface without irregularities as shown in FIG. This is because the position where the runner 71 of the upper mold 7 is provided corresponds to a portion cut out from the main body of the seal member 4 by trimming. Therefore, even if a gate mark is formed at a position corresponding to the runner 71, the gate mark is not left in the main body of the seal member 4 because it is removed by trimming.
  • the runner is provided at such a position, the constituent material of the base body cannot be sufficiently allowed to flow into the recess of the lower mold. That is, since the flow of the constituent material of the base that flows into the recess from the runner is biased, the position where the runner is provided is limited.
  • the outer mold runner groove 73 having a size corresponding to the outer shape of the seal member 4 is provided in the upper mold 7. Therefore, the constituent material of the base body 40 flows into the recess 81 from the entire periphery of the recess 81 of the lower mold 8 by the outer peripheral runner groove 73. Thereby, the flow of the constituent material of the base body flowing from the runner 71 into the concave portion 81 can be prevented from being biased, and the constituent material of the base body 40 can flow into the entire concave portion 81 of the lower mold 8.
  • the runner 71 of the upper mold 7 can be provided at a position corresponding to a portion cut from the main body of the seal member 4 by trimming.
  • gate traces are prevented from being formed on the base body 40 of the seal member 4, and the outer surface of the tip end portion of the seal member 4 becomes a smooth surface with no irregularities.
  • tip part has a smooth surface, the appearance of the sealing member 4 can also be improved.
  • seal member 4 According to the seal member 4 according to the first embodiment described above and the syringe 1 provided with the seal member 4, peeling of the ultrahigh molecular weight polyethylene film 6 can be suppressed. At the same time, it is possible to provide the seal member 4 exhibiting good sliding performance or the syringe 1 provided with the seal member 4. Furthermore, since it is not necessary to use silicone oil, it is possible to prevent elution of silicone oil into the chemical solution and peeling of the coating film.
  • the ultrahigh molecular weight polyethylene layer 61 of the ultrahigh molecular weight polyethylene film 6 from only the ultrahigh molecular weight polyethylene, even the ultrahigh molecular weight polyethylene film 6 not containing silicon can be satisfactorily adhered. If such an ultra high molecular weight polyethylene film 6 is used, elution of silicone oil into the chemical solution and peeling of the coating film can be more reliably prevented.
  • the manufacturing method of the sealing member 4 according to the first embodiment it is possible to manufacture a sealing member that can suppress peeling of the ultrahigh molecular weight polyethylene film and that exhibits good sliding performance. Furthermore, gate traces can be prevented from being formed on the outer surface of the tip portion of the seal member 4. Thereby, the front-end
  • the position where the outer peripheral runner groove 73 of the upper mold 7 is provided may be a position facing the opening 82 of the lower mold 8. Further, the position where the outer peripheral runner groove 73 is provided may be slightly inside the opening 82. Even when the outer peripheral runner groove 73 is provided at such a position, the constituent material of the base body 40 can be poured into the entire recess 81 of the lower mold 8.
  • FIG. 11 is a schematic cross-sectional view showing a state in which the constituent material of the substrate is injected in the molding process of the seal member, showing the upper mold 27 on the upper side and the lower mold 28 on the lower side.
  • the runner 71 of the upper mold 7 is open outside the outer peripheral runner groove 73.
  • the runner 271 of the upper mold 27 opens in the outer peripheral runner groove 273.
  • the upper mold 27 is arranged to face the lower mold 28.
  • the lower mold 28 includes a recess 281 into which the protruding portion 272 of the upper mold 27 is inserted during molding, and an air vent 285 as an air vent hole.
  • the recess 281 has an inner surface shape corresponding to the outer surface shape of the seal member 4, and the protruding portion 272 is inserted into the recess 281 through the opening 282 of the recess 281.
  • the upper mold 27 includes a runner 271 for injecting the constituent material of the base body 40, a projecting portion 272 having an outer surface shape corresponding to the inner surface shape of the concave portion 46 of the seal member 4, and when the mold is closed.
  • a gate 274 for narrowing the flow path of the constituent material of the base 40 and an air vent 275 as an air vent hole are provided.
  • channel 273 can be selected from various shapes similarly to 1st Embodiment.
  • the runner 271 of the upper mold 27 is opened in the outer peripheral runner groove 273.
  • the process of forming the seal member 4 is substantially the same as in the first embodiment. That is, first, the ultrahigh molecular weight polyethylene film 6 is placed on the lower mold 28. Next, the protruding portion 272 of the upper mold 27 is brought into contact with the ultrahigh molecular weight polyethylene film 6, and the ultrahigh molecular weight polyethylene film 6 is pushed into the recess 281 of the lower mold 28. Thereafter, the constituent material of the base body 40 is supplied from the runner 271 of the upper mold 27. At this time, the constituent material of the base body 40 is guided to the outer peripheral runner groove 273 and flows into the recess 281 from the entire periphery of the protruding portion 272.
  • the ultrahigh molecular weight polyethylene film 6 is pushed into the recess 281 from the entire periphery of the protruding portion 272 by the constituent material of the injected base body 40. After the molding, a trimming process is performed, and an excess portion protruding from the main body of the seal member 4 is cut off, whereby the seal member 4 is manufactured.
  • the manufacturing method of the sealing member 4 of the second embodiment it is possible to manufacture a sealing member that can suppress the peeling of the ultrahigh molecular weight polyethylene film and that exhibits good sliding performance. Furthermore, gate traces can be prevented from being formed on the outer surface of the tip portion of the seal member 4. Thereby, the front-end
  • FIG. 12 is a schematic perspective view of a chemical liquid injector (injector) 320 according to the third embodiment. Moreover, FIG.13 and FIG.14 shows the prefilled syringe with which the chemical
  • a chemical solution injection device 320 for injecting a chemical solution such as a contrast medium into a patient is provided with a first syringe 301 and a second syringe 302, an adapter 311 for attaching the first syringe 301, and a second syringe 302. Adapter 312. And the 1st syringe 301 and the 2nd syringe 302 are provided with the sealing member 4 (not shown) mentioned above.
  • a tube 303 is connected to the first syringe 301 and the second syringe 302. Further, the head of the chemical solution injector 320 is rotatably held on an upper portion of a stand pole 317 on a movable stand base 316 placed on the floor surface.
  • the head end side (the side on which the first syringe 301 and the second syringe 302 are mounted) is directed toward the floor, and the rear end side of the head (the side on which the first syringe 301 and the second syringe 302 are not mounted). ) Can be turned to a posture in which the head is directed toward the floor.
  • the chemical solution injector 320 is wired or wirelessly connected to an imaging device (not shown), and various data are transmitted and received between the imaging device and the chemical injector 320 when the chemical solution is injected and when an image is taken.
  • an imaging apparatus include an MRI (Magnetic Resonance Imaging) apparatus, a CT (Computed Tomography) apparatus, an angio imaging apparatus, a PET (Positron Emission Tomography) apparatus, a SPECT (Single Photon Emission Computed Tomography) apparatus, and a CT angio apparatus.
  • MRI Magnetic Resonance Imaging
  • CT Computed Tomography
  • angio imaging apparatus angio imaging apparatus
  • PET Positron Emission Tomography
  • SPECT Single Photon Emission Computed Tomography
  • CT angio apparatus a CT angio apparatus
  • medical imaging devices such as MR angio devices, ultrasonic diagnostic devices, and blood vessel imaging devices.
  • the chemical liquid injector 320 further includes a control device such as a console (not shown).
  • the head of the chemical liquid injector 320 and the control device are wired or wirelessly connected.
  • This control device includes a touch panel and is connected to a hand switch by wire or wirelessly and functions as a controller. Further, the control device prestores operation pattern (injection protocol) data, drug solution data, and the like.
  • injection protocol injection protocol
  • the operator operates the touch panel to input patient physical data such as an injection rate, an injection amount, an injection time, and a body weight, and data on the type of the drug solution.
  • the control device calculates optimal injection conditions according to the input data and data stored in advance. Thereafter, the control device determines the amount of the medical solution to be injected into the patient and the injection protocol based on the calculated injection conditions.
  • the control device determines the amount of the chemical and the injection protocol
  • the control device displays predetermined data or a graph on the touch panel. Then, the operator checks the displayed data or graph and presses the start button on the head if the injection operation is actually started. When the start button is pressed, the injection of the chemical is started. Alternatively, injection can be initiated by pressing a button on the hand switch.
  • the operation pattern (injection protocol) data, drug solution data, and the like can be input from an external storage medium.
  • the first syringe 301 and the second syringe 302 are both prefilled syringes.
  • the cylinders 2 of the first syringe 301 and the second syringe 302 are filled with a chemical solution in advance.
  • the prefilled syringe will be described with reference to FIGS. 13 and 14 by taking the first syringe 301 as an example.
  • the first syringe 301 shown in FIG. 13 is a 200 ml sized prefilled syringe, a schematic perspective view of the entire syringe is shown in the upper left of FIG. 13, and a schematic perspective view of the cylinder 2 viewed from the rear end side is shown in the lower right of FIG. ing.
  • the first syringe 301 includes a cylinder 2 filled with a chemical solution, a plunger 3 slidable in the cylinder 2, and the above-described seal member 4 (not shown) attached to the tip of the plunger 3. Prepare.
  • the plunger 3 is attached by screwing into the seal member 4.
  • a sealing member such as a cap is provided at the tip of the cylinder 2, and the sealing member is removed before the first syringe 301 is attached, and the tube 303 is connected to the tip of the first syringe 301. Is done.
  • a flange is formed at the rear end of the cylinder 2.
  • the flange includes a notch 313 for fitting into the adapter 311 (FIG. 12) of the chemical liquid injector 320, a ring-shaped rib 314, and a rib 315 that rises in the rear end direction of the cylinder 2.
  • the flange of the first syringe 301 can be inserted into the adapter 311 of the chemical liquid injector 320 and rotated to fit the flange into the adapter 311 and be fixed.
  • five ribs 315 are formed, but four or fewer ribs 315 or six or more ribs 315 may be formed.
  • the 1st syringe 301 shown in FIG. 14 is a 100 ml size prefilled syringe, the schematic perspective view of the whole syringe is shown on the upper left, and the schematic perspective view which looked at the cylinder 2 from the rear end side is shown on the lower right.
  • the first syringe 301 also includes a cylinder 2 filled with a chemical, a plunger 3 slidable in the cylinder 2, and the above-described seal member 4 (not shown) attached to the tip of the plunger 3.
  • a flange is formed at the rear end of the cylinder 2, and the flange includes a notch 313 for fitting into the adapter 311 (FIG.
  • the first syringe 301 shown in FIG. 14 is different from FIG. 13 in that it does not have a rib 315 that rises in the rear end direction. However, in FIG. 14, plate-like ribs 315 can be formed.
  • the chemical solution injection system 300 since the above-described seal member 4 is provided, good sliding performance can be exhibited, so that stable chemical solution injection is possible.
  • the 1st syringe 301 or the 2nd syringe 302 syringes of various sizes, such as 200 ml, 100 ml, and 50 ml, can be used.
  • the first syringe 301 or the second syringe 302 may be a suction type syringe that sucks a chemical solution from a chemical solution bag or the like.
  • the method of adhering the ultra high molecular weight polyethylene film 6 is not limited to the method described in the above embodiment.
  • the ultrahigh molecular weight polyethylene film 6 can be bonded using a three-dimensional film forming method. Specifically, adhesion of the ultrahigh molecular weight polyethylene film 6 using a three-dimensional film forming method is performed as follows. First, the base body 40 is set in the lower housing. And the ultra high molecular weight polyethylene film 6 is set between the upper housing and the lower housing facing the lower housing. Thereafter, the upper casing is lowered toward the lower casing, and the space between the upper casing and the lower casing is vacuum-sucked. And the ultra high molecular weight polyethylene film 6 is heated with the heater provided in the upper side housing. Next, the ultrahigh molecular weight polyethylene film 6 is adhered to the substrate 40 by atmospheric pressure or compressed air pressure.
  • the ultrahigh molecular weight polyethylene film 6 can be adhered by blowing compressed air to the portion corresponding to the annular recess 45.
  • This blowing of compressed air can be performed by blowing compressed air through an air hole having an annular shape corresponding to the annular recess 45.
  • the ultrahigh molecular weight polyethylene film 6 can be adhered to the entire annular recess 45 by blowing compressed air through an air hole provided at a position facing the annular recess 45 and rotating the substrate 40.
  • the ultrahigh molecular weight polyethylene film 6 is not limited to a two-layer structure, and may have a layer structure of three or more layers.
  • an ultrahigh molecular weight polyethylene film 6 having a three-layer structure including two adhesive film layers 62 and an ultrahigh molecular weight polyethylene layer 61 may be used.
  • the ultrahigh molecular weight polyethylene layer 61 various films containing ultrahigh molecular weight polyethylene can be used, but it is desirable to use a film composed only of ultrahigh molecular weight polyethylene.
  • the ultrahigh molecular weight polyethylene film 6 was provided on the entire outer surface of the seal member 4.
  • the ultrahigh molecular weight polyethylene film 6 can be provided only in a partial region of the outer surface of the seal member 4, for example, only in a portion that contacts the chemical solution or only in a portion that contacts the inner surface of the cylinder 2. Further, the ultrahigh molecular weight polyethylene film 6 can be adhered to the inner surface of the cylinder 2 similarly to the seal member 4.

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Abstract

The purpose of the present invention is to provide a syringe which is provided with a sealing member that exhibits good sliding performance, while being suppressed in separation of an ultra high molecular weight polyethylene film. A syringe (1) is provided with a cylinder (2) and a sealing member (4) that is in contact with the inner surface of the cylinder (2) and is slidable within the cylinder (2). This syringe (1) is characterized in that: the sealing member (4) comprises a base (40) and an ultra high molecular weight polyethylene film (6) that is bonded onto the base (40); the ultra high molecular weight polyethylene film (6) has an ultra high molecular weight polyethylene layer (61) and an adhesive film layer (62); and the ultra high molecular weight polyethylene film (6) is bonded to the base (40) by means of the adhesive film layer (62).

Description

シリンジ、薬液注入装置、シール部材及びシール部材の製造方法Syringe, chemical injection device, sealing member, and manufacturing method of sealing member
 本発明は、シリンジ、特に超高分子量ポリエチレンフィルムが接着されたシール部材を備え、薬液を注入するためのシリンジ、該シリンジに用いられるシール部材、及び該シール部材の製造方法に関する。 The present invention relates to a syringe, particularly a syringe having an ultra high molecular weight polyethylene film bonded thereto, and a syringe for injecting a chemical solution, a seal member used for the syringe, and a method for manufacturing the seal member.
 従来、ガスケットのような摺動部材を有する医療用器具であって、摺動部材が熱可塑性エラストマー層と、外表面側に被覆された超高分子量ポリエチレン等を含有する熱可塑性合成樹脂層とから構成され、熱可塑性合成樹脂層が潤滑成分を含んでいる医療用器具が知られていた(特許文献1)。 Conventionally, a medical instrument having a sliding member such as a gasket, the sliding member comprising a thermoplastic elastomer layer and a thermoplastic synthetic resin layer containing ultrahigh molecular weight polyethylene or the like coated on the outer surface side There has been known a medical device that is configured and has a thermoplastic synthetic resin layer containing a lubricating component (Patent Document 1).
特開平5-57018号公報JP-A-5-57018
 しかし、このような従来の医療用器具においては、超高分子量ポリエチレン等を含有する樹脂層が摺動部材の基体から剥離しやすいという問題があった。これに対して、ガスケット等のシール部材の表面にシリコーンオイルの塗布膜を形成して摺動性能を向上させる技術も知られている。しかし、シリコーンオイルを使用する場合は、薬液に接触したシリコーンオイルが薬液中へ溶出する可能性が指摘されていた。さらに、形成された塗布膜が剥離して、薬液中に混入する可能性も指摘されていた。 However, such a conventional medical device has a problem that the resin layer containing ultrahigh molecular weight polyethylene or the like is easily peeled off from the base of the sliding member. On the other hand, a technique for improving the sliding performance by forming a coating film of silicone oil on the surface of a sealing member such as a gasket is also known. However, when silicone oil is used, it has been pointed out that silicone oil in contact with the chemical solution may elute into the chemical solution. Furthermore, it has been pointed out that the formed coating film may be peeled off and mixed into the chemical solution.
 上記課題を解決するため、本発明の一例としてのシリンジは、薬液を充填するためのシリンダと、前記シリンダの内面と接触し、前記シリンダ内において摺動可能なシール部材とを備え、前記シール部材は、基体と、前記基体上に接着された超高分子量ポリエチレンフィルムとを有し、前記超高分子量ポリエチレンフィルムは、超高分子量ポリエチレン層及び接着フィルム層を有すると共に、前記接着フィルム層を介して前記基体に接着されていることを特徴とする。 In order to solve the above problems, a syringe as an example of the present invention includes a cylinder for filling a chemical solution, and a seal member that contacts an inner surface of the cylinder and is slidable in the cylinder. Comprises a substrate and an ultrahigh molecular weight polyethylene film adhered on the substrate, the ultrahigh molecular weight polyethylene film having an ultrahigh molecular weight polyethylene layer and an adhesive film layer, and through the adhesive film layer It is bonded to the substrate.
 本発明の他の例としての薬液注入装置は、上記シリンジを備えることを特徴とする。 A chemical injection device as another example of the present invention includes the syringe.
 また、本発明の他の例としてのシール部材は、薬液を注入するためのシリンジに用いられるシール部材であって、前記シール部材は、基体と、前記基体上に接着された超高分子量ポリエチレンフィルムとを有し、前記超高分子量ポリエチレンフィルムは、超高分子量ポリエチレン層及び接着フィルム層を有すると共に、前記接着フィルム層を介して前記基体に接着されていることを特徴とする。 Further, another example of the sealing member of the present invention is a sealing member used in a syringe for injecting a chemical solution, and the sealing member includes a base and an ultrahigh molecular weight polyethylene film bonded onto the base. The ultra high molecular weight polyethylene film has an ultra high molecular weight polyethylene layer and an adhesive film layer, and is bonded to the substrate via the adhesive film layer.
 これにより、超高分子量ポリエチレンフィルムの剥離を抑制することができると共に、良好な摺動性能を発揮するシール部材、及び該シール部材を備えたシリンジ、又は薬液注入装置を提供することができる。さらには、シリコーンオイルを使用する必要がないので、薬液中へのシリコーンオイルの溶出及び塗布膜の剥離を防止することもできる。 Thus, it is possible to provide a seal member that can suppress peeling of the ultrahigh molecular weight polyethylene film and that exhibits good sliding performance, and a syringe or a chemical solution injection device that includes the seal member. Furthermore, since it is not necessary to use silicone oil, it is possible to prevent elution of silicone oil into the chemical solution and peeling of the coating film.
 また、本発明の他の例としてのシール部材の製造方法は、薬液を注入するためのシリンジに用いられるシール部材の製造方法であって、前記シール部材の基体の構成材料が供給される凹部を備えた第1の金型と、前記凹部を囲むような形状を有する外周ランナー溝及び前記構成材料を供給するためのランナーを備えた第2の金型と、を対向配置し、前記外周ランナー溝を介して前記構成材料を前記凹部に供給することにより、前記基体を成形することを特徴とする。 Further, another example of the manufacturing method of the sealing member of the present invention is a manufacturing method of a sealing member used for a syringe for injecting a chemical solution, and the concave member to which the constituent material of the base member of the sealing member is supplied. A first mold provided, and an outer peripheral runner groove having a shape surrounding the recess and a second mold provided with a runner for supplying the constituent material, and the outer peripheral runner groove The base material is formed by supplying the constituent material to the concave portion via the substrate.
 これにより、超高分子量ポリエチレンフィルムの剥離を抑制することができると共に、良好な摺動性能を発揮するシール部材を製造することができる。 Thereby, it is possible to produce a seal member that can suppress peeling of the ultra-high molecular weight polyethylene film and that exhibits good sliding performance.
 本発明のさらなる特徴は、添付図面を参照して例示的に示した以下の実施例の説明から明らかになる。 Further features of the present invention will become apparent from the following description of embodiments, given by way of example with reference to the accompanying drawings.
シリンジの概略断面図である。It is a schematic sectional drawing of a syringe. シール部材の概略断面図及び概略外観図である。It is the schematic sectional drawing and schematic external view of a sealing member. シール部材の概略正面図及び概略裏面図である。It is the schematic front view and schematic back view of a sealing member. 接着された超高分子量ポリエチレンフィルムを示す概略拡大断面図である。It is a general | schematic expanded sectional view which shows the adhere | attached ultra high molecular weight polyethylene film. シール部材の摺動性能を示すグラフである。It is a graph which shows the sliding performance of a sealing member. シール部材の成形工程を説明する概略断面図である。It is a schematic sectional drawing explaining the formation process of a sealing member. シール部材の成形工程を説明する概略断面図である。It is a schematic sectional drawing explaining the formation process of a sealing member. シール部材の成形工程を説明する概略断面図である。It is a schematic sectional drawing explaining the formation process of a sealing member. シール部材のトリミング工程を説明する概略断面図である。It is a schematic sectional drawing explaining the trimming process of a sealing member. 比較例としてのシール部材の成形工程を説明する概略断面図である。It is a schematic sectional drawing explaining the formation process of the sealing member as a comparative example. 第2実施形態に係るシール部材の成形工程を説明する概略断面図である。It is a schematic sectional drawing explaining the formation process of the sealing member which concerns on 2nd Embodiment. 第3実施形態に係る薬液注入装置の概略斜視図である。It is a schematic perspective view of the chemical injection device concerning a 3rd embodiment. 第3実施形態に係るプレフィルドシリンジの概略斜視図である。It is a schematic perspective view of the prefilled syringe which concerns on 3rd Embodiment. 第3実施形態に係るプレフィルドシリンジの概略斜視図である。It is a schematic perspective view of the prefilled syringe which concerns on 3rd Embodiment.
 以下、本発明を実施するための例示的な実施例を、図面を参照して詳細に説明する。ただし、特別な記載がある場合を除き、以下の実施例で説明する寸法、材料、形状、構成要素の相対的な位置等は任意であり、本発明が適用される装置の構成又は様々な条件に応じて変更できる。また、特別な記載がない限り、本発明の範囲は、以下に具体的に記載された実施例に限定されるものではない。 Hereinafter, exemplary embodiments for carrying out the present invention will be described in detail with reference to the drawings. However, unless otherwise specified, the dimensions, materials, shapes, and relative positions of the components described in the following examples are arbitrary, and the configuration of the apparatus to which the present invention is applied or various conditions. Can be changed according to Further, unless otherwise specified, the scope of the present invention is not limited to the examples specifically described below.
[第1実施形態]
 図1に示された薬液を注入するためのシリンジ1は、注入する薬液を充填するためのシリンダ2と、該シリンダ2内において摺動可能なプランジャー3と、該プランジャー3の先端に設けられると共に、シリンダ2の内面と接触し且つシリンダ2内において摺動可能なシール部材4とを備える。シリンダ2は中空の円筒状部分を有しており、シリンダ2の先端部21には不図示のチューブを介して翼状針等が接続される。なお、シール部材4におけるプランジャー3の頂上部に対向する部分と、プランジャー3の頂上部との間には僅かな隙間が設けられている。
[First Embodiment]
A syringe 1 for injecting a chemical liquid shown in FIG. 1 is provided at a cylinder 2 for filling the chemical liquid to be injected, a plunger 3 slidable in the cylinder 2, and a tip of the plunger 3. And a seal member 4 that is in contact with the inner surface of the cylinder 2 and is slidable in the cylinder 2. The cylinder 2 has a hollow cylindrical portion, and a winged needle or the like is connected to the distal end portion 21 of the cylinder 2 via a tube (not shown). A slight gap is provided between the portion of the seal member 4 facing the top of the plunger 3 and the top of the plunger 3.
 このシリンジ1において、薬液を充填するときには、プランジャー3をシリンダ2の後端部22の方向に向かって引き出し、チューブ等を介してシリンダ2内に薬液を充填する。また、薬液を注入するときには、プランジャー3をシリンダ2の先端部21の方向に向かって押し込み、チューブ等を介して患者の体内に薬液を注入する。なお、シリンダ2及びプランジャー3は、硬質樹脂、軟質樹脂、エンジニアリングプラスチック又はガラス等から形成することができる。 In this syringe 1, when filling the chemical solution, the plunger 3 is pulled out toward the rear end portion 22 of the cylinder 2, and the cylinder 2 is filled with the chemical solution through a tube or the like. In addition, when injecting the drug solution, the plunger 3 is pushed toward the tip portion 21 of the cylinder 2 to inject the drug solution into the patient's body through a tube or the like. The cylinder 2 and the plunger 3 can be formed from hard resin, soft resin, engineering plastic, glass, or the like.
 このシリンジ1は、予めシリンダ内に薬液が充填されたプレフィルドシリンジであってもよい。プレフィルドシリンジの場合は、予め薬液が充填されたシリンダ2を備えており、シリンダ2の先端部21には、薬液が漏出しないようにシリンダ2を封止する封止部材が設けられる。充填された薬液は、この封止部材とシール部材4とによってシリンダ2内に収容保持される。なお、プレフィルドシリンジの場合も含め、シリンジ1に充填される薬液としては、例えば、造影剤、生理食塩水又は抗がん剤等が挙げられる。 The syringe 1 may be a prefilled syringe in which a chemical solution is filled in a cylinder in advance. In the case of a prefilled syringe, it is provided with a cylinder 2 filled with a chemical solution in advance, and a tip member 21 of the cylinder 2 is provided with a sealing member for sealing the cylinder 2 so that the chemical solution does not leak. The filled chemical solution is accommodated and held in the cylinder 2 by the sealing member and the seal member 4. In addition, as a chemical | medical solution with which the syringe 1 is filled also including the case of a prefilled syringe, a contrast agent, physiological saline, an anticancer agent, etc. are mentioned, for example.
 このようなシリンジ1は、自動注入装置であるインジェクターにセットして用いられる。インジェクターは、薬液が充填されたシリンジ1が装着されるシリンジ保持部と、該シリンジ1のプランジャー3をシリンダ2に向けて押し込む駆動手段と、駆動手段の動作を制御すると共にメモリ及びCPU等を備える制御回路とを有している。そして、インジェクターは、キャスター付きのスタンド上等に保持され、患者の体内に薬液を注入する際に用いることができる。 Such a syringe 1 is used by being set in an injector which is an automatic injection device. The injector controls the operation of the syringe holding unit to which the syringe 1 filled with the chemical solution is mounted, the plunger 3 of the syringe 1 toward the cylinder 2, the memory, the CPU, and the like. And a control circuit provided. And an injector is hold | maintained on the stand with a caster etc., and can be used when inject | pouring a chemical | medical solution into a patient's body.
 図2は、シール部材4としてのガスケットの中央断面を示す概略断面図と、側方から見た場合の概略外観図を示す。なお、図2においては、左側に断面図を示し、右側に外観図を示している。また、図3は、シール部材4の概略正面図及び概略裏面図を示す。ここで、正面とは図2に示すシール部材4を図面上方から見た場合の表面のことをいい、裏面とは図2に示すシール部材4を図面下方から見た場合の表面のことをいう。なお、図3においては、上側に正面図を示し、下側に裏面図を示す。 FIG. 2 shows a schematic sectional view showing a central section of the gasket as the sealing member 4 and a schematic external view when viewed from the side. In FIG. 2, a cross-sectional view is shown on the left side, and an external view is shown on the right side. FIG. 3 shows a schematic front view and a schematic back view of the seal member 4. Here, the front means the surface when the seal member 4 shown in FIG. 2 is viewed from above, and the back means the surface when the seal member 4 shown in FIG. 2 is viewed from below. . In FIG. 3, a front view is shown on the upper side, and a back view is shown on the lower side.
 シール部材4は、基体40と、基体40上に接着された超高分子量ポリエチレンフィルム6とを備える。また、シール部材4は、先端部43の頂点から後端部までにおいて、例えば、9~20mmの高さを有する。そして、超高分子量ポリエチレンフィルム6は、例えば、10~100μmの厚さを有する。シール部材4の先端部43は、略円錐状の形状を有し、シリンダ2内において充填された薬液と接触する部分である。 The sealing member 4 includes a base body 40 and an ultrahigh molecular weight polyethylene film 6 bonded on the base body 40. Further, the seal member 4 has a height of, for example, 9 to 20 mm from the apex of the front end portion 43 to the rear end portion. The ultrahigh molecular weight polyethylene film 6 has a thickness of 10 to 100 μm, for example. The distal end portion 43 of the seal member 4 has a substantially conical shape and is a portion that comes into contact with the chemical solution filled in the cylinder 2.
 また、シール部材4の側面には、シリンダ2の内面と接触する2つの環状突部41と、環状突部41同士の間に設けられる環状凹部45とが形成されている。そして、超高分子量ポリエチレンフィルム6は、シール部材4の先端部43、環状突部41及び環状凹部45に密着するように、後述する接着フィルム層62により接着されている。さらに、シール部材4の内側にはプランジャー3の先端が挿入される凹部46が形成されている。この凹部46には係合溝42が形成されており、プランジャー3の先端を挿入することにより、係合溝42をプランジャー3の先端に形成された突部と係合させることができる。また、プランジャー3の先端を雄ねじ状に構成するようにねじ溝を設けると共に、シール部材4の凹部46内面を雌ねじ状に構成するようにねじ溝を設けた、ねじ式の係留方式を用いることもできる。 Further, two annular protrusions 41 that are in contact with the inner surface of the cylinder 2 and an annular recess 45 provided between the annular protrusions 41 are formed on the side surface of the seal member 4. The ultrahigh molecular weight polyethylene film 6 is adhered by an adhesive film layer 62 described later so as to be in close contact with the tip portion 43, the annular protrusion 41, and the annular recess 45 of the seal member 4. Further, a recess 46 into which the tip of the plunger 3 is inserted is formed inside the seal member 4. An engagement groove 42 is formed in the recess 46, and the engagement groove 42 can be engaged with a protrusion formed at the tip of the plunger 3 by inserting the tip of the plunger 3. In addition, a screw type mooring system is used in which a screw groove is provided so that the tip of the plunger 3 is formed in a male screw shape, and a screw groove is provided so that the inner surface of the concave portion 46 of the seal member 4 is formed in a female screw shape. You can also.
 図3に示すように、シール部材4は、シリンダ2の円筒状部分の内面に接触するように略円形の外形を有している。また、シール部材4の後端側には、凹部46と連通する開口47が形成されている。そして、プランジャー3の先端は、該開口47を介して凹部46内に挿入される。なお、基体40は、スチレン系エラストマー、ハロゲン化ブチルゴム、スチレンブタジエンゴム又はシリコーンゴム等から形成することができる。 As shown in FIG. 3, the seal member 4 has a substantially circular outer shape so as to contact the inner surface of the cylindrical portion of the cylinder 2. An opening 47 that communicates with the recess 46 is formed on the rear end side of the seal member 4. The tip of the plunger 3 is inserted into the recess 46 through the opening 47. The substrate 40 can be formed from styrene elastomer, halogenated butyl rubber, styrene butadiene rubber, silicone rubber, or the like.
 次に、接着された超高分子量ポリエチレンフィルム6について、図4を参照して説明する。超高分子量ポリエチレンフィルム6は、超高分子量ポリエチレン層61及び接着フィルム層62を有している。そして、超高分子量ポリエチレンフィルム6は、該接着フィルム層62を介して基体40に接着されている。この接着フィルム層62は、超高分子量ポリエチレン層61よりも融点が低い熱可塑性樹脂から構成されている。そして、接着フィルム層62は、例えば、10~100μmの厚さを有する。 Next, the bonded ultra-high molecular weight polyethylene film 6 will be described with reference to FIG. The ultra high molecular weight polyethylene film 6 has an ultra high molecular weight polyethylene layer 61 and an adhesive film layer 62. The ultrahigh molecular weight polyethylene film 6 is bonded to the substrate 40 through the adhesive film layer 62. The adhesive film layer 62 is made of a thermoplastic resin having a melting point lower than that of the ultrahigh molecular weight polyethylene layer 61. The adhesive film layer 62 has a thickness of 10 to 100 μm, for example.
 このような接着フィルム層62としては、例えば、ポリエチレンフィルム、ポリビニルアルコールフィルム、エチレン-酢酸ビニル共重合体フィルム、エチレン-ビニルアルコール共重合体フィルム、エチレン-メタクリル酸共重合体フィルム、リニア低密度(ローデンシティ)ポリエチレンフィルム等が挙げられる。この内、リニア低密度ポリエチレンフィルム又はエチレン-酢酸ビニル共重合体フィルムが接着性に優れている。そのため、接着フィルム層62は、リニア低密度ポリエチレンフィルム又はエチレン-酢酸ビニル共重合体フィルムからなることが好ましい。特に、リニア低密度ポリエチレンフィルムは接着性に優れているので、接着フィルム層62は、リニア低密度ポリエチレンフィルムから構成することがより好ましい。このリニア低密度ポリエチレンフィルムには、有害な添加剤が用いられていないので、薬液を注入するためのシリンジ1に用いられるフィルムとしても好適である。 Examples of such adhesive film layer 62 include polyethylene film, polyvinyl alcohol film, ethylene-vinyl acetate copolymer film, ethylene-vinyl alcohol copolymer film, ethylene-methacrylic acid copolymer film, linear low density ( Rhodenity) polyethylene film and the like. Among these, a linear low density polyethylene film or an ethylene-vinyl acetate copolymer film is excellent in adhesiveness. Therefore, the adhesive film layer 62 is preferably made of a linear low density polyethylene film or an ethylene-vinyl acetate copolymer film. In particular, since the linear low density polyethylene film is excellent in adhesiveness, the adhesive film layer 62 is more preferably composed of a linear low density polyethylene film. Since no harmful additive is used in this linear low density polyethylene film, it is also suitable as a film used in the syringe 1 for injecting a chemical solution.
 また、接着フィルム層62用のフィルムは、低密度ポリエチレン、中密度ポリエチレン、アイオノマー、エチレン-アクリル酸エステル共重合体、エチレン-メタクリル酸エステル共重合体、エチレン-プロピレン共重合体、ポリ(エチレンブチレン)ポリスチレンブロック共重合体およびポリプロピレンを含んでなる樹脂混合物、スチレンブタジエンゴムの水素添加物およびポリエチレンを含んでなる樹脂混合物、及びスチレンブタジエンゴムの水素添加物およびポリプロピレンを含んでなる樹脂混合物等から選択される樹脂から構成することができる。 Further, the film for the adhesive film layer 62 includes low density polyethylene, medium density polyethylene, ionomer, ethylene-acrylic acid ester copolymer, ethylene-methacrylic acid ester copolymer, ethylene-propylene copolymer, poly (ethylene butylene). ) Selected from a resin mixture comprising a polystyrene block copolymer and polypropylene, a hydrogenated styrene butadiene rubber and a resin mixture comprising polyethylene, a hydrogenated styrene butadiene rubber and a resin mixture comprising polypropylene, etc. It can be comprised from the resin made.
 このようなシール部材4の摺動抵抗について、比較例のシール部材と比較したグラフを図5に示す。なお、図5において、縦軸はプランジャー押力(N)を示し、横軸は時間(sec)を示す。また、比較例のシール部材においては、シリコーンゴムから形成された基体の表面にシリコーンオイルを塗布している。比較は、水を充填した50mlサイズのシリンジに21Gの翼状針を接続し、該シリンジを固定した状態で、プランジャーをシリンダ内に押し込むことにより行った。また、プランジャーの押し込みはシリンジの載置面に対して水平に行い、押し込み時のプランジャー押力を測定した。なお、プランジャー押力の測定にはプッシュプルゲージ(テスター)を使用し、押し込み中に押力値が変化しなくなる時点の値を測定した。また、シリンジには、ポリプロビレン樹脂からなるシリンジを用いている。 FIG. 5 shows a graph comparing the sliding resistance of the sealing member 4 with that of the comparative sealing member. In FIG. 5, the vertical axis indicates the plunger pressing force (N), and the horizontal axis indicates the time (sec). Further, in the sealing member of the comparative example, silicone oil is applied to the surface of the base made of silicone rubber. The comparison was performed by connecting a 21G winged needle to a 50 ml size syringe filled with water and pushing the plunger into the cylinder with the syringe fixed. The plunger was pushed horizontally with respect to the mounting surface of the syringe, and the plunger pushing force at the time of pushing was measured. Note that a push-pull gauge (tester) was used to measure the plunger pressing force, and the value at the time when the pressing force value did not change during pressing was measured. Moreover, the syringe which uses a polypropylene resin is used for the syringe.
 図5に示されているように、本実施形態に係るシール部材4のプランジャー押力は、比較例におけるシール部材のプランジャー押力とおおよそ20N程度の相違があるのみであり、同程度の良好な摺動性能を有しているといえる。すなわち、シリコーンオイルを使用せずに、同程度の良好な摺動性能を発揮させることができる。このシール部材4を用いることにより、薬液中へのシリコーンオイルの溶出、及び塗布膜の剥離を防止することができる。さらに、本実施形態に係るシール部材4によれば、良好な摺動性能を発揮させることができるので、安定した薬液の注入が可能となる。また、このようなシール部材4によれば、手動でプランジャー3を押して薬液を注入することもできる。 As shown in FIG. 5, the plunger pressing force of the seal member 4 according to the present embodiment has only a difference of about 20 N from the plunger pressing force of the seal member in the comparative example. It can be said that it has good sliding performance. That is, the same good sliding performance can be exhibited without using silicone oil. By using this sealing member 4, it is possible to prevent the elution of silicone oil into the chemical solution and the peeling of the coating film. Furthermore, according to the seal member 4 according to the present embodiment, good sliding performance can be exhibited, so that stable chemical injection can be performed. Moreover, according to such a sealing member 4, a chemical | medical solution can also be inject | poured by pushing the plunger 3 manually.
 続いて、図6乃至9を参照し、薬液を注入するためのシリンジ1に用いられるシリンジ部材4の製造方法を説明する。図6は、シール部材4の成形前の状態にある成形用金型を示す概略断面図であり、下側に下金型8(第1の金型)を示し、上側に上金型7(第2の金型)を示す。また、図7は、シール部材4の成形工程において、基体40の構成材料を射出する前の状態を示す概略断面図である。また、図8は、シール部材4の成形工程において、基体40の構成材料を射出する状態を示す概略断面である。そして、図9は、基体40を成形した後に、シール部材4のトリミングを行うトリミング工程を説明する概略断面図である。なお、図9においては、説明の便宜のため下金型8及び上金型7の図示を省略している。 Subsequently, a method for manufacturing the syringe member 4 used in the syringe 1 for injecting a chemical solution will be described with reference to FIGS. FIG. 6 is a schematic cross-sectional view showing the molding die in a state before molding of the seal member 4, showing the lower die 8 (first die) on the lower side and the upper die 7 ( 2nd mold). FIG. 7 is a schematic cross-sectional view showing a state before the constituent material of the base body 40 is injected in the molding process of the seal member 4. FIG. 8 is a schematic cross section showing a state in which the constituent material of the base body 40 is injected in the molding process of the seal member 4. FIG. 9 is a schematic cross-sectional view for explaining a trimming process for trimming the seal member 4 after the base body 40 is formed. In FIG. 9, the lower mold 8 and the upper mold 7 are not shown for convenience of explanation.
 図6に示すように、下金型8は、成形時に上金型7の突出部分72が挿入される凹部81と、空気抜き孔としてのエアベント85とを備える。この凹部81は、シール部材4の外面形状に対応する内面形状、すなわち、シール部材4の外面形状にほぼ一致する内面形状を有する。そして、該凹部81内に、突出部分72が凹部81の開口82を介して挿入される。後述するように、この凹部81には、シール部材4の基体40の構成材料が供給される。なお、上金型7又は下金型8は、上下方向において、不図示の移動機構によって他方に対して相対的に移動させることができる。 As shown in FIG. 6, the lower mold 8 includes a recess 81 into which the protruding portion 72 of the upper mold 7 is inserted during molding, and an air vent 85 as an air vent hole. The recess 81 has an inner surface shape corresponding to the outer surface shape of the seal member 4, that is, an inner surface shape that substantially matches the outer surface shape of the seal member 4. Then, the protruding portion 72 is inserted into the recess 81 through the opening 82 of the recess 81. As will be described later, the constituent material of the base body 40 of the seal member 4 is supplied to the recess 81. The upper mold 7 or the lower mold 8 can be moved relative to the other in the vertical direction by a moving mechanism (not shown).
 上金型7は、基体40の構成材料を供給するためのランナー71を備える。なお、本実施形態において、上金型7のランナー71は2つであるが、1つ又は3つ以上のランナーであってもよい。また、上金型7は、シール部材4の凹部46の内面形状に対応する外面形状を有する突出部分72と、ランナー71と突出部分72との間に位置すると共に、下金型8の凹部81を囲むような形状を有する外周ランナー溝73と、金型を閉じたときに基体40の構成材料の流路を狭めるゲート74と、空気抜き孔としてのエアベント75とを備えている。この外周ランナー溝73の形状は、円状、楕円状、多角形状等の種々の形状から選択することができる。 The upper mold 7 includes a runner 71 for supplying the constituent material of the base body 40. In addition, in this embodiment, although the runner 71 of the upper mold | die 7 is two, one or three or more runners may be sufficient. The upper mold 7 is positioned between the protruding portion 72 having an outer surface shape corresponding to the inner surface shape of the concave portion 46 of the seal member 4, the runner 71 and the protruding portion 72, and the concave portion 81 of the lower mold 8. The outer peripheral runner groove 73 having a shape surrounding the gate, the gate 74 that narrows the flow path of the constituent material of the base 40 when the mold is closed, and the air vent 75 as an air vent hole are provided. The shape of the outer peripheral runner groove 73 can be selected from various shapes such as a circular shape, an elliptical shape, and a polygonal shape.
 そして、本実施形態の外周ランナー溝73は、下金型8の凹部81の開口82を囲むような形状を有する。さらに、本実施形態の場合、外周ランナー溝73はシール部材4の外形によりも大きく、好ましくは円状の形状を有する。すなわち、外周ランナー溝73は、開口82の僅かに外側に位置するように構成されている。そのため、図6の矢印Aで示すように、外周ランナー溝73は開口82の径よりも大きい径(内径)を有する。これにより、外周ランナー溝73は、成形されるシール部材4の外寸よりも大きな内径を有することになる。なお、図6においては、ゲート74の幅が、外周ランナー溝73の内径と開口82の径との差に略対応している。 And the outer periphery runner groove | channel 73 of this embodiment has a shape surrounding the opening 82 of the recessed part 81 of the lower metal mold | die 8. FIG. Furthermore, in the case of this embodiment, the outer periphery runner groove 73 is larger than the outer shape of the seal member 4, and preferably has a circular shape. That is, the outer peripheral runner groove 73 is configured to be located slightly outside the opening 82. Therefore, as shown by the arrow A in FIG. 6, the outer peripheral runner groove 73 has a diameter (inner diameter) larger than the diameter of the opening 82. Thereby, the outer periphery runner groove | channel 73 has an internal diameter larger than the outer dimension of the sealing member 4 shape | molded. In FIG. 6, the width of the gate 74 substantially corresponds to the difference between the inner diameter of the outer peripheral runner groove 73 and the diameter of the opening 82.
 シール部材4を成形する場合、まず凹部81を備えた下金型8と、外周ランナー溝73及びランナー71を備えた上金型7とを対向配置する。そして、下金型8上に、超高分子量ポリエチレンフィルム6を接着フィルム層62がランナー71側を向くように載置する。次いで、図7に示すように、上金型7の突出部分72を超高分子量ポリエチレンフィルム6に接触させ、超高分子量ポリエチレンフィルム6を下金型8の凹部81内に押し込む。同時に、図8に示すように、上金型7のランナー71から基体40の構成材料を射出する。このとき、図8の矢印で示すように、外周ランナー溝73を介して基体40の構成材料を凹部81に供給する。そのため、基体40の構成材料は、外周ランナー溝73に導かれて突出部分72の周囲全体から凹部81内に流入する。すなわち、基体40の構成材料は、外周ランナー溝73の内側を回り込むように流れて凹部81内に流入する。 When the seal member 4 is molded, first, the lower mold 8 provided with the concave portion 81 and the upper mold 7 provided with the outer peripheral runner groove 73 and the runner 71 are arranged to face each other. Then, the ultrahigh molecular weight polyethylene film 6 is placed on the lower mold 8 so that the adhesive film layer 62 faces the runner 71 side. Next, as shown in FIG. 7, the protruding portion 72 of the upper mold 7 is brought into contact with the ultrahigh molecular weight polyethylene film 6, and the ultrahigh molecular weight polyethylene film 6 is pushed into the recess 81 of the lower mold 8. At the same time, as shown in FIG. 8, the constituent material of the base body 40 is injected from the runner 71 of the upper mold 7. At this time, as shown by an arrow in FIG. 8, the constituent material of the base body 40 is supplied to the recess 81 through the outer peripheral runner groove 73. Therefore, the constituent material of the base body 40 is guided to the outer peripheral runner groove 73 and flows into the recess 81 from the entire periphery of the protruding portion 72. That is, the constituent material of the base body 40 flows around the inner side of the outer peripheral runner groove 73 and flows into the recess 81.
 そして、超高分子量ポリエチレンフィルム6は、基体40の構成材料によって、突出部分72の周囲全体から凹部81内に押し込まれる。そのため、上金型7によって予備賦形をしなくとも、超高分子量ポリエチレンフィルム6を凹部81内に精度よく押し込むことができる。これにより、超高分子量ポリエチレンフィルム6の予備賦形工程を省略することができる。そして、シール部材4の成形が完了した後は、図9の点線で示す位置でトリミングを行い、シール部材4の本体からはみ出した余分な部分を切除する。具体的には、該はみ出した部分には、ゲート74に対応する位置に凹部が形成されており、ランナー71に対応する位置に凸部が形成されている。そのため、このような凹部及び凸部が、トリミングによって切除される。こうして、シール部材4が製造される。なお、トリミングは、シール部材4の外形に沿った位置で行われる。 Then, the ultrahigh molecular weight polyethylene film 6 is pushed into the recess 81 from the entire periphery of the protruding portion 72 by the constituent material of the base body 40. Therefore, the ultrahigh molecular weight polyethylene film 6 can be accurately pushed into the recess 81 without performing pre-shaping with the upper mold 7. Thereby, the preliminary shaping process of the ultra high molecular weight polyethylene film 6 can be omitted. Then, after the molding of the seal member 4 is completed, trimming is performed at a position indicated by a dotted line in FIG. 9 to cut off an excess portion protruding from the main body of the seal member 4. Specifically, a concave portion is formed at a position corresponding to the gate 74 in the protruding portion, and a convex portion is formed at a position corresponding to the runner 71. Therefore, such a recessed part and a convex part are excised by trimming. Thus, the seal member 4 is manufactured. The trimming is performed at a position along the outer shape of the seal member 4.
 このように製造されたシール部材4は、別途製造されたプランジャー3及びシリンダ2と組み合わされる。すなわち、シール部材4の凹部46にプランジャー3の先端を挿入して、凹部46内の係合溝42にプランジャー3の先端に形成された突部を係合させる。そして、シール部材4が取り付けられたプランジャー3を、シリンダ2内に挿入する。このようにして、シリンジ1が製造される。さらに、プレフィルドシリンジの場合は、シリンダ2に薬液を充填し、シリンダ2の先端部21に封止部材を取り付ける。 The seal member 4 manufactured in this way is combined with the plunger 3 and the cylinder 2 manufactured separately. That is, the tip of the plunger 3 is inserted into the recess 46 of the seal member 4, and the protrusion formed at the tip of the plunger 3 is engaged with the engagement groove 42 in the recess 46. Then, the plunger 3 to which the seal member 4 is attached is inserted into the cylinder 2. In this way, the syringe 1 is manufactured. Furthermore, in the case of a prefilled syringe, the cylinder 2 is filled with a chemical solution, and a sealing member is attached to the tip portion 21 of the cylinder 2.
 本実施形態に係るシール部材4の製造方法によれば、シール部材4の基体40にゲート痕が形成されてしまうことを防止することができる。ここでゲート痕とは、シール部材の基体を成形する際に、基体における金型のゲートに対応する部分に形成される突部又は凹部のことである。この点、従来の成形方法においては、図10に示すように、基体140の構成材料を射出するための上金型170のランナー171及びゲート174が、シール部材104の基体140の先端部分内側に対応する位置に配置される。そのため、基体140の先端部分内側には、ランナー171と対応する位置にゲート痕172が形成されてしまう。一方、基体140の先端部分外側には、ランナー171と対応する位置(エアベント175と対応する位置)にゲート痕173が形成されてしまう。 According to the manufacturing method of the seal member 4 according to the present embodiment, it is possible to prevent the gate mark from being formed on the base body 40 of the seal member 4. Here, the gate mark is a protrusion or a recess formed in a portion of the base corresponding to the gate of the mold when the base of the seal member is formed. In this regard, in the conventional molding method, as shown in FIG. 10, the runner 171 and the gate 174 of the upper mold 170 for injecting the constituent material of the base 140 are located inside the tip portion of the base 140 of the seal member 104. It is arranged at the corresponding position. Therefore, a gate mark 172 is formed at a position corresponding to the runner 171 inside the tip portion of the base body 140. On the other hand, a gate mark 173 is formed at a position corresponding to the runner 171 (a position corresponding to the air vent 175) outside the tip portion of the base 140.
 そして、ゲート痕173が形成されてしまうと、該ゲート痕173と基体140を被覆するフィルム106との間の部分から、フィルム106が剥離しやすくなってしまう。さらに、基体140のゲート痕173は、シール部材104の先端部分外側にも反映される。そして、シール部材104の先端部分外側は薬液と接触するため、薬液内に気泡が生じてしまう可能性がある。すなわち、先端部分外側の凹部に微小気泡が集まることにより、薬液内に気泡が生じやすくなってしまう。また、このような凹部が形成されたシール部材104は、見た目が悪いという問題もある。 When the gate mark 173 is formed, the film 106 is easily peeled off from a portion between the gate mark 173 and the film 106 covering the base 140. Further, the gate mark 173 of the base 140 is also reflected on the outer side of the tip portion of the seal member 104. And since the front-end | tip part outer side of the sealing member 104 contacts with a chemical | medical solution, there exists a possibility that a bubble may arise in a chemical | medical solution. That is, air bubbles are likely to be generated in the chemical liquid due to the collection of micro bubbles in the concave portion outside the tip portion. Further, the sealing member 104 having such a recess has a problem that it looks bad.
 これに対して、本実施形態に係る製造方法により製造されたシール部材4の先端部分外面は、図2に示すように凹凸が無い滑らかな表面となる。これは、上金型7のランナー71が設けられている位置が、シール部材4の本体からトリミングによって切除される部分に対応するからである。そのため、仮にランナー71に対応する位置にゲート痕が形成されても、トリミングによって切除されるので、シール部材4の本体にゲート痕が残ることはない。この点、従来の製造方法において、このような位置にランナーを設けようとすると、基体の構成材料を下金型の凹部内に十分に流入させることができなかった。すなわち、ランナーから凹部内に流入する基体の構成材料の流れが偏ってしまうため、ランナーを設ける位置が制限されていた。 On the other hand, the outer surface of the distal end portion of the seal member 4 manufactured by the manufacturing method according to the present embodiment is a smooth surface without irregularities as shown in FIG. This is because the position where the runner 71 of the upper mold 7 is provided corresponds to a portion cut out from the main body of the seal member 4 by trimming. Therefore, even if a gate mark is formed at a position corresponding to the runner 71, the gate mark is not left in the main body of the seal member 4 because it is removed by trimming. In this regard, in the conventional manufacturing method, if the runner is provided at such a position, the constituent material of the base body cannot be sufficiently allowed to flow into the recess of the lower mold. That is, since the flow of the constituent material of the base that flows into the recess from the runner is biased, the position where the runner is provided is limited.
 これに対して、本実施形態に係る製造方法においては、シール部材4の外形に対応する大きさを有する外周ランナー溝73が上金型7に設けられている。そのため、該外周ランナー溝73により、基体40の構成材料は、下金型8の凹部81の周囲全体から凹部81内に流入する。これにより、ランナー71から凹部81内に流入する基体の構成材料の流れが偏ることを防止し、基体40の構成材料を下金型8の凹部81の全体に流入させることができる。したがって、本実施形態に係る製造方法によれば、シール部材4の本体からトリミングによって切除される部分に対応する位置に、上金型7のランナー71を設けることができる。これにより、シール部材4の基体40にゲート痕が形成されてしまうことを防止し、シール部材4の先端部分外面は凹凸が無い滑らかな表面となる。そして、先端部分が滑らかな表面を有するため、シール部材4の見た目も向上させることができる。 In contrast, in the manufacturing method according to the present embodiment, the outer mold runner groove 73 having a size corresponding to the outer shape of the seal member 4 is provided in the upper mold 7. Therefore, the constituent material of the base body 40 flows into the recess 81 from the entire periphery of the recess 81 of the lower mold 8 by the outer peripheral runner groove 73. Thereby, the flow of the constituent material of the base body flowing from the runner 71 into the concave portion 81 can be prevented from being biased, and the constituent material of the base body 40 can flow into the entire concave portion 81 of the lower mold 8. Therefore, according to the manufacturing method according to the present embodiment, the runner 71 of the upper mold 7 can be provided at a position corresponding to a portion cut from the main body of the seal member 4 by trimming. As a result, gate traces are prevented from being formed on the base body 40 of the seal member 4, and the outer surface of the tip end portion of the seal member 4 becomes a smooth surface with no irregularities. And since the front-end | tip part has a smooth surface, the appearance of the sealing member 4 can also be improved.
 以上説明した第1実施形態に係るシール部材4、及び該シール部材4を備えたシリンジ1によれば、超高分子量ポリエチレンフィルム6の剥離を抑制することができる。同時に、良好な摺動性能を発揮するシール部材4、又は該シール部材4を備えたシリンジ1を提供することができる。さらには、シリコーンオイルを使用する必要がないので、薬液中へのシリコーンオイルの溶出及び塗布膜の剥離を防止することもできる。 According to the seal member 4 according to the first embodiment described above and the syringe 1 provided with the seal member 4, peeling of the ultrahigh molecular weight polyethylene film 6 can be suppressed. At the same time, it is possible to provide the seal member 4 exhibiting good sliding performance or the syringe 1 provided with the seal member 4. Furthermore, since it is not necessary to use silicone oil, it is possible to prevent elution of silicone oil into the chemical solution and peeling of the coating film.
 さらに、超高分子量ポリエチレンフィルム6の超高分子量ポリエチレン層61を超高分子量ポリエチレンのみから構成することにより、シリコンを含まない超高分子量ポリエチレンフィルム6であっても良好に接着させることができる。このような超高分子量ポリエチレンフィルム6を使用すれば、薬液中へのシリコーンオイルの溶出及び塗布膜の剥離をより確実に防止することができる。 Furthermore, by forming the ultrahigh molecular weight polyethylene layer 61 of the ultrahigh molecular weight polyethylene film 6 from only the ultrahigh molecular weight polyethylene, even the ultrahigh molecular weight polyethylene film 6 not containing silicon can be satisfactorily adhered. If such an ultra high molecular weight polyethylene film 6 is used, elution of silicone oil into the chemical solution and peeling of the coating film can be more reliably prevented.
 また、第1実施形態に係るシール部材4の製造方法によれば、超高分子量ポリエチレンフィルムの剥離を抑制することができると共に、良好な摺動性能を発揮するシール部材を製造することができる。さらに、シール部材4の先端部分外面にゲート痕が形成されることを防止できる。これにより、シール部材4の先端部分外面を、凹凸が無い滑らかな表面とすることができる。さらに、予備賦形工程を省略できるので、製造コストを低減することができると共に、製造時間を短縮することができる。 Moreover, according to the manufacturing method of the sealing member 4 according to the first embodiment, it is possible to manufacture a sealing member that can suppress peeling of the ultrahigh molecular weight polyethylene film and that exhibits good sliding performance. Furthermore, gate traces can be prevented from being formed on the outer surface of the tip portion of the seal member 4. Thereby, the front-end | tip part outer surface of the sealing member 4 can be made into the smooth surface without an unevenness | corrugation. Furthermore, since the preliminary shaping step can be omitted, the manufacturing cost can be reduced and the manufacturing time can be shortened.
 なお、上金型7の外周ランナー溝73を設ける位置は、下金型8の開口82に対向する位置であってもよい。また、外周ランナー溝73を設ける位置は、開口82の僅かに内側であってもよい。このような位置に外周ランナー溝73を設けた場合であっても、下金型8の凹部81全体に基体40の構成材料を流し込むことができる。 The position where the outer peripheral runner groove 73 of the upper mold 7 is provided may be a position facing the opening 82 of the lower mold 8. Further, the position where the outer peripheral runner groove 73 is provided may be slightly inside the opening 82. Even when the outer peripheral runner groove 73 is provided at such a position, the constituent material of the base body 40 can be poured into the entire recess 81 of the lower mold 8.
[第2実施形態]
 続いて図11を参照して第2実施形態に係るシール部材4の製造方法を説明する。なお、第2実施形態の説明においては、第1実施形態との相違点について説明し、第1実施形態で説明した構成要素については同じ参照番号を付し、その説明を省略する。特に説明した場合を除き、同じ参照符号を付した構成要素は略同一の動作及び機能を奏し、その作用効果も略同一である。
[Second Embodiment]
Then, with reference to FIG. 11, the manufacturing method of the sealing member 4 which concerns on 2nd Embodiment is demonstrated. In the description of the second embodiment, differences from the first embodiment will be described, and the components described in the first embodiment will be denoted by the same reference numerals and description thereof will be omitted. Except for the case where it is specifically described, the components given the same reference numerals perform substantially the same operations and functions, and the effects thereof are also substantially the same.
 図11は、シール部材の成形工程において、基体の構成材料を射出する状態を示す概略断面図であり、上側に上金型27を示し、下側に下金型28を示す。第1実施形態においては、上金型7のランナー71が、外周ランナー溝73の外側で開口していた。一方、第2実施形態においては、上金型27のランナー271は、外周ランナー溝273内において開口する。 FIG. 11 is a schematic cross-sectional view showing a state in which the constituent material of the substrate is injected in the molding process of the seal member, showing the upper mold 27 on the upper side and the lower mold 28 on the lower side. In the first embodiment, the runner 71 of the upper mold 7 is open outside the outer peripheral runner groove 73. On the other hand, in the second embodiment, the runner 271 of the upper mold 27 opens in the outer peripheral runner groove 273.
 第1実施形態と同様に、上金型27は下金型28に対向するように配置される。そして、下金型28は、成形時に上金型27の突出部分272が挿入される凹部281と、空気抜き孔としてのエアベント285とを備える。この凹部281は、シール部材4の外面形状に対応する内面形状を有し、突出部分272は凹部281の開口282を介して該凹部281内に挿入される。一方、上金型27は、基体40の構成材料を射出するためのランナー271と、シール部材4の凹部46の内面形状に対応する外面形状を有する突出部分272と、金型を閉じたときに基体40の構成材料の流路を狭めるゲート274と、空気抜き孔としてのエアベント275とを備える。なお、第1実施形態と同様に、外周ランナー溝273の形状は種々の形状から選択することができる。そして、第2実施形態においては、上金型27のランナー271が、外周ランナー溝273内において開口している。 As in the first embodiment, the upper mold 27 is arranged to face the lower mold 28. The lower mold 28 includes a recess 281 into which the protruding portion 272 of the upper mold 27 is inserted during molding, and an air vent 285 as an air vent hole. The recess 281 has an inner surface shape corresponding to the outer surface shape of the seal member 4, and the protruding portion 272 is inserted into the recess 281 through the opening 282 of the recess 281. On the other hand, the upper mold 27 includes a runner 271 for injecting the constituent material of the base body 40, a projecting portion 272 having an outer surface shape corresponding to the inner surface shape of the concave portion 46 of the seal member 4, and when the mold is closed. A gate 274 for narrowing the flow path of the constituent material of the base 40 and an air vent 275 as an air vent hole are provided. In addition, the shape of the outer periphery runner groove | channel 273 can be selected from various shapes similarly to 1st Embodiment. In the second embodiment, the runner 271 of the upper mold 27 is opened in the outer peripheral runner groove 273.
 第2実施形態においても、シール部材4を成形する工程は第1実施形態と略同様である。すなわち、まず下金型28上に超高分子量ポリエチレンフィルム6を配置する。次いで、上金型27の突出分272を超高分子量ポリエチレンフィルム6に接触させ、超高分子量ポリエチレンフィルム6を下金型28の凹部281内に押し込む。その後、上金型27のランナー271から基体40の構成材料を供給する。このとき、基体40の構成材料は、外周ランナー溝273に導かれて突出部分272の周囲全体から凹部281内に流入する。そのため、超高分子量ポリエチレンフィルム6は、射出された基体40の構成材料によって、突出部分272の周囲全体から凹部281内に押し込まれる。成形後には、トリミング工程を行い、シール部材4の本体からはみ出した余分な部分を切除して、シール部材4が製造される。 Also in the second embodiment, the process of forming the seal member 4 is substantially the same as in the first embodiment. That is, first, the ultrahigh molecular weight polyethylene film 6 is placed on the lower mold 28. Next, the protruding portion 272 of the upper mold 27 is brought into contact with the ultrahigh molecular weight polyethylene film 6, and the ultrahigh molecular weight polyethylene film 6 is pushed into the recess 281 of the lower mold 28. Thereafter, the constituent material of the base body 40 is supplied from the runner 271 of the upper mold 27. At this time, the constituent material of the base body 40 is guided to the outer peripheral runner groove 273 and flows into the recess 281 from the entire periphery of the protruding portion 272. Therefore, the ultrahigh molecular weight polyethylene film 6 is pushed into the recess 281 from the entire periphery of the protruding portion 272 by the constituent material of the injected base body 40. After the molding, a trimming process is performed, and an excess portion protruding from the main body of the seal member 4 is cut off, whereby the seal member 4 is manufactured.
 このような第2実施形態のシール部材4の製造方法によっても、超高分子量ポリエチレンフィルムの剥離を抑制することができると共に、良好な摺動性能を発揮するシール部材を製造することができる。さらに、シール部材4の先端部分外面にゲート痕が形成されることを防止できる。これにより、シール部材4の先端部分外面を、凹凸が無い滑らかな表面とすることができる。さらに、予備賦形工程を省略できるので、製造コストを低減することができると共に、製造時間を短縮することができる。 Also by the manufacturing method of the sealing member 4 of the second embodiment, it is possible to manufacture a sealing member that can suppress the peeling of the ultrahigh molecular weight polyethylene film and that exhibits good sliding performance. Furthermore, gate traces can be prevented from being formed on the outer surface of the tip portion of the seal member 4. Thereby, the front-end | tip part outer surface of the sealing member 4 can be made into the smooth surface without an unevenness | corrugation. Furthermore, since the preliminary shaping step can be omitted, the manufacturing cost can be reduced and the manufacturing time can be shortened.
[第3実施形態]
 図12は、第3実施形態に係る薬液注入装置(インジェクター)320の概略斜視図を示す。また、図13及び図14は第3実施形態に係る薬液注入装置320に装着されるプレフィルドシリンジを示す。
[Third Embodiment]
FIG. 12 is a schematic perspective view of a chemical liquid injector (injector) 320 according to the third embodiment. Moreover, FIG.13 and FIG.14 shows the prefilled syringe with which the chemical | medical solution injection apparatus 320 which concerns on 3rd Embodiment is mounted | worn.
 患者に造影剤等の薬液を注入するための薬液注入装置320は、第1シリンジ301及び第2シリンジ302と、第1シリンジ301を装着するためのアダプター311と、第2シリンジ302を装着するためのアダプター312とを備えている。そして、第1シリンジ301及び第2シリンジ302は、上述したシール部材4(不図示)を備えている。この第1シリンジ301及び第2シリンジ302には、チューブ303が接続される。また、薬液注入装置320のヘッドは、床面に置かれた可動式のスタンドベース316上のスタンドポール317の上部に回動自在に保持されている。これにより、ヘッドの先端側(第1シリンジ301及び第2シリンジ302が装着される側)を床面に向ける姿勢と、ヘッドの後端側(第1シリンジ301及び第2シリンジ302が装着されない側)を床面に向ける姿勢とにヘッドを回動できる。 A chemical solution injection device 320 for injecting a chemical solution such as a contrast medium into a patient is provided with a first syringe 301 and a second syringe 302, an adapter 311 for attaching the first syringe 301, and a second syringe 302. Adapter 312. And the 1st syringe 301 and the 2nd syringe 302 are provided with the sealing member 4 (not shown) mentioned above. A tube 303 is connected to the first syringe 301 and the second syringe 302. Further, the head of the chemical solution injector 320 is rotatably held on an upper portion of a stand pole 317 on a movable stand base 316 placed on the floor surface. Accordingly, the head end side (the side on which the first syringe 301 and the second syringe 302 are mounted) is directed toward the floor, and the rear end side of the head (the side on which the first syringe 301 and the second syringe 302 are not mounted). ) Can be turned to a posture in which the head is directed toward the floor.
 薬液注入装置320は、撮像装置(不図示)に有線又は無線接続され、薬液の注入時及び画像の撮影時には撮像装置と薬液注入装置320との間で各種データが送受信される。このような撮像装置としては、例えば、MRI(Magnetic Resonance Imaging)装置、CT(Computed Tomography)装置、アンギオ撮像装置、PET(Positron Emission Tomography)装置、SPECT(Single Photon Emission Computed Tomography)装置、CTアンギオ装置、MRアンギオ装置、超音波診断装置、血管撮像装置等の各種医療用撮像装置がある。 The chemical solution injector 320 is wired or wirelessly connected to an imaging device (not shown), and various data are transmitted and received between the imaging device and the chemical injector 320 when the chemical solution is injected and when an image is taken. Examples of such an imaging apparatus include an MRI (Magnetic Resonance Imaging) apparatus, a CT (Computed Tomography) apparatus, an angio imaging apparatus, a PET (Positron Emission Tomography) apparatus, a SPECT (Single Photon Emission Computed Tomography) apparatus, and a CT angio apparatus. There are various medical imaging devices such as MR angio devices, ultrasonic diagnostic devices, and blood vessel imaging devices.
 また、薬液注入装置320は、不図示のコンソール等の制御装置をさらに備える。そして、薬液注入装置320のヘッドと制御装置とは、有線又は無線接続されている。この制御装置は、タッチパネルを備えると共に、ハンドスイッチに有線又は無線接続されており、コントローラーとして機能する。また、制御装置には、動作パターン(注入プロトコル)のデータ、及び薬液のデータ等が予め記憶されている。患者に薬液を注入する場合、オペレータは、タッチパネルを操作して、注入速度、注入量、注入時間、体重などの患者の身体的データ、及び薬液の種類のデータ等を入力する。そして、制御装置は、入力されたデータと予め記憶されているデータに応じて、最適な注入条件を算出する。その後、制御装置は、算出された注入条件に基づいて、患者に注入する薬液の量及び注入プロトコルを決定する。 Moreover, the chemical liquid injector 320 further includes a control device such as a console (not shown). The head of the chemical liquid injector 320 and the control device are wired or wirelessly connected. This control device includes a touch panel and is connected to a hand switch by wire or wirelessly and functions as a controller. Further, the control device prestores operation pattern (injection protocol) data, drug solution data, and the like. When injecting a drug solution into a patient, the operator operates the touch panel to input patient physical data such as an injection rate, an injection amount, an injection time, and a body weight, and data on the type of the drug solution. Then, the control device calculates optimal injection conditions according to the input data and data stored in advance. Thereafter, the control device determines the amount of the medical solution to be injected into the patient and the injection protocol based on the calculated injection conditions.
 制御装置は、薬液の量及び注入プロトコルを決定すると、所定のデータ又はグラフなどをタッチパネルに表示させる。そして、オペレータは、表示されたデータ又はグラフなどを確認し、実際に注入動作をスタートさせるならばヘッドのスタートボタンを押す。スタートボタンが押されると薬液の注入が開始される。また、ハンドスイッチのボタンを押して注入を開始することもできる。なお、動作パターン(注入プロトコル)のデータ、及び薬液のデータ等は、外部の記憶媒体から入力することもできる。 When the control device determines the amount of the chemical and the injection protocol, the control device displays predetermined data or a graph on the touch panel. Then, the operator checks the displayed data or graph and presses the start button on the head if the injection operation is actually started. When the start button is pressed, the injection of the chemical is started. Alternatively, injection can be initiated by pressing a button on the hand switch. Note that the operation pattern (injection protocol) data, drug solution data, and the like can be input from an external storage medium.
 第3実施形態においては、第1シリンジ301及び第2シリンジ302がいずれもプレフィルドシリンジである。そして、第1シリンジ301及び第2シリンジ302のシリンダ2には予めに薬液が充填されている。このプレフィルドシリンジについて、第1シリンジ301を例に、図13及び図14を参照して説明する。 In the third embodiment, the first syringe 301 and the second syringe 302 are both prefilled syringes. The cylinders 2 of the first syringe 301 and the second syringe 302 are filled with a chemical solution in advance. The prefilled syringe will be described with reference to FIGS. 13 and 14 by taking the first syringe 301 as an example.
 図13に示す第1シリンジ301は、200mlサイズのプレフィルドシリンジであり、シリンジ全体の概略斜視図を図13左上に示し、シリンダ2を後端側から見た概略斜視図を図13右下に示している。この第1シリンジ301は、薬液が充填されたシリンダ2と、該シリンダ2内において摺動可能なプランジャー3と、該プランジャー3の先端に取り付けられる上述したシール部材4(不図示)とを備える。そして、プランジャー3は、シール部材4にねじ込むことによって取り付けられている。シリンダ2の先端部には、キャップ等の封止部材(不図示)が設けられており、第1シリンジ301を装着する前に封止部材が外されチューブ303が第1シリンジ301の先端に接続される。 The first syringe 301 shown in FIG. 13 is a 200 ml sized prefilled syringe, a schematic perspective view of the entire syringe is shown in the upper left of FIG. 13, and a schematic perspective view of the cylinder 2 viewed from the rear end side is shown in the lower right of FIG. ing. The first syringe 301 includes a cylinder 2 filled with a chemical solution, a plunger 3 slidable in the cylinder 2, and the above-described seal member 4 (not shown) attached to the tip of the plunger 3. Prepare. The plunger 3 is attached by screwing into the seal member 4. A sealing member (not shown) such as a cap is provided at the tip of the cylinder 2, and the sealing member is removed before the first syringe 301 is attached, and the tube 303 is connected to the tip of the first syringe 301. Is done.
 また、シリンダ2の後端にはフランジが形成されている。そして、フランジは、薬液注入装置320のアダプター311(図12)に嵌めるための切り欠き313と、リング状のリブ314と、シリンダ2の後端方向に立ち上がったリブ315とを有する。そして、第1シリンジ301を装着する際には、第1シリンジ301のフランジを薬液注入装置320のアダプター311に挿入し回転させることにより、フランジをアダプター311に嵌めて固定することができる。なお、図13においてはリブ315が5つ形成されているが、4つ以下又は6つ以上のリブ315を形成することもできる。 Also, a flange is formed at the rear end of the cylinder 2. The flange includes a notch 313 for fitting into the adapter 311 (FIG. 12) of the chemical liquid injector 320, a ring-shaped rib 314, and a rib 315 that rises in the rear end direction of the cylinder 2. When mounting the first syringe 301, the flange of the first syringe 301 can be inserted into the adapter 311 of the chemical liquid injector 320 and rotated to fit the flange into the adapter 311 and be fixed. In FIG. 13, five ribs 315 are formed, but four or fewer ribs 315 or six or more ribs 315 may be formed.
 一方、図14に示す第1シリンジ301は、100mlサイズのプレフィルドシリンジであり、シリンジ全体の概略斜視図を左上に示し、シリンダ2を後端側から見た概略斜視図を右下に示している。この第1シリンジ301も、薬液が充填されたシリンダ2と、該シリンダ2内において摺動可能なプランジャー3と、該プランジャー3の先端に取り付けられる上述したシール部材4(不図示)とを備える。図14においても、シリンダ2の後端にはフランジが形成されており、該フランジは、薬液注入装置320のアダプター311(図12)に嵌めるための切り欠き313と、リング状のリブ314とを有する。この図14に示す第1シリンジ301は、後端方向に立ち上がったリブ315を有していない点で図13とは異なる。ただし、図14において、板状のリブ315を形成することもできる。 On the other hand, the 1st syringe 301 shown in FIG. 14 is a 100 ml size prefilled syringe, the schematic perspective view of the whole syringe is shown on the upper left, and the schematic perspective view which looked at the cylinder 2 from the rear end side is shown on the lower right. . The first syringe 301 also includes a cylinder 2 filled with a chemical, a plunger 3 slidable in the cylinder 2, and the above-described seal member 4 (not shown) attached to the tip of the plunger 3. Prepare. Also in FIG. 14, a flange is formed at the rear end of the cylinder 2, and the flange includes a notch 313 for fitting into the adapter 311 (FIG. 12) of the chemical liquid injector 320 and a ring-shaped rib 314. Have. The first syringe 301 shown in FIG. 14 is different from FIG. 13 in that it does not have a rib 315 that rises in the rear end direction. However, in FIG. 14, plate-like ribs 315 can be formed.
 このような第3実施形態に係る薬液注入システム300によれば、上述したシール部材4を備えることにより良好な摺動性能を発揮させることができるので、安定した薬液の注入が可能となる。なお、第1シリンジ301又は第2シリンジ302としては、200ml、100ml、50ml等の各種サイズのシリンジを用いることができる。また、第1シリンジ301又は第2シリンジ302は、薬液バッグ等から薬液を吸引する吸引タイプのシリンジであってもよい。 According to the chemical solution injection system 300 according to the third embodiment as described above, since the above-described seal member 4 is provided, good sliding performance can be exhibited, so that stable chemical solution injection is possible. In addition, as the 1st syringe 301 or the 2nd syringe 302, syringes of various sizes, such as 200 ml, 100 ml, and 50 ml, can be used. Further, the first syringe 301 or the second syringe 302 may be a suction type syringe that sucks a chemical solution from a chemical solution bag or the like.
 以上、実施例を参照して本発明について説明したが、本発明は上記実施例に限定されるものではない。本発明に反しない範囲で変更された発明、及び本発明と均等な発明も本発明に含まれる。また、上述の各実施形態及び変形例は、本発明に反しない範囲で適宜組み合わせることができる。 The present invention has been described above with reference to the embodiments, but the present invention is not limited to the above embodiments. Inventions modified within the scope not departing from the present invention and inventions equivalent to the present invention are also included in the present invention. Moreover, each above-mentioned embodiment and modification can be combined suitably in the range which is not contrary to this invention.
 なお、超高分子量ポリエチレンフィルム6を接着する方法は上記実施例に挙げた方法に限定されない。例えば、三次元フィルム成形法を用いて、超高分子量ポリエチレンフィルム6を接着することもできる。具体的に三次元フィルム成形法を用いた超高分子量ポリエチレンフィルム6の接着は、以下のように行う。まず、下側筺体内に基体40をセットする。そして、下側筺体に対向する上側筺体と下側筺体との間に、超高分子量ポリエチレンフィルム6をセットする。その後、上側筺体を下側筺体に向かって下降させ、上側筺体と下側筺体との間の空間を真空吸引する。そして、上側筺体に設けられたヒータによって、超高分子量ポリエチレンフィルム6を加熱する。次いで、大気圧力又は圧縮空気の圧力によって超高分子量ポリエチレンフィルム6を基体40に接着させる。 In addition, the method of adhering the ultra high molecular weight polyethylene film 6 is not limited to the method described in the above embodiment. For example, the ultrahigh molecular weight polyethylene film 6 can be bonded using a three-dimensional film forming method. Specifically, adhesion of the ultrahigh molecular weight polyethylene film 6 using a three-dimensional film forming method is performed as follows. First, the base body 40 is set in the lower housing. And the ultra high molecular weight polyethylene film 6 is set between the upper housing and the lower housing facing the lower housing. Thereafter, the upper casing is lowered toward the lower casing, and the space between the upper casing and the lower casing is vacuum-sucked. And the ultra high molecular weight polyethylene film 6 is heated with the heater provided in the upper side housing. Next, the ultrahigh molecular weight polyethylene film 6 is adhered to the substrate 40 by atmospheric pressure or compressed air pressure.
 この三次元フィルム成形法による接着においては、シール部材4の側面、特に環状凹部45に対応する部分に超高分子量ポリエチレンフィルム6を接着させることが困難である場合がある。そのような場合は、環状凹部45に対応する部分に圧縮空気を吹き付けることにより、超高分子量ポリエチレンフィルム6を接着させることができる。この圧縮空気の吹き付けは、環状凹部45に対応する環状の形状を有する空気孔を介して圧縮空気を吹き付けることにより行うことができる。または、環状凹部45に対向する位置に設けられた空気孔を介して圧縮空気を吹き付けると共に、基体40を回転させることによって、環状凹部45全体に超高分子量ポリエチレンフィルム6を接着させることもできる。 In the bonding by this three-dimensional film forming method, it may be difficult to bond the ultrahigh molecular weight polyethylene film 6 to the side surface of the seal member 4, particularly to the portion corresponding to the annular recess 45. In such a case, the ultrahigh molecular weight polyethylene film 6 can be adhered by blowing compressed air to the portion corresponding to the annular recess 45. This blowing of compressed air can be performed by blowing compressed air through an air hole having an annular shape corresponding to the annular recess 45. Alternatively, the ultrahigh molecular weight polyethylene film 6 can be adhered to the entire annular recess 45 by blowing compressed air through an air hole provided at a position facing the annular recess 45 and rotating the substrate 40.
 また、超高分子量ポリエチレンフィルム6は、2層構造には限定されず、3層以上の層構造を有していてもよい。例えば、2層の接着フィルム層62と、超高分子量ポリエチレン層61とを有する3層構造の超高分子量ポリエチレンフィルム6であってもよい。また、超高分子量ポリエチレン層61としては、超高分子量ポリエチレンを含む種々のフィルムを用いることもできるが、超高分子量ポリエチレンのみから構成されたフィルムを用いることが望ましい。 Moreover, the ultrahigh molecular weight polyethylene film 6 is not limited to a two-layer structure, and may have a layer structure of three or more layers. For example, an ultrahigh molecular weight polyethylene film 6 having a three-layer structure including two adhesive film layers 62 and an ultrahigh molecular weight polyethylene layer 61 may be used. As the ultrahigh molecular weight polyethylene layer 61, various films containing ultrahigh molecular weight polyethylene can be used, but it is desirable to use a film composed only of ultrahigh molecular weight polyethylene.
 さらに、上記実施例においては、シール部材4の外面全体に超高分子量ポリエチレンフィルム6が設けられていた。しかし、超高分子量ポリエチレンフィルム6は、シール部材4の外面の一部の領域のみ、例えば、薬液と接触する部分のみ、又はシリンダ2の内面と接触する部分のみに設けることもできる。また、超高分子量ポリエチレンフィルム6は、シール部材4と同様にシリンダ2の内面にも接着させることができる。 Furthermore, in the above embodiment, the ultrahigh molecular weight polyethylene film 6 was provided on the entire outer surface of the seal member 4. However, the ultrahigh molecular weight polyethylene film 6 can be provided only in a partial region of the outer surface of the seal member 4, for example, only in a portion that contacts the chemical solution or only in a portion that contacts the inner surface of the cylinder 2. Further, the ultrahigh molecular weight polyethylene film 6 can be adhered to the inner surface of the cylinder 2 similarly to the seal member 4.
 この出願は2012年10月4日に出願された日本国特許出願第2012-222349号からの優先権を主張するものであり、その内容を引用してこの出願の一部とするものである。 This application claims priority from Japanese Patent Application No. 2012-222349 filed on October 4, 2012, the contents of which are incorporated herein by reference.
 1:シリンジ、2:シリンダ、3:プランジャー、4:シール部材、6:超高分子量ポリエチレンフィルム、7:上金型、8:下金型、21:先端部、22:後端部、27:上金型、28:下金型、40:基体、41:環状突部、42:係合溝、43:先端部、45:環状凹部、46:凹部、47:開口、61:超高分子量ポリエチレン層、62:接着フィルム層、71:ランナー、72:突出部分、73:外周ランナー溝、74:ゲート、75:エアベント、81:凹部、82:開口、85:エアベント、104:シール部材、106:フィルム、140:基体、170:上金型、171:ランナー、172:ゲート痕、173:ゲート痕、174:ゲート、175:エアベント、271:ランナー、272:突出部分、273:外周ランナー溝、274:ゲート、275:エアベント、281:凹部、282:開口、285:エアベント、301:第1シリンジ、302:第2シリンジ、303:チューブ、311:アダプター、312:アダプター、313:切り欠き、314:リブ、315:リブ、316:スタンドベース、317:スタンドポール、320:薬液注入装置 1: Syringe, 2: Cylinder, 3: Plunger, 4: Sealing member, 6: Ultra high molecular weight polyethylene film, 7: Upper mold, 8: Lower mold, 21: Front end, 22: Rear end, 27 : Upper mold, 28: lower mold, 40: base, 41: annular protrusion, 42: engagement groove, 43: tip, 45: annular recess, 46: recess, 47: opening, 61: ultra high molecular weight Polyethylene layer, 62: adhesive film layer, 71: runner, 72: protruding portion, 73: outer peripheral runner groove, 74: gate, 75: air vent, 81: recess, 82: opening, 85: air vent, 104: seal member, 106 : Film, 140: Substrate, 170: Upper mold, 171: Runner, 172: Gate mark, 173: Gate mark, 174: Gate, 175: Air vent, 271: Runner, 272: Protruding part, 273: Outer circumference Ner groove, 274: gate, 275: air vent, 281: recess, 282: opening, 285: air vent, 301: first syringe, 302: second syringe, 303: tube, 311: adapter, 312: adapter, 313: cut Notch, 314: rib, 315: rib, 316: stand base, 317: stand pole, 320: chemical injection device

Claims (9)

  1.  シリンダと、
     前記シリンダの内面と接触し、前記シリンダ内において摺動可能なシール部材とを備え、
     前記シール部材は、基体と、前記基体上に接着された超高分子量ポリエチレンフィルムとを有し、
     前記超高分子量ポリエチレンフィルムは、超高分子量ポリエチレン層及び接着フィルム層を有すると共に、前記接着フィルム層を介して前記基体に接着されていることを特徴とするシリンジ。
    A cylinder,
    A seal member that contacts the inner surface of the cylinder and is slidable in the cylinder;
    The seal member has a base and an ultra-high molecular weight polyethylene film adhered on the base,
    The ultra high molecular weight polyethylene film has an ultra high molecular weight polyethylene layer and an adhesive film layer, and is bonded to the substrate through the adhesive film layer.
  2.  前記接着フィルム層は、リニア低密度ポリエチレンフィルム又はエチレン-酢酸ビニル共重合体フィルムからなることを特徴とする請求項1に記載のシリンジ。 The syringe according to claim 1, wherein the adhesive film layer is made of a linear low density polyethylene film or an ethylene-vinyl acetate copolymer film.
  3.  前記シリンジは、前記シリンダに薬液が充填されたプレフィルドシリンジであることを特徴とする請求項1又は2に記載のシリンジ。 The syringe according to claim 1 or 2, wherein the syringe is a prefilled syringe in which the cylinder is filled with a chemical solution.
  4.  請求項1乃至3のいずれか1項に記載のシリンジを備えることを特徴とする薬液注入装置。 A chemical injection device comprising the syringe according to any one of claims 1 to 3.
  5.  薬液を注入するためのシリンジに用いられるシール部材であって、
     前記シール部材は、基体と、前記基体上に接着された超高分子量ポリエチレンフィルムとを有し、
     前記超高分子量ポリエチレンフィルムは、超高分子量ポリエチレン層及び接着フィルム層を有すると共に、前記接着フィルム層を介して前記基体に接着されていることを特徴とするシール部材。
    A seal member used in a syringe for injecting a chemical solution,
    The sealing member has a base and an ultra-high molecular weight polyethylene film adhered on the base,
    The ultra high molecular weight polyethylene film has an ultra high molecular weight polyethylene layer and an adhesive film layer, and is bonded to the substrate via the adhesive film layer.
  6.  薬液を注入するためのシリンジに用いられるシール部材の製造方法であって、
     前記シール部材の基体の構成材料が供給される凹部を備えた第1の金型と、前記凹部を囲むような形状を有する外周ランナー溝及び前記構成材料を供給するためのランナーを備えた第2の金型と、を対向配置し、
     前記外周ランナー溝を介して前記構成材料を前記凹部に供給することにより、前記基体を成形することを特徴とするシール部材の製造方法。
    A method for producing a seal member used in a syringe for injecting a chemical solution,
    A first mold having a recess to which the constituent material of the base member of the seal member is supplied; a second outer runner groove having a shape surrounding the recess; and a second runner for supplying the constituent material. Are placed opposite to each other,
    A method for producing a seal member, comprising: forming the base by supplying the constituent material to the recess through the outer peripheral runner groove.
  7.  前記外周ランナー溝は、前記凹部の開口を囲むような形状を有することを特徴とする請求項6に記載のシール部材の製造方法。 The manufacturing method of a seal member according to claim 6, wherein the outer peripheral runner groove has a shape surrounding the opening of the recess.
  8.  前記外周ランナー溝は、前記開口の径よりも大きな径を有することを特徴とする請求項7に記載のシール部材の製造方法。 The manufacturing method of a seal member according to claim 7, wherein the outer peripheral runner groove has a diameter larger than the diameter of the opening.
  9.  前記ランナーは、前記外周ランナー溝内において開口することを特徴とする請求項6乃至8のいずれか1項に記載のシール部材の製造方法。

     
     
    The said runner opens in the said outer periphery runner groove | channel, The manufacturing method of the sealing member of any one of Claim 6 thru | or 8 characterized by the above-mentioned.


PCT/JP2013/005857 2012-10-04 2013-10-01 Syringe, drug solution injector, sealing member and method for producing sealing member WO2014054279A1 (en)

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JP2001322171A (en) * 2000-05-17 2001-11-20 Nipro Corp Refrigeration storage container
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JP2001322171A (en) * 2000-05-17 2001-11-20 Nipro Corp Refrigeration storage container
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CN107261259B (en) * 2016-03-30 2021-08-03 住友橡胶工业株式会社 Medical syringe, gasket, and method for producing same

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