WO2014054279A1 - Seringue, injecteur de solution médicamenteuse, élément d'étanchéité et procédé de fabrication d'un élément d'étanchéité - Google Patents

Seringue, injecteur de solution médicamenteuse, élément d'étanchéité et procédé de fabrication d'un élément d'étanchéité 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
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English (en)
Japanese (ja)
Inventor
根本　茂
宗仁 栗本
Original Assignee
株式会社根本杏林堂
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Filing date
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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/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14546—Front-loading type injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31515—Connection of piston with piston rod
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/14—Injection 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
    • B29C45/14778—Injection 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0222—Materials for reducing friction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7544—Injection 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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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Mechanical Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Le but de la présente invention est de produire une seringue qui est munie d'un élément d'étanchéité qui présente une bonne performance de coulissement et dont on empêche sa séparation d'avec un film de polyéthylène à haut poids moléculaire. Une seringue (1) est pourvue d'un cylindre (2) et d'un élément d'étanchéité (4) qui est en contact avec la surface interne du cylindre (2) et peut coulisser dans le cylindre (2). Cette seringue (1) est caractérisée en ce que l'élément d'étanchéité (4) comprend une base (40) et un film de polyéthylène à haut poids moléculaire (6) qui est fixé sur la base (40) ; le film de polyéthylène à haut poids moléculaire (6) comporte une couche de polyéthylène à haut poids moléculaire (61) et une couche de film adhésif (62) ; et le film de polyéthylène à haut poids moléculaire (6) est fixé sur la base (40) au moyen de la couche de film adhésif (62).
PCT/JP2013/005857 2012-10-04 2013-10-01 Seringue, injecteur de solution médicamenteuse, élément d'étanchéité et procédé de fabrication d'un élément d'étanchéité WO2014054279A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2012-222349 2012-10-04
JP2012222349A JP6104553B2 (ja) 2012-10-04 2012-10-04 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

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WO2014054279A1 true WO2014054279A1 (fr) 2014-04-10

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107261259A (zh) * 2016-03-30 2017-10-20 住友橡胶工业株式会社 医疗用注射器、密封垫及其制造方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001322171A (ja) * 2000-05-17 2001-11-20 Nipro Corp 冷凍保存用容器
JP2004162761A (ja) * 2002-11-11 2004-06-10 Terumo Corp ガスケットおよびシリンジ
JP2007528808A (ja) * 2003-07-10 2007-10-18 ハネウェル・インターナショナル・インコーポレーテッド 耐摩耗性シート材料

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001322171A (ja) * 2000-05-17 2001-11-20 Nipro Corp 冷凍保存用容器
JP2004162761A (ja) * 2002-11-11 2004-06-10 Terumo Corp ガスケットおよびシリンジ
JP2007528808A (ja) * 2003-07-10 2007-10-18 ハネウェル・インターナショナル・インコーポレーテッド 耐摩耗性シート材料

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107261259A (zh) * 2016-03-30 2017-10-20 住友橡胶工业株式会社 医疗用注射器、密封垫及其制造方法
CN107261259B (zh) * 2016-03-30 2021-08-03 住友橡胶工业株式会社 医疗用注射器、密封垫及其制造方法

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JP6104553B2 (ja) 2017-03-29

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