WO2018135639A1 - Article moulé par injection et instrument médical - Google Patents

Article moulé par injection et instrument médical Download PDF

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Publication number
WO2018135639A1
WO2018135639A1 PCT/JP2018/001645 JP2018001645W WO2018135639A1 WO 2018135639 A1 WO2018135639 A1 WO 2018135639A1 JP 2018001645 W JP2018001645 W JP 2018001645W WO 2018135639 A1 WO2018135639 A1 WO 2018135639A1
Authority
WO
WIPO (PCT)
Prior art keywords
injection molded
molded product
opening
peripheral surface
inner peripheral
Prior art date
Application number
PCT/JP2018/001645
Other languages
English (en)
Japanese (ja)
Inventor
佑介 鈴木
内田　直樹
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2018562461A priority Critical patent/JPWO2018135639A1/ja
Publication of WO2018135639A1 publication Critical patent/WO2018135639A1/fr

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    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • 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
    • 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

Definitions

  • This disclosure relates to injection molded products and medical instruments.
  • an injection molded product having an opening for constituting a medical instrument is known.
  • a medical connector used in an infusion set or the like or a syringe is known.
  • the opening of the injection-molded product is an opening (for example, see Patent Document 1) of a female connector (for example, a female luer) of a medical connector or a male connector (for example, a medical connector).
  • An opening of the male lure is an opening of a tip (for example, male luer) of a cylinder member of the syringe.
  • the inner peripheral surface of the opening in the female connector portion of the medical connector includes a fitting surface with a male connector portion of another medical connector, or includes a contact surface with a valve body that closes the opening.
  • the inner peripheral surface of the opening at the tip of the cylinder member of the syringe may form a flow path for a fluid such as a chemical solution or may include a fitting surface with the needle member.
  • the injection molded product as described above is subjected to injection molding from the outer peripheral edge of the sprue disk portion disposed in the opening of the injection molded product through an annular thin gate.
  • An object of the present invention is to provide an injection-molded product and a medical device for constituting a medical device that can suppress the above-described problem.
  • the injection molded product as one aspect of the present invention is An injection molded article having an opening for constituting a medical instrument,
  • the arithmetic average height Sa of the entire inner peripheral surface of the opening is 3 ⁇ m or less.
  • an injection molded article is The inner peripheral surface comprises a cylindrical first region and the remaining second region,
  • the arithmetic average height Sa of the entire first region is 6 ⁇ m or less.
  • the injection molded product has an arithmetic average height Sa of the entire second region of 0.8 ⁇ m or less.
  • the injection molded product has an axial width of the first region of 5 mm or less.
  • the first region is a cut surface.
  • a medical instrument as one aspect of the present invention includes an injection molded product according to one aspect of the present invention.
  • the present disclosure it is possible to make it difficult to damage an object that fits or contacts the inner peripheral surface of the opening, or it is possible to suppress the flow resistance of the flow channel formed by the inner peripheral surface of the opening. It is possible to provide an injection-molded product and a medical device for constituting a medical device.
  • FIG. 1 It is a perspective view showing typically an injection-molded article concerning one embodiment of the present invention. It is a longitudinal cross-sectional view of the injection molded product shown in FIG. It is a perspective view showing typically various examples of a medical instrument concerning one embodiment of the present invention, (a) shows a medical connector constituted as a three-way stopcock, (b) shows an I type port. (C) shows a medical connector configured as a T-type port, and (d) shows a syringe. It is sectional drawing which shows the mode at the time of injection molding of the injection molded product shown in FIG. It is sectional drawing which shows a mode that the cyclic
  • the axial direction means a direction along the central axis O of the inner peripheral surface 3 of the opening 2 of the injection molded product 1.
  • the injection molded product 1 according to the present embodiment has an opening 2.
  • the inner peripheral surface 3 of the opening 2 has a cylindrical shape.
  • the inner peripheral surface 3 may have a cylindrical shape such as an elliptical cylindrical shape.
  • the injection molded product 1 is schematically shown as a cylindrical one, but if the injection molded product 1 has an opening 2, a medical device constituted by the injection molded product 1. Depending on the form of the appliance 4, it can have various shapes.
  • the injection-molded product 1 is, for example, a medical connector 4a to 4c as shown in FIGS. 3A to 3C used in an infusion set that can be sent to a living body such as a human body, for example, FIG. 3D. It is for comprising the medical instrument 4 such as a syringe 4d as shown in FIG.
  • the injection-molded product 1 constitutes a closed female connector portion 5a (for example, a slip-type or lock-type closed female luer) of a medical connector 4a configured as a three-way cock as shown in FIG. 3 (a). It may be.
  • the inner peripheral surface 3 of the opening 2 of the injection molded product 1 includes a contact surface with the valve body 6a.
  • the inner peripheral surface 3 may include a fitting surface with a male connector portion (for example, a slip-type or lock-type male luer) of another medical connector.
  • the injection molded product 1 may constitute an open female connector portion 7a (for example, a slip-type or lock-type open female luer) of the medical connector 4a.
  • the inner peripheral surface 3 of the opening 2 of the injection molded product 1 includes a fitting surface with a male connector portion (for example, a slip-type or lock-type male luer) of another medical connector.
  • the injection-molded product 1 may constitute a male connector portion 8a (for example, a slip-type or lock-type male luer as shown) of such a medical connector 4a.
  • the inner peripheral surface 3 of the opening 2 of the injection molded product 1 forms a flow path for a fluid such as a chemical solution.
  • the injection-molded product 1 constitutes a closed female connector portion 5b (for example, a slip-type or lock-type closed female luer) of a medical connector 4b configured as an I-type port, as shown in FIG. 3 (b). It may be a thing.
  • the inner peripheral surface 3 of the opening 2 of the injection molded product 1 includes a contact surface with the valve body 6b.
  • the inner peripheral surface 3 may include a fitting surface with a male connector portion (for example, a slip-type or lock-type male luer) of another medical connector.
  • the injection-molded product 1 may constitute a male connector portion 8b (for example, a slip-type or a lock-type male luer as shown) of such a medical connector 4b.
  • the inner peripheral surface 3 of the opening 2 of the injection molded product 1 forms a flow path for a fluid such as a chemical solution.
  • the injection molded product 1 constitutes a closed female connector portion 5c (for example, a slip-type or lock-type closed female luer) of a medical connector 4c configured as a T-shaped port as shown in FIG. It may be a thing.
  • the inner peripheral surface 3 of the opening 2 of the injection molded product 1 includes a contact surface with the valve body 6c.
  • the inner peripheral surface 3 may include a fitting surface with a male connector portion (for example, a slip-type or lock-type male luer) of another medical connector.
  • the injection molded product 1 may constitute an open female connector portion 7c (for example, a slip-type or lock-type open female luer) of the medical connector 4c.
  • the inner peripheral surface 3 of the opening 2 of the injection molded product 1 includes a fitting surface with a male connector portion (for example, a slip-type or lock-type male luer) of another medical connector.
  • the injection molded product 1 may constitute a male connector portion 8c (for example, a slip-type or a lock-type male luer as shown) of such a medical connector 4c.
  • the inner peripheral surface 3 of the opening 2 of the injection molded product 1 forms a flow path for a fluid such as a chemical solution.
  • the injection molded product 1 may constitute a syringe 4d as shown in FIG.
  • the syringe 4d is composed of a cylinder member 9 and a piston member 10.
  • the cylinder member 9 has a tip portion 11 having an inner peripheral surface that forms a flow path of a fluid such as a chemical solution.
  • the injection molded product 1 is a cylinder member 9, and the inner peripheral surface 3 of the opening 2 of the injection molded product 1 is an inner peripheral surface of the tip end portion 11. Therefore, the inner peripheral surface 3 of the opening 2 of the injection molded product 1 forms a flow path.
  • the tip portion 11 may have a configuration having an inner peripheral surface into which the needle member can be fitted. In this case, the inner peripheral surface 3 of the opening 2 of the injection molded product 1 includes a fitting surface that fits with the needle member.
  • the injection molded product 1 is formed from the outer peripheral edge of the disc portion 13 of the sprue 12 disposed in the opening 2 of the injection molded product 1 during the injection molding. It is manufactured by injecting molten resin into the product part through an annular thin gate 14 and cutting and removing the disk part 13 and the gate 14 from the inner peripheral surface 3 of the opening 2. Therefore, in the injection molded product 1, the formation of the weld line is suppressed, and the strength of the product is improved.
  • the inner peripheral surface 3 of the opening 2 of the injection-molded product 1 is a cylindrical first composed of a cut surface formed by cutting and removing the gate 14. It consists of a region 3a and the remaining second region 3b.
  • the disk portion 13 and the gate 14 are cut and removed from the inner peripheral surface 3 by the pins 16 inserted from the top surface side end portion 15 side of the opening 2.
  • the injection molded product 1 is shown in FIG.
  • the cutting direction of the disk portion 13 and the gate 14 from the inner peripheral surface 3 is not limited to the one from the top surface side end portion 15 side.
  • the molten resin material examples include polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymer; ethylene-vinyl acetate copolymer (EVA); polyvinyl chloride; polyvinylidene chloride; polystyrene; polyamide; Polyamideimide; Polycarbonate; Poly- (4-methylpentene-1); Ionomer; Acrylic resin; Polymethyl methacrylate; Acrylonitrile-butadiene-styrene copolymer (ABS resin); Acrylonitrile-styrene copolymer (AS resin); -Styrene copolymer; Polyester such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polycyclohexane terephthalate (PCT); polyether; polyether ketone Polyetheretherketone (PEEK); Polyetherimide; Polyacetal (POM); Polyphenylene oxide; Modified polyphenylene
  • molten resin can contain fillers such as glass fiber, inorganic filler, whisker, and carbon fiber in order to give suitable rigidity.
  • various additives may be added to the above-described molten resin in order to improve material characteristics at the time of manufacture or mechanical or chemical characteristics of the product.
  • the arithmetic average height Sa of the entire inner peripheral surface 3 of the opening 2 is 0.1 ⁇ m or more and 3 ⁇ m or less, preferably 0.5 ⁇ m or more and 1 ⁇ m or less.
  • the arithmetic average height Sa is a three-dimensional extension of the arithmetic average roughness Ra specified in JIS B 0601 so that it can be applied to the measurement surface. For example, it can be measured with a non-contact measuring instrument such as a laser microscope. It is.
  • the arithmetic average height Sa of the entire first region 3a is preferably 0.1 ⁇ m or more and 6 ⁇ m or less, more preferably 1 ⁇ m or more and 5 ⁇ m or less. In this way, by setting the arithmetic average height Sa of the entire first region 3a to 6 ⁇ m or less, it is possible to more reliably suppress the occurrence of scratches on the object fitted or in contact with the inner peripheral surface 3, or the inner peripheral surface. The flow path resistance of the flow path formed by 3 can be suppressed.
  • the arithmetic average height Sa of the entire second region 3b is preferably 0.1 ⁇ m or more and 0.8 ⁇ m or less, more preferably 0.3 ⁇ m or more and 0.5 ⁇ m. It is as follows. In this way, by setting the arithmetic average height Sa of the entire second region 3b to 0.8 ⁇ m or less, it is possible to more reliably suppress the occurrence of scratches on the object fitted or in contact with the inner peripheral surface 3, or The flow path resistance of the flow path formed by the peripheral surface 3 can be suppressed.
  • the arithmetic average height Sa of the entire inner peripheral surface 3 of the opening 2 in the injection molded product 1 is a numerical range in a state where surface treatment such as coating is not performed.
  • the medical instrument 4 is comprised by the injection molded product 1 which does not give such surface treatment.
  • the axial width Wa (see FIG. 2) of the first region 3a is preferably 0.1 mm or more and 5 mm or less, more preferably 0.1 mm or more, 0. 9 mm or less.
  • the axial width W (see FIG. 2) of the inner peripheral surface 3 of the opening 2 is preferably 0.1 mm or more and 5 mm or less.
  • the inner diameter of the opening 2 is ⁇ 4.
  • the distance D from the top surface side end 15 of the opening 2 to the first region 3a (that is, the top surface side end 15 of the opening 2 and the first region shown in FIG.
  • the distance D) in the axial direction between the opening 2 and the end on the top surface side end 15 side of the opening 3a is preferably 0.5 mm or more and 1.5 mm or less, more preferably 0. It is 8 mm or more and 1 mm or less.
  • the distance D is set to such a range, and the arithmetic average height Sa of the entire first region 3a of the opening 2 is set to the above range, so that the closed female connector portions 5a to 5c are fitted.
  • the male connector part of another medical connector can be made hard to be damaged. That is, if the distance D is within the above range, the outer peripheral surface of the male connector portion normally does not come into contact with the first region 3a, and even when it comes into contact, the arithmetic average height Sa of the entire first region 3a is If it is in the said range, generation
  • a sample of an injection molded product according to the above-described embodiment was manufactured.
  • a sample of an injection molded product for constituting the closed type female luer of the medical connector shown in FIG. 3A was manufactured by the manufacturing method described with reference to FIGS.
  • the axial width W of the inner peripheral surface of the sample is 0.9 mm (area is 11.7 mm 2 )
  • the axial width Wa of the first region is 0.1 mm (area is 1.3 mm 2 )
  • the width Wb was 0.8 mm (the area was 10.4 mm 2 ).
  • Measurement instrument Laser microscope LEXT OLS4000 (manufactured by OLYMPUS) Objective lens magnification: x20 ⁇ Cutoff: 80 ⁇ m

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Manufacturing & Machinery (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Moulds For Moulding Plastics Or The Like (AREA)
  • Injection Moulding Of Plastics Or The Like (AREA)

Abstract

Cet article moulé par injection présente une ouverture et est utilisé dans le but de constituer un instrument médical; et la hauteur moyenne arithmétique Sa de la totalité de la surface circonférentielle interne de l'ouverture est inférieure ou égale à 3 µm. Un instrument médical selon la présente invention est pourvu de cet article moulé par injection.
PCT/JP2018/001645 2017-01-20 2018-01-19 Article moulé par injection et instrument médical WO2018135639A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2018562461A JPWO2018135639A1 (ja) 2017-01-20 2018-01-19 射出成形品及び医療用器具

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2017008616 2017-01-20
JP2017-008616 2017-01-20

Publications (1)

Publication Number Publication Date
WO2018135639A1 true WO2018135639A1 (fr) 2018-07-26

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PCT/JP2018/001645 WO2018135639A1 (fr) 2017-01-20 2018-01-19 Article moulé par injection et instrument médical

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JP (1) JPWO2018135639A1 (fr)
WO (1) WO2018135639A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61213057A (ja) * 1985-03-19 1986-09-22 日本ゼオン株式会社 医療用の流体導管用コネクタ
JPH1052504A (ja) * 1996-06-19 1998-02-24 Becton Dickinson & Co 改良表面仕上げを施したコネクタ部分を持つ医療装置
WO2014162338A1 (fr) * 2013-04-01 2014-10-09 テルモ株式会社 Procédé de production de bouchon
JP2017225816A (ja) * 2016-06-20 2017-12-28 株式会社ジェイ・エム・エス 管状部材の接続構造、該接続構造に用いられるメス部材及びオス部材

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61213057A (ja) * 1985-03-19 1986-09-22 日本ゼオン株式会社 医療用の流体導管用コネクタ
JPH1052504A (ja) * 1996-06-19 1998-02-24 Becton Dickinson & Co 改良表面仕上げを施したコネクタ部分を持つ医療装置
WO2014162338A1 (fr) * 2013-04-01 2014-10-09 テルモ株式会社 Procédé de production de bouchon
JP2017225816A (ja) * 2016-06-20 2017-12-28 株式会社ジェイ・エム・エス 管状部材の接続構造、該接続構造に用いられるメス部材及びオス部材

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JPWO2018135639A1 (ja) 2019-11-07

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