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WO2020153013A1 - Cathéter et procédé de fabrication d'un cathéter - Google Patents

Cathéter et procédé de fabrication d'un cathéter Download PDF

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Publication number
WO2020153013A1
WO2020153013A1 PCT/JP2019/047873 JP2019047873W WO2020153013A1 WO 2020153013 A1 WO2020153013 A1 WO 2020153013A1 JP 2019047873 W JP2019047873 W JP 2019047873W WO 2020153013 A1 WO2020153013 A1 WO 2020153013A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
metal wire
ray opaque
opaque marker
marker
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2019/047873
Other languages
English (en)
Japanese (ja)
Inventor
宏成 加藤
佳孝 重本
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tokai Medical Products Inc
Original Assignee
Tokai Medical Products Inc
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 Tokai Medical Products Inc filed Critical Tokai Medical Products Inc
Publication of WO2020153013A1 publication Critical patent/WO2020153013A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes

Definitions

  • the present invention relates to a catheter and a method for manufacturing the catheter.
  • a radiopaque marker is attached to the outer circumference of the catheter to grasp the position of the catheter when it is inserted into the body during surgery.
  • a catheter having a radiopaque marker attached for example, a metal marker is attached to the outer circumference of a catheter tube, and a pair of fixed tubes having a tapered outer circumference is attached to both sides of the metal marker.
  • Patent Document 1 a catheter formed so that no step is formed between the fixed tube and the fixed tube and between the fixed tube and the catheter tube.
  • a catheter formed by winding a metal wire around the outer circumference of such an inner tube is flexible and bendable in order to ensure followability when advancing inside a lumen such as a blood vessel.
  • a lumen such as a blood vessel.
  • the present invention has been made in view of the above-mentioned problems, and the outer diameter does not become thick even when the radiopaque marker is attached to the catheter on which the metal wire is wound. It is also an object of the present invention to provide a catheter capable of suppressing deterioration of bending performance as much as possible.
  • the present invention has adopted the following means in order to achieve the above object.
  • the catheter according to the present invention In a catheter in which a metal wire is wound around the outer circumference of the inner tube in a spiral shape or a coil shape at intervals, An X-ray opaque marker is wound in a gap between the wound metal wire and an adjacent metal wire.
  • the X-ray opaque marker is directly wound around the inner tube between the metal wires which are spirally or wound, the X-ray is provided on the outer peripheral side of the metal wire. It is possible to prevent the portion where the X-ray opaque marker is attached from becoming thicker as compared with the case where the opaque marker is attached.
  • the metal wire may be braided with a resin wire made of resin.
  • the X-ray opaque marker may have a diameter smaller than that of the metal wire.
  • the X-ray opaque marker may be characterized in that a plurality of windings are provided between metal wires.
  • the area occupied by the X-ray opaque marker can be increased, so that the portion that can be visually recognized by the X-ray becomes larger, so that the visibility is enhanced and the insertion position of the catheter can be easily recognized.
  • the catheter according to the present invention may be characterized in that the metal wire and the X-ray opaque marker are coated with a resin on the outer circumference thereof.
  • the positions of the radiopaque marker and the metal line can be fixed, and the possibility that the radiopaque marker will fall off can be reduced.
  • the production method for producing a catheter having a radiopaque marker is (1) Metal wire winding step of winding a metal wire around the outer circumference of the inner tube (2) X-ray between the metal wire and the metal wire at an arbitrary position of the inner tube around which the metal wire is wound Adhere one end of the opaque marker to the inner tube, wind the X-ray opaque marker along the gap between the metal wires, and then attach the other end of the X-ray opaque marker to the inner tube.
  • X-ray opaque marker attaching process by attaching to X-ray opaque marker to inner tube (3) After covering with a resin-made covering tube, heat shrink to cover the metal wire and X-ray opaque marker with the covering tube A resin coating step of coating is included.
  • the above-mentioned catheter can be produced by such a method.
  • the catheter of the present invention it is possible to provide a catheter that reduces or prevents the region having the radiopaque marker from becoming thick even if the catheter has the radiopaque marker attached.
  • FIG. 1 is a schematic side view of a catheter device 110 having a catheter 100 and a hand operation unit 200 according to the embodiment.
  • 2A is an enlarged side schematic view showing a portion AA of FIG. 1 in the catheter 100 according to the embodiment
  • FIG. 2B is a sectional view taken along the line BB of FIG.
  • FIG. 3 is a side view showing another example of the catheter 100 according to the embodiment.
  • FIG. 4 is a side view showing yet another example of the catheter 100 according to the embodiment.
  • FIG. 5 is a cross-sectional view showing yet another example of the catheter 100 according to the embodiment.
  • FIG. 6 is a side view showing a state in which the outer circumference of the catheter according to the embodiment is coated with resin.
  • FIG. 1 is a schematic side view of a catheter device 110 using the catheter 100 according to the first embodiment
  • FIG. 2A is an enlarged schematic side view of a portion AA which is a part of the catheter 100 of FIG. 2B is a sectional view taken along line BB of FIG. 2A.
  • a catheter device 110 including the catheter 100 according to the first embodiment includes a catheter 100, a distal end portion 50 at a distal end thereof, and a hand operation portion 200 at a proximal end side thereof. ..
  • Various members are attached to the tip portion 50 depending on the intended use.
  • a flexible plastic tip or a pressure sensor for measuring blood pressure can be attached to improve vascular progression.
  • the shape of the tip portion 50 is not particularly limited, and any shape may be adopted as the hand operation portion 200. It is possible to appropriately add components other than the tip portion 50 and the hand operation portion 200.
  • the catheter 100 is a member mainly for moving the distal end portion 50 to the surgical region and is formed in an elongated linear shape.
  • the metal wire 10 is spirally or coiled around the outer circumference of the inner tube 20.
  • the metal wire 10 wound in a spiral shape or a coil shape is wound so as to leave a space ⁇ between adjacent metal wires 10 so as to ensure flexibility in order to improve the followability in the lumen of the catheter 100. It has been turned.
  • the interval ⁇ between the adjacent metal wires 10 is not limited, but is preferably set to about 0.5 mm to 1.5 mm.
  • the thickness of the metal wire 10 is not particularly limited, but it is preferable to use a wire having a diameter of about 10 ⁇ m to 100 ⁇ m. Further, the metal wire 10 is not limited to a wire having a circular cross section, and a flat wire may be used.
  • the type of metal material forming the metal wire 10 is not particularly limited. Suitably, for example, tungsten, tantalum, cobalt, rhodium, titanium, alloys thereof, stainless steel, nickel alloys or molybdenum alloys are used.
  • the catheter 100 wound with the metal wire 10 in this manner is attached with an X-ray opaque marker 15 at one or more arbitrary positions so that the position can be easily confirmed under X-ray fluoroscopy.
  • a material that can be imaged by X-ray for example, platinum, gold or palladium is used. Of course, it is not limited to these.
  • These X-ray opaque markers 15 are usually attached to the outer circumference of the catheter by winding them like bands. However, when the metal wire is wound around the outer circumference, there is a problem that the outer circumference becomes thick only at that portion. If a part of the catheter is formed thick, there is a risk that the thickened part may be caught in the lumen when the catheter is introduced into the body.
  • the X-ray opaque marker 15 to be attached is attached by winding a linear wire formed in a gap between the metal wire 10 and an adjacent metal wire.
  • the metal wire 10 is directly wound around the inner tube 20 at a pitch substantially similar to the winding pitch of the metal wire 10 so as to be arranged in the gap between the wound metal wires 10.
  • the number of X-ray opaque markers 15 is not particularly limited, and a plurality of X-ray opaque markers 15 may be provided in parallel as shown in FIG. 2 or may be one as shown in FIG.
  • a plurality of radiopaque markers 15 may be wound without a gap between the metal wires 10 as shown in FIG. As shown in, a gap may be provided between the respective X-ray opaque markers 15. By providing the gap, the flexibility of the catheter 100 can be ensured even in the region around which the radiopaque marker 15 is wound.
  • the thickness of the X-ray opaque marker 15 it is preferable to use the same thickness having the same diameter as the cross-sectional diameter of the metal wire 10 or a thin one having a diameter shorter than the cross-sectional diameter of the metal wire 10.
  • the X-ray opaque marker 15 By using the X-ray opaque marker 15 thinner than the metal wire 10, the X-ray opaque marker 15 is not located outside the outer periphery of the metal wire 10 and the X-ray opaque marker 15 is attached. It is possible to prevent the outer circumference of the catheter 100 at a different portion from becoming thick.
  • the cross-sectional shape of the X-ray opaque marker 15 is not limited, and in addition to the circular cross-section shown in FIG. 2, various cross-sectional shapes such as an elliptical cross section, a rectangular cross section, and a flat line shape are used. be able to.
  • the metal wire 10 and the resin wire 30 made of resin may be braided. Positioning of the metal wire 10 can be prevented by braiding with the resin wire 30. Further, the X-ray opaque marker 15 can also be made hard to be displaced by the resin wire 30.
  • the resin wire 30 is preferably thinner than the metal wire 10 and the X-ray opaque marker 15. By using the resin wire 30 that is thinner than the metal line 10 and the X-ray opaque marker 15, it is possible to exert the function of preventing positional deviation without hindering the arrangement of the metal line 10 and the X-ray opaque marker 15. ..
  • the outer layer may be optionally covered with a resin as shown in FIG.
  • a resin coating layer 40 polyamide, polyolefin, polyester, fluorine resin, or the like can be used.
  • the coating can be formed by covering the outer peripheral surface of the portion to which the radiopaque marker 15 is attached with a heat-shrinkable tube and then applying heat to shrink the tube.
  • the metal wire 10 is wound around the inner tube 20 in a spiral shape or a coil shape, and the catheter 100 in which the metal wire 10 is wound around the outer peripheral side of the inner tube 20 is manufactured.
  • the resin wire 30 is braided, the metal wire 10 and the resin wire 30 can be simultaneously braided and wound.
  • the X-ray opaque marker 15 is wound around a gap between the metal wire 10 and the adjacent metal wire 10 at an arbitrary position of the catheter 100 around which the metal wire 10 is wound.
  • the end portion of the X-ray opaque marker 15 is adhered to the inner tube 20 with an adhesive.
  • the X-ray opaque marker 15 is wound along the gap of the metal wire 10.
  • the number of rotations for winding is not limited, but it is preferably about 1 to 5 rotations.
  • the other end of the radiopaque marker 15 is finally attached to the inner tube 20 with an adhesive.
  • a step of arbitrarily fixing the X-ray opaque marker 15 to the inner tube 20 or the metal wire 10 may be performed.
  • a fixing method a method of welding the adjacent metal wire 10 with a laser or the like, a method of fixing the X-ray opaque marker 15 by plating, and in the case of a braid of the metal wire 10 and the resin wire 30, heat is applied. Therefore, a method of integrally fixing the resin wire 30 and the X-ray opaque marker 15 and the like can be considered.
  • the adhesive agent that has fixed the X-ray opaque marker 15 may be removed using an adhesive removing agent. .. Removing the adhesive can reduce the likelihood that the adhesive will elute during use of the catheter.
  • Resin coating step In this way, after the X-ray opaque marker 15 is fixed with the adhesive, or (3) after being fixed in the X-ray opaque marker fixing step, a resin-covered tube is covered and heated.
  • the catheter 100 in which the metal wire 10 and the X-ray opaque marker 15 are coated with the resin of the coating tube can be produced by heat-shrinking the coating tube.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Le problème décrit par la présente invention est de fournir un cathéter dont le diamètre de circonférence externe ne s'élargit pas, même lorsque des marqueurs radio-opaques sont fixés à un cathéter entouré d'un fil métallique. À cet effet, l'invention porte sur un cathéter 100 qui est muni d'un fil métallique 10 enroulé autour de la circonférence externe d'un tube interne 20, avec des espaces entre des spires du fil métallique, sous la forme de spirales ou de bobines séparées par des espaces. Ce cathéter est caractérisé en ce que des marqueurs radio-opaques sont enroulés dans des espaces entre une partie du fil métallique enroulé et une partie adjacente à celui-ci.
PCT/JP2019/047873 2019-01-23 2019-12-06 Cathéter et procédé de fabrication d'un cathéter Ceased WO2020153013A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2019-009657 2019-01-23
JP2019009657A JP7251765B2 (ja) 2019-01-23 2019-01-23 カテーテル及びカテーテルの作製方法

Publications (1)

Publication Number Publication Date
WO2020153013A1 true WO2020153013A1 (fr) 2020-07-30

Family

ID=71736773

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2019/047873 Ceased WO2020153013A1 (fr) 2019-01-23 2019-12-06 Cathéter et procédé de fabrication d'un cathéter

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JP (2) JP7251765B2 (fr)
WO (1) WO2020153013A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119564997A (zh) * 2024-12-04 2025-03-07 宁波琳盛高分子材料有限公司 带有显影标记的peek医疗复合导管及其制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0847538A (ja) * 1994-08-08 1996-02-20 Nippon Zeon Co Ltd スライディングカテーテル
JP2006288944A (ja) * 2005-04-14 2006-10-26 Kaneka Corp 医療用カテーテルチューブならびにその製造方法
JP2006314623A (ja) * 2005-05-13 2006-11-24 Terumo Corp カテーテル
WO2007013545A1 (fr) * 2005-07-28 2007-02-01 Kaneka Corporation Tube de catheter medical et son processus de fabrication
JP2018526185A (ja) * 2015-09-11 2018-09-13 キャセラ， インコーポレイテッド カテーテルシャフトならびに関連する装置、システム、及び方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0847538A (ja) * 1994-08-08 1996-02-20 Nippon Zeon Co Ltd スライディングカテーテル
JP2006288944A (ja) * 2005-04-14 2006-10-26 Kaneka Corp 医療用カテーテルチューブならびにその製造方法
JP2006314623A (ja) * 2005-05-13 2006-11-24 Terumo Corp カテーテル
WO2007013545A1 (fr) * 2005-07-28 2007-02-01 Kaneka Corporation Tube de catheter medical et son processus de fabrication
JP2018526185A (ja) * 2015-09-11 2018-09-13 キャセラ， インコーポレイテッド カテーテルシャフトならびに関連する装置、システム、及び方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119564997A (zh) * 2024-12-04 2025-03-07 宁波琳盛高分子材料有限公司 带有显影标记的peek医疗复合导管及其制备方法

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JP7407490B2 (ja) 2024-01-04
JP2020116126A (ja) 2020-08-06
JP7251765B2 (ja) 2023-04-04
JP2023063495A (ja) 2023-05-09

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