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WO2013114985A1 - Fil-guide - Google Patents

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Publication number
WO2013114985A1
WO2013114985A1 PCT/JP2013/051037 JP2013051037W WO2013114985A1 WO 2013114985 A1 WO2013114985 A1 WO 2013114985A1 JP 2013051037 W JP2013051037 W JP 2013051037W WO 2013114985 A1 WO2013114985 A1 WO 2013114985A1
Authority
WO
WIPO (PCT)
Prior art keywords
coil spring
wire
guide wire
plated
shape
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2013/051037
Other languages
English (en)
Japanese (ja)
Inventor
隆之 瀬戸
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.)
Piolax Medical Devices Inc
Original Assignee
Piolax Medical Devices 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 Piolax Medical Devices Inc filed Critical Piolax Medical Devices Inc
Priority to JP2013556313A priority Critical patent/JP5913383B2/ja
Publication of WO2013114985A1 publication Critical patent/WO2013114985A1/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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A61M2025/09091—Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09108—Methods for making a guide wire
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/0915—Guide wires having features for changing the stiffness

Definitions

  • the present invention relates to a guide wire used when a tube such as a catheter is inserted into a human tubular organ such as a blood vessel, a ureter, a bile duct, or a trachea.
  • a catheter is inserted into the tubular organ through a guide wire, and imaging or drug solution is administered. ing.
  • the guide wire for example, a wire composed of a core wire whose one end is reduced in diameter and a coil attached to the outer periphery of the one end of the core wire is used. Both ends of the coil are fixed by soldering to the core wire.
  • a predetermined tubular organ is selected and a guide wire is inserted at a location where a plurality of tubular organs are branched.
  • one end portion of the guide wire is pre-shaped in a bent shape such as an angle shape of a predetermined angle or a J shape or a U shape so that the guide wire can be easily inserted into a desired tubular organ.
  • a shaping member such as a rod-shaped shaping mandrel
  • the tip of the guide wire is squeezed so that the tip of the coil and core wire are bent and attached to a predetermined shape. I try to shape it.
  • each branch portion has a shaped shape that facilitates insertion of a guide wire. Since they are different, an operation is performed in which the guide wire is once extracted, the tip portion is reshaped, and then inserted again.
  • the tip of the guide wire can be easily shaped into a desired shape, can be easily reshaped by returning to the shape before shaping, and has durability that can withstand use even if such operations are repeated. Is desired.
  • Patent Document 1 describes a medical guide wire including a core member having a thin front end portion and a coil spring body having both ends fixed to the front end portion of the core member.
  • the tip of the coil spring body is fixed to the tip of the core material with a brazing material, and a predetermined portion of the coil spring body is melted with a metal ball of a radiopaque material such as Au low or Ag low. It is fixed to the core material through the fixing point.
  • an object of the present invention is to provide a guide wire that can be easily shaped into a predetermined bent shape at the end portion to which the coil spring is attached, and can be easily shaped into another bent shape. It is to provide.
  • a guide wire according to the present invention includes a core wire having at least one end reduced in diameter, a coil spring mounted on the outer periphery of the reduced diameter portion of the core wire, and a resin layer that covers the core wire and the coil spring.
  • the coil spring is soldered to the core wire at predetermined intervals at both ends and intermediate portions, and the resin layer is filled to the inside of the coil spring.
  • the total length of the plurality of soldered portions of the coil spring along the axial direction is 20 to 85% with respect to the total length of the coil spring.
  • the coil spring is formed of a metal wire material having poor bondability to the solder, and is plated with a plated portion plated with a metal having bondability to the solder. It is preferable that a non-plated portion is provided, and the plated portion is fixed to the core wire by the solder.
  • the wire diameter of the metal wire of the coil spring is 1 to 20% larger than the wire diameter of the non-plated portion, and the non-plated portion of the coil spring is formed. It is preferable that the wire is covered with the resin layer without being cut.
  • the soldering portion is formed so that the solder covers the outer periphery of the coil spring and the outer periphery of the soldering portion forms a smooth surface.
  • the length of each soldering portion of the coil spring along the axial direction is 0.1 to 1.0 mm, and the gap between adjacent soldering portions is 0. 0 mm. It is preferably 1 to 1.0 mm.
  • both end portions and intermediate portions of the coil spring are soldered to the core wire at predetermined intervals, and the resin layer is filled up to the inside of the coil spring. It becomes difficult to slip. For this reason, for example, when shaping the end portion of the guide wire with a shaping member such as a rod-shaped shaping mandrel, the coil spring does not move, and it is easy to shape the shape as intended. It is possible to maintain the shape after shaping. Also, if you take out the guide wire in the middle of insertion of the catheter, etc., reshape the tip and insert it again, it becomes easier to return to the original shape by the resin filled up to the inside of the coil, Re-shaping is also easy, and durability during re-shaping can be improved.
  • a shaping member such as a rod-shaped shaping mandrel
  • FIG. 1 shows an embodiment of a guide wire of the present invention and is a cross-sectional view thereof. It is a principal part expanded sectional view of the guide wire.
  • the manufacturing method of the guide wire is shown and it is explanatory drawing of the 1st process. It is explanatory drawing of the 2nd process of the manufacturing method. It is explanatory drawing of the 3rd process of the manufacturing method.
  • the other shape of the metal wire of the coil spring which comprises the guide wire of this invention is shown, (a) is sectional drawing in the case of an ellipse, (b) is sectional drawing in the case of a square, (c) is the case of a rectangle (D) is sectional drawing in the case of elongate and circular arc shape at both ends.
  • the guide wire 10 in this embodiment includes a core wire 20 whose one end portion 23 is reduced in diameter, a coil spring 30 attached to the outer periphery of one end portion of the core wire 20, the core wire 20 and the core wire 20. And a resin layer 50 coated on the outer periphery of the coil spring 30.
  • the core wire 20 includes a base portion 21 having a constant diameter and a predetermined length, a taper portion 25 extending gradually from the tip end of the base portion 21 toward the tip end of the core wire, and the taper portion 25. And a small-diameter portion 27 extending linearly with a constant diameter.
  • the tapered portion 25 and the small diameter portion 27 form one end portion 23 in the present invention.
  • the one end portion 23 may have a tapered shape that gradually decreases in diameter toward the tip, or may have a stepped shape by gradually reducing the diameter toward the tip, and is not particularly limited.
  • an X-ray impermeable metal is preferably employed, and the bonding property to solder is poor. More preferably, it is a metal.
  • a material of such a metal wire 31 for example, W, Ti, Cr, Al, and alloys thereof (for example, Cr-based stainless steel) can be employed, and W and Ti-based alloys are particularly preferable.
  • the metal wire 31 in this embodiment has a circular cross section, and the wire diameter R1 (see FIG. 5) is preferably 0.01 to 0.1 mm, and preferably 0.04 mm to 0. More preferably, it is 0.07 mm.
  • the metal wire 31 is not limited to a circular cross-section, and for example, a cross-sectional shape shown in FIGS. 6 (a) to 6 (d) may be employed.
  • the metal wire 31a shown in FIG. 6 (a) has an elliptical cross-section
  • the metal wire 31b shown in FIG. 6 (b) has a square cross-section
  • the metal wire 31c shown in FIG. 6 (c) The cross-sectional shape is rectangular
  • the metal wire 31d shown in FIG. 6 (d) has an elongated shape and has a cross-sectional shape in which both end surfaces are rounded in an arc shape.
  • the length W1 along the longitudinal direction of the metal wires 31a, 31c, 31d is preferably 0.03 to 0.21 mm, and more preferably 0.06 to 0.10 mm.
  • the length W2 along the short direction of the metal wires 31a, 31c, 31d is preferably 0.01 to 0.07 mm, and more preferably 0.02 to 0.05 mm.
  • the length W1 is preferably 2 to 3 times the length W2.
  • the length W3 of one side of the metal wire 31b is preferably 0.01 to 0.1 mm, and more preferably 0.04 to 0.07 mm.
  • the gap C1 (see FIG. 5) between the adjacent metal wires 31, 31 is preferably 0 to 0.2 mm, and more preferably 0.01 to 0.05 mm.
  • the total length L1 of the coil spring 30 is preferably 10 to 500 mm, and more preferably 20 to 70 mm.
  • the outer diameter D (see FIG. 1) of the coil spring 30 is preferably 0.15 to 0.5 mm, and more preferably 0.2 to 0.25 mm.
  • the mounting range S of the coil spring 30 with respect to the one end portion 23 of the core wire 20 preferably covers at least 10 mm from the most distal portion of the core wire 20. More preferably, it covers the range of 30 to 50 mm.
  • the coil spring 30 includes a metal wire 31 made of a metal that is radiopaque and has poor bondability to solder, for example, W, formed in a spiral shape, and a predetermined portion of the metal wire 31. Furthermore, it is preferable to have a plated portion 33 plated with a metal having bonding properties to solder and a non-plated portion 35 not plated with the same.
  • plating portions 33 are formed at both ends of the coil spring 30, and a plurality of plating portions 33 are formed at intermediate intervals between both ends of the coil spring 30, and plating is performed.
  • the portions 33 and the non-plated portions 35 are alternately formed along the axial direction, and the plated portions 33 are formed at equal intervals.
  • Examples of metals having solderability for forming the plated portion 33 include Au, Ag, Cu, Zn, Cd, Sn, Ni, Cr, Pd, Ni—Cr, Zn—Fe, and Zn—.
  • Examples of the alloy include Ni, Sn—Zn, Sn—Ag, and Sn—Co.
  • the plated portion 33 can be formed by applying a plating layer made of these metals in one or more layers.
  • the plated portion 33 and the non-plated portion 35 can be formed, for example, by plating the entire coil spring 30 and then removing the plating from the metal wire 31 at a predetermined location of the coil spring 30 by a plating removing unit. As a result, the non-plated portion 35 is formed in the portion of the coil spring 30 where the plating is removed, and the portion where the plating is not removed becomes the plated portion 33. Further, as the plating removing means, for example, the plating is melted and removed by irradiating a laser beam, the plating is removed by scraping with a file or the like, or the plating portion 33 is masked, and then the plating is removed. Means such as immersing in a solvent and dissolving and removing portions other than the plating portion 33 can be employed. Alternatively, the plated portion 33 and the non-plated portion 35 may be formed by partially plating predetermined portions of the coil spring 30.
  • the coil spring 30 is fixed to the core wire 20 at both ends and intermediate portions thereof via the soldering portion 40, and the coil spring 30 is mounted on the outer periphery of the one end portion 23 of the core wire 20. ing.
  • the solder does not adhere to the non-plated portion 35 where the metal wire 31 made of a metal having poor bondability to solder is exposed, and only the plated portion 33 plated with a metal having bondability to solder. Solder adheres and the soldering part 40 is formed (refer FIG.1 and FIG.2).
  • the soldering portion 40 at the tip of the coil spring 30 has a rounded shape.
  • the soldering portion 40 is filled with the solder between the inner periphery of the coil spring 30 and the outer periphery of the one end portion 23 of the core wire 20 and covers the outer periphery of the coil spring 30.
  • the outer periphery thereof is scraped with a grinding tool such as a file, a leuter, or a grinder to form a cylindrical smooth surface 41.
  • the smooth surface 41 on the outer periphery of the soldering portion 40 is set to the same height as the outer peripheral surface of the metal wire 31 of the non-plated portion 35.
  • solders include alloys such as Sn, Pb, Au, Ag, Zn, Co, Cu, Bi, In, and Al, such as Sn—Ag alloys, Sn—Cu alloys, Sn—Bi alloys, and Sn—Ag.
  • Sn—Ag alloys such as Sn, Pb, Au, Ag, Zn, Co, Cu, Bi, In, and Al
  • Sn—Ag alloys such as Sn—Cu alloys, Sn—Bi alloys, and Sn—Ag.
  • a —Cu alloy, Sn—Ag—In alloy, or the like can be used.
  • the length L2 (see FIG. 2) along the axial direction of the soldering portion 40 is preferably 0.1 to 1.0 mm, and more preferably 0.3 to 0.5 mm. .
  • the length L2 of the soldering portion 40 is less than 0.1 mm, the bonding strength with the core wire 20 decreases, and when the length L2 exceeds 1.0 mm, the hard portion due to solder increases and the tip of the guide wire It becomes difficult to secure the flexibility, and it becomes easy to kink.
  • the gap C2 (see FIG. 2) between the adjacent soldered portions 40, 40 is preferably 0.1 to 1.0 mm, and more preferably 0.5 to 0.7 mm. If the gap C2 is less than 0.1 mm, when the guide wire is shaped, the soldering portions 40 and 40 are likely to interfere with each other, and the formability may be reduced. If it exceeds the upper limit, the hard portions due to the solder are arranged at intervals, so that it becomes easy to kink at the portion in between.
  • the total length L2 of the soldering portions 40 provided in the coil spring 30 along the axial direction is 20 to 85% with respect to the total length L1 of the coil spring 30. Preferably, it is 35 to 65%. If the total length L2 is less than 20% of the total length L1, the ratio of the soldered portion 40 to the coil spring 30 is small, and the shapeability, shape maintenance, and repetitive attachment at one end of the guidewire 10 are reduced. It becomes difficult to ensure the durability at the time of forming, and if it exceeds 80%, the soldering portion 40 increases with respect to the coil spring 30 and the coil spring 30 lacks flexibility, which hinders the insertion of the guide wire into the tubular organ. Is likely to occur.
  • the wire diameter R2 of the metal wire 31 of the coil spring 30 is 1 to 20% larger than the wire diameter R1 of the non-plated portion 35. It is preferable that it is formed to be 10% larger.
  • the wire diameter R2 is larger than the wire diameter 1 but the ratio is less than 1%, the metal wire 31 of the non-plated portion 35 may be shaved when the soldering portion 40 is shaved. If the percentage exceeds 50%, there may be inconveniences such as interference with the metal wire 31 of the non-plated portion 35 or irregularities on the outer periphery of one end of the guide wire 10 when the guide wire is shaped.
  • the metal wire 31 of the non-plating part 35 is coat
  • the plated portion 33 is formed for one turn of the metal wire 31, and the plated portion 33 is formed for two turns of the metal wire 31 at the intermediate portion. This is for convenience, and the plated portion 33 may be formed on the metal wire 31 having a larger number of turns (for example, five turns of the metal wire 31).
  • a resin layer 50 is coated on the outer periphery of the coil spring 30 and the outer periphery of the core wire 20.
  • the resin layer 50 is also filled in the coil spring 30 so that the core wire 20, the coil spring 30, and the soldered portion 40 are embedded in the resin layer (see FIGS. 1 and 2). ).
  • the resin layer 50 only needs to be covered by at least a portion where the coil spring 30 at the tip of the core wire 20 is attached, and does not necessarily have to be covered by the entire core wire 20.
  • the resin layer 50 is made of, for example, polyurethane, nylon elastomer, polyether block amide, polyethylene, polyvinyl chloride, vinyl acetate, polytetrafluoroethylene (PTFE), perfluoroalkoxy resin (PFA), ethylene tetrafluoride-6 Fluorine-based resins such as fluorinated propylene copolymer (FEP) and tetrafluoroethylene-ethylene copolymer (ETFE) can be used.
  • PTFE polytetrafluoroethylene
  • PFA perfluoroalkoxy resin
  • FEP fluorinated propylene copolymer
  • ETFE tetrafluoroethylene-ethylene copolymer
  • the outer periphery of the resin layer 50 may be covered with a resin film 52 made of a hydrophilic resin such as polyvinyl pyrrolidone, polyethylene glycol, or methyl vinyl ether maleic anhydride copolymer.
  • a resin film 52 made of a hydrophilic resin such as polyvinyl pyrrolidone, polyethylene glycol, or methyl vinyl ether maleic anhydride copolymer.
  • a coil spring 30 made of a metal wire 31 having X-ray opacity and poor bonding to solder is formed, and the coil spring 30 is attached to both ends and a plurality of intermediate portions with respect to solder.
  • the plating is removed from the metal wire 31 at a predetermined position of the coil spring 30 by a plating removing means such as laser light irradiation, so that the coil spring 30 is plated. 33 and the non-plating part 35 are formed.
  • the coil spring 30 is disposed on the outer periphery of the one end portion 23 having a reduced diameter of the core wire 20, and the tip end of the coil spring 30 and the tip end portion of the one end portion 23 of the core wire 20 are aligned.
  • the plated portion 33 at the tip of 30 is soldered to the tip of the core wire 20, and the coil spring 30 is temporarily fixed to the core wire 20.
  • the core wire 20 and the coil spring 30 temporarily fixed to the core wire 20 are immersed in a solder bath filled with molten solder liquid. Then, as shown in FIG. 4, the solder does not adhere to the non-plated portion 35 of the coil spring 30 but adheres to each of the plurality of plated portions 33 and fills between the inner periphery of the coil spring 30 and the outer periphery of the core wire 20.
  • a plurality of soldering portions 40 are formed so as to cover the outer periphery of each plating portion 33, and the coil spring 30 is attached to the outer periphery of the one end portion 23 of the core wire 20 via these soldering portions 40.
  • the coil spring 30 by providing the coil spring 30 with the plated portion 33 and the non-plated portion 35, it is possible to make it easier to attach solder only to the plated portion 33, and the position and length of the soldered portion 40.
  • L2 (see FIG. 2) can be formed with high accuracy, and variations in products can be reduced.
  • the solder in the method of immersing the coil spring 30 in the solder liquid, the solder can be smoothly attached to the plurality of plating portions 33, and the solder attaching operation can be performed efficiently.
  • each soldering portion 40 is shaved with a grinding tool such as a file, a router, a grinder, etc.
  • a smooth surface 41 is formed (see FIG. 5).
  • the outer periphery of the core wire 20 and the outer periphery of the coil spring 30 are covered with molten resin by pultrusion molding or extrusion molding.
  • the melted resin is applied to the outer periphery of the core wire 20 and, as shown by the arrows in the partially enlarged view of FIG. 5, from the outer periphery of the coil spring 30 between the metal wires 31 and 31 in each non-plated portion 35. From the gap C1 or the gap between the metal wire 31 of the non-plated portion 35 and the plated portion 33, it flows into the coil spring 30 and is filled between the inner periphery of the coil spring 30 and the outer periphery of the core wire 20, and the resin layer 50 is filled. It is formed.
  • the wire diameter R2 of the metal wire 31 of the coil spring 30 is 1 to 20% larger than the wire diameter R1 of the non-plated portion 35, and the non-plated portion 35 is formed.
  • the metal wire 31 is not cut and is disposed while the original circular shape is maintained, so that the gap C1 between the metal wires 31, 31 and the metal wire 31 of the non-plated portion 35 and the plating are provided.
  • the molten resin can smoothly flow in the gap with the portion 33, and as a result, the molten resin can be efficiently filled into the coil spring 30 and the variation of the product can be reduced.
  • the coil spring 30 is formed by the elliptical metal wire 31a shown in FIG. 6A and the metal wire 31d having both ends shown in FIG. The same effect as above can be obtained.
  • the coil spring 30 is filled with a resin made of an adhesive, and a shrinkable resin tube is placed on the outer periphery of the coil spring 30, and the resin tube is contracted.
  • a method of attaching to the coil spring 30 can also be adopted.
  • a shrinkable tube for example, a tube that is swollen with a solvent and shrinks when dried, a tube that thermally shrinks by heat treatment, or the like can be used.
  • the guide wire 10 as shown in FIGS. 1 and 2 can be manufactured by covering the outer periphery of the resin layer 50 with a resin film 52 such as a hydrophilic resin.
  • the smooth surface 41 is formed on the entire outer periphery of the plurality of soldering portions 40.
  • the protruding state is obtained without scraping the outer periphery of the plurality of soldering portions 40 on the proximal end side of the coil spring 30.
  • the resin layer 50 may be covered on the outer periphery of the core wire 20 and the coil spring 30 in that state. In this case, since the protruding portion of the outer periphery of the soldering portion 40 functions as an anchor ring and bites deeply into the resin layer 50, the resin layer 50 is difficult to shift.
  • the end portion to which the coil spring 30 is attached can be shaped into a predetermined shape in advance so that the guide wire 10 can be inserted into a target portion of the tubular organ.
  • the shaping member such as a rod-shaped shaping mandrel is shaped into a predetermined shape by pressing the shaping member while pressing the shaping member such as a rod-shaped shaping mandrel against the end of the guide wire 10 to which the coil spring 30 is attached.
  • both end portions and a plurality of intermediate portions of the coil spring 30 are soldered to the core wire 20 through the soldering portion 40 at a predetermined interval, and the inside of the coil spring 30. Since the resin layer 50 is filled in portions other than the soldering portion 40, the coil spring 30 is less likely to be displaced with respect to the core wire 20.
  • the shaping member as described above, when the end portion of the guide wire 10 is squeezed and shaped, the metal wire 31 of the coil spring 30 is prevented from opening or clogging, Since the metal wires 31 are prevented from interfering with each other and climbing up, the shaped part does not bend three-dimensionally in an unintended direction.
  • an intended shape such as a J shape or a U shape It becomes easy to bend.
  • a predetermined shape such as a J-shape or U-shape with a shaping mandrel or the like, even if the shaping mandrel or the like is separated from the end of the guide wire 10, it may be twisted or distorted.
  • the tip of the guide wire 10 can be easily shaped without being deformed into an unintended shape.
  • the guide wire 10 shaped in a predetermined bending shape as described above is inserted into a tubular organ (not shown) through the skin via a puncture needle, a sheath-like sheath or the like. Then, the guide wire 10 is inserted by selecting the target route at the branch portion where the tubular organ branches, but in order to reach the target location, it must pass through a plurality of branch portions. In many cases, the insertion direction changes depending on each branch portion, and the shape of the distal end portion of the guide wire that is easy to insert also differs.
  • the catheter is advanced to the vicinity of the distal end of the guide wire, and then the guide wire is once extracted from the catheter, and the distal end is re-shaped to be easily inserted into the next branch.
  • the operation of shaping and reinserting the catheter is repeated a plurality of times.
  • the guide wire 10 is pulled out from the tubular organ, returned to the original straight shape before shaping, and then shaped again into another bent shape using a shaping mandrel or the like.
  • the resin layer 50 filled in a portion other than the soldering portion 40 inside the coil spring 30 prevents the metal wire 31 of the coil spring 30 from interfering with and climbing up. Since the guide wire 10 is held in a shaped state, when the end portion of the guide wire 10 is returned to the original shape, the guide wire 10 can be smoothly returned to the original shape. Shaping can also be performed easily.
  • the resin layer 50 is filled up to the inside of the coil spring 30 and the tip end portion of the core wire 20 and the coil spring 30 are embedded in the resin layer 50, durability when repeatedly forming is provided. Can be increased.
  • the total length L2 of the plurality of soldering portions 40 of the coil spring 30 along the axial direction is 20 to 85% with respect to the total length L1 of the coil spring 30.
  • the shapeability at the one end of 10, the shape maintenance property, and the durability when repeatedly shaping can be further enhanced.
  • each soldering portion 40 of the coil spring 30 forms a smooth surface 41
  • the end portion of the guide wire 10 is crushed with a shaping member such as a rod-shaped shaping mandrel.
  • a shaping member such as a rod-shaped shaping mandrel.
  • each soldering portion 40 of the coil spring 30 is set to 0.1 to 1.0 mm, and adjacent soldering portions are arranged. Since the gap C2 between 40 and 40 is 0.1 to 1.0 mm, the attachment portions 40 and 40 are likely to interfere with each other. The durability when repeatedly forming can be further enhanced.
  • FIG. 7 shows another embodiment of the guide wire of the present invention. Note that substantially the same parts as those of the above-described embodiment are denoted by the same reference numerals, and description thereof is omitted.
  • the guide wire 10a in this embodiment has a shape in which both ends of the core wire 20 are reduced in diameter, and has coil springs 30 and 30 attached to both ends of the reduced diameter.
  • both end portions thereof can be pre-shaped into a predetermined bent shape.
  • one end of the guide wire 10a is shaped into a shape suitable for a certain branched portion, for example, a J-shape, and the other end is shaped into a shape suitable for the next branched portion, for example, a U-shape.
  • FIG. 8 shows still another embodiment of the guide wire of the present invention. Note that substantially the same parts as those of the above-described embodiment are denoted by the same reference numerals, and description thereof is omitted.
  • the guide wire 10b in this embodiment is covered with the first resin layer 50a from the proximal end of the core wire 20 to the middle of the tapered portion 25, and the remaining portion of the core wire 20 and the outer periphery of the coil spring 30 are A second resin layer 50 b made of a material different from that of the first resin layer 50 a is covered, and the second resin layer 50 b has a structure in which the coil spring 30 is filled.
  • the outer periphery of the first resin layer 50a and the second resin layer 50b is covered with a resin film 52 made of a hydrophilic resin or the like.
  • the first resin layer 50a is formed of a relatively hard resin to increase torque transmission
  • the second resin layer 50b is formed of a relatively soft resin to increase flexibility. It is possible to select a guide wire 10b that is easy to use.
  • Example preparation The guide wires of Examples 1 to 18 having the same structure as the embodiment shown in FIGS. 1 to 5 were manufactured.
  • a core wire was made of a Ni—Ti alloy, and a coil wire 30 was made by winding a metal wire 31 made of a W alloy.
  • the wire diameter R1 of the metal wire 31 is 0.045 mm, the total length of the coil spring 30 is 50 mm, and the outer diameter D of the coil spring 30 is 0.22 mm.
  • the Ni-plating is applied to the coil spring 30 as a base, and the Au-based plating is performed on the plating, and then the plating is removed by irradiating a predetermined portion with a laser beam, so that the plated portion 33 and the non-plated portion 35 are formed.
  • the plated portion 33 was soldered, and the coil spring 30 was attached to the core wire 20 via the soldered portion 40.
  • the ratio of the soldered portion and the ratio of the resin layer to the total length of the coil spring in each example is as shown in Table 1 below.
  • the outer periphery of the core wire 20 and the coil spring 30 was covered with a resin layer 50 made of polyurethane, and the resin layer 50 was filled inside the coil spring.
  • Comparative Example 1 was produced under the same conditions as in Examples 1 to 18 except that the non-plated part 35 was not produced and the ratio of the soldered part to the total length of the coil spring was 100%.
  • each guide wire is inserted and pushed into the microcatheter 60 in which the lumen is filled with physiological saline at 37 ° C. (see FIG. 9B). It protruded from the front-end
  • tip part of the microcatheter 60 (refer FIG.9 (c)), Then, each guide wire was pulled back and extracted from the microcatheter 60 (refer FIG.9 (d)). At that time, an angle ⁇ (see FIG. 9D) of the shaped part of the guide wire with respect to the axis of the guide wire is measured, and based on this angle ⁇ , the shape maintenance ratio (%) is obtained by the following equation (i). Was calculated. Table 1 shows the average of 10 guide wires of Examples 1 to 18 and Comparative Example 1. Shape maintenance ratio (%) angle after test ⁇ / 90 ⁇ 100 (i) In addition, it can be evaluated that the higher the shape maintenance ratio is, the more the shape at the time of shaping of the guide wire end portion is maintained and the better the shape maintenance property.
  • the deformation amount T (mm) of the shaped part of the guide wire in the direction perpendicular to the axis was measured (see FIG. 9D).
  • the amount of deformation T represents the amount of three-dimensional torsional deformation of the guide wire, and the larger the amount of deformation T, the more difficult it is to bend the guide wire into the intended shape.
  • Table 1 shows the average of 10 guide wires of Examples 1 to 18 and Comparative Example 1.
  • the guide wire of Comparative Example 1 has good shapeability, but the shape retention rate is extremely low.
  • the guide wire of the example has a shape retention rate and a deformation amount T after shaping. Both of them are good, and a guide wire with good shape maintenance and shapeability can be obtained.
  • the shape maintainability and shapeability of the guide wires (Examples 3 to 16) having a soldered portion ratio of 20 to 85% with respect to the total length of the coil spring were good.

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PCT/JP2013/051037 2012-02-01 2013-01-21 Fil-guide Ceased WO2013114985A1 (fr)

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Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015048750A3 (fr) * 2013-09-30 2015-07-16 Abbott Cardiovascular Systems, Inc. Cœur de fil-guide possédant une ductilité en torsion améliorée
CN105268084A (zh) * 2015-11-10 2016-01-27 深圳麦普奇医疗科技有限公司 应用于临床血管内的介入治疗用导引导丝及其制作方法
CN105268085A (zh) * 2015-11-10 2016-01-27 深圳麦普奇医疗科技有限公司 一种微创介入用亲水微导丝及其制备方法
US10335580B2 (en) 2013-09-30 2019-07-02 Abbott Cardiovascular Systems Inc. Guidewire with varying properties
CN113084341A (zh) * 2019-12-19 2021-07-09 先健科技(深圳)有限公司 导丝、焊接装置及焊接方法
EP3789072A4 (fr) * 2018-05-01 2021-12-22 Asahi Intecc Co., Ltd. Fil-guide
WO2022185813A1 (fr) * 2021-03-03 2022-09-09 朝日インテック株式会社 Fil-guide
CN115175723A (zh) * 2020-03-11 2022-10-11 朝日英达科株式会社 导丝
JP2023020157A (ja) * 2021-07-30 2023-02-09 朝日インテック株式会社 サポートデバイス
US11684759B2 (en) 2020-01-22 2023-06-27 Abbott Cardiovascular Systems Inc. Guidewire having varying diameters and method of making
WO2023175087A1 (fr) * 2022-03-16 2023-09-21 Boston Scientific Medical Device Limited Fil-guide ayant des parties à rigidité réduite
EP4091659A4 (fr) * 2020-01-17 2024-03-06 Asahi Intecc Co., Ltd. Fil-guide

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JP6866493B2 (ja) * 2017-09-30 2021-04-28 朝日インテック株式会社 ガイドワイヤ

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WO2010134364A1 (fr) * 2009-05-20 2010-11-25 日本ライフライン株式会社 Fil guide médical
JP2011143077A (ja) * 2010-01-15 2011-07-28 Piolax Medical Device:Kk ガイドワイヤ

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JP2002210552A (ja) * 2001-01-15 2002-07-30 Senju Metal Ind Co Ltd 部分はんだ付着金属片の製造方法
US7553287B2 (en) * 2003-10-30 2009-06-30 Boston Scientific Scimed, Inc. Guidewire having an embedded matrix polymer
JP2006149804A (ja) * 2004-11-30 2006-06-15 Japan Lifeline Co Ltd 医療用ガイドワイヤ
JP3694312B1 (ja) * 2005-01-26 2005-09-14 朝日インテック株式会社 医療用ガイドワイヤ
JP4308782B2 (ja) * 2005-01-27 2009-08-05 株式会社エフエムディ 医療用ガイドワイヤ及びその製造方法。
JP5578704B2 (ja) * 2010-03-09 2014-08-27 Ｓｈマテリアル株式会社 半導体素子搭載用基板及びその製造方法

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JPH07505561A (ja) * 1993-05-11 1995-06-22 ターゲット　セラピューティクス，インコーポレイテッド 超弾性合金ガイドワイヤ
JP2005253809A (ja) * 2004-03-15 2005-09-22 Asahi Intecc Co Ltd 医療用ガイドワイヤ
WO2010134364A1 (fr) * 2009-05-20 2010-11-25 日本ライフライン株式会社 Fil guide médical
JP2011143077A (ja) * 2010-01-15 2011-07-28 Piolax Medical Device:Kk ガイドワイヤ

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015048750A3 (fr) * 2013-09-30 2015-07-16 Abbott Cardiovascular Systems, Inc. Cœur de fil-guide possédant une ductilité en torsion améliorée
US10335580B2 (en) 2013-09-30 2019-07-02 Abbott Cardiovascular Systems Inc. Guidewire with varying properties
CN105268084A (zh) * 2015-11-10 2016-01-27 深圳麦普奇医疗科技有限公司 应用于临床血管内的介入治疗用导引导丝及其制作方法
CN105268085A (zh) * 2015-11-10 2016-01-27 深圳麦普奇医疗科技有限公司 一种微创介入用亲水微导丝及其制备方法
EP3789072A4 (fr) * 2018-05-01 2021-12-22 Asahi Intecc Co., Ltd. Fil-guide
CN113084341A (zh) * 2019-12-19 2021-07-09 先健科技(深圳)有限公司 导丝、焊接装置及焊接方法
EP4091659A4 (fr) * 2020-01-17 2024-03-06 Asahi Intecc Co., Ltd. Fil-guide
US11684759B2 (en) 2020-01-22 2023-06-27 Abbott Cardiovascular Systems Inc. Guidewire having varying diameters and method of making
CN115175723A (zh) * 2020-03-11 2022-10-11 朝日英达科株式会社 导丝
EP4119182A4 (fr) * 2020-03-11 2024-04-24 Asahi Intecc Co., Ltd. Fil-guide
WO2022185813A1 (fr) * 2021-03-03 2022-09-09 朝日インテック株式会社 Fil-guide
JP2023020157A (ja) * 2021-07-30 2023-02-09 朝日インテック株式会社 サポートデバイス
JP7742732B2 (ja) 2021-07-30 2025-09-22 朝日インテック株式会社 サポートデバイス
WO2023175087A1 (fr) * 2022-03-16 2023-09-21 Boston Scientific Medical Device Limited Fil-guide ayant des parties à rigidité réduite
JP2025508191A (ja) * 2022-03-16 2025-03-21 ボストン サイエンティフィック メディカル デバイス リミテッド 剛性が低減された部分を備えるガイドワイヤ

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